10-Q - TAOX - Equibles

Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
	For the quarterly period ended June 30, 2022

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

	For the transition period from __________________ to __________________

Commission File Number: 001-40458

SYNAPTOGENIX, INC.

(Exact name of registrant as specified in its charter)

Delaware	46-1585656
(State or other jurisdiction of incorporation or	(I.R.S. Employer
organization)	Identification No.)
1185 Avenue of the Americas , 3rd Floor
New York , New York ****	10036
(Address of principal executive offices)	(Zip code)

( 973 ) 242-0005

(Registrant’s telephone number, including area code)

(Former name, former address and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered

Common Stock, $0.0001 par value per share	SNPX	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act) Yes ☐ No ☒

As of August 5, 2022, there were 6,840,629 shares of the registrant’s common stock, $0.0001 par value per share, issued and outstanding.

Table of Contents CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION

Certain statements in this report contain or may contain forward-looking statements. These statements, identified by words such as “plan,” “anticipate,” “believe,” “estimate,” “should,” “expect” and similar expressions, include our expectations and objectives regarding our future financial position, operating results and business strategy. These statements are subject to known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. These forward-looking statements were based on various factors and were derived utilizing numerous assumptions and other factors that could cause our actual results to differ materially from those in the forward-looking statements. These factors include, but are not limited to, the significant length of time associated with drug development and related insufficient cash flows and resulting illiquidity, our patent portfolio, our inability to expand our business, significant government regulation of pharmaceuticals and the healthcare industry, lack of product diversification, availability of our raw materials, existing or increased competition, stock volatility and illiquidity, and our failure to implement our business plans or strategies. Most of these factors are difficult to predict accurately and are generally beyond our control. You should consider the areas of risk described in connection with any forward-looking statements that may be made herein. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. You should carefully review this report in its entirety, including but not limited to our financial statements and the notes thereto and the risks described in Annual Report on Form 10-K for the fiscal year ended December 31, 2021, filed with the Securities and Exchange Commission (the “SEC”) on March 29, 2022. We advise you to carefully review the reports and documents we file from time to time with the SEC including our current reports on Form 8-K. Except for our ongoing obligations to disclose material information under securities laws, we undertake no obligation to publicly release any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

Table of Contents TABLE OF CONTENTS

	Page
Part I – FINANCIAL INFORMATION	3
Item 1. Financial Statements (Unaudited)	3
Condensed Balance Sheets as of June 30, 2022 and December 31, 2021	3
Condensed Statements of Operations for the three and six months ended June 30, 2022 and 2021	4
Condensed Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2022 and 2021	5
Condensed Statements of Cash Flows for the six months ended June 30, 2022 and 2021	7
Notes to Condensed Financial Statements	8
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	21
Item 3. Quantitative and Qualitative Disclosures about Market Risk	28
Item 4. Controls and Procedures	29
Part II – OTHER INFORMATION	30
Item 1. Legal Proceedings	30
Item 1A. Risk Factors	30
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	30
Item 3. Defaults upon Senior Securities	30
Item 4. Mine Safety Disclosures	30
Item 5. Other Information	30
Item 6. Exhibits	31
Signatures	32

Table of Contents PART I

FINANCIAL INFORMATION

Item 1. Financial Statements.

Synaptogenix, Inc.

Condensed Balance Sheets

(Unaudited)


	June 30,		December 31,
	2022		2021
ASSETS

CURRENT ASSETS
Cash and cash equivalents	$	28,754,621	$	34,213,989
Prepaid Clinical trial expenses		280,820		410,357
Prepaid expenses and other current assets		523,034		879,869

TOTAL CURRENT ASSETS		29,558,475		35,504,215

Fixed assets, net of accumulated depreciation		20,777		20,445

TOTAL ASSETS	$	29,579,252	$	35,524,660


LIABILITIES AND SHAREHOLDERS’ EQUITY

CURRENT LIABILITIES
Accounts payable	$	280,865	$	1,296,506
Accrued expenses		345,114		698,406

TOTAL CURRENT LIABILITIES		625,979		1,994,912

Commitments and contingencies

SHAREHOLDERS’ EQUITY
Preferred stock - 1,000,000 shares authorized as of June 30, 2022, $0.0001 par value; 0 shares issued and outstanding as of June 30, 2022 and December 31, 2021		—		—
Common stock - 150,000,000 shares authorized as of March 31, 2022, $0.0001 par value; 6,810,326 shares issued and outstanding as of June 30, 2022 and 6,730,180 shares issued and outstanding as of December 31, 2021.		682		674
Additional paid-in capital		50,124,087		47,670,744
Accumulated deficit		(21,171,496)		(14,141,670)

TOTAL SHAREHOLDERS’ EQUITY		28,953,273		33,529,748

TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY	$	29,579,252	$	35,524,660

See accompanying notes to condensed financial statements.

Table of Contents Synaptogenix, Inc.

Condensed Statements of Operations

(Unaudited)


	****	Three Months Ended		****	Three Months Ended		****	Six Months Ended		****	Six Months Ended
		June 30,			June 30,			June 30,			June 30,
		2022			2021			2022			2021
OPERATING EXPENSES:
Research and development		$	1,941,101		$	986,280		$	3,427,175		$	2,138,060
General and administrative			1,855,290			1,308,893			3,651,748			3,312,306

TOTAL OPERATING EXPENSES			3,796,391			2,295,173			7,078,923			5,450,366

OTHER INCOME (EXPENSE):
Interest income			44,487			1,331			49,097			2,147

Net loss before income taxes			3,751,904			2,293,842			7,029,826			5,448,219

Provision for income taxes			—			—			—			—

Net loss attributable to common shareholders		$	3,751,904		$	2,293,842		$	7,029,826		$	5,448,219

PER SHARE DATA:

Basic and diluted loss per common share		$	0.54		$	0.58		$	1.01		$	1.53

Basic and diluted weighted average common shares outstanding			6,959,400			3,971,200			6,949,400			3,551,600

See accompanying notes to condensed financial statements.

Table of Contents Synaptogenix, Inc.

Condensed Statements of Changes in Stockholders’ Equity

(Unaudited)


	****	Three Months Ended June 30, 2021
													Additional
		Common Stock					Preferred Stock						Paid-In			Accumulated
	****	Shares	****	Amount		****	Shares		****	Amount		****	Capital		****	Deficit		****	Total

Balance April 1, 2021		3,508,129		$	351		$	—		$	—		$	20,093,707		$	(4,684,850)		$	15,409,208

Reverse stock split rounding		(345)			—			—			—			(1,529)			—			(1,529)

Stock based compensation		—			—			—			—			151,552			—			151,552

Issuance of warrants for consulting fees		—			—			—			—			52,681			—			52,681

Issuance of common stock for consulting fees		2,590			—			—			—			18,156			—			18,156

Private placement of common stock and warrants		1,587,030			159			—			—			11,271,335			—			11,271,494

Exercise of common stock warrants		941,394			94			—			—			7,582,182			—			7,582,276

Net loss		—			—			—			—			—			(2,293,842)			(2,293,842)

Balance June 30, 2021		6,038,798		$	604		$	—		$	—		$	39,168,084		$	(6,978,692)		$	32,189,996


	Six Months Ended June 30, 2021
								Additional
	Common Stock				Preferred Stock			Paid-In		Accumulated
	Shares	Amount			Shares	Amount		Capital		Deficit		Total

Balance January 1, 2021	1,257,579	$	126		—	$	—	$	6,668,859	$	(1,530,473)	$	5,138,512

Reverse stock split rounding	(345)		—		—		—		(1,529)		—		(1,529)

Stock based compensation	—		—		—		—		719,791		—		719,791

Issuance of warrants for consulting fees	—		—		—		—		396,848		—		396,848

Issuance of common stock for consulting fees	2,590		—		—		—		18,156				18,156

Private placement of common stock and warrants	3,837,580		384		—		—		23,783,777		—		23,784,161

Exercise of common stock warrants	941,394		94		—		—		7,582,182		—		7,582,276

Net loss	—		—		—		—		—		(5,448,219)		(5,448,219)

Balance June 30, 2021	6,038,798	$	604	$	—	$	—	$	39,168,084	$	(6,978,692)	$	32,189,996

Table of Contents


	****	Three Months Ended June 30, 2022
								Additional
		Common Stock			Preferred Stock			Paid-In		Accumulated
		Shares	Amount		Shares	Amount		Capital		Deficit		Total

Balance April 1, 2022		6,809,647	$	682	—	$	—	$	49,102,898	$	(17,419,592)	$	31,683,988

Stock based compensation		—		—	—		—		1,016,690		—		1,016,690

Issuance of warrants for consulting fees		—		—	—		—		—		—		—

Issuance of common stock for consulting fees		679		—	—		—		4,499		—		4,499

Exercise of common stock warrants		—		—	—		—		—		—		—

Net loss		—		—	—		—		—		(3,751,904)		(3,751,904)

Balance June 30, 2022		6,810,326	$	682	—	$	—	$	50,124,087	$	(21,171,496)	$	28,953,273


	Six Months Ended June 30, 2022
							Additional
	Common Stock			Preferred Stock			Paid-In		Accumulated
	Shares	Amount		Shares	Amount		Capital		Deficit		Total

Balance January 1, 2022	6,730,180	$	674	—	$	—	$	47,670,744	$	(14,141,670)	$	33,529,748

Stock based compensation	—		—	—		—		1,728,248		—		1,728,248

Issuance of warrants for consulting fees	—		—	—		—		71,603		—		71,603

Issuance of common stock for consulting fees	15,146		1	—		—		100,349		—		100,350

Exercise of common stock warrants	65,000		7	—		—		553,143		—		553,150

Net loss	—		—	—		—		—		(7,029,826)		(7,029,826)

Balance June 30, 2022	6,810,326	$	682	—	$	—	$	50,124,087	$	(21,171,496)	$	28,953,273

See accompanying notes to condensed financial statements.

Table of Contents Synaptogenix, Inc.

Condensed Statements of Cash Flows

(Unaudited)


	****	Six Months Ended		****	Six Months Ended
		June 30, 2022			June 30, 2021
CASH FLOW USED IN OPERATING ACTIVITIES
Net loss		$	(7,029,826)		$	(5,448,219)
Adjustments to reconcile net loss to net cash used by operating activities
Stock based compensation			1,728,248			719,791
Consulting services paid by issuance of common stock			100,349			18,156
Consulting services paid by issuance of common stock warrants			71,603			396,848
Depreciation expense			2,697			2,487
Change in assets and liabilities
Decrease (Increase) in prepaid expenses			486,372			(431,869)
(Increase) in accounts payable			(1,015,640)			(612,171)
(Increase) in accrued expenses			(353,292)			(230,345)
Total adjustments			1,020,337			(137,103)

Net Cash Used in Operating Activities			(6,009,489)			(5,585,322)

CASH FLOWS USED IN INVESTING ACTIVITIES
Purchase of fixed assets			(3,029)			—

Net Cash Used in Investing Activities			(3,029)			—

CASH FLOWS FROM FINANCING ACTIVITIES
Private placements of common stock and warrants			—			23,784,161
Proceeds from exercise of investor warrants			553,150			7,582,276
Grant funding received			—			127,445
Cash in lieu of shares for reverse stock split			—			(1,529)

Net Cash Provided by Financing Activities			553,150			31,492,353

NET (DECREASE) INCREASE IN CASH AND EQUIVALENTS			(5,459,368)			25,907,031

CASH AND EQUIVALENTS AT BEGINNING OF PERIOD			34,213,989			5,795,055

CASH AND EQUIVALENTS AT END OF PERIOD		$	28,754,621		$	31,702,086

See accompanying notes to condensed financial statements.

Table of Contents SYNAPTOGENIX, INC.

NOTES TO FINANCIAL STATEMENTS

(UNAUDITED)

Unless the context otherwise indicates, references in these Notes to the accompanying financial statements to “we,” “us,” “our” and “the Company” refer to Synaptogenix, Inc. (formerly known as Neurotrope Bioscience, Inc.), a Delaware corporation. References to “Neurotrope”, “Parent Company” or “Parent” refer to Neurotrope, Inc., a Nevada corporation. Unless otherwise noted, all share and per share data give effect to the 1-for-4 reverse stock split of our common stock that was effected on May 19, 2021.

Note 1 – Organization, Business, Risks and Uncertainties:

Organization and Business

On May 17, 2020, Neurotrope, Inc. (“Neurotrope” or “the Parent”) announced plans for the complete legal and structural separation of its wholly owned subsidiary, Neurotrope Bioscience, Inc., from Neurotrope (the “Spin-Off”). Under the Separation and Distribution Agreement, Neurotrope planned to distribute all of its equity interest in this wholly owned subsidiary to Neurotrope’s stockholders. Following the Spin-Off, Neurotrope does not own any equity interest in the Company, and the Company operates independently from Neurotrope. On December 7, 2020, the Company became an independent company, Synaptogenix, Inc., a Delaware corporation (formerly known as Neurotrope Bioscience, Inc.) (the “Company” or “Synaptogenix”) when the Company filed an amended and restated certificate of incorporation which, among other things, changed its name to Synaptogenix, Inc. The Company’s shares of common stock, par value $0.0001 per share (the “Common Stock”), are listed on The Nasdaq Capital Market under the symbol “SNPX.”

Neurotrope Bioscience, Inc. was incorporated in Delaware on October 31, 2012 to advance new therapeutic and diagnostic technologies in the field of neurodegenerative disease, primarily Alzheimer’s disease (“AD”). The Company is collaborating with Cognitive Research Enterprises, Inc. (formerly known as the Blanchette Rockefeller Neurosciences Institute, or BRNI) (“CRE”), a related party, in this process. The exclusive rights to certain technology were licensed by CRE to the Company on February 28, 2013 (see Note 4 - Related Party Transactions and Licensing / Research Agreements).

In connection with the separation from Neurotrope, we entered into a Separation and Distribution Agreement and several other ancillary agreements. These agreements govern the relationship between the parties after the separation and allocate between the parties’ various assets, liabilities, rights and obligations following the separation, including employee benefits, intellectual property, information technology, insurance and tax-related liabilities.

Liquidity Uncertainties

As of June 30, 2022, the Company had approximately $28.8 million in cash and cash equivalents as compared to $34.2 million at December 31, 2021. The Company expects that its current cash and cash equivalents, approximately $27.4 million as of the date of this quarterly report, will be sufficient to support its projected operating requirements for at least the next 12 months from this date. The operating requirements include the current development plans for Bryostatin-1, our novel drug candidate targeting the activation of Protein Kinase C Epsilon and other development projects.

The Company expects to need additional capital in order to initiate and pursue potential additional development projects, including the continuing development beyond the ongoing Phase 2 trial of Bryostatin-1. Any additional equity financing, if available, may not be on favorable terms and would likely be significantly dilutive to the Company’s current stockholders, and debt financing, if available, may involve restrictive covenants. If the Company is able to access funds through collaborative or licensing arrangements, it may be required to relinquish rights to some of its technologies or product candidates that the Company would otherwise seek to develop or commercialize on its own, on terms that are not favorable to the Company. The Company’s ability to access capital when needed is not assured and, if not achieved on a timely basis, will likely have a materially adverse effect on our business, financial condition and results of operations. 8

Table of Contents

Other Risks and Uncertainties

The Company operates in an industry that is subject to rapid technological change, intense competition, and significant government regulation. The Company’s operations are subject to significant risk and uncertainties including financial, operational, technological and regulatory. Such factors include, but are not necessarily limited to, the results of clinical testing and trial activities, the ability to obtain regulatory approval, the limited supply of raw materials, the ability to obtain favorable licensing, manufacturing or other agreements, including risk associated with our CRE licensing agreement, and the ability to raise capital to achieve strategic objectives.

CRE has entered into a material transfer agreement with the National Cancer Institute of the National Institutes of Health (“NCI”), pursuant to which the NCI has agreed to supply bryostatin required for the Company’s pre-clinical research and clinical trials. This agreement does not provide for a sufficient amount of bryostatin to support the completion of all of the clinical trials that the Company is required to conduct in order to seek U.S. Food and Drug Administration (“FDA”) approval. Therefore, CRE or the Company would have to enter into one or more subsequent agreements with the NCI for the supply of additional amounts of bryostatin. If CRE or the Company were unable to secure such additional agreements, or if the NCI otherwise discontinues the supply, the Company would have to either secure another source of bryostatin or discontinue its efforts to develop and commercialize Bryostatin-1 for the treatment of AD. In June 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to be the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company received its initial order of one gram synthetic bryostatin. See Note 3.

The Company also faces the ongoing risk that the coronavirus pandemic may slow, for an unforeseeable period, the conduct of the Company’s trial. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our current Phase 2 clinical trial. In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services. These and other factors outside of our control could delay our ability to conduct clinical trials or release clinical trial results. In addition, the effects of a pandemic resurgence may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and suppliers.

Note 2 – Summary of Significant Accounting Policies:

Basis of Presentation:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial reporting and with the instructions to Form 10-Q and Article 10 of Regulation S-X. In the opinion of management, the unaudited condensed financial statements included herein contain all adjustments necessary to present fairly the Company’s financial position and the results of its operations and cash flows for the interim periods presented. Such adjustments are of a normal recurring nature. The results of operations for the six months ended June 30, 2022 may not be indicative of results for the full year. These unaudited condensed financial statements should be read in conjunction with the audited condensed financial statements and the notes to those statements for the year ended December 31, 2021 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 29, 2022.

Use of Estimates:

The preparation of financial statements in conformity with GAAP requires management to make significant estimates that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Management evaluates its estimates on an ongoing basis using historical experience and other factors, including the general economic environment and actions it may take in the future. The Company adjusts such estimates when facts and circumstances dictate. However, these estimates may involve significant uncertainties and judgments and cannot be determined with precision. In addition, these estimates are based on management’s best judgment at a point in time and as such these estimates may ultimately differ from actual results.

Table of Contents Cash and Cash Equivalents and Concentration of Credit Risk:

The Company considers all highly liquid cash investments with an original maturity of three months or less when purchased to be cash equivalents. At June 30, 2022, the Company’s cash balances that exceed the current insured amounts under the Federal Deposit Insurance Corporation (“FDIC”) were approximately $1.0 million. In addition, approximately $27.6 million included in cash and cash equivalents were invested in a money market fund, which is not insured under the FDIC.

Fixed Assets:

Fixed assets are stated at cost less accumulated depreciation. Depreciation is computed on a straight line basis over the estimated useful life of the asset, which is deemed to be between three and ten years.

Research and Development Costs:

All research and development costs, including costs to maintain or expand the Company’s patent portfolio licensed from CRE are expensed when incurred. Non-refundable advance payments for research and development are capitalized because the right to receive those services represents an economic benefit. Such capitalized advances will be expensed when the services occur and the economic benefit is realized. There were no capitalized research and development services, other than non-refundable advance payments as mentioned below for Worldwide Clinical Trials, at June 30, 2022 and December 31, 2021.

Income Taxes:

The Company accounts for income taxes using the asset and liability approach which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amount of assets and liabilities for financial reporting purposes and amounts reportable for income tax purposes under the “Separate return method.” Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more-likely-than-not that some portion or all of the deferred tax assets will not be realized.

The Company applies the provisions for accounting for uncertainty in income taxes recognized in an enterprise’s financial statements and prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. The Company has determined that there are no significant uncertain tax positions requiring recognition in the accompanying financial statements. The tax period that is subject to examination by major tax jurisdictions is generally three years from the date of filing.

The Company had federal and state net operating loss carryforwards for income tax purposes of approximately $84.4 million for the period from October 31, 2012 (inception) through June 30, 2022. The net operating loss carryforwards resulted in a deferred tax asset of approximately $17.7 million at June 30, 2022. Income tax effects of share-based payments are recognized in the financial statements for those awards that will normally result in tax deductions under existing tax law. The deferred tax asset is offset by a full valuation allowance.

The Company may be subject to significant U.S. federal income tax-related liabilities with respect to the Spin-Off if there is a determination that the Spin-Off is taxable for U.S. federal income tax purposes. In connection with the Spin-Off, the Company believes that, among other things, the Spin-Off should qualify as a tax-free transaction for U.S. federal income tax purposes under Section 355 and Section 368(a)(1)(D) of the Internal Revenue Code of 1986 (the “Code”). If the conclusions of the tax opinions are not correct, or if the Spin-Off is otherwise ultimately determined to be a taxable transaction, the Company would be liable for U.S. federal income tax related liabilities. Pursuant to the Separation and Distribution Agreement and the Tax Matters Agreement, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses. At June 30, 2022 and as of the date of financial statement issuance date, the Company does not have any indemnification liabilities. 10

Table of Contents Under Section 382 of the Code, as amended, changes in the Company’s ownership may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. This limitation would generally apply in the event of a cumulative change in ownership of the Company of more than 50% within a three-year period. In addition, the significant historical operating losses incurred by the Company may limit the amount of its net operating loss carryforwards that could be utilized annually to offset future taxable income, if any. The Company believes that operating loss carryforwards are limited under Section 382 limitations although Section 382 studies have not been conducted to determine the actual limitations.

Expense Reimbursement for Grant Award:

The Company reduces its research and development expenses by funding received or receivable from an NIH grant during the period that the expenses are incurred. The Company recognized grant related expense reductions during the three and six months ended June 30, 2022 of approximately $100,000 and $0, respectively, and $0 for the three and six months ended June 30, 2021, respectively. See Note 5, “Clinical Trial Services Agreements.”

Of the total $2.7 million available from the NIH grant, the Company has received the maximum reimbursements under the grant as of June 30, 2022.

Recent Accounting Pronouncements:

In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06, which reduces the number of accounting models for convertible instruments, amends diluted earnings per share calculations for convertible instruments and allows more contracts to qualify for equity classification. ASU 2020-06 will be effective for interim and annual periods beginning after December 15, 2021. Early adoption is permitted. The Company has evaluated the adoption of ASU 2020-06 and has concluded that it does not apply at this time.

Note 3– Collaborative Agreements and Commitments:

Stanford License Agreements

On May 12, 2014, the Company entered into a license agreement (the “Stanford Agreement”) with The Board of Trustees of The Leland Stanford Junior University (“Stanford”), pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of bryostatin structural derivatives, known as “bryologs,” for use in the treatment of central nervous system disorders, lysosomal storage diseases, stroke, cardio protection and traumatic brain injury, for the life of the licensed patents. The Company is required to use commercially reasonable efforts to develop, manufacture and sell products (“Licensed Products”) in the Licensed Field of Use (as defined in the Stanford Agreement) during the term of the licensing agreement which expires upon the termination of the last valid claim of any licensed patent under this agreement. In addition, the Company must meet specific product development milestones, and upon meeting such milestones, make specific milestone payments to Stanford. The Company must also pay Stanford royalties of 3% of net sales, if any, of Licensed Products (as defined in the Stanford Agreement) and milestone payments of up to $3.7 million dependent upon stage of product development. As of June 30, 2022, no royalties nor milestone payments have been required.

On January 19, 2017, the Company entered into a second license agreement with Stanford, pursuant to which Stanford has granted to the Company a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under certain patent rights and related technology for the use of “Bryostatin Compounds and Methods of Preparing the Same,” or synthesized bryostatin, for use in the treatment of neurological diseases, cognitive dysfunction and psychiatric disorders, for the life of the licensed patents. The Company paid Stanford $70,000 upon executing the license and is obligated to pay an additional $10,000 annually as a license maintenance fee. In addition, based upon certain milestones that include product development and commercialization, the Company will be obligated to pay up to an additional $2.1 million and between 1.5% and 4.5% royalty payments on certain revenues generated by the Company relating to the licensed technology. On November 9, 2021, the Company revised the existing licensing agreement with Stanford. The revisions extended all the required future product development and commercialization milestones. The Company is currently in full compliance with the revised agreement and is moving forward on its commitments. As of the end of the period covered by this quarterly report, no royalties nor milestone payments have been earned or made. 11

Table of Contents Mt. Sinai License Agreement

On July 14, 2014, the Company entered into an Exclusive License Agreement (the “Mount Sinai Agreement”) with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”). Pursuant to the Mount Sinai Agreement, Mount Sinai granted the Company (a) a revenue-bearing, world-wide right and exclusive license, with the right to grant sublicenses (on certain conditions), under Mount Sinai’s interest in certain joint patents held by the Company and Mount Sinai (the “Joint Patents”) as well as in certain results and data (the “Data Package”) and (b) a non-exclusive license, with the right to grant sublicenses on certain conditions, to certain technical information, both relating to the diagnostic, prophylactic or therapeutic use for treating diseases or disorders in humans relying on activation of Protein Kinase C Epsilon (“PKC ε”), which includes Niemann-Pick Disease (the “Mount Sinai Field of Use”). The Mount Sinai Agreement allows the Company to research, discover, develop, make, have made, use, have used, import, lease, sell, have sold and offer certain products, processes or methods that are covered by valid claims of Mount Sinai’s interest in the Joint Patents or an Orphan Drug Designation Application covering the Data Package (“Mount Sinai Licensed Products”) in the Mount Sinai Field of Use (as such terms are defined in the Mount Sinai Agreement).

The Company is required to pay Mt. Sinai milestone payments of $2.0 million upon approval of a new drug applications (“NDA”) in the United States and an additional $1.5 million for an NDA approval in the European Union or Japan. In addition, the Company is required to pay Mt. Sinai royalties on net sales of licensed product of 2.0% for up to $250 million of net sales and 3.0% of net sales over $250 million. Since inception, the Company has paid Mt. Sinai approximately $180,000 consisting of licensing fees of $105,000 plus development costs and patent fees of approximately $75,000. As of June 30, 2022, no royalties nor milestone payments have been required.

Agreements with BryoLogyx

On June 9, 2020, the Company entered into a supply agreement (the “Supply Agreement”) with BryoLogyx Inc. (“BryoLogyx”), pursuant to which BryoLogyx agreed to serve as the Company’s exclusive supplier of synthetic bryostatin. Pursuant to the terms of the Supply Agreement, the Company placed an initial order and subsequently received one gram of current good manufacturing practice (“cGMP”) synthetic bryostatin as an active pharmaceutical ingredient to be used in a drug product (“API”). The Company may place additional orders for API beyond the initial order by making a written request to BryoLogyx no later than six months prior to the requested delivery date. The Company is not currently using synthetic bryostatin for its current Phase 2 clinical trial and will determine when to incorporate the synthetic into the clinical trial process.

In connection with the Supply Agreement, on June 9, 2020, the Company entered into a transfer agreement (the “Transfer Agreement”) with BryoLogyx. Pursuant to the terms of the Transfer Agreement, the Company agreed to assign and transfer to BryoLogyx all of the Company’s right, title and interest in and to that certain Cooperative Research and Development Agreement, dated as of January 29, 2019 (the “CRADA”), by and between the Company and the U.S. Department of Health and Human Services, as represented by the NCI, under which Bryostatin-1’s ability to modulate CD22 in patients with relapsed/refractory CD22+ disease has been evaluated to date. Pursuant to guidance provided by NCI, the Company CRADA has been cancelled and BryoLogyx has initiated a request for a new CRADA in its name. BryoLogyx will be filing its own investigational new drug application (“IND”) for CD22 with the FDA. As consideration for the transfer of rights to the CRADA, BryoLogyx has agreed to pay to the Company 2% of the gross revenue received in connection with the sale of bryostatin products, up to an aggregate payment amount of $1 million. No such revenues have been earned as of June 30, 2022.

Nemours Agreement

On September 5, 2018, we announced a collaboration with Nemours A.I. DuPont Hospital (“Nemours”), a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X syndrome, a genetic disorder. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, the Company announced its memorandum of understanding with Nemours to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. The Company intends to provide the Bryostatin-1 and obtain the investigational new drug documentation (“IND”) and Nemours intends to provide the clinical site and attendant support for the trial. The Company and Nemours, jointly, will develop the trial protocol. The Company estimates its total trial and IND cost to be approximately $700,000. As of the end of the period covered by this quarterly report, the Company has not incurred any expenses associated with this agreement.

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Cleveland Clinic

On February 23, 2022, the Company announced its collaboration with the Cleveland Clinic to pursue possible treatments for Multiple Sclerosis. The collaboration entails filing an IND and conducting initial clinical trials using Bryostatin-1. Future development work will be conducted pursuant to statements of work to be determined.

Cognitive Research Enterprises, Inc. (“CRE”)

Effective October 31, 2012, the Company executed a Technology License and Services Agreement (the “TLSA”) with CRE, a related party, and NRV II, LLC (“NRV II”), another affiliate of CRE, which was amended by Amendment No. 1 to the TLSA as of August 21, 2013, as amended and restated on February 4, 2015 (the “CRE License Agreement”). The CRE License Agreement provides research services and has granted the Company the exclusive and nontransferable world-wide, royalty-bearing right, with a right to sublicense (in accordance with the terms and conditions described below), under CRE’s and NRV II’s respective right, title and interest in and to certain patents and technology owned by CRE or licensed to NRV II by CRE as of or subsequent to October 31, 2012, to develop, use, manufacture, market, offer for sale, sell, distribute, import and export certain products or services for therapeutic applications for AD and other cognitive dysfunctions in humans or animals (the “Field of Use”). Additionally, the CRE License Agreement specifies that all patents that issue from a certain patent application shall constitute licensed patents and all trade secrets, know-how and other confidential information claimed by such patents constitute licensed technology under the CRE License. The CRE License Agreement terminates on the later of the date (a) the last of the licensed patent expires, is abandoned, or is declared unenforceable or invalid or (b) the last of the intellectual property enters the public domain.

After Neurotrope’s initial Series A Stock financing, the CRE License Agreement required the Company to enter into scope of work agreements with CRE as the preferred service provider for any research and development services or other related scientific assistance and support services. There were no such statements of work agreements entered into during the years ended December 31, 2021 and 2020, respectively, or during the three and six months ended June 30, 2022.

In addition, on November 10, 2018, the Company and CRE entered into a second amendment (the “Second Amendment”) to the TLSA pursuant to which CRE granted certain patent prosecution and maintenance rights to the Company. Under the Second Amendment, the Company will have the sole and exclusive right and the obligation, to apply for, file, prosecute and maintain patents and applications for the intellectual property licensed to the Company, and pay all fees, costs and expenses related to the licensed intellectual property.

Note 4- Related Party Transactions:

Related Party Agreements

On August 4, 2016, Neurotrope, Inc. entered into a consulting agreement with SM Capital Management, LLC (“SMCM”), a limited liability company owned and controlled by the Company’s Chairman of the Board, Mr. Joshua N. Silverman (the “Consulting Agreement”). Pursuant to the Consulting Agreement, SMCM shall provide consulting services which shall include, but not be limited to, providing business development, financial communications and management transition services, for a one-year period, subject to annual review thereafter. SMCM’s annual consulting fee is $120,000, payable by the Company in monthly installments of $10,000. This contract was assigned to Synaptogenix, Inc. as of December 1, 2020. For the three and six months ended June 30, 2022 and 2021, $30,000 and $60,000 is reflected in the Company’s statements of operations, respectively.

Note 5 – Other Commitments:

Clinical Trial Services Agreements

On July 23, 2020, the Company entered into the 2020 Services Agreement with Worldwide Clinical Trials, Inc. (“WCT”). The 2020 Services Agreement relates to services for the current Phase 2 clinical trial assessing the safety, tolerability and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment (the “2020 Study”). 13

Table of Contents Pursuant to the terms of the 2020 Services Agreement, WCT is providing services to enroll approximately one hundred (100) 2020 Study subjects, which enrollment is currently completed. The first 2020 Study site was initiated during the third quarter of 2020. On January 22, 2022, the Company executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million. In addition, on February 10, 2022, the Company signed an additional agreement with a third-party vendor to assist with the increased trial recruitment retention totaling approximately $1.0 million. The updated total estimated budget for the services, including pass-through costs, is currently approximately $12.0 million. The Company may terminate the 2020 Services Agreement without cause upon sixty (60) days prior written notice.

The Company was awarded a $2.7 million grant from the NIH, which will be used to support the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to the Company of $9.3 million. The NIH grant provides for funds in the first year, which began in April 2020, of approximately $1.0 million and funding in year two, which began April 2021, of approximately $1.7 million. As of February 22, 2022, virtually all of the NIH grant has been received and offset against the clinical trial costs. The Company incurred approximately $9.4 million of cumulative expenses associated with the current Phase 2 clinical trial as of June 30, 2022. Of the total $9.4 million incurred for the trial to date, approximately $1.2 million and $2.5 million is reflected in the statement of operations for the three and six months ended June 30, 2022 and 2021, respectively. As of June 30, 2022 included in the Company’s balance sheet, approximately $281,000 of WCT prepayments is included as a prepaid expense and other current assets. In addition, approximately $414,000 is included in accounts payable and accrued expenses.

On May 12, 2022, the Company entered into the 2022 Services Agreement with WCT. The 2022 Services Agreement relates to services for a Phase 2 “open label,” dose ranging study, clinical trial assessing the safety, tolerability and efficacy of Bryostatin-1 administered via infusion in the treatment of moderately severe to severe AD subjects not receiving memantine treatment (the “2022 Study”).

On January 19, 2022, the Company issued a work order (the “Work Order”) to Cyprotex US, LLC (“Cyprotex”), pursuant to which Cyprotex will perform certain drug interaction services for the Company for an aggregate fee of $165,455. The Work Order is governed by the Cyprotex’s Standard Terms and Conditions for Discovery Services dated August 2, 2021. The Company incurred approximately $169,000 and $177,000 for this Work Order for the three and six months ended June 30, 2022, respectively.

On January 31, 2022, the Company entered into a Statement of Work (the “SOW”) with Charles River Laboratories, Inc. (“Charles River”). The Statement of Work is subject to the General Terms and Conditions of Charles River. Pursuant to the SOW, Charles River will conduct a certain pre-clinical animal study (the “Study”) relating to Bryostatin-1 pharmacodynamics and drug distribution, for an initial aggregate fee of $197,600. Either party may terminate the 2022 Services Agreement without cause upon ninety days prior written notice. Furthermore, in the event of a material breach by the other party, which breach is not cured by the breaching party, the other party may terminate the agreement upon 30 days’ prior written notice. The Company has not incurred any expense relating to this SOW as of June 30, 2022.

Other Consulting Agreements

Effective as of June 1, 2019, the Company entered into a consulting agreement with Katalyst Securities LLC (“Katalyst”), pursuant to which Katalyst provided investment banking consulting services to the Company and Neurotrope (the “Katalyst Agreement”). The term of the Katalyst Agreement continued until it was canceled. As consideration for its services under the Katalyst Agreement, the Company paid Katalyst $25,000 per month thru December 1, 2020, plus five-year warrants to purchase 4,500 shares of Neurotrope’s common stock on the effective date of the Katalyst Agreement and on each of the three-month anniversaries following the effective date with the last issuance on December 1, 2020. 14

Table of Contents Effective as of January 1, 2021, the Company entered into an amended consulting agreement with Katalyst reducing the cash payment to $20,000 per month. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with Katalyst reducing the cash payment to $10,000 per month beginning February 1, 2022 thru December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, Katalyst was granted warrants to purchase 25,000 shares of Common Stock at $11.46 per share, on April 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.80 per share, on July 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.76 per share, on October 1, 2021, was granted warrants to purchase an additional 4,500 shares of Common Stock at $9.30 per share, and, on January 3, 2022, was granted warrants to purchase an additional 4,500 shares of Common Stock at $8.69 per share. Each of the warrants issued to Katalyst are exercisable for a period of five years from the date of issuance. For the three months ended June 30, 2022 and 2021, $30,000 and $93,687 is reflected in the Company’s statements of operations, respectively, and $111,283 and $399,700 is reflected in the Company’s statements of operations for the six months ended June 30, 2022 and 2021, respectively, pursuant to the consulting agreement.

Effective as of June 5, 2019, the Company entered into a consulting agreement with GP Nurmenkari, Inc. (“GPN”) (the “GPN Agreement”), pursuant to which GPN agreed to provide investment banking consulting services to the Company and Neurotrope. The term of the agreement continued until December 1, 2020. On February 1, 2020, the Company amended the GPN Agreement, increasing the cash compensation to $17,500 per month thru November 30, 2020 and increasing the number of warrants issued each three-month period to 2,500, with the last issuance on December 1, 2020.

Effective as of January 1, 2021, the Company entered into an amended consulting agreement with GPN reducing the cash payment to $12,000 per month. Effective as of July 1, 2021, the Company entered into a second amended consulting agreement with GPN increasing the cash payment to $20,000 per month and increasing warrant issued for each three-month period beginning July 1, 2021 to 5,800, with the last issuance on October 1, 2021. Effective as of January 1, 2022, the Company entered into an additional amended consulting agreement with GPN reducing the cash payment to $10,000 per month beginning February 1, 2022 thru December 31, 2022 and eliminating any further warrant issuances. In addition, on February 16, 2021, GPN was granted warrants to purchase 10,000 shares of Common Stock at $11.46 per share, on April 1, 2021, was granted warrants to purchase an additional 2,500 shares of Common Stock at $8.80 per share, on July 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.76 per share, on October 1, 2021, was granted warrants to purchase an additional 5,800 shares of Common Stock at $9.30 per share, and, on January 3, 2022, was granted warrants to purchase an additional 5,800 shares of Common Stock at $8.69 per share. Each of the warrants issued to GPN are exercisable for a period of five years from the date of issuance. For the three months ended June 30, 2022 and 2021, $30,000 and $54,815 is reflected in the Company’s statements of operations, and $120,320 and $189,148 is reflected in the Company’s statements of operations for the six months ended June 30, 2022 and 2021, respectively, pursuant to the GPN Agreement.

Employment Agreements

On December 7, 2020, the Company entered into an offer letter (the “Offer Letter”) with Alan J. Tuchman, M.D., pursuant to which Dr. Tuchman agreed to serve as the Company’s Chief Executive Officer, commencing on December 7, 2020. In addition, in connection with his appointment as the Company’s Chief Executive Officer, Dr. Tuchman was appointed to the board of directors of the Company. Dr. Tuchman will receive an initial annual base salary of $222,000, with an annual discretionary bonus of up to 50% of his base salary then in effect. Dr. Tuchman also received an initial equity grant (subject to Board approval which was received in January 2021) of options to purchase a number of shares of Common Stock equal to at least 1% of the Company’s outstanding shares of Common Stock immediately following the Spin-Off. As of December 7, 2021, such options are fully vested.

The term of Dr. Tuchman’s employment pursuant to the Offer Letter is one year, which shall be extended automatically for six month periods unless either party gives timely written notice. Dr. Tuchman’s agreement was previously extended until December 7, 2022. On August 4, 2022, the Company entered into an amendment to the Offer Letter to extend the term of Dr. Tuchman’s employment through June 7, 2023, and such term shall be extended for an additional six months upon Dr. Tuchman’s written notice to the Company at least 30 days prior to June 7, 2023. Pursuant to the Amendment, if Dr. Tuchman is terminated without Cause, Dr. Tuchman shall be entitled to severance equal to six months of Dr. Tuchman’s annual base salary. 15

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Other Commitments and Agreements

See Notes 3 and 4 for Collaboration and License Agreement related commitments.

Pursuant to the Separation Agreement and Tax Matters Agreement with Neurotrope, Neurotrope agreed to indemnify Synaptogenix for certain liabilities, and Synaptogenix agreed to indemnify Neurotrope for certain liabilities, in each case for uncapped amounts. Indemnities that Synaptogenix may be required to provide Neurotrope are not subject to any cap, may be significant and could negatively impact Synaptogenix’s business, particularly with respect to indemnities provided in the Tax Matters Agreement. Third parties could also seek to hold Synaptogenix responsible for any of the liabilities that Neurotrope has agreed to retain. Further, the indemnity from Neurotrope may not be sufficient to protect Synaptogenix against the full amount of such liabilities, and Neurotrope may not be able to fully satisfy its indemnification obligations. Moreover, even if Synaptogenix ultimately succeeds in recovering from Neurotrope any amounts for which Synaptogenix is held liable, Synaptogenix may be temporarily required to bear these losses ourselves. As of the reporting date, there are no claims relating to the indemnification agreement.

Note 6 – Stockholders’ Equity:

The Company’s certificate of incorporation authorizes it to issue 150,000,000 shares of Common Stock and 1,000,000 shares of preferred stock, par value $0.0001 per share.

The holders of Common Stock are entitled to receive dividends out of assets or funds legally available for the payment of dividends at such times and in such amounts as the Board from time to time may determine. To date, the Company has not paid dividends on its Common Stock. Holders of Common Stock are entitled to one vote for each share held on all matters submitted to a vote of stockholders. There is no cumulative voting of the election of directors then standing for election. The Common Stock is not entitled to pre-emptive rights and is not subject to conversion or redemption. Upon liquidation, dissolution or winding up of the Company, the assets legally available for distribution to stockholders are distributable ratably among the holders of Common Stock after payment of liabilities, accrued dividends and liquidation preferences, if any. Each outstanding share of Common Stock is duly and validly issued, fully paid and non-assessable.

January 2021 Private Placement

On January 21, 2021, the Company entered into Securities Purchase Agreements (the “Purchase Agreement”) with certain accredited investors (the “Purchasers”) to issue (a) an aggregate of 2,333,884 shares of Common Stock and/or prefunded warrants to purchase shares of Common Stock at an exercise price of $0.04 per share (the “Pre-Funded Warrants”), (b) Series E warrants to purchase 2,333,908 shares of Common Stock, with an exercise price of $8.51 per share (subject to adjustment), for a period of twelve months from the date of an effective registration statement (the “Series E Warrants”) and (c) Series F warrants to purchase up to an aggregate of 2,333,908 shares of Common stock, with an exercise price of $6.90 per share (subject to adjustment), for a period of five years from the date of issuance (the “Series F Warrants” and together with the Series E Warrants, the “Warrants”) at a combined purchase price of $6.00 per share of Common Stock and Warrants (the “Offering”). The Company received total gross proceeds of approximately $14,000,000 and net proceeds of approximately $12.5 million.

In connection with the Offering, we paid our placement agents Katalyst and GPN (i) a cash fee equal to ten percent (10%) of the gross proceeds from any sale of securities in the Offering sold to Purchasers introduced by the Placement Agent and (ii) 233,391 warrants to purchase 233,391 shares of Common Stock (equal to ten percent (10%) of the number of shares of Common Stock sold to Purchasers introduced by the placement agents), with an exercise price of $6.90 per share and a five-year term.

June 2021 Private Placement

On June 14, 2021, the Company entered into Securities Purchase Agreements (the “June Purchase Agreement”) with certain accredited investors (the “June Purchasers”) to issue (a) an aggregate of 1,653,281 shares of the Company’s Common Stock and/or prefunded warrants to purchase shares of Common Stock at an exercise price of $0.01 per share (the “June Pre-Funded Warrants”) and (b) Series G warrants to purchase up to an aggregate of 1,653,281 shares of Common stock, with an exercise price of $8.51 per share (subject to adjustment), for a period of five years from the date of issuance (the “June Warrants”) at a combined purchase price of $7.547 per share of Common Stock and June Warrant (the “June Offering”). The Company received total gross proceeds of approximately $12.5 million and net proceeds of approximately $11.2 million. 16

Table of Contents In connection with the June Offering, pursuant to an Engagement Agreement, dated June 14, 2021 (the “June Engagement Agreement”), between the Company and Katalyst Securities LLC (the “June Placement Agent”), the Company paid the June Placement Agent (i) a cash fee equal to ten percent (10%) of the gross proceeds from the sale of securities in the June Offering sold to June Purchasers introduced by the June Placement Agent and (ii) 152,378 warrants to purchase 152,378 shares of Common Stock (equal to ten percent (10%) of the number of shares of Common Stock sold to June Purchasers introduced by the June Placement Agent), with an exercise price of $7.547 per share and a five-year term (the “June Broker Warrants”). Furthermore, the Company agreed to pay the June Placement Agent a warrant exercise fee equal to ten percent (10%) of the aggregate exercise price that is paid in connection with each exercise, if any, of the June Warrants initially held by June Purchasers introduced by the June Placement Agent. The total potential fee payable to the June Placement Agent if all Series G warrants are exercised is approximately $1.4 million. The June Placement Agent is also entitled to the foregoing fees with respect to any future financing or capital-raising transaction by the Company (a “Subsequent Financing”), to the extent such financing or capital is provided to the Company by investors whom the Placement Agent had introduced to the Company, in the event such Subsequent Financing is consummated within eighteen (18) months following the closing of the June Offering.

Adoption of a Shareholder Rights Plan

On January 13, 2021, the Company adopted a shareholder rights plan (the “Rights Plan”). The Rights Plan is intended to protect the interests of the Company’s stockholders and enable them to realize the full potential value of their investment by reducing the likelihood that any person or group gains control of the Company, through open market accumulation or other tactics, without appropriately compensating all stockholders. Pursuant to the Rights Plan, the Company will issue, by means of a dividend, one preferred share purchase right for each outstanding share of our Common Stock to shareholders of record on the close of business on January 25, 2021. Initially, these Rights will trade with, and be represented by, the shares of our Common Stock. The Rights will generally become exercisable only if any person (or any persons acting as a group) acquires 15% or more of our outstanding Common Stock (the “Acquiring Person”) in a transaction not approved by the Board, subject to certain exceptions, as explained below.

If the Rights become exercisable, all holders of Rights, other than the Acquiring Person, will be entitled to acquire shares of Common Stock at a 50% discount or the Company may exchange each Right held by such holders for one share of Common Stock. In such situation, Rights held by the Acquiring Person would become void and will not be exercisable. If any person at the time of the first public announcement of the Rights Plan owns more than the triggering percentage, then that stockholder’s existing ownership percentage will be grandfathered, although, with certain exceptions, the Rights will become exercisable if at any time after the announcement of the Rights Plan such stockholder increases its ownership of Common Stock.

On January 13, 2021, the board of directors of the Company (the “Board”)declared a dividend of one preferred share purchase right (a “Right”), payable on January 25, 2021, for each share of Common Stock outstanding on January 25, 2021 (the “Record Date”) to the stockholders of record on that date. In connection with the distribution of the Rights, the Company entered into a Rights Agreement (the “Rights Agreement”), dated as of January 19, 2021, between the Company and Philadelphia Stock Transfer, Inc., as rights agent. Each Right entitles the registered holder to purchase from the Company one one-thousandth of a share of Series A Preferred Stock, par value $0.001 per share (the “Preferred Shares”), of the Company at a price of $20 per one one-thousandth of a Preferred Share represented by a Right (the “Purchase Price”), subject to adjustment.

Unless earlier redeemed, terminated or exchanged pursuant to the terms of the Rights Plan, the Rights will expire at the close of business on January 13, 2023. The Board may terminate the Rights Plan before that date if the Board determines that there is no longer a threat to shareholder value.

Reverse Stock Split

At the Special Meeting (as defined below), the stockholders approved our proposal to effect one reverse stock split of the Company’s outstanding shares of Common stock, at any ratio between 1-for-1.5 and 1-for-20, at such time as the Company’s Board of Directors shall determine, in its sole discretion, before December 31, 2022. On May 19, 2021, the Company effected a 1-for-4 reverse stock split of its Common Stock. As a result of the reverse stock split, every four (4) shares of the Company’s pre-reverse split Common Stock was combined and reclassified into one share of Common Stock. These financial statements have been adjusted to retrospectively reflect this reverse stock split.

Table of Contents Note 7 – Stock Based Compensation:

2020 Equity Incentive Plan

Upon completion of the Spin-Off, the Company’s 2020 Equity Incentive Plan (the “2020 Plan”) became effective on December 7, 2020. The total number of securities available for grant under the 2020 Plan was 250,000 shares of Common Stock, subject to adjustment. On April 7, 2021, the Company held a special meeting of stockholders (“Special Meeting”) in which the Company’s stockholders approved an amendment to the Company’s 2020 Plan to increase the total number of shares of Common Stock from 250,000 to an aggregate of 625,000 shares of Common Stock.

Stock and Option Grants

The following is a summary of stock option activity under the stock option plans for the six months ended June 30, 2022:


	****		****			****	Weighted-	****
							Average		Aggregate
				Weighted-			Remaining		Intrinsic
		Number		Average			Contractual		Value
		of		Exercise			Term		(in
		Shares		Price			(Years)		millions)
Options outstanding at January 1, 2022		123,850		$	9.84		9.00		$	—
Options granted		6,150		$	7.29		—			—
Less options forfeited		—		$	—		—			—
Less options expired/cancelled		—		$	—		—			—
Less options exercised		—		$	—		—			—
Options outstanding at June 30, 2022		130,000		$	9.72		8.60		$	—
Options exercisable at June 30, 2022		125,388		$	9.81		8.57		$	—

As of June 30, 2022, the Company had unrecognized stock option expense of approximately $16,900 and a remaining weighted average period for recognition of 0.63 years.

On February 16, 2022, pursuant to its 2020 Plan, the Company granted stock options to purchase an aggregate of 6,150 shares of Common Stock to its Chief Executive Officer. The stock options have an exercise price of $7.29 per share and an expiration date that is ten years from the date of issuance. 25% of the options vest each quarter over one year, with the initial 25% vesting on May 16, 2022.

On March 12, 2021, Synaptogenix adopted a new non-employee director compensation policy (the “Director Compensation Policy”). The Director Compensation Policy provides for the annual automatic grant of nonqualified stock options to purchase up to 1,500 shares of Synaptogenix’s Common Stock to each of Synaptogenix’s nonemployee directors. Such grants shall occur annually on the fifth business day after the filing of Synaptogenix’s Annual Report on Form 10-K and shall vest on the one-year anniversary from the date of grant subject to the director’s continued service on the Board of Directors on the vesting date. The Director Compensation Policy also provides for the automatic grant of nonqualified stock options to purchase up to 1,200 shares of Synaptogenix’s Common Stock, plus options to purchase an additional 300 shares of Common Stock for service on a committee of the Board of Directors, to each newly appointed director following the date of his or her appointment. Such options shall vest as follows: fifty percent (50%) on the date of the grant, twenty-five percent (25%) on the one year anniversary from the date of the grant, and twenty-five percent (25%) on the second year anniversary from the date of the grant, subject to the director’s continued service on the Board of Directors on the applicable vesting dates.

The Company recorded total expense relating to the outstanding stock options of $11,544 and $151,552 for the three months ended June 30, 2022 and 2021, respectively, and $47,918 and $719,791 for the six months ended June 30, 2022 and 2021.

Restricted Stock Unit Grants

On July 13, 2021, the Company granted a total of 495,000 restricted stock units (RSUs), of which 425,000 were granted to seven Board members (including two executives), 60,000 to the Company’s CFO and 10,000 to two employees. The RSUs were amended on January 12, 2022 to vest 100% on September 15, 2022 and then further amended on June 20, 2022 to vest 100% on the 18

Table of Contents earlier of release of Phase 2 clinical trial top line data or December 31, 2022. Top line data is expected to be announced during the fourth quarter of 2022.

As of June 30, 2022, the Company had unrecognized RSUs expense of approximately $885,000 and a remaining weighted average period for recognition of 0.44 years. The fair value of the RSUs issued was based upon the closing trading price of the Common Stock on the grant date of $9.75 per share. The grant date fair value of the RSUs granted was approximately $4.8 million. The Company recorded total expense of $1,005,146 and $1,680,331 relating to the outstanding RSUs for the three and six months ended June 30, 2022, respectively.

Restricted Stock Issuances

On February 15, 2022, the Company granted 13,775 shares of restricted stock to two consultants that were engaged to provide investor relations services with a total fair market value on date of issuance of $98,078. On March 14, 2022, the Company granted 692 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On June 7, 2022, the Company granted 679 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $4,500. On July 8, 2022, the Company granted 30,303 shares of restricted stock to a consultant that was engaged to provide investor relations services with a total fair market value on date of issuance of $150,000 and warrants to purchase 21,067 shares of Common Stock with an exercise price of $9.90 per share for a period of five years from the date of issuance.

Stock Compensation Expense

Total stock-based compensation for the three and six months ended June 30, 2022 was $1,016,690 and $1,728,248, respectively of which $171,653 and $845,037 was classified as research and development expense, respectively, and $845,037 and $1,435,545 was classified as general and administrative expense. Total stock-based compensation for the three and six months ended June 30, 2021 was $151,552 and $719,791, respectively, of which $35,763 and $209,465 was classified as research and development expense, respectively, and $115,789 and $510,326 was classified as general and administrative expense.

Note 8 – Common Stock Warrants:

As of June 30, 2022, the Company had warrants outstanding consisting of the following:


	****	Number
		of shares
Warrants outstanding January 1, 2022		6,265,525
Warrants issued		10,300
Warrants exercised		(65,000)
Warrants expired		(1,049,368)
Warrants outstanding June 30, 2022		5,161,457

On January 3, 2022, pursuant to its advisory agreements, the Company issued warrants to purchase 10,300 shares of Common Stock, with an exercise price of $8.96 per share, for a period of five years from the issuance date. The Company used the Black-Scholes valuation model to calculate the value of these warrants issued to advisors during the six months ended June 30, 2022. The fair value of the warrants was estimated at the date of issuance using the following weighted average assumptions: Dividend yield 0%; Expected term five years; volatility based upon a blend of the Parent company’s and guideline company historical volatility 112.9%; and Risk-free interest rate of 1.37%. The total expense recorded during the year period was approximately $72,000.

As of June 30, 2022, the weighted average exercise price and the weighted average remaining life of the total warrants were $13.34 per warrant and 3.7 years, respectively. The intrinsic value of the warrants as of June 30, 2022 was approximately $0.8 million.

During the six months ended June 30, 2022, three affiliated warrant holders exercised 50,000 Series E Warrants to purchase 50,000 shares of Common Stock at $8.51 per share and one holder exercised 15,000 Series G Warrants to purchase 15,000 shares of Common Stock at $8.51 per share. Total cash proceeds from these warrant exercises was approximately $600,000.

Table of Contents Note 9 – Subsequent Events

See Note 5 and Note 7 above.

Table of Contents

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing elsewhere in this report. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included elsewhere in this report and our annual report on Form 10-K for the year ended December 31, 2021.

The following discussion highlights our results of operations and the principal factors that have affected our financial condition as well as our liquidity and capital resources for the periods described, and provides information that management believes is relevant for an assessment and understanding of the statements of financial condition and results of operations presented herein. The following discussion and analysis are based on the unaudited financial statements contained in this report, which we have prepared in accordance with United States generally accepted accounting principles. You should read the discussion and analysis together with such financial statements and the related notes thereto.

Explanatory Note

On May 17, 2020, Neurotrope, Inc. (Neurotrope or Parent) announced plans for the complete legal and structural separation of us from Neurotrope, also known as the Spin-Off. Under the Separation and Distribution Agreement, Neurotrope planned to distribute all of its equity interest in us to Neurotrope’s stockholders. Following the Spin-Off, Neurotrope would not own any equity interest in us, and we would operate independently from Neurotrope. Neurotrope Bioscience, Inc. was a wholly-owned subsidiary of Neurotrope prior to the completion of the Spin-Off on December 7, 2020 (see below for description of Spin-Off). Neurotrope Bioscience, Inc. represented substantially all the business of Neurotrope.

On December 6, 2020, Neurotrope approved the final distribution ratio and holders of record of Neurotrope common stock, Neurotrope preferred stock and certain warrants as of November 30, 2020 received a pro rata distribution at the rate of (i) one share of our Common Stock for every five shares of Neurotrope common stock held, (ii) one share of our Common Stock for every five shares of Neurotrope common stock issuable upon conversion of Neurotrope preferred stock held and (iii) one share of our Common Stock for every five shares of Neurotrope common stock issuable upon exercise of certain Neurotrope warrants held that were entitled to participate in the Spin-Off pursuant to the terms thereof.

Basis of Presentation

The unaudited financial statements for the three and six months ended June 30,2022 and 2021 include a summary of our significant accounting policies and should be read in conjunction with the discussion below and our financial statements and related notes included elsewhere in this quarterly report. In the opinion of management, all material adjustments necessary to present fairly the results of operations for such periods have been included in the financial statements. All such adjustments are of a normal recurring nature.

Overview

We are a biopharmaceutical company with product candidates in pre-clinical and clinical development. We began operations in October 2012. We are principally focused on developing a product platform based upon a drug candidate called Bryostatin-1 for the treatment of Alzheimer’s disease, which is in the clinical testing stage. We are also evaluating Bryostatin-1 for other neurodegenerative or cognitive diseases and dysfunctions, such as Fragile X syndrome, Multiple Sclerosis, and Niemann-Pick Type C disease, which have undergone pre-clinical testing. 21

Table of Contents Neurotrope had been a party to a technology license and services agreement with the original Blanchette Rockefeller Neurosciences Institute (which has been known as Cognitive Research Enterprises, Inc. since October 2016), and its affiliate NRV II, LLC, which we collectively refer to herein as “CRE,” pursuant to which we now have an exclusive non-transferable license to certain patents and technologies required to develop our proposed products. We were formed for the primary purpose of commercializing the technologies initially developed by BRNI for therapeutic applications for AD or other cognitive dysfunctions. These technologies have been under development by BRNI since 1999 and, until March 2013, had been financed through funding from a variety of non-investor sources (which include not-for-profit foundations, the NIH, which is part of the U.S. Department of Health and Human Services, and individual philanthropists). From March 2013 forward, development of the licensed technology has been funded principally through us in collaboration with CRE.

Reverse Stock Split

On April 7, 2021, our stockholders approved our proposal to effect one reverse stock split of our outstanding shares of Common Stock, at any ratio between 1-for-1.5 and 1-for-20, at such time as the Board shall determine, in its sole discretion, before December 31, 2022. On May 19, 2021, we effected a 1-for-4 reverse stock split of our shares of Common Stock. As a result of the reverse stock split, every four (4) shares of our pre-reverse split Common Stock was combined and reclassified into one share of Common Stock. All share and per share information herein has been adjusted to retrospectively reflect this reverse stock split.

Results of Most Recent Confirmatory Phase 2 Clinical Trial

On September 9, 2019, Neurotrope issued a press release announcing that the confirmatory Phase 2 study of Bryostatin-1 in moderate to severe AD did not achieve statistical significance on the primary endpoint, which was changed from baseline to Week 13 in the Severe Impairment Battery (“SIB”) total score.

An average increase in SIB total score of 1.3 points and 2.1 points was observed for the Bryostatin-1 and placebo groups, respectively, at Week 13. There were multiple secondary outcome measures in this trial, including the changes from baseline at Weeks 5, 9 and 15 in the SIB total score. No statistically significant difference was observed in the change from baseline in SIB total score between the Bryostatin -1 and placebo treatment groups.

The confirmatory Phase 2 multicenter trial was designed to assess the safety and efficacy of Bryostatin-1 as a treatment for cognitive deficits in patients with moderate to severe AD — defined as a MMSE-2 score of 4-15 – who are not currently taking memantine. Patients were randomized 1:1 to be treated with either Bryostatin-1 20μg or placebo, receiving 7 doses over 12 weeks. Patients on memantine, an NMDA receptor antagonist, were excluded unless they had been discontinued from memantine treatment for a 30-day washout period prior to study enrollment. The primary efficacy endpoint was the change in the SIB score between the baseline and week 13. Secondary endpoints included repeated SIB changes from baseline SIB at weeks 5, 9, 13 and 15.

On January 22, 2020, we announced the completion of an additional analysis in connection with the confirmatory Phase 2 study, which examined moderately severe to severe AD patients treated with Bryostatin-1 in the absence of memantine. To adjust for the baseline imbalance observed in the study, a post-hoc analysis was conducted using paired data for individual patients, with each patient as his/her own control. For the pre-specified moderate stratum (i.e., MMSE-2 baseline scores 10-15), the baseline value and the week 13 value were used, resulting in pairs of observations for each patient. The changes from baseline for each patient were calculated and a paired t-test was used to compare the mean change from baseline to week 13 for each patient. A total of 65 patients had both baseline and week 13 values, from which there were 32 patients in the Bryostatin-1 treatment group and 33 patients in the placebo group. There was a statistically significant improvement over baseline (4.8 points) in the mean SIB at week 13 for subjects in the Bryostatin-1 treatment group (32 subjects), paired t-test p < 0.0076, 2-tailed. In the placebo group (33 subjects), there was also a statistically significant increase from baseline in the mean SIB at week 13, for paired t-test p < 0.0144, consistent with the placebo effect seen in the overall 203 study. Although there was a signal of Bryostatin-1’s benefit for the moderately severe stratum, the difference between the Bryostatin-1 and placebo treatment groups was not statistically significant (p=0.2727). As a further test of the robustness of this Moderate Stratum benefit signal, a pre-specified trend analysis (measuring increase of SIB improvement as a function of successive drug doses) was performed on the repeated SIB measures over time (Weeks 0, 5, 9, and 13). These trend analyses showed a significant positive slope of improvement for the treatment groups in the 203 study that was significantly greater than for the placebo group (p<.01). 22

Table of Contents In connection with the additional analysis, we also announced the approval of a $2.7 million award from the NIH to support an additional Phase 2 clinical study focused on the moderate stratum for which we saw improvement in the 203 study. The grant provides for funds in the first year of approximately $1.0 million and funding in year two of approximately $1.7 million subject to satisfactory progress of the project. We are planning to meet with the FDA to present the totality of the clinical data for Bryostatin-1.

On July 23, 2020, we entered into the 2020 Services Agreement with WCT. The 2020 Services Agreement relates to services for our Phase 2 clinical study assessing the safety, tolerability and long-term efficacy of Bryostatin-1 in the treatment of moderately severe AD subjects not receiving memantine treatment. On January 22, 2022, the Company executed a change order with WCT to accelerate trial subject recruitment totaling approximately $1.4 million. In addition, on February 10, 2022, the Company signed an additional agreement with a third-party vendor to assist with the increased trial recruitment retention totaling approximately $1.0 million. The updated total estimated budget for the services, including pass-through costs, is approximately $12.0 million. As previously disclosed, on January 22, 2020, we were granted a $2.7 million award from the NIH, which award is being used to support the 2020 Study, resulting in an estimated net budgeted cost of the 2020 Study to us of $9.3 million. Of the $2.7 million grant, virtually all has been received as of February 22, 2022.

As of June 30, 2022, we incurred cumulative expenses of approximately $9.4 million associated with services provided by WCT and certain pass thru expenses incurred by WCT, which was offset by NIH reimbursements recognized of $2.7 million and, for the three months ended June 30, 2022, we incurred expenses of approximately $1.3 million associated with services provided by WCT and certain pass thru expenses incurred by WCT.

Additional Phase 2 Clinical Trial

Pursuant to the terms of the 2022 Services Agreement, WCT is providing services to enroll approximately 12 2022 Study subjects, which enrollment is currently underway. The first 2022 Study site was initiated during the third quarter of 2022. The total estimated budget for the services, including pass-through costs, is currently approximately $2.0 million. During the three and six months ended June 30, 2022, the Company incurred a total of approximately $450,000 for this clinical trial and, as of June 30, 2022, recorded a payable of approximately $80,000 on its balance sheet. During July 2022, the Company paid WCT 20%, or approximately $400,000, as a prepayment for services, pass thru and site expenses to be incurred for the 2022 Services Agreement. Either party may terminate the 2022 Services Agreement without cause upon ninety days prior written notice. Furthermore, in the event of a material breach by the other party, which breach is not cured by the breaching party, the other party may terminate the agreement upon 30 days’ prior written notice.

Other Development Projects

To the extent resources permit, we may pursue development of selected technology platforms with indications related to the treatment of various disorders, including neurodegenerative disorders such as AD, based on our currently licensed technology and/or technologies available from third party licensors or collaborators.

Nemours Agreement

On September 5, 2018, we announced a collaboration with Nemours, a premier U.S. children’s hospital, to initiate a clinical trial in children with Fragile X. In addition to the primary objective of safety and tolerability, measurements will be made of working memory, language and other functional aspects such as anxiety, repetitive behavior, executive functioning, and social behavior. On August 5, 2021, the Company announced its memorandum of understanding with Nemours A.I. DuPont Hospital (“Nemours”) to initiate a clinical trial using Bryostatin-1, under Orphan Drug Status, to treat Fragile X. The Company intends to provide the Bryostatin-1 drug product candidate and obtain the investigational new drug documentation (“IND”) and Nemours intends to provide the clinical site and attendant support for the trial. The Company and Nemours, jointly, will develop the trial protocol. The Company estimates its total trial and IND cost to be approximately $700,000. The Company plans to initiate a Phase 1 clinical trial during the second half of 2022. 23

Table of Contents Cleveland Clinic

Impact of COVID-19

We face the ongoing risk that the coronavirus pandemic may slow the conduct of our current trials. In order to prioritize patient health and that of the investigators at clinical trial sites, we will monitor enrollment of new patients in our Phase 2 clinical trials of Bryostatin-1 for the treatment of patients with Alzheimer’s disease. In addition, some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines or travel restrictions impede patient movement or interrupt healthcare services. These and other factors outside of our control could delay our ability to conduct clinical trials or release clinical trial results. In addition, the effects of the ongoing coronavirus pandemic may also increase non-trial costs such as insurance premiums, increase the demand for and cost of capital, increase loss of work time from key personnel, and negatively impact our key clinical trial vendors and supplier of API.

In light of the COVID-19 outbreak, the FDA has issued a number of new guidance documents. Specifically, as a result of the potential effect of the COVID-19 outbreak on many clinical trial programs in the US and globally, the FDA issued guidance concerning potential impacts on clinical trial programs, changes that may be necessary to such programs if they proceed, considerations regarding trial suspensions and discontinuations, the potential need to consult with or make submissions to relevant ethics committees, Institutional Review Board (“IRBs”), and the FDA, the use of alternative drug delivery methods, and considerations with respect the outbreak’s impacts on endpoints, data collection, study procedures, and analysis. Such developments may result in delays in our development of Bryostatin-1.

Results of Operations

Comparison of the six months ended June 30, 2022 and 2021

The following table summarizes our results of operations for the six months ended June 30, 2022 and 2021:


		Six Months ended										****
		June 30,						Dollar				****
	****	2022		****	2021		****	Change		****	% Change	****
Revenue		$	—		$	—		$	—		0	%
Operating Expenses:
Research and development expenses		$	3,427,175		$	2,138,060		$	1,289,115		60.3	%
General and administrative expenses		$	3,651,748		$	3,312,306		$	339,442		10.2	%
Other income, net		$	49,097		$	2,147		$	46,950		2,186.8	%
Net loss		$	7,029,826		$	5,448,219		$	1,581,607		29.0	%

Revenues

We did not generate any revenues for the six months ended June 30, 2022 and 2021.

Operating Expenses

Overview

Total operating expenses for the six months ended June 30, 2022 were $7,078,923 as compared to $5,450,366 for the six months ended June 30, 2021, an increase of approximately 29.9%. The increase in total operating expenses is due to the increase in research and development activities and general and administrative expenses. 24

Table of Contents Research and Development Expenses

For the six months ended June 30, 2022, we incurred $3,427,175 in research and development expenses as compared to $2,138,060 for the six months ended June 30, 2021, an increase of approximately 60.3%. These expenses were incurred primarily pursuant to developing the potential AD therapeutic product, specifically expenses relating to our ongoing Phase 2 clinical trial for AD. Of these expenses, for the six months ended June 30, 2022, $2,943,402 was incurred principally relating to our current confirmatory clinical trial and related storage of drug product, $152,658 for clinical consulting services, $14,931 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $23,481 for development of alternative drug supply with Stanford University and $292,703 of non-cash stock options compensation expense; comparatively, for the six months ended June 30, 2021, $1,732,669 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $156,853 for clinical consulting services, $14,876 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $24,197 for development of alternative drug supply with Stanford University and $209,465 of non-cash stock options compensation expense.

We expect our research and development expenses to level off as we expect that our current Phase 2 clinical trial for AD will be materially concluded by the end of 2022 while, to a lesser extent, our Phase 2 dose ranging study activities increase. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1.

General and Administrative Expenses

We incurred $3,651,748 and $3,312,306 of general and administrative expenses for the six months ended June 30, 2022 and 2021, respectively, an increase of approximately 10.2%. During the six months ended June 30, 2022, $601,507 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $667,552 for the six months ended June 30, 2021. The decrease in wages is primarily attributable to the reduction of bonus accruals for our former Chief Executive Officer; $207,019 was incurred for legal expenses versus $468,406 for the 2021 comparable period. The decrease in legal fees for 2022 is based upon prior year’s increased fees for one-time work for fundraising planning in 2021; $589,454 was incurred for outside operations consulting services during the six months ended June 30, 2022, versus $956,530 for the comparable period in 2021 as, during such period in 2021, we incurred additional non-cash expenses associated with warrant issuances for investment banking consulting services; $39,131 was incurred for travel expenses during the six months ended June 30, 2022, versus $28,167 for the comparable period in 2021; $133,569 was incurred for investor relations services during the six months ended June 30, 2022, versus $156,528 for the comparable period in 2021; $109,725 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the six months ended June 30, 2022, versus $88,163 for the comparable period in 2021; $365,544 was incurred for insurance during the six months ended June 30, 2022, versus $327,545 for the comparable period in 2021, which increase is primarily attributable to an increase in premiums; $170,254 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the six months ended June 30, 2022, versus $109,089 for the comparable period in 2021, with the increase for 2022 primary attributable to stock market up-listing fees to Nasdaq and rent expenses associated with our new Maryland laboratory facility; and $1,435,545 was recorded as non-cash stock options compensation expense during the six months ended June 30, 2022, versus $510,326 for the comparable period in 2021, which increase is primarily attributable to equity awards granted after June 30, 2021 expensed in 2022.

Other Income / Expense

We earned $49,097 of net interest income for the six months ended June 30, 2022 as compared to $2,147 for the six months ended June 30, 2021 on funds deposited in interest bearing money market accounts. The increase is primarily attributable to the increase in money market interest income rates and higher average cash balances in 2022 compared to the corresponding period in 2021.

Net loss

We incurred losses of $7,029,826 and $5,448,219 for the six months ended June 30, 2022 and 2021, respectively. The increased loss was primarily attributable to the increase in net research and development expenses associated with our current Phase 2 confirmatory clinical trial and an increase in general and administrative expenses. 25

Table of Contents

Comparison of the three months ended June 30, 2022 and 2021

The following table summarizes our results of operations for the three months ended June 30, 2022 and 2021:


	****	Three Months ended
		June 30,				Dollar
		2022		2021		Change		% Change	****
Revenue		$	—	$	—	$	—	0	%
Operating Expenses:
Research and development expenses		$	1,941,101	$	986,280	$	954,821	96.8	%
General and administrative expenses		$	1,855,290	$	1,308,893	$	546,397	41.7	%
Other income, net		$	44,487	$	1,331	$	43,156	3,242.4	%
Net loss		$	3,751,904	$	2,293,842	$	1,458,062	63.6	%

Revenues

We did not generate any revenues for the three months ended June 30, 2022 and 2021.

Operating Expenses

Overview

Total operating expenses for the three months ended June 30, 2022 were $3,796,391 as compared to $2,295,173 for the three months ended June 30, 2021, an increase of approximately 65.4%. The increase in total operating expenses is due to the increase in research and development and general and administrative expenses.

Research and Development Expenses

For the three months ended June 30, 2022, we incurred $1,832,792 in research and development expenses as compared to $986,280 for the three months ended June 30, 2021, an increase of approximately 85.8%. These expenses were incurred primarily pursuant to developing the potential AD therapeutic product, specifically expenses relating to our ongoing Phase 2 clinical trial for AD. Of these expenses, for the three months ended June 30, 2022, $1,680,918 was incurred principally relating to our current confirmatory clinical trial and related storage of drug product, $73,113 for clinical consulting services, $7,479 of amortization of prepaid licensing fees relating to the Stanford License Agreement and Mount Sinai Agreement, $7,938 for development of alternative drug supply with Stanford University and $171,653 of non-cash stock options compensation expense as compared to, for the three months ended June 30, 2021, $834,080 was incurred principally relating to our confirmatory clinical trial and related storage of drug product, $93,203 for clinical consulting services, $7,479 of amortization of prepaid licensing fees relating to the Stanford and Mount Sinai license agreements, $15,755 for development of alternative drug supply with Stanford University and $35,763 of non-cash stock options compensation expense.

We expect our research and development expenses to level off as our current Phase 2 clinical trial for AD will be materially concluded by the end of 2022 while, to a lesser extent, our Phase 2 dose ranging study activities increases. Other development expenses might increase, as our resources permit, in order to advance our potential products. We are continuing to determine how to proceed with respect to our other current development programs for Bryostatin-1. 26

Table of Contents General and Administrative Expenses

We incurred $1,855,290 and $1,308,893 of general and administrative expenses for the three months ended June 30, 2022 and 2021, respectively, an increase of approximately 41.7%. Of the amounts for the three months ended June 30, 2022, as compared to the comparable 2021 period: $307,603 was incurred primarily for wages, bonuses, vacation pay, severance, taxes and insurance, versus $237,337 for the 2021 comparable period. The increase is primarily attributable to the reclassification of our former Chief Executive Officer’s compensation to consulting fees for the comparable 2021 period; $77,804 was incurred for legal expenses versus $233,822 for the 2021 comparable period. The decrease for 2022 is based upon prior year’s increased fees for one-time work for fundraising planning in 2021; $193,250 was incurred for outside operations consulting services during the three months ended June 30, 2022, versus $363,854 for the comparable period in 2021 as, during such period in 2021, we incurred additional non-cash expenses associated with warrant issuances for investment banking consulting services; $24,479 was incurred for travel expenses during the three months ended June 30, 2022, versus $17,417 for the comparable period in 2021; $61,355 was incurred for investor relations services during the three months ended June 30, 2022, versus $89,459 for the comparable period in 2021; $87,677 was incurred for professional fees associated with auditing, financial, accounting and tax advisory services during the three months ended June 30, 2022, versus $38,268 for the comparable period in 2021. The increase for 2022 is attributable to expensing the 2021 audit in the second quarter of 2022 versus during the first quarter in 2021; $181,236 was incurred for insurance during the three months ended June 30, 2022, versus $165,437 for the comparable period in 2021, which increase is primarily attributable to an increase in premiums; $76,849 was incurred for utilities, supplies, license fees, filing costs, rent, advertising and other during the three months ended June 30, 2022, versus $47,510 for the comparable period in 2021, with the increase for 2022 primary attributable to stock market up-listing fees to Nasdaq and rent expenses associated with our new Maryland laboratory facility; and $845,037 was recorded as non-cash stock options compensation expense during the three months ended June 30, 2022, versus $115,789 for the comparable period in 2021, which increase is primarily attributable to equity awards granted after June 30, 2021 expensed in 2022.

Other Income / Expense

We earned $44,487 of net interest income for the three months ended June 30, 2022 as compared to $1,331 for the three months ended June 30, 2021 on funds deposited in interest bearing money market accounts. The increase is primarily attributable to the increase in money market interest income rates and higher average cash balances in 2022 compared to the corresponding period in 2021.

Net loss

We incurred losses of $3,751,904 and $2,293,842 for the three months ended June 30, 2022 and 2021, respectively. The increased loss was primarily attributable to the increase in net research and development expenses associated with our current Phase 2 confirmatory clinical trial and the increase in general and administrative expenses.

Financial Condition, Liquidity and Capital Resources

Cash and Working Capital

Since inception, we have incurred negative cash flows from operations. As of June 30, 2022, we had working capital of $28,932,496 as compared to working capital of $33,509,303 as of December 31, 2021. The $4,576,807 decrease in working capital was primarily attributable to approximately $7.1 million of operating expenses partially offset by non-cash expenses of approximately $1.8 million and cash proceeds from warrant exercises of approximately $553,000.

We expect that our current cash and cash equivalents of approximately $27.4 million will be sufficient to support our projected operating requirements for at least the next 12 months from the Form 10-Q filing date, which would include the continuing development and current Phase 2 clinical trial, of Bryostatin-1, our novel drug candidate targeting the activation of PKC epsilon. 27

Table of Contents We expect to require additional capital in order to initiate, pursue and complete all potential AD clinical trials and obtain regulatory approval of one or more therapeutic candidates. However, additional future funding may not be available to us on acceptable terms, or at all. If we are unable to access additional funds when needed, we may not be able to initiate, pursue and complete all planned clinical trials or continue the development of our product candidates or we could be required to delay, scale back or eliminate some or all of our development programs and operations. Any additional equity financing, if available, may not be available on favorable terms, would most likely be significantly dilutive to our current stockholders and debt financing, if available, and may involve restrictive covenants. If we are able to access funds through collaborative or licensing arrangements, we may be required to relinquish rights to some of our technologies or product candidates that we would otherwise seek to develop or commercialize on our own, on terms that are not favorable to us. Our ability to access capital when needed is not assured and, if not achieved on a timely basis, would likely materially harm our business and financial condition.

Sources and Uses of Liquidity

Since inception, we have satisfied our operating cash requirements from transfers of cash from Neurotrope, which was raised by Neurotrope through the private placement of equity securities sold principally to outside investors and through the Company’s two private placements. We expect to continue to incur expenses, resulting in losses and negative cash flows from operations, over at least the next several years as we continue to develop AD and other therapeutic products. We anticipate that this development may include clinical trials in addition to our current ongoing clinical trial and additional research and development expenditures.


		Six Months Ended June 30,
	****	2022		****	2021
Cash used in operating activities		$	6,009,489		$	5,585,322
Cash used in investing activities			3,029			—
Cash provided by financing activities			553,150			31,492,353

Net Cash Used in Operating Activities

Cash used in operating activities was $6,009,489 for the six months ended June 30, 2022, compared to $5,585,322 for the six months ended June 30, 2021. The $424,167 increase primarily resulted from the increase in net loss of approximately $1.6 million and the decrease in accounts payable of approximately $403,000 partially offset by a decrease in net of prepaid and accrued expenses of approximately $795,000 and an increase in non-cash stock-based compensation of approximately $765,000 for the six months ended June 30, 2022.

Net Cash Used in Investing Activities

Net cash used in investing activities was $3,029 for the six months ended June 30, 2022 compared to $0 for the six months ended June 30, 2021. The cash used in investing activities for the six months ended June 30, 2022 was for capital expenditures.

Net Cash Provided by Financing Activities

Net cash provided by financing activities was $553,150 for the six months ended June 30, 2022 compared to cash provided by financing activities of $31,492,353 for the six months ended June 30, 2021. The net cash provided by financing activities for 2022 resulted from the exercise of investor warrants issued in 2021. The net cash provided by financing activities in 2021 was primarily attributable to $23.7 million of net proceeds from our private placement offerings, $7.6 million from warrant exercises and $127,000 from NIH grant funding proceeds

Item 3. Quantitative and Qualitative Disclosures about Market Risk

Not applicable to a smaller reporting company.

Table of Contents Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

An evaluation was performed under the supervision and with the participation of our Chief Executive Officer and our Chief Financial Officer, our principal executive officer and principal financial and accounting officer, respectively, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) or 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this report. Based on their evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are not effective due to: inadequate segregation of duties consistent with control objectives in the areas over certain payroll and banking systems and user access controls; ineffective processes over period end financial disclosure and reporting including documentation of GAAP disclosure and reporting reviews supporting the financial reporting process and changes to chart of accounts; and ineffective information technology (IT) general computing controls including lack of risk and design assessments supporting IT security policies and procedures, user access, and IT controls within third party contracts. These weaknesses may affect management’s ability to determine if errors or inappropriate actions have taken place. Management is required to apply its judgment in evaluating the cost-benefit relationship of possible changes in our disclosure controls and procedures.

We previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, that our management, including our Chairman of the Board, principal executive officer and principal financial and accounting officer, assessed the effectiveness of our internal control over financial reporting based on the criteria for effective internal control over financial reporting established in the 2013 Internal Control— Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and SEC guidance on conducting such assessments. Based on that evaluation, they concluded that, during the period covered by the Annual Report on Form 10-K for the fiscal year ended December 31, 2021, such internal controls and procedures were not effective to detect the inappropriate application of US generally accepted accounting principles.

Based on management’s review, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were ineffective as of June 30, 2022. Notwithstanding the material weaknesses described above, our management, including the Chief Executive Officer and Chief Financial Officer, has concluded that financial statements, and other financial information included in this quarterly report, fairly present in all material respects our financial condition, results of operations, and cash flows as of and for the periods presented in this quarterly report.

Changes in Internal Controls over Financial Reporting

There was no change in our internal controls over financial reporting that occurred during the period covered by this report, which has materially affected, or is reasonably likely to materially affect, our internal controls over financial reporting.

Table of Contents PART II

OTHER INFORMATION

Item 1. Legal Proceedings.

None.

Item 1A. Risk Factors.

You should carefully review and consider the information regarding certain factors that could materially affect our business, consolidated financial condition or results of operations set forth under Item 1A. Risk Factors in our 2021 Annual Report on Form 10-K. There have been no material changes from the risk factors disclosed in our 2021 Annual Report on Form 10-K. We may disclose changes to risk factors from time to time in our future filings with the SEC.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

On June 7, 2022, we issued 679 shares of Common Stock to Neil Cataldi in exchange for investor relations services.

The foregoing transaction did not involve any underwriters or any public offering. The sale of the above securities was deemed to be exempt from registration under the Securities Act in reliance on Section 4(a)(2) of the Securities Act (and Regulation D promulgated thereunder) or Rule 701 promulgated under Section 3(b) of the Securities Act as transactions by an issuer not involving any public offering. The recipients of the securities in the transaction represented their intentions to acquire the securities for investment only and not with a view to, or for sale in connection with, any distribution thereof, and appropriate legends were affixed to the securities issued in these transactions. All recipients received or had, through their relationships with us, adequate access to information about us.

Item 3. Defaults upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

As previously disclosed, the Company entered into an offer letter (the “Offer Letter”) with Alan J. Tuchman, M.D., pursuant to which Dr. Tuchman agreed to serve as the Company’s Chief Executive Officer, commencing on December 7, 2020. The term of Dr. Tuchman’s employment pursuant to the Offer Letter is one year, which shall be extended automatically for six month periods unless either party gives timely written notice. Dr. Tuchman’s agreement was previously extended until December 7, 2022. On August 4, 2022, the Company entered into an amendment to the Offer Letter (the “Amendment”) to extend the term of Dr. Tuchman’s employment through June 7, 2023, and such term shall be extended for an additional six months upon Dr. Tuchman’s written notice to the Company at least 30 days prior to June 7, 2023. Pursuant to the Amendment, if Dr. Tuchman is terminated without Cause, Dr. Tuchman shall be entitled to severance equal to six months of Dr. Tuchman’s annual base salary.

The foregoing description of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Amendment, a copy of which is filed as Exhibit 10.2 to this Quarterly Report on Form 10-Q and incorporated herein by reference.

Table of Contents Item 6. Exhibits.

Exhibit<br>Number
10.1		Master Services Agreement, between Synaptogenix, Inc. and Worldwide Clinical Trials, Inc., dated as of February 7, 2022 and Work Order, dated May 12, 2022.

10.2+		Amendment to the offer letter, dated August 4, 2022, by and between the Company and Alan J. Tuchman, M.D.

31.1		Certification of the President and Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2		Certification of the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*		Certification of the President and Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2*		Certification of the Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101		The following financial information from this Quarterly Report on Form 10-Q for the period ended June 30, 2022, formatted in iXBRL (Inline Extensible Business Reporting Language): (i) the Condensed Statements of Operations; (ii) the Condensed Balance Sheets; (iii) the Condensed Statements of Cash Flows; and (iv) the Notes to Financial Statements, tagged as blocks of text.

104		Cover Page Interactive Data File (Embedded within the Inline XBRL document and included in Exhibit)

* The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Synaptogenix, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of such Form 10-Q), irrespective of any general incorporation language contained in such filing.

+ Management contract or compensatory plan or arrangement.

Table of Contents SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Synaptogenix, Inc.
Date: August 5, 2022	By:	/s/ Alan J. Tuchman, M.D.
		Alan J. Tuchman, M.D.
		Chief Executive Officer
		(principal executive officer)
Date: August 5, 2022	By:	/s/ Robert Weinstein
		Robert Weinstein
		Chief Financial Officer, Executive Vice President, Secretary and Treasurer
		(principal financial officer)

Exhibit 10.1

WORK ORDER

PROTOCOL NUMBER: NTRP101-205

This Work Order is made and entered as of the 12^th^ day of May, 2022 (the “Effective Date”) by and between Synaptogenix, Inc. (“Sponsor”) and Worldwide Clinical Trials, Inc. (“Worldwide”).

WHEREAS, Sponsor and Worldwide have entered into that certain Master Services Agreement effective February 7, 2022 (hereinafter referred to as the “Agreement”); and

WHEREAS, pursuant to the Agreement, Worldwide has agreed to perform certain Services in accordance with Work Orders from time to time entered into by the Parties, as more fully provided in Section 1.0 of the Agreement, and Sponsor and Worldwide now desire to enter into such a Work Order, (the “Work Order”).

WHEREAS, Worldwide and Sponsor desire that Worldwide provide certain Services with respect to A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of Bryostatin 1 Administered via IV Bolus Infusion for the Treatment of Subjects with Moderate to Severe Alzheimer's Disease (AD) Not Receiving Memantine Treatment, (the “Study”) for the study of the drug Bryostatin (“Study Drug”).

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the Parties hereby agree as follows:

1.Scope of Services. Worldwide shall perform the Services described in the Scope of Services, attached to this Work Order as Attachment A (“Assumptions and Scope of Services”).

2.Compensation. For performance of these Services, Sponsor shall pay to Worldwide the amounts set forth in the Budget set forth in Attachment B to this Work Order, which amounts shall be payable pursuant to the Payment Schedule set forth in Attachment C to this Work Order.

3.Term and Termination. The term of this Work Order shall commence upon the Effective Date stated above and shall continue until completion of Services as described in Attachment A, provided, however, the provisions of the Agreement shall govern its termination prior to completion.

4.Incorporation by Reference; Conflict. This Work Order is an integral part of, and shall be included in Exhibit A of the Agreement, incorporated into the Agreement and governed by the terms of the Agreement. In the event of a conflict between the terms and conditions of this Work Order and those of the Agreement, the terms of the Agreement shall take precedence and control over those of this Work Order unless the Work Order expressly and specifically states an intent to supersede the Agreement on a specific matter by reference. Unless otherwise specifically defined herein, each term used herein which is defined in the Agreement shall have the meaning assigned to such term in the Agreement.

5.Timely Completion. The Timeline for this Work Order is attached as Attachment D.

6.Currency. All invoices and amounts to be paid shall be in USD.

Page 1 of 50

IN WITNESS WHEREOF , the Parties have hereunto signed this Work Order as of the Effective Date.


Worldwide Clinical Trials, Inc.		Synaptogenix, Inc.

By:	/s/ Gabrielle Lewis	By:	/s/ Alan J. Tuchman, M.D.
Name:	Gabrielle Lewis	Name:	Alan J. Tuchman, M.D.
Title:	Legal Counsel	Title:	CEO
Date:	19-May-2022	Date:	5-2-2022

LIST OF ATTACHMENTS:

ATTACHMENT A:	****	ASSUMPTIONS AND SCOPE OF SERVICES
ATTACHMENT B:		BUDGET
ATTACHMENT C:		PAYMENT SCHEDULE
ATTACHMENT D:		TIMELINE

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MASTER SERVICES AGREEMENT

This Master Services Agreement (the “Agreement”) is made and entered into as of February 7^th^, 2022 (the “Effective Date”), by and between Worldwide Clinical Trials, Inc., with offices at 600 Park Offices Drive, Suite 200, Research Triangle Park, Durham, NC 27709 (together with its Affiliates, “Worldwide”) and Synaptogenix, Inc., with offices at 1185 Avenue of the Americas, 3rd Floor, New York, NY 10036 (“Sponsor”), both hereinafter referred to as the “Parties”.

For purposes of this Agreement, “Affiliates” means any entity that controls, is controlled by or is under common control with, that Party. “Control” means the possession, directly or indirectly, of at least 50% of the share capital or voting rights or of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of voting securities, by contract or otherwise.

WHEREAS, Sponsor is engaged in the research and development of pharmaceutical products;

WHEREAS, Worldwide is engaged in providing services to pharmaceutical companies in support of their clinical research and product development activities;

WHEREAS, Sponsor wishes to retain Worldwide, from time to time, to assist in certain product development activities relating to certain of Sponsor’s clinical studies (each of which shall be referred to as a “Study”); and

WHEREAS, Sponsor agrees to compensate Worldwide for its services.

NOW THEREFORE, in consideration of the premises and the mutual promises and undertakings herein contained, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

1.0	SERVICES

Worldwide, itself or through one of its Affiliates (if applicable) hereby agrees to perform the services (the “Services”) in accordance with the terms of this Agreement and any associated Work Order(s) (as hereinafter defined). In the event that Sponsor requires the performance of Services, it shall enter into a Work Order, defined as a separate written agreement between Sponsor and Worldwide, specifying the basic parameters of a project, including, without limitation, the assumptions, the costs, payment schedule, and the time period for completing a project, or as applicable, other Services to be performed by Worldwide for Sponsor (the “Work Order”). The Work Order shall be in the form as attached hereto as Exhibit A. To the extent any term or provision of a Work Order conflict with the terms and provisions of this Agreement, the terms and provisions of this Agreement shall prevail, except to the extent the Parties agree, or the applicable Work Order expressly and specifically states an intent to supersede this Agreement on a specific matter.

1.1	Performance

Worldwide shall use its commercially reasonable efforts to perform the Services within the estimated time frame set forth in Attachment D of the applicable Work Order. Such time estimate assumes, however, the full cooperation of Sponsor, Regulatory Authorities, Ethics Committees and investigators and other third parties not under Worldwide’s control, and shall be subject to adjustment (including costs) if the work for the Services is delayed due to circumstances not attributable to Worldwide.

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1.2	Compliance with Laws/Agreements

The Parties shall perform their obligations under this Agreement and each Work Order in accordance with the terms of this Agreement, the applicable Work Order, applicable provisions of the Study protocol, agreed upon standard operating procedures, the current Guidelines for Good Clinical Practice and the Declaration of Helsinki (both as applicable to the Services and in accordance with the specific standards and versions identified in the applicable Study protocol), all applicable laws and regulations, and applicable data privacy regulations, including (as applicable to Services) the European Union’s General Data Protection Regulation (“GDPR”) and the California Consumer Privacy Act (“CCPA”). Notwithstanding the foregoing, the Parties acknowledge that CCPA exempts Personal information collected as part of a clinical trial or other biomedical research study subject to, or conducted in accordance with, the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, pursuant to good clinical practice guidelines issued by the International Council for Harmonisation or pursuant to human subject protection requirements of the United States Food and Drug Administration, provided that the information is not sold or shared in a manner not permitted by this subparagraph, and if it is inconsistent, that participants be informed of that use and provide consent Cal. Civ. Code § 1798.145(c). Each Party shall ensure that all consents and authorizations required by applicable law are obtained, such that the other Party and each of the other Party’s permitted employees, agents, contractors, and representatives are permitted to access and/or process Personal Data of the other Party’s employees, agents, contractors, and representatives, for the purpose of fulfilling any obligation under this Agreement or for the purpose of complying with any requirement under applicable law or any other legal or regulatory requirement to which the Parties are subject. In addition, where GDPR is in scope, the terms of the Standard Contractual Clauses attached to this Agreement as Exhibit B incorporated herein by reference shall apply with respect to the applicable processing activity.

The Parties and their respective owners, officers, directors, employees or agents have not and shall not pay, give, offer or promise to pay or give, or authorize the payment, directly or indirectly, of any money or anything of value to any foreign government official or employee (including employees of state-owned institutions), for the purpose of (i) influencing any act or decision of such official or of such government,

(ii) inducing that person to do or omit doing any act in violation of his or her lawful duty, (iii) securing an improper advantage, or (iv) influencing such official to use his influence with the government to effect or influence the decision of such government, in order to assist Sponsor or Worldwide in obtaining or retaining business for or with or directing business to any person.

Each Party agrees to comply with all applicable anticorruption laws, rules and regulations. The Parties agree to reasonably cooperate with each other’s diligence efforts in order to satisfy each Party’s obligations under the United States Foreign Corrupt Practices Act, as amended (FCPA), the UK Bribery Act and any implementing legislation under the OECD Convention Against Bribery of Foreign Government Officials in International Business Transactions. Each Party represents and certifies that it maintains adequate internal controls and accurate books and records to the extent required in order to comply with applicable anti-corruption laws.

1.3	Transfer of Obligations

Each Work Order shall constitute a unique agreement and shall stand alone with respect to any other Work Order entered into under this Agreement. As required under Title 21 CFR Part 312.52 or such other substantially equivalent regulation as may be required by the applicable jurisdiction where the Study is conducted, including but not limited to Directive 2001/20/EC and Directive 2005/28/EC as applicable, the Parties shall document in writing the transfer by Sponsor to Worldwide of any of Sponsor’s responsibilities. Notwithstanding the foregoing, Sponsor will retain the ultimate authority and oversight over and responsibility for each Study.

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1.4	Changes

The terms of a Work Order may be amended or modified by mutual written agreement of Worldwide and Sponsor. Sponsor may request changes to a Work Order or, if Worldwide believes a change in the scope or scale of Services is necessary or advisable, Worldwide shall so advise Sponsor. In either case, the Parties will negotiate diligently and in good faith any proposed revisions and execute a Change Order (“Change Order”) to the applicable Work Order within a reasonable amount of time.

If a Change Order is not agreed by the Parties and executed promptly upon identification of scope change, then each change will be discussed, agreed and recorded in either an out of scope log (“Out of Scope Log”) or Change Notification Form (“CNF”) and executed by the Parties prior to being formalized in a Change Order on the achievement of an agreed aggregate Change Order threshold. The amended scope of Services and any associated changes to the budget as reflected in the signed or approved Out of Scope log entries or CNF is binding on both parties and shall be implemented. The Change Order threshold shall be identified in each applicable Work Order. Once any Out of Scope Log, CNF, or combination thereof has reached the Change Order threshold as outlined in the applicable Work Order, a formal Change Order will be prepared and executed by the Parties. Notwithstanding the aforementioned, in the event Worldwide provides additional services or expends resources at Sponsor’s written request and in strict accordance with Sponsor’s requirements, in the absence of a Change Order, Sponsor will compensate and/or reimburse Worldwide for all reasonable fees and reasonable costs incurred. In the event Sponsor fails to adhere to the terms of this provision and to compensate and/or reimburse Worldwide for out of scope Services within a reasonable amount of time, Worldwide reserves the right to suspend services under the applicable Work Order until such payment obligations have been met.

2.0****WORK PRODUCT

During the term of each Work Order, Worldwide shall maintain all materials and all other data or documents included in the Trial Master File obtained or generated by Worldwide in the course of providing the relevant Services in accordance with Worldwide’s standard operating procedures, including all computerized records and files (“Work Product”), in a secure area reasonably protected from fire, theft and destruction. At the expiration or termination of a Work Order and subject to satisfaction of the Parties’ obligations thereunder, Worldwide shall, at Sponsor’s expense, provide for the disposition of the Work Product as agreed in the applicable Work Order. The Work Order shall provide that Worldwide (a) deliver the Work Product, in the form in which Worldwide currently holds it, to a designated Sponsor location or to such other entity or at such other address as Sponsor may specify, (b) retain the materials for the period of time specified in the Work Order, or (c) destroy all such materials except for those which Worldwide is required by law or regulation to store or maintain. Upon expiration or termination of a Work Order, any storage, destruction or shipping costs or services relating to such disposition of the Work Product will be billed by Worldwide to Sponsor as Pass-through Expenses (as defined below) and all regulatory responsibilities with respect to the maintenance of such Work Product shall be conferred to Sponsor, as evidenced by Sponsor’s written acknowledgement of acceptance. Notwithstanding the foregoing, Worldwide may retain copies of any portion of the Work Product as may be reasonably necessary for regulatory or insurance purposes and one electronic, archival backup copy in accordance with Worldwide’s data retention standard operating procedures, subject to its ongoing obligation to maintain the confidentiality of such materials. For the avoidance of doubt, study records, documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced, (“Records”) are not required by regulatory bodies to be retained beyond the contractual agreement with the Sponsor. By default all Records will be returned to Sponsor at Sponsor’s expense if not specified otherwise in a Work Order.

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3.0	PAYMENT AND COMPENSATION

The Parties agree that the fees and other reimbursements that Worldwide will receive for performing the Services hereunder will be outlined in each Work Order and are subject to the following terms and conditions.

3.1	Compensation for Services

As compensation for providing the Services, Sponsor shall pay Worldwide in accordance with the terms in this Agreement and each applicable Work Order. Each Work Order will include as attachments a Study budget containing Worldwide’s estimated service fees and Pass-through Expenses (the “Budget”), a payment schedule (the “Payment Schedule”) and a timeline showing performance milestones (the “Timeline”).

3.2	Pass-through Expenses

Sponsor will reimburse Worldwide for travel and other reasonable out-of-pocket expenses, exclusive of grant payments (described below), incurred by Worldwide as identified in the Budget or otherwise approved by the Sponsor which Worldwide will invoice to the Sponsor without mark-up (“Pass-through Expenses”). Pass-through Expenses shall include, but shall not be limited to lodging, travel, third party vendor costs, and other reasonable costs.

3.3	Invoices

Worldwide shall submit a reasonably detailed invoice by email to Sponsor (atuchman@synaptogen.com on a monthly basis with appropriate supporting summary documentation. Each invoiced line-item Pass- through Expense includes a URL to the applicable receipt. Additional detailed back-up of Pass-through Expenses, including actual expense reports and/or expense receipts will not be provided to Sponsor. Worldwide shall retain receipts for review by Sponsor upon Sponsor’s written request.

3.4	Payment Terms

Sponsor agrees to pay for Services and Pass-through Expenses in accordance with the Payment Schedule outlined in each Work Order or associated Change Order. Sponsor will pay for all Services, Pass-through Expenses and other undisputed invoiced items within thirty (30) days of receipt of an invoice. Worldwide reserves the right to suspend Services in the event undisputed invoices are not paid in accordance with the payment terms contained herein. All payments will be made in the currency noted in the Work Order. All fees for Services and Pass-through Expenses under this Agreement are stated exclusive of any local, state, federal or foreign sales and use taxes, VAT, if any, as any such taxes shall be paid by Sponsor. If such taxes are applicable under local regulations, Worldwide will add these taxes to the invoices at the relevant rate. Worldwide reserves the right to apply inflation to fees for new and ongoing services that extend beyond the term agreed in the applicable Work Order, however, no such fee will be applied more frequently than annually and, in the event such inflation factor would increase by more than five percent (5%) from the inflation factors established in the Work Order Budget, the Parties agree to negotiate in good faith a mutually agreeable adjustment.

Payments shall be made by Sponsor via wire transfer of immediately available funds to Worldwide’s account set forth in the applicable Work Order.

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3.5	Project Delays

In the event Sponsor delays, suspends or places a hold on the Study for any reason, Sponsor shall promptly provide Worldwide with written notice of such delay, hold or suspension, and Sponsor and Worldwide will, within thirty (30) days of such notice, agree on appropriate revisions to the applicable Work Order and each Party will complete its respective duties and obligations as described in any resulting Change Order. During the period following Worldwide’s receipt of Sponsor’s notice of delay, hold or suspension, Sponsor will compensate Worldwide for additional service fees and Pass-through Expenses incurred by Worldwide as a result of such delay or suspension, as agreed to and set forth in any such resulting Change Order.

In the event that a Study is delayed or placed on-hold for more than thirty (30) calendar days, Sponsor shall have the right to retain, at Sponsor’s expense, all core team members, at their contracted rate for the duration of the delay or on-hold period. If Sponsor does not wish to retain any core team members for the duration of the delay or on-hold period, Worldwide shall have the right to reallocate any and all such staff after such thirty (30) calendar day period. If the delay or on-hold period continues for ninety (90) days, either Party may, by provision of written notice, terminate the applicable Work Order.

3.6	Currency Management

For service fees, the bid currencies will be tracked and managed against the contract currency established in each Work Order. At the end of each calendar quarter, a currency review may occur to assess the impact of currency fluctuation by comparing the actual average exchange rate(s) as published by Reuters.com (historical currency converter; average exchange rate with the basis the MID between the bid and the ask rate) to the currency exchange rate(s) set out in the Work Order If the actual average exchange rate differs (up or down) by more than 2% from the currency exchange rate(s) in the applicable Work Order, Worldwide will apply this percent difference against the amounts invoiced for fees since the last review was carried out. Such currency exchange rate adjustment will be credited (or debited) against the next invoice issued to Sponsor. If more than one bid currency is being tracked, the currency fluctuation review will compare the weighted average actual exchange rate to the weighted average exchange rate set out in the applicable Work Order.

3.7	Disputed Invoices

In the event Sponsor disputes one or more items in an invoice, Sponsor will notify Worldwide in writing within ten (10) business days of receipt of the invoice and such notice shall contain a reasonably detailed description of the item(s) being disputed and the basis therefor. Worldwide will respond to Sponsor within ten (10) business days of receipt of the notification. This written communication pattern will continue until Worldwide has provided Sponsor with sufficient justification for the disputed item(s) or until the Parties agree to a resolution of the disputed amount. Sponsor shall pay the undisputed portion of the invoice in accordance with the payment terms and shall use its best efforts to pay the disputed amount within twenty (20) days of resolution of the dispute. In the event the Parties are unable to reach a satisfactory resolution within sixty (60) days of the original invoice, either Party may pursue alternative remedies in accordance with this Agreement.

4.0	THIRD PARTY AGREEMENTS

Worldwide may retain one (1) or more third party providers to perform, in whole or part, Services required under any Work Order governed by this Agreement. Worldwide shall ensure each third party provider is bound by terms and conditions at least as restrictive as the obligations outlined in this Agreement regarding intellectual property and confidential information in connection with the performance of Services under any Work Order.

Page 7 of 50

In the event Worldwide contracts with its approved third party provider, Worldwide hereby agrees to manage and assume responsibility for such third party provider’s performance.

In the event Sponsor requests Worldwide to use a particular third party provider, and Worldwide, at its reasonable discretion, does not wish to contract with such third party provider, then Sponsor shall contract directly with such third party provider (a “Sponsor Designated Provider”). In no case will Worldwide be liable to Sponsor for Sponsor Designated Provider’s performance or conformance with any obligations under this Agreement or the instruction or supervision of such Sponsor Designated Provider.

4.1	Institutions/Investigators

Worldwide’s Services under a Work Order may include identifying potential medical institutions (“Institutions”) or clinical investigators (“Investigators”) (Institutions and Investigators together, the “Sites”) and/or negotiating, executing and/or administering contracts with such parties which will govern their participation in the Study (“Clinical Trial Agreements”). If, pursuant to a Work Order, Sponsor delegates to Worldwide the responsibility for negotiating and/or executing Clinical Trial Agreements, the following provisions will apply:

(a)	Sponsor may provide Worldwide with a list of suggested Sites to be recruited by Worldwide for a Study. Worldwide shall notify Sponsor in writing as to any listed Site with which Worldwide does not wish to contract.

(b)	Selection of all Sites will be subject to approval by Sponsor prior to initiation of any Study-related activities involving that Site or the start of any negotiations with such Site.

(c)	Where Worldwide is negotiating Clinical Trial Agreements on behalf of Sponsor, Worldwide templates and fallback parameters shall be used. Templates, parameters and negotiation process will be subject to approval by Sponsor prior to the start of negotiation with the Sites and shall be incorporated into a Contract and Budget Plan executed by the Parties.

(d)

In ex-US regions, local laws, practices and logistical considerations may make it necessary or preferable for Worldwide to act as a contracting party to the Clinical Trial Agreements. For such regions, Worldwide may enter into Clinical Trial Agreements directly as an agent on behalf of Sponsor. Unless otherwise required by applicable law, each template shall clearly identify the agency relationship between Sponsor and Worldwide and all Sponsor rights and obligations under the Clinical Trial Agreement shall remain with Sponsor as principal.

(e)

If a Site requests indemnification from Sponsor, standard indemnification language, generated by the Sponsor, will be provided to the Site. If the Site requests changes to the standard language, Worldwide will negotiate with the Site on Sponsor’s behalf with Sponsor’s input and approval, and if agreed, Sponsor will issue a letter of indemnification directly to the Site. Sponsor acknowledges that Worldwide shall have no indemnification obligation to any Site relative to the Study drug or the applicable Study protocol. In addition, Worldwide shall not be deemed to have failed to perform under this Agreement in the event a Site declines participation in a Study as a result of Sponsor’s refusal to indemnify such Site.

(f)	The Sponsor may elect that grant payments to Sites be administered on its behalf by Worldwide, acting solely as payment agent unless otherwise agreed to by Worldwide in writing. Worldwide shall distribute all payments to Sites according to the provisions of the applicable Clinical Trial Agreement and Work Order. Sponsor acknowledges and agrees that Worldwide will manage all

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administration of payments or other obligations to Sites for Services rendered in connection with relevant Studies solely out of funds provided to Worldwide from Sponsor for this specific purpose. Furthermore, Sponsor acknowledges and agrees that Worldwide intends to maintain a cash neutral policy with regard to Site payments. In the event Worldwide or the Sites incur bank fees with respect to the remittance of these grant payments, such fees will be borne by Sponsor. All payments to Sites and any associated bank fees will be made by Worldwide solely from the funds that have been specifically provided by Sponsor to Worldwide for this purpose and not from Worldwide funds. Worldwide will not be liable for payments not made on a timely basis to any Site as a result of Sponsor’s failure to provide, in advance, sufficient funds for such payments.

The Parties acknowledge and agree that, for the purposes of this Agreement or any Work Order, Sites shall not be considered as employees, agents or subcontractors of Worldwide or Sponsor and that Sites will be required to exercise their own independent medical judgement. Worldwide’s responsibilities with respect to Sites shall be limited to those specifically set forth in the applicable Work Order.

5.0****CONFIDENTIAL INFORMATION

The Parties acknowledge and agree that in the course of performing Services hereunder, either Party may be exposed to or be given confidential or proprietary information of the other Party (“Confidential Information”). The Parties agree to hold all Confidential Information in secrecy for a period of five (5) years from the date hereof and shall disclose Confidential Information to agents, employees and/or third parties strictly on a need-to-know basis for purposes of this Agreement. Without limiting the generality of the foregoing, Confidential Information shall include, without limitation, financial information, protocols, brochures, formulations, proposals, employee information, research and development programs, methodology, testing techniques, analytical test method, test samples and prototypes, information gathered or viewed during a site visit, audit or inspection of a Party, analyses, software, source codes and technological or other know-how. Confidential Information shall be deemed to be all such information given by the disclosing Party to the receiving Party except for information which is (i) publicly available or later becomes publicly available through no fault of the receiving Party; (ii) obtained by the receiving Party from a third party entitled to disclose it; (iii) already in possession of the receiving Party as indicated in its competent written records; (iv) independently developed by the receiving Party without use of the Confidential Information as evidenced by competent written records; or (v) required by any law, rule, regulation, order, decision, decree, or subpoena or other judicial, administrative, or legal process to be disclosed.

Both Parties shall ensure that all of its officers, employees, consultants, agents, subcontractors, third party vendors, investigators or contractors who receive such Confidential Information understand and shall be bound by confidentiality provisions at least as stringent as the confidentiality obligations in this Agreement.

Unless otherwise agreed in writing, within thirty (30) days after the termination of the Agreement or the written request by the disclosing Party, and if the disclosing Party is Sponsor, Sponsor’s payment of all outstanding , undisputed invoices, the receiving Party shall return to the disclosing Party all Confidential Information in documentary or permanent form including any and all copies thereof, except for one archival copy that the receiving Party can keep for its records (which may be electronic). Worldwide is responsible for abiding by the terms of this Section 5.0 and for the secure storage of Sponsor’s Confidential Information under all circumstances, including in the event that Worldwide withholds Sponsor’s Confidential Information in a payment dispute as contemplated herein. Under no circumstances will Worldwide withhold Sponsor’s study data and results.

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The Parties agree that each Party is and shall remain the exclusive owner of its Confidential Information and all patent, copyright, trade secret and other intellectual property rights therein unless and until a further agreement is executed.

The Parties acknowledge that any violation of the terms of this Section 5 may result in irreparable injury and damage to disclosing Party that is not adequately compensable in money damages, and for which disclosing Party may have no adequate remedy at law. Accordingly, the receiving Party agrees that the disclosing Party shall be entitled to seek (without waiving any additional rights or remedies, including monetary damages, otherwise available to the disclosing Party at law, in equity, or by statute) preliminary and permanent injunctive relief in the event of a breach or intended or threatened breach by the receiving Party.

6.0****OWNERSHIP OF DATA AND INTELLECTUAL PROPERTY

Any invention, discovery, or improvement directly related to Sponsor’s, Confidential Information products or technology which is conceived or reduced to practice as a direct consequence of Worldwide’s performance of the Services hereunder (the “Inventions”) shall become Sponsor property and shall be used by Sponsor as Sponsor deems appropriate. Worldwide agrees to execute and have executed assignments of the Inventions to Sponsor, along with other documents that be necessary or helpful to Sponsor in filing patent applications, or which may relate to any litigation or interference and/or controversy in connection therewith. The entire control, prosecution, and conduct of any patent application filed by Sponsor shall be outside the jurisdiction of and without expense to Worldwide and its officers, employees, representatives and agents. Worldwide acknowledges that Sponsor has the exclusive right to file patent applications in connection with the Inventions. Worldwide warrants that neither it, nor its employees, agents and representatives, will prevent Sponsor from filing patent applications for, or from applying the results of the research carried out for Sponsor hereunder. Worldwide further warrants that its employees are obligated by contract to assign their rights in any Inventions and take steps necessary to perfect Sponsor’s rights therein.

All reports, data, technical information, original works of authorship and all other information, furnished by or on behalf of Sponsor, or created specifically for Sponsor as a deliverable under a Work Order, shall be the sole property of Sponsor. Except as expressly provided in this Section 6, nothing in this Agreement shall be construed as (i) granting to any Party any rights under any patent, copyright or other intellectual property right of the other Party (ii) granting to any Party any rights in or to the Confidential Information of the other Party other than the limited right to use such Confidential Information solely for the purposes expressly permitted by Section 5 of this Agreement.

Sponsor acknowledges that all computer programs, applications, algorithms, databases, methods, techniques, processes and other materials and ideas used by Worldwide in performance of the work under this Agreement, and not supplied to Worldwide by Sponsor (“Worldwide Works”), are the exclusive property of Worldwide or its licensors. Sponsor agrees that any improvements, alterations or enhancements to the Worldwide Works during the term of this Agreement or the Study shall be the sole property of Worldwide. Subject to Section 5 hereof, in no event shall Worldwide be precluded from use of its general knowledge, skills and experience, and any of its ideas, concepts, know-how and techniques used or developed by it in the course of providing Services under this Agreement.

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7.0	TERM AND TERMINATION

7.1	Term

This Agreement shall commence on the Effective Date and, unless otherwise terminated, shall continue for three (3) years (“Term”). Upon the expiration of the three (3) year term, the Agreement shall automatically renew for periods of one (1) year (“Extension Term”); unless either Party provides notice of intent not to renew the Agreement within thirty (30) days of the expiration date of the applicable Term or Extension Term. Termination of this Agreement shall not affect any Work Order and each Work Order shall continue in full force and effect until its expiration date or final payment is received, unless specifically earlier terminated in accordance with the terms of this Agreement or the terms of that Work Order.

7.2	Termination for Material Breach

In the event that either Party commits a material breach in any of the terms or conditions of this Agreement or a Work Order, and that Party fails to cure the breach to the reasonable satisfaction of the non-breaching Party within thirty (30) days after receipt of notice of the default or breach from the other Party, the Party giving notice may, at its option, immediately terminate this Agreement, or the Work Order, as applicable, at the end of the 30-day period. For the avoidance of doubt, non-payment of an undisputed invoice hereunder shall automatically be deemed a material breach.

7.3	Termination by Sponsor without Cause

Sponsor shall have the right to terminate this Agreement or a Work Order (for other than breach by Worldwide) at any time by giving written notice at least ninety (90) days prior to the desired termination date.

7.4	Termination by Worldwide without Cause

Worldwide shall have the right to terminate this Agreement or any Work Order hereunder (for other than breach by Sponsor) at any time by giving appropriate written notice at least ninety (90) days prior to the desired termination date; provided, however, if Worldwide terminates this Agreement while any Work Order remains in effect, the terms of this Agreement will continue in force until Worldwide has completed the Services under the applicable Work Order and has received full payment therefor.

7.5	Termination for Other Reasons

Either Party shall have the right to terminate a Work Order due to patient safety at any time by giving appropriate written notice to the other Party. Either Party shall have the right to terminate this Agreement and/or one or more Work Orders at any time upon receipt of written notice to the other Party, if the other Party shall be adjudicated insolvent or shall petition for or consent to any relief under any insolvency, re- organization, receivership, liquidation, compromise, or any moratorium statute, whether now or hereafter in effect, or shall make an assignment for the benefit of its creditors, or shall petition for the appointment of a receiver, liquidator, trustee, or custodian for all or a substantial part of its assets, or if a receiver, liquidator, trustee or custodian is appointed for all or a substantial part of its assets and is not discharged within thirty (30) days after the date of such appointment. In the event that any of the above events occur, that Party shall immediately notify the other, in writing, of its occurrence.

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7.6	Termination Procedures

Upon termination of this Agreement or any Work Order, the Parties will reasonably cooperate with each other to provide for an orderly cessation and transition, if applicable, of Worldwide’s Services. Worldwide shall use its commercially reasonable efforts to minimize costs associated with the cessation of the Services. In the event a Work Order is terminated, Worldwide shall be entitled to receive payment for all Services actually performed in accordance with the terms of this Agreement and the respective Work Order (based on units completed) and expenses incurred or irrevocably committed to third parties up to the effective date of termination in accordance with the contracted payment terms. In addition, in the event that this Agreement or any Work Order is terminated, Sponsor shall pay all reasonable fees and expenses incurred by Worldwide that are necessary or reasonably required in connection with the orderly cessation or transition of the Services. Upon satisfaction of the Parties’ obligations under this Section 7.6, Worldwide shall deliver all final deliverables to Sponsor and the Parties shall execute a final reconciliation and release agreement pertaining to the applicable Work Order(s). If a Study, Work Order, or the Agreement is cancelled or terminated before the Services have been performed completely, Worldwide shall refund to Sponsor any funds advanced to Worldwide for fees and costs not yet incurred or due to the extent that the payments for the liabilities associated with such fees or costs can reasonably be avoided in whole or in part.

8.0****DEBARMENT CERTIFICATION

Worldwide certifies that it has not been debarred under Section 306 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §335a(a) or (b) or any equivalent local law or regulation. In the event that Worldwide becomes debarred, Worldwide agrees to notify Sponsor immediately.

Worldwide certifies that it has not and will not use in any capacity the services of any individual, corporation, partnership, or association which has been debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C §335a (a) or (b) or any equivalent local law or regulation. In the event that Worldwide becomes aware of or receives notice of the debarment of any individual, corporation, partnership, or association providing services to Worldwide, which relate to the Services being provided under this Agreement, Worldwide agrees to notify Sponsor immediately.

9.0	QUALITY ASSURANCE AND AUDITS

9.1	Financial Record Audits

Worldwide shall maintain complete and accurate financial records relating to its performance of the Services and Pass-through Expenses incurred in connection therewith for a period of four (4) years or such later period as required by law.

9.2	Quality GxP Audits by Sponsor

(a)

During the term of each Work Order, Worldwide will permit representatives of the Sponsor to audit any Services provided by Worldwide, to determine that the Services were conducted in accordance with this Agreement and the applicable Work Order; provided that the audit will take place at a reasonable time during normal business hours and reasonable advance written notice is given (i.e. no less than ten (10) business days prior to commencing an audit for/ or without cause, and subject to availability of relevant Worldwide staff and any prior Worldwide inspection or audit commitments). No-cause Sponsor audits are conducted at the Sponsor’s sole cost and expense. Any Sponsor audit may include review of: (i) the facilities where the Services are being, will be or

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have been conducted; (ii) related Study documentation; and (iii) any other relevant information necessary for Sponsor to confirm that the Services are being or will be or have been conducted in conformance with applicable standard operating procedures, the specific Work Orders, this Agreement, and in compliance with applicable laws and regulations. Worldwide will provide copies of any materials reasonably requested by Sponsor during such Sponsor audit. The Sponsor representative conducting the audit of Worldwide under this section shall not be a Competitor of Worldwide. For purposes of this Section a “Competitor” of Worldwide means a service provider that performs services substantially similar to the services Worldwide performs for its customers and that is identified to Sponsor in writing prior to Sponsor’s notice of an audit – notwithstanding any CRO i.e. PPD, Syneos, IQVIA, Parexel, ICON, etc. shall be considered a ‘Competitor’ of Worldwide.

(b)

Sponsor QA or its representative may conduct audits of a Site to enable Sponsor to assess whether the Services are being provided in accordance with this Agreement and shall work directly with such Sites and Worldwide’s project team in connection with such audit. Worldwide will in good faith and as requested by Sponsor in writing, assist Sponsor in obtaining the information requested, or required in the conduct of the audit. Sponsor shall not disclose to any third party any Confidential Information of Worldwide disclosed to Sponsor in the course of an audit except in accordance with the confidentiality obligations under this Agreement and in no event shall Sponsor disclose Worldwide Confidential Information to a Competitor of Worldwide. If requested by Worldwide in advance, in writing, Sponsor shall reimburse Worldwide for out of pocket costs for the provision of Worldwide personnel to assist with translation during the conduct of an audit.

(c)

If Corrective and Preventive Actions (“CAPAs”) are necessary at the Site or in connection with the investigation or as a result of an audit, Sponsor and Worldwide shall agree in writing as to any Services to be provided by Worldwide in connection with the CAPA and Sponsor shall compensate Worldwide for all related fees expenses to be incurred, provided that Sponsor shall not be liable for any Service fees or expenses directly arising out of a CAPA to the extent any audit findings are the result of Worldwide’s breach of this Agreement or Work Order.

(d)

For purposes of this Section, if any audit by Sponsor is conducted by a party other than a Sponsor employee (“Third Party Auditor”), the Third Party Auditor will be (i) duly qualified by Sponsor to conduct an audit of the Services; and (ii) will, prior to any access to a Worldwide facility or disclosure of any Confidential Information or materials by Worldwide, have agreed to and execute a confidentiality and nondisclosure agreement with Worldwide as to Worldwide Confidential Information that is consistent with and not less stringent than the confidentiality obligations in this Agreement.

10.0****REGULATORY AUTHORITIES COMMUNICATIONS AND INSPECTIONS

10.1	Inspection by Regulatory Authorities

(a)

During the term of each Work Order, each Party will permit regulatory authorities to examine: (i) the facilities where the Services are being conducted; (ii) Study documentation; and (iii) any other relevant information, including information that may be designated by one or both of the Parties as confidential, reasonably necessary for regulatory authorities to confirm that the Services are being conducted in compliance with applicable laws and regulations. Worldwide will notify Sponsor as soon as possible, but no later than one (1) business day if any regulatory authority schedules, or without scheduling, begins an inspection that relates to the Services or Worldwide’s obligations hereunder.

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(b)

Worldwide shall notify Sponsor within one (1) business day of receipt of a non-routine inquiry, correspondence, inspection or other contact by a regulatory authority in connection with a Study, or this Agreement (each a “Non-Routine Regulatory Contact”) including, but not limited to, inspections of any Sites. For avoidance of doubt, “Non-Routine Regulatory Contact” means any contact by a regulatory authority that is other than a contact that reasonable could be expected in the normal course of business.

(c)	Each Party shall immediately forward to the other Party copies of any correspondence or other documentation from or to any regulatory authority relating solely to a Study or this Agreement.

(d)

As to a regulatory finding, observation or other contact to which Worldwide is required or is reasonably expected to submit a written response in relation to a Study or this Agreement, Worldwide will use reasonable efforts to provide Sponsor with a reasonable opportunity to review and comment on any response (“Response”) required from Worldwide to a regulatory authority. Worldwide shall in good faith consider the inclusion of any comments from Sponsor in its Response but shall not be obligated to incorporate any such comments in a Response. In the event that Worldwide does not incorporate Sponsor comments in the Response, Worldwide shall use reasonable efforts to notify Sponsor prior to the submission of such Response in order to mutually resolve any issues. In any event Worldwide shall promptly provide to Sponsor a copy of the Response submitted by Worldwide to any regulatory authority that (i) solely relates to a Study or this Agreement; or (ii) that would have a material negative impact on the ability of Worldwide to provide the Services provided that Worldwide shall not disclose any information relating to a third party or matter that does not have a material negative impact on the ability of Worldwide to provide the Services.

(e)	Each Party acknowledges that it may not direct or manage the manner in which the other Party fulfils its obligation to permit/conduct inspections by a regulatory authority.

10.2	Serious Breach

(a)	“Serious Breach” may include (a) violation of the conditions and principles of GCP in connection with the trial or (b) the protocol relating to the trial, which is likely to effect to a significant degree: (i) the safety or physical or mental integrity of the subjects of the trial; or (ii) the scientific value of the trial.

(b)	Each Party will notify the other in writing of any Serious Breaches within forty-eight (48) hours of confirmation.

(c)	Upon notification of a Serious Breach the Parties will collaborate on the intended course of action; and inform together the relevant IRB or regulatory authority (for example, MHRA, FDA), if appropriate. Sponsor shall be responsible for any reporting to the regulatory authority and ethics committee unless otherwise agreed in writing.

(d)	Either Party may inform relevant regulatory authorities of any such Serious Breach if, in its opinion, such reporting is required by regulation.

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11.0	INDEMNIFICATION

11.1	Indemnification by Worldwide

Worldwide shall indemnify Sponsor and its Affiliates and their officers, directors, employees and agents from any loss, damage, cost or expense (including reasonable attorney’s fees) arising from any third party claim, demand, assessment, action, suit or proceeding (a “Claim”) to the extent caused by Worldwide’s breach of this Agreement, negligence or intentional misconduct. Sponsor will have no obligation to indemnify Worldwide to the extent that a Claim is caused by Worldwide’s breach of this Agreement, negligence or wilful misconduct.

11.2	Indemnification by Sponsor

Sponsor shall indemnify Worldwide and its Affiliates and their respective officers, directors, employees and agents (the “Worldwide Group”) arising out of any Claim related to (i) Worldwide’s performance of the Services in accordance with the terms of this Agreement, the applicable Work Order, or any protocol related thereto, (ii) the Study drug’s harmful or otherwise adverse effect, including, without limitation, a Claim based upon the consumption, sale, distribution or marketing of any substance, including the Study drug, (iii) Sponsor’s breach of this Agreement or the applicable Work Order, or the negligence or intentional misconduct of Sponsor, except to the extent such Claim is caused by Worldwide’s breach of this Agreement, negligence or wilful misconduct.

In the event Worldwide incurs costs or expenses as a result of its becoming involved in, or being required to appear or otherwise participate in, a matter (i) relating to a Study that is the subject of a claim or any proceeding, litigation, arbitration or some other dispute resolution mechanism, and (ii) where Worldwide’s performance of the Services in a manner other than in compliance with this Agreement is not directly and in good faith at issue in such claim, then Sponsor shall reimburse Worldwide for its reasonable costs or expenses. The Parties agree to cooperate with each other and to use commercially reasonable efforts in good faith to minimize Worldwide’s participation in and the costs or expenses relating to such disputes.

11.3	Indemnification Procedures

Upon receipt of written notice of any Claim which may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification (the “Indemnified Party”) shall give written notice thereof to the other Party (the “Indemnifying Party”). The Indemnified Party shall permit the Indemnifying Party, at its own option and expense, to assume the complete defense of such Claim, provided that the Indemnified Party will have the right to participate in the defense of any such Claim at its own cost and expense. As to those Claims with respect to which the Indemnifying Party does not elect to assume control, the Indemnified Party will afford the Indemnifying Party an opportunity to participate in such defense, at the Indemnifying Party’s own cost and expense.

12.0	LIMITATION OF LIABILITY

Except for the indemnification obligations of either Party under Section 11, under no circumstances shall either Party be liable under this Agreement for any indirect, incidental, special or consequential damages of the other Party resulting from such Party’s performance or failure to perform under this Agreement. In addition, and except for the indemnification obligations of Worldwide under Section 11.1, in no event shall the collective, aggregate liability of the Worldwide Group to Sponsor exceed the amount of fees actually payable to Worldwide from Sponsor pursuant to the Work Order from which such liability arose.

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13.0	INSURANCE

For each applicable Work Order, Sponsor hereby represents and warrants that it shall maintain adequate clinical trial and product liability insurance coverage, with insurance companies having an A. M. Best Rating of "A-, VII" or better, consistent with industry standards to cover all personal injury, death or loss suffered as a result of the Study drug, participation in the trial or the trial screening process. Other than as set forth in Section 11.1, to the extent that Worldwide provides depot services to Sponsor, Worldwide does not take any responsibility for loss or damage to the Study drug while stored at Worldwide’s premises or in transit. Sponsor hereby acknowledges that Worldwide does not carry separate property insurance to cover the value of the Study drug(s). Sponsor shall provide Worldwide with a copy of Sponsor’s effective Certificate of Insurance, Insurance Policy, and any additional policy documents or such other documented evidence reasonably requested by Worldwide to confirm that it has such coverage. Furthermore, for each Study, Sponsor shall execute a Clinical Trial Insurance Declaration in a form substantially similar to Exhibit C attached hereto. Sponsor shall maintain such insurance for the entire duration of the Study and shall notify Worldwide of any changes in coverage which impact the coverage requirements set forth above.

Prior to commencement of any work under this Agreement, Worldwide shall, at its sole expense, maintain the following insurance on its own behalf, with insurance companies having an A. M. Best Rating of "A-, VII", or better:

(1)Commercial General Liability (including Premises Operations). The policy must be on an occurrence form and include the following limits: Each Occurrence: $1,000,000; General Aggregate: $2,000,000.

(2)Commercial Umbrella Liability. This policy must include the following limits: Occurrence Limit: $4,000,000; Aggregate Limit (where applicable); $4,000,000 Policy to be excess of the Commercial General Liability, Commercial Automobile Liability and Employers Liability.

(3)Product/Professional Liability Coverage (Errors & Omissions): Each Claim Limit: $ 10,000,000; Aggregate Limit: $10,000,000. Throughout the Term of this Agreement, the Errors & Omissions Liability insurance’s retroactive date will be no later than the Effective Date of this Agreement.

Sponsor shall be named an additional insured on Worldwide’s general liability policy (excluding products and completed operations).

14.0****REPRESENTATIONS AND WARRANTIES

Each Party represents that it is authorized to enter into this Agreement, and any Work Order issued hereunder, and that the terms of this Agreement are not inconsistent with or a violation of any contracted or other legal obligation to which it is subject.

Each Party represents that it has all qualifications, authorizations, licenses or permits which are necessary for performance of its obligations under this Agreement.

15.0****DISCLAIMER

Sponsor acknowledges that the results of the Studies for which the Services are to be provided hereunder are inherently uncertain and that, accordingly, there can be no assurance, representation or warranty by Worldwide that the product covered by this Agreement can, either during the term of this Agreement or thereafter, be successfully developed or receive the required approval by the regulatory authorities.

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Sponsor acknowledges that the development of the protocol concept and scientific rationale shall be the sole responsibility of Sponsor regardless of Worldwide’s involvement in Study design or protocol-writing (or lack thereof).

16.0****EMPLOYEES; NON-SOLICITATION

Worldwide’s staff is not, nor shall they be deemed to be at any time during the term of this Agreement, the employees of Sponsor. In consideration of the fees and benefits provided in this Agreement, Sponsor agrees that, without Worldwide’s prior written consent, during the term of this Agreement and for a period of twelve (12) months following its expiration or other termination, neither Sponsor nor any of its Affiliates shall directly solicit for employment or contract, attempt to employ or contract with, or assist any other entity in employing, contracting with or soliciting for employment or contract any employee who is at that time employed/contracted by Worldwide and who had been employed/contracted by Worldwide in connection with one or more Work Orders issued hereunder. In the event of a breach of this Section 16, Worldwide shall be entitled to liquidated damages from Sponsor in an amount equal to six (6) months of such person’s salary. The Parties expressly agree that this amount is not a penalty but is a reasonable estimate of the damages that would result from any breach. In the event that legal action becomes necessary for the enforcement of all or any part of this provision or to collect the liquidated damages provided for herein, the prevailing party shall receive in addition to any other damages or relief awarded, its reasonable attorneys’ fees, together with appropriate costs and interest. Sponsor acknowledges that in the event of a breach of this Section 16, Worldwide shall be entitled to recover injunctive relief as well as liquidated damages, and that the liquidated damages provision included herein does not provide Worldwide with an adequate remedy at law for any such breach. Worldwide acknowledges and agrees that response by a Worldwide employee to a publicly-posted employment advertisement of Sponsor or any of its Affiliates does not violate this Section 16.

17.0****NOTICES

All notices provided for in this Agreement shall be in English and shall be sent by registered first class mail, postage prepaid, return receipt requested, addressed to the respective Parties as follows:

If to Sponsor:

Synaptogenix, Inc.,

1185 Avenue of the Americas

3rd Floor, New York

NY 10036

ATTN: Robert Weinstein

If to Worldwide:

c/o Worldwide Clinical Trials, Inc.

600 Park Offices Drive, Suite 200

Research Triangle Park

Durham, NC 27709

ATTN: Legal Department

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18.0	MISCELLANEOUS

18.1	Modification

This Agreement may be supplemented, amended or modified only by mutual agreement of the Parties. No supplement, modification or amendment of this Agreement will be binding unless it is in writing and signed by both Parties.

18.2	Assignment

Neither Party shall have the right to assign this Agreement or any of the rights or obligations hereunder, except that (a) Worldwide may subcontract with such individuals or entities it deems necessary and appropriate in order to perform the Services provided that Worldwide will remain responsible for the performance of such subcontracted Services as if it had provided the Services itself, and (b) either Party may assign this Agreement to (i) an Affiliate or (ii) a purchaser of or successor to that area of its business to which this Agreement is related (or, the case of Sponsor, the outstanding Work Orders relate), upon written notice, where such Affiliate or successor has the financial and operational capacity and ability to perform the assigning Party’s obligations hereunder.

18.3	Force Majeure

Neither Sponsor nor Worldwide shall be liable for delays in performing or any failure to perform any of the terms of this Agreement or a Work Order caused by the effects of natural disaster, strike, war (declared or undeclared), insurrection, acts of terror, government sanction, restriction or prohibition, or other causes reasonably beyond its control and without its fault, but the Party failing to perform shall use all commercially reasonable efforts to resume performance of this Agreement as soon as reasonably feasible. Any episode of force majeure which continues for thirty (30) days from the date of notification of its existence shall give the non-affected Party the right to terminate this Agreement upon thirty (30) days additional notice.

18.4	Severability

If any provision of this Agreement is found by a court to be void, invalid or unenforceable, the same shall either be reformed to comply with applicable laws and regulations or stricken if not so conformable, so as not to affect the validity or enforceability of the remaining provisions of this Agreement, except if the principal intent of this Agreement is frustrated by such reformation or deletion in which case this Agreement shall terminate.

18.5	Entire Agreement

The Parties hereto acknowledge that each has read this Agreement, understands it and agrees to be bound by its terms. The Parties agree that this Agreement, along with each Work Order, is the complete agreement between the Parties on the subject matter and supersedes all proposals (oral or written), letters of intent, understandings, representations, conditions, warranties, covenants and other communications between the Parties relating to the same subject matter.

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18.6	Survival

The terms contained in Sections 3, 11, 12 and 18 of this Agreement shall survive the completion of performance, expiration or termination of this Agreement. Sections 5 and 6 shall survive for the period expressly set forth in such Section or, if none, the applicable statute of limitations period applicable to a claim for breach of such provision.

18.7	Governing Law and Arbitration

This Agreement shall be interpreted and enforced in accordance with the laws of the Commonwealth of Massachusetts, USA. In the event a dispute relating to this Agreement or any Work Order arises between the Parties, the Parties shall confer in good faith to resolve the dispute through negotiations between respective senior executives of the Parties. In the event that the Parties are unable to resolve the dispute, disputes shall be settled by arbitration administered by the American Arbitration Association under its Commercial Arbitration Rules in Boston, Massachusetts. Judgment shall be rendered by a mutually agreed upon single arbitrator. The provisions of this Section may be enforced by any court of competent jurisdiction, and the Party seeking enforcement shall be entitled to an award of all costs, fees and expenses, including reasonable attorneys’ fees, to be paid by the Party against whom enforcement is ordered.

18.8	Waiver

No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances will be deemed to be construed as a further or continuing waiver of such term, provision or condition or of any other term, provision or condition of this Agreement.

18.9	Independent Contractors

The Parties’ relationship, as established by this Agreement, is solely that of independent contractors. This Agreement does not create any partnership, joint venture or similar business relationship between the Parties. Subject to Section 11.0 and/or as may be expressly agreed otherwise in a Work Order in the case of legal representation in the EU, neither Party is a legal representative of the other Party, and neither Party can assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of the other Party for any purpose whatsoever.

18.10	Counterparts

This Agreement may be executed in counterparts, each of which shall be deemed an original but all of which taken together shall constitute one and the same instrument. In the event that any signature is delivered by facsimile transmission, by e-mail delivery of a “.pdf” format data file or other electronic means, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such signature page were an original thereof.

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IN WITNESS WHEREOF , the undersigned have caused this Agreement to be executed by their respective duly authorized representatives effective as of the Effective Date.


Synaptogenix, Inc.		WORLDWIDE CLINICAL TRIALS, INC.

By:	/s/ Alan J. Tuchman, M.D.	By:	/s/ Anthony Hinman
Name:	Alan J. Tuchman, M.D.	Name:	Anthony Hinman
Title:	CEO, Synaptogenix, Inc.	Title:	Director, Legal
Date:	2-9-2022	Date:	09-Feb-2022

LIST OF EXHIBITS:

EXHIBIT A:Form of Work Order

EXHIBIT B:Standard Contractual Clauses

EXHIBIT C:Form of Clinical Trial Insurance Declaration Page 20 of 50

Exhibit 10.2

August 4, 2022

Personal and Confidential

Re: Amendment to Offer Letter

Dear Alan:

This amendment (this “Amendment”) will serve to implement certain changes to your Offer Letter with Synaptogenix Inc. (the “Company”), dated December 7, 2020 (the “Agreement”). Capitalized terms used but not defined herein shall have the meaning attributed by the Agreement.

1.	Term. Section 2 of the Agreement is deleted in its entirety and replaced with the following:

“2. Term. Your employment pursuant to this Offer commenced on December 7, 2020 (the “Effective Date”) and shall continue until June 7, 2023 (the “Term”); provided the Term shall be extended, at your election, for an additional six (6) month period (the “Extension Term”) upon your written notice to the Company at least thirty (30) days prior to June 7, 2023. Notwithstanding the foregoing, the Company may cancel the Extension Term (and/or your ability to extend the Term) upon the Company’s written notice to you at least one (1) week prior to such cancellation.”

2.	Severance. Section 7 of the Agreement is deleted in its entirety and replaced with the following:

“7. Severance.

(a)

If you are terminated by the Company without Cause (as defined below), you will be entitled to severance equal to six (6) months of your Base Salary, payable in the form of a salary continuation over the six (6) month period following your termination. The severance will be paid pursuant to the Company’s payroll schedule then in effect commencing on the sixtieth (60th) day following your termination date, with such first installment to include and satisfy all installments that would have otherwise been made up to such date assuming for such purpose that the installments had commenced on the first payroll date following your termination date. For the avoidance of doubt, a termination due to expiration of the Term (including, without limitation, by election of the Company not to extend the Term) shall not be treated as a termination without Cause and no severance shall be payable.

(b)

As a condition precedent to receiving any severance payments, you must execute (without revocation) a separation agreement in a form to be provided by the Company (the “Release”), which Release shall include a general release of all claims against the Company and its affiliates. The Release must be effective and irrevocable prior to the sixtieth (60th) day following the Termination Date. If you fail to execute the Release pursuant to this Section*,* you shall forfeit and not be entitled to any severance hereunder.

(c)	For purposes of this Agreement, “Cause” means, the good faith determination by the Company of any of the following: (i) your engaging

in any acts of fraud, theft, or embezzlement involving the Company or its affiliates; (ii) your willful or gross neglect of the material duties or responsibilities of your position; (iii) your engaging in any willful material act of dishonesty in connection with your responsibilities; (iv) your indictment, including any plea of guilty or nolo contendere, of any felony or crime of moral turpitude which the Company reasonably determines is relevant to your position or is damaging to the reputation or business of the Company or its affiliates; (v) any conduct or omission which could reasonably be expected to, or which does, cause the Company or its affiliates material public disgrace, disrepute or economic harm; (vi) your material violation of any written policies or procedures of the Company or its affiliates; and/or (vii) your breach of any of the material terms of any written agreement with the Company or its affiliates. With respect to subsections (ii), (vi) and (vii), you shall have ten (10) business days from the delivery of written notice by the Company within which to cure any acts constituting Cause; provided however, that, if the Company reasonably expects irreparable injury from a delay of ten (10) business days, the Company may give you notice of such shorter period within which to cure as is reasonable under the circumstances.

3.	No Other Changes. Except as expressly set forth in this Amendment, there have been no other changes or modifications to the Agreement, and the Agreement remains otherwise unchanged and in full force and effect.

You may accept this Amendment by countersigning below where indicated and returning it to me.

	Best Regards,

	Synaptogenix Inc.

	/s/ Robert Weinstein
	Name: Robert Weinstein
	Title: Chief Financial Officer

Agreed to and Accepted:

/s/ Alan J.Tuchman
Dr. Alan J. Tuchman
Date:	8/4/2022

Exhibit 31.1

CERTIFICATION

ALAN J. TUCHMAN, M.D.

CHIEF EXECUTIVE OFFICER

SYNAPTOGENIX, INC.

I, Alan J. Tuchman, M.D., Chief Executive Officer of Synaptogenix, Inc., certify that:

I have reviewed this quarterly report on Form 10-Q of Synaptogenix, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors:

a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 5, 2022

	/s/ Alan J. Tuchman, M.D.
	Alan J. Tuchman, M.D.
	Chief Executive Officer
	(principal executive officer)

Exhibit 31.2

CERTIFICATION

ROBERT WEINSTEIN

CHIEF FINANCIAL OFFICER

SYNAPTOGENIX, INC.

I, Robert Weinstein, Chief Financial Officer of Synaptogenix, Inc., certify that:

I have reviewed this quarterly report on Form 10-Q of Synaptogenix, Inc.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant's board of directors:

b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: August 5, 2022


	/s/ Robert Weinstein
	Robert Weinstein
	Chief Financial Officer, Executive Vice President, Secretary and Treasurer
	(principal financial officer and principal accounting officer)

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Synaptogenix, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Alan J. Tuchman, M.D., Chief Executive Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.


Date: August 5, 2022	/s/ Alan J. Tuchman, M.D.
	Alan J. Tuchman, M.D.
	Chief Executive Officer
	(principal executive officer)

Exhibit 32.2

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report of Synaptogenix, Inc. (the “Company”) on Form 10-Q for the period ending June 30, 2022, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert Weinstein, Chief Financial Officer of the Company, state and certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: August 5, 2022

	/s/ Robert Weinstein
	Robert Weinstein
	Chief Financial Officer, Executive Vice President, Secretary and Treasurer
	(principal financial officer and principal accounting officer)