Annovis Bio, Inc 10-K for FY2022

Annovis Bio, Inc. (ANVS)

10-K 2023-03-31 For: 2022-12-31

Added on April 08, 2026

About this 10-K

Annovis Bio, Inc filed this 10-K on March 31, 2023, covering the fiscal year ended December 31, 2022 (FY2022).

Headline figures

Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $0
Net loss: $25.33M; compared with a net loss of $14.49M a year earlier
Diluted EPS: -$3.10; compared with -$1.90 a year earlier

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

For the fiscal year ended December 31, 2022

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

For the transition period from to


Title of Each Class	Trading Symbol	Name of Each Exchange on Which Registered
Common Stock, par value $0.0001 per share	ANVS	New York Stock Exchange


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


		Page
Cautionary Note Regarding Forward-Looking Statements.		3

Summary of Risk Factors.		4

Part I.		6

Item 1.	Business.	6

Item1A.	Risk Factors.	32

Item1B.	Unresolved Staff Comments.	80

Item 2.	Properties.	81

Item 3.	Legal Proceedings.	81

Item 4.	Mine Safety Disclosures.	81

Part II.		82

Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.	82

Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	82

Item 7A.	Quantitative and Qualitative Disclosures About Market Risk.	91

Item 8.	Financial Statements and Supplementary Data.	91

Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.	91

Item 9A.	Controls and Procedures.	91

Item 9B.	Other Information.	92

Part III.		92

Item 10.	Directors, Executive Officers and Corporate Governance.	92

Item 11.	Executive Compensation.	93

Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.	93

Item 13.	Certain Relationships and Related Transactions and Director Independence.	93

Item 14.	Principal Accountants Fees and Services.	93

Part IV.		93

Item 15.	Exhibits and Financial Statement Schedules.	93

Item 16.	Form 10-K Summary.	95

Index to Financial Statements.		F-1

Signatures.		92


	Year Ended
	December 31,
	2022		2021

	(in thousands)
Operating expenses:
Research and development	$	16,515.5	$	8,479.0
General and administrative	$	8,995.7	$	6,058.2
Other income:
Interest income	$	182.7	$	13.3
Grant income	$	—	$	36.8


Delaware (State or other jurisdiction of incorporation or organization)	26-2540421 (I.R.S. Employer Identification No.)


Name		Position
Maria Maccecchini		President and Chief Executive Officer
Henry Hagopian		Chief Financial Officer


	Number of
	securities to be issued			Number of securities remaining
	upon exercise of	Weighted-average		available for future issuance under
	outstanding options,	exercise price of outstanding		equity compensation plans (excluding
Plan category	warrants and rights	options, warrants and rights		securities reflected in column (a))
	(a)	(b)		(c)
Equity compensation plans approved by security holders	1,657,342	$	13.95	392,874
Equity compensation plans not approved by security holders	2,400	$	7.50	—
Total	1,659,742	$	13.95	392,874


Exhibit Number		Description of Exhibit

3.1		Amended and Restated Certificate of Incorporation of the Registrant. (Incorporated by reference to Exhibit 3.1 to Form 8-K filed February 6, 2020.)


Exhibit Number		Description of Exhibit

3.2		Amended and Restated Bylaws of the Registrant. (Incorporated by reference to Exhibit 3.2 to Form 8-K filed February 6, 2020.)

4.1		Specimen Certificate evidencing shares of the Registrant’s common stock. (Incorporated by reference to Exhibit 4.1 to Amendment No. 3 to Form S-1 filed September 20, 2019.)

4.2		Form of Warrant to purchase common stock issued to ThinkEquity, a division of Fordham Financial Management, Inc. in connection with the closing of the IPO. (Incorporated by reference to Exhibit 4.2 to Form 10-K filed March 25, 2020.)

4.3		Description of Registrant’s Securities. (Incorporated by reference to Exhibit 4.3 to Form 10-K filed March 25, 2020.)

10.1+		Second Amended and Restated Employment Agreement dated as of March 24, 2020 between the Registrant and Maria Maccecchini. (Incorporated by reference to Exhibit 10.1 to Form 10-K filed March 25, 2020.)

10.2+		Annovis Bio, Inc. 2018 Equity Incentive Plan. (Incorporated by reference to Exhibit 10.2 to Form S-1 filed July 3, 2019.)

10.3		Registration Rights Agreement dated as of December 19, 2014 among the Registrant and the signatories thereto. (Incorporated by reference to Exhibit 10.5 to Amendment No. 1 to Form S-1 filed August 8, 2019.)

10.4		Investigator-Initiated Clinical Trial Agreement dated June 27, 2016 between The Regents of the University of California and the Registrant. (Incorporated by reference to Exhibit 10.7 to Form S-1 filed July 3, 2019.)

10.5+		Annovis Bio, Inc. 2019 Equity Incentive Plan. (Incorporated by reference to Appendix A to the Proxy Statement on Schedule 14A filed on April 19, 2021.)

10.6+		Form of Stock Option Award Agreement for the Annovis Bio, Inc. 2019 Equity Incentive Plan.

10.7+		Offer Letter, dated August 29, 2022, by and between the Registrant and Henry Hagopian III. (Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed August 29, 2022.)

10.8+		Separation Agreement, dated September 9, 2022, by and between the Registrant and Jeffrey B. McGroarty. (Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed September 12, 2022.)

23.1		Consent of WithumSmith+Brown, PC.

24.1		Power of Attorney. (Included on signature page to this Annual Report on Form 10-K.)

31.1		Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2		Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1		Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2		Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.


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101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

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101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

104		Cover Page Interactive Data File – the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.


		Page(s)
Report of Independent Registered Public Accounting Firm		F-2
Balance Sheets as of December 31, 2022 and 2021		F-3
Statements of Operations for the Years ended December 31, 2022 and 2021		F-4
Statements of Changes in Stockholders’ Equity for the Years ended December 31, 2022 and 2021		F-5
Statements of Cash Flows for the Years ended December 31, 2022 and 2021		F-6
Notes to Financial Statements		F-7


	As of December 31,
	2022		2021

Assets
Current assets:
Cash and cash equivalents	$	28,377,693	$	45,686,014
Prepaid expenses and other current assets		7,644,376		315,464
Total current assets		36,022,069		46,001,478
Total assets	$	36,022,069	$	46,001,478
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	3,961,254	$	688,074
Accrued expenses		3,737,285		818,440
Total current liabilities		7,698,539		1,506,514
Total liabilities		7,698,539		1,506,514
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock - $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding		—		—
Common stock - $0.0001 par value, 35,000,000 shares authorized and 8,163,923 and 8,100,570 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively		816		810
Additional paid-in capital		82,377,488		73,220,361
Accumulated deficit		(54,054,774)		(28,726,207)
Total stockholders’ equity		28,323,530		44,494,964
Total liabilities and stockholders’ equity	$	36,022,069	$	46,001,478


	Year Ended December 31,

	2022		2021
Operating expenses:
Research and development	$	16,515,543	$	8,479,031
General and administrative		8,995,736		6,058,190
Total operating expenses		25,511,279		14,537,221
Operating loss		(25,511,279)		(14,537,221)
Other income:
Interest income		182,712		13,335
Grant income		—		36,754
Total other income		182,712		50,089
Loss before income taxes		(25,328,567)		(14,487,132)
Income tax expense (benefit)		—		—
Net loss	$	(25,328,567)	$	(14,487,132)
Basic and diluted loss per common share	$	(3.10)	$	(1.90)
Weighted average number of common shares outstanding, basic and diluted		8,162,326		7,626,278


	Stockholders’ Equity (Deficit)
				Additional			Total	Total
	Common Stock			Paid-In		Accumulated		Stockholders’
	Shares	Amount		Capital		Deficit		Equity
Balance, December 31, 2020	6,891,608	$	689	$	21,779,340	$	(14,239,075)	$	7,540,954
Issuance of common stock, net of issuance costs	1,000,000		100		46,648,313		—		46,648,413
Exercise of stock options	155,038		16		95,086		—		95,102
Cashless exercise of warrants	53,924		5		(5)		—		—
Stock-based compensation expense	—		—		4,697,627		—		4,697,627
Net loss	—		—		—		(14,487,132)		(14,487,132)
Balance, December 31, 2021	8,100,570		810		73,220,361		(28,726,207)		44,494,964
Exercise of stock options	63,353		6		4,607		—		4,613
Stock-based compensation expense	—		—		9,152,520		—		9,152,520
Net loss	—		—		—		(25,328,567)		(25,328,567)
Balance, December 31, 2022	8,163,923	$	816	$	82,377,488	$	(54,054,774)	$	28,323,530


			Fair Value Measurement at
			December 31, 2022
	Carrying Value		Level 1		Level 2		Level 3
Cash equivalents	$	26,001,934	$	26,001,934	$	—	$	—


			Fair Value Measurement at
			December 31, 2021
	Carrying Value		Level 1		Level 2		Level 3
Cash equivalents	$	60,031	$	60,031	$	—	$	—


				Weighted
				Average
				Remaining
		Weighted		Contractual	Aggregate
	Number of	Average		Term	Intrinsic
	Shares	Exercise Price		(Years)	Value
Outstanding at December 31, 2020	1,111,466		$ 2.57
Granted	538,095		$ 33.78
Exercised	(159,813)		$ 2.83
Forfeited	—		$ -
Outstanding at December 31, 2021	1,489,748		$ 13.82
Granted	348,294		$ 15.90
Exercised	(70,101)		$ 1.97
Forfeited	(110,599)		$ 25.93
Outstanding at December 31, 2022	1,657,342		$ 13.95	6.2	$ 9,907,660
Exercisable at December 31, 2022	1,310,667		$ 11.64	5.4	$ 9,591,460


	As of March 31, 2022
	(unaudited)
	As		Restatement		As
	Reported		Impacts		Restated
Assets
Current assets:
Cash and cash equivalents	$	42,668,838	$	—	$	42,668,838
Prepaid expenses and other current assets		627,902		800,840		1,428,742
Deferred clinical materials		—		—		—
Total current assets		43,296,740		800,840		44,097,580
Total Assets	$	43,296,740	$	800,840	$	44,097,580
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	928,997	$	—	$	928,997
Accrued expenses		327,435		140,690		468,125
Total current liabilities		1,256,432		140,690		1,397,122
Total liabilities	$	1,256,432	$	140,690	$	1,397,122
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock – $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding		—		—		—
Common stock – $0.0001 par value, 35,000,000 shares authorized and 8,163,923 and 8,100,570 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively		816		—		816
Additional paid-in capital		76,659,912		—		76,659,912
Accumulated deficit		(34,620,420)		660,150		(33,960,270)
Total stockholders’ equity		42,040,308		660,150		42,700,458
Total liabilities and stockholders’ equity	$	43,296,740	$	800,840	$	44,097,580


	Three Months Ended March 31, 2022
	As		Restatement		As
	Reported		Impacts		Restated
Operating expenses:
Research and development	$	2,809,791	$	(660,150)	$	2,149,641
General and administrative		3,104,071		—		3,104,071
Total operating expenses		5,913,862		(660,150)		5,253,712

Operating loss		(5,913,862)		660,150		(5,253,712)
Other income:
Interest income		19,649		—		19,649
Grant Income		—		—		—
Total other income		19,649		—		19,649

Loss before income taxes		(5,894,213)		660,150		(5,234,063)
Income tax expense (benefit)		—		—		—
Net loss	$	(5,894,213)	$	660,150	$	(5,234,063)
Basic and diluted loss per common share	$	(0.72)		—	$	(0.64)
Weighted average number of common shares outstanding, basic and diluted		8,157,445		—		8,157,445


	Three Months Ended March 31, 2022
	As			As
	Reported		Restatement Impacts	Restated
Cash flows from operating activities:
Net loss	$	(5,894,213)	660,150	$	(5,234,063)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		3,434,944	—		3,434,944
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(312,438)	(800,840)		(1,113,278)
Accounts payable		240,923	—		240,923
Accrued expenses		(491,005)	140,690		(350,315)
Net cash used in operating activities		(3,021,789)	—		(3,021,789)
Cash flows from financing activities:
Proceeds from exercise of stock options		4,613	—		4,613
Net cash used in financing activities		4,613	—		4,613
Net (decrease) increase in cash and cash equivalents		(3,017,176)	—		(3,017,176)
Cash and cash equivalents, beginning of period		45,686,014	—		45,686,014
Cash and cash equivalents, end of period	$	42,668,838	—	$	42,668,838


	As of June 30, 2022
	(unaudited)
	As		Restatement		As
	Reported		Impacts		Restated
Assets
Current assets:
Cash and cash equivalents	$	35,974,251	$	—	$	35,974,251
Prepaid expenses and other current assets		551,072		3,441,895		3,992,967
Deferred clinical materials		—		—		—
Total current assets		36,525,323		3,441,895		39,967,218
Total Assets	$	36,525,323	$	3,441,895	$	39,967,218
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	901,841	$	—	$	901,841
Accrued expenses		397,544		—		397,544
Total current liabilities		1,299,385		—		1,299,385
Total liabilities	$	1,299,385	$	—	$	1,299,385
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock – $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding		—		—		—
Common stock – $0.0001 par value, 35,000,000 shares authorized and 8,163,923 and 8,100,570 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		816		—		816
Additional paid-in capital		78,563,673		—		78,563,673
Accumulated deficit		(43,338,551)		3,441,895		(39,896,656)
Total stockholders’ equity		35,225,938		3,441,895		38,667,833
Total liabilities and stockholders’ equity	$	36,525,323	$	3,441,895	$	39,967,218


	Three Months Ended June 30, 2022
	As		Restatement		As
	Reported		Impacts		Restated
Operating expenses:
Research and development	$	6,815,708	$	(2,781,745)	$	4,033,963
General and administrative		1,938,447		–		1,938,447
Total operating expenses		8,754,155		(2,781,745)		5,972,410

Operating loss		(8,754,155)		2,781,745		(5,972,410)
Other income:
Interest income		36,024		—		36,024
Grant Income		—		—		—
Total other income		36,024		—		36,024

Loss before income taxes		(8,718,131)		2,781,745		(5,936,386)
Income tax expense (benefit)		—		—		—
Net loss	$	(8,718,131)	$	2,781,745	$	(5,936,386)
Basic and diluted loss per common share	$	(1.07)		—	$	(0.73)
Weighted average number of common shares outstanding, basic and diluted		8,163,923		—		8,163,923


	Six Months Ended June 30, 2022
	As		Restatement		As
	Reported		Impacts		Restated
Operating expenses:
Research and development	$	9,625,499	$	(3,441,895)	$	6,183,604
General and administrative		5,042,518		—		5,042,518
Total operating expenses		14,668,017		(3,441,895)		11,226,122

Operating loss		(14,668,017)		3,441,895		(11,226,122)
Other income:
Interest income		55,673		—		55,673
Grant Income		—		—		—
Total other income		55,673		—		55,673

Loss before income taxes		(14,612,344)		3,441,895		(11,170,449)
Income tax expense (benefit)		—		—		—
Net loss	$	(14,612,344)	$	3,441,895	$	(11,170,449)
Basic and diluted loss per common share	$	(1.79)		—	$	(1.37)
Weighted average number of common shares outstanding, basic and diluted		8,160,702		—		8,160,702


	As of September 30, 2022
	(unaudited)

	As		Restatement		As
	Reported		Impacts		Restated
Assets
Current assets:
Cash and cash equivalents	$	31,987,091	$	—	$	31,987,091
Prepaid expenses and other current assets		499,947		4,631,390		5,131,337
Total current assets		32,487,038		4,631,390		37,118,428
Total Assets	$	32,487,038	$	4,631,390	$	37,118,428
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable	$	1,845,705	$	—	$	1,845,705
Accrued expenses		680,830		—		680,830
Total current liabilities		2,526,535		—		2,526,535
Total liabilities	$	2,526,535	$	—	$	2,526,535
Commitments and contingencies (Note 7)
Stockholders’ equity:
Preferred stock – $0.0001 par value, 2,000,000 shares authorized and 0 shares issued and outstanding		—		—		—
Common stock – $0.0001 par value, 35,000,000 shares authorized and 8,163,923 and 8,100,570 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		816		—		816
Additional paid-in capital		80,919,684		—		80,919,684
Accumulated deficit		(50,959,997)		4,631,390		(46,328,607)
Total stockholders’ equity		29,960,503		4,631,390		34,591,893
Total liabilities and stockholders’ equity	$	32,487,038	$	4,631,390	$	37,118,428


	Three Months Ended September 30, 2022
	As		Restatement		As
	Reported		Impacts		Restated
Operating expenses:
Research and development	$	5,313,033	$	(1,189,495)	$	4,123,538
General and administrative		2,361,299		—		2,361,299
Total operating expenses		7,674,332		(1,189,495)		6,484,837

Operating loss		(7,674,332)		1,189,495		(6,484,837)
Other income:
Interest income		52,886		—		52,886
Grant Income		—		—		—
Total other income		52,886		—		52,886

Loss before income taxes		(7,621,446)		1,189,495		(6,431,951)
Income tax expense (benefit)		—		—		—
Net loss	$	(7,621,446)	$	1,189,495	$	(6,431,951)
Basic and diluted loss per common share	$	(0.93)		—	$	(0.79)
Weighted average number of common shares outstanding, basic and diluted		8,163,923		—		8,163,923


	Nine Months Ended September 30, 2022
	As		Restatement		As
	Reported		Impacts		Restated
Operating expenses:
Research and development	$	14,938,532	$	(4,631,390)	$	10,307,142
General and administrative		7,403,817		–		7,403,817
Total operating expenses		22,342,349		(4,631,390)		17,710,959

Operating loss		(22,342,349)		4,631,390		(17,710,959)
Other income:
Interest income		108,559		—		108,559
Grant Income		—		—		–
Total other income		108,559		—		108,559

Loss before income taxes		(22,233,790)		4,631,390		(17,602,400)
Income tax expense (benefit)		—		—		—
Net loss	$	(22,233,790)	$	4,631,390	$	(17,602,400)
Basic and diluted loss per common share	$	(2.72)		—	$	(2.16)
Weighted average number of common shares outstanding, basic and diluted		8,161,787		—		8,161,787


ANNOVIS BIO, INC.

By:	/s/ MARIA MACCECCHINI
	Name:	Maria Maccecchini
	Title:	President and Chief Executive Officer


Signature	Title	Date

/s/ MARIA MACCECCHINI	President and Chief Executive Officer	March 31, 2023
Maria Maccecchini	(principal executive officer)

/s/ HENRY HAGOPIAN	Chief Financial Officer (principal	March 31, 2023
Henry Hagopian	financial and accounting officer)

/s/ MICHAEL HOFFMAN	Chairman of the Board and Director	March 31, 2023
Michael Hoffman

/s/ CLAUDINE BRUCK	Director	March 31, 2023
Claudine Bruck

/s/ REID MCCARTHY	Director	March 31, 2023
Reid McCarthy

/s/ MARK WHITE	Director	March 31, 2023
Mark White

	ANNOVIS BIO, INC.


	By:
		Henry Hagopian III
		Chief Executive Officer



	[Employee Name]


	Employee’s Address:



	Email Address:


/s/ WithumSmith+Brown, PC

East Brunswick, New Jersey
March 31, 2023

Date: March 31, 2023		/s/ Maria Maccecchini
		Maria Maccecchini
		President and Chief Executive Officer