Soligenix, Inc 10-Q for FY2022 Q2

Soligenix, Inc. (SNGX)

10-Q 2022-08-12 For: 2022-06-30

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on August 12, 2022, covering the quarter ended June 30, 2022 (FY2022 Q2).

Headline figures

Quarter ended June 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $228.64K; up 6.4% from $214.82K a year earlier
Net loss: $2.39M; compared with a net loss of $1.9M a year earlier
Diluted EPS: -$0.06; compared with -$0.05 a year earlier

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DELAWARE		41-1505029
(State or other jurisdiction of		(I.R.S. Employer
incorporation or organization)		Identification Number)



29 EMMONS DRIVE, SUITE B-10 PRINCETON, NJ		08540
(Address of principal executive offices)		(Zip Code)


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $.001 per share	SNGX	The Nasdaq Capital Market


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

	Description	Page

Part I	FINANCIAL INFORMATION

Item 1	Consolidated Financial Statements
	Consolidated Balance Sheets as of June 30, 2022 (unaudited) and December 31, 2021	1
	Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2022 and 2021 (unaudited)	2
	Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2022 and 2021 (unaudited)	3
	Consolidated Statements of Changes in Shareholders’ Equity for the Six Months Ended June 30, 2022 and 2021 (unaudited)	4
	Consolidated Statements of Changes in Shareholders’ Equity for the Three Months Ended June 30, 2022 and 2021 (unaudited)	5
	Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021 (unaudited)	6
	Notes to Consolidated Financial Statements (unaudited)	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3	Quantitative and Qualitative Disclosures About Market Risk	48
Item 4	Controls and Procedures	48

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	49
Item 1A	Risk Factors	50
Item 6	Exhibits	51

SIGNATURES		52


	June 30,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	20,157,692	$	26,043,897
Licensing, contracts and grants receivable		321,779		138,889
Research and development incentives receivable		109,017		103,832
Prepaid expenses and other current assets		237,135		282,903
Total current assets		20,825,623		26,569,521
Security deposit		22,777		22,777
Office furniture and equipment, net of accumulated depreciation of $106,948 and $167,848		26,299		22,220
Deferred issuance cost		20,266		20,266
Right-of-use lease assets		393,226		106,155
Research and development incentives receivable		24,263		121,238
Other assets		—		7,750
Total assets	$	21,312,454	$	26,869,927

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	4,141,006	$	2,925,544
Accrued expenses		2,437,596		2,956,545
Accrued compensation		57,762		302,936
Lease liabilities, current		103,949		106,151
Convertible debt, current		2,000,000		—
Deferred revenue, current		100,000		—
Total current liabilities		8,840,313		6,291,176
Non-current liabilities:
Convertible debt, net of current portion and debt discount of $123,249 and $143,847		7,876,751		9,856,153
Lease liabilities, net of current portion		289,504		—
Deferred revenue, net of current portion		100,000		—
Total liabilities		17,106,568		16,147,329
Commitments and contingencies
Shareholders’ equity:
Preferred stock, 350,000 shares authorized; none issued or outstanding		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 43,050,245 shares and 42,873,445 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively		43,050		42,873
Additional paid-in capital		216,652,655		216,402,890
Accumulated other comprehensive income		11,069		41,942
Accumulated deficit		(212,500,888)		(205,765,107)
Total shareholders’ equity		4,205,886		10,722,598
Total liabilities and shareholders’ equity	$	21,312,454	$	26,869,927


		Three Months Ended			Six Months Ended
		June 30,			June 30,
	2022		2021		2022		2021
Revenues:
Licensing revenue	$	—	$	—	$	50,000	$	—
Contract revenue		—		—		—		33,351
Grant revenue		228,640		214,824		366,703		329,066
Total revenues		228,640		214,824		416,703		362,417
Cost of revenues		(193,304)		(204,317)		(285,517)		(326,677)
Gross profit		35,336		10,507		131,186		35,740
Operating expenses:
Research and development		2,047,839		1,936,608		3,794,607		3,246,130
General and administrative		1,382,793		1,062,558		3,924,261		2,011,876
Total operating expenses		3,430,632		2,999,166		7,718,868		5,258,006
Loss from operations		(3,395,296)		(2,988,659)		(7,587,682)		(5,222,266)
Other income (expense):
Gain on forgiveness of PPP loan		—		421,584		—		421,584
Foreign currency transaction (loss)/gain		94,900		17,330		(13,393)		44,583
Interest expense, net		(214,908)		(235,736)		(426,622)		(449,241)
Research and development incentives		(26,391)		23,671		136,981		81,052
Total other income (expense)		(146,399)		226,849		(303,034)		97,978
Net loss before income taxes		(3,541,695)		(2,761,810)		(7,890,716)		(5,124,288)
Income tax benefit		1,154,935		864,742		1,154,935		864,742
Net loss applicable to common stockholders	$	(2,386,760)	$	(1,897,068)	$	(6,735,781)	$	(4,259,546)
Basic and diluted net loss per share	$	(0.06)	$	(0.05)	$	(0.16)	$	(0.11)
Basic and diluted weighted average common shares outstanding		43,012,206		40,074,275		42,966,378		38,455,210


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Income		Deficit		Total
Balance, December 31, 2021	42,873,445	$	42,873	$	216,402,890	$	41,942	$	(205,765,107)	$	10,722,598
Issuance of common stock to vendors	176,800		177		99,824		—		—		100,001
Share-based compensation expense	—		—		149,941		—		—		149,941
Foreign currency translation adjustment	—		—		—		(30,873)		—		(30,873)
Net loss	—		—		—		—		(6,735,781)		(6,735,781)
Balance, June 30, 2022	43,050,245	$	43,050	$	216,652,655	$	11,069	$	(212,500,888)	$	4,205,886


	2022		2021
Operating activities:
Net loss	$	(6,735,781)	$	(4,259,546)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		16,744		17,739
Non-cash lease expense		60,475		56,698
Share-based compensation		149,941		175,426
Issuance of common stock to vendors for services		100,001		—
Amortization of deferred issuance costs associated with convertible debt		20,598		20,986
Gain on forgiveness of PPP loan		—		(421,584)
Change in operating assets and liabilities:
Licensing, contracts and grants receivable		(182,890)		86,094
Prepaid expenses and other current assets		45,768		76,879
Research and development incentives receivable		70,335		306,651
Operating lease liability		(60,244)		(56,698)
Deferred revenue		200,000		—
Accounts payable and accrued expenses		793,324		(838,749)
Accrued compensation		(245,174)		(808,043)
Net cash used in operating activities		(5,766,903)		(5,644,147)

Investing activities:
Purchases of office furniture and equipment		(13,073)		—
Net cash used in investing activities		(13,073)		—

Financing activities:
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement		—		16,490,329
Costs associated with B. Riley At Market Issuance Sales Agreement		—		(496,450)
Proceeds from the exercise of warrants		—		51
Costs associated with issuance of convertible debt		—		(45,512)
Principal repayment – financing lease		—		(4,048)
Net cash provided by financing activities		—		15,944,370
Effect of exchange rate on cash and cash equivalents		(106,229)		3,083
Net (decrease)/increase in cash and cash equivalents		(5,886,205)		10,303,306
Cash and cash equivalents at beginning of period		26,043,897		18,676,663
Cash and cash equivalents at end of period	$	20,157,692	$	28,979,969
Supplemental information:
Cash paid for state income taxes	$	5,600	$	7,382
Cash paid for interest	$	432,751	$	444,814
Cash paid for lease liabilities:
Operating lease	$	66,650	$	66,650
Financing lease	$	—	$	4,272
Non-cash activities:
Right-of-use assets and lease liabilities recorded	$	347,546	$	—
Deferred issuance cost reclassified to additional paid-in capital	$	—	$	47,727


	Current		Long-Term		Total
Balance at December 31, 2021	$	103,832	$	121,238	$	225,070
UK research and development incentives, transfer		121,238		(121,238)		—
UK research and development incentives		—		29,075		29,075
Additional 2020 incentive earned		107,906		—		107,906
UK research and development incentives cash receipt		(209,166)		—		(209,166)
Foreign currency translation		(14,793)		(4,812)		(19,605)
Balance at June 30, 2022	$	109,017	$	24,263	$	133,280


	As of June 30,
	2022	2021
Common stock purchase warrants	59,872	5,731,464
Stock options	2,195,306	1,939,386
Convertible debt	2,439,024	2,439,024
Total	4,694,202	10,109,874


	Operating
	Lease
Right-of-use lease asset:
Right-of-use lease asset, January 1, 2022	$	106,155
New lease extension 6/21/2022		347,546
Reduction/amortization		(60,475)
Right of use lease asset, June 30, 2022	$	393,226

Lease liability:
Lease liability, January 1, 2022	$	106,151
New lease extension 6/21/2022		347,546
Repayments		(60,244)
Lease liability, June 30, 2022	$	393,453

Lease expense for the six months ended June 30, 2022:
Lease expense	$	66,881
Total	$	66,881

Lease expense for the six months ended June 30, 2021:
Lease expense	$	66,650
Total	$	66,650

Contractual cash payments for the remaining lease term as of June 30, 2022:
2022	$	66,650
2023		133,817
2024		136,917
2025		116,250
Total	$	453,634
Remaining lease term (months) as of June 30, 2022		40


	June 30,		December 31,
	2022		2021
Clinical trial expenses	$	2,019,712	$	2,625,779
Other		417,884		330,766
Total	$	2,437,596	$	2,956,545


Year	Principal		Interest		Total
2022	$	—	$	426,981	$	426,981
2023		4,000,000		719,138		4,719,138
2024		4,000,000		380,338		4,380,338
2025		2,000,000		60,566		2,060,566
Total	$	10,000,000	$	1,587,023	$	11,587,023


	Research and		Property and
Year	Development		Other Leases		Total
July 1 through December 31, 2022	$	33,500	$	66,650	$	100,150
2023		96,000		133,817		229,817
2024		46,000		136,917		182,917
2025		46,000		116,250		162,250
2026		46,000		—		46,000
Total	$	267,500	$	453,634	$	721,134


	As of		As of
	June 30,		December 31,
	2022		2021
Identifiable Assets
Specialized BioTherapeutics	$	167,524	$	128,645
Public Health Solutions		330,545		146,296
Corporate		20,814,385		26,594,986
Total	$	21,312,454	$	26,869,927


Soligenix Product Candidate	Therapeutic Indication	Stage of Development
HyBryte™	Cutaneous T-Cell Lymphoma	Phase 2 trial completed; demonstrated significantly higher response rate compared to placebo; Phase 3 trial completed; demonstrated statistical significance in primary endpoint in March 2020 (Cycle 1) and demonstrated continued improvement in treatment response with extended treatment in April 2020 (Cycle 2) and October 2020 (Cycle 3); NDA filing planned for Q4 2022

SGX302	Mild-to-Moderate Psoriasis	Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a protocol and Investigation New Drug (“IND”) clearance received from the Food and Drug Administration (“FDA”); Phase 2a study initiation anticipated Q4 2022

SGX942	Oral Mucositis in Head and Neck Cancer	Phase 2 trial completed; demonstrated significant response compared to placebo with positive long-term (12 month) safety also reported; Phase 3 clinical trial results announced December 2020: the primary endpoint of median duration of severe oral mucositis (“SOM”) did not achieve the pre-specified criterion for statistical significance (p≤0.05); although biological activity was observed with a 56% reduction in the median duration of SOM from 18 days in the placebo group to 8 days in the SGX942 treatment group; analyze full dataset from Phase 3 study and design a second Phase 3 clinical trial

SGX203†	Pediatric Crohn’s disease	Phase 1/2 clinical trial completed; efficacy data, pharmacokinetic(PK)/pharmacodynamic(PD) profile and safety profile demonstrated; Phase 3 clinical trial initiation contingent upon additional funding, such as through partnership


	2022		2021
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	252,808	$	259,282
SGX942 (Dusquetide)		210,838		167,433
HyBryte™ (SGX301 or synthetic hypericin)		3,106,030		2,578,591
Other		224,931		240,824
Total	$	3,794,607	$	3,246,130

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	22,161	$	102,916
SGX942 (Dusquetide)		—		(15,000)
CiVax™		217,381		204,582
SGX943		45,975		34,179
Total		285,517		326,677
Grand Total	$	4,080,124	$	3,572,807


EXHIBIT NO.		DESCRIPTION

31.1		Certification of Chief Executive Officer pursuant to Exchange Act rule 13(a)-14(a) (under Section 302 of the Sarbanes-Oxley Act of 2002).

31.2		Certification of Chief Financial Officer pursuant to Exchange Act rule 13(a)-14(a) (under Section 302 of the Sarbanes-Oxley Act of 2002).

32.1		Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2		Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

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	SOLIGENIX, INC.

August 12, 2022	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

August 12, 2022	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


August 12, 2022		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer


August 12, 2022		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer