Soligenix, Inc 10-Q for FY2023 Q3

Soligenix, Inc. (SNGX)

10-Q 2023-11-13 For: 2023-09-30

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on November 13, 2023, covering the quarter ended September 30, 2023 (FY2023 Q3).

Headline figures

Quarter ended September 30, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $130.44K; down 21.5% from $166.14K a year earlier
Net loss: $1.66M; compared with a net loss of $3.31M a year earlier
Diluted EPS: -$0.16; compared with -$1.15 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	Condensed Consolidated Financial Statements
	Condensed Consolidated Balance Sheets as of September 30, 2023 (unaudited) and December 31, 2022	1
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited)	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2023 and 2022 (unaudited)	3
	Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Equity/(Deficit) for the Nine Months Ended September 30, 2023 and 2022 (unaudited)	4
	Condensed Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Equity/(Deficit) for the Three Months Ended September 30, 2023 and 2022 (unaudited)	5
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2023 and 2022 (unaudited)	6
	Notes to Condensed Consolidated Financial Statements (unaudited)	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	28
Item 3	Quantitative and Qualitative Disclosures About Market Risk	59
Item 4	Controls and Procedures	59

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	60
Item 1A	Risk Factors	61
Item 6	Exhibits	62

SIGNATURES		63


	September 30,		December 31,
	2023		2022
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	10,298,534	$	13,359,615
Contracts and grants receivable		66,051		115,130
Research and development incentives receivable, current		22,852		104,198
Prepaid expenses and other current assets		584,438		274,209
Total current assets		10,971,875		13,853,152
Security deposit		22,777		22,777
Office furniture and equipment, net of accumulated depreciation of $119,730 and $114,766		13,517		18,481
Deferred issuance cost		17,867		20,206
Right-of-use lease assets		258,487		340,987
Research and development incentives receivable, net of current portion		18,306		24,114
Total assets	$	11,302,829	$	14,279,717

Liabilities, mezzanine equity and shareholders' equity/(deficit)
Current liabilities:
Accounts payable	$	1,460,715	$	3,865,796
Accrued expenses		2,386,836		2,307,746
Accrued compensation		55,543		336,692
Lease liabilities, current		118,459		108,948
Convertible debt, net of debt discount of $0 and $102,309		1,500,000		9,897,691
Total current liabilities		5,521,553		16,516,873
Non-current liabilities:
Convertible debt		1,416,463		—
Lease liabilities, net of current portion		143,658		233,627
Total liabilities		7,081,674		16,750,500

Commitments and contingencies

Mezzanine equity:
Series D preferred stock, $.001 par value; 0 and 50,000 shares authorized, none issued or outstanding as of September 30, 2023 and December 31, 2022, respectively		—		43

Shareholders’ equity/(deficit):
Preferred stock, 350,000 and 300,000 shares authorized as of September 30, 2023 and December 31, 2022, respectively; none issued or outstanding		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 10,378,238 and 2,908,578 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively⁽¹⁾		10,378		2,909
Additional paid-in capital		228,070,740		217,064,964
Accumulated other comprehensive income		24,318		24,747
Accumulated deficit		(223,884,281)		(219,563,446)
Total shareholders’ equity/(deficit)		4,221,155		(2,470,826)
Total liabilities, mezzanine equity and shareholders’ equity/(deficit)	$	11,302,829	$	14,279,717


		Three Months Ended			Nine Months Ended
		September 30,			September 30,
	2023		2022		2023		2022
Revenues:
Licensing revenue	$	—	$	—	$	—	$	50,000
Grant revenue		130,440		166,140		594,547		532,843
Total revenues		130,440		166,140		594,547		582,843
Cost of revenues		(110,441)		(129,440)		(520,502)		(414,957)
Gross profit		19,999		36,700		74,045		167,886
Operating expenses:
Research and development		826,015		1,791,695		2,535,165		5,586,302
General and administrative		973,040		1,326,249		3,098,949		5,250,510
Total operating expenses		1,799,055		3,117,944		5,634,114		10,836,812
Loss from operations		(1,779,056)		(3,081,244)		(5,560,069)		(10,668,926)
Other income (expense):
Foreign currency transaction gain (loss)		(3,046)		(12,613)		310		(26,006)
Interest income (expense), net		66,363		(215,146)		(97,399)		(641,768)
Research and development incentives		4,729		—		17,386		136,981
CARES Act Employee Retention Credit		120,771		—		120,771		—
Other income		—		—		43,223		—
Loss on extinguishment of debt		—		—		(393,791)		—
Change in fair value of convertible debt		(72,463)		—		387,537		—
Total other income (expense)		116,354		(227,759)		78,037		(530,793)
Net loss before income taxes		(1,662,702)		(3,309,003)		(5,482,032)		(11,199,719)
Income tax benefit		—		—		1,161,197		1,154,935
Net loss applicable to common stockholders	$	(1,662,702)	$	(3,309,003)	$	(4,320,835)	$	(10,044,784)
Basic and diluted net loss per share ⁽¹⁾	$	(0.16)	$	(1.15)	$	(0.63)	$	(3.50)
Basic and diluted weighted average common shares outstanding ⁽¹⁾		10,379,854		2,872,262		6,874,493		2,867,076


									Accumulated
	Mezzanine Equity-						Additional		Other
	Series D Preferred Stock			Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Shares	Par Value		Capital		Income (Loss)		Deficit		Total
Balance, December 31, 2022	—	$	43	2,908,578	$	2,909	$	217,064,964	$	24,747	$	(219,563,446)	$	(2,470,826)
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement				851,130		851		3,090,611		—		—		3,091,462
Issuance costs associated with B. Riley At Market Issuance Sales Agreement				—		—		(95,348)		—		—		(95,348)
Redemption of Series D preferred stock	—		(43)	—		—		—		—		—		—
Issuance of common stock and pre-funded warrants in connection with May 2023 public offering				2,301,500		2,301		8,493,516		—		—		8,495,817
Issuance costs associated with May 2023 public offering				—		—		(834,061)		—		—		(834,061)
Issuance of common stock to vendors				50,000		50		72,950		—		—		73,000
Issuance of common stock upon exercise of pre-funded warrants				4,235,384		4,235		(936)		—		—		3,299
Issuance of common stock in connection with Silk Roads purchase option				31,646		32		49,968		—		—		50,000
Share-based compensation expense				—		—		229,076		—		—		229,076
Foreign currency translation adjustment				—		—		—		(429)		—		(429)
Net loss				—		—		—		—		(4,320,835)		(4,320,835)
Balance, September 30, 2023	—	$	—	10,378,238	$	10,378	$	228,070,740	$	24,318	$	(223,884,281)	$	4,221,155


	2023		2022
Operating activities:
Net loss	$	(4,320,835)	$	(10,044,784)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		4,964		21,538
Non-cash lease expense		82,500		86,326
Share-based compensation		229,076		220,656
Issuance of common stock to vendors for services		73,000		150,002
Issuance of common stock to Silk Roads for purchase option		50,000		—
Loss on extinguishment of debt		393,791		—
Change in fair value of convertible debt		(387,537)		—
Amortization of deferred issuance costs associated with convertible debt		12,518		31,068
Change in operating assets and liabilities:
Licensing, contracts and grants receivable		49,079		8,147
Prepaid expenses and other current assets		(310,229)		(113,452)
Research and development incentives receivable		92,092		67,912
Operating lease liability		(80,458)		(85,415)
Deferred revenue		—		200,000
Accounts payable and accrued expenses		(2,382,708)		679,268
Accrued compensation		(281,149)		(243,146)
Net cash used in operating activities		(6,775,896)		(9,021,880)

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		3,091,462		—
Costs associated with B. Riley At Market Issuance Sales Agreement		(93,009)		—
Proceeds from issuance of common stock and pre-funded warrants pursuant to public offering		8,495,817		—
Stock issuance costs associated with public offering		(787,881)		—
Proceeds from the exercise of pre-funded warrants		3,299		—
Convertible debt repayments		(7,000,000)		—
Net cash provided by financing activities		3,709,688		—
Effect of exchange rate on cash and cash equivalents		5,127		(143,302)
Net decrease in cash and cash equivalents		(3,061,081)		(9,178,255)
Cash and cash equivalents at beginning of period		13,359,615		26,043,897
Cash and cash equivalents at end of period	$	10,298,534	$	16,865,642
Supplemental information:
Cash paid for state income taxes	$	13,006	$	13,243
Cash paid for interest	$	488,011	$	643,921
Cash paid for lease liabilities:
Operating lease	$	99,975	$	99,975
Non-cash investing and financing activities:
Right-of-use assets and lease liabilities recorded	$	—	$	347,546
Deferred issuance cost reclassified to additional paid-in capital	$	2,339	$	—
Redemption liability for Series D preferred stock	$	43	$	—
Stock issuance costs included in accounts payable	$	46,180	$	—


		Balance, December 31, 2022		Issued		Adjustment to fair value		Balance, September 30, 2023

Convertible debt at fair value	$	-	$	3,304,000	$	(387,537)	$	2,916,463


	Current		Long-Term		Total
Balance at December 31, 2022	$	104,198	$	24,114	$	128,312
UK research and development incentives, transfer		24,114		(24,114)		—
UK research and development incentives		—		18,536		18,536
Adjustments to 2021 and 2022 incentives earned		(1,150)		—		(1,150)
UK research and development incentives cash receipt		(104,422)		—		(104,422)
Foreign currency translation		112		(230)		(118)
Balance at September 30, 2023	$	22,852	$	18,306	$	41,158


	As of September 30,
	2023	2022
Common stock purchase warrants	6,538,500	3,992
Stock options	206,589	145,505
Convertible debt	2,159,414	162,602
Total	8,904,503	312,099


	Operating
	Lease
Right-of-use lease asset:
Right-of-use lease asset, January 1, 2023	$	340,987
Less: reduction/amortization		82,500
Right-of-use lease asset, September 30, 2023	$	258,487

Lease liability:
Lease liability, January 1, 2023	$	342,575
Less: repayments		80,458
Lease liability, September 30, 2023	$	262,117

Lease expense for the nine months ended September 30, 2023:
Lease expense	$	102,016
Total	$	102,016

Lease expense for the nine months ended September 30, 2022:
Lease expense	$	100,887
Total	$	100,887

Contractual cash payments for the remaining lease term as of September 30, 2023:
2023	$	33,841
2024		136,917
2025		116,250
Total	$	287,008
Remaining lease term (months) as of September 30, 2023		25


	September 30,		December 31,
	2023		2022
Clinical trial expenses	$	2,082,200	$	1,884,117
Other		304,636		423,629
Total	$	2,386,836	$	2,307,746


Assumptions	4/19/2023		9/30/2023
Stock price	$	1.72	$	0.56
Volatility		75.20%		110.50%
Discount rate		16.28%		14.84%
Risk-free rate		4.27%		5.24%


Year	Principal		Interest		Total
2023	$	—	$	128,094	$	128,094
2024		2,250,000		206,761		2,456,761
2025		750,000		16,012		766,012
Total	$	3,000,000	$	350,867	$	3,350,867


	Research and		Property and
Year	Development		Other Leases		Total
October 1 through December 31, 2023	$	21,000	$	33,841	$	54,841
2024		46,000		136,917		182,917
2025		46,000		116,250		162,250
2026		46,000		—		46,000
2027		46,000		—		46,000
Total	$	205,000	$	287,008	$	492,008


	As of		As of
	September 30,		December 31,
	2023		2022
Identifiable Assets
Specialized BioTherapeutics	$	58,704	$	103,742
Public Health Solutions		70,557		121,290
Corporate		11,173,568		14,054,685
Total	$	11,302,829	$	14,279,717


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 submitted December 2022; FDA RTF letter received February 2023; Type A meeting with the FDA convened April 2023, in which the FDA determined that a second positive Phase 3 study would be required to support a NDA submission; actively engage in formal protocol discussions with FDA to define the protocol for, and evaluate feasibility of conducting, an additional Phase 3 clinical trial (as requested by the FDA); the outcome of these discussions are anticipated before year-end


	2023		2022
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	100,613	$	299,086
SGX942 (Dusquetide)		(47,088)		242,610
HyBryte™ (SGX301 or synthetic hypericin)		2,147,245		4,745,133
Other		334,395		299,473
Total	$	2,535,165	$	5,586,302

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	—	$	22,161
CiVax™		260,778		315,845
SGX943		35,429		76,951
HyBryte™ (investigator initiated study)		224,295		—
Total		520,502		414,957
Grand Total	$	3,055,667	$	6,001,259


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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101.DEF		Inline XBRL Taxonomy Definition Linkbase

101.LAB		Inline XBRL Taxonomy Label Linkbase

101.PRE		Inline XBRL Taxonomy Presentation Linkbase

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	SOLIGENIX, INC.

November 13, 2023	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

November 13, 2023	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


November 13, 2023		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer


November 13, 2023		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer