Soligenix, Inc 10-Q for FY2024 Q3

Soligenix, Inc. (SNGX)

10-Q 2024-11-08 For: 2024-09-30

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on November 8, 2024, covering the quarter ended September 30, 2024 (FY2024 Q3).

Headline figures

Quarter ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $1.72M; compared with a net loss of $1.66M a year earlier
Diluted EPS: -$0.78; compared with -$2.56 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 (unaudited)
	Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023	1
	Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023	3
	Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit) for the Nine Months Ended September 30, 2024 and 2023	4
	Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit) for the Three Months Ended September 30, 2024 and 2023	5
	Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023	6
	Notes to Condensed Consolidated Financial Statements	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	50
Item 4	Controls and Procedures	51

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	51
Item 1A	Risk Factors	51
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	52
Item 5	Other Information	52
Item 6	Exhibits	53

SIGNATURES		54


	September 30,		December 31,
	2024		2023
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	9,840,177	$	8,446,158
Unbilled revenue		—		171,254
Research and development incentives receivable, current		—		23,894
Deferred issuance cost		126,385		—
Prepaid expenses and other current assets		340,330		866,014
Total current assets		10,306,892		9,507,320
Security deposit		22,777		22,777
Office furniture and equipment, net		7,162		11,927
Right-of-use lease assets		140,148		229,834
Research and development incentives receivable, net of current portion		—		25,468
Total assets	$	10,476,979	$	9,797,326

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	891,227	$	1,111,226
Accrued expenses		1,363,235		2,418,002
Accrued compensation		84,362		251,115
Lease liabilities, current		132,114		121,765
Convertible debt		2,059,309		2,250,000
Total current liabilities		4,530,247		6,152,108
Non-current liabilities:
Convertible debt		—		1,010,934
Lease liabilities, net of current portion		11,544		111,862
Total liabilities		4,541,791		7,274,904

Commitments and contingencies (Note 6)

Shareholders’ equity:
Preferred stock, 350,000 shares authorized; none issued or outstanding at September 30, 2024 and December 31, 2023, respectively		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 2,295,304 and 648,761 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively⁽¹⁾		2,295		649
Additional paid-in capital ⁽¹⁾		236,878,806		228,203,706
Accumulated other comprehensive income		37,473		22,243
Accumulated deficit		(230,983,386)		(225,704,176)
Total shareholders’ equity		5,935,188		2,522,422
Total liabilities and shareholders’ equity	$	10,476,979	$	9,797,326


		Three Months Ended			Nine Months Ended
		September 30,			September 30,
	2024		2023		2024		2023
Revenues:
Grant revenue		—		130,440	$	119,371	$	594,547
Total revenues		—		130,440		119,371		594,547
Cost of revenues		—		(110,441)		(119,371)		(520,502)
Gross profit		—		19,999		—		74,045
Operating expenses:
Research and development		968,689		826,015		2,564,887		2,535,165
General and administrative		896,547		973,040		3,162,115		3,098,949
Total operating expenses		1,865,236		1,799,055		5,727,002		5,634,114
Loss from operations		(1,865,236)		(1,779,056)		(5,727,002)		(5,560,069)
Other income (expense):
Foreign currency transaction gain (loss)		575		(3,046)		2,257		310
Interest income (expense), net		78,836		66,363		143,603		(97,399)
Research and development incentives		—		4,729		(25,488)		17,386
CARES Act Employee Retention Credit		66,444		120,771		66,444		120,771
Other income		—		—		43		43,223
Loss on extinguishment of debt		—		—		—		(393,791)
Change in fair value of convertible debt		—		(72,463)		260,933		387,537
Total other income		145,855		116,354		447,792		78,037
Net loss before income taxes		(1,719,381)		(1,662,702)		(5,279,210)		(5,482,032)
Income tax benefit		—		—		—		1,161,197
Net loss applicable to common stockholders	$	(1,719,381)	$	(1,662,702)	$	(5,279,210)	$	(4,320,835)
Basic and diluted net loss per share ⁽¹⁾	$	(0.78)	$	(2.56)	$	(3.84)	$	(10.05)
Basic and diluted weighted average common shares outstanding ⁽¹⁾		2,203,929		648,860		1,376,568		429,773


									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, 2023	—	$	—	648,761	$	649	$	228,203,706	$	22,243	$	(225,704,176)	$	2,522,422
Issuance of common stock pursuant to At Market Issuance Sales Agreement				14,883		15		58,421		—		—		58,436
Issuance costs associated with sales of common stock pursuant to At Market Issuance Sales Agreement				—		—		(1,947)		—		—		(1,947)
Issuance of common stock and pre-funded warrants in connection with April 2024 public offering	—		—	204,694		205		4,741,195		—		—		4,741,400
Issuance costs associated with April 2024 public offering	—		—	—		—		(625,065)		—		—		(625,065)
Fractional shares issued in June 2024 reverse stock split	—		—	114,735		115		(115)		—		—		—
Issuance of common stock upon exercise of warrants	—		—	34,816		35		222,787		—		—		222,822
Issuance of common stock upon exercise of pre-funded warrants	—		—	537,500		537		8,063		—		—		8,600
Issuance of common stock from warrant inducement	—		—	703,125		703		4,218,047						4,218,750
Issuance costs associated with warrant inducement	—		—	—		—		(7,552,457)		—		—		(7,552,457)
Warrant modification - incremental fair value	—		—	—		—		7,177,683		—		—		7,177,683
Issuance of common stock from conversion of debt	—		—	36,790		36		254,220						254,256
Share-based compensation expense	—		—	—		—		174,268		—		—		174,268
Foreign currency translation adjustment	—		—	—		—		—		15,230		—		15,230
Net loss	—		—	—		—		—		—		(5,279,210)		(5,279,210)
Balance, September 30, 2024	—	$	—	2,295,304	$	2,295	$	236,878,806	$	37,473	$	(230,983,386)	$	5,935,188


	2024		2023
Operating activities:
Net loss	$	(5,279,210)	$	(4,320,835)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		4,765		4,964
Non-cash lease expense		89,686		82,500
Share-based compensation		174,268		229,076
Issuance of common stock to vendors for services		—		73,000
Issuance of common stock for purchase option		—		50,000
Loss on extinguishment of debt		—		393,791
Change in fair value of convertible debt		(260,933)		(387,537)
Amortization of deferred issuance costs associated with convertible debt		—		12,518
Change in operating assets and liabilities:
Contracts and grants receivable		171,254		49,079
Prepaid expenses and other current assets		525,684		(310,229)
Research and development incentives receivable		51,879		92,092
Operating lease liability		(89,969)		(80,458)
Accounts payable and accrued expenses		(1,391,432)		(2,382,708)
Accrued compensation		(166,753)		(281,149)
Net cash flows from operating activities		(6,170,761)		(6,775,896)

Financing activities:
Proceeds from issuance of common stock pursuant to At Market Issuance Sales Agreement		58,436		3,091,462
Costs associated with an At Market Issuance Sales Agreement		(44,522)		(93,009)
Proceeds from issuance of common stock and pre-funded warrants		4,741,400		8,495,817
Stock issuance costs associated with public offerings		(625,065)		(787,881)
Proceeds from the exercise of warrants		4,450,172		3,299
Issuance costs associated with warrant inducement		(374,774)		—
Convertible debt repayments		(686,436)		(7,000,000)
Net cash flows from financing activities		7,519,211		3,709,688
Effect of exchange rate on cash and cash equivalents		45,569		5,127
Net increase in cash and cash equivalents		1,394,019		(3,061,081)
Cash and cash equivalents at beginning of period		8,446,158		13,359,615
Cash and cash equivalents at end of period	$	9,840,177	$	10,298,534
Supplemental information:
Cash paid for state income taxes	$	42,162	$	13,006
Cash paid for interest	$	183,771	$	488,011
Cash paid for lease liabilities:
Operating lease	$	102,300	$	99,975
Non-cash investing and financing activities:
Pontifax conversion of portion of debt principal into common stock	$	254,256	$	—
Deferred issuance cost reclassified to additional paid-in capital	$	228,161	$	2,339
Redemption liability for Series D preferred stock	$	—	$	43
Offering costs included in accounts payable	$	83,810	$	46,180
Warrant modification - incremental value	$	7,177,683	$	—


			Pontifax
			Conversions
			January 3, 2024
		Debt Balance	and		Adjustment to		Principal		Debt Balance
	December 31, 2023		April 15, 2024		fair value		Repayments		September 30, 2024
Convertible debt at fair value	$	3,260,934	$	(254,256)	$	(260,933)	$	(686,436)	$	2,059,309


	As of September 30,
	2024	2023
Common stock purchase warrants	1,467,581	408,640
Stock options	56,427	12,843
Convertible debt	75,710	1,172,645
Total	1,599,718	1,594,128


	September 30,		December 31,
	2024		2023
Clinical trial expenses	$	951,029	$	1,993,784
Other		412,206		424,218
Total	$	1,363,235	$	2,418,002


	Research and
Year	Development		Leases		Total
October 1 through December 31, 2024	$	21,000	$	34,617	$	55,617
2025		46,000		116,250		162,250
2026		46,000		—		46,000
2027		46,000		—		46,000
2028		46,000		—		46,000
Total	$	205,000	$	150,867	$	355,867


	As of		As of
	September 30,		December 31,
	2024		2023
Identifiable Assets
Specialized BioTherapeutics	$	45,674	$	272,099
Public Health Solutions		2,387		3,976
Corporate		10,428,918		9,521,251
Total	$	10,476,979	$	9,797,326


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 to FDA December 2022; FDA RTF letter received February 2023; second Phase 3 trial based upon EMA-accepted protocol targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026; discussions continue with FDA on modifying the development path to adequately address FDA’s preference for a longer duration comparative study over a placebo-controlled trial.

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 FDA; Phase 2a study remains ongoing having demonstrated biological effect in Cohort 1 and clinically meaningful benefit in Cohort 2

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; analyzed full dataset from Phase 3 study and designing a second Phase 3 clinical trial; continued development contingent upon identification of partnership


Soligenix Product Candidate	Indication	Stage of Development
ThermoVax^®	Thermostability of vaccines for Ricin toxin, Ebola, and Marburg viruses	Pre-clinical

RiVax^®	Vaccine against Ricin Toxin Poisoning	Phase 1a, 1b, and 1c trials completed, safety and neutralizing antibodies for protection demonstrated

SGX943	Therapeutic against Emerging Infectious Diseases	Pre-clinical


	2024		2023
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	165,183	$	100,613
SGX942 (Dusquetide)		(435,562)		(47,088)
HyBryte™ (SGX301 or synthetic hypericin)		2,411,168		2,147,245
Other		424,098		334,395
Total	$	2,564,887	$	2,535,165

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	—	$	—
CiVax™		—		260,778
SGX943		—		35,429
HyBryte™ (investigator-initiated study)		119,371		224,295
Total		119,371		520,502
Grand Total	$	2,684,258	$	3,055,667


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.

November 8, 2024	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

November 8, 2024	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


November 8, 2024		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer



November 8, 2024		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer