Soligenix, Inc 10-Q for FY2025 Q1

Soligenix, Inc. (SNGX)

10-Q 2025-05-09 For: 2025-03-31

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on May 9, 2025, covering the quarter ended March 31, 2025 (FY2025 Q1).

Headline figures

Quarter ended March 31, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.

Net loss: $3.24M; compared with a net loss of $1.92M a year earlier
Diluted EPS: -$1.06; compared with -$2.91 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	1

Item 1	Condensed Consolidated Financial Statements (unaudited)	1
	Condensed Consolidated Balance Sheets as of March 31, 2025 and December 31, 2024	1
	Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2025 and 2024	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2025 and 2024	3
	Condensed Consolidated Statements of Changes in Shareholders’ Equity for the Three Months Ended March 31, 2025 and 2024	4
	Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2025 and 2024	5
	Notes to Condensed Consolidated Financial Statements	6
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3	Quantitative and Qualitative Disclosures About Market Risk	42
Item 4	Controls and Procedures	42

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	43
Item 1A	Risk Factors	43
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	60
Item 5	Other Information	60
Item 6	Exhibits	61

SIGNATURES		62


	March 31,		December 31,
	2025		2024
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	7,297,171	$	7,819,514
Deferred issuance cost		43,836		103,847
Prepaid expenses and other current assets		299,735		905,269
Total current assets		7,640,742		8,828,630
Security deposit		22,777		22,777
Office furniture and equipment, net		5,505		6,113
Right-of-use lease assets		77,096		108,963
Total assets	$	7,746,120	$	8,966,483

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	599,688	$	667,896
Accrued expenses		3,404,332		2,359,339
Accrued compensation		50,537		336,442
Lease liabilities, current		79,125		111,862
Convertible debt		—		1,372,873
Total liabilities		4,133,682		4,848,412

Commitments and contingencies (Note 6)

Shareholders’ equity:
Preferred stock, 350,000 shares authorized; none issued or outstanding at March 31, 2025 and December 31, 2024, respectively		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 3,183,992 and 2,514,499 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively⁽¹⁾		3,183		2,514
Additional paid-in capital ⁽¹⁾		240,770,981		238,040,520
Accumulated other comprehensive income		45,789		45,789
Accumulated deficit		(237,207,515)		(233,970,752)
Total shareholders’ equity		3,612,438		4,118,071
Total liabilities and shareholders’ equity	$	7,746,120	$	8,966,483


	Three Months Ended
	March 31,
	2025		2024
Revenues:
Grant revenue	$	—	$	117,029
Total revenues		—		117,029
Cost of revenues		—		(117,029)
Gross profit		—		—
Operating expenses:
Research and development		2,227,175		1,095,040
General and administrative		1,084,828		1,022,051
Total operating expenses		3,312,003		2,117,091
Loss from operations		(3,312,003)		(2,117,091)
Other income (expense):
Foreign currency transaction (loss) gain		(788)		1,209
Interest income, net		76,028		28,842
Research and development incentives		—		6,331
Change in fair value of convertible debt		—		165,382
Total other income		75,240		201,764
Net loss applicable to common stockholders	$	(3,236,763)	$	(1,915,327)
Basic and diluted net loss per share ⁽¹⁾	$	(1.06)	$	(2.91)
Basic and diluted weighted average common shares outstanding ⁽¹⁾		3,049,625		657,698


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Income (Loss)		Deficit		Total
Balance, December 31, 2024	2,514,499	$	2,514	$	238,040,520	$	45,789	$	(233,970,752)	$	4,118,071
Issuance of common stock pursuant to At Market Issuance Sales Agreement	657,147		657		2,696,885		—		—		2,697,542
Issuance costs associated with sales of common stock pursuant to At Market Issuance Sales Agreement	—		—		(60,011)		—		—		(60,011)
Issuance of common stock to vendors	12,346		12		29,988						30,000
Share-based compensation expense	—		—		63,599		—		—		63,599
Net loss	—		—		—		—		(3,236,763)		(3,236,763)
Balance, March 31, 2025	3,183,992	$	3,183	$	240,770,981	$	45,789	$	(237,207,515)	$	3,612,438


	2025		2024
Operating activities:
Net loss	$	(3,236,763)	$	(1,915,327)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		608		1,588
Non-cash lease expense		31,867		29,265
Share-based compensation		63,599		59,961
Issuance of common stock to vendors for services		30,000		—
Change in fair value of convertible debt		—		(165,382)
Change in operating assets and liabilities:
Contracts and grants receivable		—		54,225
Prepaid expenses and other current assets		605,534		414,138
Research and development incentives receivable		—		17,379
Operating lease liability		(32,737)		(29,359)
Accounts payable and accrued expenses		976,785		391,929
Accrued compensation		(285,905)		(200,899)
Net cash flows from operating activities		(1,847,012)		(1,342,482)

Financing activities:
Proceeds from issuance of common stock pursuant to At Market Issuance Sales Agreement		2,697,542		—
Issuance costs associated with public offerings		—		(8,992)
Convertible debt repayments		(1,372,873)		—
Net cash flows from financing activities		1,324,669		(8,992)
Effect of exchange rate on cash and cash equivalents		—		(3,136)
Net decrease in cash and cash equivalents		(522,343)		(1,354,610)
Cash and cash equivalents at beginning of year		7,819,514		8,446,158
Cash and cash equivalents at end of year	$	7,297,171	$	7,091,548
Supplemental information:
Cash paid for state income taxes	$	56,169	$	17,965
Cash paid for interest	$	35,044	$	64,047
Cash paid for lease liabilities:
Operating lease	$	34,875	$	34,100
Non-cash investing and financing activities:
Pontifax conversion of portion of debt principal into common stock	$	—	$	99,416
Deferred issuance cost reclassified to additional paid-in capital	$	60,011	$	—
Offering costs included in accounts payable	$	—	$	123,689


	As of March 31,
	2025	2024
Common stock purchase warrants	1,467,581	408,640
Stock options	229,919	56,568
Convertible debt	—	335,716
Total	1,697,500	800,924


	March 31,		December 31,
	2025		2024
Clinical trial expenses	$	1,388,546	$	1,135,542
Other		2,015,786		1,223,797
Total	$	3,404,332	$	2,359,339


	Research and
Year	Development		Leases		Total
2025	$	46,000	$	81,375	$	127,375
2026		46,000		—		46,000
2027		46,000		—		46,000
2028		46,000		—		46,000
2029		46,000		—		46,000
Total	$	230,000	$	81,375	$	311,375


	Specialized BioTherapeutics		Public Health Solutions		Total Segments		Adjustments		Corporate		Adjustments		Consolidated
Revenues	$	-	$	-	$	-	$	-	$	-	$	-	$	-
Cost of revenues		-		-		-		-		-		-		-
Gross profit		-		-		-		-		-		-		-
Significant expenses:
Research and development		2,036,097		58,335		2,094,432		27,753		104,990		-		2,227,175
General and administrative		-		-		-		-		1,048,374		36,454		1,084,828
Adjusted loss from operations		(2,036,097)		(58,335)		(2,094,432)		(27,753)		(1,153,364)		(36,454)		(3,312,003)
Share-based compensation		26,488		840		27,328		(27,328)		36,271		(36,271)		-
Depreciation and amortization		364		61		425		(425)		183		(183)		-
Loss from operations		(2,062,949)		(59,236)		(2,122,185)		-		(1,189,818)		-		(3,312,003)
Other (expenses) income, net		-		-		-		-		75,240		-		75,240
Net loss before income taxes	$	(2,062,949)	$	(59,236)	$	(2,122,185)	$	-	$	(1,114,578)	$	-	$	(3,236,763)


	2025		2024
Loss from operations - reportable segments	$	(2,122,185)	$	(906,601)
Loss from operations - corporate		(1,189,818)		(1,210,490)
Interest income (expense), net		76,028		28,842
Other income (expense), net		(788)		172,922
Net loss before income taxes	$	(3,236,763)	$	(1,915,327)


	Specialized BioTherapeutics		Public Health Solutions		Total Segments		Corporate		Consolidated
Total assets	$	301,709	$	120,475	$	422,184	$	7,636,201	$	8,058,385


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); new drug application (“NDA’) submitted to FDA December 2022; FDA refusal to file (“RTF”) letter received February 2023; second Phase 3 trial based upon EMA-accepted protocol began patient enrollment in December 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


	2025		2024
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	59,175	$	45,839
SGX942 (Dusquetide)		74,061		19,258
HyBryte™ (SGX301 or synthetic hypericin)		1,988,525		840,393
Other		105,414		189,550
Total	$	2,227,175	$	1,095,040

Reimbursed under Government Contracts and Grants
HyBryte™ (investigator-initiated study)		—		117,029
Total		—		117,029
Grand Total	$	2,227,175	$	1,212,069


EXHIBIT NO.		DESCRIPTION

10.1		Fourth Amendment to Employment Agreement dated as of May 5, 2025, between Soligenix, Inc. and Christopher J. Schaber, PhD.

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.

101.INS		Inline XBRL Instance Document

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	SOLIGENIX, INC.

May 9, 2025	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

May 9, 2025	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


May 9, 2025		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer



May 9, 2025		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer