Form 10-Q - Quarterly report [Sections 13 or 15(d)]

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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

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

For the Quarterly Period Ended September 30, 2024

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

For the transition period from ____________ to ____________

Commission File No. 001-14778

SOLIGENIX, INC.

(Exact name of registrant as specified in its charter)


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)

(609) 538-8200

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:


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

Indicate by check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


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

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 1, 2024, 2,509,499 shares of the registrant’s common stock (par value, $.001 per share) were outstanding.

Table of Contents

SOLIGENIX, INC.

Index

	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

Table of Contents

PART I - FINANCIAL INFORMATION

ITEM 1 - FINANCIAL STATEMENTS

Soligenix, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets


	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

(1)

Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

Table of Contents

Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

For the Three and Nine Months Ended September 30, 2024 and 2023

(Unaudited)


		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

(1)

Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

Table of Contents

Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Loss

For the Three and Nine Months Ended September 30, 2024 and 2023

(Unaudited)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2024		2023		2024		2023
Net loss	$	(1,719,381)	$	(1,662,702)	$	(5,279,210)	$	(4,320,835)
Other comprehensive income (loss):
Foreign currency translation adjustments		9,874		18,257		15,230		(429)
Comprehensive loss	$	(1,709,507)	$	(1,644,445)	$	(5,263,980)	$	(4,321,264)

The accompanying notes are an integral part of these condensed consolidated financial statements.

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Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit)

For the Nine Months Ended September 30, 2024 and 2023

(Unaudited)


									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


									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	181,898	$	182	$	217,067,691	$	24,747	$	(219,563,446)	$	(2,470,826)
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement	—		—	53,202		53		3,091,409		—		—		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 in May 2023 public offering	—		—	143,844		144		8,495,673		—		—		8,495,817
Issuance costs associated with May 2023 public offering	—		—	—		—		(834,061)		—		—		(834,061)
Issuance of common stock to vendors	—		—	3,125		3		72,997		—		—		73,000
Issuance of common stock for purchase option	—		—	1,978		2		49,998		—		—		50,000
Exercise of pre-funded warrants	—		—	264,714		265		3,034		—		—		3,299
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	—	$	—	648,761	$	649	$	228,080,469	$	24,318	$	(223,884,281)	$	4,221,155

Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

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Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Shareholders’ Equity

For the Three Months Ended September 30, 2024 and 2023

(Unaudited)


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Income		Deficit		Total
Balance, June 30, 2024	1,542,480	$	1,542	$	232,699,640	$	27,599	$	(229,264,005)	$	3,464,776
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 upon exercise of warrants	34,816		35		222,787		—		—		222,822
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
Share-based compensation expense	—		—		56,632		—		—		56,632
Foreign currency translation adjustment	—		—		—		9,874		—		9,874
Net loss	—		—		—		—		(1,719,381)		(1,719,381)
Balance, September 30, 2024	2,295,304	$	2,295	$	236,878,806	$	37,473	$	(230,983,386)	$	5,935,188


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Income		Deficit		Total
Balance, June 30, 2023	615,236	$	615	$	228,015,103	$	6,061	$	(222,221,579)	$	5,800,200
Issuance of common stock upon exercise of pre-funded warrants	33,525		34		(34)		—		—		—
Share-based compensation expense	—		—		65,400		—		—		65,400
Foreign currency translation adjustment	—		—		—		18,257		—		18,257
Net loss	—		—		—		—		(1,662,702)		(1,662,702)
Balance, September 30, 2023	648,761	$	649	$	228,080,469	$	24,318	$	(223,884,281)	$	4,221,155

Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

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Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

For the Nine Months Ended September 30, 2024 and 2023

(Unaudited)


	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	$	—

The accompanying notes are an integral part of these condensed consolidated financial statements.

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Soligenix, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Note 1. Nature of Business

Basis of Presentation

Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions.

The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease, the Company is targeting to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026. Upon successful completion of the second Phase 3 study, called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2), regulatory approval will be sought to support potential commercialization worldwide.

Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease.

The Company’s Public Health Solutions business segment includes development programs for RiVax^®, its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs incorporates the use of the Company’s proprietary heat stabilization platform technology, known as ThermoVax^®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.

The Company primarily generates revenues under government grants and contracts. The Company was awarded a subcontract that originally provided for approximately $1.1 million from a U.S. Food and Drug Administration (“FDA”) Orphan Products Development grant over four years for an expanded study of HyBryte™ in the treatment of CTCL. The Company will continue to apply for additional government funding.

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability.

Results for the three and nine months ended September 30, 2024 are not necessarily indicative of results that may be expected for the full year.

Liquidity

The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. As of September 30, 2024, the Company had an

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accumulated deficit of $230,983,386. During the nine months ended September 30, 2024, the Company incurred a net loss of $5,279,210 and used $6,170,761 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due through the second quarter of 2025. The Company does not have sufficient cash and cash equivalents as of the date of filing this Quarterly Report on Form 10-Q to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued.

To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company’s plans include:

●

Securing additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations.

●

Securing additional proceeds from government contract and grant programs.

●

Securing additional proceeds from the sale of shares of the Company’s common stock via the At Market Issuance Sales Agreement (“AGP Sales Agreement”) with A.G.P/Alliance Global Partners (“AGP”).

●

Amending the loan agreement with Pontifax Medison Finance (“Pontifax”) (See Note 4) to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce the Company’s debt repayments.

Other than the AGP Sales Agreement which was entered into on August 16, 2024 and the second amendment to the Pontifax loan agreement which was completed on October 8, 2024, none of these alternatives are committed at this time. There can be no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that it will require, or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations.

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

As of September 30, 2024, the Company had cash and cash equivalents of $9,840,177 as compared to $8,446,158 as of December 31, 2023. As of September 30, 2024, the Company had working capital of $5,776,645 as compared to working capital of $3,355,212 as of December 31, 2023.

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The Company’s plans with respect to its liquidity management include, but are not limited to, the following:

●

The Company has up to approximately $554,000 in active government grant funding still available as of September 30, 2024 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding.

●

The Company will continue to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and e

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