Soligenix, Inc 10-Q for FY2024 Q2

Soligenix, Inc. (SNGX)

10-Q 2024-08-09 For: 2024-06-30

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on August 9, 2024, covering the quarter ended June 30, 2024 (FY2024 Q2).

Headline figures

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

Revenue: $2342; down 98.9% from $206.93K a year earlier
Net loss: $1.64M; compared with a net loss of $1.61M a year earlier
Diluted EPS: -$1.31; compared with -$3.56 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
	Condensed Consolidated Balance Sheets as of June 30, 2024 (unaudited) and December 31, 2023	1
	Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited)	2
	Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2024 and 2023 (unaudited)	3
	Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit) for the Six Months Ended June 30, 2024 and 2023 (unaudited)	4
	Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit) for the Three Months Ended June 30, 2024 and 2023 (unaudited)	5
	Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2024 and 2023 (unaudited)	6
	Notes to Condensed Consolidated Financial Statements (unaudited)	7
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23
Item 3	Quantitative and Qualitative Disclosures About Market Risk	52
Item 4	Controls and Procedures	52

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	53
Item 1A	Risk Factors	53
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	54
Item 5	Other Information	54
Item 6	Exhibits	55

SIGNATURES		56


	June 30,		December 31,
	2024		2023
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	9,412,539	$	8,446,158
Unbilled revenue		—		171,254
Research and development incentives receivable, current		—		23,894
Deferred issuance cost		5,861		—
Prepaid expenses and other current assets		244,472		866,014
Total current assets		9,662,872		9,507,320
Security deposit		22,777		22,777
Office furniture and equipment, net		8,751		11,927
Right-of-use lease assets		170,679		229,834
Research and development incentives receivable, net of current portion		—		25,468
Total assets	$	9,865,079	$	9,797,326

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	1,698,225	$	1,111,226
Accrued expenses		1,701,806		2,418,002
Accrued compensation		80,244		251,115
Lease liabilities, current		128,592		121,765
Convertible debt		2,745,745		2,250,000
Total current liabilities		6,354,612		6,152,108
Non-current liabilities:
Convertible debt		—		1,010,934
Lease liabilities, net of current portion		45,691		111,862
Total liabilities		6,400,303		7,274,904

Commitments and contingencies (Note 6)

Shareholders’ equity:
Preferred stock, 350,000 shares authorized; none issued or outstanding at June 30, 2024 and December 31, 2023, respectively		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 1,542,480 and 648,761 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively⁽¹⁾		1,542		649
Additional paid-in capital ⁽¹⁾		232,699,640		228,203,706
Accumulated other comprehensive income		27,599		22,243
Accumulated deficit		(229,264,005)		(225,704,176)
Total shareholders’ equity		3,464,776		2,522,422
Total liabilities and shareholders’ equity	$	9,865,079	$	9,797,326


		Three Months Ended			Six Months Ended
		June 30,			June 30,
	2024		2023		2024		2023
Revenues:
Grant revenue		2,342		206,929	$	119,371	$	464,107
Total revenues		2,342		206,929		119,371		464,107
Cost of revenues		(2,342)		(184,021)		(119,371)		(410,061)
Gross profit		—		22,908		—		54,046
Operating expenses:
Research and development		501,158		762,699		1,596,198		1,709,150
General and administrative		1,243,517		890,533		2,265,568		2,125,909
Total operating expenses		1,744,675		1,653,232		3,861,766		3,835,059
Loss from operations		(1,744,675)		(1,630,324)		(3,861,766)		(3,781,013)
Other income (expense):
Foreign currency transaction gain		473		3,722		1,682		3,356
Interest income (expense), net		35,925		(60,194)		64,767		(163,762)
Research and development incentives		(31,819)		6,209		(25,488)		12,657
Other income		43		2,354		43		43,223
Loss on extinguishment of debt		—		(393,791)		—		(393,791)
Change in fair value of convertible debt		95,551		460,000		260,933		460,000
Total other income (expense)		100,173		18,300		301,937		(38,317)
Net loss before income taxes		(1,644,502)		(1,612,024)		(3,559,829)		(3,819,330)
Income tax benefit		—		—		—		1,161,197
Net loss applicable to common stockholders	$	(1,644,502)	$	(1,612,024)	$	(3,559,829)	$	(2,658,133)
Basic and diluted net loss per share ⁽¹⁾	$	(1.31)	$	(3.56)	$	(3.71)	$	(8.35)
Basic and diluted weighted average common shares outstanding ⁽¹⁾		1,258,985		453,035		958,341		318,414


									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 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 pre-funded warrants	—		—	537,500		537		8,063		—		—		8,600
Issuance of common stock associated with conversion of debt	—		—	36,790		36		254,220		—		—		254,256
Share-based compensation expense	—		—	—		—		117,636		—		—		117,636
Foreign currency translation adjustment	—		—	—		—		—		5,356		—		5,356
Net loss	—		—	—		—		—		—		(3,559,829)		(3,559,829)
Balance, June 30, 2024	—	$	—	1,542,480	$	1,542	$	232,699,640	$	27,599	$	(229,264,005)	$	3,464,776


	2024		2023
Operating activities:
Net loss	$	(3,559,829)	$	(2,658,133)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		3,176		3,375
Non-cash lease expense		59,155		54,432
Share-based compensation		117,636		163,676
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)		(460,000)
Amortization of deferred issuance costs associated with convertible debt		—		12,518
Change in operating assets and liabilities:
Contracts and grants receivable		171,254		1,374
Prepaid expenses and other current assets		621,542		102,882
Research and development incentives receivable		48,994		93,821
Operating lease liability		(59,344)		(53,071)
Accounts payable and accrued expenses		(231,089)		(1,604,414)
Accrued compensation		(170,871)		(262,831)
Net cash flows from operating activities		(3,260,309)		(4,089,580)

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		4,741,400		8,495,817
Stock issuance costs associated with public offering		(524,226)		(612,611)
Proceeds from the exercise of warrants		8,600		3,299
Convertible debt repayments		—		(7,000,000)
Net cash flows from financing activities		4,225,774		3,884,958
Effect of exchange rate on cash and cash equivalents		916		5,946
Net increase in cash and cash equivalents		966,381		(198,676)
Cash and cash equivalents at beginning of period		8,446,158		13,359,615
Cash and cash equivalents at end of period	$	9,412,539	$	13,160,939
Supplemental information:
Cash paid for state income taxes	$	33,665	$	10,879
Cash paid for interest	$	125,286	$	424,660
Cash paid for lease liabilities:
Operating lease	$	68,200	$	66,650
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	$	—	$	2,339
Redemption liability for Series D preferred stock	$	—	$	43
Public offering costs included in accounts payable	$	100,839	$	221,450


			Pontifax
			Conversions
	Balance		January 3, 2024			Adjustment to	Balance
	December 31, 2023		and April 15, 2024		fair value		June 30, 2024
Convertible debt at fair value	$	3,260,934	$	(254,256)	$	(260,933)	$	2,745,745


	As of June 30,
	2024	2023
Common stock purchase warrants	1,150,834	442,232
Stock options	56,699	12,879
Convertible debt	100,947	133,451
Total	1,308,480	588,562


	June 30,		December 31,
	2024		2023
Clinical trial expenses	$	1,356,608	$	1,993,784
Other		345,198		424,218
Total	$	1,701,806	$	2,418,002


Year	Principal		Interest		Total
Remainder of 2024	$	1,372,872	$	73,274	$	1,446,146
2025		686,437		14,336		700,773
Total	$	2,059,309	$	87,610	$	2,146,919


	Research and		Property and
Year	Development		Other Leases		Total
July 1 through December 31, 2024	$	46,000	$	68,717	$	114,717
2025		46,000		116,250		162,250
2026		46,000		—		46,000
2027		46,000		—		46,000
2028		46,000		—		46,000
Total	$	230,000	$	184,967	$	414,967


	As of		As of
	June 30,		December 31,
	2024		2023
Identifiable Assets
Specialized BioTherapeutics	$	183,858	$	272,099
Public Health Solutions		2,917		3,976
Corporate		9,678,304		9,521,251
Total	$	9,865,079	$	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	$	107,731	$	55,953
SGX942 (Dusquetide)		(194,846)		(45,358)
HyBryte™ (SGX301 or synthetic hypericin)		1,336,749		1,466,859
Other		346,564		231,696
Total	$	1,596,198	$	1,709,150

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	—	$	—
CiVax™		—		150,337
SGX943		—		35,429
HyBryte™ (investigator-initiated study)		119,371		224,295
Total		119,371		410,061
Grand Total	$	1,715,569	$	2,119,211


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 9, 2024	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

August 9, 2024	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


August 9, 2024		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer


August 9, 2024		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer