Soligenix, Inc 10-Q for FY2022 Q3

Soligenix, Inc. (SNGX)

10-Q 2022-11-10 For: 2022-09-30

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on November 10, 2022, covering the quarter ended September 30, 2022 (FY2022 Q3).

Headline figures

Quarter ended September 30, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $166.14K; down 10.8% from $186.2K a year earlier
Net loss: $3.31M; compared with a net loss of $3.59M a year earlier
Diluted EPS: -$0.08; compared with -$0.09 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	Consolidated Financial Statements
	Consolidated Balance Sheets as of September 30, 2022 (unaudited) and December 31, 2021	1
	Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2022 and 2021 (unaudited)	2
	Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2022 and 2021 (unaudited)	3
	Consolidated Statements of Changes in Shareholders’ Equity for the Nine Months Ended September 30, 2022 and 2021 (unaudited)	4
	Consolidated Statements of Changes in Shareholders’ Equity for the Three Months Ended September 30, 2022 and 2021 (unaudited)	5
	Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2022 and 2021 (unaudited)	6
	Notes to Consolidated Financial Statements (unaudited)	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	48
Item 4	Controls and Procedures	49

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	49
Item 1A	Risk Factors	50
Item 2	Unregistered Sales of Equity Securities and Use of Proceeds	51
Item 6	Exhibits	52

SIGNATURES		53


	September 30,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	16,865,642	$	26,043,897
Licensing, contracts and grants receivable		130,742		138,889
Research and development incentives receivable		100,372		103,832
Prepaid expenses and other current assets		396,355		282,903
Total current assets		17,493,111		26,569,521
Security deposit		22,777		22,777
Office furniture and equipment, net of accumulated depreciation of $111,742 and $167,848		21,505		22,220
Deferred issuance cost		20,266		20,266
Right-of-use lease assets		367,375		106,155
Research and development incentives receivable		22,339		121,238
Other assets		—		7,750
Total assets	$	17,947,373	$	26,869,927

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	4,164,627	$	2,925,544
Accrued expenses		2,235,451		2,956,545
Accrued compensation		59,790		302,936
Lease liabilities, current		106,165		106,151
Convertible debt, current		3,000,000		—
Deferred revenue, current		100,000		—
Total current liabilities		9,666,033		6,291,176
Non-current liabilities:
Convertible debt, net of current portion and debt discount of $112,779 and $143,847		6,887,221		9,856,153
Lease liabilities, net of current portion		262,117		—
Deferred revenue, net of current portion		100,000		—
Total liabilities		16,915,371		16,147,329
Commitments and contingencies
Shareholders’ equity:
Preferred stock, 350,000 shares authorized; none issued or outstanding		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 43,105,191 shares and 42,873,445 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively		43,105		42,873
Additional paid-in capital		216,773,316		216,402,890
Accumulated other comprehensive income		25,472		41,942
Accumulated deficit		(215,809,891)		(205,765,107)
Total shareholders’ equity		1,032,002		10,722,598
Total liabilities and shareholders’ equity	$	17,947,373	$	26,869,927


		Three Months Ended			Nine Months Ended
		September 30,			September 30,
	2022		2021		2022		2021
Revenues:
Licensing revenue	$	—	$	—	$	50,000	$	—
Contract revenue		—		—		—		33,351
Grant revenue		166,140		186,198		532,843		515,264
Total revenues		166,140		186,198		582,843		548,615
Cost of revenues		(129,440)		(166,265)		(414,957)		(492,942)
Gross profit		36,700		19,933		167,886		55,673
Operating expenses:
Research and development		1,791,695		2,237,565		5,586,302		5,483,695
General and administrative		1,326,249		1,147,279		5,250,510		3,159,155
Total operating expenses		3,117,944		3,384,844		10,836,812		8,642,850
Loss from operations		(3,081,244)		(3,364,911)		(10,668,926)		(8,587,177)
Other income (expense):
Gain on forgiveness of PPP loan		—		—		—		421,584
Foreign currency transaction loss		(12,613)		(66,967)		(26,006)		(22,384)
Interest expense, net		(215,146)		(227,271)		(641,768)		(676,512)
Research and development incentives		—		40,844		136,981		121,896
Other income (expense)		—		30,754		—		30,754
Total other income (expense)		(227,759)		(222,640)		(530,793)		(124,662)
Net loss before income taxes		(3,309,003)		(3,587,551)		(11,199,719)		(8,711,839)
Income tax benefit		—		—		1,154,935		864,742
Net loss applicable to common stockholders	$	(3,309,003)	$	(3,587,551)	$	(10,044,784)	$	(7,847,097)
Basic and diluted net loss per share	$	(0.08)	$	(0.09)	$	(0.23)	$	(0.20)
Basic and diluted weighted average common shares outstanding		43,083,690		40,697,888		43,005,912		39,210,984


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Income (Loss)		Deficit		Total
Balance, December 31, 2021	42,873,445	$	42,873	$	216,402,890	$	41,942	$	(205,765,107)	$	10,722,598
Issuance of common stock to vendors	231,746		232		149,770		—		—		150,002
Share-based compensation expense	—		—		220,656		—		—		220,656
Foreign currency translation adjustment	—		—		—		(16,470)		—		(16,470)
Net loss	—		—		—		—		(10,044,784)		(10,044,784)
Balance, September 30, 2022	43,105,191	$	43,105	$	216,773,316	$	25,472	$	(215,809,891)	$	1,032,002


	2022		2021
Operating activities:
Net loss	$	(10,044,784)	$	(7,847,097)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		21,538		26,614
Non-cash lease expense		86,326		86,124
Share-based compensation		220,656		255,147
Issuance of common stock to vendors for services		150,002		27,500
Amortization of deferred issuance costs associated with convertible debt		31,068		31,456
Gain on forgiveness of PPP loan		—		(421,584)
Change in operating assets and liabilities:
Licensing, contracts and grants receivable		8,147		159,590
Prepaid expenses and other current assets		(113,452)		(203,619)
Research and development incentives receivable		67,912		258,509
Operating lease liability		(85,415)		(86,124)
Deferred revenue		200,000		—
Accounts payable and accrued expenses		679,268		(154,415)
Accrued compensation		(243,146)		(816,367)
Net cash used in operating activities		(9,021,880)		(8,684,266)

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		—		19,417,290
Costs associated with B. Riley At Market Issuance Sales Agreement		—		(584,334)
Proceeds from the exercise of warrants		—		51
Proceeds from the exercises of stock options		—		25,835
Costs associated with issuance of convertible debt		—		(45,512)
Principal repayment – financing lease		—		(6,149)
Net cash provided by financing activities		—		18,807,181
Effect of exchange rate on cash and cash equivalents		(143,302)		67,909
Net (decrease)/increase in cash and cash equivalents		(9,178,255)		10,190,824
Cash and cash equivalents at beginning of period		26,043,897		18,676,663
Cash and cash equivalents at end of period	$	16,865,642	$	28,867,487
Supplemental information:
Cash paid for state income taxes	$	13,243	$	7,382
Cash paid for interest	$	643,921	$	444,814
Cash paid for lease liabilities:
Operating lease	$	99,975	$	99,975
Financing lease	$	—	$	6,408
Non-cash activities:
Right-of-use assets and lease liabilities recorded	$	347,546	$	—
Deferred issuance cost in accounts payable	$	—	$	22,700
Deferred issuance cost reclassified to additional paid-in capital	$	—	$	55,572


	Current		Long-Term		Total
Balance at December 31, 2021	$	103,832	$	121,238	$	225,070
UK research and development incentives, transfer		121,238		(121,238)		—
UK research and development incentives		—		29,075		29,075
Additional 2020 incentive earned		107,906		—		107,906
UK research and development incentives cash receipt		(209,166)		—		(209,166)
Foreign currency translation		(23,438)		(6,736)		(30,174)
Balance at September 30, 2022	$	100,372	$	22,339	$	122,711


	As of September 30,
	2022	2021
Common stock purchase warrants	59,872	5,731,464
Stock options	2,183,406	1,996,890
Convertible debt	2,439,024	4,878,048
Total	4,682,302	12,606,402


	Operating
	Lease
Right-of-use lease asset:
Right-of-use lease asset, January 1, 2022	$	106,155
New lease extension June 21, 2022		347,546
Reduction/amortization		(86,326)
Right of use lease asset, September 30, 2022	$	367,375

Lease liability:
Lease liability, January 1, 2022	$	106,151
New lease extension June 21, 2022		347,546
Repayments		(85,415)
Lease liability, September 30, 2022	$	368,282

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

Lease expense for the nine months ended September 30, 2021:
Lease expense	$	99,975
Total	$	99,975

Contractual cash payments for the remaining lease term as of September 30, 2022:
2022	$	33,325
2023		133,817
2024		136,917
2025		116,250
Total	$	420,309
Remaining lease term (months) as of September 30, 2022		37


	September 30,		December 31,
	2022		2021
Clinical trial expenses	$	1,913,221	$	2,625,779
Other		322,230		330,766
Total	$	2,235,451	$	2,956,545


Year	Principal		Interest		Total
2022	$	—	$	213,490	$	213,490
2023		4,000,000		719,138		4,719,138
2024		4,000,000		380,338		4,380,338
2025		2,000,000		60,566		2,060,566
Total	$	10,000,000	$	1,373,532	$	11,373,532


	Research and		Property and
Year	Development		Other Leases		Total
October 1 through December 31, 2022	$	21,000	$	33,325	$	54,325
2023		96,000		133,817		229,817
2024		46,000		136,917		182,917
2025		46,000		116,250		162,250
2026		46,000		—		46,000
Total	$	255,000	$	420,309	$	675,309


	As of		As of
	September 30,		December 31,
	2022		2021
Identifiable Assets
Specialized BioTherapeutics	$	121,567	$	128,645
Public Health Solutions		137,910		146,296
Corporate		17,687,896		26,594,986
Total	$	17,947,373	$	26,869,927


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 filing planned for Q4 2022

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 Food and Drug Administration (“FDA”); Phase 2a study initiation anticipated December 2022

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

SGX203†	Pediatric Crohn’s disease	Phase 1/2 clinical trial completed; efficacy data, pharmacokinetic(PK)/pharmacodynamic(PD) profile and safety profile demonstrated; Phase 3 clinical trial initiation contingent upon additional funding, such as through partnership


	2022		2021
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	299,086	$	455,186
SGX942 (Dusquetide)		242,610		327,580
HyBryte™ (SGX301 or synthetic hypericin)		4,745,133		4,336,738
Other		299,473		364,191
Total	$	5,586,302	$	5,483,695

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	22,161	$	126,287
SGX942 (Dusquetide)		—		—
CiVax™		315,845		314,833
SGX943		76,951		51,822
Total		414,957		492,942
Grand Total	$	6,001,259	$	5,976,637


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 10, 2022	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

November 10, 2022	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


November 10, 2022		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer


November 10, 2022		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer