Soligenix, Inc 10-Q for FY2023 Q1

Soligenix, Inc. (SNGX)

10-Q 2023-05-15 For: 2023-03-31

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on May 15, 2023, covering the quarter ended March 31, 2023 (FY2023 Q1).

Headline figures

Quarter ended March 31, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $257.18K; up 36.8% from $188.06K a year earlier
Net loss: $1.05M; compared with a net loss of $4.35M a year earlier
Diluted EPS: -$0.36; compared with -$1.52 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 March 31, 2023 (unaudited) and December 31, 2022	1
	Consolidated Statements of Operations for the Three Months Ended March 31, 2023 and 2022 (unaudited)	2
	Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2023 and 2022 (unaudited)	3
	Consolidated Statements of Changes in Mezzanine Equity and Shareholders’ Deficit for the Three Months Ended March 31, 2023 and 2022 (unaudited)	4
	Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2023 and 2022 (unaudited)	5
	Notes to Consolidated Financial Statements (unaudited)	6
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23
Item 3	Quantitative and Qualitative Disclosures About Market Risk	51
Item 4	Controls and Procedures	51

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	52
Item 1A	Risk Factors	53
Item 6	Exhibits	54

SIGNATURES		55


	March 31,		December 31,
	2023		2022
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	10,265,850	$	13,359,615
Contracts and grants receivable		218,008		115,130
Research and development incentives receivable, current		24,774		104,198
Prepaid expenses and other current assets		213,315		274,209
Total current assets		10,721,947		13,853,152
Security deposit		22,777		22,777
Office furniture and equipment, net of accumulated depreciation of $116,551 and $114,766		16,696		18,481
Deferred issuance cost		20,153		20,206
Right-of-use lease assets		314,051		340,987
Research and development incentives receivable, net of current portion		6,193		24,114
Total assets	$	11,101,817	$	14,279,717

Liabilities, mezzanine equity and shareholders' deficit
Current liabilities:
Accounts payable	$	2,768,999	$	3,865,796
Accrued expenses		2,451,139		2,307,746
Accrued compensation		44,492		336,692
Lease liabilities, current		112,051		108,948
Convertible debt, net of debt discount of $0 and $102,309		6,000,000		9,897,691
Total current liabilities		11,376,681		16,516,873
Non-current liabilities:
Convertible debt, net of debt discount of $92,067		2,907,933		—
Lease liabilities, net of current portion		204,268		233,627
Total liabilities		14,488,882		16,750,500

Commitments and contingencies

Mezzanine equity:
Series D preferred stock, $.001 par value; 0 and 50,000 shares authorized, none issued or outstanding as of March 31, 2023 and December 31, 2022, respectively		—		43

Shareholders’ deficit:
Preferred stock, 350,000 and 300,000 shares authorized as of March 31, 2023 and December 31, 2022, respectively; none issued or outstanding		—		—
Common stock, $.001 par value; 75,000,000 shares authorized; 2,929,773 and 2,908,578 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively⁽¹⁾		2,930		2,909
Additional paid-in capital		217,206,966		217,064,964
Accumulated other comprehensive income		12,594		24,747
Accumulated deficit		(220,609,555)		(219,563,446)
Total shareholders’ deficit		(3,387,065)		(2,470,826)
Total liabilities, mezzanine equity and shareholders’ deficit	$	11,101,817	$	14,279,717


	Three Months Ended
	March 31,
	2023		2022
Revenues:
Licensing revenue	$	—	$	50,000
Grant revenue		257,178		138,063
Total revenues		257,178		188,063
Cost of revenues		(226,040)		(92,213)
Gross profit		31,138		95,850
Operating expenses:
Research and development		946,451		1,746,768
General and administrative		1,235,376		2,541,468
Total operating expenses		2,181,827		4,288,236
Loss from operations		(2,150,689)		(4,192,386)
Other income (expense):
Foreign currency transaction loss		(366)		(108,293)
Interest expense, net		(103,568)		(211,714)
Research and development incentives		6,448		163,372
Other income		40,869		—
Total other income (expense)		(56,617)		(156,635)
Net loss before income taxes		(2,207,306)		(4,349,021)
Income tax benefit		1,161,197		—
Net loss applicable to common stockholders	$	(1,046,109)	$	(4,349,021)
Basic and diluted net loss per share ⁽¹⁾	$	(0.36)	$	(1.52)
Basic and diluted weighted average common shares outstanding ⁽¹⁾		2,914,929		2,861,351


									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	2,908,578	$	2,909	$	217,064,964	$	24,747	$	(219,563,446)	$	(2,470,826)
Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement				21,195		21		70,709		—		—		70,730
Issuance costs associated with B. Riley At Market Issuance Sales Agreement				—		—		(2,341)		—		—		(2,341)
Redemption of Series D preferred stock	—		(43)	—		—		—		—		—		—
Share-based compensation expense				—		—		73,634		—		—		73,634
Foreign currency translation adjustment				—		—		—		(12,153)		—		(12,153)
Net loss				—		—		—		—		(1,046,109)		(1,046,109)
Balance, March 31, 2023	—	$	—	2,929,773	$	2,930	$	217,206,966	$	12,594	$	(220,609,555)	$	(3,387,065)


	2023		2022
Operating activities:
Net loss	$	(1,046,109)	$	(4,349,021)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		1,785		8,232
Non-cash lease expense		26,936		30,925
Share-based compensation		73,634		78,271
Issuance of common stock to vendors for services		—		50,001
Amortization of deferred issuance costs associated with convertible debt		10,242		10,242
Change in operating assets and liabilities:
Licensing, contracts and grants receivable		(102,878)		15,197
Prepaid expenses and other current assets		60,894		(70,732)
Research and development incentives receivable		98,456		55,466
Operating lease liability		(26,256)		(30,921)
Accounts payable and accrued expenses		(970,757)		1,228,383
Accrued compensation		(292,200)		(264,886)
Net cash used in operating activities		(2,166,253)		(3,238,843)

Investing activities:
Purchases of office furniture and equipment		—		(9,823)
Net cash used in investing activities		—		(9,823)

Financing activities:
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement		70,730		—
Costs associated with B. Riley At Market Issuance Sales Agreement		(2,288)		—
Convertible debt repayment		(1,000,000)		—
Net cash used in financing activities		(931,558)		—
Effect of exchange rate on cash and cash equivalents		4,046		80,448
Net decrease in cash and cash equivalents		(3,093,765)		(3,168,218)
Cash and cash equivalents at beginning of period		13,359,615		26,043,897
Cash and cash equivalents at end of period	$	10,265,850	$	22,875,679
Supplemental information:
Cash paid for state income taxes	$	2,110	$	—
Cash paid for interest	$	213,490	$	223,901
Cash paid for lease liabilities:
Operating lease	$	33,325	$	33,325
Non-cash investing and financing activities:
Deferred issuance cost reclassified to additional paid-in capital	$	53	$	—
Redemption liability for Series D preferred stock	$	43	$	—


	Current		Long-Term		Total
Balance at December 31, 2022	$	104,198	$	24,114	$	128,312
UK research and development incentives, transfer		24,114		(24,114)		—
UK research and development incentives		—		6,023		6,023
Additional 2021 incentive earned		425		—		425
UK research and development incentives cash receipt		(104,422)		—		(104,422)
Foreign currency translation		459		171		630
Balance at March 31, 2023	$	24,774	$	6,193	$	30,967


	As of March 31,
	2023	2022
Common stock purchase warrants	—	3,992
Stock options	192,273	146,285
Convertible debt	146,342	162,602
Total	338,615	312,879


	Operating
	Lease
Right-of-use lease asset:
Right-of-use lease asset, January 1, 2023	$	340,987
Less: reduction/amortization		26,936
Right-of-use lease asset, March 31, 2023	$	314,051

Lease liability:
Lease liability, January 1, 2023	$	342,575
Less: repayments		26,256
Lease liability, March 31, 2023	$	316,319

Lease expense for the three months ended March 31, 2023:
Lease expense	$	34,005
Total	$	34,005

Lease expense for the three months ended March 31, 2022:
Lease expense	$	33,330
Total	$	33,330

Contractual cash payments for the remaining lease term as of March 31, 2023:
2023	$	100,492
2024		136,917
2025		116,250
Total	$	353,659
Remaining lease term (months) as of March 31, 2023		31


	March 31,		December 31,
	2023		2022
Clinical trial expenses	$	2,014,026	$	1,884,117
Other		437,113		423,629
Total	$	2,451,139	$	2,307,746


Year	Principal		Interest		Total
2023	$	6,000,000	$	402,615	$	6,402,615
2024		2,250,000		206,761		2,456,761
2025		750,000		16,012		766,012
Total	$	9,000,000	$	625,388	$	9,625,388


	Research and		Property and
Year	Development		Other Leases		Total
April 1 through December 31, 2023	$	46,000	$	100,492	$	146,492
2024		46,000		136,917		182,917
2025		46,000		116,250		162,250
2026		46,000		—		46,000
2027		46,000		—		46,000
Total	$	230,000	$	353,659	$	583,659


	As of		As of
	March 31,		December 31,
	2023		2022
Identifiable Assets
Specialized BioTherapeutics	$	71,689	$	103,742
Public Health Solutions		223,573		121,290
Corporate		10,806,555		14,054,685
Total	$	11,101,817	$	14,279,717


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 December 2022; FDA RTF letter received February 2023; Type A meeting with the FDA convened April 2023, in which the FDA determined that a second positive Phase 3 study would be required to support a NDA submission; requested and granted a follow-on Type A meeting with FDA to engage in formal protocol discussions with FDA to define the protocol for, and evaluate feasibility of conducting, an additional Phase 3 clinical trial (as requested by the FDA); feedback from this follow-on Type A meeting will be provided by or before the end of June 2023

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 initiated 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


	2023		2022
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	30,533	$	201,723
SGX942 (Dusquetide)		(318)		409,536
HyBryte™ (SGX301 or synthetic hypericin)		822,096		1,020,274
Other		94,140		115,235
Total	$	946,451	$	1,746,768

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	—	$	15,703
CiVax™		35,247		52,700
SGX943		35,429		23,810
HyBryte™ (investigator initiated study)		155,365		—
Total		226,040		92,213
Grand Total	$	1,172,491	$	1,838,981


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.

May 15, 2023	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

May 15, 2023	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


May 15, 2023		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer


May 15, 2023		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer