Soligenix, Inc 10-Q for FY2022 Q1

Soligenix, Inc. (SNGX)

10-Q 2022-05-13 For: 2022-03-31

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on May 13, 2022, covering the quarter ended March 31, 2022 (FY2022 Q1).

Headline figures

Quarter ended March 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $188.06K; up 27.4% from $147.59K a year earlier
Net loss: $4.35M; compared with a net loss of $2.36M a year earlier
Diluted EPS: -$0.10; compared with -$0.06 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, 2022 (unaudited) and December 31, 2021	1
	Consolidated Statements of Operations for the Three Months Ended March 31, 2022 and 2021 (unaudited)	2
	Consolidated Statements of Comprehensive Loss for the Three Months Ended March 31, 2022 and 2021 (unaudited)	3
	Consolidated Statements of Changes in Shareholders’ Equity for the Three Months Ended March 31, 2022 and 2021 (unaudited)	4
	Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2022 and 2021 (unaudited)	5
	Notes to Consolidated Financial Statements (unaudited)	6
Item 2	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3	Quantitative and Qualitative Disclosures About Market Risk	43
Item 4	Controls and Procedures	43

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	44
Item 1A	Risk Factors	45
Item 6	Exhibits	46

SIGNATURES		47


	March 31,		December 31,
	2022		2021
Assets
Current assets:
Cash and cash equivalents	$	22,875,679	$	26,043,897
Contracts and grants receivable		123,692		138,889
Research and development incentives receivable		121,238		103,832
Prepaid expenses and other current assets		353,635		282,903
Total current assets		23,474,244		26,569,521
Security deposit		22,777		22,777
Office furniture and equipment, net of accumulated depreciation of $172,204 and $167,848		27,686		22,220
Deferred issuance cost		20,266		20,266
Right-of-use lease assets		75,230		106,155
Research and development incentives receivable		50,566		121,238
Other assets		3,875		7,750
Total assets	$	23,674,644	$	26,869,927

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	4,518,174	$	2,925,544
Accrued expenses		2,592,296		2,956,545
Accrued compensation		38,050		302,936
Lease liabilities - current		75,230		106,151
Total current liabilities		7,223,750		6,291,176
Non-current liabilities:
Convertible debt, net of debt discount of $133,605 and $143,847		9,866,395		9,856,153
Total liabilities		17,090,145		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; 42,954,091 shares and 42,873,445 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively		42,954		42,873
Additional paid-in capital		216,531,081		216,402,890
Accumulated other comprehensive income		124,592		41,942
Accumulated deficit		(210,114,128)		(205,765,107)
Total shareholders’ equity		6,584,499		10,722,598
Total liabilities and shareholders’ equity	$	23,674,644	$	26,869,927


	Three Months Ended
	March 31,
	2022		2021
Revenues:
Contract revenue	$	50,000	$	33,351
Grant revenue		138,063		114,242
Total revenues		188,063		147,593
Cost of revenues		(92,213)		(122,360)
Gross profit		95,850		25,233
Operating expenses:
Research and development		1,746,768		1,309,522
General and administrative		2,551,710		949,318
Total operating expenses		4,298,478		2,258,840
Loss from operations		(4,202,628)		(2,233,607)
Other expense:
Foreign currency transaction (loss)/gain		(108,293)		27,253
Interest expense, net		(201,472)		(213,505)
Research and development incentives		163,372		57,381
Total other expense		(146,393)		(128,871)
Net loss applicable to common stockholders	$	(4,349,021)	$	(2,362,478)
Basic and diluted net loss per share	$	(0.10)	$	(0.06)
Basic and diluted weighted average common shares outstanding		42,920,040		36,818,154


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Income		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	80,646		81		49,920		—		—		50,001
Share-based compensation expense	—		—		78,271		—		—		78,271
Foreign currency translation adjustment	—		—		—		82,650		—		82,650
Net loss	—		—		—		—		(4,349,021)		(4,349,021)
Balance, March 31, 2022	42,954,091	$	42,954	$	216,531,081	$	124,592	$	(210,114,128)	$	6,584,499


	2022		2021
Operating activities:
Net loss	$	(4,349,021)	$	(2,362,478)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		8,232		8,899
Non-cash lease expense		30,925		27,995
Share-based compensation		78,271		94,805
Issuance of common stock to vendors		50,001		—
Amortization of deferred issuance costs associated with convertible debt		10,242		10,155
Change in operating assets and liabilities:
Contracts and grants receivable		15,197		42,050
Prepaid expenses and other current assets		(70,732)		(245,384)
Research and development incentives receivable		55,466		327,293
Operating lease liability		(30,921)		(27,996)
Accounts payable and accrued expenses		1,228,383		(1,032,095)
Accrued compensation		(264,886)		(828,471)
Net cash used in operating activities		(3,238,843)		(3,985,227)

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		—		16,395,606
Costs associated with B. Riley At Market Issuance Sales Agreement		—		(492,445)
Proceeds from the exercise of warrants		—		51
Costs associated with issuance of convertible debt		—		(45,512)
Principal repayment – financing lease		—		(1,999)
Net cash provided by financing activities		—		15,855,701
Effect of exchange rate on cash and cash equivalents		80,448		(5,193)
Net (decrease)/increase in cash and cash equivalents		(3,168,218)		11,865,281
Cash and cash equivalents at beginning of period		26,043,897		18,676,663
Cash and cash equivalents at end of period	$	22,875,679	$	30,541,944
Supplemental information:
Cash paid for state income taxes	$	—	$	2,132
Cash paid for interest	$	223,901	$	221,178
Cash paid for lease liabilities:
Operating lease	$	33,325	$	33,325
Financing lease	$	—	$	2,136
Non-cash activities:
Deferred issuance cost reclassified to additional-paid-in capital	$	—	$	47,452


	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		—		55,466		55,466
Additional 2020 incentive earned		107,906		—		107,906
UK research and development incentives cash receipt		(209,166)		—		(209,166)
Foreign currency translation		(2,572)		(4,900)		(7,472)
Balance at March 31, 2022	$	121,238	$	50,566	$	171,804


	As of March 31,
	2022	2021
Common stock purchase warrants	59,872	5,731,464
Stock options	2,195,140	1,993,804
Convertible debt	2,439,024	2,439,024
Total	4,694,036	10,164,292


	Operating
	Lease
Right-of-use lease asset:
Right-of-use lease asset, January 1, 2022	$	106,155
Reduction/amortization		30,925
Right of use lease asset, March 31, 2022	$	75,230

Lease liability:
Lease liability, January 1, 2022	$	106,151
Repayments		30,921
Lease liability, March 31, 2022	$	75,230

Lease expenses 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, 2022:
2022		77,758
Total	$	77,758
Remaining lease term (months) as of March 31, 2022		7


	March 31,		December 31,
	2022		2021
Clinical trial expenses	$	1,997,721	$	2,625,779
Other		594,575		330,766
Total	$	2,592,296	$	2,956,545


Year	Principal		Interest		Total
2022	$	—	$	638,151	$	638,151
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	$	1,798,193	$	11,798,193


	Research and		Property and
Year	Development		Other Leases		Total
April 1 through December 31, 2022	$	46,000	$	77,758	$	123,758
2023		96,000		—		96,000
2024		46,000		—		46,000
2025		46,000		—		46,000
2026		46,000		—		46,000
Total	$	280,000	$	77,758	$	357,758


	Three Months Ended
	March 31,
	2022		2021
Revenues
Specialized BioTherapeutics	$	—	$	—
Public Health Solutions		188,063		147,593
Total	$	188,063	$	147,593

Loss from Operations
Specialized BioTherapeutics	$	(1,539,728)	$	(1,112,408)
Public Health Solutions		(120,621)		(130,781)
Corporate		(2,542,279)		(990,418)
Total	$	(4,202,628)	$	(2,233,607)

Amortization and Depreciation Expense
Specialized BioTherapeutics	$	2,614	$	1,899
Public Health Solutions		436		316
Corporate		5,182		6,684
Total	$	8,232	$	8,899

Other (Expense)/Income, Net
Specialized BioTherapeutics	$	55,079	$	84,634
Corporate		(201,472)		(213,505)
Total	$	(146,393)	$	(128,871)

Share-Based Compensation
Specialized BioTherapeutics	$	28,504	$	29,579
Public Health Solutions		1,054		6,295
Corporate		48,713		58,931
Total	$	78,271	$	94,805


	As of		As of
	March 31,		December 31,
	2022		2021
Identifiable Assets
Specialized BioTherapeutics	$	223,895	$	128,645
Public Health Solutions		132,921		146,296
Corporate		23,317,828		26,594,986
Total	$	23,674,644	$	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 filling planned for 2H 2022

SGX302	Mild-to-Moderate Psoriasis	Positive proof-of-concept demonstrated in a small Phase 1/2 pilot study; Phase 2a study anticipated 2H 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

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	$	201,723	$	130,184
SGX942 (Dusquetide)		409,536		380,385
HyBryte™ (SGX301 or synthetic hypericin)		1,020,274		699,976
Other		115,235		98,977
Total	$	1,746,768	$	1,309,522

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	15,703	$	49,617
SGX942 (Dusquetide)		—		17,816
CiVax™		52,700		54,927
SGX943		23,810		—
Total		92,213		122,360
Grand Total	$	1,838,981	$	1,431,882


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 13, 2022	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

May 13, 2022	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)


May 13, 2022		/s/ Christopher J. Schaber
		Christopher J. Schaber, Ph.D.
		President and Chief Executive Officer


May 13, 2022		/s/ Jonathan Guarino
		Jonathan Guarino
		Senior Vice President and Chief Financial Officer