Soligenix, Inc 10-Q for FY2021 Q2

Soligenix, Inc. (SNGX)

10-Q 2021-08-13 For: 2021-06-30

Added on April 07, 2026

About this 10-Q

Soligenix, Inc filed this 10-Q on August 13, 2021, covering the quarter ended June 30, 2021 (FY2021 Q2).

Headline figures

Quarter ended June 30, 2021, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $214.82K; down 57.5% from $505.29K a year earlier
Net loss: $1.9M; compared with a net loss of $2.78M 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
Common Stock Purchase Warrants	SNGXW	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 June 30, 2021 (unaudited) and December 31, 2020	1
	Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020 (unaudited)	2
	Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2021 and 2020 (unaudited)	3
	Consolidated Statements of Changes in Shareholders’ Equity for the Six Months Ended June 30, 2021 and 2020 (unaudited)	4
	Consolidated Statements of Changes in Shareholders’ Equity for the Three Months Ended June 30, 2021 and 2020 (unaudited)	5
	Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020 (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	49
Item 4	Controls and Procedures	49

Part II	OTHER INFORMATION

Item 1	Legal Proceedings	50
Item 1A	Risk Factors	51
Item 6	Exhibits	52

SIGNATURES		53


	June 30,		December 31,
	2021		2020
Assets	(unaudited)
Current assets:
Cash and cash equivalents	$	28,979,969	$	18,676,663
Contracts and grants receivable		117,680		203,774
Research and development incentives receivable		106,598		361,096
Prepaid expenses and other current assets		148,594		225,473
Total current assets		29,352,841		19,467,006
Security deposit		22,777		22,777
Office furniture and equipment, net of accumulated depreciation of $161,037 and $154,769		17,242		23,510
Deferred issuance cost		5,796		53,523
Right-of-use lease assets		167,608		228,027
Research and development incentives receivable		28,525		73,142
Other assets		15,500		23,250
Total assets	$	29,610,289	$	19,891,235

Liabilities and shareholders' equity
Current liabilities:
Accounts payable	$	1,482,359	$	2,129,844
Accrued expenses		2,461,630		2,638,308
Accrued compensation		67,053		875,096
Paycheck Protection Program loan		—		324,979
Lease liabilities - current		113,664		112,294
Total current liabilities		4,124,706		6,080,521
Non-current liabilities:
Convertible debt, net of debt discount of $164,787 and $140,261		9,835,213		9,859,739
Paycheck Protection Program loan, net of current		—		92,851
Lease liabilities, net of current		54,180		116,296
Total liabilities		14,014,099		16,149,407
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; 40,078,760 shares and 30,643,656 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively		40,079		30,644
Additional paid-in capital		213,061,849		196,949,655
Accumulated other comprehensive loss		(32,058)		(24,337)
Accumulated deficit		(197,473,680)		(193,214,134)
Total shareholders’ equity		15,596,190		3,741,828
Total liabilities and shareholders’ equity	$	29,610,289	$	19,891,235


		Three Months Ended			Six Months Ended
		June 30,			June 30,
	2021		2020		2021		2020
Revenues:
Contract revenue	$	—	$	292,461	$	33,351	$	1,137,647
Grant revenue		214,824		212,827		329,066		292,195
Total revenues		214,824		505,288		362,417		1,429,842
Cost of revenues		(204,317)		(363,339)		(326,677)		(1,192,844)
Gross profit		10,507		141,949		35,740		236,998
Operating expenses:
Research and development		2,104,872		2,170,045		3,472,272		4,870,216
General and administrative		915,280		785,776		1,806,720		1,654,443
Research and development expense – milestone		—		—		—		5,000,000
Total operating expenses		3,020,152		2,955,821		5,278,992		11,524,659
Loss from operations		(3,009,645)		(2,813,872)		(5,243,252)		(11,287,661)
Other income (expense):
Gain on forgiveness of PPP loan		421,584		—		421,584		—
Foreign currency transaction gain/(loss)		17,330		(3,583)		44,583		(26,818)
Interest (expense)/income		(214,750)		2,017		(428,255)		23,964
Research and development incentives		23,671		38,675		81,052		95,525
Net loss before income taxes		(2,761,810)		(2,776,763)		(5,124,288)		(11,194,990)
Income tax benefit		864,742		—		864,742		836,893
Net loss applicable to common stockholders	$	(1,897,068)	$	(2,776,763)	$	(4,259,546)	$	(10,358,097)
Basic and diluted net loss per share	$	(0.05)	$	(0.10)	$	(0.11)	$	(0.41)
Basic and diluted weighted average common shares outstanding		40,074,275		26,901,781		38,455,210		25,153,350


						Accumulated
				Additional		Other
	Common Stock			Paid–In		Comprehensive		Accumulated
	Shares	Par Value		Capital		Loss		Deficit		Total
Balance, December 31, 2020	30,643,656	$	30,644	$	196,949,655	$	(24,337)	$	(193,214,134)	$	3,741,828
Issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement	9,435,091		9,435		16,480,894		—		—		16,490,329
Issuance costs associated with B. Riley At Market Issuance Sales Agreement	—		—		(544,177)		—		—		(544,177)
Exercise of warrants	13		—		51		—		—		51
Share-based compensation expense	—		—		175,426		—		—		175,426
Foreign currency translation adjustment	—		—		—		(7,721)		—		(7,721)
Net loss	—		—		—		—		(4,259,546)		(4,259,546)
Balance, June 30, 2021	40,078,760	$	40,079	$	213,061,849	$	(32,058)	$	(197,473,680)	$	15,596,190


	2021		2020
Operating activities:
Net loss	$	(4,259,546)	$	(10,358,097)
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization and depreciation		17,739		35,448
Non-cash lease expense		56,698		66,298
Share-based compensation		175,426		144,694
Issuance of common stock for milestone		—		5,000,000
Issuance of common stock for services		—		59,000
Amortization of deferred issuance costs associated with convertible debt		20,986		—
Gain on forgiveness of PPP loan		(421,584)		—
Change in operating assets and liabilities:
Contracts and grants receivable		86,094		684,048
Prepaid expenses and other current assets		76,879		434,877
Research and development incentives receivable		306,651		19,754
Operating lease liability		(56,698)		(67,004)
Accounts payable and accrued expenses		(838,749)		(136,035)
Accrued compensation		(808,043)		(221,513)
Total adjustments		(1,384,601)		6,019,567
Net cash used in operating activities		(5,644,147)		(4,338,530)

Investing activities:
Purchases of office furniture and equipment		—		(7,147)
Net cash used in investing activities		—		(7,147)

Financing activities:
Proceeds from issuance of common stock pursuant to B. Riley At Market Issuance Sales Agreement		16,490,329		9,459,949
Costs associated with B. Riley At Market Issuance Sales Agreement		(496,450)		(425,915)
Proceeds from the exercise of warrants		51		685,384
Costs associated with issuance of convertible debt		(45,512)		—
Principal repayment – financing lease		(4,048)		(3,664)
Proceeds from paycheck protection program		—		417,830
Net cash provided by financing activities		15,944,370		10,133,584
Effect of exchange rate on cash and cash equivalents		3,083		(40,310)
Net increase in cash and cash equivalents		10,303,306		5,747,597
Cash and cash equivalents at beginning of period		18,676,663		5,420,708
Cash and cash equivalents at end of period	$	28,979,969	$	11,168,305
Supplemental information:
Cash paid for state income taxes	$	7,382	$	—
Cash paid for interest	$	444,814	$	—
Cash paid for lease liabilities:
Operating lease	$	66,650	$	71,298
Financing lease	$	4,272	$	4,272
Non-cash activities:
Deferred issuance cost in accounts payable	$	—	$	85,657
Deferred issuance cost reclassified to additional-paid-in capital	$	47,727	$	85,266
Issuance of stock options, cash exercise price received in December 2019	$	—	$	1,882


	Current		Long-Term		Total
Balance at December 31, 2020	$	361,096	$	73,142	$	434,238
UK research and development incentives, transfer		73,142		(73,142)		—
UK research and development incentives		—		29,159		29,159
Additional 2019 incentive earned		51,893		—		51,893
UK research and development incentives cash receipt		(383,933)		—		(383,933)
Foreign currency translation		4,400		(634)		3,766
Balance at June 30, 2021	$	106,598	$	28,525	$	135,123


	As of June 30,
	2021	2020
Common stock purchase warrants	5,731,464	5,886,817
Stock options	1,939,386	1,499,580
Total	7,670,850	7,386,397


	Operating		Financing
	Lease		Lease
Right-of-use lease asset:
Right-of-use lease asset, January 1,2021	$	222,445	$	5,582
Reduction/amortization		(56,698)		(3,721)
Right of use lease asset, June 30, 2021	$	165,747	$	1,861

Lease liability:

Lease liability, January 1, 2021	$	222,441	$	6,149
Repayments		(56,698)		(4,048)
Lease liability, June 30, 2021	$	165,743	$	2,101

Lease expense for the six months ended June 30, 2021:
Lease expense	$	66,650	$	—
Amortization expense		—		3,721
Interest expense		—		224
Total	$	66,650	$	3,945

Contractual cash payments for the remaining lease term as of June 30, 2021:
2021	$	66,650	$	2,136
2022		111,083		—
Total	$	177,733	$	2,136
Remaining lease term (months) as of June 30, 2021		16		3


	June 30,		December 31,
	2021		2020
Clinical trial expenses	$	2,442,105	$	2,510,111
Other		19,525		128,197
Total	$	2,461,630	$	2,638,308


Year	Principal		Interest		Total
July 2021 to December 2021	$	—	$	452,186	$	452,186
2022		—		897,000		897,000
2023		4,000,000		769,138		4,769,138
2024		4,000,000		430,338		4,430,338
2025		2,000,000		110,566		2,110,566
Total	$	10,000,000	$	2,659,228	$	12,659,228


	Research and		Property and
Year	Development		Other Leases		Total
July 1 through December 31, 2021	$	50,000	$	68,786	$	118,786
2022		100,000		111,083		211,083
2023		100,000		—		100,000
2024		100,000		—		100,000
2025		100,000		—		100,000
Total	$	450,000	$	179,869	$	629,869


	As of		As of
	June 30,		December 31,
	2021		2020
Identifiable Assets
Public Health Solutions	$	123,427	$	176,447
Specialized BioTherapeutics		34,272		147,784
Corporate		29,452,590		19,567,004
Total	$	29,610,289	$	19,891,235


Soligenix Product
Candidate	Therapeutic Indication	Stage of Development
HyBryte™ (SGX301 or synthetic hypericin)	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)

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

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

SGX201†	Acute Radiation Enteritis	Phase 1/2 clinical trial completed; safety profile and preliminary efficacy demonstrated; further clinical development contingent upon additional funding, such as through partnership


	2021		2020
Research & Development Expenses
RiVax^® and ThermoVax^® Vaccines	$	363,475	$	427,087
SGX942 (Dusquetide)		144,020		2,281,418
CiVax™		20,000		—
SGX943		851,661		—
HyBryte™ (SGX301 or synthetic hypericin)		1,852,294		1,907,390
Other		240,822		254,321
Total	$	3,472,272	$	4,870,216

Reimbursed under Government Contracts and Grants
RiVax^® and ThermoVax^® Vaccines	$	102,916	$	1,112,019
SGX942 (Dusquetide)		(15,000)		80,825
CiVax™		204,582		—
SGX943		34,179		—
Total		326,677		1,192,844
Grand Total	$	3,798,949	$	6,063,060


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 13, 2021	By	/s/ Christopher J. Schaber
		Christopher J. Schaber, PhD
		President and Chief Executive Officer
		(Principal Executive Officer)

August 13, 2021	By	/s/ Jonathan Guarino
		Jonathan Guarino
		Chief Financial Officer, Senior Vice President,
		and Corporate Secretary
		(Principal Financial and Accounting Officer)