Prospectus Supplement No. 2

(To Prospectus dated December 15, 2023)

Filed Pursuant to Rule 424(b)(3)

Registration Statement No. 333-274265

Graphic

Up to $5,800,000 of shares of Common Stock

 

This Prospectus Supplement No. 2 (this “Prospectus Supplement”) supplements the prospectus dated December 15, 2023 (the “Final Prospectus”), relating to the offer and sale by us of up to $5,800,000 shares of our common stock.

 

This Prospectus Supplement contains the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 that we filed with the U.S. Securities and Exchange Commission on November 8, 2024. This Prospectus Supplement should be read in conjunction with, and may not be utilized without, the Final Prospectus, which is to be delivered with this Prospectus Supplement. This Prospectus Supplement is qualified by reference to the Final Prospectus except to the extent that the information in this Prospectus Supplement updates and supersedes the information contained in the Final Prospectus, including any supplements or amendments thereto.

 

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.

 

 

 

Prospectus Supplement No. 2 dated November 8, 2024.


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended September 30, 2024

or

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ____________ to ____________

Commission File No. 001-14778

SOLIGENIX, INC.

(Exact name of registrant as specified in its charter)

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)

(609) 538-8200


(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

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

Indicate by check whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

As of November 1, 2024, 2,509,499 shares of the registrant’s common stock (par value, $.001 per share) were outstanding.


SOLIGENIX, INC.

Index

    

Description

    

Page

Part I

FINANCIAL INFORMATION

Item 1

Condensed Consolidated Financial Statements (unaudited)

Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023

1

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2024 and 2023

2

Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2024 and 2023

3

Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit) for the Nine Months Ended September 30, 2024 and 2023

4

Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit) for the Three Months Ended September 30, 2024 and 2023

5

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2024 and 2023

6

Notes to Condensed Consolidated Financial Statements

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

50

Item 4

Controls and Procedures

51

Part II

OTHER INFORMATION

Item 1

Legal Proceedings

51

Item 1A

Risk Factors

51

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

52

Item 5

Other Information

52

Item 6

Exhibits

53

SIGNATURES

54

i


PART I - FINANCIAL INFORMATION

ITEM 1 - FINANCIAL STATEMENTS

Soligenix, Inc. and Subsidiaries

Condensed Consolidated Balance Sheets

September 30, 

December 31, 

    

2024

    

2023

Assets

 

(unaudited)

 

  

Current assets:

 

  

 

  

Cash and cash equivalents

$

9,840,177

$

8,446,158

Unbilled revenue

171,254

Research and development incentives receivable, current

 

 

23,894

Deferred issuance cost

126,385

Prepaid expenses and other current assets

 

340,330

 

866,014

Total current assets

 

10,306,892

 

9,507,320

Security deposit

 

22,777

 

22,777

Office furniture and equipment, net

 

7,162

 

11,927

Right-of-use lease assets

 

140,148

 

229,834

Research and development incentives receivable, net of current portion

 

 

25,468

Total assets

$

10,476,979

$

9,797,326

Liabilities and shareholders' equity

 

  

 

  

Current liabilities:

 

  

 

  

Accounts payable

$

891,227

$

1,111,226

Accrued expenses

 

1,363,235

 

2,418,002

Accrued compensation

 

84,362

 

251,115

Lease liabilities, current

 

132,114

 

121,765

Convertible debt

2,059,309

2,250,000

Total current liabilities

 

4,530,247

 

6,152,108

Non-current liabilities:

 

  

 

  

Convertible debt

 

 

1,010,934

Lease liabilities, net of current portion

 

11,544

 

111,862

Total liabilities

 

4,541,791

 

7,274,904

Commitments and contingencies (Note 6)

 

  

 

  

Shareholders’ equity:

 

  

 

  

Preferred stock, 350,000 shares authorized; none issued or outstanding at September 30, 2024 and December 31, 2023, respectively

Common stock, $.001 par value; 75,000,000 shares authorized; 2,295,304 and 648,761 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively⁽¹⁾

 

2,295

 

649

Additional paid-in capital (1)

 

236,878,806

 

228,203,706

Accumulated other comprehensive income

 

37,473

 

22,243

Accumulated deficit

 

(230,983,386)

 

(225,704,176)

Total shareholders’ equity

 

5,935,188

 

2,522,422

Total liabilities and shareholders’ equity

$

10,476,979

$

9,797,326

(1)Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

1


Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Operations

For the Three and Nine Months Ended September 30, 2024 and 2023

(Unaudited)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2024

    

2023

    

2024

    

2023

Revenues:

 

  

 

  

 

  

 

  

Grant revenue

 

 

130,440

$

119,371

$

594,547

Total revenues

 

 

130,440

 

119,371

 

594,547

Cost of revenues

 

 

(110,441)

 

(119,371)

 

(520,502)

Gross profit

 

 

19,999

 

 

74,045

Operating expenses:

 

  

 

  

 

  

 

  

Research and development

 

968,689

 

826,015

 

2,564,887

 

2,535,165

General and administrative

 

896,547

 

973,040

 

3,162,115

 

3,098,949

Total operating expenses

 

1,865,236

 

1,799,055

 

5,727,002

 

5,634,114

Loss from operations

 

(1,865,236)

 

(1,779,056)

 

(5,727,002)

 

(5,560,069)

Other income (expense):

 

  

 

  

 

  

 

  

Foreign currency transaction gain (loss)

 

575

 

(3,046)

 

2,257

 

310

Interest income (expense), net

 

78,836

 

66,363

 

143,603

 

(97,399)

Research and development incentives

4,729

(25,488)

17,386

CARES Act Employee Retention Credit

66,444

120,771

66,444

120,771

Other income

43

43,223

Loss on extinguishment of debt

 

 

 

 

(393,791)

Change in fair value of convertible debt

(72,463)

260,933

387,537

Total other income

145,855

116,354

447,792

78,037

Net loss before income taxes

 

(1,719,381)

 

(1,662,702)

 

(5,279,210)

 

(5,482,032)

Income tax benefit

 

 

 

 

1,161,197

Net loss applicable to common stockholders

$

(1,719,381)

$

(1,662,702)

$

(5,279,210)

$

(4,320,835)

Basic and diluted net loss per share (1)

$

(0.78)

$

(2.56)

$

(3.84)

$

(10.05)

Basic and diluted weighted average common shares outstanding (1)

 

2,203,929

 

648,860

 

1,376,568

 

429,773

(1)Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

2


Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Comprehensive Loss

For the Three and Nine Months Ended September 30, 2024 and 2023

(Unaudited)

Three Months Ended

Nine Months Ended

September 30, 

September 30, 

    

2024

    

2023

    

2024

    

2023

Net loss

$

(1,719,381)

$

(1,662,702)

$

(5,279,210)

$

(4,320,835)

Other comprehensive income (loss):

 

 

 

 

Foreign currency translation adjustments

9,874

18,257

15,230

(429)

Comprehensive loss

$

(1,709,507)

$

(1,644,445)

$

(5,263,980)

$

(4,321,264)

The accompanying notes are an integral part of these condensed consolidated financial statements.

3


Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Shareholders’ Equity/(Deficit)

For the Nine Months Ended September 30, 2024 and 2023

(Unaudited)

    

    

    

    

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 pursuant to At Market Issuance Sales Agreement

 

14,883

 

15

 

58,421

 

 

 

58,436

Issuance costs associated with sales of common stock pursuant to At Market Issuance Sales Agreement

 

 

 

(1,947)

 

 

 

(1,947)

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 warrants

 

34,816

 

35

 

222,787

 

 

 

222,822

Issuance of common stock upon exercise of pre-funded warrants

 

537,500

 

537

 

8,063

 

 

 

8,600

Issuance of common stock from warrant inducement

703,125

703

4,218,047

4,218,750

Issuance costs associated with warrant inducement

 

 

 

(7,552,457)

 

 

 

(7,552,457)

Warrant modification - incremental fair value

7,177,683

7,177,683

Issuance of common stock from conversion of debt

36,790

36

254,220

254,256

Share-based compensation expense

 

 

 

174,268

 

 

 

174,268

Foreign currency translation adjustment

 

 

 

 

15,230

 

 

15,230

Net loss

 

 

 

 

 

(5,279,210)

(5,279,210)

Balance, September 30, 2024

 

$

2,295,304

$

2,295

$

236,878,806

$

37,473

$

(230,983,386)

$

5,935,188

    

    

    

    

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

181,898

$

182

$

217,067,691

$

24,747

$

(219,563,446)

$

(2,470,826)

Sale of common stock pursuant to B. Riley At Market Issuance Sales Agreement

 

53,202

 

53

 

3,091,409

 

 

3,091,462

Issuance costs associated with B. Riley At Market Issuance Sales Agreement

 

 

 

(95,348)

 

 

(95,348)

Redemption of Series D preferred stock

(43)

Issuance of common stock in May 2023 public offering

 

143,844

144

8,495,673

 

8,495,817

Issuance costs associated with May 2023 public offering

(834,061)

(834,061)

Issuance of common stock to vendors

 

3,125

3

72,997

 

73,000

Issuance of common stock for purchase option

 

1,978

 

2

 

49,998

 

 

 

50,000

Exercise of pre-funded warrants

 

264,714

 

265

 

3,034

 

 

 

3,299

Share-based compensation expense

 

 

 

229,076

 

 

 

229,076

Foreign currency translation adjustment

 

 

 

 

(429)

 

 

(429)

Net loss

 

 

 

 

 

(4,320,835)

 

(4,320,835)

Balance, September 30, 2023

 

$

648,761

$

649

$

228,080,469

$

24,318

$

(223,884,281)

$

4,221,155

Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

4


Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Changes in Shareholders’ Equity

For the Three Months Ended September 30, 2024 and 2023

(Unaudited)

    

    

    

    

Accumulated

    

    

Additional

Other

Common Stock

Paid–In

Comprehensive

Accumulated

Shares

Par Value

Capital

Income

Deficit

Total

Balance, June 30, 2024

 

1,542,480

$

1,542

$

232,699,640

$

27,599

$

(229,264,005)

$

3,464,776

Issuance of common stock pursuant to At Market Issuance Sales Agreement

 

14,883

 

15

 

58,421

 

 

 

58,436

Issuance costs associated with sales of common stock pursuant to At Market Issuance Sales Agreement

 

 

 

(1,947)

 

 

 

(1,947)

Issuance of common stock upon exercise of warrants

34,816

35

222,787

222,822

Issuance of common stock from warrant inducement

703,125

703

4,218,047

4,218,750

Issuance costs associated with warrant inducement

(7,552,457)

(7,552,457)

Warrant modification - incremental fair value

7,177,683

7,177,683

Share-based compensation expense

 

 

 

56,632

 

 

 

56,632

Foreign currency translation adjustment

 

 

 

 

9,874

 

 

9,874

Net loss

 

 

 

 

 

(1,719,381)

 

(1,719,381)

Balance, September 30, 2024

 

2,295,304

$

2,295

$

236,878,806

$

37,473

$

(230,983,386)

$

5,935,188

    

    

    

    

Accumulated

    

    

Additional

Other

Common Stock

Paid–In

Comprehensive

Accumulated

Shares

Par Value

Capital

Income

Deficit

Total

Balance, June 30, 2023

 

615,236

$

615

$

228,015,103

$

6,061

$

(222,221,579)

$

5,800,200

Issuance of common stock upon exercise of pre-funded warrants

 

33,525

34

(34)

 

Share-based compensation expense

 

 

 

65,400

 

 

 

65,400

Foreign currency translation adjustment

 

 

 

 

18,257

 

 

18,257

Net loss

 

 

 

 

 

(1,662,702)

 

(1,662,702)

Balance, September 30, 2023

 

648,761

$

649

$

228,080,469

$

24,318

$

(223,884,281)

$

4,221,155

Adjusted to reflect the reverse stock split of one-for-sixteen effective June 5, 2024.

The accompanying notes are an integral part of these condensed consolidated financial statements.

5


Soligenix, Inc. and Subsidiaries

Condensed Consolidated Statements of Cash Flows

For the Nine Months Ended September 30, 2024 and 2023

(Unaudited)

    

2024

    

2023

Operating activities:

 

  

 

  

Net loss

$

(5,279,210)

$

(4,320,835)

Adjustments to reconcile net loss to net cash used in operating activities:

 

  

 

  

Amortization and depreciation

 

4,765

 

4,964

Non-cash lease expense

 

89,686

 

82,500

Share-based compensation

 

174,268

 

229,076

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)

(387,537)

Amortization of deferred issuance costs associated with convertible debt

 

 

12,518

Change in operating assets and liabilities:

 

 

Contracts and grants receivable

 

171,254

 

49,079

Prepaid expenses and other current assets

 

525,684

 

(310,229)

Research and development incentives receivable

 

51,879

 

92,092

Operating lease liability

 

(89,969)

 

(80,458)

Accounts payable and accrued expenses

 

(1,391,432)

 

(2,382,708)

Accrued compensation

 

(166,753)

 

(281,149)

Net cash flows from operating activities

 

(6,170,761)

 

(6,775,896)

Financing activities:

 

  

 

  

Proceeds from issuance of common stock pursuant to At Market Issuance Sales Agreement

 

58,436

 

3,091,462

Costs associated with an At Market Issuance Sales Agreement

 

(44,522)

 

(93,009)

Proceeds from issuance of common stock and pre-funded warrants

4,741,400

8,495,817

Stock issuance costs associated with public offerings

(625,065)

(787,881)

Proceeds from the exercise of warrants

4,450,172

3,299

Issuance costs associated with warrant inducement

(374,774)

Convertible debt repayments

 

(686,436)

 

(7,000,000)

Net cash flows from financing activities

 

7,519,211

 

3,709,688

Effect of exchange rate on cash and cash equivalents

 

45,569

 

5,127

Net increase in cash and cash equivalents

 

1,394,019

 

(3,061,081)

Cash and cash equivalents at beginning of period

 

8,446,158

 

13,359,615

Cash and cash equivalents at end of period

$

9,840,177

$

10,298,534

Supplemental information:

 

  

 

  

Cash paid for state income taxes

$

42,162

$

13,006

Cash paid for interest

$

183,771

$

488,011

Cash paid for lease liabilities:

 

 

  

Operating lease

$

102,300

$

99,975

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

$

228,161

$

2,339

Redemption liability for Series D preferred stock

$

$

43

Offering costs included in accounts payable

$

83,810

$

46,180

Warrant modification - incremental value

$

7,177,683

$

The accompanying notes are an integral part of these condensed consolidated financial statements.

6


Soligenix, Inc. and Subsidiaries

Notes to Condensed Consolidated Financial Statements

(Unaudited)

Note 1. Nature of Business

Basis of Presentation

Soligenix, Inc. (the “Company”) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company maintains two active business segments: Specialized BioTherapeutics and Public Health Solutions.

The Company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (a proposed proprietary name of SGX301 or synthetic hypericin sodium), a novel photodynamic therapy utilizing topical synthetic hypericin activated with safe visible light for the treatment of cutaneous T-cell lymphoma (“CTCL”). With agreement from the European Medicines Agency (“EMA”) on the key design components of a confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™ in the treatment of CTCL patients with early-stage disease, the Company is targeting to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026. Upon successful completion of the second Phase 3 study, called “FLASH2” (Fluorescent Light Activated Synthetic Hypericin 2), regulatory approval will be sought to support potential commercialization worldwide.

Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the Company’s first-in-class innate defense regulator technology, and dusquetide (SGX942 and SGX945) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer and aphthous ulcers in Behçet’s Disease.

The Company’s Public Health Solutions business segment includes development programs for RiVax®, its ricin toxin vaccine candidate and SGX943, its therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of the vaccine programs incorporates the use of the Company’s proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (“NIAID”), the Biomedical Advanced Research and Development Authority and the Defense Threat Reduction Agency.

The Company primarily generates revenues under government grants and contracts. The Company was awarded a subcontract that originally provided for approximately $1.1 million from a U.S. Food and Drug Administration (“FDA”) Orphan Products Development grant over four years for an expanded study of HyBryte™ in the treatment of CTCL. The Company will continue to apply for additional government funding.

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, development of new technological innovations, dependence on key personnel, protections of proprietary technology, compliance with the FDA regulations, and other regulatory authorities, litigation, and product liability.

Results for the three and nine months ended September 30, 2024 are not necessarily indicative of results that may be expected for the full year.

Liquidity

The Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. As of September 30, 2024, the Company had an

7


accumulated deficit of $230,983,386. During the nine months ended September 30, 2024, the Company incurred a net loss of $5,279,210 and used $6,170,761 of cash in operating activities. The Company expects to continue to generate losses in the foreseeable future. The Company’s liquidity needs will be determined largely by the budgeted operational expenditures incurred in regards to the progression of its product candidates. Management believes that the Company has sufficient resources available to support its development activities and business operations and timely satisfy its obligations as they become due through the second quarter of 2025. The Company does not have sufficient cash and cash equivalents as of the date of filing this Quarterly Report on Form 10-Q to support its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are issued.

To alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, the Company’s plans include:

Securing additional capital, potentially through a combination of public or private equity offerings and strategic transactions, including potential alliances and drug product collaborations.
Securing additional proceeds from government contract and grant programs.

Securing additional proceeds from the sale of shares of the Company’s common stock via the At Market Issuance Sales Agreement (“AGP Sales Agreement”) with A.G.P/Alliance Global Partners (“AGP”).

Amending the loan agreement with Pontifax Medison Finance (“Pontifax”) (See Note 4) to reduce the conversion price in order to allow for conversion of a portion of the debt which will reduce the Company’s debt repayments.

Other than the AGP Sales Agreement which was entered into on August 16, 2024 and the second amendment to the Pontifax loan agreement which was completed on October 8, 2024, none of these alternatives are committed at this time. There can be no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms to fund continuing operations, if at all, identify and enter into any strategic transactions that will provide the capital that it will require, or achieve the other strategies to alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern. If none of these alternatives are available, or if available, are not available on satisfactory terms, the Company will not have sufficient cash resources and liquidity to fund its business operations for at least the 12 months following the date the financial statements are issued. The failure to obtain sufficient capital on acceptable terms when needed may require the Company to delay, limit, or eliminate the development of business opportunities and its ability to achieve its business objectives and its competitiveness, and its business, financial condition, and results of operations will be materially adversely affected. In addition, the perception that the Company may not be able to continue as a going concern may cause others to choose not to deal with it due to concerns about its ability to meet its contractual obligations.

 

The accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue as a going concern.

As of September 30, 2024, the Company had cash and cash equivalents of $9,840,177 as compared to $8,446,158 as of December 31, 2023. As of September 30, 2024, the Company had working capital of $5,776,645 as compared to working capital of $3,355,212 as of December 31, 2023.

8


The Company’s plans with respect to its liquidity management include, but are not limited to, the following:

The Company has up to approximately $554,000 in active government grant funding still available as of September 30, 2024 to support its associated research programs through May 2026, provided the federal agencies do not elect to terminate the grants for convenience. The Company plans to submit additional contract and grant applications for further support of its programs with various funding agencies. However, there can be no assurance that the Company will obtain additional governmental grant funding.
The Company will continue to use equity instruments to provide a portion of the compensation due to vendors and collaboration partners and expects to continue to do so for the foreseeable future.
The Company will continue to pursue Net Operating Loss (“NOL”) sales in the state of New Jersey pursuant to its Technology Business Tax Certificate Transfer Program if the program is available.
The Company plans to pursue potential partnerships for pipeline programs as well as continue to explore merger and acquisition strategies. However, there can be no assurances that the Company can consummate such transactions.
The Company completed a public offering on April 22, 2024 of 204,694 shares of its common stock, pre-funded warrants to purchase 537,500 shares of its common stock and common warrants to purchase up to 742,194 shares of its common stock at a combined public offering price of $6.40. The pre-funded warrants have an exercise price of $0.02. The common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses of approximately $0.45 million. The Company plans to use the proceeds for further support of its programs, as well as for working capital.
The Company entered into a warrant inducement agreement (the “Inducement Agreement”) on July 9, 2024 with certain holders (the “Holders”) of the Company’s existing Warrant to Purchase Shares of Common Stock (“Existing Warrants”) to purchase shares of common stock of the Company. In consideration of the Holders’ agreement to exercise their Existing Warrants, the Company (i) decreased the exercise price of the Existing Warrants from $6.40 per share to $6.00 per share and (ii) issued new warrants (“New Warrants”) to the Holders to purchase a number of shares of common stock equal to 150% of the number of shares of common stock issued upon exercise of the Holders’ Existing Warrants. Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash their Existing Warrants to purchase up to 703,125 shares of the Company’s common stock at a reduced exercise price of $6.00 per share on July 9, 2024, the date of the Inducement Agreement, until 1:30 p.m., Eastern Time. The total gross proceeds to the Company was approximately $4.2 million from the exercise of the Existing Warrants before deducting financial advisory fees and other expenses. The Company plans to use the proceeds for further support of its programs, as well as for working capital.
The Company has up to approximately $4.7 million remaining from the AGP Sales Agreement as of November 1, 2024 under the prospectus supplement dated August 16, 2024. From October 1, 2024 through November 1, 2024, the Company sold 229,078 shares of common stock pursuant to the AGP Sales Agreement at a weighted average price of $4.72 per share for total gross proceeds of approximately $1.1 million.
The Company is currently evaluating additional equity/debt financing opportunities on an ongoing basis and may execute them when appropriate. However, there can be no assurances that the Company can consummate such a transaction, or consummate a transaction at favorable pricing.

9


Management’s business strategy can be outlined as follows:

Following agreement from the EMA on the key design components for the second confirmatory Phase 3 placebo-controlled FLASH2 clinical trial of HyBryte™ in CTCL and positive primary endpoint results from the first Phase 3 FLASH study, initiate the FLASH2 study, while at the same time, continuing discussions with the FDA on potential modifications to the development path to adequately address their feedback.
Expanding development of synthetic hypericin under the research name SGX302 into psoriasis with the conduct of a Phase 2a clinical trial, following the positive Phase 3 FLASH study and positive proof-of-concept demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients.
Following feedback from the United Kingdom (“UK”) Medicines and Healthcare products Regulatory Agency (“MHRA”) that a second Phase 3 clinical trial of SGX942 (dusquetide) in the treatment in oral mucositis would be required to support a marketing authorization; design a second study and attempt to identify a potential partner(s) to continue this development program.
Expanding development of dusquetide under the research name SGX945 into Behçet’s Disease by conducting a Phase 2a clinical trial, where previous studies with dusquetide in oral mucositis have validated the biologic activity in aphthous ulcers induced by chemotherapy and radiation.
Continue development of the Company’s heat stabilization platform technology, ThermoVax®, in combination with its programs for RiVax® (ricin toxin vaccine), and filovirus vaccines (targeting Ebola, Sudan, and Marburg viruses and multivalent combinations), with United States (“U.S.”) government or non-governmental organization funding support.
Continue to apply for and secure additional government funding for the Specialized BioTherapeutics and Public Health Solutions programs through grants, contracts and/or procurements.
Pursue business development opportunities for pipeline programs, as well as explore all strategic alternatives, including but not limited to merger/acquisition strategies.
Acquire or in-license new clinical-stage compounds for development, as well as evaluate new indications with existing pipeline compounds for development.

Reverse Stock Split

On June 5, 2024, the Company completed a reverse stock split of its issued and outstanding shares of common stock at a ratio of one-for-sixteen, whereby every sixteen shares of the Company’s issued and outstanding common stock were automatically combined into one issued and outstanding share of common stock without any change in the par value per share. No fractional shares were issued as a result of the reverse stock split. Any fractional shares that would otherwise have resulted from the reverse stock split were rounded up to the next whole number. The Company’s common stock began trading on The Nasdaq Capital Market on a reverse split basis at the market opening on June 6, 2024. All share and per share data have been restated to reflect this reverse stock split.

10


Note 2. Summary of Significant Accounting Policies

Principles of Consolidation

The condensed consolidated financial statements include Soligenix, Inc., and its wholly and majority owned subsidiaries. All significant intercompany accounts and transactions have been eliminated as a result of consolidation.

Operating Segments

Operating segments are defined as components of an enterprise about which separate financial information is available that is evaluated on a regular basis by the chief operating decision maker, or decision-making group, in deciding how to allocate resources to an individual segment and in assessing the performance of the segment. The Company divides its operations into two operating segments: Specialized BioTherapeutics and Public Health Solutions.

Cash and Cash Equivalents

The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents.

Contracts and Grants Receivable

Contracts and grants receivable consist of amounts due from various grants from the NIH and contracts from NIAID, an institute of NIH, for costs incurred prior to the period end under reimbursement contracts. The amounts were billed to the respective governmental agencies in the month subsequent to period end and collected shortly thereafter. Accordingly, no allowance for credit losses has been established. If amounts become uncollectible, they are charged to operations.

Impairment of Long-Lived Assets

Office furniture and equipment and right of use assets with finite lives are evaluated and reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. The Company recognizes impairment of long-lived assets in the event the net book value of such assets exceeds the estimated future undiscounted cash flows attributable to such assets. If the sum of the expected undiscounted cash flows is less than the carrying value of the related asset or group of assets, a loss is recognized for the difference between the fair value and the carrying value of the related asset or group of assets. Such analyses necessarily involve significant judgment.

The Company did not record any impairment of long-lived assets for the three and nine months ended September 30, 2024 and 2023.

Fair Value of Financial Instruments

Fair Value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Disclosures about the fair value of financial instruments are based on pertinent information available to the Company on September 30, 2024. Accordingly, the estimates presented in these financial statements are not necessarily indicative of the amounts that could be realized on disposition of the financial instruments.

Fair Value valuation techniques include a three level hierarchy based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to

11


unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurement) and the lowest priority to unobservable inputs (Level 3 measurement).

The three levels of the fair value hierarchy are as follows:

Level 1 — Quoted prices in active markets for identical assets or liabilities that the reporting entity has the ability to access at the measurement date. Level 1 primarily consists of financial instruments whose value is based on quoted market prices such as exchange-traded instruments and listed equities.
Level 2 — Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models consider various assumptions, including volatility factors, current market prices and contractual prices for the underlying financial instruments. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.
Level 3 — Unobservable inputs for the asset or liability. Financial instruments are considered Level 3 when their fair values are determined using pricing models, discounted cash flows or similar techniques and at least one significant model assumption or input is unobservable.

In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability.

The carrying amounts reported in the condensed consolidated balance sheet for cash and cash equivalents, contracts and grants receivable, research and development incentives receivable, accounts payable, accrued expenses, and accrued compensation approximate their fair value based on the short-term maturity of these instruments.

The carrying amount reported in the condensed consolidated balance sheet as of September 30, 2024 for the convertible debt is its fair value which totals $2,059,309 and was approximately equivalent to the face value of the convertible debt at September 30, 2024. The fair value estimate represents a Level 3 measurement in the fair value hierarchy.

A roll forward of the fair value of convertible debt to September 30, 2024 is as follows:

Pontifax

Conversions

January 3, 2024

Debt Balance

and

Adjustment to

Principal

Debt Balance

December 31, 2023

April 15, 2024

fair value

Repayments

   

September 30, 2024

Convertible debt at fair value

$

3,260,934

$

(254,256)

$

(260,933)

$

(686,436)

$

2,059,309

Deferred Issuance Costs

The Company capitalizes certain legal, professional accounting and other third-party fees that are directly associated with in-process equity financings as deferred issuance costs until such financings are consummated. After consummation of the equity financing, these costs are recorded in shareholders’ equity as a reduction of additional paid-in capital generated as a result of the issuance.

12


Change in Accounting Estimates

The Company accrues clinical trial expenses per contracts with clinical sites over the course of the clinical trial period. Accrued trial expenses are assessed for accuracy on an ongoing basis during the trial period and beyond. For the three and nine months ended September 30, 2024, the Company made adjustments to estimated accrued clinical trial expenses for completed trials of approximately $375,000 and $1.3 million, respectively. These adjustments resulted in decreases to research and development expenses in the accompanying condensed consolidated statements of operations during the three and nine months ended September 30, 2024, respectively.  

Revenue Recognition

The Company’s revenues include revenues generated from government contracts and grants. The revenue from government contracts and grants is based upon subcontractor costs and internal costs incurred that are specifically covered by the contracts and grants, plus a facilities and administrative rate that provides funding for overhead expenses and management fees. These revenues are recognized when expenses have been incurred by subcontractors or when the Company incurs reimbursable internal expenses that are related to the government contracts and grants.

The Company also records revenue from contracts with customers in accordance with applicable accounting guidance which requires an entity to recognize revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of this guidance, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of this guidance, the Company assesses the goods or services promised within each contract and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Certain amounts received from or billed to customers in accordance with contract terms are deferred and recognized as future performance obligations are satisfied. All amounts earned under contracts with customers other than sales-based royalties are classified as licensing revenue. Sales-based royalties under the Company’s license agreements would be recognized as royalty revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied or partially satisfied. To date, the Company has not recognized any royalty revenue.

Research and Development Costs

Research and development costs are charged to expense when incurred in accordance with applicable accounting guidance. Research and development includes costs such as clinical trial expenses, contracted research and license agreement fees with no alternative future use, supplies and materials, salaries, share-based compensation, employee benefits, equipment depreciation and allocation of various corporate costs.

Share-Based Compensation

Stock options are issued with an exercise price equal to the market price on the date of grant. Stock options issued to directors upon re-election vest quarterly for a period of one year (new director issuances are fully vested upon issuance). Stock options issued to employees generally vest 25% on the grant date, then 25% each subsequent year for a period of three years. These options have a ten-year life for as long as the

13


individuals remain employees or directors. In general, when an employee or director terminates their position, the options will expire within three months, unless otherwise extended by the Board.

From time to time, the Company issues restricted shares of common stock to vendors and consultants as compensation for services performed under the Company’s 2015 Equity Incentive Plan (the “2015 Plan”). The 2015 Plan provides for the grant of stock options, restricted stock, deferred stock and unrestricted stock to the Company’s employees and non-employees (including consultants). The shares issued under the 2015 Plan are registered on Form S-8 (SEC File No. 333-208515). However, as shares of common stock are not covered by a reoffer prospectus, the certificates reflecting such shares reflect a Securities Act of 1933, as amended restrictive legend. Stock compensation expense for equity-classified awards to non-employees is measured on the date of grant and is recognized when the services are performed.

There were no options issued during the three months ended September 30, 2024 and 2023.

The fair value of each option grant made during the nine months ended September 30, 2024 and 2023 was estimated on the date of each grant and recognized as share-based compensation expense ratably over the option vesting periods, which approximates the service period.

Foreign Currency Transactions and Translation

In accordance with FASB ASC 830 Foreign Currency Matters, the UK subsidiary expresses its U.S. dollar and Euro denominated transactions in its functional currency, the British Pound, with related transaction gains or losses included in net loss. On a quarterly basis, the financial statements of the UK subsidiary are translated into U.S. dollars and consolidated into the Company’s financials, with related translation adjustments reported as a cumulative translation adjustment, which is a component of accumulated other comprehensive income. During the nine months ended September 30, 2024 and 2023, the Company recognized a foreign currency transaction gain of $575 and a foreign currency transaction loss of ($3,046), respectively, in the accompanying condensed consolidated statements of operations. During the nine months ended September 30, 2024 and 2023, the Company recognized foreign currency transaction gains of $2,257 and $310, respectively, in the accompanying condensed consolidated statements of operations.

Loss Per Share

Basic earnings per share (“EPS”) is computed by dividing loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Included within the Company’s weighted average common shares outstanding (basic and diluted) for the three and nine months ended September 30, 2024, are common shares issuable upon the exercise of the pre-funded warrants as these pre-funded warrants are exercisable at any time for nominal consideration.

The following table summarizes outstanding instruments which were not included in the computation of diluted EPS as to do so would have been antidilutive:

As of September 30, 

    

2024

    

2023

    

Common stock purchase warrants

1,467,581

408,640

Stock options

 

56,427

 

12,843

 

Convertible debt

 

75,710

 

1,172,645

 

Total

 

1,599,718

 

1,594,128

 

Use of Estimates and Assumptions

The preparation of financial statements requires management to make estimates and assumptions such as the fair value of warrants and stock options and to accrue for clinical trials in process that affect the reported amounts in the financial statements and accompanying notes. Actual results could differ from those estimates.

14


Note 3. Accrued Expenses

The following is a summary of the Company’s accrued expenses:

September 30, 

December 31, 

    

2024

    

2023

    

Clinical trial expenses

$

951,029

$

1,993,784

Other

 

412,206

 

424,218

Total

$

1,363,235

$

2,418,002

Note 4. Debt

In December 2020, the Company entered into a $20 million convertible debt financing agreement with Pontifax (the “Loan Agreement”). Under the terms of the Loan Agreement, the Company had access to up to $20 million in convertible debt financing in three tranches, which will mature on June 15, 2025 and had an interest-only period for the first two years with a fixed interest rate of 8.47% on borrowed amounts and an interest rate of 1% on amounts available but not borrowed as an unused line of credit fee. After the interest-only period, the outstanding principal was to be repaid in quarterly payments of $1 million each commencing in the first quarter of 2023. The agreement is secured by a lien on substantially all of the Company’s assets, other than intellectual property.

Upon the closing of this transaction, the Company borrowed the first tranche of $10 million, had the option to draw the second tranche of $5 million at any time during the initial 12 months of the loan and the third tranche of $5 million upon filing of the new drug application for HyBryte™, subject to certain conditions. The Company elected to let the options to borrow both the second and third tranches expire as of December 15, 2021 and March 15, 2022, respectively.

In April 2023, the Company entered into an amendment to the Loan Agreement (the “2023 Amendment”). The 2023 Amendment called for the immediate payment of $5 million of the outstanding principal balance and any accrued interest, waived any prepayment charge in connection with the repayment of this amount and resulted in an outstanding principal balance of $3 million. The 2023 Amendment also provided for interest only  through June 30, 2024, reduced quarterly principal repayments to $750,000, and eliminated the minimum cash covenant. Further, the 2023 Amendment reduced the conversion price with respect to the remaining principal amount to (i) 90% of the closing price of the Company’s common stock on the day before the delivery of a conversion notice with respect to the first 36,790 shares of the Company’s common stock issuable upon conversion and to (ii) $27.20 with respect to all shares of the Company’s common stock issuable upon conversion thereafter. The remaining terms of the agreement remained unmodified.

On January 3, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 9,139 shares of the Company’s common stock at $10.88 per share, reducing the remaining principal balance by $99,416.

On April 15, 2024, Pontifax delivered a conversion notice to the Company electing to convert a portion of the remaining principal balance into shares of the Company’s common stock. Upon conversion, the Company issued 27,651 shares of the Company’s common stock at $5.60 per share, reducing the remaining principal balance by $154,840.

The 2023 Amendment resulted in the extinguishment of the original convertible debt for accounting purposes. The Company elected to account for the amended convertible debt using the fair value option. As of September 30, 2024, the Company determined the carrying amount of the convertible debt was approximately equivalent to the face value of the convertible debt. The Company recognized $0 and $260,933 of other income

15


from the change in the fair value of the convertible debt in its accompanying condensed consolidated statements of operations during the three and nine months ended September 30, 2024, respectively.

In October 2024, the Company entered into an amendment (the “2024 Amendment”) to the Loan Agreement, as amended. The 2024 Amendment reduced the conversion price with respect to the remaining principal amount outstanding to (i) $3.81 for the first 501,648 shares of the Company’s common stock issuable upon conversion and (ii) $4.23 with respect to all shares of the Company’s common stock issuable upon conversion thereafter. The remaining terms of the agreement remain in effect without modification.

Note 5. Shareholders’ Equity

Common Stock

The Company completed a public offering on April 22, 2024 of 204,694 shares of its common stock, pre-funded warrants to purchase 537,500 shares of its common stock and common warrants to purchase up to 742,194 shares of its common stock at an offering price of $6.40. The pre-funded warrants have an exercise price of $0.02. The common warrants have an exercise price of $6.40 per share, are exercisable immediately and expire five years from the issuance date. The total gross proceeds to the Company from this offering were approximately $4.75 million before deducting commissions and other estimated offering expenses payable by the Company of approximately $0.45 million.

Common stock transactions for the nine months ended September 30, 2024 are as follows:

The Company issued Pontifax 9,139 shares of fully vested common stock pursuant to conversion of a portion of the convertible debt principal balance at a conversion price of $10.88 per share on January 3, 2024. The conversion price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice.
The Company issued Pontifax 27,651 shares of fully vested common stock pursuant to conversion of a portion of the convertible debt principal balance at a conversion price of $5.60 per share on April 15, 2024. The conversion price was based on 90% of the closing price of the Company’s common stock on the day before the delivery of the conversion notice.
The Company sold 204,694 shares of common stock and 537,500 pre-funded warrants pursuant to the April 2024 public offering for $6.40 per share on April 22, 2024.
The Company issued 97,375 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on April 22, 2024.
The Company issued 69,125 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 11, 2024.
The Company issued 117,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 14, 2024.
The Company issued 130,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 20, 2024.
The Company issued 124,000 shares of common stock pursuant to the exercise of pre-funded warrants associated with the April 2024 public offering with an exercise price of $0.02 on June 25, 2024.

16


The Company issued 703,125 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.00 on July 10, 2024.
The Company issued 31,250 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.40 on July 10, 2024.
The Company issued 2,190 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.40 on July 11, 2024.
The Company issued 1,376 shares of common stock pursuant to the exercise of warrants associated with the April 2024 public offering with an exercise price of $6.40 on July 23, 2024.
The Company sold 14,883 shares of common stock pursuant to the AGP Sales Agreement at a weighted average price of $3.93 per share.

The issuance of the Company’s common stock in connection with the convertible debt financing agreement as described above was exempt under Section 3(a)(9) of the Securities Act of 1933, as amended.

The issuances of the Company’s common stock in connection with the April 2024 public offering and upon the exercise of warrants described above were registered on a Registration Statement on Form S-1.

The issuance of the Company’s common stock pursuant to the AGP Sales Agreement described above was registered on a Registration Statement on Form S-3.

AGP At Market Issuance Sales Agreement

In August 2024, the Company entered into the AGP Sales Agreement to sell shares of the Company’s common stock from time to time, through an “at-the-market” equity offering program (the “AGP ATM”). In connection with the sale of shares via the AGP ATM, the Company determines, among other things, the number of shares to be issued, the time period during which sales may be requested to be made, limitation on the number of shares that may be sold in any one trading day, and any minimum price below which sales may not be made. Pursuant to the terms, AGP is entitled to compensation for its services in an amount up to 3% of the gross proceeds from the sale of shares under the AGP ATM. The Company has no obligation to sell any shares under the AGP ATM, and may suspend solicitation and offers at any time. The AGP ATM may be terminated by the Company or AGP upon notice, or at any time under certain circumstances, including but not limited to the occurrence of a material adverse change in the Company. The AGP ATM will terminate upon the earliest of (a) December 15, 2026, (b) the sale of all of the shares of common stock subject to the AGP ATM, (c) the termination of the AGP Sales Agreement as permitted therein, or (d) the mutual agreement of the parties.

The AGP Sales Agreement provides for the offer and sale of shares of common stock having an aggregate offering price of up to $5.8 million. As of November 1, 2024, there was approximately $4.7 million available for future sale of common stock pursuant to the AGP ATM.

July 2024 Warrant Inducement

On July 9, 2024, the Company entered into the Inducement Agreement with the Holders of the Company’s Existing Warrants to purchase shares of common stock of the Company. Pursuant to the Inducement Agreement, the Holders agreed to exercise for cash their Existing Warrants to purchase up to 703,125 shares of common stock at a reduced exercise price of $6.00 per share on July 9, 2024, the date of the Inducement Agreement, until 1:30 p.m. Eastern Time. The aggregate gross proceeds received by the Company was approximately $4.2 million from the exercise of the Existing Warrants offset by total issuance costs of approximately $7.5 million. Issuance costs include financial advisory, banker, and legal fees of approximately $0.4 million and the fair value of the warrant modification and the fair value of the New Warrants issued totaling approximately $7.2 million. Because the modification represented a short-term inducement, the Company

17


applied modification accounting guidance related to the fair value of the modification associated with the warrants that were exercised under the Inducement Agreement. Accordingly, the Company recognized the incremental fair value of the modification of the Existing Warrants exercised along with the fair value of the New Warrants issued as compared to the original warrants, together totaling approximately $7.2 million, as an issuance cost of the warrant exercise. Per the terms of the Inducement Agreement, the Company issued an aggregate of 1,054,688 New Warrants.

The fair value of the New Warrants issued under the Inducement Agreement was estimated using the Black-Scholes warrant-pricing model and the following assumptions:

a dividend yield of 0%;
an expected life of 5 years;
volatility of 127.25%; and
risk free interest rate of 4.24%.

Note 6. Commitments and Contingencies

Contractual Obligations

The Company has commitments of approximately $205,000 as of September 30, 2024 over the next five years for several licensing agreements with partners and universities. Additionally, the Company is party to other agreements which include cash milestone payments, royalties and other fees payable, which are all contingent upon clinical or commercialization success. There can be no assurance that clinical or commercialization success will occur.

The Company currently leases office space pursuant to a lease which expires in October 2025 and requires monthly rent of $11,367 through October 2024 and $11,625 per month thereafter.

In September 2014, the Company entered into an asset purchase agreement with Hy Biopharma Inc. (“Hy Biopharma”) pursuant to which the Company acquired certain intangible assets, properties and rights of Hy Biopharma related to the development of Hy BioPharma’s synthetic hypericin product. As consideration for the assets acquired, the Company paid $275,000 in cash and issued 771 shares of common stock with a fair value based on the Company’s stock price on the date of grant of $3.75 million. These amounts were charged to research and development expense during the third quarter of 2014 as the assets will be used in the Company’s research and development activities and do not have alternative future use. In March 2020, the Company issued 8,151 shares of common stock to Hy Biopharma as payment for achieving a milestone: the Company determining the Phase 3 clinical trial of HyBryte™ to be successful in the treatment of CTCL. The number of shares of common stock issued to Hy Biopharma was calculated using an effective price of $614.40 per share, based upon a formula set forth in the purchase agreement.

Provided the sole remaining future success-oriented milestone of FDA approval is attained, the Company will be required to make an additional payment of $5 million, if and when achieved. Such payment will be payable in restricted securities of the Company provided such number of shares does not exceed 19.9% ownership of the Company’s outstanding stock. As of September 30, 2024, no other milestone or royalty payments have been paid or accrued.

18


As a result of the above agreements, the Company has the following contractual obligations:

    

Research and

    

    

    

Year

    

Development

    

Leases

    

Total

October 1 through December 31, 2024

$

21,000

$

34,617

$

55,617

2025

 

46,000

 

116,250

 

162,250

2026

 

46,000

 

 

46,000

2027

46,000

46,000

2028

46,000

46,000

Total

$

205,000

$

150,867

$

355,867

Note 7. Operating Segments

The Company maintains two active operating segments: Specialized BioTherapeutics and Public Health Solutions. Each segment includes an element of overhead costs specifically associated with its operations, with its corporate shared services group responsible for support functions generic to both operating segments.

    

Three Months Ended

    

September 30, 

    

2024

    

2023

Revenues

  

 

  

Specialized BioTherapeutics

$

$

Public Health Solutions

130,440

Total

$

$

130,440

Income (loss) from Operations

 

  

 

  

Specialized BioTherapeutics

$

(834,654)

$

(705,753)

Public Health Solutions

(57,611)

(24,819)

Corporate

 

(972,971)

 

(1,048,484)

Total

$

(1,865,236)

$

(1,779,056)

Amortization and Depreciation Expense

 

  

 

  

Specialized BioTherapeutics

$

953

$

954

Public Health Solutions

158

159

Corporate

 

478

 

476

Total

$

1,589

$

1,589

Other (Expense) Income, Net

 

  

 

  

Specialized BioTherapeutics

$

1,409

$

1,683

Corporate

 

144,446

 

114,671

Total

$

145,855

$

116,354

Share-Based Compensation

 

  

 

  

Specialized BioTherapeutics

$

20,598

$

27,427

Public Health Solutions

618

994

Corporate

 

35,416

 

36,979

Total

$

56,632

$

65,400

19


    

Nine Months Ended

    

September 30, 

    

2024

    

2023

Revenues

  

 

  

Specialized BioTherapeutics

$

119,371

$

223,870

Public Health Solutions

370,677

Total

$

119,371

$

594,547

Income (loss) from Operations

 

  

 

  

Specialized BioTherapeutics

$

(1,978,464)

$

(2,227,430)

Public Health Solutions

(165,660)

(26,639)

Corporate

 

(3,582,878)

 

(3,306,000)

Total

$

(5,727,002)

$

(5,560,069)

Amortization and Depreciation Expense

 

  

 

  

Specialized BioTherapeutics

$

2,859

$

2,979

Public Health Solutions

476

496

Corporate

 

1,430

 

1,489

Total

$

4,765

$

4,964

Other (Expense) Income, Net

 

  

 

  

Specialized BioTherapeutics

$