Entero Therapeutics, Inc.
For the period ended Jun 30, 2025. Filed Aug 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 14, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
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Item 1. Unaudited Condensed Consolidated Financial Statements
In our opinion, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting only of normal recurring adjustments) necessary to present fairly our financial position, results of operations, and cash flows for the interim periods presented. We have consolidated such financial statements in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”). Therefore, such financial statements do not include all disclosures required by accounting principles generally accepted in the United States of America. In preparing these unaudited condensed consolidated financial statements, the Company has evaluated events and transactions for potential recognition or disclosure through the date the unaudited condensed consolidated financial statements were issued by filing with the SEC.
These financial statements should be read in conjunction with our audited financial statements for the year ended December 31, 2024, included in our Annual Report filed on Form 10 – K/A, filed with the SEC on April 9, 2025.
The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the fiscal year ending December 31, 2025.
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Consolidated Balance Sheets (unaudited)
| | | | | | | |
|---|---|---|---|---|---|---|
| · June 30, · · | ||||||
| · · 2025 · · December 31, | ||||||
| · · (unaudited) · · 2024 | ||||||
| ASSETS | | | | | | |
| | | | | | | |
| Current Assets: | | | | | | |
| Cash and cash equivalents | | $4,474 | | $163,476 | ||
| Prepaid expenses | | 144,159 | | | 145,319 | |
| Assets of disposal group held-for-sale | | | 83,170,009 | | | 83,170,009 |
| Total Current Assets | | 83,318,642 | | | 83,478,804 | |
| | | | | | | |
| Other Assets: | | | | | | |
| Restricted cash | | 7,005 | | | 21,516 | |
| Goodwill | | | 1,684,182 | | | 1,684,182 |
| Operating lease right-of-use assets | | — | | | 126,753 | |
| Deposits | | 49,122 | | | 98,251 | |
| Total Other Assets | | 1,740,309 | | | 1,930,702 | |
| | | | | | | |
| Total Assets | | $85,058,951 | | $85,409,506 | ||
| | | | | | | |
| LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) | | | | | | |
| | | | | | | |
| Current Liabilities: | | | | | | |
| Accounts payable | | $3,298,447 | | $2,959,248 | ||
| Accrued expenses | | | 415,444 | | | 252,048 |
| Accrued dividend payable | | 1,474,009 | | | 1,310,581 | |
| Line of credit | | 700,000 | | | — | |
| Operating lease liabilities - current | | | 135,609 | | | 81,510 |
| Liabilities held-for-sale | | | 23,546,478 | | | 22,941,497 |
| Other current liabilities | | 105,918 | | | 1,236 | |
| Total Current Liabilities | | | 29,675,905 | | | 27,546,120 |
| | | | | | | |
| Operating lease liabilities – non-current | | — | | | 59,024 | |
| Total Liabilities | | 29,675,905 | | | 27,605,144 | |
| | | | | | | |
| Mezzanine Equity: | | | | | | |
| Series G preferred stock- Par value $0.0001 per share; 13,000 shares designated; 0 and 12,373.226 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. | | | 61,681,100 | | | 61,681,100 |
| Stockholders’ Equity (Deficit): | | | | | | |
| Series B preferred stock- Par value $0.0001 per share; 5,194.81 shares authorized; 0 and 475.56 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. | | — | | | — | |
| Series C preferred stock- Par value $0.0001 per share; 75,000 shares authorized; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024. | | | — | | | — |
| Series D preferred stock- Par value $0.0001 per share; 150 shares designated; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024. | | | — | | | — |
| Series E preferred stock- Par value $0.0001 per share; 150 shares designated; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024. | | | — | | | — |
| Series F preferred stock- Par value $0.0001 per share; 7,000 shares designated; 0 shares issued and outstanding at June 30, 2025 and December 31, 2024. | | | — | | | — |
| Common stock - Par value $0.0001 per share; 100,000,000 shares authorized; 4,765,729 and 4,754,038 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. | | 477 | | | 475 | |
| Additional paid-in capital | | 198,347,367 | | | 198,510,795 | |
| Accumulated deficit | | (204,645,898) | | | (202,388,008) | |
| Total Stockholders’ Equity (Deficit) | | (6,298,054) | | | (3,876,738) | |
| Total Liabilities, Mezzanine Equity and Stockholders’ Equity (Deficit) | | $85,058,951 | | $85,409,506 | ||
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Consolidated Statements of Operations (unaudited)
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · Three Months Ended June 30, · · · Six Months Ended June 30, | |||||||||||||
| · · 2025 · 2024 · · 2025 · 2024 | |||||||||||||
| Operating expenses: | | | | | | | | | | | | | |
| Research and development expenses | | $10,631 | | $219,591 | | | $26,458 | | $675,523 | ||||
| General and administrative expenses | | | 628,233 | | | 3,206,517 | | | | 1,433,791 | | | 11,849,633 |
| Total operating expenses | | | 638,864 | | | 3,426,108 | | | | 1,460,249 | | | 12,525,156 |
| | | | | | | | | | | | | | |
| Loss from operations | | (638,864) | | | (3,426,108) | | | | (1,460,249) | | | (12,525,156) | |
| | | | | | | | | | | | | | |
| Other expenses: | | | | | | | | | | | | | |
| Interest income (expense), net | | | (36,067) | | | 218 | | | | (53,968) | | | 446 |
| Other expense, net | | — | | | (4,332) | | | | (108,818) | | | (4,985) | |
| Total other expenses | | (36,067) | | | (4,114) | | | | (162,786) | | | (4,539) | |
| | | | | | | | | | | | | | |
| Loss from continued operations | | $(674,931) | | $(3,430,222) | | | $(1,623,035) | | $(12,529,695) | ||||
| | | | | | | | | | | | | | |
| Income tax benefit | | | — | | | (4,255,247) | | | | — | | | 10,604,640 |
| Net loss from continued operations | | $(674,931) | | $(7,685,469) | | | $(1,623,035) | | $1,925,055 | ||||
| | | | | | | | | | | | | | |
| Loss from discontinued operations net of tax | | | (323,340) | | | (1,122,233) | | | | (634,855) | | | (1,315,041) |
| Net loss | | $(998,271) | | $(8,807,702) | | | $(2,257,890) | | $(3,240,096) | ||||
| | | | | | | | | | | | | | |
| Preferred stock dividends | | | (82,165) | | | (38,058) | | | | (163,428) | | | (104,202) |
| Net loss applicable to common shareholders | | $(1,080,436) | | $(8,845,760) | | | $(2,421,318) | | $(3,344,298) | ||||
| | | | | | | | | | | | | | |
| Weighted average shares outstanding, basic and diluted | | | 4,765,004 | | | 2,294,208 | | | | 4,765,004 | | | 2,028,080 |
| Loss per share, basic and diluted | | $(0.21) | | $(3.86) | | | $(0.51) | | $(1.65) | ||||
| Loss per share from discontinued operations, basic and diluted | | $(0.07) | | $(0.49) | | | $(0.13) | | $(0.65) | ||||
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Consolidated Statements of Mezzanine Equity and Changes in Stockholders’ Equity (Deficit) (unaudited)
| · · · · · · · · · · · · · · · · · · · · · · · · | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series G Convertible · · Series B Convertible · · · · · · · Additional · · · · · Total | |||||||||||||||||||||||
| · · Preferred Stock · · Preferred Stock · · Common Stock · · Paid In · · Accumulated · · Stockholders’ | |||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · Capital · Deficit · Equity | |||||||||||||||||||||||
| Balance, April 1, 2025 | 12,373.23 | | $61,681,100 | | 476 | | $— | | 4,765,729 | | $477 | | $198,429,532 | | $(203,647,628) | | $(5,217,619) | ||||||
| Deemed dividend of Series B preferred stock | — | | | — | | — | | | — | | — | | | — | | | (82,165) | | | — | | | (82,165) |
| Net loss | — | | | — | | — | | | — | | — | | | — | | | — | | | (998,270) | | | (998,270) |
| Balance, June 30, 2025 | 12,373 | | $61,681,100 | | 476 | | $— | | 4,765,729 | | $477 | | $198,347,367 | | $(204,645,898) | | $(6,298,054) | ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · Series G Convertible · Series B Convertible · · · · · Additional · · · Total | ||||||||||||||||||||||||
| · · Preferred Stock · · Preferred Stock · · Common Stock · · Paid In · · Accumulated · · Stockholders’ | ||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · Capital · Deficit · Equity | ||||||||||||||||||||||||
| Balance, April 1, 2024 | 12,373 | | $61,681,100 | 505 | | $— | 2,025,208 | | $203 | | $194,943,707 | | $(178,761,066) | | $16,182,844 | |||||||||
| Issuance of common stock, pre-funded warrants and warrants in registered direct offering, net of issuance costs | — | | — | — | | — | 275,000 | | | 27 | | | 890,563 | | | — | | | 890,590 | |||||
| Exercise of pre-funded warrants into common stock | | — | | | — | | — | | | — | | 360,000 | | | 36 | | | — | | | — | | | 36 |
| Deemed dividend of Series B preferred stock | | — | | | — | | — | | | — | | — | | | — | | | (38,058) | | | — | | | (38,058) |
| Conversion of Series B preferred shares into common stock | | — | | | — | | (20) | | | — | | 18 | | | — | | | — | | | — | | | — |
| Common stock issued to consultants | | — | | | — | | — | | | — | | 250,000 | | | 25 | | | 760,970 | | | — | | | 760,995 |
| Issuance of common stock from RSU vest | — | | — | — | | — | 30,882 | | | 3 | | | (3) | | | — | | | — | |||||
| Stock-based compensation | — | | — | — | | — | — | | | — | | | 131,890 | | | — | | | 131,890 | |||||
| Net loss | — | | — | — | | — | — | | | — | | | — | | | (8,807,702) | | | (8,807,702) | |||||
| Balance, June 30, 2024 | 12,373 | | $61,681,100 | 485 | | $— | 2,941,108 | | $294 | | $196,689,069 | | $(187,568,768) | | $9,120,595 | |||||||||
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ENTERO THERAPEUTICS, INC.
Condensed Consolidated Statements of Mezzanine Equity and Changes in Stockholders’ Equity (Deficit) (unaudited)
| · · · · · · · · · · · · · · · · · · · · · · · · | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Series G Convertible · · Series B Convertible · · · · · · · Additional · · · · · Total | |||||||||||||||||||||||
| · · Preferred Stock · · Preferred Stock · · Common Stock · · Paid In · · Accumulated · · Stockholders’ | |||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · Capital · Deficit · Equity | |||||||||||||||||||||||
| Balance, January 1, 2025 | 12,373.23 | | $61,681,100 | | 476 | | $— | | 4,754,038 | | $475 | | $198,510,795 | | $(202,388,008) | | $(3,876,738) | ||||||
| Deemed dividend of Series B preferred stock | — | | | — | | — | | | — | | — | | | — | | | (163,428) | | | — | | | (163,428) |
| Issuance of common stock from RSU vest | — | | | — | | — | | | — | | 11,691 | | | 2 | | | — | | | — | | | 2 |
| Net loss | — | | | — | | — | | | — | | — | | | — | | | — | | | (998,270) | | | (998,270) |
| Balance, June 30, 2025 | 12,373 | | $61,681,100 | | 476 | | $— | | 4,765,729 | | $477 | | $198,347,367 | | $(204,645,898) | | $(6,298,054) | ||||||
| | | | | | | | | | | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · Series G Convertible · Series B Convertible · · · · · Additional · · · Total | ||||||||||||||||||||||||
| · · Preferred Stock · · Preferred Stock · · Common Stock · · Paid In · · Accumulated · · Stockholders’ | ||||||||||||||||||||||||
| · Shares · Amount · Shares · Amount · Shares · Amount · Capital · Deficit · Equity | ||||||||||||||||||||||||
| Balance, January 1, 2024 | — | | $— | 515 | | $— | 1,560,998 | | $156 | | $187,931,445 | | $(184,328,672) | | $3,602,929 | |||||||||
| Issuance of common stock, pre-funded warrants and warrants in registered direct offerings, net of issuance costs | — | | — | — | | — | 448,100 | | | 44 | | | 4,495,482 | | | — | | | 4,495,526 | |||||
| Issuance of Series G convertible preferred stock upon acquisition of IMGX | 11,777 | | 57,790,474 | — | | — | — | | | — | | | — | | | — | | | — | |||||
| Issuance of common stock upon acquisition of IMGX | — | | — | — | | — | 36,830 | | | 4 | | | 2,300,496 | | | — | | | 2,300,500 | |||||
| Issuance of Series G convertible preferred stock to financial advisors | 596 | | 3,890,626 | — | | — | — | | | — | | | — | | | — | | | — | |||||
| Issuance of common stock to financial advisors | | — | | | — | | — | | | — | | 18,475 | | | 2 | | | 120,646 | | | — | | | 120,648 |
| Exercise of pre-funded warrants into common stock | | — | | | — | | — | | | — | | 443,525 | | | 45 | | | — | | | — | | | 45 |
| Deemed dividend of Series B preferred stock | | — | | | — | | — | | | — | | — | | | — | | | (104,202) | | | — | | | (104,202) |
| Conversion of Series B preferred shares into common stock | | — | | | — | | (30) | | | — | | 27 | | | — | | | — | | | — | | | — |
| Common stock issued to consultants | | — | | | — | | — | | | — | | 350,000 | | | 35 | | | 1,541,960 | | | — | | | 1,541,995 |
| Issuance of common stock from RSU vest | — | | — | — | | — | 83,153 | | | 8 | | | (8) | | | — | | | — | |||||
| Stock-based compensation | — | | — | — | | — | — | | | — | | | 403,250 | | | — | | | 403,250 | |||||
| Net loss | — | | — | — | | — | — | | | — | | | — | | | (3,240,096) | | | (3,240,096) | |||||
| Balance, June 30, 2024 | 12,373 | | $61,681,100 | 485 | | $— | 2,941,108 | | $294 | | $196,689,069 | | $(187,568,768) | | $9,120,595 | |||||||||
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Consolidated Statements of Cash Flows (unaudited)
| | | | | | | |
|---|---|---|---|---|---|---|
| | Six Months Ended June 30, | |||||
| | | 2025 | 2024 | |||
| Cash flows from operating activities: | | | | | | |
| Net income (loss) | | $(2,257,890) | | $(3,240,096) | ||
| Adjustments to reconcile net income (loss) to net cash used in operating activities: | | | | | | |
| Depreciation and amortization | | | — | | | 47,610 |
| Amortization of debt discount | | — | | 5,847 | ||
| Change in right-of-use assets | | 17,994 | | | 37,935 | |
| Impairment of right-of-use assets | | | 108,759 | | | — |
| Stock-based compensation | | — | | | 403,250 | |
| Common stock granted to consultants | | — | | | 1,541,995 | |
| Common stock issued to financial advisors at acquisition | | | — | | | 120,648 |
| Series G convertible preferred stock issued to financial advisors at acquisition | | | — | | | 3,890,626 |
| Deferred taxes | | | — | | | (10,604,640) |
| Changes in assets and liabilities: | | | | | | |
| Prepaid expenses | | 1,160 | | | 690,021 | |
| Lease liabilities | | | (4,925) | | | (39,204) |
| Deposits | | 49,129 | | | (20,500) | |
| Accounts payable | | 339,199 | | | 744,594 | |
| Accrued expenses | | 163,396 | | | (780,637) | |
| Other liabilities | | 709,665 | | | 4,735 | |
| Net cash used in operating activities | | (873,513) | | | (7,197,816) | |
| | | | | | | |
| Cash flows from investing activities: | | | | | | |
| Cash acquired in acquisition of IMGX | | — | | | 88,169 | |
| Net cash provided by investing activities | | — | | | 88,169 | |
| | | | | | | |
| Cash flows from financing activities: | | | | | | |
| Proceeds from issuance of common stock, prefunded warrants and warrants, net | | — | | | 4,495,526 | |
| Proceeds from exercise of warrants | | | — | | | 45 |
| Repayments of note payable | | — | | | (467,019) | |
| Proceeds from note payable | | | 700,000 | | | 31,798 |
| Net cash provided by financing activities | | 700,000 | | | 4,060,350 | |
| | | | | | | |
| Net (decrease) in cash, cash equivalents and restricted cash | | | (173,513) | | | (3,049,297) |
| | | | | | | |
| Cash, cash equivalents and restricted cash, beginning balance | | | 184,992 | | | 3,733,292 |
| Cash, cash equivalents and restricted cash, ending balance | | $11,479 | | $683,995 | ||
| | | | | | | |
| Supplemental disclosures of cash flow information: | | | | | | |
| Cash paid for interest | | $— | | $22,464 | ||
| | | | | | | |
| Non-cash investing and financing activities: | | | | | | |
| Fair value of common shares issued in the IMGX acquisition, net of cash | | $— | | $152,331 | ||
| Fair value of the Series G preferred stock issued in the IMGX acquisition | | $— | | $57,790,474 | ||
| Fair value of options assumed in the IMGX acquisition | | $— | | $1,271,000 | ||
| Fair value of warrants assumed in the IMGX acquisition | | $— | | $789,000 | ||
| Accrued dividends on preferred stock | | $(163,428) | | $(104,202) | ||
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Notes to Unaudited Condensed Consolidated Financial Statements
June 30, 2025
Note 1 - The Company and Basis of Presentation
The Company
Entero Therapeutics, Inc. (“Entero”) and its wholly-owned subsidiaries, First Wave Bio, Inc. (“FWB”) and ImmunogenX, LLC (“IMGX”), are collectively referred to as the “Company”. The Company is engaged in the research and development of targeted, non-systemic therapies for the treatment of patients with gastrointestinal (“GI”) diseases. Non-systemic therapies are non-absorbable drugs that act locally, i.e., in the intestinal lumen, skin or mucosa, without reaching an individual’s systemic circulation.
In May 2024, the Company changed its name from First Wave Biopharma, Inc. to Entero Therapeutics, Inc.
The Company’s development pipeline consists of gut-restricted GI clinical drug candidates, including the biologic Adrulipase (formerly MS1819), a recombinant lipase enzyme designed to enable the digestion of fats and other nutrients. The Company plans to continue development of its Adrulipase program in 2025.
In March 2024, the Company acquired ImmunogenX, Inc. (“ImmunogenX”) (the Company’s acquisition of ImmunogenX, the “Merger”), a private, clinical-stage biopharmaceutical company founded in 2013, which was developing the biologic, Latiglutenase, for celiac disease. ImmunogenX was also developing CypCel, a metabolic marker compound that can measure the state of small-intestinal recovery of celiac patients undergoing gluten-free diets (“GFDs”). The Company is seeking avenues to dispose of certain assets and liabilities of IMGX, including Latiglutenase and CypCel. As of December 31, 2024, these were classified as assets and liabilities held for sale and are reported at their fair value less cost to sell. The Company determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on the Company’s operations and financial statements. See Note 3 for additional details regarding the Merger and see Note 4 for additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations.
The Company terminated its license agreement with Sanofi on Feb 26, 2025 and no payments have been made since for its Capeserod program, a selective 5-HT4 receptor partial agonist. The Company is also exploring strategic alternatives for its Niclosamide program, an oral small molecule with anti-viral and anti-inflammatory properties.
Risks and Uncertainties
The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development and regulatory success, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and ability to secure additional capital to fund clinical trials and operations.
Worldwide supply chain constraints and economic and capital markets uncertainty arising out of conflicts between Russia and Ukraine and conflicts in the Middle East triggered by attacks on Israel in October of 2023 have disrupted commercial and capital markets and emerged as new barriers to long-term economic recovery. Capital markets uncertainty, with public stock price decreases and volatility, could make it more difficult for us to raise capital when needed.
In addition, the Company is subject to other challenges and risks specific to its business, its ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and its ability to execute on its strategy, as well as risks and uncertainties common to companies in the biotechnology and pharmaceutical industries with development and commercial operations, including, without limitation, risks and uncertainties associated with: obtaining regulatory approval of its drug candidates; delays or problems in the manufacture and supply of its drug candidates, loss of single source suppliers or failure to comply with manufacturing regulations; identifying, acquiring or in-licensing additional products or drug candidates; pharmaceutical product development and the inherent uncertainty of clinical success; and the challenges of protecting and enhancing our intellectual property rights; complying with applicable regulatory requirements.
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Principles of Consolidation
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) and include the accounts of Entero and its wholly owned subsidiaries, FWB and IMGX. Intercompany transactions and balances have been eliminated upon consolidation.
In our opinion, the accompanying unaudited interim condensed consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations, and cash flows. The consolidated balance sheet at December 31, 2024, has been derived from audited financial statements of that date. The unaudited interim condensed consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with GAAP have been omitted pursuant to instructions, rules, and regulations prescribed by the SEC. The Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited interim condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously distributed in the Company’s Annual Report Form 10-K/A for the year ended December 31, 2024, filed with the SEC on April 9, 2025.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying unaudited interim condensed consolidated financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. On June 30, 2025, the Company had cash and cash equivalents of approximately $3,427 and an accumulated deficit of approximately $204.6 million. The Company has incurred recurring losses, has experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. Historically, the Company’s major sources of cash have been comprised of proceeds from various public and private offerings of its capital stock. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations.
The Company has been, and is expected to continue, exploring various potential strategies available including but not limited to raising capital, restructuring its indebtedness and identifying and evaluating potential strategic alternatives but there can be no assurance that these efforts will be successful, that the Company will be able to raise necessary capital on acceptable terms, reach agreement with lenders, or that the strategic review process will result in the Company pursuing any transaction or that any transaction, if pursued, will be completed on attractive terms or at all. The Company is evaluating all potential strategic options, including a merger, reverse merger, sale, wind-down, liquidation and dissolution or other strategic transaction. Additionally, there can be no assurances that any particular course of action, business arrangement or transaction, or series of transactions, will be pursued, successfully consummated or lead to increased stakeholder value or that it will make any cash distributions to stockholders. Any failure in these efforts could force the Company to delay, limit or terminate operations, make reductions in its workforce, discontinue research and development programs, liquidate all or a portion of assets or pursue other strategic alternatives, and/or seek protection under the provisions of the U.S. Bankruptcy Code.
Without adequate working capital, the Company may not be able to meet its obligations and continue as a going concern. These conditions raise substantial doubt about the Company’s ability to continue as a going concern one year from the date these financial statements are issued. If the Company is not able to obtain necessary capital, it may be required to terminate operations, liquidate all or a portion of assets and/or seek bankruptcy protection. As a result, the Company concluded that its plans at this stage do not alleviate substantial doubt about the ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Note 2 - Significant Accounting Policies and Recent Accounting Pronouncements
Use of Estimates
The accompanying unaudited condensed consolidated financial statements are prepared in conformity with GAAP and include certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements (including goodwill), and the reported amounts of revenue and expense during the reporting period, including contingencies. Accordingly, actual results may differ from those estimates.
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Segment Information
The Company operates asone operating segment with a focus on research and development. The Chief Executive Officer (“CEO”), as the Company’s chief operating decision maker, manages and allocates resources to the operations of the Company on an aggregated basis. This enables the CEO to assess the Company’s overall level of available resources and determine how best to deploy these resources across functions, product and service lines, and strategic opportunities in line with the long-term Company-wide strategic goals.
Reverse Stock Split
On December 18, 2023, the Company effected a reverse stock split, whereby every twenty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.
Cash and Cash Equivalents and Restricted Cash
The Company considers all highly liquid investments with maturities of three months or less from date of purchase to be cash equivalents. As of June 30, 2025 and December 31, 2024, the Company has classified approximately $4,474 and $163,476 respectively as restricted cash.
Concentrations of Credit Risk
Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash. The Company primarily maintains its cash balances with financial institutions in federally insured accounts in the U.S. The Company may from time to time have cash in banks in excess of FDIC insurance limits. The Company has not experienced any losses to date resulting from this practice. The Company mitigates its risk by maintaining the majority of its cash and equivalents with high quality financial institutions.
Equity-Based Payments to Non-Employees
Equity-based payments to non-employees are measured at fair value on the grant date per ASU No. 2018-07, Improvements to Nonemployee Share-Based Payment Accounting.
Fair Value Measurements
The Company follows Accounting Standards Codification*(“ASC”) Topic 820-10, Fair Value Measurements and Disclosures(*“ASC 820”), which among other things, defines fair value, establishes a consistent framework for measuring fair value and expands disclosure for each major asset and liability category measured at fair value on either a recurring or nonrecurring basis. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability.
As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities;
Level 2: Inputs, other than the quoted prices in active markets, that are observable either directly or indirectly; and
Level 3: Unobservable inputs in which there is little or no market data, which require the reporting entity to develop its own assumptions, which reflect those that a market participant would use.
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, an instrument’s level within the fair value hierarchy is based on the lowest level of input that is significant to the overall fair value
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measurement. 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 financial instrument.
The Company recognizes transfers between levels as if the transfers occurred on the last day of the reporting period.
Goodwill and Intangible Assets
Goodwill represents the excess of the purchase price of the acquired business over the fair value of amounts assigned to assets acquired and liabilities assumed. Goodwill and other intangible assets with indefinite useful lives are reviewed for impairment annually or more frequently if events or circumstances indicate impairment may be present. Any excess in carrying value over the estimated fair value is charged to results of operations. The Company hasnot recognized any impairment charges through June 30, 2025 related to goodwill.
Impairment of Long-Lived Assets
The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment*(*“ASC 360”). Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. The recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has not recognized any impairment charges through June 30, 2025.
Income Taxes
Income taxes are recorded in accordance with ASC 740, Accounting for Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. The Company determines its deferred tax assets and liabilities based on differences between financial reporting and tax bases of assets and liabilities, which are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. At June 30, 2025 and December 31, 2024, the Company does not have any significant uncertain tax positions.
Leases
Leases are recorded on the balance sheet as right of use assets and lease obligations. Lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. Leases with a term of 12 months or less at inception are expensed monthly over the lease term. The lease term is determined by assuming the exercise of renewal options that are reasonably certain. The implicit interest rate or the incremental borrowing rate is used in determining the present value of future payments. The company has not entered into any new leases in the six months ended June 30.2025.
Income (Loss) Per Share
Basic income (loss) per share (“EPS”) is computed by dividing the loss attributable to common shareholders by the weighted average number of shares of Common Stock outstanding. Diluted EPS reflects the potential dilution that could occur from shares of Common Stock issuable through the exercise or conversion of stock options, restricted stock awards, warrants and convertible securities. In certain circumstances, the conversion of options is excluded from diluted EPS if the effect of such inclusion would be anti-dilutive.
The dilutive effect of stock options is determined using the treasury stock method. Stock options to purchase shares of Common Stock of the Company during 2024 and for the three and six months ended June 30, 2025 were not included in the computation of diluted EPS because the Company has incurred a loss for the three and six months ended June 30, 2025 and year ended December 31, 2024 and the effect would be anti-dilutive.
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Research and Development
Research and development costs are charged to operations when incurred and are included in operating expenses, except for goodwill related to patents. Research and development costs consist principally of compensation of consultants that perform the Company’s research activities, payments to third parties for preclinical and non-clinical activities, expenses with clinical research organizations (“CROs”), investigative sites, consultants and contractors that conduct or provide other services relating to clinical trials, costs to acquire drug product, drug supply and clinical trial materials from contract development and manufacturing organization (“CDMOs”) and third-party contractors relating to chemistry, manufacturing and controls (“CMC”) efforts, the fees paid for and to maintain the Company’s licenses and research and development costs related to Adrulipase, Capeserod and Niclosamide. Depending upon the timing of payments to the service providers, the Company recognizes prepaid expenses or accrued expenses related to these costs. These accrued or prepaid expenses are based on management’s estimates of the work performed under service agreements, milestones achieved and experience with similar contracts. The Company monitors each of these factors and adjusts estimates accordingly.
Research and Development– Intellectual Property Acquired
The Company records intellectual property acquired in business acquisitions that has not reached technological feasibility and which has no alternative future use, as In-Process R&D (“IPR&D”) at the acquisition date. On March 13, 2024, the Company entered into an acquisition agreement with IMGX which included the intellectual property and patents for Latiglutenase and CypCel, which was accounted for as a business acquisition (see Note 3 and Note 4).
Intangible assets related to IPR&D are considered indefinite-lived intangible assets and are assessed for impairment annually or more frequently if impairment indicators exist. If the associated research and development effort is abandoned, the related assets will be written-off, and the Company will record a noncash impairment loss on its Consolidated Statements of Operations. For those compounds that reach commercialization, the IPR&D assets will be amortized over their estimated useful lives. The impairment test for indefinite-lived intangible assets is a one-step test that compares the fair value of the intangible asset to its carrying value. If the carrying value exceeds its fair value, an impairment loss is recognized in an amount equal to the excess. The Company has not recognized any impairment charges through June 30, 2025 related to IPR&D.
For tax purposes, intangible assets related to IPR&D are considered indefinite-lived intangible assets.
Stock-Based Compensation
The Company’s board of directors (the “Board”) and stockholders have adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”) which took effect on May 12, 2014, and the 2020 Omnibus Equity Incentive Plan, which took effect on September 11, 2020 (the “2020 Plan”). From the effective date of the 2020 Plan, no new awards have been or will be made under the 2014 Plan. On March 13, 2024, in connection with the IMGX acquisition, the Company assumed IMGX’s 2021 Stock Option Plan (the “IMGX Plan”), including all IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan. The Company accounts for its stock-based compensation awards to employees, consultants, and Board members in accordance with ASC Topic 718, Compensation-Stock Compensation (“ASC 718”). ASC 718 requires all stock-based payments to employees, consultants, and Board members, including grants of employee stock options, to be recognized in the statements of operations by measuring the fair value of the award on the date of grant and recognizing this fair value as stock-based compensation using a straight-line method over the requisite service period, generally the vesting period.
For awards with performance conditions that affect their vesting, such as the occurrence of certain transactions or the achievement of certain operating or financial milestones, recognition of fair value of the award occurs when vesting becomes probable.
The Company estimates the grant date fair value of stock option awards using the Black-Scholes option-pricing model. The use of the Black-Scholes option-pricing model requires management to make assumptions with respect to the expected term of the option, the expected volatility of the Common Stock consistent with the expected life of the option, risk-free interest rates and expected dividend yields of the Common Stock.
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Assets Held for Sale and Discontinued Operations
Assets and liabilities are classified as held for sale when all of the following criteria for a plan of sale have been met: (1) management, having the authority to approve the action, commits to a plan to sell the assets; (2) the assets are available for immediate sale, in their present condition, subject only to terms that are usual and customary for sales of such assets; (3) an active program to locate a buyer and other actions required to complete the plan to sell the assets have been initiated; (4) the sale of the assets is probable and is expected to be completed within one year; (5) the assets are being actively marketed for a price that is reasonable in relation to their current fair value; and (6) actions required to complete the plan indicate that it is unlikely that significant changes to the plan will be made or the plan will be withdrawn. When all of these criteria have been met, the assets and liabilities are classified as held for sale in the condensed consolidated balance sheet. A newly acquired business in a business combination that has met the held for sale criteria should be measured at fair value less costs to sell. This is because the business has been recently acquired and its carrying value has been adjusted to its fair value. Depreciation and amortization of assets cease upon designation as held for sale.
Discontinued operations comprise activities that were disposed of, discontinued or held for sale at the end of the period, represent a separate major line of business that can be clearly distinguished for operational and financial reporting purposes, and represent a strategic business shift having a major effect on the Company’s operations and financial results according to ASC Topic 205, Presentation of Financial Statements.
Additional details surrounding the Company’s assets and liabilities held for sale and discontinued operations are included in Note 4.
Recent Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The amendments are effective for all public entities for fiscal years beginning after December 15, 2024. The Company adopted ASU 2023-09 on January 1, 2025 and the adoption did not have a material effect on the Company’s financial statement disclosures.
In July 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-05, Measurement of Credit Losses for Accounts Receivable and Contract Assets. ASU 2025-05 amends ASC 326, Financial Instruments—Credit Losses, introducing a practical expedient and an accounting policy election for certain entities in estimating expected credit losses for current accounts receivable and current contract assets arising from transactions within the scope of ASC 606, Revenue from Contracts with Customers. Under the practical expedient, entities may assume that current conditions as of the balance sheet date remain unchanged for the remaining life of the asset when developing forecasts. ASU 2025-05 is effective for the Company beginning in the first quarter of 2026, with early adoption permitted, and should be applied prospectively. The Company is currently evaluating the potential impact of the new guidance on its consolidated financial statements; however, no material effect is expected based on the current nature of the Company’s receivables and contract assets.
In May 2025, the FASB issued ASU 2025-04, Compensation—Stock Compensation (Topic 718) and Revenue from Contracts with Customers (Topic 606). ASU 2025-04 revises the definition of “performance condition” for share-based consideration payable to a customer, removes the policy election to account for forfeitures as they occur for awards with service conditions, and clarifies that ASC 606 variable consideration guidance does not apply to such awards. This guidance is effective for the Company beginning in the first quarter of 2027, with early adoption permitted, and may be applied on a modified retrospective or retrospective basis. The Company does not currently issue share-based consideration to customers and does not expect the adoption of ASU 2025-04 to have a material impact, but will continue to monitor for applicability.
In May 2025, the FASB issued ASU 2025-03, Business Combinations (Topic 805) and Consolidation (Topic 810): Determining the Accounting Acquirer in the Acquisition of a Variable Interest Entity. ASU 2025-03 clarifies the determination of the accounting acquirer in certain equity-based acquisitions when the legal acquiree is a variable interest entity (“VIE”) that meets the definition of a business. This guidance is effective for the Company beginning in the first quarter of 2027, with early adoption permitted, and must be applied prospectively to relevant transactions. The Company has not entered into such transactions to date and does not expect a material impact upon adoption.
In November 2024, the FASB issued ASU 2024-04, Induced Conversions of Convertible Debt Instruments. This ASU clarifies the requirements for determining whether certain settlements of convertible debt should be accounted for as induced conversions. The guidance is effective for the Company beginning in the first quarter of 2026, with early adoption permitted, and may be applied
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prospectively or retrospectively. While the Company has outstanding convertible debt, no induced conversions have been undertaken. Management does not expect the adoption of ASU 2024-04 to have a material impact unless future inducement transactions occur.
In November 2024, the FASB issued ASU 2024-03, Income Statement — Reporting Comprehensive Income — Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires additional disclosures of specified expense categories, qualitative descriptions of remaining amounts in expense captions, and disclosure of selling expenses and the Company’s definition thereof. This guidance is effective for the Company beginning with the 2027 annual report, with early adoption permitted. The Company is evaluating its reporting processes to ensure compliance with the new disclosure requirements.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. ASU 2023-09 requires expanded disclosures of rate reconciliation categories, significant reconciling items, and disaggregated income taxes paid, net of refunds. The guidance is effective for the Company beginning with the 2025 annual report, with early adoption permitted, and should be applied prospectively, with retrospective adoption also permitted. The Company is evaluating enhancements to its income tax disclosures in preparation for adoption.
Management has reviewed the above standards and, based on the Company’s current operations and transactions, does not expect their adoption to have a material impact on the Company’s consolidated financial statements.
The Company has evaluated other recently issued accounting pronouncements and has concluded that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s financial position or results of operations upon adoption.
Note 3 – Business Acquisition
On March 13, 2024, the Company acquired ImmunogenX, Inc., a Delaware corporation, in accordance with the terms of an Agreement and Plan of Merger, dated March 13, 2024 (the “Merger Agreement”), by and among the Company, IMMUNO Merger Sub I, Inc., a Delaware corporation (“First Merger Sub”), IMMUNO Merger Sub II, LLC, a Delaware limited liability company (“Second Merger Sub”), and ImmunogenX. Pursuant to the Merger Agreement, First Merger Sub merged with and into ImmunogenX, pursuant to which ImmunogenX was the surviving corporation (the “First Merger”). Immediately following the First Merger, IMGX merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity and a wholly owned subsidiary of the Company (the “Second Merger” and, together with the First Merger, the “IMGX Merger”). Second Merger Sub subsequently changed its name to ImmunogenX, LLC. The Merger is intended to qualify as a tax-free reorganization for U.S. federal income tax purposes.
Under the terms of the Merger Agreement, following the consummation of the Merger (the “Closing”), in exchange for the outstanding shares of capital stock of ImmunogenX immediately prior to the effective time of the First Merger, the Company issued to the stockholders of ImmunogenX an aggregate of (A)36,830 shares of Common Stock, and (B)11,777.418 shares of Series G Preferred Stock, each share of which is convertible into 1,000 shares of Common Stock, upon shareholder approval. Following the closing of the acquisition, the Company had 2,303,135 shares of common stock issued and outstanding.
The Company incurred transaction costs of $5,456,038 which are included in the Company’s condensed consolidated statement of operations.
In addition, the Company assumed (i) all ImmunogenX stock options immediately outstanding prior to the First Merger, each becoming an option to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Options”) and (ii) all ImmunogenX warrants immediately outstanding prior to the First Merger, each becoming a warrant to purchase Common Stock subject to adjustment pursuant to the terms of the Merger Agreement (the “Assumed Warrants”). The Assumed Options are exercisable for an aggregate of 200,652 shares of Common Stock, have an exercise price of $0.81 and expire between February 1, 2031 and June 6, 2033. The Assumed Warrants are exercisable for an aggregate of 127,680 shares of Common Stock, have exercise prices ranging from $3.03 to $3.92 and expire between September 30, 2032 and September 6, 2033.
Tungsten Partners LLC (“Tungsten”) acted as financial advisor to the Company in connection with the Merger. As partial compensation for services rendered by Tungsten, the Company issued to Tungsten or its affiliates or designees an aggregate of 18,475 shares of Common Stock and 595.808 shares of Series G Preferred Stock. The fair value of the advisory fees was approximately $4.0 million which are included in the approximately $5.5 million of transaction costs noted above.
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The Merger was accounted for as a business combination under the acquisition method of accounting with First Wave as the accounting acquirer. Under the acquisition method, the total purchase price of the acquisition is allocated to the net identifiable tangible and intangible assets acquired and liabilities assumed based on the fair values as of the date of such acquisition. The fair value of the consideration totaled approximately $60.1 million, summarized as follows:
| · · · | ||
|---|---|---|
| | Amount | |
| Common stock issued to ImmunogenX stockholders | | $240,500 |
| Replacement options | | 1,271,000 |
| Replacement warrants | | 789,000 |
| Preferred stock issued to ImmunogenX stockholders | | 57,790,474 |
| Total consideration paid | | $60,090,974 |
The Company has made an allocation of the purchase price of the Merger to the assets acquired and the liabilities assumed as of the purchase date. The following table summarizes the purchase price allocations relating to the Merger:
| | | | |
|---|---|---|---|
| Assets acquired: · · | |||
| Cash and cash equivalents | | $88,169 | |
| Prepaid expenses and other current assets | | 3,131,929 | |
| Property and equipment, net | | 18,963 | |
| Intangibles | | 63,370,000 | |
| Operating lease right-of-use assets | | 4,232 | |
| Total assets | | $66,613,293 | |
| Liabilities assumed: | | ||
| Accounts payable | | 916,209 | |
| Accrued expenses and other current liabilities | | 2,131,439 | |
| Long term debt | | 6,397,889 | |
| Deferred tax liability | | 15,431,108 | |
| Total liabilities | | $24,876,645 | |
| Goodwill recorded: | | | |
| Goodwill | | $18,354,326 | |
| Net assets acquired | | $60,090,974 | |
The fair value of IPR&D was capitalized as of the IMGX Merger date and accounted for as indefinite-lived intangible assets until completion or disposition of the assets or abandonment of the associated research and development efforts. Upon successful completion of the development efforts, the useful lives of the IPR&D assets will be determined based on the anticipated period of regulatory exclusivity and will be amortized within operating expenses. The goodwill recorded related to the IMGX Merger is the excess of the fair value of the consideration transferred by the acquirer over the fair value of the net identifiable assets acquired and liabilities assumed at the date of such acquisition. The goodwill recorded is not deductible for tax purposes.
All intangible assets acquired are subject to amortization and their associated estimated acquisition date fair values are as follows:
| · · · · · | |||
|---|---|---|---|
| · Estimated · Acquisition Date | |||
| Intangible Asset · · Useful Life · · Fair Value | |||
| Patents | 2 years | | $140,000 |
| Trade names and trademarks | 6 years | | 230,000 |
| IPR&D – Latiglutenase | Indefinite | | 54,000,000 |
| IPR&D - CypCel | Indefinite | | $9,000,000 |
Net loss in the Condensed Consolidated Statement of Operations for the six months ended June 30, 2025 includes net losses of IMGX from the date of acquisition to June 30, 2025 of approximately $0.6 million, which is classified as discontinued operations.
The Merger is classified as held for sale as of June 30, 2025. Refer to Note 4 for further information.
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Pro forma disclosure for the IMGX acquisition
The following unaudited pro forma financial information reflects the consolidated results of operations of the Company as if the Acquisition had taken place on January 1, 2024. The pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transactions been effected on the assumed date:
| | | | | | | |
|---|---|---|---|---|---|---|
| · Six Months · Twelve Months Ended | ||||||
| · · Ended June, 2025 · · December 31, 2024 | ||||||
| Operating expenses | | $— | | $15,621,274 | ||
| Loss before income tax benefit | | — | | (15,619,022) | ||
| Loss from discontinued operations | | (634,855) | | (2,440,315) | ||
| Net loss applicable to common shareholders | | | (634,855) | | | (18,300,301) |
| | | | | | | |
| Basic and diluted weighted average shares outstanding | | 4,765,004 | | 45,657 | ||
| Loss per share - basic and diluted | | $(0.13) | | $(400.82) | ||
Note 4 – Discontinued Operations and Assets and Liabilities Held for Sale
The Company has initiated a plan to dispose of certain assets and liabilities of IMGX within 12 months of the date of the Merger with IMGX. These are classified as assets and liabilities held for sale and, due to the short period of time since the close of the Merger, are reported at their fair value less cost to sell. The Company determined that the discontinued operations of IMGX represents a strategic shift that will have a major effect on the Company’s operations and financial statements.
In March 2025, the Company announced that it entered into a rescission agreement (the “Rescission Agreement”), by and among the Company, IMGX and the former shareholders of IMGX (the “IMGX Shareholders”). Under the terms of the Rescission Agreement, the parties have amicably determined that it is in their collective best interest to: (i) rescind the issuances of the shares of Common Stock and Series G Preferred Stock that the Company has issued to the IMGX Shareholders as part of the Merger, (ii) convey to the IMGX Shareholders all of the issued and outstanding membership interests (the “Membership Interests”) of IMGX currently held by the Company, (iii) cancel the Assumed Options and Assumed Warrants, and (iv) provide for such additional agreements as are set forth in the Rescission Agreement. Also as set forth in the Rescission Agreement, following the closing, the Company will retain up to approximately $695,000 of IMGX’s accounts payable, and IMGX will remain responsible for approximately $9,278,400 of IMGX’s secured debt. On June 30, 2025, the Company and the IMGX Shareholders representative mutually agreed that the transactions contemplated by the Rescission Agreement may be consummated on or prior to September 30, 2025.The Company expects that the closing of the Rescission Agreement will occur on or prior to September 30, 2025, subject to satisfaction of all conditions for closing, including obtaining shareholder approval by the Company for the transfer of the Membership Interests to the IMGX Shareholders. After the transactions contemplated by the Rescission Agreement have been consummated, IMGX will no longer be a subsidiary of the Company, and the Company will no longer be holding any interest in IMGX. In July 2025, the Company announced the it entered into an amendment to the Rescission Agreement, by and among the Company, IMGX and the IMGX Shareholders (“Rescission Agreement Amendment”), whereby the parties to the Rescission Agreement Amendment agreed to add additional shareholder representations and warranties, including providing for an accredited investor representation by each of the IMGX Shareholders.
The following table summarizes the Company’s loss from discontinued operations for the six months ended June 30, 2025 and six months ended June 30, 2025.
| · · · · · · · · · · · · | ||||||||
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended · · Six Months Ended | ||||||||
| · · June 30, · · June 30, | ||||||||
| · 2025 · 2024 · 2025 · 2024 | ||||||||
| Operating expenses: · · · · | ||||||||
| Research and development expenses | | $— | | $802,470 | | $— | | $923,872 |
| General and administrative expenses | | — | | 70,012 | | — | | 75,216 |
| Total operating expenses | | — | | 872,482 | | — | | 999,088 |
| Interest expense | | (323,340) | | (298,480) | | (634,855) | | (364,682) |
| Other (expense) income | | — | | 48,729 | | — | | 48,729 |
| Loss from discontinued operations | | $(323,340) | | $(1,122,233) | | $(634,855) | | $(1,315,041) |
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The assets and liabilities associated with discontinued operations consist of the following as of June 30, 2025:
| | | | |
|---|---|---|---|
| Assets held for sale: · | |||
| Prepaid expenses and other current assets | | $3,131,929 | |
| Property and equipment, net | | 16,180 | |
| Goodwill and intangible assets | | 80,021,900 | |
| Total assets held for sale | | $83,170,009 | |
| Liabilities held for sale: | | ||
| Accounts payable | | $141,906 | |
| Accrued expenses and other current liabilities | | 3,128,151 | |
| Debt | | 6,403,737 | |
| Deferred tax liability | | | 13,872,684 |
| Total liabilities held for sale | | $23,546,478 | |
Total assets and liabilities classified as held for sale are presented as current assets and liabilities, respectively, as they are anticipated to be sold within 12 months.
Note 5 - Fair Value Disclosures
Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework that prioritizes and ranks the level of observability of inputs used in measuring fair value.
The fair value of the Company’s financial instruments are as follows:
| | | | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · · · · Fair Value Measured at Reporting Date · · · | |||||||||||||||
| · · · · · Using · · · | |||||||||||||||
| · · Carrying · · · · · · · · · · · · | |||||||||||||||
| | Amount | Level 1 | Level 2 | Level 3 | Fair Value | ||||||||||
| June 30, 2025 (unaudited): | | | | | | | | | | | | | | | |
| Money market funds | | $18 | | $18 | | $— | | $— | | $18 | |||||
| Note Payable | | $700,000 | | | — | | $700,000 | | | — | | $700,000 | |||
| | | | | | | | | | | | | | | | |
| December 31, 2024: | | | | | | | | | | | | | | | |
| Money market funds | | $12,723 | | $12,723 | | $— | | $— | | $12,723 | |||||
At June 30, 2025 and December 31, 2024, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP.
Note 6 –Goodwill
Goodwill is as follows:
| · · · | ||
|---|---|---|
| | Goodwill | |
| Balance on Dec 31, 2024 | | $1,684,182 |
| Balance on March 31, 2025 | | 1,684,182 |
| Goodwill associated with IMGX acquisition | | 18,354,326 |
| Goodwill reclassified as held for sale | | $(18,354,326) |
| Balance on June 30, 2025 (unaudited) | | $1,684,182 |
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Note 7 – Intangible Assets and In-Process R&D
Intangible assets consist of IPR&D, patents, tradenames and trademarks acquired from ImmunogenX. As of June 30, 2025, Intangible assets have been reclassified as held for sale. Intangible assets and IPR&D activity is as follows:
| | | | | | |
|---|---|---|---|---|---|
| · · Estimated · · June 30, | |||||
| · Useful Life · 2025 | |||||
| Patents | 2 years | | $140,000 | ||
| Trademarks and trade names | 6 years | | 230,000 | ||
| Less: accumulated amortization | | | | (31,598) | |
| Intangible assets, net | | | | 338,402 | |
| In-process R&D | | | | 63,000,000 | |
| Intangible assets and in-process R&D reclassified as held for sale | | | | | (63,338,402) |
| Total intangible assets and in-process R&D, net | | | | $— | |
Note 8 - Accrued Expenses
Accrued expenses consisted of the following:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · June 30, · · · | ||||||
| · 2025 · December 31, | ||||||
| · · (unaudited) · · 2024 | ||||||
| Professional fees | | | 103,530 | | | 186,173 |
| Consulting fees | | | 129,262 | | | 65,875 |
| Total accrued expenses | | $232,792 | | $252,048 | ||
Note 9– Capital Stock
Our certificate of incorporation, as amended and restated (the “Charter”) authorized the issuance of up to 100,000,000 shares of Common Stock, par value $0.0001 per share, and 10,000,000 shares of preferred stock, par value $0.0001 per share.
On December 18, 2023, the Company effected a reverse stock split, whereby every twenty shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
On January 18, 2023, the Company effected a reverse stock split, whereby every seven shares of the Company’s issued and outstanding common stock was converted automatically into one issued and outstanding share of common stock, but without any change in the number of authorized shares of common stock and the par value per share.
All share and per share amounts have been retroactively restated to reflect the reverse stock splits referenced above.
Common Stock
The Company had 4,765,729 and 4,754,038 shares of its Common Stock issued andoutstanding at June 30, 2025 and December 31, 2024, respectively.
Each holder of Common Stock is entitled to one vote for each share of Common Stock held on all matters submitted to a vote of the stockholders. The Company’s Charter and Amended and Restated Bylaws (the “Bylaws”) do not provide for cumulative voting rights.
In addition, the holders of the Company’s Common Stock will be entitled to receive ratably such dividends, if any, as may be declared by the Board out of legally available funds; however, the current policy of the Board is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of the Company’s Common Stock will be entitled to share ratably in all assets that are legally available for distribution.
Holders of the Company’s Common Stock have no preemptive, conversion or subscription rights, and there are no redemption or sinking fund provisions applicable to the Common Stock. The rights, preferences and privileges of the holders of Common Stock are subject to,
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and may be adversely affected by, the rights of the holders of shares of any series of the Company’s preferred stock that it may designate and issue in the future.
Preferred Stock
The Board is authorized to divide the preferred stock into any number of series, fix the designation and number of each such series, and determine or change the designation, relative rights, preferences, and limitations of any series of preferred stock. The Board of may increase or decrease the number of shares initially fixed for any series, but no decrease may reduce the number below the shares then outstanding and duly reserved for issuance.
On July 16, 2020, the Company designated approximately 5,194.81 shares as Series B Preferred Stock. As of June 30, 2025 and December 31, 2024,475.56 shares of Series B Preferred Stock were issued andoutstanding, respectively. Approximately 2,282.23 shares of Series B Preferred Stock remain authorized but undesignated and unissued.
On January 5, 2021, the Company designated 75,000 shares as Series C Preferred Stock. Shares of Series C Preferred Stock converted into Common Stock (or Prefunded Warrants, as applicable) or redeemed shall be canceled and shall not be reissued. As of June 30, 2025 and December 31, 2024,0 shares of Series C Preferred Stock were issued and outstanding, with approximately 41,903 shares of Series C Preferred Stock remaining authorized but unissued.
On July 15, 2022, the Company designated 150 shares as Series D Preferred Stock and had 0 shares of Series D Preferred Stock issued and outstanding on as of June 30, 2025 and December 31, 2024.
On July 15, 2022, the Company designated 150 shares as Series E Preferred Stock and had 0 shares of Series E Preferred Stock issued and outstanding on June 30, 2025 and December 31, 2024.
On November 28, 2022, the Company designated 7,000 shares as Series F Preferred Stock and had 0 shares of Series F Preferred Stock issued and outstanding on June 30, 2025 and December 31, 2024.
Most Favored Nations Exchange Right and Waiver Agreements
In the event the Company effects any issuance by the Company or any of its subsidiaries of Common Stock or Common Stock equivalents for cash consideration, or a combination of units thereof (a “Subsequent Financing”), each holder of the Series B Preferred Stock used to have the right, subject to certain exceptions set forth in the Series B Certificate of Designations, at its option, to exchange (in lieu of cash subscription payments) all or some of the Series B Preferred Stock then held (with a value per share of Series B Preferred Stock equal to the stated value of each share of Series B Preferred Stock, or $7,700.00, plus accrued and unpaid dividends thereon, of the Series B Preferred Stock (the “Exchange Amount”)) for any securities or units issued in a Subsequent Financing on dollar-for-dollar basis (the “Series B Exchange Right”). Effective May 12, 2022, the holders of 81.3% of the outstanding shares of the Series B Preferred Stock permanently waived for themselves and all other holders of the Series B Preferred Stock the Series B Exchange Right with respect to any Subsequent Financing occurring on or after January 1, 2022 (the “Permanent Waiver”). Holders of Series B Preferred Stock as of the April 27, 2022 record date were entitled to notice of and to consent to the Permanent Waiver.
As of December 31, 2024, (i) holders of approximately 1,839.76 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $14.4 million had previously elected to exercise their Series B Exchange Rights into Series C Preferred Stock, convertible into an aggregate of 395 shares of Common Stock (which conversion the Company has elected to make in full), and additional Investor Warrants exercisable for up to an aggregate of 395 shares of Common Stock, (ii) holders of approximately 169.57 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $1.6 million had previously elected to exercise their Series B Exchange Rights into 136 shares of Common Stock with no warrants, and (iii) holders of approximately 30.91 shares of Series B Preferred Stock with an aggregate Exchange Amount of approximately $265,000 had previously elected to exercise their Series B Exchange Rights into 44 shares of Common Stock, and additional Series C Warrants exercisable for up to an aggregate of 44 shares of Common Stock.
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Mezzanine Equity
Series G Preferred Stock
The Company had 12,373.226 and 0 shares of Series G stock issued and outstanding on June 30, 2025 and December 31, 2024, respectively.
On March 13, 2024, the Company issued 12,373.226 shares of Series G Preferred stock in connection with the IMGX Merger. The following is a summary of the principal terms of the Series G Preferred Stock as set forth in the Certificate of Designation of the Series G Preferred Stock:
General; Transferability. Share of Series G Preferred Stock will be uncertificated and issued in book-entry form. Shares of Series G Preferred Stock may be transferred by the holders thereof without the consent of the Company, provided that such transfer is in compliance with applicable securities laws.
Conversion. Following stockholder approval of the conversion of the Series G Preferred Stock into Common Stock in accordance with the listing rules of the Nasdaq Stock Market (the “Conversion”), each share of Series G Preferred Stock will automatically convert into 1,000 shares of Common Stock, subject to certain limitations, including that a holder of Series G Preferred Stock is prohibited from converting shares of Series G Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
The Series G Preferred Stock is redeemable for cash at the option of the holder thereof at any time following the date that is six months after the initial issuance of the Series G Preferred Stock (without regard to the lack of obtaining the requisite stockholder approval to convert the Series G Preferred Stock into Common Stock), at a price per share equal to the then-current fair value of the Series G Preferred Stock, which shall be the last reported closing sale price of the Company’s Common Stock as reported on the Nasdaq Stock Market as of the trading day immediately prior to the conversion event. As such, Series G Preferred Stock is classified as Mezzanine Equity on the balance sheet.
Voting Rights. Except as otherwise required by law, the Series G Preferred Stock does not have voting rights. However, as long as any shares of Series G Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series G Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series G Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series G Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series G Preferred Stock, (iii) prior to the earlier of stockholder approval of the Conversion or the six-month anniversary of issuance, consummate either: (A) any Fundamental Transaction (as in the Certificate of Designation) or (B) any stock sale to, or any merger, consolidation or other business combination of the Company with or into, another entity in which the stockholders of the Company immediately before such transaction do not hold at least a majority of the capital stock of the Company immediately after such transaction, or (iv) enter into any agreement with respect to any of the foregoing.
Liquidation Preference. The Series G Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.
Dividend Rights. Holders of Series G Preferred Stock are entitled to receive dividends on shares of Series G Preferred Stock equal to, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock.
Redemption. The shares of Series G Preferred Stock shall not be redeemable at the option of the Company or the holder thereof.
Trading Market. There is no established trading market for any of the Series G Preferred Stock, and we do not expect a market to develop. We do not intend to apply for a listing for any of the Series G Preferred Stock on any securities exchange or other nationally recognized trading system. Without an active trading market, the liquidity of the Series G Preferred Stock will be limited.
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At The Market Agreement with H.C. Wainwright
On May 26, 2021, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), as sales agent, pursuant to which the Company may issue and sell, from time to time, through Wainwright, shares of its Common Stock, and pursuant to which Wainwright may sell its Common Stock by any method permitted by law deemed to be an “at the market offering” as defined by Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended. The Company will pay Wainwright a commission of 3.0% of the aggregate gross proceeds from each sale of Common Stock. As of May 24, 2022, the Company was authorized to offer and sell up to $8.0 million of its Common Stock pursuant to the ATM Agreement. The Company did not utilize the ATM Agreement during the six months ended June 30, 2025 or the year ended December 31, 2024.
July 2024 Inducement Offering
On July 10, 2024, the Company entered into a warrant exercise inducement offer letter (the “Inducement Letter”) with a holder (the “Holder”) of warrants to purchase shares of the Company’s common stock (the “Existing Warrants”) pursuant to which the Holder agreed to exercise for cash their Existing Warrants to purchase 1,762,674 shares of the Company’s common stock (the “Existing Warrant Shares”), in the aggregate, at a reduced exercised price of $1.09 per share, in exchange for the Company’s agreement to issue new warrants (the “Inducement Warrants”) on substantially the same terms as the Existing Warrants as described below, to purchase up to 3,525,348 shares of the Company’s common stock (the “Inducement Warrant Shares”). The Inducement Warrants will be exercisable upon the receipt of stockholder approval and may be exercised until the fifth anniversary of the date on which such stockholder approval is obtained. The Company received aggregate gross proceeds of approximately $1.9 million from the exercise of the Existing Warrants by the Holder and the sale of the Inducement Warrants. The Company engaged Roth Capital Partners, LLC (“Roth”) to act as its financial advisor in connection with the transactions summarized above and paid Roth approximately $0.1 million for its services, in addition to reimbursement for certain expenses.
May 2024 Registered Direct Offering
On May 14, 2024, the Company completed a Registered Direct Offering (the “May 2024 Offering”) priced at market under Nasdaq rules, for an aggregate of (i)275,000 shares of Common Stock, (ii) pre-funded warrants (the “May 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 91,000 shares of Common Stock and (iii) common warrants (the “May 2024 Warrants”) to purchase up to an aggregate of 732,000 shares of Common Stock. The public offering price for each share of Common Stock and accompanying May 2024 Warrant to purchaseone share of Common Stock was $2.95 per share. The May 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The May 2024 Warrants have an exercise price of $2.70 per share, are exercisable immediately and will expiresix years from the initial exercise date.
The Company received gross proceeds of approximately $1.1 million less placement agent’s fees and other offering expenses of approximately $0.2 million.
March 2024 Registered Direct Offering
On March 6, 2024, the Company completed a Registered Direct Offering (the “March 2024 Offering”) priced at market under Nasdaq rules, for an aggregate of (i)173,100 shares of Common Stock, (ii) pre-funded warrants (the “March 2024 Pre-Funded Warrants”) to purchase up to an aggregate of 352,525 shares of Common Stock and (iii) common warrants (the “March 2024 Warrants”) to purchase up to an aggregate of 525,625 shares of Common Stock. The public offering price for each share of Common Stock and accompanying March 2024 Warrant to purchaseone share of Common Stock was $7.61 per share. The March 2024 Pre-Funded Warrants have an exercise price of $0.0001 per share, are exercisable immediately and will expire when exercised in full. The March 2024 Warrants have an exercise price of $7.48 per share, are exercisable immediately and will expire five years from the initial exercise date. The Company received gross proceeds of approximately $4.0 million less placement agent’s fees and other offering expenses of approximately $0.4 million.
Common Stock Issuances
Issuances for the Three Months Ended June 30, 2025
There wereno issuances of common stock during the three months ended June 30, 2025
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Issuances for the Six Months Ended June 30, 2025
During the six months ended June 30, 2025, the Company issued an aggregate of 11,691 shares of Common Stock upon the vesting of RSUs (See Note 11).
Issuances for the Three Months Ended June 30, 2024
During the three months ended June 30, 2024, the Company issued 275,000 shares of Common Stock under the May 2024 Offering for which the Company received net proceeds of approximately $0.9 million.
During the three months ended June 30, 2024, the Company issued an aggregate of 360,000 shares of Common Stock upon the exercise of pre-funded warrants issued at a par value of $0.0001 (See Note 11).
During the three months ended June 30, 2024, the Company issued an aggregate of 18 shares of Common Stock upon the exchange of an aggregate of 20 shares of Series B Preferred Stock with a stated value of approximately $156,251 plus accrued dividends of approximately $47,659.
During the three months ended June 30, 2024, the Company issued an aggregate of 250,000 shares of its Common Stock to consultants with a grant date fair value of approximately $760,995 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.
During the three months ended June 30, 2024, the Company issued an aggregate of 30,882 shares of Common Stock upon the vesting of RSUs (See Note 11).
Issuances for the Six Months Ended June 30, 2024
During the six months ended June 30, 2024, the Company issued 173,100 and 275,000 shares of Common Stock under the March 2024 Offering and May 2024 Offering, respectively, for which the Company received net proceeds of approximately $4.5 million.
During the six months ended June 30, 2024, the Company issued an aggregate of 36,830 shares of Common Stock with a value of $2.3 million in connection with the IMGX acquisition.
During the six months ended June 30, 2024, the Company issued an aggregate of 18,475 shares of Common Stock with a value of $0.1 million to its financial advisors in connection with the IMGX acquisition.
During the six months ended June 30, 2024, the Company issued an aggregate of 443,525 shares of Common Stock upon the exercise of pre-funded warrants issued at a par value of $0.0001 (See Note 11).
During the six months ended June 30, 2024, the Company issued an aggregate of 27 shares of Common Stock upon the exchange of an aggregate of 30 shares of Series B Preferred Stock with a stated value of approximately $234,376 plus accrued dividends of approximately $70,429.
During the six months ended June 30, 2024, the Company issued an aggregate of 350,000 shares of its Common Stock to consultants with a grant date fair value of approximately $1,541,995 for investor relations services provided, which was recorded as stock-based compensation and included as part of general and administrative expense.
During the six months ended June 30, 2024, the Company issued an aggregate of 83,153 shares of Common Stock upon the vesting of RSUs (See Note 11).
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Note 10– Warrants
Warrant activity for the six months ended June 30, 2025 and June 30, 2024 was as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · · · Weighted · · Weighted | |||||||
| · · · · Average · · Average | |||||||
| · · Number of · · Exercise Price · · Remaining | |||||||
| · Warrants · Per Share · Term in Years | |||||||
| Warrants outstanding and exercisable on January 1, 2025 | 4,927,714 | | $6.98 | | 4.71 | ||
| Issued during the period | — | | | — | | — | |
| Expired during the period | | (23) | | | 50,107.83 | | — |
| Exercised during the period | — | | | — | | — | |
| Warrants outstanding and exercisable on June 30, 2025 | 4,927,691 | | $6.75 | | 4.21 | ||
| | | | | | | | |
| Warrants outstanding and exercisable on January 1, 2024 | 1,779,780 | | $19.29 | | 4.99 | ||
| Issued during the period | 1,701,150 | | | 3.47 | | 5.26 | |
| Assumed from IMGX | 127,680 | | | 3.48 | | 8.72 | |
| Exercised during the period | (443,525) | | | — | | 4.93 | |
| Warrants outstanding and exercisable on June 30, 2024 | 3,165,085 | | $12.85 | | 5.01 | ||
As of June 30, 2025, the outstanding warrants expire from 2025 through 2033.
Note 11 – Equity Incentive Plan
The Company’s Board and stockholders adopted and approved the Amended and Restated 2014 Omnibus Equity Incentive Plan (the “2014 Plan”), which took effect on May 12, 2014. The Company’s Board and stockholders adopted and approved the 2020 Omnibus Equity Incentive Plan (the “2020 Plan”), which took effect on September 11, 2020. From the adoption and approval of the 2020 Plan, no new awards have been or will be made under the 2014 Plan.
The 2020 Plan allows for the issuance of securities, including stock options to employees, Board members and consultants. The initial number of shares of Common Stock available for issuance under the 2020 Plan was 238 shares, which will, on January 1 of each calendar year, unless the Board decides otherwise, automatically increase to equal ten percent (10)% of the total number of shares of Common Stock outstanding on December 31 of the immediately preceding calendar year, calculated on an As Converted Basis. As Converted Shares include all outstanding shares of Common Stock and all shares of Common Stock issuable upon the conversion of outstanding preferred stock, warrants and other convertible securities, but will not include any shares of Common Stock issuable upon the exercise of options and other convertible securities issued pursuant to either the 2014 Plan, the 2020 Plan, or the IMGX Plan. The number of shares permitted to be issued as “incentive stock options” (“ISOs”) is 357 under the 2020 Plan.
On March 13, 2024, in connection with the IMGX acquisition, the Company assumed the IMGX Plan, including all 200,652 IMGX stock options immediately outstanding prior to the IMGX acquisition, with each becoming an option to purchase Common Stock, subject to adjustment. Such stock options were the only awards that had been made under the IMGX Plan as of the closing of the IMGX acquisition. The IMGX Plan was adopted and approved by the board of directors and stockholders of IMGX in 2021. Following the assumption of the IMGX Plan by the Company, no new awards have been or will be made under the IMGX Plan.
As of June 30, 2025, there were an aggregate of 73 total shares available (but un-issuable) under the 2014 Plan, of which 9 are issued and outstanding, and 4 shares are reserved subject to issuance of restricted stock and RSUs.
As of June 30, 2025,969,356 total shares were authorized under the 2020 Plan, of which 150,823 were issued and outstanding and 818,533 shares were available for potential issuances.
As of January 1, 2025, the number of shares of Common Stock available for issuance under the 2020 Plan automatically increased to 969,356 under the 2020 Plan’s evergreen provision.
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During the six months ended June 30, 2025 and 2024, stock option activity under the 2014 Plan, 2020 Plan, and IMGX 2021 Plan was as follows:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Average · · Remaining · · · | ||||||||||
| · · Number · · Exercise · · Contract · · Intrinsic | ||||||||||
| · of Shares · Price · Life (Years) · Value | ||||||||||
| Outstanding at January 1, 2025 | 89,849 | | $2,727.22 | | 7.06 | | $— | |||
| Expired | | (81,581) | | $75.69 | | — | | | — | |
| Assumed from IMGX | — | | | — | | — | | | — | |
| Outstanding at June 30, 2025 | 8,268 | | $13,041.72 | | 6.29 | | $— | |||
| Exercisable at June 30, 2025 | 8,268 | | $13,041.72 | | 6.29 | | $— | |||
| | | | | | | | | | | |
| | | | | Average | | Remaining | | | | |
| | | Number | | Exercise | | Contract | | Intrinsic | ||
| | of Shares | Price | Life (Years) | Value | ||||||
| Outstanding at January 1, 2024 | 426 | | $6,103.81 | | 8.53 | | $— | |||
| Expired | | (1) | | | — | | — | | | — |
| Assumed from ImmunogenX | 200,652 | | | 0.81 | | 7.31 | | | 84,274 | |
| Outstanding at June 30, 2024 | 201,077 | | $13.37 | | 7.31 | | $84,274 | |||
| Exercisable at June 30, 2024 | 201,053 | | $11.62 | | 7.31 | | $84,278 | |||
There wereno grant of options during the six months ended June 30, 2025 by the Company. During the six months ended June 30, 2024, the Company assumed fully vested options to purchase 200,652 shares of the Company’s Common Stock issued under the IMGX 2021 Plan.
For the six months ended June 30, 2025 and 2024, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions:
| · · · · · | ||||
|---|---|---|---|---|
| · 2025 · 2024 | ||||
| Contractual term (in years) | — | | 7.6 | |
| Expected Volatility | —% | 110.35% | ||
| Risk-free interest rate | —% | 4.20% | ||
| Expected Dividend yield | —% | 0% | ||
Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock assumed during the three months ended June 30, 2024 was $6.32.
Restricted Stock and Restricted Stock Units
Restricted stock refers to shares of Common Stock subject to vesting based on certain service, performance, and market conditions. Restricted stock units (“RSUs”) refer to an award which constitutes a promise to grant shares of Common Stock at the end of a specified restriction period.
As of each June 30, 2025 and June 30, 2024, under the 2014 Plan, the Company had 5 shares of restricted stock outstanding and an aggregate unrecognized restricted Common Stock expense of approximately $269,500, which will be recognized when vesting of certain milestones become probable.
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During the six months ended June 30, 2025 and 2024, RSU activity under the 2020 Plan was as follows:
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| · · · Weighted-Average · Weighted-Average | |||||||
| · · Number · · Grant Date · · Remaining Recognition | |||||||
| · of Shares · Fair Value · Period (Years) | |||||||
| Non-vested Outstanding at January 1, 2025 | | 5,000 | | $3.96 | | 2.24 | |
| Awarded | — | | | — | | — | |
| Vested | | — | | | — | | — |
| Cancelled | (5,000) | | 3.96 | — | |||
| Non-vested Outstanding at June 30, 2025 | — | | $— | — | |||
| | | | | | | | |
| Non-vested Outstanding at January 1, 2024 | | 52,271 | | $4.31 | | 9.96 | |
| Awarded | | 150,421 | | | 3.57 | | — |
| Vested | | (83,153) | | | 4.13 | | — |
| Non-vested Outstanding at June 30, 2024 | | 119,539 | | $3.50 | | 0.65 | |
During the six months ended June 30, 2025 and June 30, 2024, the Board approved the grant of 0 and 150,421 RSUs, respectively. All grants of RSUs were pursuant to the 2020 Plan and vest quarterly over aone-year period.
Stock - based Compensation Expense
The total stock-based compensation expense for employees and non-employees is included in the accompanying condensed consolidated statements of operations and as follows:
| · · · · · · · · · · · · | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended June 30, · · Six Months Ended June 30, | |||||||||||
| · 2025 · 2024 · 2025 · 2024 | |||||||||||
| Research and development | | $— | | $2,622 | | $— | | $37,694 | |||
| General and administrative | | — | | | 123,772 | | | — | | | 352,755 |
| Total stock-based compensation expense | | $— | | $126,394 | | $— | | $390,449 | |||
As of June 30, 2024, the Company had $0.4 million in unrecognized stock-based compensation expense. The Company will recognize the expense related to these milestones when the milestones become probable. Stock-based compensation related to IMGX for the three and six months ended June 30, 2024 of approximately $13,000 and $5,000,respectively, is included in discontinued operations on the statement of operations. There wasnone for 2025.
Note 12 – Agreements
License Agreement with Sanofi
On September 13, 2023, the Company entered into a License Agreement with Sanofi, pursuant to which the Company received a license to obtain certain exclusive worldwide rights to develop and commercialize Capeserod, a selective 5-HT4 receptor partial agonist which the Company intended to repurpose and develop for gastrointestinal indications.
The Company paid Sanofi an upfront payment of $500,000 in October 2023 and Sanofi was eligible to receive up to $46.0 million in potential development and regulatory milestone payments and up to $235.0 million in potential commercial milestone payments. Sanofi was also eligible to receive mid-to-high single-digit royalties on net sales, as well as a percentage of sublicense and transfer revenues with respect to Capeserod. Sanofi also had a right of first refusal with respect to Capeserod out-licensing transactions.
The upfront payment of $500,000 was recorded as research and development expense in the year ended December 31, 2023. Depending on the status of development at the time a contingent payment is recognized, the Company may determine that the payment should be expensed as research and development or be capitalized as an intangible asset. This determination will be based on the facts and circumstances that exist at the time a contingent payment is recognized.
The License Agreement was to expire on a country-by-country basis upon the later of: (i) the expiration of the last to expire valid claim of an applicable patent in such country covering such licensed product, (ii) the expiration of the regulatory exclusivity for such licensed product in the applicable country and (iii) the tenth anniversary of the date of first commercial sale of a licensed product in such country.
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Each party may terminate the License Agreement if the other party materially breaches its obligations under the License Agreement and fails to cure such material breach within 60 days from the date of such notice of breach, except in the case of payment breach, as to which the breaching party will have only aten-day cure period. Sanofi may terminate the License Agreement upon any bankruptcy proceedings by the Company. The Company may terminate the License Agreement by providing Sanofi with at least 60 days prior written notice; provided, however, that Sanofi shall be entitled to any and all payments due and owed to Sanofi prior to the effective date of termination. On February 26, 2025, the Company provided notice to Sanofi to terminate the License Agreement. No payments are due to Sanofi and the Company terminated it’s agreement effective in February 2025.
Note 13 – Leases
On March 20, 2025, the Company received notice that it’s lease for the office space of 3,472 square feet in Boca Raton, Florida that was used for its corporate headquarters with a term through August 31, 2026, was in default. The Company no longer has rights to the premises. Lease expenses amounted to approximately $35,000 for the six months ended June 30, 2025.
The weighted-average remaining lease term and weighted-average discount rate under operating leases are:
| · · · · · | |||
|---|---|---|---|
| · · June 30, · · June 30, | |||
| · 2025 · 2024 | |||
| Lease term and discount rate · · · · · | |||
| Weighted-average remaining lease term (years) | 1.2 | 2.2 | |
| Weighted-average discount rate | 7.00% | 7.00% | |
As a result of the default, the Company fully impaired the related the Right-of-Use (ROU) asset. The carrying amounts of lease liability, which was moved to current as of June 30, 2025 were as follows:
| · · · | |
|---|---|
| Lease Liability | $135,609 |
The impairment of the right of use asset was $108,759, which is included in the income statement under “Other Expenses.” Additionally, an accrual of $100,902 has been made to cover outstanding payments and penalties.
The default was accounted for in accordance with ASC 842, resulting in the following impact on the financial statements:
| · · · | ||
|---|---|---|
| Impairment of ROU Asset | $108,759 | |
| Increase in general and administrative expenses | | $100,902 |
Note 14 – Debt
Debt consists of the following:
| | | | |
|---|---|---|---|
| | | ||
| · · | |||
| · · Revolving | |||
| · · line of credit | |||
| Principal balance as of January 1, 2025 | | $— | |
| Additions | | | 700,000 |
| Payments | | — | |
| Debt discount | | — | |
| Reclassification to liabilities held for sale | | | — |
| Total debt as of June 30, 2025 | | $700,000 | |
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Revolving line of credit
Effective January 31, 2025, we entered into a Revolving Loan Agreement dated January 27, 2025 (the “Revolving Loan Agreement”), with a Lender pursuant to which the Lender agreed to make loans to us. Pursuant to and under the terms of the Revolving Loan Agreement, we issued to the Lender a revolving note dated January 27, 2025 in the principal amount of $2,000,000 (the “Revolving Note” and such amount, the “Total Outstanding Amount”). This transaction is referred to as the “Financing”. We shall use the proceeds from the Financing for general corporate purposes, including but not limited to finance the expense of a Qualified Public Equity Offering (as defined below) and payment of certain items. Out of the Total Outstanding Amount, the Lender disbursed a loan amount of $700,000. The Revolving Note bears interest at the rate of 18% per annum interest accumulated as of June 30, 2025 was approximately $48,000.
In connection with the IMGX acquisition, the Company assumed a revolving line of credit. In October 2022, ImmunogenX entered into a credit agreement, which allowed for a revolving line of credit (the “Revolver”) for borrowings up to $6.0 million, initially maturing on October 1, 2024, and bearing interest per annum of theprime rate plus 4.5%. The credit agreement was amended in September 2023 (the “First Amendment”) to increase the maximum borrowings of the Revolver to $7.5 million. The credit agreement was amended and restated on March 13, 2024 (the “Second Amendment”). Terms under the Second Amendment include an extended maturity date of September 13, 2025, interest per annum of theprime rate plus 6.0%, and no further draws on the line of credit after March 13, 2024. As of June 30, 2025, the Revolver and accrued interest has been reclassified to liabilities of disposal group held for sale (see Note 4).
Promissory notes
In connection with the IMGX acquisition, the Company assumedtwo promissory notes, one of which is with a related party. The notes are each in the amount of $0.5 million, accrue interest at a rate of theprime rate plus 4.5% per annum, and have a maturity date of September 30, 2025. As of June 30, 2025, the promissory notes and all accrued interest has been reclassified to liabilities of disposal group held for sale.
EIDL** **loan
In connection with the IMGX acquisition, the Company assumed an Economic Injury Disaster Loan (“EIDL”) loan with a principal balance of $0.5 million bearing interest of 3.75% per annum, with interest payable monthly in arrears. The Company determined the loan has a fair value as of the assumption date of March 13, 2024 of $38,000, resulting in a discount of $462,000 which is amortized over the remaining life of the loan. All unpaid principal and interest are due at maturity on June 30, 2050. As of June 30, 2025, the EIDL loan and all accrued interest has been reclassified to liabilities of disposal group held for sale.
Directors and Officer**’**s Liability Insurance
On February 5, 2025, the Company entered into 10-month financing agreements for its directors and officer’s liability insurance, as well as other corporate insurances, in the amount of approximately $0.1 million that bears interest at an annual rate of 10.75%. Monthly payments going forward, including principal and interest, are approximately $15,000 per month. The balance due under these financing agreements was $0.1 million at June 30, 2025 and $0 at December 31, 2024.
Note 15 – Net (Loss) Income per Common Share
Basic net loss per share is computed by dividing net loss available to Common Stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share reflect, in periods in which they have a dilutive effect, the impact of common shares issuable upon exercise of stock options and warrants and conversion of convertible debt that are not deemed to be anti-dilutive.
For the six months ended June 30, 2025 stock options in the amount of 8,268 and warrants in the amount of 4,927,691 were excluded from the calculation of diluted net loss per share as they did not have a dilutive effect.
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All shares of Common Stock that may potentially be issued in the future are as follows:
| | | | | |
|---|---|---|---|---|
| | | June 30, 2025 | | June 30, 2024 |
| · (unaudited) · (unaudited) | ||||
| Series G convertible preferred stock | | 12,373,226 | | 12,373,226 |
| Common stock warrants | 4,927,691 | | 3,165,085 | |
| Stock options | 8,268 | | 201,077 | |
| RSUs not yet issued | | 1 | | 119,539 |
| Series B convertible preferred stock (1) | 138 | | 135 | |
| Restricted stock not yet issued | 4 | | 4 | |
| Total shares of common stock issuable | 17,309,328 | | 15,859,066 | |
| (1) | Series B convertible preferred stock is assumed to be converted at the rate of $32,340 per common share, which is the conversion price as of June 30, 2025. |
Note 16 - Employee Benefit Plans
401(k) Plan
Since 2015, the Company has sponsored a multiple employer defined contribution benefit plan, which complies with Section 401(k) of the Internal Revenue Code covering substantially all employees of the Company. All employees are eligible to participate in the plan. Employees may contribute from 1% to 100% of their compensation and the Company matches an amount equal to 100% on the first 6% of the employee contribution and may also make discretionary profit-sharing contributions.
Employer contributions under this 401(k) plan amounted to approximately $1,000 and $30,000 for the six months ended June 30, 2025 and 2024, respectively, and approximately $95,000 for year ended December 31, 2024.
Note 17 - Income Taxes
The Company files income tax returns in the U.S. federal jurisdiction and various state jurisdictions. Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Where applicable, the Company records a valuation allowance to reduce any deferred tax assets that it determines will not be realizable in the future.
The Company recognizes the benefit of an uncertain tax position that it has taken or expects to take on income tax returns it files if such tax position is more likely than not to be sustained on examination by the taxing authorities, based on the technical merits of the position. These tax benefits are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate resolution. Although the Company believes that it has adequately reserved for uncertain tax positions (including interest and penalties), it can provide no assurance that the final tax outcome of these matters will not be materially different. The Company makes adjustments to these reserves in accordance with the income tax accounting guidance when facts and circumstances change, such as the closing of a tax audit or the refinement of an estimate. To the extent that the final tax outcome of these matters is different than the amounts recorded, such differences will affect the provision for income taxes in the period in which such determination is made and could have a material impact on the Company’s financial condition and operating results. Carryforward attributes that were generated in tax years prior to those that remain open for examination may still be adjusted by relevant tax authorities upon examination if they either have been, or will be, used in a future period.
In applying the estimated annual effective tax rate approach prescribed under ASC 740 - 270 and based on present evidence and conclusions around the realizability of deferred tax assets, the Company determined that any deferred tax benefits related to the forecasted tax rate and pretax activity during the first quarter of 2025 and 2024 are neither more likely than not to be realized in the current year nor realizable as a deferred tax asset at the end of the year. Therefore, the appropriate amount of income tax benefit to recognize related to deferred tax assets generated during the three months ended June 30, 2025 and 2024 iszero.
The Company’s effective income tax rate was approximately 0% and 160% for the six months ended June 30, 2025 and 2024, respectively. The income tax provision for interim periods is determined using an estimate of the annual effective tax rate adjusted for
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discrete items. The Company’s effective tax rate for the six months ended June 30, 2025 differs from the applicable statutory tax rate primarily due to the valuation allowance recorded against its deferred tax assets. The Company’s effective tax rate for the six months ended June 30, 2024 differs from the applicable statutory tax rate primarily due to the impact of the accounting for the IMGX Merger during the period, which resulted in the release of a portion of the valuation allowance that had previously been recorded against the deferred tax assets of the Company.
Note 18 - Contingencies
On December 31, 2024, Mattress Liquidators, Inc. filed a Complaint in the District Court, Boulder County, State of Colorado against Defendants IMGX, Jack A. Syage and Elizabeth T. Syage Revocable Trust, Case No. 2024CV31070.
Succinctly, Plaintiff complains that it entered into a Credit Agreement on October 3, 2022 with IMGX for a loan in the principal amount of $6,000,000. Jack Syage and Elizabeth T. Syage Revocable Trust executed a Guaranty of Payment that same day. The Credit Agreement was modified on September 6, 2023, which increased the principal amount of the loan to $7,500,000. Once more, on March 13, 2024, the Credit Agreement was modified to increase the principal amount of the loan to $8,212,345.17. Plaintiff alleges that in the summer of 2024, Defendants were not repaying the loan so on August 2, 2024, a Notice of Default was sent, which demanded immediately payment of the entire balance. After being provided with additional information, on August 29, 2024, Plaintiff suspended the Notice of Default and demanded Defendants provide certain financial reporting information under Section 7.5 of the Credit Agreement. On October 11, 2024, November 7, 2024, and November 14, 2024, Plaintiff sent Defendants letters of non-compliance regarding their financial reporting obligations. Thereafter, on November 21, 2024, Plaintiff sent Defendants a Notice of Default and Demand for Payment, which accelerated the Loan obligations, demanded that Defendants cure the financial reporting defaults, and demanded that Defendants pay all loan obligations no later than December 5, 2024.
Plaintiff claims that as of December 31, 2024, the total amount due and owing is $7,575,568.91, which consists of $7,460,245.47 in principal, $115,323.44 in accrued contract interest, and $47,069 in authorized attorneys’ fees and costs. Plaintiff asserts three causes of action. The first is against IMGX for alleged breach of the Credit Agreement. The other two causes of action asserted are alleged breaches of the Guaranty’s by Jack Syage, and the Elizabeth T. Syage Revocable Trust.
After receiving an extension, IMGX timely filed its Answer on February 28, 2025. The case is now at issue. A required meet and confer with counsel to discuss drafting the (proposed) case management order and to discuss procedural matters was held on March 14, 2025. Our Initial Disclosures are due on April 4, 2025.
Under the terms of the Rescission Agreement entered into in March 2025, by and among the Company, IIMGX, and each of the individuals or entities who are the former shareholders of IMGX, upon consummation of the transactions contemplated in Recission Agreement, the Company shall have no further duties, liabilities or obligations in connection with this complaint.
On May 8, 2025 the Company’s subsidiary ImmunogenX, LLC entered into a settlement agreement effective April 9, 2025 with Mattress Liquidators Inc. (the “Plaintiff”), Jack A. Syage and The Jack A. Syage and Elizabeth T. Syage Revocable Trust (the “Trust”, and Trust collectively with Jack, the “Guarantors”) (such agreement, the “Settlement Agreement”). Under the Settlement Agreement, the Guarantors agreed to pay the Plaintiff (a) $5,500,000.00 to be applied to the obligations amounting to approximately $7.9 million owed to the Plaintiff (which amount was paid to the Plaintiff on April 9, 2025) with the Guarantors being solely responsible for payment of all obligations due to be paid to the Plaintiff. In addition, ImmunogenX, LLC agreed to pay all of Plaintiff’s attorneys’ fees and costs incurred to date amounting to approximately $62,000.
The parties to the Settlement Agreement also agreed to enter into amended and restated loan documents dated April 9, 2025 which provide for, among others, a revolving loan of $2,436,338.30 (the “Commitment”) to ImmunogenX, LLC, to be repaid and the principal amount thereof reborrowed before the earliest of: (i) April 9, 2028; (ii) the date ImmunogenX, LLC prepays the revolving loan in full in accordance with amended and restated credit agreement; or (iii) the date on which the Commitment is terminated in whole pursuant to amended and restated credit agreement. Under amended and restated guarantees, the Guarantors unconditionally guaranteed the prompt payment of all monies owed by ImmunogenX, LLC to Plaintiff under the terms and conditions as stated herein. Under the Settlement Agreement, the Plaintiff agreed to release its security interest in ImmunogenX, LLC, and the parties agreed to execute a Stipulation of Dismissal with Prejudice to be filed in the action before the District Court, Boulder County, State of Colorado.
On July 15, 2025, the Company, ImmunogenX, LLC (“Immuno LLC”) and each of the individuals or entities (each a “Shareholder” and collectively, the “Shareholders”) who are the former shareholders of ImmunogenX, Inc., entered into an Amendment to the Rescission Agreement (“Rescission Agreement Amendment”), originally entered into by the parties on March 25, 2025, whereby the parties agreed
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to add additional shareholder representations and warranties, including providing for an accredited investor representation by each Shareholder.
On March 17, 2025, Ellenoff Grossman & Schole LLP (“EGS”) initiated an action against the Company by filing a summons and complaint in the Supreme Court of the State of New York, New York County. The complaint alleges that the Company owes to EGS $749,301.00 in fees for legal services EGS allegedly provided to the Company between September 2023 to January 2025, a period of time prior to the appointment of certain new directors to the Board and of Mr. Paolone as Interim Chief Executive Officer. EGS’s lawsuit alleges breach of contract, account stated, and quantum meruit claims. The Company is in the process of investigating the allegations of the complaint and plans to defend the action. On July 28, 2025, the parties filed a Stipulation Extending the Company's Time to Answer, Move, or Otherwise Respond to the Complaint until September 30, 2025.
Note 19 - Subsequent Events
On July 2, 2025, the Company received written notice from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, as a result of actions taken at the Company’s annual meeting of stockholders held on June 30, 2025, the Company had regained compliance with Nasdaq Listing Rule 5620(a), which requires that a listed company hold an annual meeting of stockholders within twelve months of the end of its fiscal year.
On June 30, 2025, the Company received a separate written notice from Nasdaq granting the Company an extension until October 8, 2025 to regain compliance with the minimum stockholders’ equity requirement set forth in Nasdaq Listing Rule 5550(b)(1).
On August 9, 2025, the Company entered into a Securities Purchase Agreement with certain institutional investors pursuant to which the Company agreed to issue and sell pre-funded warrants to purchase shares of common stock and common warrants to purchase shares of common stock, for aggregate gross proceeds of approximately $3.0 million. The agreement provided for $1.0 million in proceeds at closing and an additional $2.0 million upon the satisfaction of certain conditions, including the effectiveness of a resale registration statement covering the securities issued in the offering.
In connection with the August 9, 2025 transaction, on August 11, 2025, the Board of Directors appointed Geordan G. Pursglove and Jason D. Sawyer as directors of the Company. Each of Messrs. Pursglove and Sawyer will receive cash compensation of $2,500 per month for their service on the Board.
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The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.