Aditxt Inc. (NASDAQ:ADTX) shares surged 52.11% in after-hours trading to $2.16 on Tuesday following the company’s filing of a definitive proxy statement for a special stockholder virtual meeting scheduled for Jan. 30, 2026.Check out the current price of ADTX stock here.Multiple Shareholder ProposalsThe proxy statement outlines several critical proposals requiring shareholder approval. According to the Securities and Exchange Commission filing dated Tuesday, stockholders of record as of Dec. 5 will vote on N ...

Clinical Development - Adimune has completed all preclinical studies for ADI-100, demonstrating potential effectiveness in restoring durable tolerance over a 10-month duration in type 1 diabetes studies [216]. - The clinical-grade drug substances for ADI-100 are being prepared for shipment to a contract manufacturer for formulation into the final drug product, pending regulatory submissions [217]. - Adimune plans to initiate human trials for Stiff Person Syndrome in 2026, with an expected enrollment of 10-20 patients, some of whom may also have type 1 diabetes [220]. - The company has engaged with a Contract Research Organization to manage clinical study processes for psoriasis and type 1 diabetes in Germany [220]. - The exclusive license agreement with Loma Linda University allows the company to commercialize ADI nucleic acid-based technology, which is currently at the pre-clinical stage [222]. Cancer Detection and Biomarkers - Pearsanta acquired assets from MDNA Life Sciences Inc. on January 4, 2024, including the Mitomic Technology platform, to develop mitochondrial DNA-based biomarkers for early cancer detection [229]. - Pearsanta is developing two product candidates for cancer screening, targeting prostate cancer and endometriosis, and is pursuing biomarker identification for several other cancers [230]. - The Mitomic Technology platform aims to detect mutations in mitochondrial DNA, potentially allowing for early disease detection before clinical presentation [239]. - The Mitomic® Prostate Test (MPT™) is being developed to quantify the 3.4kb mitochondrial DNA deletion, potentially aiding in the identification of clinically significant prostate cancer in men with PSA levels below 10 ng/ml [242]. - The Mitomic Endometriosis Test (MET™) aims to quantify mitochondrial DNA deletions associated with endometriosis, a condition affecting approximately 10% of women [243]. - Endometriosis diagnosis averages ten years, with over 90% of diagnosed patients experiencing moderate to severe symptoms [244]. - Pearsanta acquired patents related to DNA adduct detection, which serve as early indicators of genomic instability and cancer risk, on March 21, 2025 [246]. - The company plans to develop a platform for comprehensive assessment of DNA adducts using various sample types, with commercial diagnostic kits anticipated in the next 2-3 years [247]. Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $37,555,792 and cash of $163,041 [283]. - Revenue for the three months ended September 30, 2025, was $748, a decrease from $6,854 for the same period in 2024 [286]. - Cost of goods sold for the three months ended September 30, 2025, was $732, down from $467,536 in 2024 [286]. - The company incurred a loss from operations of $3,140,630 for the three months ended September 30, 2025, compared to a loss of $4,701,038 in 2024 [287][288]. - General and administrative expenses for the three months ended September 30, 2025, were $2,462,561, including approximately $963,485 in payroll expenses [287]. - Other expenses for the three months ended September 30, 2025, totaled $21,067,039, primarily due to a loss on the change in the fair value of the Evofem F-1 preferred stock of $23,001,919 [290]. - Revenue for the nine months ended September 30, 2025, was $2,770, a significant decrease from $130,810 in the same period of 2024, reflecting a decline in AditxtScore orders due to reduced COVID testing [292]. - Cost of goods sold for the nine months ended September 30, 2025, was $2,471, down from $556,469 in 2024, indicating a similar trend in decreased operational activity [292]. - The company incurred a loss from operations of $14,901,140 for the nine months ended September 30, 2025, compared to a loss of $22,212,665 in the same period of 2024, showing an improvement in operational losses [293][294]. - General and administrative expenses for the nine months ended September 30, 2025, were $11,849,871, which included payroll expenses of approximately $3,042,658 and professional fees of $4,994,013 [293]. - Research and development expenses decreased to $2,645,577 in 2025 from $10,190,978 in 2024, primarily due to reduced spending in this area [295][294]. - Other expenses for the nine months ended September 30, 2025, totaled $22,654,652, significantly higher than $7,260,221 in 2024, mainly due to a loss on the change in fair value of the Evofem F-1 preferred stock [296][297]. - As of September 30, 2025, the company had an accumulated deficit of $205,107,091 and working capital of $(20,238,149) [299]. - The company has limited historical financial information, making future profitability uncertain [285]. - The company believes its remaining funds will not be sufficient to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern [284]. - The company expects to incur additional net expenses over the next several years as it continues to maintain and expand operations [285]. - The company plans to seek significant additional capital through various means, including selling common stock, preferred stock, or convertible debt securities, to fund operations and clinical trials [301]. - The company has not purchased any fixed assets during the nine months ended September 30, 2025, indicating a focus on conserving cash [299]. - The company believes that current cash reserves should be sufficient to fund operations for the foreseeable future, although there is doubt about its ability to continue as a going concern [302]. Corporate Actions - Adivir, Inc., formed in April 2023, focuses on developing antiviral and antimicrobial products to address infectious diseases [248]. - The company entered into a Merger Agreement with Evofem Biosciences on December 11, 2023, with Evofem becoming a wholly owned subsidiary [250]. - The company assumed $13.0 million in notes payable and recognized a debt discount of $1,924,276 related to the merger with Evofem [251]. - At the effective time of the merger, Evofem's common stock will convert into the right to receive an aggregate of $1,800,000 [261]. - The merger agreement includes provisions for the treatment of Evofem options and employee stock purchase plans, which will be canceled without consideration [264].

Core Viewpoint - Aditxt, Inc. is preparing for a reverse stock split scheduled for November 3, 2025, consolidating 113 shares into 1 share to adjust the share price and attract more investors [1][5]. Summary by Sections Reverse Stock Split - The reverse stock split aims to adjust the share price and potentially attract more investors, with the current stock price at $0.068, having decreased by 40.61% [2][5]. - The reverse split is expected to help stabilize the stock price by reducing the number of shares available, which may also reduce volatility [2][5]. Market Capitalization and Trading Activity - Aditxt's market capitalization is approximately $165.318 million, reflecting the company's current valuation [3]. - The trading volume today is 38.18 million shares, indicating active trading activity [3]. - Over the past year, the stock has experienced a high of $140 and a low of $0.06, showcasing its volatility [3]. Strategic Implications - Despite the reverse split, Aditxt will maintain its presence on the NASDAQ exchange, aligning with the company's strategy to remain competitive and appealing to investors [4]. - The reverse split is viewed as a strategic move to enhance the stock's marketability and potentially improve its financial standing [4].

Core Points - Evofem Biosciences' shareholders did not approve the merger with Aditxt, leading to the termination of the merger agreement [1] - The company is now focusing on regaining a national stock listing and securing growth capital to achieve sustainable positive EBITDA by 2027 [2] - Evofem has two FDA-approved products: PHEXXI, a hormone-free contraceptive gel, and SOLOSEC, an oral antibiotic for bacterial vaginosis and trichomoniasis [3][5] Company Strategy - The company aims to deliver value for investors and healthcare providers by executing its long-term growth strategy [2] - Collaboration with Aditxt is expected to enhance the commercialization of Mitomic diagnostic tests for women's health conditions [2] Financial Performance - Evofem has experienced four consecutive years of net sales growth as of 2024 [3]

Core Viewpoint - Evofem Biosciences, Inc. anticipates the approval of a merger with Aditxt, Inc. and its subsidiary Adifem, which is set to be voted on at a Special Meeting of Stockholders on September 26, 2025 [1][2]. Summary by Sections Merger Details - The merger involves Adifem merging with Evofem, with Evofem becoming a wholly owned subsidiary of Aditxt, aimed at enhancing women's health initiatives [2][7]. - The proposal requires approval from at least a majority of the combined voting power of common stock, Series E-1, and G-1 [2][8]. Stockholder Support - CEO Saundra Pelletier indicated that support agreements are in place with holders of Series E-1 and G-1, which collectively represent 53.71% of the combined voting power [2][3]. - The holders of Series E-1 and G-1 have 13.87% and 39.84% of the voting power, respectively [3]. Company Mission and Products - Evofem is focused on delivering innovations in sexual and reproductive healthcare, with two FDA-approved products generating revenue: PHEXXI and SOLOSEC [4][5][6]. - PHEXXI is a hormone-free contraceptive vaginal gel, while SOLOSEC is an oral antibiotic for treating bacterial vaginosis and trichomoniasis [5][6].

[Cautionary Note Regarding Forward-Looking Statements and Industry Data](index=3&type=section&id=Cautionary%20Note%20Regarding%20Forward-Looking%20Statements%20and%20Industry%20Data) This section outlines forward-looking statements, emphasizing that actual results may differ due to known and unknown risks - The company has generated **no significant revenue** from commercial sales to date and future profitability is uncertain[9](index=9&type=chunk) - The company's financial situation creates substantial doubt about its ability to continue as a going concern, requiring additional funding which may not be available or may be dilutive[9](index=9&type=chunk)[42](index=42&type=chunk) - Significant risks include regulatory approval process challenges, potential delays in clinical studies, and the inability to successfully commercialize product candidates[9](index=9&type=chunk) - Dilution risk exists due to significant issuance of convertible preferred stock, warrants, and potential future equity sales (e.g., **$150M common stock purchase agreement**, **$35M ATM offering**)[10](index=10&type=chunk)[14](index=14&type=chunk) [PART I FINANCIAL INFORMATION](index=6&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) This part presents Aditxt's unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, and cash flows [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(Unaudited)) This section provides core unaudited condensed consolidated financial statements, offering a snapshot of the company's financial health [Condensed Consolidated Balance Sheets as of June 30, 2025 and December 31, 2024](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) | Metric | June 30, 2025 | December 31, 2024 | Change | | :--------------------------------- | :-------------- | :---------------- | :----- | | Cash | $323,679 | $833,031 | $(509,352) | | Total Current Assets | $433,655 | $1,999,841 | $(1,566,186) | | Notes receivable, related party, net of discount | $2,196,826 | $- | $2,196,826 | | Investment in Evofem | $27,542,071 | $27,277,211 | $264,860 | | Total Assets | $32,691,232 | $32,144,390 | $546,842 | | Total Current Liabilities | $20,582,619 | $23,407,123 | $(2,824,504) | | Total Liabilities | $20,696,368 | $23,857,994 | $(3,161,626) | | Total Stockholders' Equity | $11,994,864 | $(86,604) | $12,081,468 | [Condensed Consolidated Statements of Operations for the three and six months ended June 30, 2025 and 2024](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | :----------------------------- | :----------------------------- | | Sales | $1,004 | $44,276 | $2,022 | $123,956 | | Cost of goods sold | $1,005 | $23,134 | $1,739 | $88,933 | | Gross profit (loss) | $(1) | $21,142 | $283 | $35,023 | | Total operating expenses | $6,152,394 | $5,997,123 | $11,760,793 | $17,546,650 | | Net loss from operations | $(6,152,395) | $(5,975,981) | $(11,760,510) | $(17,511,627) | | Total other expense | $(1,243,263) | $(1,647,898) | $(1,587,613) | $(4,980,946) | | Net loss before income taxes | $(7,395,658) | $(7,623,879) | $(13,348,123) | $(22,492,573) | | Net loss attributable to Aditxt, Inc. & Subsidiaries | $(7,256,808) | $(7,549,619) | $(12,967,117) | $(22,279,346) | | Net loss per share, basic and diluted | $(3.45) | $(1,047.17) | $(9.22) | $(3,262.64) | | Weighted average number of shares outstanding | 2,101,701 | 7,210 | 1,406,545 | 6,829 | - The decrease in revenue and cost of goods sold is attributed to decreased AditxtScore orders due to reduced COVID testing[246](index=246&type=chunk)[251](index=251&type=chunk) - Net loss per share significantly improved from **$(1,047.17)** to **$(3.45)** for the three months ended June 30, 2025, and from **$(3,262.64)** to **$(9.22)** for the six months ended June 30, 2025, despite continued operational losses[19](index=19&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity for the three and six months ended June 30, 2025 and 2024](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) | Metric | December 31, 2024 | June 30, 2025 | Change | | :--------------------------------- | :---------------- | :-------------- | :----- | | Total Stockholders' Equity (Deficit) | $(86,604) | $11,994,864 | $12,081,468 | | Additional Paid-in Capital | $168,792,592 | $194,219,137 | $25,426,545 | | Accumulated Deficit | $(168,094,569) | $(181,061,686) | $(12,967,117) | - Issuance of shares from registered direct offerings and ELOC (Equity Line of Credit) significantly contributed to **additional paid-in capital**[22](index=22&type=chunk) - The company redeemed Series A-1 and Series C-1 Convertible Preferred Stock during the period[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2025 and 2024](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--------------------------------- | :----------------------------- | :----------------------------- | :----- | | Net loss | $(13,348,123) | $(22,492,573) | $9,144,450 | | Net cash used in operating activities | $(14,098,132) | $(8,250,807) | $(5,847,325) | | Net cash provided by investing activities | $(2,425,000) | $(1,000,000) | $(1,425,000) | | Net cash provided by financing activities | $16,013,780 | $9,244,928 | $6,768,852 | | NET DECREASE IN CASH | $(509,352) | $(5,879) | $(503,473) | | CASH AT END OF PERIOD | $323,679 | $91,223 | $232,456 | - Cash used in operating activities significantly increased from **$(8.25) million** in 2024 to **$(14.10) million** in 2025[28](index=28&type=chunk) - Proceeds from common stock and warrants issued for cash, net of issuance costs, were **$24.78 million** in 2025, a substantial increase from **$3.02 million** in 2024[28](index=28&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed disclosures on accounting policies, financial instruments, and related party transactions [NOTE 1 – ORGANIZATION AND NATURE OF BUSINESS](index=11&type=section&id=NOTE%201%20%E2%80%93%20ORGANIZATION%20AND%20NATURE%20OF%20BUSINESS) - Aditxt, Inc. operates as an innovation platform focused on discovering, developing, and deploying promising innovations through an ecosystem of research institutions, industry partners, and shareholders[30](index=30&type=chunk) - The company effectuated a **1-for-40 reverse stock split** on October 2, 2024, and a **1-for-250 reverse stock split** on March 14, 2025, to adjust its stock trading basis on Nasdaq[31](index=31&type=chunk)[32](index=32&type=chunk) - In May and August 2024, the company completed private placements and registered direct offerings, raising approximately **$4.2 million** and **$1.2 million gross proceeds**, respectively, for working capital and merger obligations[34](index=34&type=chunk)[36](index=36&type=chunk) - The company has a limited operating history and is in the very early stages of generating revenue, facing risks related to the biotechnology regulatory environment, technological advances, clinical trial resources, and competition[37](index=37&type=chunk) [NOTE 2 – GOING CONCERN ANALYSIS](index=12&type=section&id=NOTE%202%20%E2%80%93%20GOING%20CONCERN%20ANALYSIS) - The company incurred a net loss of **$13,348,123** and negative cash flow from operating activities of **$14,098,132** for the six months ended June 30, 2025, with a cash balance of **$323,679**[38](index=38&type=chunk) - As of June 30, 2025, the company was subject to the **"Baby Shelf Limitation"** under Form S-3, restricting its ability to offer and sell securities under its shelf registration statement to one-third of the aggregate market value of non-affiliate equity[39](index=39&type=chunk) - The company's financial situation creates substantial doubt about its ability to continue as a going concern, actively pursuing capital raising transactions (equity, debt, private placements, public offerings, related-party loans) to meet existing and longer-term capital needs[41](index=41&type=chunk)[42](index=42&type=chunk)[44](index=44&type=chunk)[45](index=45&type=chunk) - Delisting from Nasdaq could adversely affect the value and liquidity of common stock, warrants, and pre-funded warrants, and hinder financing efforts[40](index=40&type=chunk) [NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES](index=13&type=section&id=NOTE%203%20%E2%80%93%20SUMMARY%20OF%20SIGNIFICANT%20ACCOUNTING%20POLICIES) - Financial statements are prepared in accordance with U.S. GAAP for interim information, reflecting normal, recurring adjustments[46](index=46&type=chunk) - Significant estimates include the value of preferred shares, derivative liability, investment in Evofem preferred stock, and fair value of stock options and warrants[49](index=49&type=chunk) | Financial Instrument | Carrying Value (June 30, 2025) | Fair Value Measurement Using Level 2 | | :--------------------------- | :----------------------------- | :----------------------------------- | | Derivative liability | $392 | $392 | | Investment in Evofem warrants | $264,860 | $264,860 | | Total | $265,252 | $265,252 | - Revenue from AditxtScore™ services is recognized upon delivery of the report, following a five-step process for identifying contracts, performance obligations, transaction price, allocation, and recognition[85](index=85&type=chunk)[93](index=93&type=chunk) - The company accounts for stock-based compensation under ASC 718, recognizing expense over the vesting period, and expenses R&D and sales & marketing costs as incurred[94](index=94&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - Non-controlling interest represents the cumulative results attributable to non-controlling shareholders in its majority-owned subsidiary, Pearsanta, Inc. (**90% owned**)[98](index=98&type=chunk) [NOTE 4 – FIXED ASSETS](index=20&type=section&id=NOTE%204%20%E2%80%93%20FIXED%20ASSETS) | Asset Category | Net Value (June 30, 2025) | Net Value (December 31, 2024) | | :--------------------- | :------------------------ | :-------------------------- | | Computers | $1,069 | $4,120 | | Lab Equipment | $1,346,092 | $1,462,751 | | Office Furniture | $32,433 | $35,121 | | Other Fixed Assets | $5,231 | $5,661 | | Leasehold Improvements | $27,451 | $40,121 | | Total Fixed Assets | $1,412,276 | $1,547,774 | - Depreciation expense for the six months ended June 30, 2025, was **$135,498**, a decrease from **$300,129** in the prior year[102](index=102&type=chunk) - All lab equipment financing agreements have matured and are in default status as of June 30, 2025, with the company having four to seven payments in arrears on various agreements[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk) [NOTE 5 – INTANGIBLE ASSETS](index=21&type=section&id=NOTE%205%20%E2%80%93%20INTANGIBLE%20ASSETS) | Asset Category | Net Value (June 30, 2025) | Net Value (December 31, 2024) | | :--------------------- | :------------------------ | :-------------------------- | | Proprietary Technology | $- | $- | | Intellectual property | $4,444 | $6,111 | | Total Intangible Assets | $4,444 | $6,111 | - Amortization expense for intangible assets was **$1,667** for the six months ended June 30, 2025[107](index=107&type=chunk) - The company's proprietary technology is fully amortized over its estimated useful life of **three years**[107](index=107&type=chunk) [NOTE 6 – RELATED PARTY TRANSACTIONS](index=22&type=section&id=NOTE%206%20%E2%80%93%20RELATED%20PARTY%20TRANSACTIONS) - CEO Amro Albanna and Chief Innovation Officer Shahrokh Shabahang provided short-term, unsecured loans to the company in May and June 2025, totaling **$493,000**, all of which were fully repaid by June 30, 2025[109](index=109&type=chunk)[110](index=110&type=chunk)[111](index=111&type=chunk) - Aditxt purchased a senior subordinated convertible note from Evofem (a related party) in April 2025 for **$1.5 million**, with a principal amount of **$2,307,692** and warrants to purchase **149,850,150 shares** of Evofem common stock[113](index=113&type=chunk) - In June 2025, Aditxt purchased another senior subordinated convertible note from Evofem for **$925,000**, with a principal amount of **$1,423,077** and warrants to purchase **92,407,592 shares** of Evofem common stock[118](index=118&type=chunk) - The Evofem notes accrue interest at **8% per annum** (**12% upon default**) and are convertible into Evofem common stock at **$0.0154 per share**, subject to a **9.99% beneficial ownership cap**[114](index=114&type=chunk)[119](index=119&type=chunk) [NOTE 7 – NOTES PAYABLE](index=24&type=section&id=NOTE%207%20%E2%80%93%20NOTES%20PAYABLE) - The November Loan Agreement (**$560,268 principal**) and January Loan Agreement (**$2,000,336 principal**) are both in default status as of June 30, 2025, with **49% interest rates**[125](index=125&type=chunk)[126](index=126&type=chunk) - The May 2025 Note, with a principal balance of **$1,114,286**, is also in default status as of June 30, 2025, bearing **10% interest** (**20% upon default**)[130](index=130&type=chunk)[132](index=132&type=chunk) - A new June Senior Note was issued for **$1,000,000 principal**, with a purchase price of **$800,000** (reflecting a **$100,000 original issue discount**), bearing **10% interest** and maturing September 30, 2025[134](index=134&type=chunk) - The company entered into forbearance agreements with preferred stock holders, agreeing to redeem Series A-1 and C-1 Preferred Shares under certain financing conditions[131](index=131&type=chunk) [NOTE 8 – LEASES](index=26&type=section&id=NOTE%208%20%E2%80%93%20LEASES) - The company's corporate headquarters lease in Mountain View, California, became month-to-month as of September 1, 2024, and payments are current[136](index=136&type=chunk) - The Richmond, Virginia, facility lease expires on August 31, 2026, and the company is **two months in arrears** as of June 30, 2025[137](index=137&type=chunk) - A default notice was received in May 2024 for **$590,557** related to the Richmond lease, with **$431,182** paid, but the company remains **two months in arrears**[138](index=138&type=chunk) | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :-------------- | :---------------- | | Right of use asset – long term | $886,014 | $1,225,781 | | Operating lease liabilities – short term | $693,613 | $683,352 | | Operating lease liabilities – long term | $113,357 | $436,354 | | Total lease liability | $806,970 | $1,119,706 | [NOTE 9 – COMMITMENTS & CONTINGENCIES](index=27&type=section&id=NOTE%209%20%E2%80%93%20COMMITMENTS%20%26%20CONTINGENCIES) - Aditxt has an exclusive worldwide license from Loma Linda University (LLU) for ADI™ technology, requiring annual fees, milestone payments (e.g., **$100,000 due Sept 30, 2024**, **$500,000 due Sept 30, 2026**), and royalties on net product/service sales[143](index=143&type=chunk)[144](index=144&type=chunk) - The company is in default on several LLU milestone deadlines, including the September 30, 2024 payment and the initiation of first-in-human clinical trials, and intends to obtain extensions[144](index=144&type=chunk)[145](index=145&type=chunk) - Aditxt holds an exclusive worldwide license from Stanford for AditxtScore™ technology, requiring an annual maintenance fee (**$60,000 starting 2025**) and royalties (**4-6% of Net Sales**)[146](index=146&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - A call option to purchase Evofem securities for **$13 million** was not exercised by its June 30, 2025, expiration[150](index=150&type=chunk) - The Arrangement Agreement with Appili was terminated effective May 31, 2025, resulting in a **$1,250,000 termination fee**, with **$1,000,000** remaining outstanding as of June 30, 2025[155](index=155&type=chunk) [NOTE 10 – STOCKHOLDERS' EQUITY](index=30&type=section&id=NOTE%2010%20%E2%80%93%20STOCKHOLDERS'%20EQUITY) - Aditxt effectuated a **1-for-250 reverse stock split** on March 14, 2025, and its subsidiary Pearsanta underwent a **1-for-60 reverse stock split** on the same date[157](index=157&type=chunk)[158](index=158&type=chunk) | Equity Offering | Period | Shares Sold | Average Price per Share | Net Proceeds | | :---------------------- | :--------------------------------- | :---------- | :---------------------- | :------------- | | ATM Offering | Six months ended June 30, 2025 | 2,048,002 | $4.18 | ~$8,560,920 | | ELOC Purchase Agreement | Six months ended June 30, 2025 | 853,959 | $18.99 | ~$16,216,915 | - The company redeemed **268 shares** of Series A-1 Convertible Preferred Stock for **$308,000** and approximately **6,110 shares** of Series C-1 Convertible Preferred Stock for **$7,027,070** during the six months ended June 30, 2025[166](index=166&type=chunk)[167](index=167&type=chunk) - Pearsanta acquired patents for DNA adduct detection, issuing **200 shares** of Pearsanta Series B Convertible Preferred Stock valued at **$10,000**[168](index=168&type=chunk) - Stock-based compensation expense for warrants was **$473,311** for the six months ended June 30, 2025, with no new stock options granted during the period[186](index=186&type=chunk)[172](index=172&type=chunk) [NOTE 11 – INCOME TAXES](index=34&type=section&id=NOTE%2011%20%E2%80%93%20INCOME%20TAXES) - The company incurred losses since inception and did not provide any income tax provision for the six months ended June 30, 2025[187](index=187&type=chunk) - A full valuation allowance has been recorded against net deferred tax assets as of June 30, 2025, due to cumulative losses, indicating uncertainty regarding the realization of these assets[187](index=187&type=chunk) [NOTE 12 – SEGMENT REPORTING](index=34&type=section&id=NOTE%2012%20%E2%80%93%20SEGMENT%20REPORTING) - Aditxt operates in one operating segment, focused on the discovery and development of biopharmaceutical products aimed at the global market[189](index=189&type=chunk) - The chief operating decision makers (CEO and CFO) use consolidated net loss, along with non-financial inputs and qualitative information, to evaluate performance, allocate resources, and establish compensation[191](index=191&type=chunk) [NOTE 13 – SUBSEQUENT EVENTS](index=34&type=section&id=NOTE%2013%20%E2%80%93%20SUBSEQUENT%20EVENTS) - From July 1, 2025, through the report date, the company redeemed approximately **275 shares** of Series C-1 Convertible Preferred Stock for **$316,632** and repaid the June 2025 Promissory Note[193](index=193&type=chunk)[194](index=194&type=chunk) - On August 13, 2025, the CEO and Chief Innovation Officer loaned an additional **$95,000 each** to the company via unsecured promissory notes[195](index=195&type=chunk) | Equity Offering | Period | Shares Sold | Average Price per Share | Net Proceeds | | :---------------------- | :--------------------------------- | :---------- | :---------------------- | :------------- | | ELOC Activity | July 1, 2025 - Report Date | 1,569,021 | $1.01 | ~$1,586,996 | | ATM Activity | July 1, 2025 - Report Date | 230,605 | $1.34 | ~$293,450 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=35&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Aditxt's financial condition, operational results, mission, and ongoing challenges, including going concern [Overview and Mission](index=35&type=section&id=Overview%20and%20Mission) - Aditxt's mission is to transform promising innovations into products and services by harnessing the power of large groups of stakeholders[199](index=199&type=chunk)[200](index=200&type=chunk) - The company was incorporated on September 28, 2017, and is headquartered in Mountain View, California[200](index=200&type=chunk) - Initial focus was on immune modulation technology (ADI/Adimune) for organ transplants, with subsequent expansion into a broader portfolio of health innovations[201](index=201&type=chunk) [ADIMUNE, INC.](index=35&type=section&id=ADIMUNE%2C%20INC.) - Adimune, Inc. (formed Jan 2023) focuses on immune modulation therapeutic programs, with its proprietary Apoptotic DNA Immunotherapy™ (ADI™) designed to induce tolerance by mimicking natural body processes[202](index=202&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) - ADI-100, the lead product candidate, has completed preclinical studies demonstrating potential effectiveness in restoring durable tolerance for type-1 diabetes, psoriasis, and autoimmune CNS diseases, without impairing immune response to infection or cancer[203](index=203&type=chunk) - Clinical-grade drug substances have been successfully manufactured, and Adimune is preparing for clinical trials in Germany and an IND submission to the FDA for Stiff Person Syndrome (SPS) with Mayo Clinic, with human trials for SPS expected in **2025**[204](index=204&type=chunk)[206](index=206&type=chunk)[207](index=207&type=chunk) - ADI™ technology, exclusively licensed from Loma Linda University, is a nucleic acid-based platform believed to selectively suppress only immune cells involved in attacking self/transplanted tissues, potentially allowing patients to live with transplanted organs with significantly reduced immune suppression[209](index=209&type=chunk)[210](index=210&type=chunk)[213](index=213&type=chunk) [PEARSANTA, INC.](index=37&type=section&id=PEARSANTA%2C%20INC.) - Pearsanta is pioneering the development of molecular tests based on mitochondrial DNA (mtDNA) for early cancer detection, leveraging the acquired Mitomic Technology platform, patents, and intellectual property[214](index=214&type=chunk)[215](index=215&type=chunk)[222](index=222&type=chunk) - Pearsanta has two product candidates in development: Mitomic® Prostate Test (MPT™) for prostate cancer diagnosis and Mitomic Endometriosis Test (MET™) for endometriosis detection, both designed as blood-based assays[216](index=216&type=chunk)[229](index=229&type=chunk)[230](index=230&type=chunk) - Pearsanta holds an exclusive worldwide sub-license for AditxtScore™ technology, which provides a personalized comprehensive profile of the immune system, intended to detect individual immune responses to various agents[217](index=217&type=chunk)[218](index=218&type=chunk)[221](index=221&type=chunk) - Pearsanta also acquired patents related to the detection and analysis of DNA adducts, intending to develop a platform for comprehensive assessment of DNA damage as early indicators of cancer risk[232](index=232&type=chunk)[233](index=233&type=chunk) [ADIVIR, INC.](index=40&type=section&id=ADIVIR%2C%20INC.) - Adivir, Inc. (formed April 2023) is a wholly-owned subsidiary focused on clinical and commercial development of innovative products for population health, including antiviral and antimicrobial products[235](index=235&type=chunk) - Aditxt had an Asset Purchase Agreement to acquire Cellvera's **50% ownership interest** in G Response Aid FZE (which holds an exclusive worldwide license for Avigan® 200mg, excluding Japan, China, and Russia) for **$24.5 million**[236](index=236&type=chunk) - The consideration for the Cellvera acquisition included forgiveness of a **$14.5 million loan** to Cellvera Global and approximately **$10 million in cash**, plus future revenue sharing[236](index=236&type=chunk) - Due to Cellvera being subject to liquidation proceedings, Aditxt does not presently believe the proposed acquisition will be completed as proposed or at all[240](index=240&type=chunk) [Our Team](index=41&type=section&id=Our%20Team) - The company has a team of experts with diverse scientific and commercial backgrounds, experienced in founding biotech companies, developing biopharmaceutical products, designing clinical trials, and managing companies[242](index=242&type=chunk) [Going Concern](index=41&type=section&id=Going%20Concern) - The company has a limited operating history, no significant revenues to date, and reported a net loss of **$13,348,123** with a cash balance of **$323,679** as of June 30, 2025[243](index=243&type=chunk) - Aditxt is over **90 days past due** on a significant number of vendor obligations and requires substantial additional capital for operations and clinical studies[244](index=244&type=chunk) - These factors create substantial doubt about the company's ability to continue as a going concern beyond one year[244](index=244&type=chunk) [Financial Results](index=41&type=section&id=Financial%20Results) - The company has a limited operating history and has incurred substantial operating losses since inception, with a net loss of **$13,348,123** as of June 30, 2025[245](index=245&type=chunk) - Aditxt expects to incur additional net expenses and significant operating losses for the foreseeable future, with future profitability being uncertain[245](index=245&type=chunk) [Results of Operations](index=41&type=section&id=Results%20of%20Operations) Aditxt saw significant revenue and gross profit decline from decreased AditxtScore orders, incurring substantial operating losses [Results of operations for the three months ended June 30, 2025 and 2024](index=41&type=section&id=Results%20of%20operations%20for%20the%20three%20months%20ended%20June%2030%2C%202025%20and%202024) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | Change | | :--------------------------------- | :----------------------------- | :----------------------------- | :----- | | Revenue | $1,004 | $44,276 | $(43,272) | | Gross profit (loss) | $(1) | $21,142 | $(21,143) | | Loss from operations | $(6,152,395) | $(5,975,981) | $(176,414) | | General and administrative expenses | $5,039,036 | $4,419,545 | $619,491 | | Research and development expenses | $764,327 | $1,553,360 | $(789,033) | | Sales and marketing expenses | $349,031 | $24,218 | $324,813 | - The decrease in revenue and cost of goods sold was due to decreased AditxtScore orders from reduced COVID testing[246](index=246&type=chunk) - General and administrative expenses increased, primarily due to professional fees, while research and development expenses decreased significantly[248](index=248&type=chunk)[249](index=249&type=chunk)[250](index=250&type=chunk) [Results of operations for the six months ended June 30, 2025 and 2024](index=42&type=section&id=Results%20of%20operations%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) | Metric | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | Change | | :--------------------------------- | :----------------------------- | :----------------------------- | :----- | | Revenue | $2,022 | $123,956 | $(121,934) | | Gross profit (loss) | $283 | $35,023 | $(34,740) | | Loss from operations | $(11,760,510) | $(17,511,627) | $5,751,117 | | General and administrative expenses | $9,387,310 | $7,783,293 | $1,604,017 | | Research and development expenses | $1,973,532 | $9,698,626 | $(7,725,094) | | Sales and marketing expenses | $399,951 | $64,731 | $335,220 | - The decrease in revenue and cost of goods sold was due to decreased AditxtScore orders from reduced COVID testing[251](index=251&type=chunk) - The decrease in total operating expenses for the six-month period was primarily due to a significant reduction in research and development spend, which included **$6,712,663** in stock-based compensation in 2024[253](index=253&type=chunk)[254](index=254&type=chunk) [Liquidity and Capital Resources](index=42&type=section&id=Liquidity%20and%20Capital%20Resources) - The company has incurred substantial operating losses since inception, with an accumulated deficit of **$181,061,686** and working capital of **$(20,148,964)** as of June 30, 2025[255](index=255&type=chunk) - Significant additional capital is required to fund operations and clinical trials, as current cash reserves are insufficient for the next 12 months, creating substantial doubt about the company's ability to continue as a going concern[257](index=257&type=chunk)[259](index=259&type=chunk) - Future financing may involve selling common stock, preferred stock, convertible debt, credit facilities, or collaborative agreements, which could result in dilution to stockholders or restrictive covenants[257](index=257&type=chunk) [Contractual Obligations](index=43&type=section&id=Contractual%20Obligations) | Obligation | Total 2025 (remaining) | 2026 | | :----------------- | :--------------------- | :--- | | Lease | $358,756 | $423,930 | | Total Lease Payments | $782,686 | | [Critical Accounting Polices and Estimates](index=43&type=section&id=Critical%20Accounting%20Polices%20and%20Estimates) - Critical accounting policies and estimates include those related to research and development expenses and stock-based compensation expense[261](index=261&type=chunk)[265](index=265&type=chunk) - These policies involve significant judgment and assumptions, and actual results differing materially from estimates could significantly affect the company's reported financial condition and results of operations[261](index=261&type=chunk) [Off-Balance Sheet Arrangements](index=43&type=section&id=Off-Balance%20Sheet%20Arrangements) - The company did not have, and does not currently have, any off-balance sheet arrangements as defined by SEC rules and regulations[262](index=262&type=chunk) [JOBS Act](index=43&type=section&id=JOBS%20Act) - As an **"emerging growth company"** under the JOBS Act, Aditxt has elected to use extended transition periods for complying with new or revised accounting standards[263](index=263&type=chunk)[264](index=264&type=chunk) - The company intends to rely on exemptions such as not providing an auditor's attestation report on internal controls over financial reporting[266](index=266&type=chunk) - Aditxt will remain an **"emerging growth company"** until the earliest of reaching **$1.07 billion** in annual gross revenues, the fifth anniversary of its IPO (December 31, 2025), issuing over **$1 billion** in nonconvertible debt, or becoming a large accelerated filer[266](index=266&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=44&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) - Management believes that recently issued ASUs either provide supplemental guidance, are technical corrections, are not applicable, or are not expected to have a significant impact on the company's financial statements[101](index=101&type=chunk)[267](index=267&type=chunk) [Recent Developments](index=44&type=section&id=Recent%20Developments) - Material recent developments are described in Note 13 – Subsequent Events[268](index=268&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Aditxt is not required to provide quantitative and qualitative disclosures about market risk as it qualifies as a "smaller reporting company" - Aditxt is exempt from providing quantitative and qualitative disclosures about market risk as it is a **"smaller reporting company"**[269](index=269&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Aditxt's CEO and CFO concluded disclosure controls were ineffective as of June 30, 2025, due to material weaknesses - As of June 30, 2025, the CEO and CFO concluded that disclosure controls and procedures were **not effective**[270](index=270&type=chunk) - Material weaknesses identified include inadequate documentation of accounting and financial reporting policies, insufficient expertise for technical and complex accounting issues, and insufficient procedures for accounts payable identification and cutoff[273](index=273&type=chunk) - These material weaknesses resulted in corrected financial statement misstatements, but no changes to previously released financial results[271](index=271&type=chunk) - No change occurred in internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or is reasonably likely to materially affect, internal control over financial reporting[272](index=272&type=chunk) [PART II OTHER INFORMATION](index=45&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers non-financial disclosures like legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=45&type=section&id=Item%201.%20Legal%20Proceedings) Aditxt may become involved in various lawsuits and legal proceedings, and adverse outcomes could materially harm the company's business - The company may become involved in various lawsuits and legal proceedings in the ordinary course of business[275](index=275&type=chunk) - Litigation is subject to inherent uncertainties, and an adverse result could materially harm the company's business[275](index=275&type=chunk) [Item 1A. Risk Factors](index=45&type=section&id=Item%201A.%20Risk%20Factors) Aditxt faces significant risks including going concern doubts, overdue vendor obligations, potential foreclosure, and dilution - The company's financial situation creates substantial doubt about its ability to continue as a going concern, with no significant revenues to date and an accumulated deficit of **$181,061,686** as of June 30, 2025[277](index=277&type=chunk) - Aditxt is over **90 days past due** on approximately **$5.7 million** of its **$9.7 million** in accounts payable, and inability to repay or refinance substantial indebtedness could lead to default and foreclosure by secured creditors[278](index=278&type=chunk)[281](index=281&type=chunk) - Delisting from Nasdaq could significantly adversely affect the value and liquidity of the company's securities and its ability to obtain financing[282](index=282&type=chunk) - A significant number of shares of common stock may be issued upon the exercise of outstanding options (**59 shares**), warrants (**602,680 shares**), and conversion of preferred stock, posing a risk of dilution and downward pressure on stock price[280](index=280&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=47&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report during the period - No unregistered sales of equity securities or use of proceeds occurred during the period[284](index=284&type=chunk) [Item 3. Defaults Upon Senior Securities](index=47&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities to report during the period - No defaults upon senior securities occurred during the period[285](index=285&type=chunk) [Item 4. Mine Safety Disclosures](index=47&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[286](index=286&type=chunk) [Item 5. Other Information](index=47&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers - No Rule 10b5-1 or non-Rule 10b5-1 trading arrangements were adopted or terminated by directors or officers during the six months ended June 30, 2025[287](index=287&type=chunk) [Item 6. Exhibits](index=47&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed as part of the Form 10-Q, including certificates of amendment and certifications - The report includes various exhibits such as Certificate of Amendment to Certificate of Incorporation, Certifications of Principal Executive and Financial Officers, and Inline XBRL documents[288](index=288&type=chunk) [Signatures](index=48&type=section&id=Signatures) The report is duly signed on behalf of Aditxt, Inc. by Amro Albanna, CEO, and Thomas J. Farley, CFO, on August 14, 2025 - The report was signed by Amro Albanna (CEO) and Thomas J. Farley (CFO) on August 14, 2025[294](index=294&type=chunk)

Core Viewpoint - Appili Therapeutics Inc. announced the termination of the arrangement agreement with Aditxt, effective May 31, 2025, which may result in a termination fee of USD 1,250,000 payable by Aditxt [1][2]. Group 1: Termination of Arrangement Agreement - Aditxt delivered a notice to terminate the arrangement agreement dated April 1, 2024, with Appili and its subsidiary Adivir, with the termination effective as of May 31, 2025 [1]. - The termination fee due to Appili is USD 1,250,000, which will be reduced by amounts previously paid by Aditxt to extend the agreement's outside date, resulting in a net payable amount of USD 1,000,000 [2]. Group 2: Company Overview - Appili Therapeutics is a biopharmaceutical company focused on developing drugs for infectious diseases and medical countermeasures, aiming to address urgent infections with unmet needs [4]. - The company is advancing a diverse range of anti-infectives, including an FDA-approved metronidazole suspension, a vaccine candidate against biological threats, and a topical antiparasitic treatment [4].

Product Development - Adimune's first product candidate, ADI-100, targets glutamic acid decarboxylase (GAD) implicated in type-1 diabetes and autoimmune diseases, with successful preclinical tests [313]. - Preclinical studies for ADI-100 demonstrated durable tolerance restoration over a 10-month duration, with no drug toxicity or antibody formation observed [314]. - Adimune plans to initiate human trials for Stiff Person Syndrome in 2025, with an expected enrollment of 10-20 patients, pending regulatory approvals [317]. - Pearsanta is developing two product candidates for cancer screening, including potential tests for prostate cancer and endometriosis [326]. - The Mitomic® Prostate Test (MPT™) is in development to quantify the 3.4kb mitochondrial DNA deletion, potentially aiding in the identification of clinically significant prostate cancer in men with PSA levels below 10 ng/ml [339]. - The Mitomic Endometriosis Test (MET™) aims to quantify mitochondrial DNA deletions associated with endometriosis, a condition affecting approximately 10% of women [340]. - AditxtScore technology provides a comprehensive immune profile, detecting responses to various agents, with rapid assays completed in approximately 3-16 hours [328]. - The Mitomic® Technology platform aims to detect mutations in mitochondrial DNA, potentially identifying diseases before clinical presentation [336]. - The Mitomic® Technology has discovered numerous biomarker targets, with ongoing development of robust assays and new products [337]. - Pearsanta's laboratory facility in Richmond, VA, is equipped for rapid development of innovative tests, ensuring high sensitivity and specificity [334]. Financial Performance - For the three months ended March 31, 2025, the company generated revenue of $1,018, a significant decrease from $79,680 in the same period in 2024, attributed to reduced AditxtScore orders due to decreased COVID testing [356]. - The company incurred a loss from operations of $5,608,115 for the three months ended March 31, 2025, compared to a loss of $11,535,646 in the same period in 2024, reflecting a decrease in general and administrative expenses [357][358]. - As of March 31, 2025, the company had an accumulated deficit of $173,804,878 and working capital of $(13,959,063) [360]. - The company has not generated significant revenues to date and requires substantial additional capital to fund operations and clinical studies [353]. - The company raised approximately $9 million from a private placement in September 2023, which was used for outstanding obligations and working capital [363]. - The company is currently over 90 days past due on several vendor obligations, raising concerns about its ability to continue as a going concern beyond one year [353]. - The company requires significant additional capital to fund operations and clinical trials, potentially through selling common stock, preferred stock, or convertible debt securities [369]. - Future financing will depend on market conditions and the progress of the clinical development program, with current cash reserves expected to be sufficient for the foreseeable future [370]. - As of March 31, 2025, the company's total contractual obligations amount to $960,322, with $536,392 due in 2025 and $423,930 in 2026 [372]. Strategic Initiatives - The company entered into an Asset Purchase Agreement to acquire a 50% ownership interest in G Response Aid FZE for $24.5 million, which includes the forgiveness of a $14.5 million loan and approximately $10 million in cash [346]. - The company anticipates that the development of the acquired Adductomics Technology will provide insights into DNA damage and cancer risk over the next two to three years [344]. - The company intends to rely on exemptions provided by the JOBS Act, including delaying the adoption of certain accounting standards until they apply to private companies [377]. - The company is classified as an "emerging growth company" and will remain so until it meets specific revenue or debt thresholds [377]. - The company is evaluating the benefits of relying on reduced reporting requirements under the JOBS Act [377]. - Recent developments and material changes are documented in the accompanying condensed consolidated financial statements [380]. - The company is not required to provide quantitative and qualitative disclosures about market risk as it is classified as a "smaller reporting company" [381].

Financial Performance and Funding - The company has generated no significant revenue from commercial sales to date, leading to uncertainty regarding future profitability[17] - The company may need to raise additional funding, which may not be available on acceptable terms, potentially impacting operations and product development[17] - The company has entered into a Common Stock Purchase Agreement allowing for the issuance and sale of up to $150 million of common stock, which could result in significant dilution[18] - The company faces significant risks, including uncertainty in future profitability and the need for additional funding to continue operations[17] - A reverse stock split of 1:250 was executed to comply with Nasdaq's minimum bid price requirement after the company's securities had a closing bid price of $0.10 or less for ten consecutive trading days[18] Strategic Focus and Development - The company is focused on five critical areas: immune health, precision health, population health, women's health, and neurologic health, developing a robust portfolio and pipeline of products[34] - The company plans to continue building its infrastructure and securing more personalized and precision health innovations, including software, AI, medical devices, and therapeutics[30] - The company aims to commercialize innovations through a systemized approach that includes innovation, operations, commercialization, finance, and engagement[28] - The company is actively seeking to acquire complementary assets and products through acquisitions and strategic transactions[34] - Pearsanta, Inc. was formed in January 2023 and aims to advance personalized medicine with a focus on "Health by the Numbers"[48] Partnerships and Collaborations - The company has established partnerships with leading health institutions, such as Mayo Clinic, to facilitate critical trials[22] - The company has engaged in strategic transactions, including a Merger Agreement with Evofem Biosciences, Inc. and an Arrangement Agreement with Appili Therapeutics, Inc.[18] Product Development and Clinical Trials - Adimune's ADI-100 has completed all preclinical studies, demonstrating potential effectiveness in restoring durable tolerance over a 10-month duration in type 1 diabetes studies[37] - Adimune has engaged a Contract Research Organization (CRO) for clinical trials in Germany, focusing on psoriasis and type 1 diabetes, with a human trial for Stiff Person Syndrome expected to start in 2025[40] - Clinical-grade drug substances for ADI-100 have been successfully manufactured and are being prepared for stability testing and clinical trials pending regulatory submissions[38] - A human trial for Stiff Person Syndrome is expected to begin in 2025, with enrollment of 10-20 patients, pending approval from the International Review Board and U.S. FDA[40] Technology and Innovation - AditxtScore technology provides a comprehensive immune profile and is designed to detect individual immune responses to various agents, with rapid assay capabilities[55] - The ADI technology platform aims to retrain the immune system to accept transplanted organs with significantly reduced immune suppression, potentially improving graft survival[44] - The Mitomic® Technology aims to detect mutations in mitochondrial DNA, potentially allowing for early disease detection[62] - Pearsanta is developing two product candidates for cancer screening, including potential products for prostate cancer and endometriosis detection[52] - Pearsanta acquired patents for Adductomics Technology, enhancing DNA adduct detection sensitivity and specificity, with plans for commercial diagnostic kits[69][70] Acquisitions and Asset Management - Pearsanta acquired the Mitomic® Technology platform and related patents from MDNA Life Sciences Inc. for 5 shares of common stock and warrants[48] - The company entered an Asset Purchase Agreement to acquire a 50% interest in G Response Aid FZE for $24.5 million, including $10 million in cash[72] - The acquisition includes exclusive rights to the antiviral medication Avigan® 200mg, excluding Japan, China, and Russia[72] - Pearsanta plans to license distribution rights for the Mitomic® Technology through agreements with U.S. and international partners, pending successful development and regulatory approval[59] Employee Relations and Organizational Structure - As of December 31, 2024, the company had 26 full-time employees, maintaining good relations with them[77] - The company believes there is a growing global need for new treatments for life-threatening viral infections, emphasizing the strategic importance of building its antiviral portfolio[76]

Core Insights - Evofem Biosciences reported a 6% increase in net sales for 2024, reaching $19.4 million, primarily driven by the sales of PHEXXI, a hormone-free contraceptive gel [1][4] - The company successfully reduced total operating expenses by 27% to $27.0 million, reflecting improved fiscal discipline [5][6] - The acquisition and relaunch of SOLOSEC contributed to revenue diversification and growth [2][4] Financial Performance - For the year ended December 31, 2024, net sales were $19.4 million compared to $18.2 million in 2023, with lower returns enhancing the gross to net ratio [4] - Total operating expenses decreased from $36.1 million in 2023 to $27.0 million in 2024, excluding a non-cash amortization expense of $0.6 million related to SOLOSEC [5][10] - The loss from operations improved significantly to $7.7 million in 2024 from $17.8 million in the previous year [6][7] Sales and Marketing Efficiency - Sales and marketing expenses as a percentage of net sales were 47% for 2024, the most favorable ratio since the launch of PHEXXI in 2020 [6][11] - In the fourth quarter of 2024, sales and marketing expenses were 31% of net sales, indicating improved efficiency [11] Quarterly Highlights - In Q4 2024, net sales reached $7.1 million, up from $4.8 million in Q4 2023, driven by increased PHEXXI sales and the addition of SOLOSEC [8][9] - Total operating expenses for Q4 2024 were $8.1 million, a slight decrease from $8.2 million in the prior year [9][10] - The loss from operations for Q4 2024 improved to $1.0 million compared to a loss of $3.4 million in Q4 2023 [11] Strategic Initiatives - The company is pursuing a merger with Aditxt, which includes a funding commitment of $1.5 million to be completed by April 7, 2025 [3] - A sourcing partnership with Windtree Therapeutics aims to reduce PHEXXI manufacturing costs and enhance U.S. operating margins [3] Product Portfolio - Evofem's product lineup includes PHEXXI, a hormone-free contraceptive gel, and SOLOSEC, an oral treatment for bacterial vaginosis and trichomoniasis, which was relaunched in November 2024 [2][16]