-- Special Meeting to be held on September 26, 2025 -- SAN DIEGO, Sept. 9, 2025 /PRNewswire/ -- In an update to stockholders today, Evofem Biosciences, Inc. ("Evofem" or the "Company") (OTCID: EVFM) anticipates the approval of the transactions (the "Merger") contemplated by the Amended and Restated Merger Agreement dated as of July 12, 2024, as amended, (collectively, the "Merger Agreement"), with Aditxt, Inc. (Nasdaq: ADTX) and Adifem, Inc., a wholly-owned subsidiary of Aditxt, at the Company's Special M ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39336 Aditxt, Inc. (Exact name of registrant as specified in its charter) (State or other juri ...

NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES HALIFAX, Nova Scotia, May 19, 2025 (GLOBE NEWSWIRE) -- Appili Therapeutics Inc. (TSX: APLI; OTCPink: APLIF) (the "Company" or "Appili"), a biopharmaceutical company focused on drug development for infectious diseases and medical countermeasures, announced that Aditxt, Inc. ("NASDAQ:ADTX") ("Aditxt") has delivered notice (the "Termination Notice") purporting to terminate the arrangement agreement dated April 1, ...

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].

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]

Core Viewpoint - Appili Therapeutics Inc. has submitted four new funding proposals totaling US$117.5 million to advance treatments for infectious diseases, aligning with public health priorities [1] Funding Opportunities - The company applied for two solicitations from the National Institute of Allergy and Infectious Diseases (NIAID), seeking US$46.3 million for a vaccine against invasive fungal infections and US$36.4 million for an antifungal monoclonal antibody targeting a rare fungal infection [2] - Additionally, two proposals were submitted to the US Medical CBRN Defense Consortium (MCDC) for a total of US$34.8 million, including US$20.1 million for a broad-spectrum treatment for viral infections and US$14.7 million for a direct-acting antiviral [3] Consortium Membership - Appili has been selected to join the MCDC, which has awarded over US$7 billion in project funding, enhancing the company's role in developing medical countermeasures [4] Previous Funding Success - The company has raised approximately US$33.2 million in prior government funding awards, which have supported the development of various pipeline programs, including ATI-1701 and LIKMEZ™ [6] Update on USAFA Awards - Appili received an update regarding its arrangement with the United States Air Force Academy (USAFA) for ATI-1701, with a total of approximately US$14 million awarded, of which US$11.6 million has been allocated for services [7][10] - A modification to the USAFA Cooperative Agreement has resulted in an increased General & Administrative overhead recovery rate, benefiting the company financially [8] Going-Private Transaction - The company is in the process of a going-private transaction with Aditxt Inc., which has received shareholder and court approvals, with an extended deadline for financing set to March 31, 2025 [11][12][13]

Core Viewpoint - Appili Therapeutics has received court approval for its transaction with Aditxt, allowing the acquisition of all issued and outstanding Class A common shares of the company, which was previously approved by shareholders [1][2]. Group 1: Transaction Details - The transaction with Aditxt is expected to close in Q4 2024, pending the satisfaction of certain closing conditions [2]. - Following the completion of the transaction, Appili's shares will be delisted from the Toronto Stock Exchange, and the company will cease to be a reporting issuer in Canada [3]. Group 2: Company Overview - Appili Therapeutics is focused on drug development 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 for biological threats, and a topical antiparasitic treatment [4].

Company Overview - Adimune, Inc. is focused on immune modulation therapeutic programs, with its product candidate ADI-100 successfully tested in preclinical models for conditions like psoriasis and type 1 diabetes[169]. - Pearsanta, Inc. aims to revolutionize personalized medicine with a platform for lab-quality testing, targeting a clinical and consumer diagnostic market projected to reach $429.3 billion by 2030[172]. Product Development - A clinical trial for ADI-100 targeting Stiff Person Syndrome is expected to begin in the first half of 2025, pending approval, with an initial enrollment of up to 20 patients[169]. - The Mitomic® Technology Platform acquired from MDNA is designed for non-invasive disease detection through mitochondrial DNA analysis, enhancing early diagnosis and treatment[172]. - The Mitomic® Endometriosis Test (MET™) aims to provide accurate, non-invasive diagnosis, potentially reducing the diagnostic delay of around ten years for endometriosis[172]. - The Mitomic® Prostate Test (MPT™) seeks to improve detection of clinically significant prostate cancer, reducing reliance on PSA testing and minimizing unnecessary procedures[174]. - AditxtScore technology offers a personalized immune system profile, enabling detection of immune responses to various agents, with rapid and accurate assays[176]. - The AditxtScore technology features a 20-fold higher dynamic range compared to conventional assays, enhancing sensitivity and specificity[177]. - A license agreement with Loma Linda University grants exclusive rights to commercialize ADI nucleic acid-based technology, currently in the pre-clinical stage[171]. - An exclusive license agreement with Stanford University secures worldwide exclusivity for the patented technology used in AditxtScore, enhancing the company's competitive position[178]. Financial Performance - For the three months ended September 30, 2024, the company generated revenue of $6,854, a decrease of 94.5% compared to $124,486 for the same period in 2023[184]. - The company incurred a net loss of $29,472,886 for the nine months ended September 30, 2024, compared to a loss of $18,111,541 for the same period in 2023, indicating a significant increase in losses[182][184]. - As of September 30, 2024, the company had an accumulated deficit of $162,867,941 and working capital of $(22,280,585)[182]. - Research and development expenses for the nine months ended September 30, 2024, were $10,190,178, which included $6,712,663 in stock-based compensation[184]. - The company expects to incur additional net expenses over the next several years as it continues to maintain and expand its operations[182]. - The company raised approximately $9 million from a private placement in September 2023, which was used for outstanding obligations and working capital[186]. - The company entered into a securities purchase agreement in December 2023, resulting in net proceeds of approximately $5.5 million for working capital and obligations[186]. - The company has not generated significant revenues to date and requires substantial additional capital to fund operations and clinical studies[181][190]. - The company generated revenue of $130,810 for the nine months ended September 30, 2024, a decrease of 76.8% compared to $563,879 for the same period in 2023[184]. Going Concern and Compliance - The company is currently over 90 days past due on a significant number of vendor obligations, raising concerns about its ability to continue as a going concern[181]. - The company is classified as an "emerging growth company" and intends to rely on exemptions under the JOBS Act until it meets certain revenue or debt thresholds[193]. - The company will remain an "emerging growth company" until it has total annual gross revenues of $1.07 billion or more or until December 31, 2025, whichever comes first[193]. - The company is evaluating the benefits of relying on reduced reporting requirements provided by the JOBS Act[193]. - There are no off-balance sheet arrangements currently or during the periods presented[192]. - The company is not required to provide market risk disclosures as it qualifies as a "smaller reporting company" under the Exchange Act[197].

Core Viewpoint - Appili Therapeutics Inc. has received overwhelming shareholder approval for a plan of arrangement to be acquired by Aditxt Inc. through its subsidiary Adivir, Inc. This transaction is aimed at advancing Appili's pipeline of anti-infective therapies and enhancing its mission to combat severe infectious diseases [1][2]. Shareholder Meeting Results - A total of 35,770,287 Appili Shares were voted, representing approximately 29.50% of the outstanding shares [2] - The transaction was approved by 99.79% of the votes cast by shareholders and 99.65% when excluding certain votes [2] Strategic Implications - The alignment with Aditxt is expected to enhance Appili's access to capital and create new opportunities in the infectious diseases sector [3] - Appili aims to prepare its drug ATI1701 for IND submission and implement FDA strategies for ATI-1801, while also enhancing commercialization for LIKMEZ™ [3] Transaction Conditions - The transaction is subject to customary closing conditions and Aditxt must raise at least US$20 million in financing [3] - The expected closing date for the transaction is in Q4 2024 [3] Company Profiles - Appili Therapeutics focuses on developing novel therapies for life-threatening infections, with a portfolio that includes an FDA-approved metronidazole suspension and a vaccine candidate [5] - Aditxt operates as an innovation platform aimed at accelerating health innovations, with a collaborative ecosystem involving research institutions and industry partners [6]

Core Viewpoint - Appili Therapeutics Inc. has entered into a third amending agreement with Aditxt, Inc. and Adivir, Inc. to modify the previously announced arrangement agreement for Aditxt to acquire all issued and outstanding Class A common shares of Appili [1][2] Group 1: Amending Agreement Details - The Outside Date for the transaction has been changed from September 30, 2024, to November 19, 2024 [2] - The deadline for convening a special shareholders' meeting to consider the transaction has been moved from September 30, 2024, to November 6, 2024 [2] - Aditxt's deadline to complete the financing has been extended from September 15, 2024, to October 18, 2024 [2] - The completion of the Continuance is now a condition for the completion of the arrangement [2] Group 2: Continuance and Regulatory Matters - The company will transition from being incorporated under the Canada Business Corporations Act to the Business Corporations Act (Ontario) to facilitate the transaction [3] - This transition will allow the company to complete the transaction through a court-approved plan of arrangement under the Business Corporations Act (Ontario) [3] Group 3: Lender Approval - Appili's senior secured lender, Long Zone Holdings Inc., has provided necessary waivers related to the loan agreement [4] - Appili has agreed to make a cash payment of $18,000 to Long Zone Holdings Inc. [4] - The company can fulfill a prior obligation to issue $18,000 worth of Class A common shares by making a cash payment instead [4] Group 4: Company Overview - Appili Therapeutics is focused on drug development for infectious diseases and medical countermeasures [1][6] - The company aims to develop a pipeline of novel therapies to address urgent infections with unmet needs [6] - Appili is advancing a diverse range of anti-infectives, including an FDA-approved metronidazole suspension and a vaccine candidate [7]