Aditx Therapeutics(US:ADTX)2025-11-17 22:46Clinical 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].