Aditx Therapeutics(ADTX) - 2025 Q1 - Quarterly Report

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].