TORONTO, May 15, 2025 (GLOBE NEWSWIRE) -- PharmAla Biotech Holdings Inc. (“PharmAla” or the “Company”) (CSE: MDMA) (OTC:MDXXF), a biotechnology company focused on the research, development, and manufacturing of LaNeo™ MDMA and novel derivatives of MDMA (MDXX class molecules), is thrilled to formally announce the launch of the Phenesafe AI platform, an AI technology stack specifically designed to derive novel substituted phenethylamine molecules for patent and subsequent development. “Over the past year, our ...

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $1.2 million, reflecting ongoing progress in partner programs [19] - Research and development expenses increased to $16.4 million from $12.2 million in the prior year, driven by advancements in internal programs [19] - Selling, general and administrative expenses rose to $9.5 million from $8.7 million, primarily due to increased stock compensation [20] - Cash, cash equivalents, and short-term investments at the end of the quarter totaled $134 million, up from $112.4 million as of December 31, 2024 [20] Business Line Data and Key Metrics Changes - The company initiated its first in-human clinical trial for ABS 101, marking its transition to a clinical-stage biotech [6] - ABS 201, targeting androgenetic alopecia, is progressing towards a first-in-human trial expected in early 2026 [13] - The company is advancing multiple programs, including ABS 301 and ABS 501, with ongoing preclinical studies [14][42] Market Data and Key Metrics Changes - ABS 201 targets a market of approximately 80 million adults in the U.S. affected by androgenetic alopecia, with potential for significant therapeutic innovation [11] - The company is exploring additional indications for ABS 201, including endometriosis, indicating a broader market strategy [34] Company Strategy and Development Direction - The company aims to leverage its AI platform to design novel therapeutics addressing unmet medical needs, focusing on high-value proprietary internal programs [17] - Plans to retain and develop ABS 201 through later stages of clinical development to maximize value [19] - The company is engaged in discussions with potential partners for drug creation partnerships, anticipating signing agreements with large pharma [16][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to execute across its portfolio, with a strong balance sheet supporting ongoing investments [21] - The FDA's proposal to reduce animal testing aligns with the company's AI-driven approach to drug development, presenting a favorable regulatory environment [15][67] - Management expects to see enhanced deal terms for future partnerships due to recent clinical successes [61] Other Important Information - The company is committed to leading biotech innovation through AI, aiming to deliver life-changing treatments [16] - Interim results from the ABS 101 trial are expected later in 2025, with a focus on safety and tolerability [8][24] Q&A Session Summary Question: What are the expectations for ABS 101's phase one top line results? - Management is looking for a favorable safety profile, low immunogenicity, and target engagement similar to previous data presented [26][27] Question: Can ABS 201 potentially be self-administered in the future? - Management believes it could be self-administered but will initially work with dermatologists for effective administration [28] Question: How is market segmentation being approached for ABS 201? - The company sees potential efficacy across various segments of the androgenetic alopecia population and will evaluate this in clinical trials [31][33] Question: What is the expected timeline for ABS 301's development candidate? - The company is progressing towards a drug candidate nomination but has not disclosed a specific timeline [42] Question: How does the company view its cost structure in the current market? - The company is focused on leveraging efficiencies from its AI platform to potentially reduce costs and reallocate resources [62]

Funding and Investment - Isomorphic Labs has raised $600 million in external capital for the first time, led by Thrive Capital with participation from GV and Alphabet [1] - The funding will accelerate the development of Isomorphic's AI drug design engine and support the goal of bringing discovered drugs to clinical trials [1] Company Background - Isomorphic Labs was founded by DeepMind co-founder Demis Hassabis, leveraging DeepMind's software for AI drug discovery, including the AlphaFold model [2] - The company secured strategic partnerships with Eli Lilly and Novartis last year, potentially generating up to $3 billion in milestone payments for access to its AI model [2] Leadership and Recognition - Demis Hassabis stated that while Isomorphic Labs did not need the capital, the funding will assist in hiring top research scientists [3] - Hassabis and DeepMind researcher John Jumper received a Nobel Prize in chemistry in 2024 for their work on AlphaFold [3]