VANCOUVER, Wash. and NEW YORK, April 14, 2025 (GLOBE NEWSWIRE) -- Absci Corporation (Nasdaq: ABSI), a data-first generative AI drug creation company, today announced the company will report business updates and financial and operating results for the first quarter 2025 after market close on Tuesday, May 13, 2025. Absci management will webcast a corresponding conference call beginning at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its business developments, financial and operating results, and ...

Core Viewpoint - Absci Corporation (NASDAQ: ABSI) has experienced a significant decline in investor confidence, with shares dropping to just above $2, nearing its 52-week low since February 2025 [1] Company Summary - Absci Corporation's stock has seen a notable decrease in value, reflecting a loss of confidence among investors [1]

In the world of upstart pharmaceuticals and healthcare companies, timing is everything. These firms often struggle for an extended period of time before becoming profitable, but when they see success with a new product—or even clinical trial results suggesting a new product could be on the horizon—they can experience huge rallies in a very short period of time. While timing the market is typically a losing proposition for investors, there is something to be said for tracking firms that other investors are i ...

Core Points - U.S. stock futures are higher, with Dow futures up approximately 0.2% [1] - Absci Corporation reported a quarterly loss of 25 cents per share, missing the analyst consensus estimate of 23 cents per share, with sales of $665,000 missing the estimate of $1.778 million [2] Company Performance - Absci Corporation shares fell 9.4% to $2.79 in pre-market trading following the disappointing financial results [2] - Regencell Bioscience Holdings Limited shares dropped 16.1% to $26.50 after a significant increase of 70% the previous day [3] - Turkcell Iletisim Hizmetleri A.S. shares fell 14.8% to $6.43 in pre-market trading [3] - HealthEquity, Inc. shares declined 14.7% to $86.68 after reporting worse-than-expected quarterly earnings [3] - Tonix Pharmaceuticals Holding Corp. shares fell 13% to $17.87 due to weak quarterly sales [3] - Waterdrop Inc. shares declined 6.5% to $1.30 following a 5% drop on Tuesday [3] - Resolute Holdings Management, Inc. shares decreased 4.3% to $34.53 after an 18% dip on Tuesday [3] - Target Hospitality Corp. shares fell 3.8% to $5.63 in pre-market trading [3] - Alpha Technology Group Limited shares dropped 3.2% to $31.47 after a 14% gain on Tuesday [3]

Drug Discovery and Development - The Integrated Drug Creation platform enables the company to go from AI-designed antibodies to wet lab-validated candidates in as little as six weeks[28]. - AI could yield time and cost savings of at least 25-50% in drug discovery up to the preclinical stage[27]. - Traditional drug discovery can take 12-15 years and cost over $1 billion to bring a drug to market[26]. - The success rate for traditional drug discovery is estimated at less than 5%[26]. - The company has developed an Integrated Drug Creation platform aimed at generating first-in-class drugs and addressing difficult-to-drug targets through AI-guided antibody drug creation and lead optimization[33]. - The platform is expected to reduce the time to IND (Investigational New Drug) from the industry average of 4-6 years to approximately 2 years, allowing for more programs to be developed in a shorter timeframe[38]. - The company has the capability to evaluate billions of unique protein variants, enhancing the probability of identifying promising product candidates[65]. - The AI models utilized by the company improve with each new program, aiming for in silico creation of novel antibody therapeutics with desired pharmacologic attributes[66]. Product Candidates - As of December 31, 2024, the company has identified four wholly owned, internally developed programs focusing on cytokine biology, with several undisclosed internal pipeline programs in early discovery phases[40]. - ABS-101, the first development candidate, targets TL1A for the treatment of Inflammatory Bowel Disease (IBD), with a market opportunity driven by an estimated 2.4 million individuals currently affected in the U.S.[42]. - ABS-101 has demonstrated a 2-3x extended half-life compared to clinical competitors, supporting an anticipated dosing interval of 8-12 weeks[46]. - ABS-201, the second development candidate, targets the prolactin receptor (PRLR) for androgenic alopecia (AGA), with a potential patient population of approximately 80 million individuals in the U.S.[50]. - In preclinical studies, ABS-201 showed superior hair regrowth compared to minoxidil, achieving full hair growth after 22 days[53]. Partnerships and Collaborations - The company has 25 active partnered programs as of December 31, 2024, across various therapeutic areas, including oncology and dermatology[57]. - The strategy focuses on leveraging generative AI models and synthetic biology to enhance the drug creation process and drive innovation in antibody therapeutics[58]. Intellectual Property and Compliance - The company emphasizes the importance of maintaining intellectual property protection for its technologies to prevent competition[13]. - The company has a broad intellectual property estate, including 79 issued patents and 159 pending patent applications worldwide[81]. - Continuous investment in the team and platform technologies is planned to maintain technological differentiation and expand the intellectual property portfolio[64]. - The company is committed to integrating ESG considerations into its business strategy as it continues to grow[85]. Regulatory and Clinical Trials - The FDA requires rigorous preclinical testing, including laboratory evaluations and animal studies, before human clinical trials can begin[91]. - An Investigational New Drug (IND) application must be submitted to the FDA, which becomes effective 30 days after receipt unless safety concerns arise[92]. - Human clinical trials are conducted in three phases: Phase 1 focuses on safety and dosage, Phase 2 evaluates efficacy and side effects, and Phase 3 assesses overall risk/benefit ratio[95]. - The Biologics License Application (BLA) must include all relevant data from preclinical and clinical studies, including both positive and negative results[99]. - The FDA aims to review standard BLAs within ten months and priority reviews within six months after acceptance for filing[100]. - Approval of a BLA is contingent upon compliance with current Good Manufacturing Practices (cGMP) and successful pre-approval inspections[101]. - The FDA may issue an approval letter for commercial marketing or a Complete Response Letter detailing deficiencies in the BLA[103]. - Expedited development programs, such as fast track and breakthrough therapy designations, are available for products addressing serious conditions[105][106]. - Priority review designation aims for FDA action within six months for applications showing significant improvement over existing therapies[107]. - Post-marketing studies may be required to monitor the safety and effectiveness of approved products[104]. - The FDA may grant accelerated approval for product candidates that show a meaningful advantage over existing therapies and demonstrate effects on surrogate endpoints[108]. - Orphan Drug Designation can be granted for products intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S., providing potential exclusivity for seven years upon first approval[110]. - The FDA requires that sponsors of orphan drugs conduct post-marketing clinical trials to verify clinical benefits, with updates required every 180 days[108]. - Pediatric exclusivity can add six months to existing exclusivity periods if a pediatric trial is completed according to FDA requests[114]. - The FDA has the authority to withdraw approval if compliance with regulatory requirements is not maintained, which can lead to significant operational disruptions[118]. - The Biologics Price Competition and Innovation Act allows for a 12-year exclusivity period for reference products, during which biosimilars cannot be approved[123]. - The FDA mandates that all advertising and promotional materials for products granted accelerated approval be submitted for review prior to marketing[108]. - Companies must comply with stringent cGMP regulations, and any deviations can result in enforcement actions that disrupt operations[116]. - The Hatch-Waxman Amendments allow for a patent term extension of up to five years for biological products, but cannot exceed a total of 14 years from the approval date[120]. - Regulatory approval in one country does not guarantee approval in others, potentially impacting the overall market strategy[124]. Company Overview and Operations - The company was originally formed in August 2011 and converted to a Delaware corporation in October 2020 under the name Absci Corporation[130]. - The company’s principal executive offices are located in Vancouver, Washington[131]. - The company files reports with the SEC, including Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, which are available on its investor relations website[133]. - The company may announce material information through SEC filings, press releases, and public conference calls[134]. - The company is subject to various anti-corruption laws, including the U.S. Foreign Corrupt Practices Act, which could impact its operations[129]. - The company has a commitment to compliance with anti-corruption laws, particularly in interactions with healthcare professionals[129]. - The company’s website provides access to its periodic and current reports free of charge[132]. - The company’s investor relations website is a key channel for disclosing material information to the public[134].

Revenue Performance - Revenue for Q4 2024 was $0.7 million, up from $0.3 million in Q4 2023, representing a 133% increase[7] - Full year 2024 revenue totaled $4.5 million, down from $5.7 million in 2023, reflecting a 21% decrease[10] - Partner program revenue for Q4 2024 was $665,000, a 96.7% increase from $338,000 in Q4 2023[22] - Total revenues for the year ended December 31, 2024, were $4,534,000, down 20.7% from $5,718,000 in 2023[22] Research and Development Expenses - Research and development expenses for Q4 2024 were $18.4 million, compared to $12.3 million in Q4 2023, marking a 50% increase[8] - Full year 2024 research and development expenses reached $63.9 million, up from $48.1 million in 2023, a 33% increase[11] - Research and development expenses increased to $18,377,000 in Q4 2024, up 49.5% from $12,269,000 in Q4 2023[22] Net Loss - Net loss for Q4 2024 was $29.0 million, compared to a net loss of $23.5 million in Q4 2023, indicating a 23% increase in losses[9] - Full year 2024 net loss was $103.1 million, down from $110.6 million in 2023, a 7% improvement[13] - Net loss for Q4 2024 was $28,983,000, compared to a net loss of $23,545,000 in Q4 2023, reflecting a 23.5% increase in losses[22] - Basic and diluted net loss per share for the year was $0.94, an improvement from $1.20 in 2023[22] Cash and Assets - Cash, cash equivalents, and short-term investments as of December 31, 2024, were $112.4 million, down from $127.1 million as of September 30, 2024[14] - Cash and cash equivalents decreased to $41,213,000 as of December 31, 2024, down 43.1% from $72,362,000 in 2023[24] - Total assets as of December 31, 2024, were $213,608,000, a decrease of 1.6% from $217,298,000 in 2023[24] Financial Position - Accumulated deficit increased to $509,601,000 in 2024, up from $406,495,000 in 2023, indicating a growing financial challenge[24] - Total stockholders' equity rose to $179,133,000 in 2024, compared to $176,176,000 in 2023, showing a slight improvement[24] - Total operating expenses for the year decreased to $113,422,000 in 2024, a reduction of 6.7% compared to $121,233,000 in 2023[22] Clinical Development - ABS-101 is expected to initiate Phase 1 clinical studies in the first half of 2025, with interim data readout anticipated in the second half of 2025[5] - ABS-201, targeting androgenic alopecia, has a potential patient population of approximately 80 million in the U.S.[5] - Absci entered into a strategic collaboration with AMD, which includes a $20 million equity investment[3]

Core Insights - Absci Corporation has made significant advancements in its AI Integrated Drug Creation platform, showcasing new breakthroughs and preparing to enter clinical stages with its drug candidates [2][5][6] Financial Performance - For Q4 2024, Absci reported revenue of $0.7 million, an increase from $0.3 million in Q4 2023 [8] - Full-year revenue for 2024 was $4.5 million, down from $5.7 million in 2023 [11] - Research and development expenses rose to $18.4 million in Q4 2024 from $12.3 million in Q4 2023, totaling $63.9 million for the full year, up from $48.1 million in 2023 [9][12] - Selling, general, and administrative expenses decreased to $8.8 million in Q4 2024 from $9.3 million in Q4 2023, totaling $36.2 million for the full year, down from $37.8 million in 2023 [10][13] - The net loss for Q4 2024 was $29.0 million, compared to $23.5 million in Q4 2023, with a full-year net loss of $103.1 million, an improvement from $110.6 million in 2023 [10][13] Pipeline Developments - The company is advancing its internal pipeline, with ABS-101 expected to initiate Phase 1 studies in the coming months, marking a significant milestone [2][5] - ABS-201, targeting androgenic alopecia, has shown promising preclinical results and is anticipated to enter Phase 1 clinical trials in early 2026 [5][6] - ABS-301, a fully human antibody for an undisclosed immuno-oncology target, has completed initial in vivo target validation studies, supporting its further development [6] Strategic Collaborations - Absci entered a strategic collaboration with AMD, which includes a $20 million investment to enhance AI drug discovery capabilities [5] - New partnerships have been established with Owkin and Invetx to co-develop therapeutic candidates and leverage Absci's generative AI models [5] Cash Position - As of December 31, 2024, Absci had cash, cash equivalents, and short-term investments totaling $112.4 million, sufficient to fund operations into the first half of 2027 [7][14]

Core Insights - Absci Corporation will report its business updates and financial results for Q4 and full year 2024 on March 18, 2025, after market close [1] - A conference call will be held at 4:30 p.m. Eastern Time to discuss the results and outlook, with a live webcast available on the company's investor relations website [2] Company Overview - Absci is a data-first generative AI drug creation company that integrates AI with scalable wet lab technologies to enhance the development of biologics [3] - The company's Integrated Drug Creation™ platform aims to accelerate the time to clinic and improve the probability of success by optimizing multiple drug characteristics simultaneously [3] - Absci can screen billions of cells weekly, transitioning from AI-designed candidates to wet lab-validated candidates in as little as six weeks [3]

Core Points - Absci Corporation granted a non-statutory stock option to a newly-hired non-executive employee for 162,800 shares as part of its 2023 Inducement Plan [1][2] - The exercise price of the stock option is set at $3.42 per share, which is the closing price on the grant date [2] - The stock option has a 10-year term and vests over four years, with 25% vesting on the one-year anniversary and the remaining 75% vesting in approximately equal monthly installments over the next three years [2] Company Overview - Absci is a generative AI drug creation company that integrates AI with scalable wet lab technologies to enhance the development of biologics [3] - The company's Integrated Drug Creation™ platform aims to accelerate the time to clinic and improve the probability of success by optimizing multiple drug characteristics simultaneously [3] - Absci can screen billions of cells weekly, transitioning from AI-designed candidates to wet lab-validated candidates in as little as six weeks [3]

Core Insights - Absci Corporation is a data-first generative AI drug creation company that will participate in the KeyBanc Capital Markets Healthcare Forum [1][2] - The company utilizes its Integrated Drug Creation™ platform to accelerate drug development and increase the probability of success by optimizing multiple drug characteristics [3] - Absci can screen billions of cells weekly, transitioning from AI-designed candidates to wet lab-validated candidates in as little as six weeks [3] Company Overview - Absci combines AI with scalable wet lab technologies to create biologics more efficiently for patients [3] - The company is headquartered in Vancouver, WA, with additional facilities in New York City and Zug, Switzerland [3] - Absci's investor relations website provides access to live and archived webcasts for interested parties [2]