Day: March 23, 2023

– Cleared dose-limiting toxicity (DLT) observation period with more frequent, dose-intensive regimen of CAB-AXL BA3011; anticipated leiomyosarcoma (LMS) cohort readout in 2H23 – Initiated the potentially registrational Phase 2, part 2 BA3011 Undifferentiated Pleomorphic Sarcoma (UPS) study in 1H23 including more frequent, dose-intensive regimens – On track for submitting a meeting request to the Food & Drug Administration (FDA) for the potentially registrational BA3011 Phase 2, part 2 non-small cell lung cancer (NSCLC) study in 1H23; anticipate both FDA feedback and initiation of Phase 2, part 2 in 2H23 – Achieved First Patient In (FPI) for CAB-ROR2 BA3021 Phase 2 squamous cell carcinoma of the head & neck (SCCHN) study – Enrolling BA3021 Phase 2 NSCLC study including more frequent, dose-intensive...

On track to complete enrollment in Phase 2/3 LIFT-AD trial of fosgonimeton for mild-to-moderate Alzheimer’s disease in mid-2023 with topline data in early 2024 Continuing to advance development of ATH-1105 as a potential clinical candidate for amyotrophic lateral sclerosis Strong balance sheet to support innovative clinical development pipeline in neurodegenerative diseases through key inflection points BOTHELL, Wash., March 23, 2023 (GLOBE NEWSWIRE) — Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and slow neurodegeneration, today announced the company’s financial results for the year ended December 31, 2022, and reviewed recent pipeline and business updates. “The progress we made throughout 2022 and in recent months continues...

4Q2022 Total Revenues of $50 Million, a 90% Y-o-Y Increase 4Q2022 Gross Profit of $14 Million, an $11 Million Y-o-Y Increase FY 2023 Total Revenue Expected to Exceed $210 Million First-Time Positive EBITDA Expected No Later than Second Half of 2023 Conference Call Scheduled for Today at 4:30 p.m. ET RAMSEY, N.J. and BOCA RATON, Fla., March 23, 2023 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (Nasdaq: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing, and developing specialty plasma-derived biologics, today announced its fourth quarter and full year 2022 financial results and provided a business update. “We achieved year-over-year revenue growth of 90% during 2022, advancing ADMA’s position as the fastest growing provider of Immunoglobulin (IG) in the U.S. market....

AUSTIN, Texas, March 23, 2023 (GLOBE NEWSWIRE) — Phunware, Inc. (NASDAQ: PHUN) (“Phunware” or “the Company”), a fully-integrated enterprise cloud platform for mobile that provides products, solutions, data and services for brands worldwide, today announced preliminary financial results for the year ended December 31, 2022. “We are thrilled to see increased interest from our channel partners, who we believe will be a key catalyst of accelerated bookings of our core software solution in 2023,” said Russ Buyse, CEO of Phunware. “Our senior management team remains laser-focused on ramping up our MaaS offering through several essential verticals, with a key focus on hospitality and healthcare. Additionally, we plan to further expand our hardware business, which in the first full year under the Phunware umbrella, helped drive total revenue...

BOSTON, March 23, 2023 (GLOBE NEWSWIRE) — PepGen Inc. (Nasdaq: PEPG), a clinical-stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2022 and highlighted recent corporate developments. “2022 was a truly transformative year for PepGen, as we generated first-in-human data for PGN-EDO51, our lead product candidate for the treatment of Duchenne muscular dystrophy (DMD), in a Phase 1 Healthy Volunteer (HV) trial, completed a successful initial public offering and made meaningful progress across our pipeline of Enhanced Delivery Oligonucleotide (EDO) investigational therapeutics,” commented James McArthur, Ph.D., President...

Company expects completion of IND-enabling studies of GT-02287 in H1 2023 Submission of dossier to start Phase 1 clinical trial of GT-02287 in GBA1 Parkinson’s Disease expected by mid-year 2023 $22.1 million in cash and cash equivalents and marketable securities as of December 31, 2022 €1.2 million non-dilutive grant awarded to Company-led consortium to advance research program in Alpha-1 Antitrypsin DeficiencyBETHESDA, Md., March 23, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today announced financial results for the full year ended December 31, 2022, and highlighted recent corporate progress. “We have made significant progress across our pipeline this past year and have amassed...

SOMERVILLE, Mass., March 23, 2023 (GLOBE NEWSWIRE) — Finch Therapeutics Group, Inc. (“Finch”, “Finch Therapeutics” or the “Company”) (Nasdaq: FNCH), a microbiome technology company with a portfolio of intellectual property and microbiome assets, today reported fourth quarter and full year 2022 financial results and provided business updates. “We believe that Finch has made significant progress towards restructuring the business to maximize value for shareholders through our robust intellectual property estate, including by continuing to support the advancement of our microbiome technology through partnerships and collaborations,” said Mark Smith, PhD, Chief Executive Officer of Finch Therapeutics. “As part of our restructuring, we have significantly decreased costs by reducing vendor and employee expenses, extending our expected...

Recent Highlights:Net revenues of $12.9 million in the fourth quarter of 2022, compared to $10.1 million in the fourth quarter of 2021 and $7.9 million in the third quarter of 2022 Gross systems shipped of 8,863, compared to 7,767 in the fourth quarter of 2021 GAAP operating loss $23.9 million in the fourth quarter of 2022, compared to $45.2 million in the fourth quarter of 2021 and $26.0 million in the third quarter of 2022 Cash and cash equivalents of $101.2 million as of December 31, 2022 Prior debt balance fully extinguished following closing of the rights offering in November 2022SAN JOSE, Calif., March 23, 2023 (GLOBE NEWSWIRE) — Eargo, Inc. (Nasdaq: EAR) (“Eargo” or the “Company”), a medical device company on a mission to improve hearing health, today reported its financial results for the fourth quarter ended December...

ESCONDIDO, Calif., March 23, 2023 (GLOBE NEWSWIRE) — One Stop Systems, Inc. (Nasdaq: OSS), a leader in AI Transportable solutions on the edge, reported results for the fourth quarter and full year ended December 31, 2022. All quarterly and full year comparisons are to the same year-ago periods, unless otherwise noted. The company will hold a conference call at 5:00 p.m. Eastern time today to discuss the results (see dial-in information below).   Q4 2022 Financial HighlightsRevenue increased 2.7% to $18.2 million. Gross profit flat at $5.0 million. Operating expenses improved as a percentage of revenue from 28.7% to 25.3%. Net loss totaled $3.3 million or $(0.16) per basic and diluted share, as compared to a loss of $386,000 or $(0.02) per basic and diluted share in 2021. The net loss in the fourth quarter of 2022 included a $3.9...

New Drug Application and Marketing Authorization Application for neffy® Currently Under Review with the FDA and EMA; FDA PDUFA Target Action Date Anticipated in Mid-2023 Strong Financial Position with $274.4 Million in Cash, Cash Equivalents and Short-term Investments to Support Operating Runway for the Next Three Years SAN DIEGO, March 23, 2023 (GLOBE NEWSWIRE) — ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis, today highlighted recent progress and reported fourth quarter and full year 2022 financial results. “This is an incredibly exciting time for ARS, with potential regulatory approvals for neffy® around the corner and a resulting transition to a commercial-stage...