Codexis (CDXS) Q1 2025 Earnings Call May 14, 2025 04:30 PM ET Speaker0 As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to your host, Carrie McKim, Director of Investor Relations. Carrie, please go ahead. Speaker1 Thank you, operator. With me today are Doctor. Stephen Dilly, Codexis' Chairman and Chief Executive Officer Georgia Erbez, Chief Financial Officer and Doctor. Stephane Lutz, Senior Vice President of Research. During this call, management will making a nu ...

Core Viewpoint - Edesa Biotech, Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on its vitiligo drug candidate EB06, while reporting financial results that reflect a strategic pivot in operational activities towards this program [1][4]. Financial Overview - For the three months ended March 31, 2025, total operating expenses decreased by $0.6 million to $1.6 million compared to $2.2 million for the same period in 2024 [7] - The company reported a net loss of $1.6 million, or $0.30 per common share, for the quarter, an improvement from a net loss of $1.9 million, or $0.58 per common share, for the same quarter last year [8] - For the six months ended March 31, 2025, total operating expenses decreased by $0.6 million to $3.5 million compared to $4.1 million for the same period in 2024 [9] - The net loss for the six months was $3.2 million, or $0.74 per common share, compared to a net loss of $3.5 million, or $1.12 per common share, for the same period last year [11] Business Development - The company completed a $15 million equity financing to support the development of EB06, an anti-CXCL10 monoclonal antibody for vitiligo [2] - Edesa has initiated outreach to potential investigators and manufacturing activities to support U.S. regulatory approval for a Phase 2 study in moderate-to-severe nonsegmental vitiligo patients [2][6] - The planned Phase 2 study for EB06 is already approved in Canada, with drug manufacturing data expected to be submitted to the FDA in the second half of 2025 [6] Research and Development - Research and development expenses decreased by $0.7 million to $0.5 million for the three months ended March 31, 2025, primarily due to decreased external research expenses related to the investigational drug paridiprubart [9][16] - General and administrative expenses increased by $0.2 million to $1.2 million for the three months ended March 31, 2025, mainly due to increased salaries and related costs [9] Cash Position - As of March 31, 2025, Edesa had cash and cash equivalents of $13.9 million and working capital of $13.5 million [12]

Core Insights - BioCardia, Inc. reported financial results for Q1 2025, highlighting advancements in its cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases [1][8] Recent Business Highlights - The CardiAMP autologous cell therapy for ischemic heart failure (BCDA-01) showed a 107-second increase in exercise tolerance and an 82% reduction in angina episodes at the six-month follow-up [2] - The CardiALLO cell therapy (BCDA-03) completed a low dose cohort with no adverse events, and the independent Data Safety Monitoring Board recommended proceeding with the study [3] - The Helix biotherapeutic delivery system demonstrated safety in the CardiAMP HF Trial, with no procedure-related deaths or complications, supporting FDA approval efforts [3] Intellectual Property - BioCardia holds over 60 patents and applications globally, with a recent patent granted in Japan for a delivery catheter that enhances minimally invasive treatment options [5][6] Financial Results - Research and development expenses increased to approximately $1.5 million in Q1 2025 from $1.2 million in Q1 2024, while selling, general, and administrative expenses rose to approximately $1.2 million from $1.1 million [11] - The net loss for Q1 2025 was approximately $2.7 million, compared to $2.3 million in Q1 2024, with net cash used in operations at approximately $1.6 million [11][15] Upcoming Milestones - The company plans to submit data to the FDA and Japan PMDA regarding the CardiAMP cell therapy and Helix delivery system, with additional enrollment in the CardiAMP HF II Trial [9][11]

LOS ANGELES, May 14, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced financial results for its first quarter ended March 31, 2025, and provided a corporate update.First Quarter 2025 and Recent Developments: Anticipating announce ...

Core Insights - Genmab is presenting 14 abstracts on epcoritamab at the 30th European Hematology Association Congress, showcasing its development across various patient populations and treatment settings [1][4] - Epcoritamab is a T-cell engaging bispecific antibody designed for treating diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) [6][7] Development Program - The abstracts include data from Phase 1/2 trials evaluating epcoritamab in combination with other therapies for relapsed/refractory DLBCL and previously untreated DLBCL [2][4] - Key trials include EPCORE NHL-2 and NHL-5, focusing on combinations with rituximab and polatuzumab vedotin [2][5] Presentation Details - Oral presentations will occur on June 15, 2025, featuring significant findings from the EPCORE NHL-2 and NHL-5 trials [5] - Additional results from NHL-1 and NHL-3 trials will be presented as posters, highlighting three years of follow-up data [2][5] Regulatory Status - Epcoritamab has received regulatory approval in specific lymphoma indications in the U.S., Japan, and the EU, and is co-developed with AbbVie [7][10] - The companies are pursuing further international regulatory approvals for additional indications [7] Future Directions - Genmab and AbbVie are conducting five ongoing Phase 3 trials to evaluate epcoritamab's efficacy as a monotherapy and in combination therapies across various hematologic malignancies [8][9] - The companies aim to establish epcoritamab as a core therapy for B-cell malignancies [4][8]

Zevra Therapeutics (ZVRA) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Nichol Ochsner - Vice President of Investor Relations & Corporate CommunicationsNeil McFarlane - President & CEOJoshua Schafer - CCOR. LaDuane Clifton - CFO, Secretary & TreasurerSumant Kulkarni - Managing DirectorJason Butler - Managing Director & Biotechnology Equity ResearchEddie Hickman - Vice President Conference Call Participants Lachlan Hanbury-Brown - Biotech Equity Research Analyst Operator Good afternoon ...

Core Insights - Absci Corporation has initiated dosing of participants in the first-in-human study of ABS-101, an anti-TL1A antibody, with interim data expected in the second half of 2025 [1][5] - The company has released non-human primate data for ABS-201, an anti-PRLR antibody, showing extended half-life and high subcutaneous bioavailability, with Phase 1 initiation anticipated in early 2026 [1][5] - Absci's cash, cash equivalents, and short-term investments are sufficient to fund operations into the first half of 2027 [1][6] Internal Pipeline Updates - The first-in-human study of ABS-101 is a randomized, double-blind, placebo-controlled trial evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics in approximately 40 healthy adult participants [5] - ABS-201 is being developed for androgenetic alopecia, targeting a significant unmet clinical need with a potential patient population of around 80 million in the U.S. [5] - The NHP study for ABS-201 demonstrated a high subcutaneous bioavailability of over 90% and the potential for Q8W-Q12W dosing intervals in humans [5] Financial Results - For Q1 2025, Absci reported revenue of $1.2 million, an increase from $0.9 million in Q1 2024 [7] - Research and development expenses rose to $16.4 million in Q1 2025 from $12.2 million in Q1 2024, driven by advancements in internal programs [8] - The net loss for Q1 2025 was $26.3 million, compared to $22.0 million in Q1 2024 [9] Cash Position - As of March 31, 2025, Absci had cash, cash equivalents, and short-term investments totaling $134.0 million, up from $112.4 million at the end of 2024 [10]

Phase 1 clinical trial of CMP-CPS-001 in Urea Cycle Disorders (UCDs) ongoing, with dosing completed in multiple ascending dose (MAD) cohort 3; safety, pharmacokinetic, and pharmacodynamic data expected Q4 2025CTA successfully submitted in Europe for Phase 1b clinical trial in female OTC heterozygotesNominated development candidate, CMP-SYNGAP-01, to address SYNGAP1-related disorders; GLP toxicology studies expected to be initiated in 2025American Society of Cell and Gene Therapy (ASGCT) oral presentations t ...

Q1 2025 net revenue of $20.4 million, driven by product net revenue of $17.2 million Completed sale of PRV for gross proceeds of $150 million, positioning balance sheet to drive the Company’s commercial launches and development programs Company to host conference call and webcast today, May 13, 2025, at 4:30 p.m. ET CELEBRATION, Fla., May 13, 2025 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living ...

First patient dosed in LINNET Phase 2 study of lorigerlimab in ovarian and other gynecologic cancers Clinical update on LORIKEET, a randomized 150-patient Phase 2 study of lorigerlimab in combination with docetaxel in patients with mCRPC, expected in second half of 2025 Advancement in portfolio of innovative ADC product candidates, including MGC026, MGC028 and MGC030 Cash, cash equivalents and marketable securities of $154.1 million as of March 31, 2025 ROCKVILLE, Md., May 13, 2025 (GLOBE NEWSWIRE) -- Macr ...