Medicus Pharma Ltd. Announces Submission of Type C Meeting Request to the Food and Drug Administration (FDA)The Company's aim is to seek FDA consent to fast track the Clinical Development Program to treat Basal Cell Carcinoma (BCC) of the skin using Dissolvable Doxorubicin-containing Microneedle Arrays (D-MNA)July 08, 2025 7:30 AM EDT | Source: Medicus Pharma Ltd.Philadelphia, Pennsylvania--(Newsfile Corp. - July 8, 2025) - Medicus Pharma Ltd. (NASDAQ: MDCX) ("Medicus" or the "Company") is ple ...

Bone Biologics Corporation BBLG stock is trading higher on Friday, with a session volume of 17.22 million compared to the average volume of 38.795K as per data from Benzinga Pro.The company filed a patent application with the U.S. Patent and Trademark Office (USPTO) for its preclinical NELL-1 protein.Bone Biologics is focusing development efforts for its bone graft substitute product on bone regeneration in spinal fusion procedures. It additionally has rights to trauma and osteoporosis applications.The pate ...

Daix (France), New York City (New York, United States), June 10, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the appointment of Renée Aguiar-Lucander to its Board of Directors. The appointment was approved by shareholders at the recent Company’s Annual General Meeting. Mark Pruzanski, Chai ...

Rapport Therapeutics (RAPP) FY Conference Summary Company Overview - **Company**: Rapport Therapeutics (RAPP) - **Industry**: Biotechnology, specifically focusing on epilepsy and related neurological disorders Key Points and Arguments Clinical Development Progress - Rapport has made significant progress since going public a year ago, focusing on the clinical development of its lead program, RAP 219 [2][3] - Completed phase one studies, including multiple ascending dose studies and a human PET study, which have increased confidence in the pharmacology and specificity of RAP 219 [3][27] - Currently conducting a phase 2a proof of concept study in refractory focal epilepsy patients, utilizing an implantable neurostimulation device for diagnostics [3][6] Study Design and Rationale - The study design aims to produce compelling proof of concept results that are translatable to a phase three registration setting [5] - The study leverages an EEG biomarker correlated with clinical seizures, addressing the limitations of traditional clinical seizure diaries [6][9] - The trial includes an eight-week retrospective data collection period followed by a 28-day prospective period and an eight-week treatment phase [7][31] Data Expectations and Efficacy Measures - Data readout is expected in September, with a focus on achieving a 30% reduction in long episodes for 40% of participants, correlating to a 50% reduction in clinical seizures [19][22] - The study is designed to ensure a robust set of baseline characteristics, with a median clinical seizure count of 10, which positions the study favorably compared to other trials [48] Pipeline and Future Development - Rapport is also developing RAP 219 for bipolar disorder and neuropathic pain, with plans to initiate a bipolar study in Q3 [34][36] - The neuropathic pain program is currently on clinical hold due to requested protocol changes by the FDA [36][38] - A long-acting injectable formulation of RAP 219 is being explored, which could transform treatment for epilepsy patients [42][45] Financial Position - The company reported a cash position of $285 million, sufficient to fund activities through at least the end of 2026, covering the upcoming phase three trials and ongoing bipolar studies [51] Risks and Confidence - Confidence in the upcoming data readout is supported by a robust preclinical package and a high concordance rate between long episodes and electrographic seizures [47][49] - The company is optimistic about the translatability of the phase 2a results to phase three studies, with plans for an end-of-phase two meeting with the FDA following positive results [24][33] Additional Important Insights - The study design has received positive feedback from the epilepsy community, highlighting its objective analysis capabilities [9][17] - The long half-life of RAP 219 (8-14 days) is seen as beneficial for patient compliance, reducing the risk of breakthrough seizures [32] - The company aims to differentiate RAP 219 from existing treatments through its efficacy, dosing flexibility, and lack of sedation [23][27]

WARRINGTON, Pa., May 16, 2025 (GLOBE NEWSWIRE) -- Windtree Therapeutics, Inc. (“Windtree” or “the Company”) (NasdaqCM: WINT), a biotechnology company focused on becoming a revenue generating company and advancing early and late-stage innovative therapies for critical conditions, today reported financial results for the first quarter ended March 31, 2025 and provided key business updates. “The first quarter of 2025 was marked with significant progress. We announced our new corporate strategy to become a reve ...

DiaMedica Therapeutics (DMAC) Q1 2025 Earnings Call May 14, 2025 08:00 AM ET Company Participants Rick Pauls - President and Chief Executive OfficerScott Kellen - CFO & Secretary Conference Call Participants Thomas Flaten - Senior Research AnalystMatthew Caufield - VP - Senior Healthcare AnalystChase Knickerbocker - Senior Equity Research Analyst - Healthcare Operator Good morning, ladies and gentlemen, and welcome to the DiaMedica Therapeutics First Quarter twenty twenty five Conference Call. An audio reco ...

Verrica Pharmaceuticals Inc (VRCA) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Kevin Gardner - Managing DirectorJayson Rieger - President & CEOJohn Kirby - Interim CFOAnish Nikhanj - Senior Associate - Biotechnology Equity Research Conference Call Participants Stacy Ku - Biotechnology Equity Research AnalystSerge Belanger - Senior AnalystKemp Dolliver - Director - Research & Senior Analyst Operator Evening, ladies and gentlemen, and welcome to the Verica Pharmaceuticals First Quarter ...

Financial Data and Key Metrics Changes - In Q1 2025, the company reported total revenues of $3,400,000, primarily from WICANT, with gross product margins around 88% [16][17] - The GAAP net loss was $9,700,000 or $0.10 per share, a significant improvement from a net loss of $20,300,000 or $0.44 per share in Q1 2024 [17] - Non-GAAP net loss for Q1 2025 was $7,800,000 or $0.08 per share, compared to $17,800,000 or $0.38 per share in the same period last year [17][18] Business Line Data and Key Metrics Changes - WICANT's dispensed applicator units increased by 16.7% over Q4 2024, surpassing 10,000 units for the first time since its launch [6][7] - Collaboration revenues totaled $17,000 in Q1 2025, related to the supply of applicators to Torii Pharmaceutical [16] Market Data and Key Metrics Changes - The company is focusing on territories with high prevalence of molluscum and has established strong insurance coverage, leading to improved sales force productivity [8][9] - The company is expanding its distribution network by adding local independent pharmacies alongside national specialty pharmacy partners [9] Company Strategy and Development Direction - The company is executing a focused commercialization strategy aimed at driving demand for WICANT, which is expected to become the standard of care for molluscum contagiosum [19] - The clinical pipeline includes advancing the phase three program for WICANT in treating common warts and the development of BP315 for basal cell carcinoma [7][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, citing positive feedback from healthcare professionals and improved patient access [19] - The company is exploring opportunities to strengthen its balance sheet while advancing commercial and clinical development efforts [18] Other Important Information - The company appointed Dr. Noah Rosenberg as Chief Medical Officer and Dr. Gavin Corcoran to the Board of Directors, enhancing its leadership team [13][14] Q&A Session Summary Question: Discussion on targeting pediatricians and summer demand - Management noted an increasing number of pediatricians prescribing WICANT, with marketing efforts aimed at building awareness for the treatment [22][25] Question: Conversion time between accounts receivable and revenue - The company offers sixty-day payment terms to distributors, expecting stabilization in cash conversion as inventory levels normalize [31][32] Question: Overall TAM for molluscum and coverage split - Management indicated a significant percentage of pediatric patients are covered under Medicaid, while dermatologists have a higher percentage of commercial pay [36] Question: Trends in reordering and applicators per patient - The company is seeing solid growth in customer retention and reordering, indicating positive clinician experiences with the product [42][43]

Protalix BioTherapeutics (PLX) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Mike Moyer - Managing DirectorDror Bashan - President, CEO & DirectorEyal Rubin - SVP and CFODaniel Smith - Equity Research Associate Conference Call Participants John Vandermosten - Senior AnalystDan Akschuti - Equity Partner - Biotech AnalystNone - Analyst Operator Good morning, ladies and gentlemen, and welcome to the Protalix Biotherapeutics First Quarter twenty twenty five Financial and Business Results C ...

Financial Data and Key Metrics Changes - CorMedix reported first quarter net sales of $39.1 million, achieving profitability with a net income of $20.6 million or $0.32 per share, compared to a net loss of $14.5 million or $0.25 per share in the same quarter of the previous year [14][15]. - Adjusted EBITDA for the first quarter was $23.6 million, slightly above earlier preannounced results [6]. Business Line Data and Key Metrics Changes - The company experienced steady utilization growth with existing anchor customer U.S. Renal Care and new utilization from smaller outpatient dialysis operators and inpatient hospitals [6]. - Inpatient hospital ordering accounted for more than 6% of shipments in April, more than double from the first quarter [7]. Market Data and Key Metrics Changes - U.S. Renal Care accounted for over 80% of shipments in the first quarter, indicating its significance as the largest customer [30][31]. - The company anticipates utilization growth in the latter half of 2025 as new patients initiate therapy and new customers are added [9]. Company Strategy and Development Direction - CorMedix is focused on expanding its customer base and therapeutic indications for DEFENCATH, with a dedicated inpatient sales team now fully operational [10][13]. - The company has initiated a Phase 3 clinical study targeting central line-associated bloodstream infections, aiming for FDA submission by late 2026 or early 2027 [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the implementation timeline with a large dialysis operator customer, expecting to start mid-2025 [9]. - The company is monitoring macroeconomic factors but does not foresee them impacting inventory or earnings significantly [25]. Other Important Information - Operating expenses increased by approximately 9% to $17.4 million, with R&D expenses rising by 281% due to increased personnel and clinical trial services [15][16]. - The company has cash and cash equivalents of $77.5 million as of March 31, 2025 [16]. Q&A Session Summary Question: Updates on LDO partnership and operational expectations - Management noted heightened preparatory activities with the LDO but did not provide specific patient numbers or timelines [20][22]. Question: Inventory control and macroeconomic impacts - Management clarified that current macroeconomic issues are not affecting inventory, which is well-stocked to meet demand [25][26]. Question: Drivers behind Q1 revenue and customer contributions - U.S. Renal Care was the primary driver of revenue, accounting for over 80% of shipments, with growth also seen in smaller customers and hospitals [30][31]. Question: Reimbursement negotiations with Medicare Advantage - Management expects to enter negotiations with MA plans during TDAPA coverage, with 40% of claims currently from MA plans [46][47]. Question: Inpatient segment growth potential - Management indicated that the inpatient segment has potential for growth but is difficult to quantify at this stage [52][53].