CORAL GABLES, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- Relmada Therapeutics, Inc. (Nasdaq: RLMD, “Relmada”, or “the Company”), a clinical-stage biotechnology company committed to advancing innovative breakthrough therapies, today announced plans to host a conference call and webcast on Monday, May 12, 2025 at 4:30 PM ET to discuss financial results for the first quarter ended March 31, 2025 and recent business progress. Conference Call and Webcast Information: Date: Monday, May 12, 2025 at 4:30 PM ETParticipa ...

Core Insights - Sibylla Biotech has appointed Dieter Weinand as Chairman of its Board of Directors, bringing over 35 years of experience in the pharmaceutical sector [1][4] - The company aims to advance its innovative PPI-FIT technology and pipeline of folding interference small molecules to address challenging therapeutic areas [1][3] Company Overview - Sibylla Biotech is focused on transforming drug discovery by targeting protein folding intermediates, which represents a new druggable dimension in pharmacology [6] - The proprietary PPI-FIT technology allows the company to predict and target intermediate steps in the protein folding process, leading to targeted protein degradation [6][7] Leadership Background - Dieter Weinand has a distinguished career, having held significant roles at major pharmaceutical companies such as Bayer Pharmaceuticals AG, Sanofi, Bristol-Meyers Squibb, and Pfizer [4][5] - His leadership experience includes overseeing the integration of R&D, manufacturing, and commercial functions, contributing to the launch of several high-impact medicines [4] Strategic Vision - The appointment of Mr. Weinand is seen as a strategic move to unlock access to previously undruggable targets and drive the next stages of Sibylla's growth [2][3] - The company is building a pipeline of treatments for high medical need diseases across multiple therapeutic areas, with a mission to bring protein folding interference therapeutics to patients [7]

Financial Data and Key Metrics Changes - R&D expenses for Q1 2025 were $118.6 million, up from $100.1 million in Q1 2024, primarily due to a $30 million payment to Alnylam and expenses related to the ECLIPSE program initiation [36] - SG&A expenses for Q1 2025 were CAD 23.9 million, down from CAD 36.3 million in Q1 2024, largely due to cost savings from headcount reductions [37] - Net loss for Q1 2025 was $121 million compared to a net loss of $65.3 million in Q1 2024, driven by a significant drop in revenue from $52 million to approximately $3 million [38] Business Line Data and Key Metrics Changes - The hepatitis delta program has initiated the ECLIPSE Phase III program, with the first patient enrolled, marking a significant milestone [22] - The oncology portfolio continues to progress, with promising data from the Pro X10 dual masked T cell engager programs, particularly in HER2 positive colorectal cancer [15][28] Market Data and Key Metrics Changes - The estimated addressable market for hepatitis delta includes approximately 61,000 RNA positive patients in the U.S. and 113,000 in EU member countries plus the UK, highlighting the potential for significant commercial opportunity [10] - The company emphasizes that hepatitis delta has characteristics of a rare disease market with severe outcomes, supporting a value-based pricing model [11] Company Strategy and Development Direction - The strategic focus remains on advancing both infectious disease and oncology programs, with a commitment to developing a new standard of care for hepatitis delta virus infection [8] - The company is exploring collaborations to maximize value from the Pro X10 platform and has advanced a broadly neutralizing antibody in its HIV cure program [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenging market environment for the biotechnology sector but emphasizes a disciplined approach to capital allocation and operational excellence [20] - The company maintains a strong cash position of approximately $1 billion, providing a runway extending into mid-2027 to advance key programs [39] Other Important Information - The agreement with Alnylam regarding the profit-sharing arrangement has been clarified, with the company recognizing CAD 30 million as R&D expense in Q1 2025 [39] - The company is preparing for the upcoming EASL Congress to present data from its hepatitis B program and the Solstice trial [26] Q&A Session Summary Question: Alnylam decision and future oncology updates - Alnylam opted out of the profit-sharing arrangement based on their strategic portfolio prioritization, prior to the latest HCV functional cure data being available [47] - Future oncology data updates will include mature data at higher dose levels and comparative data between dosing regimens, expected to be shared at medical congresses or focused investor events [46] Question: ECLIPSE study enrollment and timelines - The ECLIPSE one study aims to complete enrollment by the end of 2025, with ECLIPSE two having a 24-week endpoint [55] Question: Competitive positioning of T cell engagers - The company believes its dual mask technology offers a favorable safety profile and differentiates it from competitors, with a focus on convenience and quality of life for patients [60][62] Question: Functional cure rates and HBV program development - The company anticipates presenting data showing a 20% functional cure rate in the doublet and a 30% in the triplet at the upcoming EASL [77] - Further development of the HBV program is contingent on securing a global development and commercialization partner [78] Question: Changes in U.S. guidelines for HBV diagnosis - No changes have been made to U.S. guidelines for delta diagnosis, but there is hope for increased awareness and reflex testing in the future [101]

Core Viewpoint - Pasithea Therapeutics has successfully closed a public offering, raising a total of approximately $6.3 million, which will be utilized for various corporate purposes including ongoing research and clinical trials [1][4]. Group 1: Offering Details - The company closed a public offering of 3,571,428 shares of common stock at a price of $1.40 per share, along with Series C and Series D warrants [1][2]. - The Series C warrants have an exercise price of $1.40 and expire in five years, while the Series D warrants also have an exercise price of $1.40 and expire in 18 months [2]. - The total gross proceeds from the offering were $5.0 million, with additional proceeds of approximately $1.3 million from the exercise of Series D warrants [4]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated for general corporate purposes, including ongoing research, clinical trials, and the development of new technologies [4]. - The company plans to invest in or acquire synergistic companies and engage in licensing activities related to its current and future product candidates [4]. Group 3: Company Overview - Pasithea Therapeutics is a clinical-stage biotechnology company focused on developing innovative treatments for central nervous system disorders and RASopathies [7].

Phase 1 Single Ascending Dose Trial of DT-216P2 for Friedreich Ataxia (FA) Program Ongoing Well-Capitalized with Cash and Securities of $229.7 Million to Fund Operations Through up to Four Potential Clinical Proof-of-Concept Data Sets CARLSBAD, Calif., May 07, 2025 (GLOBE NEWSWIRE) -- Design Therapeutics, Inc. (Nasdaq: DSGN), a clinical-stage biotechnology company developing treatments for serious degenerative genetic diseases, today announced progress across its portfolio of GeneTAC candidates and reported ...

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NEW YORK, May 07, 2025 (GLOBE NEWSWIRE) -- The Gross Law Firm issues the following notice to shareholders of Sana Biotechnology, Inc. (NASDAQ: SANA). Shareholders who purchased shares of SANA during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT US HERE: https://securitiesclasslaw.com/securities/sana-biotechnology-inc-loss-submission-form/?id=147117&from=3 CLASS PERIOD ...

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has prepared detailed reports on more than 1,000 companies [1]

NeuroSense Announces Global CDMO Selection and Manufacturing Scale-Up, Enabling Rapid Pathway to Commercialization for What is Projected to be a $100-150M Canadian Market OpportunityCAMBRIDGE, Mass., May 7, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) ("NeuroSense"), a late-stage clinical biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that it has successfully scaled-up its production of PrimeC to commercial scale, marking a signif ...

Core Insights - Alterity Therapeutics is set to present multiple clinical program findings related to ATH434 for Multiple System Atrophy (MSA) at the 2025 International MSA Congress in Boston, MA, from May 9 to 11, 2025 [1][2] - The company has received Fast Track Designation from the US FDA for ATH434, indicating significant interest in its clinical advancements [2][4] Company Overview - Alterity Therapeutics is a biotechnology company focused on developing disease-modifying treatments for neurodegenerative diseases, particularly MSA and Parkinson's disease [3][9] - The lead candidate, ATH434, is designed to inhibit the aggregation of pathological proteins and has shown preclinical efficacy in reducing α-synuclein pathology [3][4] Clinical Trial Details - The ATH434-201 Phase 2 clinical trial involved 77 adults and demonstrated statistically significant improvements in the modified Unified Multiple System Atrophy Rating Scale (UMSARS) Part I compared to placebo [5] - The trial also indicated that ATH434 stabilized or reduced iron accumulation in MSA-affected brain regions and was well tolerated with no serious adverse events attributed to the drug [5][4] Research Collaborations - The bioMUSE natural history study, conducted in collaboration with Vanderbilt University Medical Center, aims to track MSA progression and has enrolled approximately 20 individuals [6] - This study provides valuable data for optimizing clinical trial designs and evaluating biomarkers for target engagement and efficacy [6] Disease Context - MSA is a rare, rapidly progressive neurodegenerative disease affecting at least 15,000 individuals in the U.S., characterized by autonomic dysfunction and impaired movement [7] - Currently, there are no approved therapies that can slow the progression of MSA, highlighting the significance of Alterity's efforts in this area [7]