Fractyl Health (GUTS) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Brian Luque - Head - IR & Corporate DevelopmentHarith Rajagopalan - Co-Founder, CEO & DirectorLisa Davidson - CFO & TreasurerChi Fong - VP - Equity ResearchAvraham Novick - Biotech Equity Research AssociateMichael Difiore - Managing DirectorWhitney Ijem - Managing Director Operator Good afternoon, and welcome to Fractal Health's First Quarter twenty twenty five Financial Results and Business Updates Call. As a reminder ...

Financial Data and Key Metrics Changes - As of March 31, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $144.8 million [23] - Revenues for Q1 2025 were zero, compared to approximately $4.9 million for Q1 2024, with the previous revenue being from a $40 million distribution agreement fully recognized by the end of 2024 [23][24] - Operating expenses for Q1 2025 were approximately $16.2 million for R&D, up from $10.1 million in Q1 2024, and general and administrative expenses were approximately $3.1 million, compared to $1.8 million in Q1 2024 [24] - The net loss for Q1 2025 was approximately $24.4 million, compared to a net loss of approximately $9.8 million for Q1 2024 [25] Business Line Data and Key Metrics Changes - The company is focused on the BLA for daramycin, aimed at treating Duchenne muscular dystrophy (DMD) cardiomyopathy, with a strong emphasis on the safety and efficacy data supporting the application [5][8] - The company has been providing daramycin to all open-label extension patients for over three years, with nearly all HOPE-three patients now in open-label extension [15] Market Data and Key Metrics Changes - The company is negotiating with Nippon Shinyaku for the distribution of deramycin in Europe, with the negotiation period extended through the end of Q2 2025 [18] - The company is also exploring opportunities for its technology in other global markets [18] Company Strategy and Development Direction - The company aims to transition from a translational medicine company to a commercial stage entity, actively working with NS Pharma on launch readiness in the U.S. [12] - The company plans to have over 100 patients transition from clinical to commercial product following potential BLA approval [14] - The company is enhancing its medical leadership to guide physicians through the prescribing process for daramycin [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of the data supporting the BLA and the unmet need in treating DMD cardiomyopathy, which could lead to FDA approval [5][6] - Management noted that the FDA has not indicated any substantive issues with the application, providing confidence in the ongoing review process [30] - The company has a cash balance of approximately $145 million, with a runway extending into 2027 without additional cash infusions [20] Other Important Information - The company is developing its Stealth Exosome Platform technology as part of a next-generation drug delivery platform, although this program has taken a backseat to daramycin [19] - The company is also working on a vaccine candidate for COVID-19 prevention under Project NextGen, with Phase 1 trials set to start in Q3 2025 [20] Q&A Session Summary Question: Has the site inspection in San Diego occurred? - The site inspection is scheduled for the upcoming quarter, and management feels prepared for it [28] Question: What is the status of negotiations with Nippon Shinyaku for Europe? - The company is actively negotiating and evaluating opportunities for commercialization in Europe, while also preparing to work directly with European authorities [37] Question: What are the key drivers of proof for the efficacy data? - The statistical significance of cardiac MRI data is a key driver, showing very little chance that the data is due to chance [46] Question: What is the plan if the FDA issues a CRL for efficacy? - The company would submit data from the HOPE-three trial for skeletal muscle dysfunction if a CRL is issued [55] Question: What is the plan for the PRV voucher? - The current plan is to sell the PRV voucher to strengthen the balance sheet [72]

SoundThinking (SSTI) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Ralph Clark - President, CEO & DirectorAlan Stewart - CFOTrevor Walsh - Director - Equity Research Conference Call Participants Richard Baldry - MD & Senior Research AnalystAditya Dagaonkar - AnalystEric Martinuzzi - Senior Research AnalystJeremy Hamblin - Senior Research Analyst Operator Good afternoon, and welcome to Sound Thinking's First Quarter twenty twenty five Earnings Conference Call. My name is Kevin, and I'll ...

Dolphin Entertainment (DLPN) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants James Carbonara - PartnerBill O’Dowd - CEOMirta Negrini - CFO & COO Conference Call Participants Allen Klee - MD, Equity Research Analyst, TMT Operator Please note this conference is being recorded. I will now turn the conference over to your host, Mr. James Carbonara of Hayden IR. Sir, you may begin. James Carbonara Thank you, operator. Good afternoon. Before we begin, I'd like to remind everyone that during th ...

Heartbeam Inc (BEAT) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Robert P. Eno - CEO & DirectorTimothy Cruickshank - Chief Financial OfficerBill Sutherland - Director of ResearchLarry Holub - Director Conference Call Participants Leo Carpio - Equity Research Analyst Operator Greetings, and welcome to the HeartBeam First Quarter twenty twenty five Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the ...

Gevo (GEVO) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Eric Frey - VP of Finance & StrategyPatrick Gruber - CEO & DirectorLynn Smull - Chief Financial OfficerChris Ryan - President, Chief Operating OfficerPaul Bloom - Chief Business OfficerWhitney Mutalemwa - Equity Research Senior AssociateDerrick Whitfield - Managing Director Conference Call Participants Amit Dayal - Managing Director & Senior Technology AnalystPeter Gastreich - Managing Director - Energy and Sustainability Analys ...

Intellinetics (INLX) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Roger Grabner - Director of MarketingJim DeSocio - President & CEOJoe Spain - CFO & COO Conference Call Participants Howard Halpern - Principal Equity Analyst Operator As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Roger Grabner, Director of Marketing. Thank you. You may begin. Roger Grabner Thank you, and good afternoon, everyone. I'm pleased to welcome you to Inteleneti ...

Tenon Medical (TNON) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Steven Foster - CEO, President & DirectorKevin Williamson - Chief Financial OfficerNicholas Sherwood - Equity Research Associate Conference Call Participants Scott Henry - Managing Director & Senior Research Analyst Operator Greetings and welcome to the Tenon Medical First Quarter twenty twenty five Financial Results and Corporate Update Conference Call. As a reminder, this call is being recorded. Your hosts today are S ...

Genasys (GNSS) Q2 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Brian Alger - SVP, Corporate Development & IRRichard Danforth - CEODennis Klahn - CFO Conference Call Participants Scott Searle - Managing Director, Senior Research AnalystMike Latimore - Managing Director & Senior Research AnalystEdward Woo - Director of Research & Senior Analyst Operator At this time, it is my pleasure to turn the floor over to your host, Brian Alger, SVP, Investor Relations and Corporate Development. Welco ...

Lineage Cell Therapeutics (LCTX) Q1 2025 Earnings Call May 13, 2025 04:30 PM ET Company Participants Ioana Hone - Head, IRBrian Culley - CEOJill Howe - Chief Financial Officer Conference Call Participants William Wood - Equity Research AnalystJack Allen - Senior Research AnalystMichael Okunewitch - Senior Biotechnology AnalystAlbert Lowe - Senior Research AnalystNone - Analyst Operator Welcome to the Lineage Cell Therapeutics First Quarter twenty twenty five Conference Call. At this time, all participants a ...