Day: March 18, 2024

– Enrollment completed in Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy; topline data expected in second quarter of 2024 – – Presented positive BAER-101 preclinical data at American Epilepsy Society (AES) and American Society for Experimental Neurotherapeutics (ASENT) Annual Meetings and in publication Drug Development Research – – Final agreement reached with FDA on study design and analysis approach for Phase 3 safety study of IV tramadol – MIAMI, March 18, 2024 (GLOBE NEWSWIRE) — Avenue Therapeutics, Inc. (Nasdaq: ATXI) (“Avenue” or the “Company”), a specialty pharmaceutical company focused on the development and commercialization of therapies for the treatment of neurologic diseases, today reported financial results and recent corporate highlights for the year ended...

– Preliminary LUNA data presented at the Annual Meeting of the Macula Society support potential best-in-class clinical activity and an encouraging safety profile in patients with wet AMD – – Completed $127.5 million private placement financing with new and existing institutional investors – – Cash runway expected into late 2025 – – 1-for-10 reverse stock split to be effective March 21, 2024 – REDWOOD CITY, Calif., March 18, 2024 (GLOBE NEWSWIRE) — Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage company pioneering the use of gene therapy as a new standard of care for highly prevalent ocular diseases, today reported financial results for the fourth quarter and full year 2023. The company also provided recent pipeline highlights and corporate updates. “We have made tremendous...

Initial Data from Ongoing MyPeak™-1 Phase 1b of TN-201 for MYBPC3-associated HCM Expected in Second Half of 2024 On Track to Dose First Patient in RIDGE™-1Phase 1b Clinical Trial of TN-401 for PKP2-associated ARVC in Second Half 2024 $47 Million Net Proceeds from Recent Financing Extends Cash Runway into Second Half of 2025 SOUTH SAN FRANCISCO, Calif., March 18, 2024 (GLOBE NEWSWIRE) — Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update. “Tenaya had a successful year of sustained execution in 2023 that meaningfully advanced our portfolio...

Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for post-operative pain and inflammation following ocular surgery Reacquired development and commercialization rights to MicroPine for progressive pediatric myopia in the U.S. and Canada Continued to advance commercial operations with launch of Mydcombi™, FDA approval of manufacturing facility, onboarding of sales organization and signing of copromotion agreement Company to host conference call and webcast today, March 18th, at 4:30 pm ET NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) — Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, today announced its financial and operating results for the fourth quarter and full-year ended December 31, 2023. Fourth Quarter 2023 and Recent Business DevelopmentsAnnounced FDA approval of clobetasol...

SAN DIEGO, March 18, 2024 (GLOBE NEWSWIRE) — Singular Genomics Systems, Inc. (Nasdaq: OMIC), a company leveraging novel next-generation sequencing (NGS) and spatial multiomics technologies to empower researchers and clinicians, today highlighted recent corporate achievements and reported financial results for the fourth quarter and full year ended December 31, 2023. “We ended 2023 on a strong note, shipping our largest number of quarterly instruments to-date,” said Drew Spaventa, Chairman and Chief Executive Officer of Singular Genomics. “We continue to build momentum in early 2024 with the recent unveiling of the G4X, the first in situ spatial sequencer. The G4X brings sequencing into tissue sections, offering new capabilities and novel data streams with industry-leading throughput and cost.” Fourth Quarter and Recent Financial...

Initiated limited U.S. commercial launch of the Pure-Vu® EVS Gastro and Gen 4 Colon system, including successful UGI procedures at several leading hospital systems The Company is engaged in the process to seek strategic partnerships aimed at accelerating commercialization of the Pure-Vu System and maximizing stockholder value Recent exercise of certain outstanding warrants provided infusion of $2.7M in gross proceeds to the Company, which extended its cash runway into the fourth quarter of 2024FORT LAUDERDALE, Fla., March 18, 2024 (GLOBE NEWSWIRE) — Motus GI Holdings, Inc., (NASDAQ: MOTS) (“Motus GI” or the “Company”), a medical technology company focused on improving endoscopic outcomes and experiences, today reported its financial results for the fourth quarter and year ended December 31, 2023, and provided a corporate update. “During...

SAN FRANCISCO, March 18, 2024 (GLOBE NEWSWIRE) — Augmedix (Nasdaq: AUGX), a leader in ambient AI medical documentation and data solutions, today reported financial results for the three and 12 months ended December 31, 2023. “The fourth quarter was a solid end to a strong year for Augmedix both operationally and financially,” stated Augmedix CEO Manny Krakaris. “We delivered a 45% increase in revenue to $12.7 million, ahead of our most recent guidance, driven by a 44% increase in clinicians in service and net revenue retention of 152%. Additionally, we made steady progress toward our profitability goals by increasing gross profit by 54% to $6.2 million, a margin expansion of 300 basis points to 49.3%, which contributed to the reduction in our operating cash burn.” “We are pleased with the early performance of Augmedix Go, our clinician-controlled...

Red Cat reports record revenue for the company in Fiscal Third Quarter 2024, the third consecutive quarter of double-digit sequential growth SAN JUAN, Puerto Rico, March 18, 2024 (GLOBE NEWSWIRE) — Red Cat Holdings, Inc. (Nasdaq: RCAT) (“Red Cat” or “Company”), a drone technology company integrating robotic hardware and software for military, government, and commercial operations, reports its financial results for the second quarter ended March 18, 2024, and provides a business update. Operating Highlights:Continued global expansion with entry into Latin America and Middle East markets Partnered with Primordial Labs to integrate AI-driven voice control technology to its platforms Part of successful joint drone industry effort resulting in the passing of the American Security Drone Act by Congress Red Cat subsidiary, Teal Drones,...

Full Year 2023 resultsUS$17.7 billion Total Payment Volume, up 67% year-over-yearRevenue of US$650 million, up 55% year-over-year150% Net Revenue Retention RateGross Profit of US$277 million, up 37% year-over-yearAdjusted EBITDA of US$202 million, up 32% year-over-year Fourth Quarter 2023US$5.1 billion Total Payment Volume, up 55% year-over-year and 11% quarter-over-quarterRevenue of US$188 million, up 59% year-over-year and 15% quarter-over-quarter149% Net Revenue Retention RateGross Profit of US$70 million, up 27% year-over-year and down -6% quarter-over-quarterAdjusted EBITDA of US$49 million, up 22% year-over-year and down -11% quarter-over-quarter dLocal reports in US dollars and in accordance with IFRS as issued by the IASB MONTEVIDEO, Uruguay , March 18, 2024 (GLOBE NEWSWIRE) — DLocal Limited (“dLocal”, “we”, “us”, and “our”)...