Day: May 12, 2022

Continued progress in three Phase 3 trials in areas of high unmet medical need, with multiple clinical milestones expected in 2022 NEW YORK, May 12, 2022 (GLOBE NEWSWIRE) — Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates against validated molecular targets in indications of high unmet medical need, today reported financial results for the first quarter ended March 31, 2022. “We made significant progress in the first quarter across all three of our Phase 3 programs,” said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. “We are pleased to have reached alignment with the FDA on Galactosemia, and are excited about the expected milestones in the year ahead.” Recent HighlightsProvided Regulatory Update on Galactosemia Program. In...

UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS for the three months ended 31 March 2022AttachmentsBML Group Quarterly Report_March 22BML Group Quarterly Report_March 22

~ FDA Prescription Drug User Fee Act (PDUFA) Target Action Date Set for September 23, 2022 ~ ~ If Approved by the FDA, PEDMARKTM Stands to Be the First Therapy for the Prevention of Cisplatin-Induced Hearing Loss in Children ~ ~ Company Has Approximately $18.3 Million in Cash and $5 Million of Funded Debt ~ RESEARCH TRIANGLE PARK, N.C., May 12, 2022 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company focused on the development of PEDMARKTM (a unique formulation of sodium thiosulfate (STS)) for the prevention of platinum-induced ototoxicity in pediatric patients, today reported its financial results for the fiscal quarter ended March 31, 2022 and provided a business update. “We are pleased that the FDA has accepted our resubmission of the NDA for PEDMARK™,” said Rosty Raykov,...

CAMBRIDGE, Mass., May 12, 2022 (GLOBE NEWSWIRE) — Evelo Biosciences, Inc. (Nasdaq: EVLO), a clinical stage biotechnology company developing a new modality of orally delivered medicines, today reported financial results and business highlights for the first quarter 2022. “This quarter we reported positive data for EDP1815 in psoriasis in three key areas: effects on systemic inflammatory cytokine markers; depth and duration of response at 6-month follow-up post dosing; and increased target site engagement with a faster release capsule. These data, together with our previously reported Phase 2 clinical efficacy data and preclinical data, demonstrate the central role of the small intestinal axis, SINTAX™, and supports the potential of EDP1815 as a new type of inflammation-resolving medicine with broad applicability,” said Simba Gill,...

$39.3 million in cash and cash equivalents at March 31, 2022 Announced initiation of DARE-HRT1 Phase 1/2 clinical study in April 2022 Organon exclusive global license agreement for XACIATO™ (clindamycin phosphate vaginal gel, 2%):Expected to close in 2Q-2022 $10 million cash payment to Daré expected in 2Q-2022 U.S. commercial launch expected in 4Q-2022Conference Call and Webcast Today at 4:30 p.m. ET SAN DIEGO, May 12, 2022 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended March 31, 2022 and provided a company update. “Our global license agreement with Organon to commercialize XACIATO, an FDA-approved treatment for females 12 years of age and older with bacterial vaginosis, is expected to close this quarter, the second quarter...

Record cash margin of $47.5 million from royalties and streams Operating cash flows from the royalties and streams segment of $40.5 million MONTRÉAL, May 12, 2022 (GLOBE NEWSWIRE) — Osisko Gold Royalties Ltd (the “Company” or “Osisko”) (OR: TSX & NYSE) today announced its consolidated financial results for the first quarter of 2022. Amounts presented are in Canadian dollars, except where otherwise noted. Q1 2022 Financial Highlights18,251 GEOs1 earned (Q1 2021 – 19,960 GEOs); Consolidated revenues of $59.4 million ($66.9 million in Q1 2021);        Revenues from the royalties and streams segment2 of $50.7 million ($66.9 million in Q1 2021, including $17.9 million from offtakes); Revenues from the mining exploration and development segment3 (i.e. Osisko Development Corp.) of $8.7 million (net of intersegment transactions);Consolidated...