Month: May 2022

~ 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...

Q1 2022 Revenues, Gross Margin and EPS are in line with Guidance Company Q2 2022 Guidance: Revenues to Decrease 16% to 20% QoQ, Non-IFRSGross Margin is Expected to be 43.0% to 45.0%, Non-IFRS Profit per Diluted ADS to be around 45.0 Cents to 50.0 CentsHistorically Q1 sales are seasonally the low point of year due to the Lunar New Year holidays. This year, starting from end of February, additional factors also weighed in, mainly new lockdowns in China to contain the spread of the Omicron variant and geographical conflict erupting in Ukraine, both causing major disruptions to supply chain. Despite these additional challenges, Company Q1 revenues, gross margin and EPS were all in line with the guidance Q1 2022 revenues was $412.8M, a decrease of 8.6% QoQ but up 33.6% YoY. Q1 GM reached 47.0%, much higher than 40.2% of the same period last...

Top-line data from pivotal 4WHIM Phase 3 clinical trial in WHIM syndrome expected in 4Q22 Clinical and regulatory updates from ongoing chronic neutropenia Phase 1b study anticipated during 3Q 2022; Waldenström’s macroglobulinemia Phase 1b study now fully enrolled with results expected in second half of 2022 Conference call to be hosted today at 8:30 a.m. EDT BOSTON, May 12, 2022 (GLOBE NEWSWIRE) — X4 Pharmaceuticals, (Nasdaq: XFOR), a leader in the discovery and development of novel oral CXCR4-targeted small molecule therapeutics to benefit people with rare immune system disorders, today reported financial results for the first quarter ended March 31, 2022. “As we quickly approach top-line results from our 4WHIM pivotal Phase 3 trial for WHIM syndrome by the end of this year, the X4 team continues to identify and expand the breadth...

Please find enclosed Eika Boligkreditt AS’ interim report for the first quarter 2022. The report is also available on http://eikbol.no/AttachmentEika Boligkreditt AS – Report 1Q 2022

Summary: Gabriel Holding A/S achieves 34% revenue growth and a 48% increase in operating profit (EBIT).The Group’s revenue was DKK 522.8 million (DKK 388.3 million), the equivalent of 34% growthRevenue in the second quarter was DKK 275.8 million (DKK 201.8 million), the equivalent of 37% growthGross profit fell to 34.1% (37.0%) in the first half-year because price increases on carriage, raw materials, components, energy etc. have not been fully compensated through price adjustments to the Group’s selling prices. Earnings before depreciation, amortisation and impairment losses (EBITDA) increased by 32% to DKK 64.1 million (DKK 48.6 million) Operating profit (EBIT) increased by 48% to DKK 44.0 million (DKK 29.7 million)Operating profit in the second quarter was DKK 23.5 million (DKK 14.5 million), an increase of 62%Profit before...