Month: May 2023

– Achieves Record EBITDA MONTREAL, May 11, 2023 (GLOBE NEWSWIRE) — Knight Therapeutics Inc. (TSX: GUD) (“Knight” or “the Company”), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2023. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified. Q1 2023 Highlights FinancialsRevenues were $82,597, an increase of $18,790 or 29% over the same period in prior year. Gross margin of $40,762 or 49% compared to $32,477 or 51% in the same period in prior year. Adjusted EBITDA1 was $18,237, an increase of $4,925 or 37% over the same period in prior year. Adjusted EBITDA per share2 of $0.17, an increase of $0.05 or 45% over the same period in prior year. Net loss...

Emergency Use Authorization (EUA) granted by the U.S. Food and Drug Administration (FDA) for Gohibic (vilobelimab) for treatment of critically ill COVID-19 patients Gohibic planned to be available to patients in the U.S. within the next few weeks Phase III study with vilobelimab in pyoderma gangrenosum (PG) underway; first patient expected to be enrolled mid-2023 Cash, cash equivalents and marketable securities approximately €72.3 million as of March 31, 2023 Additional €53.5 million in aggregate proceeds subsequently raised under at-the-market (ATM) program and by an underwritten public offering of ordinary sharesJENA, Germany, May 11, 2023 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating...

Nearing Manufacturing Start Up of First Kitted Product IRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today reported financial results for the first quarter 2023, ended March 31, 2023. First Quarter 2023 and Recent Highlights:Completed an equity capital raise of $13.86 million from the sale and issuance of common stock to strengthen the balance sheet and further support the Company’s product portfolio. Implemented additional cost cutting initiatives to accelerate our transition to a capital-light business model based on commercializing kitted product versions of our novel diagnostic tests. Published a peer-reviewed article in Clinical Cancer Research on the results of a study applying DetermaIO™ to samples collected from the randomized Phase II AtezoTRIBE...

– Continued to enroll patients in VIRAGE, the Phase 2b clinical trial of systemically administered VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma – – Presented data from the ongoing Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant recipients at the 33rd European Congress of Clinical Microbiology & Infectious Disease; Cohort 2 continues to enroll patients – – As of March 31, 2023, Theriva Biologics reports $36.1 million in cash, which is expected to provide runway into the third quarter of 2024 – – Conference call and webcast to be held on Thursday, May 11th at 8:30 a.m. ET – ROCKVILLE, Md., May 11, 2023 (GLOBE NEWSWIRE) — Theriva Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and...

Cash on Hand of $15.5M Expected to Support Completion of the CAReS Trial and Operations into Second Half of 2024 SOLANA BEACH, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today reported financial and operating results for the three months ended March 31, 2023 and provided a business update. “Given the positive safety profile observed in the patients with cancer-associated anorexia participating in the Phase 1b portion of our Cancer Appetite Recovery Study (CAReS) for our drug candidate, ART27.13, in April we advanced to the Phase 2a stage of the study,” said Gregory D. Gorgas, President and Chief Executive Officer of Artelo...

Company maintains strong cash position of $231.6 million SOUTH SAN FRANCISCO, Calif., May 11, 2023 (GLOBE NEWSWIRE) — RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based therapeutics company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in inflammatory diseases and oncology, today reported financial results for the first quarter ended March 31, 2023. “In 2023, we are continuing to focus on advancing our two lead programs, RPT193 and FLX475,” said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics. “In the first quarter, we expanded our RPT193 program with the initiation of a Phase 2a clinical trial in asthma. We continue to enroll our Phase 2b trial of RPT193 in atopic dermatitis and expect top...

Completed enrollment of the pivotal STRIDE study; topline results anticipated 4Q 2023 Raised $68.3 million in gross proceeds from a concurrent public offering and private placementIRVINE, Calif., May 11, 2023 (GLOBE NEWSWIRE) — Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today reported financial results for the quarter ended March 31, 2023 and provided a business update. “In the first quarter we achieved a key milestone with the completion of enrollment of the pivotal STRIDE study. We have been encouraged by the patient interest in our mavodelpar program, which led to an over-enrollment in STRIDE and high rate of rollover into the STRIDE AHEAD open-label long-term extension...

Portfolio Overview Portfolio OverviewAll of the amounts disclosed in this press release are in U.S. dollars unless otherwise noted TEL AVIV, Israel, May 11, 2023 (GLOBE NEWSWIRE) — Enlight Renewable Energy Ltd. (NASDAQ: ENLT, TASE: ENLT) today reported financial results for the first quarter ended March 31, 2023. The Company’s quarterly earnings materials and a link to the earnings webcast, which will be held today at 8:00 AM ET, may be found on the investor relations section of Enlight’s website at https://enlightenergy.co.il/data/financial-reports/ “We delivered record results in the first quarter of 2023, with Revenue up 103%, Net Income up 275% and Adjusted EBITDA* up 118%, driven by the 810 MW of projects that went into operation over the past year. Moreover, we believe that we have strong visibility on future growth. With...

On track to report interim clinical data for two lead programs, PBGM01 for GM1 gangliosidosis and PBFT02 for frontotemporal dementia (FTD), in 2023 Submitted protocol amendment to regulatory authorities for Imagine-1 study for GM1 gangliosidosis to treat patients at a third, higher dose; expect to dose first patient at Dose 3 in second half of 2023 Continued momentum in upliFT-D trial for FTD with four global trial sites now initiated Execution supported by strong balance sheet, with cash on hand to fund operations into first half of 2025PHILADELPHIA, May 11, 2023 (GLOBE NEWSWIRE) — Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company focused on developing transformative therapies for central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2023 and...

Demonstrated Long-term Clinical Benefit of Govorestat in ACTION-Galactosemia Kids Trial Strengthened Balance Sheet with $30 Million Private Placement of Equity Phase 3 INSPIRE Trial of Govorestat in Sorbitol Dehydrogenase (SORD) Deficiency and ARISE-HF Trial of AT-001 in Diabetic Cardiomyopathy on Track for Data in 2023 NEW YORK, May 11, 2023 (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, 2023. “We are committed to bringing transformative therapies to patients with debilitating diseases and no treatment options, including Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy,”...