Year: 2023

Company to host investor call and webcast today, November 14th, at 8:30am EDT PITTSBURGH, Nov. 14, 2023 (GLOBE NEWSWIRE) — Predictive Oncology (Nasdaq: POAI), a science driven company leveraging its proprietary artificial intelligence and machine learning capabilities, extensive biorepository of tumor samples, CLIA laboratory and GMP facility, to accelerate oncologic drug discovery and enable drug development, today reported financial and operating results for the three and nine months ended September 30, 2023, and provided a corporate update. The company reported a net loss of $3.2 million on total net revenue of $0.7 million for the third quarter 2023. Q3 2023 and Recent Highlights:Successfully delivered actionable results of first campaign with Cancer Research Horizons (CRH) in which Predictive Oncology predicted, with a high...

Completed full enrollment and dosing of the 50 mg cohort in Phase 2 Friedreich’s ataxia (FA) dose exploration trial; based on blinded observations during the dosing period, there were no serious adverse events in either the CTI-1601 (nomlabofusp) or placebo groups. Top-line safety, pharmacokinetic, and frataxin data from the Phase 2 trial now expected in Q1 2024, refined from H1 2024 Initiation of open label extension (OLE) trial with 25 mg daily dosing of nomlabofusp remains on track for Q1 2024; interim data expected in Q4 2024 Cash, cash equivalents and marketable securities of $95.6 million as of September 30, 2023, provides projected cash runway into Q1 2025BALA CYNWYD, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) — Larimar Therapeutics, Inc. (“Larimar”) (Nasdaq: LRMR), a clinical-stage biotechnology company focused on developing...

FDA confirms need for new trial for avasopasem; GRECO trials with rucosopasem to be discontinued Company evaluating potential strategic options to optimize shareholder value MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2023 and provided recent corporate updates. “Given the considerable time and investment required for additional clinical trials, we find it prudent to explore strategic options,” said Mel Sorensen, M.D., Galera’s President and CEO. “We also made the difficult decision to discontinue our GRECO trials, which we believe...

CINCINNATI, Nov. 14, 2023 (GLOBE NEWSWIRE) — Workhorse Group Inc. (Nasdaq: WKHS) (“Workhorse” or “the Company”), an American technology company with a vision to pioneer the transition to zero emission commercial vehicles, today reported financial results for the third quarter ended September 30, 2023. Management Commentary “We continued to deliver on our key priorities during the third quarter, making important progress across our commercial EV, drone and last mile delivery product roadmaps,” said Workhorse CEO Rick Dauch. “In Q3, we completed both durability and systems testing, which enabled us to launch production of the W56 stripped chassis and step van models on time. We also increased production and successfully completed customer demonstrations of the W750 step van. We added two new certified dealers to our commercial vehicle...

Phase 1 clinical study of GT-02287 initiated; dosing escalation on schedule BETHESDA, Md., Nov. 14, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced financial results for the third quarter ended September 30, 2023, and highlighted recent corporate progress. “With the compelling preclinical data we presented at the International Congress of Parkinson’s Disease and Movement Disorders and the initiation of our Phase 1 clinical trial of GT-02287, we have made tremendous progress this past quarter,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics. “Dose escalation continues as planned, and we look forward to providing updates...

Figure 1Quarterly Production and AISC ChartFigure 2Quarterly Total Ore Processed, Development Metres Advanced and Total Mined Material ChartFigure 3Process Plant Throughput Performance and Daily RecordsFigure 4Overview of Mine Infrastructure UpgradesFigure 5Comparison of 800 Portal Incline and Twin Incline InfrastructureFigure 6Mining Front Location LongsectionVANCOUVER, British Columbia, Nov. 14, 2023 (GLOBE NEWSWIRE) — K92 Mining Inc. (“K92” or the “Company”) (TSX: KNT; OTCQX: KNTNF) is pleased to announce financial results for the three months and nine months ended September 30, 2023. ProductionQuarterly production of 26,225 ounces gold equivalent (“AuEq”) (1)(2) or 22,227 oz gold, 1,784,009 lbs copper and 40,233 oz silver. Cash costs of US$684/oz gold (2) and all-in sustaining...

 – 510(k) product clearance gained for lead product, FemaSeed potentially allowing sooner-than-expected product commercialization – – Patient enrollment has commenced in landmark, pivotal FINALE trial for lead product candidate, FemBloc®, with academic sites enrolling trial participants – – Raised $11.3 million extending cash runway due to the exercise of warrants and sale of shares under its at-the-market facility – ATLANTA, Nov. 14, 2023 (GLOBE NEWSWIRE) — Femasys Inc. (Nasdaq: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a leading late-clinical stage product candidate and innovative therapeutic and diagnostic products, today announced financial results for the third quarter ended...

Company continues to advance launch, reports initial revenue from Omisirge® (omidubicel-onlv) Company to host conference call today at 8:30 a.m. ET BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) — Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter ended September 30, 2023, and provided a business update. “The third quarter marked the first patients receiving Omisirge following FDA approval and the point at which Gamida Cell truly transitioned to a commercial-stage company with our first revenue reported,” said Abbey Jenkins, President and Chief Executive Officer of Gamida Cell. “Our lean launch prioritized two key performance indicators – transplant center onboarding and market access – both of which have surpassed our expectations,...

Company previously announced statistically significant topline TRV045 data from two proof-of-concept studies evaluating S1PR mechanism of action and CNS target engagement Company reported favorable safety and tolerability data from TRV045 POC studies Three abstracts for OLINVYK presented at American Society of Anesthesiologists (ASA) Conference $15 million tranche from ex-US royalty-based financing agreement received in September Company to host conference call today, November 14, 2023 at 8:00 a.m. ET CHESTERBROOK, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) — Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today reported its financial results for the third quarter ended September 30, 2023 and provided...

— Top-line Data for Pivotal REASSURE Trial Expected in Early Q1 2024 – –Resubmission of NDA for uUTI Expected in Q2 2024-– DUBLIN, Ireland and CHICAGO, Nov. 14, 2023 (GLOBE NEWSWIRE) — Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today reported financial results for the third quarter ended September 30, 2023. “Last month, we completed the enrollment of 2,229 patients in our REASSURE trial in a 12-month period and expect to report top-line data early in the first quarter of 2024,” said Corey Fishman, Iterum’s Chief Executive Officer. “Subject to our analysis of the data, we plan to resubmit our NDA for the...