Fennec Pharmaceuticals Inc. - FENC STOCK NEWS

Fennec Pharmaceuticals (NASDAQ:FENC) announced a significant investment agreement with Petrichor Healthcare Capital Management, potentially worth up to $45 million. The deal consists of $5 million in senior secured promissory notes and an additional $20 million contingent on FDA approval of PEDMARK™ by September 30, 2022. This funding aims to support the commercialization of PEDMARK™, which seeks to mitigate ototoxicity in pediatric cancer patients undergoing chemotherapy. The notes bear a five-year term with interest tied to the US Prime Rate plus 4.5%.

Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced the successful election of its director nominees at the Annual General Meeting held on June 14, 2022, in New York. All nominees received a strong majority of votes, with Dr. Khalid Islam receiving 99.59% in favor. Additionally, shareholders voted overwhelmingly (99.23%) to appoint Haskell & White LLP as auditors and approved the executive compensation package with 99.03% support. The meeting reflects strong shareholder confidence in the company's leadership and governance.

Fennec Pharmaceuticals Inc. (NASDAQ:FENC) announced its participation in several upcoming investor conferences, including the H.C. Wainwright Global Investment Conference on May 24, the Craig-Hallum Institutional Investor Conference on June 1, and the JMP Securities Life Sciences Conference on June 15. The focus of the company is on PEDMARK™, a formulation aimed at preventing platinum-induced ototoxicity in pediatric patients, with significant implications for children undergoing chemotherapy. The Marketing Authorization Application for PEDMARK is under review by the European Medicines Agency.

Fennec Pharmaceuticals Inc. reported its Q1 2022 financial results, highlighting a net loss of $3.7 million, a decrease from $4.7 million in Q1 2021. Cash and cash equivalents stand at approximately $18.3 million, down from $21.1 million at year-end 2021, primarily due to ongoing costs related to the resubmission of the NDA for PEDMARK™. R&D expenses fell to $1.4 million from $2.4 million year-over-year, reflecting a shift towards pre-commercialization efforts. The FDA's PDUFA target action date for PEDMARK™ is set for September 23, 2022, potentially marking a significant milestone if approved.

Fennec Pharmaceuticals announced that its resubmitted New Drug Application (NDA) for PEDMARK, aimed at preventing platinum-induced ototoxicity in pediatric patients, has been accepted by the FDA. The PDUFA action date is set for September 23, 2022. This development is significant as PEDMARK has received Breakthrough Therapy and Fast Track Designation, indicating its potential to transform treatment for children at risk of hearing loss from chemotherapy. The company continues its efforts to facilitate the FDA's review process.

Fennec Pharmaceuticals (NASDAQ: FENC) will participate in the 2022 Maxim Group Virtual Growth Conference from March 28-30, 2022. CFO Robert Andrade will engage in a fireside chat on March 28 at 4:00 p.m. ET. The conference will cover key discussions on Fennec's developments, including PEDMARK™, aimed at preventing platinum-induced ototoxicity in children undergoing chemotherapy. PEDMARK has garnered Breakthrough Therapy and Fast Track Designations from the FDA and is currently under evaluation by the European Medicines Agency for marketing authorization.

Fennec Pharmaceuticals has resubmitted its New Drug Application (NDA) for PEDMARK™, aimed at preventing platinum-induced ototoxicity in pediatric cancer patients. The FDA's feedback during the process was appreciated, and the company is committed to making PEDMARK™ available for those affected. With over 10,000 children potentially receiving platinum-based chemotherapy annually in the U.S. and Europe, the need for an effective preventive agent is vital. The application is also under review by the European Medicines Agency, highlighting the global importance of PEDMARK™.

Fennec Pharmaceuticals (NASDAQ:FENC) announced a planned resubmission of the New Drug Application (NDA) for PEDMARK™ in Q1 2022. The company reported a net loss of $17.3 million for 2021 ($0.67 per share), a slight improvement from $18.1 million in 2020. Cash and cash equivalents stood at $21.1 million as of December 31, 2021, down from $30.3 million the previous year. Research and Development expenditures were $5 million, with General and Administrative expenses totaling $12.2 million, both showing minor fluctuations compared to 2020.

Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX:FRX) announced the resignation of Chief Commercial Officer Shubh Goel, effective late February 2022. The company's CEO, Rosty Raykov, expressed gratitude for Goel's contributions while emphasizing the commitment to commercialize PEDMARK™, a sodium thiosulfate formulation designed to prevent platinum-induced ototoxicity in children receiving chemotherapy. PEDMARK™ has received FDA Breakthrough Therapy and Fast Track Designations, and its Marketing Authorization Application is under review by the European Medicines Agency.