Fennec Pharmaceuticals Inc Stock Price, News & Analysis

Fennec Pharmaceuticals announced participation in three virtual investor conferences in September 2021. These include the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, Oppenheimer Fall Healthcare Life Sciences & MedTech Summit from September 20-23, and the Cantor Virtual Global Healthcare Conference from September 27-30. The company focuses on its product PEDMARK™, designed to prevent platinum-induced ototoxicity in pediatric cancer patients, which is pivotal as over 10,000 children annually risk hearing loss from treatments.

Fennec Pharmaceuticals reported its Q2 2021 financial results, highlighting a net loss of $4 million ($0.15 per share), improved from a $4.8 million loss in Q2 2020. The company has $27.3 million in cash and equivalents, down from $30.3 million at the end of 2020, due to R&D and administrative expenses. Fennec is focused on its PEDMARK™ therapy for preventing cisplatin-induced hearing loss in children, with a crucial FDA PDUFA action date set for November 27, 2021. R&D expenses decreased to $800,000 from $1.1 million, reflecting a shift towards essential launch preparations.

On June 29, 2021, Fennec Pharmaceuticals announced the election of its management's proposed board nominees at the Annual General Meeting in Irvine, California. The results show strong shareholder support, with Dr. Khalid Islam receiving 99.05% approval and other nominees like Adrian Haigh and Chris A. Rallis also garnering over 97% support. Furthermore, 99.88% of shareholders approved the appointment of Haskell & White LLP as auditors, and 97.48% voted in favor of executive compensation. This indicates significant confidence from shareholders in the company's direction.

Fennec Pharmaceuticals (NASDAQ:FENC; TSX:FRX) has announced an amendment to its debt facility with Bridge Bank, increasing the total amount from $18 million to $20 million. This facility includes three term loans, with $5 million available upon closing and $7.5 million contingent on FDA approval of PEDMARK^TM. The funds will support the company’s working capital and commercialization activities for PEDMARK, which aims to prevent platinum-induced ototoxicity in pediatric patients. The FDA has set a PDUFA date for the NDA of PEDMARK on November 27, 2021.

Fennec Pharmaceuticals announced that the FDA has accepted its NDA resubmission for PEDMARK™ to prevent cisplatin-induced ototoxicity in pediatric patients with localized, non-metastatic solid tumors. The PDUFA action date is set for November 27, 2021. If approved, PEDMARK™ would be the first therapy for this indication. The drug has received Fast Track and Breakthrough Therapy Designations. The previous CRL cited manufacturing deficiencies but raised no safety or efficacy concerns, indicating no need for additional clinical data.

Fennec Pharmaceuticals Inc. has resubmitted its New Drug Application (NDA) to the FDA for PEDMARK™, a therapy aimed at preventing cisplatin-induced hearing loss in children aged 1 month to < 18 years. The resubmission follows FDA's Type A meeting feedback and focuses on resolving manufacturing facility issues, with no additional clinical data required. If approved, PEDMARK would be the first therapy to address this serious side effect of chemotherapy. The drug has received Breakthrough Therapy and Fast Track Designation from the FDA.

Fennec Pharmaceuticals (NASDAQ:FENC) is moving forward with plans to finalize and resubmit its New Drug Application for PEDMARK to the FDA by Q2 2021. The company reported Q1 2021 financial results, showing cash reserves of approximately $27 million and no outstanding debt. R&D expenses increased to $2.4 million, reflecting heightened development activities, while general and administrative costs remained stable at $2.5 million. The net loss for the quarter was $4.7 million, or $0.18 per share, slightly up from a loss of $3.8 million in Q1 2020.

Fennec Pharmaceuticals (NASDAQ:FENC) is advancing its New Drug Application (NDA) resubmission for PEDMARK™, a treatment for preventing platinum-induced ototoxicity in children, targeting Q2 2021. The company has $30 million in cash and no debt, with a net loss of $18.1 million ($0.76 per share) for 2020. R&D expenses fell to $5.1 million, while G&A costs rose to $13 million due to commercialization efforts. Despite a net increase in cash from a $32 million equity financing, Fennec sees ongoing losses but confirms financial stability for planned activities in 2021.

Fennec Pharmaceuticals reports Q3 2020 financial results, highlighting key developments on PEDMARK™, aimed at preventing platinum-induced ototoxicity in children. Following a constructive FDA meeting, the company plans to resubmit its New Drug Application without the need for additional studies. Financially, Fennec holds $33.2 million in cash and no debt. However, it posted a net loss of $6.2 million, an increase from $1.8 million the previous year, primarily due to rising R&D and G&A expenses related to commercialization efforts.