Fennec Pharmaceuticals Inc. - FENC STOCK NEWS

Fennec Pharmaceuticals has launched PEDMARK (sodium thiosulfate injection), the first FDA-approved therapy to mitigate cisplatin-induced hearing loss in pediatric patients aged one month and older with localized, non-metastatic solid tumors. This breakthrough therapy offers substantial help to patients at risk of permanent hearing loss, previously managed with cochlear implants. The company also introduced the Fennec HEARS™ program, providing financial support and care coordination. PEDMARK, which received FDA approval in September 2022, addresses a significant medical need, as approximately 60% of pediatric patients treated with cisplatin face irreversible hearing loss.

Fennec Pharmaceuticals Inc. has successfully completed a second closing of $20 million in senior secured promissory notes as part of an investment agreement with Petrichor Healthcare Capital Management. This funding followed the FDA approval of PEDMARK®, aimed at reducing cisplatin-induced ototoxicity in pediatric patients. The company may access an additional $20 million before December 31, 2023, under the agreement. PEDMARK® is the only FDA-approved therapy for preventing this type of hearing loss, offering vital protection for children undergoing chemotherapy.

Fennec Pharmaceuticals announced that the FDA has approved PEDMARK (sodium thiosulfate injection), marking it as the first and only therapy approved to reduce the risk of ototoxicity from cisplatin in pediatric patients. This approval addresses a significant unmet medical need, as cisplatin treatment often leads to severe hearing loss in children. Clinical trials showed that the incidence of hearing loss in patients receiving PEDMARK was significantly lower than in those treated with cisplatin alone (21.4% vs. 73.3% and 32.7% vs. 63%). PEDMARK is indicated for patients aged one month and older with localized, non-metastatic solid tumors.

Fennec Pharmaceuticals reported the completion of a $5 million financing milestone under an investment agreement with Petrichor Healthcare Capital Management. An additional $20 million may be provided upon FDA approval of PEDMARK, a drug aimed at preventing chemotherapy-induced hearing loss in pediatric patients. The FDA's action date for the New Drug Application is set for September 23, 2022. The funding will also help Fennec repay existing debts. The company has potential access to $20 million by the end of 2023, contingent on meeting agreement terms.

Fennec Pharmaceuticals (NASDAQ:FENC) announced significant developments regarding its PEDMARKTM drug for preventing cisplatin-induced ototoxicity in pediatric patients. With a Prescription Drug User Fee Act (PDUFA) target action date set for September 23, 2022, the company is gearing up for a U.S. launch, bolstered by a $45 million investment from Petrichor Healthcare. Financial results reveal a net loss of $5.1 million for Q2 2022, increasing from $4.0 million in Q2 2021, with cash reserves at $14.9 million as of June 30, 2022, reflecting a decline due to pre-commercialization expenses.

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.