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Southpoint holdings in Fennec Pharmaceuticals Inc. (TSX: FENC)
Globenewswire· 2025-12-26 22:44
Core Viewpoint - Southpoint Capital Advisors LP has disposed of 1,000,000 common shares of Fennec Pharmaceuticals Inc., representing approximately 2.93% of the outstanding shares, for investment purposes [1][3]. Group 1: Share Transaction Details - The common shares were sold at a price of USD$7.50 per share [2]. - Following the sale, Southpoint now controls 2.7 million common shares, which is about 8% of the outstanding shares [2]. Group 2: Future Ownership Intentions - Southpoint may adjust its beneficial ownership of common shares depending on market conditions through various means such as market transactions or private agreements [3].
Fennec Pharmaceuticals: A Compelling Single-Asset Growth Story For 2026 (NASDAQ:FENC)
Seeking Alpha· 2025-12-22 03:01
Company Overview - Fennec Pharmaceuticals Inc. is a commercial-stage specialty pharmaceutical company focused on producing a drug to reduce cisplatin-induced ototoxicity (CIO) [1] - The drug is known as Pedmark in the US and Pedmarqsi in Europe, which is a sodium thiosulfate injection [1] Product Details - Cisplatin is a widely used chemotherapy drug that can cause hearing loss as a side effect, making the development of Pedmark/Pedmarqsi significant for patients undergoing treatment [1]
Fennec Pharmaceuticals: A Compelling Single-Asset Growth Story For 2026
Seeking Alpha· 2025-12-22 03:01
Company Overview - Fennec Pharmaceuticals Inc. is a commercial-stage specialty pharmaceutical company focused on producing a drug aimed at reducing cisplatin-induced ototoxicity (CIO) [1] - The drug is marketed as Pedmark in the US and Pedmarqsi in Europe, which is a sodium thiosulfate injection [1] Product Details - Cisplatin is recognized as a highly effective chemotherapy agent, but it is associated with significant side effects, including ototoxicity [1]
Fennec Pharmaceuticals Announces Investigator-Sponsored Trial to Be Conducted by City of Hope in Metastatic Testicular Germ Cell Tumors
Globenewswire· 2025-12-09 12:00
Core Insights - Fennec Pharmaceuticals is initiating a study to evaluate PEDMARK for preventing cisplatin-induced ototoxicity in adult men with stage II-III metastatic testicular germ cell tumors, reflecting a growing clinical interest in addressing hearing loss among cancer patients [1][4]. Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on reducing the risk of ototoxicity in cancer patients receiving cisplatin-based chemotherapy. The company has received FDA approval for PEDMARK in September 2022 and European Commission approval in June 2023 [24][25]. Study Details - The investigator-sponsored study by City of Hope will assess the addition of PEDMARK to standard cisplatin chemotherapy to reduce drug-induced ear damage in men with metastatic testicular germ cell tumors. The study is a Phase I trial (NCT07218913) [5][6]. Clinical Context - Cisplatin has significantly improved survival rates for patients with germ cell tumors, but it can lead to permanent hearing loss in up to 80% of survivors, impacting their quality of life [2][8]. The study aims to integrate hearing protection into comprehensive cancer care [4]. Product Information - PEDMARK (sodium thiosulfate injection) is the first FDA-approved therapy to reduce the risk of ototoxicity associated with cisplatin in pediatric patients aged one month and older with localized, non-metastatic solid tumors. It is also recommended for adolescent and young adult patients by the National Comprehensive Cancer Network [3][12]. Market Opportunity - Approximately 500,000 patients in the U.S. are diagnosed annually with cancers treatable by platinum-based chemotherapy, highlighting a significant market opportunity for PEDMARK. The incidence of ototoxicity varies between 60-90% depending on treatment specifics [13][9]. Future Collaborations - Multiple other investigator-initiated studies are under review or in advanced stages of contracting, which are expected to strengthen Fennec's clinical and commercial foundation [7].
Fennec Pharmaceuticals (NasdaqCM:FENC) FY Conference Transcript
2025-12-03 19:02
Summary of Fennec Pharmaceuticals FY Conference Call Company Overview - **Company**: Fennec Pharmaceuticals (NasdaqCM:FENC) - **Product**: PEDMARK, the first and only FDA-approved product to prevent cisplatin-induced ototoxicity [1][3] Industry Context - **Target Market**: Pediatric patients aged 1-18 and adolescents/young adults (AYA) aged 15-39 receiving cisplatin for localized non-metastatic tumors [4][6] - **Cisplatin Usage**: Approximately 2,000 pediatric patients and 20,000 AYA patients treated annually with cisplatin in the U.S. [5][29] Core Product Insights - **Efficacy**: PEDMARK has proven efficacy and safety data established through two phase three trials, with recent positive results from a trial in Japan [3][46] - **Administration**: PEDMARK is administered as a 15-minute IV infusion six hours after cisplatin treatment [25] - **Market Segmentation**: The product targets two segments: pediatric (2,000 patients) and AYA (20,000 patients), with a focus on germ cell/testicular cancer patients [5][13] Commercial Strategy - **Sales Infrastructure**: Fennec has approximately 40 employees, with half in customer-facing roles, including traditional sales reps and medical science liaisons (MSLs) [20][21] - **Growth in Awareness**: The company has doubled its MSL presence and established key account directors to enhance awareness in larger oncology networks [21][22] - **Home Health Administration**: About 33-40% of PEDMARK patients are now receiving infusions at home, reflecting growth in this area [27] Financial Performance - **Sales Growth**: Quarterly sales increased from approximately $7 million to $12.5 million, primarily driven by the AYA market [29] - **Pricing**: The wholesale acquisition cost (WAC) for PEDMARK is $11,000 per vial, with a gross-to-net discount of about 20% [39][40] Regulatory and Market Access - **Payer Reimbursement**: 100% reimbursement achieved across major carriers, indicating strong payer support for PEDMARK [38] - **Intellectual Property**: Fennec holds orphan drug exclusivity until September 2029 and six Orange Book patents extending to July 2039 [44] International Expansion - **Japan**: Positive trial results in Japan are expected to facilitate approval and market entry, with plans to partner with local entities [46][47] - **Europe**: Fennec has partnered with Norgine for European distribution, with initial launches in the UK and Germany [50][51] Challenges and Considerations - **Awareness Among Practitioners**: There is a need to increase awareness of PEDMARK among oncologists and nurses, particularly in community settings [32][33] - **Ototoxicity Management**: Education is crucial as once hearing loss occurs, it is irreversible, emphasizing the importance of prophylactic use of PEDMARK [35][36] Future Outlook - **Potential for Expansion**: Interest in conducting trials for PEDMARK in metastatic disease and adult populations is being explored [48] - **Continued Growth**: The company aims to build awareness and expand its market presence, particularly in the AYA segment [33][39]
Fennec Pharmaceuticals Announces Positive Topline Results From Investigator-Initiated Clinical Study of PEDMARK® in Japan to Reduce Cisplatin-Induced Hearing Loss
Globenewswire· 2025-12-02 12:01
Core Insights - The study demonstrated that PEDMARK significantly reduces hearing loss in pediatric patients aged 3-18 years receiving cisplatin, with rates of 24% and 16% for hearing loss compared to historical rates of 56-63% in cisplatin-only groups [1][2][4] - PEDMARK did not interfere with the antitumor activity of cisplatin, showing a clinical response rate of approximately 95% [1][3] - The company plans to pursue registration for PEDMARK in Japan and is exploring partnership or licensing opportunities based on these positive results [1][5] Study Details - The STS-J01 clinical trial enrolled 33 patients, including 27 in the primary cohort (ages 3-18) and 6 in exploratory cohorts, focusing on the prevention of cisplatin-induced ototoxicity [6][7] - The primary endpoint was the incidence of hearing impairment at the end of treatment, assessed using ASHA criteria, with secondary endpoints including safety and antitumor efficacy [7] Pharmacokinetics and Safety - Pharmacokinetic analyses indicated no reduction in cisplatin exposure, confirming that PEDMARK does not adversely interact with cisplatin [3] - The study reported over 200 treatment-emergent adverse events, none attributed to PEDMARK, indicating it was well-tolerated [4] Clinical Implications - The findings support the effectiveness of PEDMARK in protecting hearing without compromising the efficacy of cisplatin, addressing a significant unmet medical need in Japan [5] - The results reinforce the global clinical evidence for PEDMARK, demonstrating its protective effect across various settings and tumor types [4] Regulatory and Market Potential - Fennec Pharmaceuticals intends to register PEDMARK in Japan and is seeking licensing opportunities, highlighting the potential for market expansion [1][5] - PEDMARK is the first FDA-approved therapy for reducing cisplatin-induced ototoxicity in pediatric patients, with significant implications for patient quality of life [10][12]
Fennec Pharmaceuticals to Participate in Piper Sandler 37th Annual Healthcare Conference
Globenewswire· 2025-11-26 10:59
Core Insights - Fennec Pharmaceuticals Inc. will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, at 1:00 p.m. ET, available via webcast [1][2] Company Overview - Fennec Pharmaceuticals is a specialty pharmaceutical company focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy [3] - The company is commercializing PEDMARK, which aims to reduce the risk of platinum-induced ototoxicity in cancer patients [3] - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] Licensing and Commercialization - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, U.K., Australia, and New Zealand [4] - PEDMARQSI is currently commercially available in the U.K. and Germany [4] Regulatory Status and Market Protection - PEDMARK has received Orphan Drug Exclusivity in the U.S., while PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing eight years plus two years of data and market protection [5] - Fennec holds patents protecting PEDMARK until 2039 in both the U.S. and internationally [5]
Fennec Pharmaceuticals Announces Completion Of Full Debt Redemption
Globenewswire· 2025-11-19 12:03
Core Insights - Fennec Pharmaceuticals has successfully repurchased and redeemed all outstanding convertible notes issued to Petrichor Opportunities Fund, eliminating its debt [1][2] - The total cost for the repurchase and redemption of the Petrichor notes was approximately $21.73 million, which included principal, accrued interest, and a redemption fee [2] - Fennec is focused on the commercialization of PEDMARK, a drug aimed at reducing platinum-induced ototoxicity in cancer patients, which has received multiple regulatory approvals [3][5] Financial Summary - The aggregate repurchase and redemption price of the Petrichor notes was $21,729,455.30, comprising $19,476,655.48 in principal, $305,134.27 in accrued interest, and a $1,947,665.55 redemption fee [2] - Prior to redemption, the notes had an interest rate tied to the prime rate with a floor of 3.5% plus a margin rate of 4.5% [2] Product and Market Information - PEDMARK received FDA approval in September 2022, European Commission approval in June 2023, and U.K. approval in October 2023 under the brand name PEDMARQSI [3] - Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [4] - PEDMARK has Orphan Drug Exclusivity in the U.S. and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [5]
Fennec Pharmaceuticals Announces Closing of Private Offering of Common Shares in Canada
Globenewswire· 2025-11-18 13:30
Core Points - Fennec Pharmaceuticals Inc. has closed a non-brokered offering of common shares in Canada at a price of US$7.50 per share, raising aggregate gross proceeds of US$5,025,000 [1][2] Group 1: Offering Details - The offering was made to prospective purchasers in Canada (excluding Quebec) under the listed issuer financing exemption, and the common shares are not subject to a hold period under Canadian securities laws [2][4] - The offering document related to this transaction can be accessed on the Company's profile at www.sedarplus.com and www.fennecpharma.com [3] Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients receiving cisplatin-based chemotherapy, with its primary product being PEDMARK, which received FDA approval in September 2022 and European Commission approval in June 2023 [6][8] - PEDMARQSI, the brand name for PEDMARK in the U.K., received approval in October 2023, and the product is now commercially available in the U.K. and Germany following an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. [7][8] Group 3: Regulatory and Market Position - PEDMARK has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing significant market protection [8] - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally, enhancing its competitive position in the market [8]
Fennec Pharmaceuticals Announces Closing of Offering of Common Shares
Globenewswire· 2025-11-17 21:15
Core Viewpoint - Fennec Pharmaceuticals Inc. has successfully closed a public offering of 5,366,667 common shares at a price of $7.50 per share, raising approximately $40.25 million in gross proceeds before expenses [1][2]. Group 1: Offering Details - The offering included the full exercise of the underwriters' option to purchase additional shares [1]. - The net proceeds will be used to repurchase certain indebtedness and for working capital and general corporate purposes [2]. - Piper Sandler & Co. and Craig-Hallum Capital Group LLC served as joint book-running managers, with H.C. Wainwright & Co. as lead manager and Stephens Inc. as co-manager [2]. Group 2: Company Overview - Fennec Pharmaceuticals is focused on combating ototoxicity in cancer patients undergoing cisplatin-based chemotherapy, primarily through its product PEDMARK [5]. - PEDMARK received FDA approval in September 2022, followed by approvals from the European Commission in June 2023 and the U.K. in October 2023 under the name PEDMARQSI [5]. - In March 2024, Fennec entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. for the commercialization of PEDMARQSI in Europe, the U.K., Australia, and New Zealand [6]. Group 3: Regulatory and Market Position - PEDMARK has Orphan Drug Exclusivity in the U.S., while PEDMARQSI has received Pediatric Use Marketing Authorization in Europe, providing it with a total of ten years of market protection [7]. - Fennec holds patents for PEDMARK that extend until 2039 in both the U.S. and internationally [7].