If You Invested in Fennec Pharmaceuticals Inc (FENC)

Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX) is a specialty pharmaceutical company focused on addressing ototoxicity, or chemotherapy-induced hearing loss, in cancer patients treated with cisplatin-based regimens. According to company disclosures, Fennec is focused on the commercialization of PEDMARK®, a sodium thiosulfate injection indicated to reduce the risk of ototoxicity associated with cisplatin in certain pediatric cancer patients with localized, non-metastatic solid tumors.

Core business and therapeutic focus

Fennec describes itself as a company committed to the fight against ototoxicity in cancer patients who receive cisplatin-based chemotherapy. Its business is centered on PEDMARK® in the United States and PEDMARQSI® in certain international markets. PEDMARK® is characterized by the company as a unique formulation of sodium thiosulfate supplied in single-dose, ready-to-use vials for intravenous use in pediatric patients. The therapy is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors, and is not indicated for pediatric patients less than 1 month of age or for pediatric patients with metastatic cancers.

The company highlights that cisplatin and other platinum-based chemotherapies are widely used to treat solid tumors but can cause permanent, irreversible hearing loss. Fennec’s stated goal is to mitigate this treatment-related burden by making PEDMARK® available to appropriate patient populations and supporting clinical work that evaluates its use in additional settings.

Regulatory approvals and market footprint

Based on recent company news, PEDMARK® received U.S. Food and Drug Administration (FDA) approval in September 2022. In Europe, the same active therapy is approved under the brand name PEDMARQSI®, with European Commission approval reported in June 2023 and United Kingdom approval in October 2023. Fennec reports that PEDMARK® has received Orphan Drug Exclusivity in the U.S., and PEDMARQSI® has received Pediatric Use Marketing Authorization in Europe, which the company states includes eight years plus two years of data and market protection.

Fennec has entered into an exclusive licensing agreement with Norgine Pharmaceuticals Ltd. under which Norgine will commercialize PEDMARQSI® in Europe, the U.K., Australia and New Zealand. According to the company, PEDMARQSI® is commercially available in the U.K. and Germany. Fennec also notes that it holds patents providing protection for PEDMARK® until 2039 in both the U.S. and internationally.

Clinical evidence and medical context

The company cites two open-label, randomized Phase 3 clinical studies, the Children’s Oncology Group (COG) Protocol ACCL0431 and SIOPEL 6, as providing efficacy and safety data and an established dosing regimen for PEDMARK®. These studies evaluated survival and reduction of ototoxicity in pediatric cancer populations treated with intensive cisplatin therapy. The COG ACCL0431 protocol enrolled childhood cancers typically treated with cisplatin, including hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, medulloblastoma and other solid tumors. SIOPEL 6 enrolled hepatoblastoma patients with localized tumors.

Fennec also references an investigator-initiated Phase 2/3 study in Japan (STS-J01) evaluating PEDMARK® for prevention of cisplatin-induced ototoxicity in pediatric and adolescent and young adult patients with localized-stage solid tumors. According to topline results described by the company, the study met its primary endpoint, with lower rates of hearing loss in patients treated with PEDMARK® compared with historically reported rates in cisplatin-only arms of earlier pivotal trials. The company reports that pharmacokinetic analyses and tumor response rates from this study indicated no evidence that PEDMARK® interfered with cisplatin’s antitumor activity.

In addition, an investigator-sponsored trial by City of Hope is planned to evaluate PEDMARK® for prevention of cisplatin-induced ototoxicity in adult men with stage II–III metastatic testicular germ cell tumors. Fennec presents this as part of growing clinical interest in reducing hearing loss among patients receiving cisplatin-based chemotherapy and as an opportunity to expand the evidence base for PEDMARK® into metastatic disease settings.

Safety profile and labeled limitations

Company materials emphasize labeled limitations and safety information for PEDMARK®. The therapy is not indicated for pediatric patients less than 1 month of age due to the increased risk of hypernatremia and is not indicated for pediatric patients with metastatic cancers. The safety and efficacy of PEDMARK® have not been established when administered following cisplatin infusions longer than six hours; the company notes that irreversible ototoxicity may have already occurred with longer infusions.

Important safety information disclosed by Fennec includes contraindication in patients with a history of severe hypersensitivity to sodium thiosulfate or any of its components. Hypersensitivity reactions, hypernatremia and hypokalemia were observed in clinical trials, and the company advises monitoring serum sodium and potassium levels and watching for signs and symptoms of electrolyte disturbances, particularly in patients with reduced glomerular filtration rate. The company also notes that PEDMARK® may contain sodium sulfite, which can trigger hypersensitivity reactions in sulfite-sensitive individuals, especially those with asthma.

Commercialization strategy and partnerships

Fennec describes itself as a commercial stage specialty pharmaceutical company. Its stated strategy is to focus on commercialization of PEDMARK® to reduce the risk of platinum-induced ototoxicity in cancer patients. In North America, this centers on the FDA-approved pediatric indication. Internationally, the company’s licensing agreement with Norgine Pharmaceuticals Ltd. is intended to support commercialization of PEDMARQSI® in Europe, the U.K., Australia and New Zealand.

Beyond direct commercialization, Fennec highlights multiple investigator-initiated and investigator-sponsored studies that have been submitted to the company and are under review or in advanced contracting or evaluation stages. According to Fennec, these collaborations are expected to strengthen its clinical and commercial foundation by expanding data on PEDMARK® across different tumor types, age groups and geographic regions.

Capital markets activity and financial structure

Fennec’s common shares trade on Nasdaq under the symbol FENC and on the Toronto Stock Exchange under the symbol FRX. The company has engaged in several equity offerings, including an underwritten registered public offering of common shares in the United States and a non-brokered offering of common shares in Canada to existing institutional shareholders. According to recent filings and news releases, Fennec used proceeds from these offerings to repurchase and redeem its outstanding senior secured floating rate convertible notes issued to Petrichor Opportunities Fund I LP and Petrichor Opportunities Fund I Intermediate LP.

A Form 8-K filed with the U.S. Securities and Exchange Commission describes a Waiver and Redemption Agreement under which Fennec agreed to repurchase and redeem the remaining outstanding Petrichor notes. The company reports that, following completion of this transaction, all of its payment obligations under those notes were satisfied in full. In a related news release, Fennec states that it has no outstanding debt after the redemption of the Petrichor convertible notes.

Regulatory and legal disclosures

Fennec’s public communications include forward-looking statement disclaimers that outline risks related to regulatory developments, clinical data, manufacturing capabilities, market size, competitive dynamics, capital access and other factors. The company directs readers to its filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2024, for a more detailed discussion of these risks.

Through its focus on PEDMARK® and PEDMARQSI®, Fennec positions itself within the biological product manufacturing and specialty pharmaceutical space, concentrating on supportive care in oncology where hearing preservation is an important component of long-term quality of life for patients treated with cisplatin-based chemotherapy.