Every 8-K that Fennec Pharmaceuticals Inc. (FENC) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow FENC and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full FENC filings page.
Fennec Pharmaceuticals Inc. (FENC) reported positive top-line data from the investigator-initiated Phase 2 STS-J01 study of PEDMARK in Japan. The trial met its primary endpoint, with American Speech-Language-Hearing Association–defined hearing loss in 24.0% of patients versus a prespecified historical benchmark of 56.4% (p=0.001), showing substantial hearing protection.
Additional results showed 84% of patients had Grade 0 hearing loss by Brock criteria, with no Grade 3 or 4 hearing loss, and objective tumor responses in 23 of 24 evaluable patients (95.8%), supporting lack of interference with cisplatin antitumor activity. The study enrolled 33 patients across 11 Japanese institutions. Fennec states it is pursuing registration in Japan and is exploring partnering or licensing opportunities for PEDMARK.
Fennec Pharmaceuticals Inc. held its annual shareholder meeting, where investors approved all proposals and director nominees. Five directors were elected, with each receiving over 20 million votes for and similar broker non-vote levels.
Shareholders approved appointing Haskell & White LLP as independent public accounting firm, an advisory vote on executive compensation, and set advisory votes on pay to occur every year. They also approved amendments to the 2020 Equity Incentive Plan and ratified and approved a new 2026 Equity Inducement Plan, with officer and director holdings deducted from the "for" tally on the 2020 plan amendment vote.
Fennec Pharmaceuticals Inc. reported that new research on PEDMARK® (sodium thiosulfate injection) will be presented at the 2026 American Society of Clinical Oncology Annual Meeting. Four independently led studies examine use of PEDMARK across pediatric, adolescent, young adult and adult patients receiving cisplatin-based chemotherapy.
Key data include a Japanese Phase 2/3 trial in 27 pediatric and adolescent patients where hearing loss rates of 16–24% with PEDMARK were lower than historically reported 56–63% with cisplatin alone, and real‑world series in young adults and adults with head and neck cancer suggesting feasible integration of PEDMARK several hours after cisplatin without compromising antitumor activity and with preservation of clinically significant hearing. The company also reiterates that PEDMARK is the first FDA‑approved therapy to reduce cisplatin‑related ototoxicity in pediatric patients with localized, non‑metastatic solid tumors.
Fennec Pharmaceuticals Inc. disclosed that its board’s Compensation Committee approved inducement stock option grants for three new non-executive employees. The awards cover an aggregate of 50,000 common shares under the 2026 Equity Inducement Plan as inducement grants pursuant to Nasdaq Listing Rule 5635(c)(4).
The stock options have an exercise price of $9.75 per share, a ten-year term, and vest over three years, with one-third vesting on the first anniversary of the May 18, 2026 grant date and the remainder vesting monthly over the following 24 months, subject to continued employment. A press release with further details was furnished as an exhibit.
Fennec Pharmaceuticals Inc. reported a planned change to its Board of Directors. On April 27, 2026, director Rostislav Raykov notified the company that he plans to retire from the Board and will not stand for re-election at the 2026 annual meeting of shareholders.
His current term will end immediately after the annual meeting, and his departure is stated to be not due to any disagreement with the company’s operations, policies, or practices. Before the meeting, the Board decided to reduce its size from six to five directors, effective immediately following the annual meeting, and the company expects no Board vacancies after the change.
Fennec Pharmaceuticals Inc. reported that four scientific abstracts involving its ototoxicity drug PEDMARK (sodium thiosulfate injection) have been accepted for presentation or publication at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
Two studies will be presented as posters, including a Japanese pediatric trial on delayed sodium thiosulfate and a randomized Phase 1 trial in men with metastatic germ cell tumors. Two additional PEDMARK-focused studies will appear as abstract-only publications, covering real-world feasibility in young adults and audiometric outcomes in adults with head and neck cancer. The company highlights PEDMARK as the first FDA-approved therapy to reduce cisplatin-related hearing loss in eligible pediatric patients, noting its clinical evidence from two Phase 3 trials and international approvals under the PEDMARQSI brand.
Fennec Pharmaceuticals Inc. reported that the University of Arizona Cancer Center has initiated an investigator-sponsored study evaluating PEDMARK® (sodium thiosulfate injection) in adolescent, young adult, and adult patients with head and neck and testicular cancers receiving cisplatin.
The company explains that cisplatin-based chemotherapy is widely used but can cause permanent hearing loss in a significant share of patients, and PEDMARK is already approved to reduce ototoxicity risk in pediatric patients with localized, non-metastatic solid tumors. The new independent, institution-led study is intended to further build real-world evidence for PEDMARK in broader cancer populations beyond those in the pivotal pediatric trials.
Fennec Pharmaceuticals reported strong growth in its core PEDMARK product but a wider loss for 2025. Net product sales reached $44.6 million for the year, up 50% from 2024, with Q4 2025 net product sales of $13.8 million, 75% above Q4 2024. Total 2025 revenue was $44.6 million versus $47.5 million in 2024, which had included one-time licensing revenue. Operating expenses rose to $51.4 million, leading to a full-year net loss of $10.1 million compared with a $0.4 million net loss in 2024. Cash and cash equivalents increased to $36.8 million as of December 31, 2025, and all term-loan debt was eliminated, helping turn shareholders’ equity from a deficit to a positive $35.1 million. The company highlighted record patient enrollments and an oversubscribed $42 million equity raise, along with positive clinical data supporting PEDMARK’s use in additional settings.
Fennec Pharmaceuticals Inc. reported that it has entered into a License Agreement with Cipla Limited and Cipla USA, Inc. to settle litigation over Cipla’s bid to market a generic version of Fennec’s PEDMARK® sodium thiosulfate injection. The lawsuit will be dismissed, with each party bearing its own costs. Cipla has agreed not to enter the U.S. market with its generic sodium thiosulfate product until September 1, 2033, subject to earlier entry under specified circumstances. PEDMARK, Fennec’s FDA-approved therapy to reduce the risk of cisplatin-induced hearing loss in certain pediatric cancer patients, remains the only approved product of its kind and is protected by orphan drug exclusivity and patents the company states extend to 2039.
Fennec Pharmaceuticals filed an 8-K to highlight a new clinical research collaboration with the Tampa General Hospital Cancer Institute. The institute is initiating a real-world study of PEDMARK (sodium thiosulfate injection) to evaluate its clinical utility in reducing cisplatin-related hearing loss in adolescent, young adult and adult cancer patients.
PEDMARK is already FDA-approved to reduce ototoxicity in pediatric patients 1 month and older with localized, non-metastatic solid tumors and carries a 2A recommendation from the National Comprehensive Cancer Network for adolescent and young adult use. The study will analyze real-world clinical data and audiology monitoring to help guide future clinical research and quality efforts in managing ototoxicity.
Fennec Pharmaceuticals Inc. reported new real-world data on its drug PEDMARK® in adults with head and neck cancers. In a multi-institutional retrospective review of 15 adult patients, PEDMARK given at least six hours after cisplatin was feasible, well tolerated, and did not disrupt cisplatin-based treatment delivery.
Investigators observed early signals of hearing preservation, including that most high-risk patients receiving PEDMARK showed no measurable hearing loss during or after treatment, despite frequent baseline impairment. PEDMARK is currently approved in the United States only to reduce the risk of ototoxicity from cisplatin in pediatric patients with localized, non-metastatic solid tumors, and its safety and efficacy in adults with head and neck cancers have not been established.
Fennec Pharmaceuticals Inc. (FENC) has fully repurchased and redeemed its remaining senior secured floating rate convertible notes held by Petrichor. On November 17, 2025, the company paid a total redemption price of $21,729,455.30, consisting of $19,476,655.48 in outstanding principal (including accrued PIK interest), $305,134.27 in accrued interest, and a $1,947,665.55 redemption fee. This follows an earlier repurchase and redemption of notes with an aggregate principal amount of $13,000,000. After this transaction, all payment obligations under the notes have been satisfied in full.
Fennec Pharmaceuticals Inc. (FENC) entered into subscription agreements with certain existing institutional shareholders to sell an aggregate of 670,000 common shares at US$7.50 per share. This equity offering, made under a listed issuer financing exemption in Canada and registered on the company’s Form S-3 shelf, closed on November 18, 2025 and generated aggregate gross proceeds of US$5,025,000 before expenses.
Fennec plans to use the first portion of these proceeds to help repurchase and redeem its outstanding Petrichor convertible notes for an aggregate price of approximately US$21,729,455 on or before November 19, 2025, with any remaining net proceeds allocated to working capital and general corporate purposes.
Fennec Pharmaceuticals Inc. entered into an underwriting agreement to conduct an underwritten public offering of 4,666,667 common shares. The shares will be sold to the public at $7.50 per share and purchased by the underwriters from the company at $6.975 per share, with Fennec receiving the net proceeds. The company also granted the underwriters a 30-day option to buy up to an additional 700,000 shares at the public offering price, less underwriting discounts and commissions.
The transaction is being carried out under an effective shelf registration statement on Form S-3, using a prospectus supplement and related prospectus. Piper Sandler & Co. and Craig-Hallum Capital Group LLC are acting as representatives of the underwriters, and the closing of the offering is expected on November 17, 2025, subject to customary conditions.