Every 8-K that Benitec Biopharma Inc. (BNTC) 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 BNTC 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 BNTC filings page.
Benitec Biopharma Inc. said the FDA requested additional available data for BB-301 as discussions continue on an open-label, single-arm pivotal study. The requested data include information from Benitec’s OPMD Natural History Study. The FDA agreed to review relevant information on a timeline that would allow Benitec to confirm the final study design in the first quarter of 2027.
Benitec says the pivotal study remains on track to begin in mid-2027, with patient enrollment planned for mid-2027. At the European Society of Gene and Cell Therapy Annual Congress in Hamburg, October 27–30, 2026, the company plans to present 12-month follow-up data for all six Cohort 1 patients and interim follow-up data for all three Cohort 2 patients in its ongoing Phase 1b/2a study.
Benitec Biopharma Inc. engaged Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending June 30, 2027. EY completed its client acceptance procedures on September 28, 2026, and the company and EY executed an engagement letter on September 29, 2026.
Benitec Biopharma Inc. (BNTC) dismissed Baker Tilly US, LLP and appointed Ernst & Young LLP as its independent registered public accounting firm for the fiscal year ending June 30, 2027; EY’s formal engagement remains subject to completion of its client acceptance process. The company said the change followed a review of its auditor engagement as a matter of good corporate governance.
Baker Tilly had served since 2020. Its reports for fiscal years ended June 30, 2025 and 2026 had no adverse opinion or disclaimer and were not qualified or modified as to going concern, uncertainty, audit scope, or accounting principles. The company reported no disagreements with Baker Tilly that, if unresolved, would have required the auditor to refer to them in its report. The only reportable event was a material weakness in controls over share-based compensation calculations, which the company said it remediated as of June 30, 2026.
Benitec Biopharma Inc. (BNTC) reported higher operating spending and net loss for the year ended June 30, 2026, while highlighting significant clinical and regulatory progress for its lead asset BB-301 in OPMD-related dysphagia.
Total operating expenses rose to $51.2 million from $41.8 million, and net loss attributable to shareholders increased to $45.5 million (or $0.98 per share) from $37.9 million (or $1.05 per share). Cash and cash equivalents grew to $180.0 million, and management characterized the company as well-capitalized. Clinically, all six low-dose Cohort 1 patients completed 12-month follow-up and the three high-dose Cohort 2 patients have been safely treated, with clinically meaningful swallowing improvements reported. A Type C FDA meeting on the BB-301 pivotal study design was held in 3Q 2026, interim data will be presented at ESGCT in October 2026, and Benitec anticipates initiating a pivotal trial in mid-2027.
Benitec Biopharma Inc. reported changes to its board of directors. On May 22, 2026, the board appointed David Friedman as a Class III director, with a term running until the company’s 2028 annual meeting of stockholders.
In connection with his appointment, Friedman received options to purchase 35,000 shares of common stock under the 2020 Equity and Incentive Compensation Plan, granted on May 26, 2026 at the Nasdaq closing price and vesting in full before the next annual meeting or on the first anniversary of the grant. On the same date, chief financial officer and secretary Megan Boston resigned from the board as part of an ongoing board composition and governance review, but continues in her executive roles, and her departure from the board was not due to any dispute or disagreement with the company.
Benitec Biopharma reported third quarter 2026 results and highlighted continued progress for its lead gene therapy BB-301 for Oculopharyngeal Muscular Dystrophy. Total expenses for the quarter ended March 31, 2026 were $13.6 million, down from $15.3 million a year earlier, reflecting lower general and administrative costs. The company recorded a net loss of $11.9 million, or $0.24 per share, compared with a loss of $14.5 million, or $0.38 per share, in the prior-year quarter.
Benitec ended March 31, 2026 with $184.8 million in cash and cash equivalents and states it is well-capitalized to advance BB-301 through completion of a pivotal study. Phase 1b/2a interim data show durable, disease-modifying responses at low and high doses, with all Cohort 1 patients completing 12-month follow-up and no treatment-related severe adverse events reported. The company plans to meet the FDA mid-year to formalize the pivotal BB-301 study design and expects updated interim clinical results for Cohorts 1 and 2 in the second half of 2026.
Benitec Biopharma reported its second fiscal quarter ended December 31, 2025, highlighting both financial results and progress for BB-301, its gene therapy for Oculopharyngeal Muscular Dystrophy-related dysphagia. Total expenses were $13.4 million, up from $10.8 million a year earlier, driven mainly by higher general and administrative costs. Net loss attributable to shareholders was $11.8 million, or $(0.26) per share, compared with a net loss of $9.6 million, also $(0.26) per share, in the prior-year quarter. The company held $189 million in cash and cash equivalents as of December 31, 2025, providing substantial funding for its clinical programs.
Clinically, all four patients in Cohort 1 of the BB-301 Phase 1b/2a study were classified as responders at 12 months using a predefined Responder Analysis, indicating durable benefit. One patient maintained and deepened improvements in swallowing measures and symptom burden at 24 months post-treatment. Enrollment in Cohort 2 at a higher BB-301 dose is ongoing, with an interim update planned for mid-2026. BB-301 has Orphan Drug and Fast Track designations, and the company plans an FDA meeting in mid-2026 to confirm the pivotal study design.
Benitec Biopharma Inc. (BNTC) filed an 8‑K stating it furnished a press release with financial results for the fiscal quarter ended September 30, 2025, and an operational update. The press release is attached as Exhibit 99.1.
The company notes the information furnished under Item 2.02, including Exhibit 99.1, is not deemed filed for liability purposes and is not incorporated by reference unless expressly stated. BNTC’s common stock trades on The Nasdaq Stock Market LLC.
Benitec Biopharma Inc. (BNTC) announced two equity offerings priced at $13.50 per share. The company agreed to sell 5,930,000 shares in a firm‑commitment underwritten offering, with a 30‑day option for underwriters to buy up to 889,500 additional shares. Concurrently, it entered a registered direct sale of 1,481,481 shares to Averill funds at the same price.
Gross proceeds are expected to be approximately $100 million before fees and expenses. Underwriting and placement fees are 6.0% of gross proceeds for their respective transactions. The company, its executives and directors, and Suvretta Capital entered 90‑day lock‑ups. Closings are expected on November 7, 2025, subject to customary conditions. Proceeds are intended to support product candidate development, working capital and general corporate purposes.
Benitec Biopharma Inc. appointed Dr. Sharon Mates to its Board. She joins as a Class I director effective November 3, 2025, with a term through the 2026 annual meeting. The Board deemed her independent under Nasdaq rules. In connection with the appointment, she will receive stock options valued at $450,000, with the number of shares determined by dividing $450,000 by the Common Stock closing price on November 5, 2025. These options vest in full on the earlier of immediately prior to the 2026 annual meeting or the first anniversary of the grant date.
The FDA granted Fast Track Designation to BB-301 for OPMD. The company also announced a live webcast of its latest interim clinical data presentation at 8:00 a.m. Eastern on November 3, 2025. Related press releases and presentation materials were included as exhibits.
Benitec Biopharma Inc. furnished an update on its business by issuing a press release with financial results for its full year ended June 30, 2025 and an operational update. The company attached this press release as Exhibit 99.1 to the current report and specified that this information is being furnished under the results of operations and financial condition item, rather than treated as filed for liability purposes or automatically incorporated into other documents.