Kura Oncology, Inc. (KURA) SEC Filings, Sep-Nov 2025

Kura Oncology, Inc. (KURA) reported an insider equity transaction by its Chief Operating Officer. On 11/13/2025, the officer acquired 48,900 shares of common stock at $0, reflecting the vesting of performance-based restricted stock units after a development milestone was achieved. On 11/14/2025, 6,902 shares were sold at $11.1769 in a sell-to-cover transaction for taxes tied to this vesting. Following these transactions, the officer directly beneficially owned 105,373 shares of Kura Oncology common stock.

Kura Oncology (KURA) announced that the FDA granted full approval of KOMZIFTI (ziftomenib) for adult patients with relapsed or refractory acute myeloid leukemia with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. KOMZIFTI is the first and only once-daily, oral menin inhibitor approved for this R/R NPM1‑mutated AML population.

Approval is supported by the pivotal KOMET‑001 trial in 112 patients, showing a complete remission (CR) plus CR with partial hematologic recovery (CRh) rate of 21.4% (95% CI: 14.2, 30.2). Median duration of CR+CRh was 5.0 months (95% CI: 1.9, 8.1), and median time to first response among responders was 2.7 months, with 88% achieving CR or CRh within six months of starting therapy. The label includes a Boxed Warning for differentiation syndrome, and common adverse reactions (≥20%) included liver enzyme elevations, infections, electrolyte changes, hemorrhage, gastrointestinal events, fatigue, edema, and QTc interval prolongation (≤ Grade 3 in 12% of patients; no Grade 4/5 reported). The wholesale acquisition cost for a one‑month supply is $48,500. Kura leads U.S. development, regulatory and commercial strategy and manufacturing under its collaboration with Kyowa Kirin; Kyowa Kirin leads outside the United States.

Kura Oncology (KURA) filed a Form S-8 to register 750,000 additional shares of common stock issuable under its 2023 Inducement Option Plan, as amended. The increase to the plan’s share reserve was approved by the Board of Directors pursuant to Nasdaq Listing Rule 5635(c)(4).

The filing incorporates prior S-8 registrations for the same plan and adds capacity for future inducement equity awards to eligible new employees.

Kura Oncology (KURA) reported Q3 2025 results with collaboration revenue of $20.8 million, driven by its Kyowa Kirin partnership, and a net loss of $74.1 million ($0.85 per share). Operating expenses rose to $100.7 million on higher R&D ($67.9 million) and G&A ($32.8 million).

Liquidity remained strong with $549.7 million in cash, cash equivalents and short-term investments as of September 30, 2025. Contract liabilities tied to deferred collaboration revenue totaled $317.6 million, reflecting services to be delivered; receivables from collaborators were $35.9 million. Shares outstanding were 87.0 million as of October 31, 2025.

The company’s NDA for ziftomenib in relapsed/refractory NPM1-mutated AML was accepted with Priority Review and a PDUFA target action date of November 30, 2025. Kura also amended its term loan on October 25, 2025 to extend interest-only payments, with a further extension possible upon an approval milestone.

Kura Oncology (KURA) furnished an 8-K announcing it issued a press release with financial results for the third quarter ended September 30, 2025, along with a corporate update.

The information under Item 2.02 and Exhibit 99.1 is being furnished, not deemed “filed” under Section 18 of the Exchange Act, and will not be incorporated by reference into Securities Act registrations unless specifically identified.

Kura Oncology announced receipt of a $30 million milestone payment from Kyowa Kirin. The payment was triggered by dosing the first patient in KOMET-017, a pair of Phase 3 registrational trials evaluating ziftomenib, a once-daily, investigational oral menin inhibitor.

KOMET-017 consists of two independent, global, randomized double-blind, placebo-controlled Phase 3 studies. They assess ziftomenib in combination with intensive and non‑intensive chemotherapy in adults with newly diagnosed NPM1‑mutated or KMT2A‑rearranged acute myeloid leukemia. The payment provides non-dilutive funding aligned with the advancement of ziftomenib into late‑stage testing.

Kura Oncology amended its 2023 Inducement Option Plan to reserve an additional 750,000 shares of common stock, increasing the plan’s total reserve to 3,250,000 shares. These shares are designated exclusively for nonstatutory stock option grants to new hires as an inducement to join the company, consistent with Nasdaq Listing Rule 5635(c)(4). The Board approved the amendment on October 15, 2025, without stockholder approval as permitted by the rule. A complete copy of the amended plan is filed as Exhibit 99.1.

Kura Oncology Form 144 notice reporting a proposed sale of 12,314 shares of common stock. The filer intends to sell the shares through Morgan Stanley Smith Barney LLC on NASDAQ around 09/29/2025, with an aggregate market value listed at $111,441.70. The shares were acquired two days earlier on 09/27/2025 as performance stock units (PSUs) issued by the company and are to be paid/settled on 09/29/2025. The filing states there were no other securities sold by the same person in the past three months and includes the standard representation that the seller is not aware of any undisclosed material adverse information about the issuer.

Kura Oncology (KURA) filed a Form 144 reporting a proposed sale of 8,805 shares of common stock valued at $79,685.25. The shares were acquired as performance stock units (PSUs) on 09/27/2025 and the proposed sale date is 09/29/2025 through Morgan Stanley Smith Barney LLC on the NASDAQ. The filing shows 87,015,518 shares outstanding, and declares no securities sold by the reporting person in the prior three months. The filer certifies they are unaware of undisclosed material adverse information.