Every 8-K that Pyxis Oncology, Inc. (PYXS) 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 PYXS 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 PYXS filings page.
Pyxis Oncology, Inc. (PYXS) reported updated Phase 1 monotherapy data for its lead antibody-drug conjugate micvotabart pelidotin (MICVO) in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma as of August 18, 2026. At the 5.4 mg/kg dose with a cap, the efficacy-evaluable cohort of 33 patients showed a 36% confirmed objective response rate and 94% disease control rate, with 75% of responders improving by the first six-week scan and 83% achieving more than 50% tumor reduction.
Median progression-free survival was 6.2 months and 12‑month overall survival probability was 79%, while median overall survival had not yet been reached. In the 35‑patient safety population, 91.4% experienced treatment-related adverse events and 54.3% had grade ≥3 events, including peripheral neuropathy and ocular events, but no treatment-related deaths were reported. The company plans an End of Phase 2 meeting in early 2027 and initiation of a pivotal ~500‑patient Phase 3 "Headliner" trial in mid‑2027, and MICVO holds FDA Fast Track Designation in this setting.
Pyxis Oncology, Inc. (PYXS) appointed Thomas Civik, previously Interim Chief Executive Officer, as permanent Chief Executive Officer effective September 4, 2026, and also named him Chairman of the Board. John Flavin, co-founder and former Chairman, became Lead Independent Director and Chair of the Compensation Committee, preserving independent board oversight.
Under an amended employment agreement, Civik receives a $710,000 annual base salary, a target bonus equal to 60% of salary, a $100,000 one-time sign-on bonus subject to clawback within six months, and a stock option for 2,503,050 shares vesting over four years with accelerated vesting protections upon certain terminations around a Change in Control. Standard severance includes up to 12 months of salary and COBRA, increasing to 18 months of salary plus target bonus and COBRA in specified Change in Control scenarios.
The company also reported that director Santhosh Palani resigned for professional time-commitment reasons, the board size was reduced from eight to seven, and his unvested equity awards were fully accelerated with option exercise periods extended. Pyxis highlighted upcoming 2026 clinical data updates for its lead ADC candidate MICVO in recurrent/metastatic head and neck cancer.
Pyxis Oncology, Inc. reported second quarter 2026 results and detailed progress for its lead antibody-drug conjugate, micvotabart pelidotin (MICVO), in recurrent/metastatic head and neck squamous cell carcinoma. For the quarter ended June 30, 2026, the company recorded a net loss of $25.3 million, or ($0.40) per share, compared with a net loss of $18.4 million, or ($0.30) per share, a year earlier, driven mainly by higher general and administrative expenses.
Research and development expenses were $16.1 million versus $17.1 million in the prior-year quarter, while general and administrative expenses increased to $9.9 million from $5.4 million, largely due to severance and stock-based compensation. As of June 30, 2026, cash, cash equivalents, restricted cash and short-term investments totaled $34.5 million.
The company completed a private placement of up to $114 million, providing approximately $50 million in upfront gross proceeds (of which $10.0 million was received by June 30, 2026) and extending its cash runway into the second quarter of 2027. Updated MICVO monotherapy data in 2L+ R/M HNSCC are expected in Fall 2026, with updated first-line combination data with KEYTRUDA in the fourth quarter of 2026. MICVO holds U.S. FDA Fast Track Designation in R/M HNSCC.
Pyxis Oncology, Inc. entered into definitive securities purchase agreements for a private placement of 19,600,153 shares of common stock at $2.551 per share, together with common warrants to purchase an equal number of shares at an exercise price of $3.289. The deal is expected to provide approximately $50 million in upfront gross proceeds and up to an additional $64 million if the warrants are exercised for cash. Management expects this funding to extend the company’s cash runway into the second quarter of 2027 and to support development of its lead cancer therapy MICVO through key Phase 1 and Phase 1/2 clinical milestones, with updated monotherapy data planned for Fall 2026 and combination data in the fourth quarter of 2026. Pyxis also granted investors registration rights to resell the shares and warrant shares.
Pyxis Oncology, Inc. held its Annual Meeting of Stockholders in virtual format on June 15, 2026. As of the April 20, 2026 record date, 62,855,464 shares of common stock were outstanding and entitled to vote. A quorum was present, with 47,302,035 shares represented virtually, in person or by proxy.
Stockholders elected three Class II directors—Thomas Civik, Freda Lewis-Hall, M.D., and Michael A. Metzger—to serve until the 2029 annual meeting and until their successors are elected and qualified. Support levels varied by nominee, with for votes ranging from 19,188,755 to 27,341,415.
Stockholders also ratified the appointment of Ernst & Young LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026, with 46,203,257 votes for, 1,076,997 against and 21,781 abstentions.
Pyxis Oncology, Inc. reported first quarter 2026 results and highlighted progress in its lead antibody-drug conjugate, micvotabart pelidotin (MICVO), for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Updated MICVO Phase 1 monotherapy data in 2L+ R/M HNSCC are planned for mid‑2026, focusing on patients treated at or below a dose cap introduced in December 2025, while updated Phase 1/2 combination data with KEYTRUDA in 1L R/M HNSCC are expected in the second half of 2026. The company also presented supportive preclinical data at the 2026 AACR meeting and completed target enrollment in the Phase 1 monotherapy dose expansion study.
Financially, Pyxis Oncology reported a Q1 2026 net loss of $23.3 million, or ($0.37) per share, compared with a net loss of $21.2 million, or ($0.35) per share, a year earlier. Research and development expenses rose to $20.0 million, while general and administrative expenses declined to $4.4 million. The company ended March 31, 2026 with $42.5 million in cash, cash equivalents, restricted cash, and short‑term investments and expects this to fund operations into the fourth quarter of 2026.
Pyxis Oncology, Inc. filed an amendment to outline the separation terms for Lara Sullivan, M.D., whose service as Chief Executive Officer and principal executive officer ended earlier in 2026. The filing also notes that she resigned from the Board of Directors on April 29, 2026, and that her resignation was not due to any dispute or disagreement over the company’s operations or policies.
Under a Separation and General Release Agreement effective April 29, 2026, Dr. Sullivan will receive her existing salary for 18 months and may continue health coverage for up to 12 months. All of her unvested restricted stock units and stock options will vest, and the period to exercise her stock options is extended to December 31, 2030. The agreement includes a one-year post-separation non-solicitation covenant for Dr. Sullivan and a one-year mutual non-disparagement covenant.
Pyxis Oncology reported a full-year 2025 net loss of $79.6 million, or ($1.28) per share, on total revenues of $13.9 million, primarily from suvemcitug milestones and the sale of Enzeshu royalty rights. Research and development expenses rose to $73.7 million, driven by MICVO monotherapy and combination trials.
As of December 31, 2025, the company held $68.3 million in cash, cash equivalents, restricted cash and short-term investments and expects its cash runway to extend into the fourth quarter of 2026. MICVO showed a 46% confirmed objective response rate and 92% disease control rate as monotherapy in 2L+ recurrent/metastatic head and neck cancer, and a 71% confirmed response rate in combination with KEYTRUDA in early data.
Pyxis completed target enrollment in its Phase 1 monotherapy dose expansion study in 2L+ head and neck cancer in the first quarter of 2026, with updated monotherapy data expected mid‑2026 and updated combination data in the second half of 2026. The company also strengthened leadership, appointing Thomas Civik as Interim CEO and adding senior clinical, program and investor relations executives.
Pyxis Oncology, Inc. announced a leadership transition in which Lara S. Sullivan, M.D. ceased serving as Chief Executive Officer and principal executive officer effective February 2, 2026. The Board appointed director Thomas (Tom) Civik as Interim Chief Executive Officer and principal executive officer, effective the same date.
Under an interim employment agreement, Mr. Civik will receive an annualized base salary of $710,000 and be eligible for a target bonus equal to 60% of that salary, prorated for his service. Subject to Board approval, he will receive stock options for 1.1% of outstanding common stock vesting in 12 equal monthly installments during his interim term, and an additional fully vested option for 0.4% of outstanding common stock upon completion of a successful financing or strategic transaction during the interim term or within six months after.
A concurrent press release highlights the Board’s ongoing search for a permanent CEO and emphasizes continuity for Pyxis Oncology’s lead antibody-drug conjugate, micvotabart pelidotin (MICVO), which is being evaluated in Phase 1 and Phase 1/2 clinical studies in recurrent/metastatic head and neck squamous cell carcinoma and other solid tumors.
Pyxis Oncology, Inc. reported positive preliminary Phase 1 data for its antibody-drug conjugate micvotabart pelidotin (MICVO) in recurrent/metastatic head and neck squamous cell carcinoma. In the monotherapy cohort at 5.4 mg/kg, 18 patients were treated and 13 were evaluable, showing a confirmed overall response rate of 46% (6/13), including one complete response, and a disease control rate of 92% (12/13). MICVO was generally well tolerated, with no Grade 4 ADC payload treatment-related adverse events of interest or Grade 5 events, though Grade ≥3 treatment-related events occurred in 56% of patients and 28% discontinued treatment.
In combination with KEYTRUDA, 7 patients were treated, all evaluable, with a confirmed overall response rate of 71% (5/7) and a disease control rate of 100% (7/7), and no Grade 3 or 4 ADC payload treatment-related events of interest or treatment-related discontinuations reported. The company also completed the sale of its rights to royalties from the commercialization of Enzeshu for a one-time cash payment of $11 million, described as non-dilutive funding to support MICVO development, and currently expects its cash runway to fund operations into the fourth quarter of 2026.
Pyxis Oncology (PYXS) furnished a Form 8-K stating it issued a press release with financial results for the quarter ended September 30, 2025 and a corporate update. The press release is provided as Exhibit 99.1.
The company indicated the information in Item 2.02, including Exhibit 99.1, is furnished and not deemed filed under Section 18 of the Exchange Act.
Pyxis Oncology, Inc. furnished an update on its business by issuing a press release with its financial results for the quarter ended June 30, 2025 and a broader corporate update. The company submitted this information in a current report so investors can access the press release, which is attached as Exhibit 99.1. The report clarifies that the press release and related information are being furnished, not filed, which limits certain legal liabilities and means the material is not automatically incorporated into other regulatory documents.
Pyxis Oncology (PYXS) Form 8-K – Item 8.01
On 31 Jul 2025 the company amended the ClinicalTrials.gov record for its first-in-human, open-label Phase 1 monotherapy trial of micvotabart pelidotin (MICVO, formerly PYX-201; NCT05720117). The revision increases the maximum number of participants that may be enrolled in both dose-escalation (Part 1) and dose-expansion (Part 2) cohorts. Management states the change is procedural and does not alter prior guidance on the expected head-and-neck squamous cell carcinoma (HNSCC) enrollment disclosed in the 15 May 2025 10-Q.
No safety, efficacy, or financial data were released, and all other disclosure items remain unchanged.
Pyxis Oncology, Inc. (Nasdaq: PYXS) filed an 8-K reporting the voting results of its June 18, 2025 virtual Annual Meeting of Stockholders.
Quorum: 43,996,450 shares (≈71% of the 61,947,665 shares outstanding as of the April 21, 2025 record date) were represented.
Proposal 1 – Election of Class I Directors (term through 2028):
- Dr. Santhosh Palani, Ph.D., CFA: 22,056,449 FOR / 7,314,363 WITHHELD / 14,625,638 broker non-votes
- Mr. Darren Cline: 22,028,914 FOR / 7,341,898 WITHHELD / 14,625,638 broker non-votes
- Dr. Rachel Humphrey, M.D.: 21,357,102 FOR / 8,013,710 WITHHELD / 14,625,638 broker non-votes
All nominees obtained simple-majority support and were elected.
Proposal 2 – Ratification of Independent Auditor: Ernst & Young LLP was re-appointed for fiscal 2025 with 43,733,259 FOR, 233,563 AGAINST and 29,628 ABSTAIN; no broker non-votes.
The filing contains no financial performance data, strategic updates or other material transactions. The matters voted on are routine governance items; both proposals passed comfortably, indicating continued shareholder support for the board slate and the external auditor.