Welcome to our dedicated page for Pyxis Oncology SEC filings (Ticker: PYXS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Pyxis Oncology, Inc. (PYXS) SEC filings page provides access to the company’s regulatory disclosures as filed with the U.S. Securities and Exchange Commission. As a Nasdaq-listed, clinical-stage biopharmaceutical company focused on antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, Pyxis Oncology uses its SEC reports to describe clinical progress, financial condition, governance matters, and material corporate events.
Investors can review Form 8-K filings that summarize significant developments such as preliminary Phase 1 data for micvotabart pelidotin (MICVO) in recurrent and metastatic head and neck squamous cell carcinoma, updates on ongoing monotherapy and combination studies, royalty and milestone transactions related to licensed antibodies, and key financial or corporate announcements. These current reports often incorporate or reference company press releases and presentations that detail MICVO’s clinical performance, safety profile, and translational findings.
In addition to 8-Ks, users can consult Pyxis Oncology’s periodic reports, including annual reports on Form 10-K and quarterly reports on Form 10-Q, which typically contain more comprehensive discussions of research and development activities, cash resources and runway expectations, collaboration agreements, and risk factors relevant to its oncology programs. Proxy materials and meeting results, such as submissions under Item 5.07 for stockholder votes, provide insight into board composition and corporate governance.
Stock Titan enhances these filings with AI-powered summaries that highlight key points from lengthy documents, helping readers quickly identify disclosures related to MICVO’s clinical trials, Fast Track Designation, collaboration with Merck on pembrolizumab combinations, and financial arrangements involving royalty streams from antibodies discovered on the APXiMAB platform. Real-time updates from EDGAR, along with structured access to forms such as 10-K, 10-Q, 8-K, and other relevant submissions, allow users to follow how Pyxis Oncology reports its oncology development and corporate trajectory over time.
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
Pyxis Oncology, Inc. has filed a shelf registration statement allowing it to offer up to $350,000,000 of securities, including common stock, preferred stock, debt, warrants, rights and units, over time. The specific terms and prices of each issuance will be set in future prospectus supplements.
Within this shelf, Pyxis also established an at-the-market program under which it may sell up to $150,000,000 of common stock from time to time through Leerink Partners, which will act as sales agent and receive up to 3.0% of the gross proceeds. Net proceeds from any sales are expected to be used for general corporate purposes such as working capital, operating expenses and capital expenditures, and potentially for complementary acquisitions.
Pyxis is a clinical-stage oncology company focused on solid tumors, particularly head and neck squamous cell carcinoma, and remains an emerging growth and smaller reporting company, which permits reduced public reporting requirements.
Pyxis Oncology (PYXS) reported Q3 2025 results, highlighting ongoing R&D investment and a going concern warning. The company posted a net loss of $22.0 million for the quarter on zero revenue. Operating expenses were $23.5 million, including $17.8 million in research and development and $5.7 million in general and administrative costs.
As of September 30, 2025, Pyxis held $76.3 million in cash, cash equivalents, and short‑term investments, with total assets of $105.6 million and stockholders’ equity of $68.8 million. Net cash used in operating activities was $53.1 million for the nine months ended September 30, 2025. The company disclosed that current liquidity will not be sufficient to fund operations over the next 12 months, which raises substantial doubt about its ability to continue as a going concern.
Pipeline updates center on micvotabart pelidotin (MICVO). The FDA granted Fast Track Designation in February 2025 for recurrent/metastatic HNSCC monotherapy after platinum and anti‑PD-(L)1 therapy. Pyxis recognized $2.8 million in milestone revenue in the nine‑month period tied to Suvemcitug approval in China. Common shares outstanding were 62,264,215 as of October 31, 2025.
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.
GordonMD entities and Craig D. Gordon report a passive 13G stake in Pyxis Oncology (PYXS). The filing shows that GordonMD Global Investments LP, GordonMD Long Biased Master Fund LP, GordonMD Long Biased GP LLC and Craig D. Gordon each report shared voting and dispositive power over 3,834,740 shares of Pyxis common stock, representing 6.2% of the class. All reported securities are owned by advisory clients of GordonMD Global Investments LP, with GordonMD Long Biased Master Fund LP identified as one advisory client that may hold more than 5%. The filing certifies the position is not intended to change or influence control of the issuer and includes a joint filing agreement and a control-person identification exhibit.
Pyxis Oncology (PYXS) is a clinical-stage oncology company focused on micvotabart pelidotin and reports significant historical losses with the expectation of continued losses while it advances development. The company has 62,018,135 shares outstanding as of June 30, 2025 and 190,000,000 shares authorized. It states a need for substantial additional capital and that failure to raise funds could delay or cut research, development or commercialization efforts. Preclinical and early clinical signals for micvotabart pelidotin are highlighted: robust tumor growth inhibition across patient-derived xenograft models, complete responses in multiple indications, tolerability in animal studies, and enhanced efficacy in combination with anti-PD-1. The company plans two ~20-patient expansion cohorts at 5.4 mg/kg IV Q3W with preliminary data expected in the second half of 2025 and the first half of 2026. Material business risks include regulatory, manufacturing, intellectual property and third-party reliance, and the company recorded no federal income tax provision for recent periods.
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.
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