PYXS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy; and

• MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior EGFR directed therapy and prior PD-(L)1 inhibitor therapy.

• We expect to report updated clinical data from both cohorts in Fall 2026. We believe this timeline allows for additional follow-up of 2L+ R/M HNSCC patients treated with MICVO at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap and will support detailed analyses of the impact of dose c…

• Dose capping and AIBW are both well-established approaches to modified weight-based dosing and have demonstrated improved tolerability without sacrificing clinical activity in studies of other ADCs. In December 2025, we implemented a dose cap for higher body weight patients. Based on internal PK sim…

• During the fourth quarter of 2025, we obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC, which continues to inform our development strategy for MICVO in this setting.

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose and are on track to report updated clinical data from this c…

• MICVO monotherapy for 2L and 3L R/M HNSCC patients who have received prior epidermal growth factor receptor (EGFR) directed therapy and prior PD-(L)1 inhibitor therapy. We expect to enroll approximately 20 patients in this expansion cohort at the 5.4 mg/kg IV Q3W dose and are on track to report upda…

• The mid-year 2026 update will focus on participants treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, and will include detailed analyses of the impact of dose capping on safety, tolerability, and efficacy. Dose capping and AIBW are both well-established approaches to modifie…

• During the fourth quarter of 2025, we obtained feedback and alignment from the U.S. Food and Drug Administration (FDA) regarding the clinical trial design for a planned pivotal monotherapy study in 2L+ R/M HNSCC.

• Comparison of the Three Months Ended March 31, 2026 and 2025

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Our management, with the participation of our Principal Executive Officer and Principal Financial and Accounting Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Our management, with the participation of our Principal Executive Officer and Principal Financial and Accounting Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. The term “disclosure controls…

• by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to provide rea…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles and legislative developments. For example, changes in federal government spending priorities, agency staffing levels, appropriations, work…

• Future issuances of equity securities, including securities issuable upon the exercise of outstanding warrants, and issuances of debt securities that are convertible into equity, may dilute our stockholders.

• We will need to raise additional capital in the future. We have recently raised capital through equity financings. For example, on July 2, 2026, we closed a private placement with certain institutional accredited investors and received gross proceeds of approximately $50 million, before deducting pl…

• In addition, holders of outstanding warrants (including warrants issued as part of the private placement) and other convertible or exercisable securities may acquire shares of our common stock in the future, resulting in additional dilution to existing stockholders. Future issuances of our common st…

• As of August 12, 2026, our executive officers and directors, together with holders of more than 5% of our outstanding common stock and their respective affiliates, beneficially owned, in the aggregate and without duplication, approximately 38.1% of our outstanding common stock, or approximately 57.6…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• In addition, regulatory authorities, including the U.S. Food and Drug Administration, have increased their focus on dose optimization and exposure-response relationships in oncology drug development, including through initiatives such as Project Optimus. Under this evolving framework, sponsors are e…

• In addition, federal agency priorities, leadership, policies, rulemaking, communications, spending, and staffing may be significantly impacted by election cycles and legislative developments. For example, the current presidential administration’s commitment to significantly reduce government spendin…

• The future issuance of equity or of debt securities that are convertible into equity will dilute our share capital.

• We will need to raise additional capital in the future. To the extent we raise additional capital through the issuance of equity or convertible debt securities in the future, there will be dilution to our existing investors and the terms of these securities may include liquidation or other preferenc…

• As of May 13, 2026, our executive officers and directors, together with holders of five percent or more of our outstanding common stock and their respective affiliates, beneficially own approximately 30.2% of our outstanding common stock. As a result, these stockholders, if acting together, have sig…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• Jitendra Wadhane, Principal Financial and Accounting Officer

• Sales of shares intended to satisfy the affirmative defense of Rule 10b5–1(c)