Ankündigung • Sep 09

Pyxis Oncology Announces Positive Updated Data From Phase 1 Monotherapy Study Of Micvotabart Pelidotin (MICVO) In Second-Line And Beyond Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

Pyxis Oncology, Inc. announced positive updated data as of the August 18, 2026 data cutoff date from its ongoing global Phase 1 monotherapy study evaluating micvotabart pelidotin (MICVO) in patients with second-line and beyond (2L+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The updated results represent a population (N=33 efficacy evaluable) dosed at 5.4 mg/kg intravenously once every three weeks with a dose equivalent to or below a dose cap. These data demonstrated rapid and deep responses, with a 36% confirmed objective response rate (cORR) and 94% disease control rate (DCR). Median progression-free survival (mPFS) was 6.2 months, and the 12-month overall survival (OS) probability was 79% while median OS (mOS) has not yet been reached. Clinical activity was observed across key patient subgroups, including HPV status and prior treatment. No new safety signals were observed (N=35 safety evaluable), and dose capping reduced the frequency and severity of adverse events in high body weight patients. MICVO, the company’s lead program, is a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix. MICVO’s differentiated, non-EGFR targeting mechanism of action positions it to potentially serve a significant patient population and address unmet need in 2L+ R/M HNSCC as the first-line treatment landscape continues to evolve. The updated results reported focus on patients treated at 5.4 mg/kg Q3W with a dose cap. MICVO is designed to generate a multi-pronged attack on difficult-to-treat cancers by directly killing cancer cells, reducing extra-cellular matrix density, inhibiting tumor angiogenesis and mobilizing an anti-tumor immune response. MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)-1 therapy. The ongoing Phase 1 monotherapy study of MICVO is a multi-part study. Part 1 was a dose escalation study across multiple doses and tumor types, with initial results shared in November 2024. Part 2 is a dose expansion study in 2L+ R/M HNSCC. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025. The dose expansion portion of the study includes two arms: post-platinum and anti-PD-(L)1 patients (Arm 1) and post-EGFR inhibitor and anti-PD-(L)1 patients (Arm 2). Target enrollment for each arm was approximately 20 patients, and the Company completed target enrollment in the Phase 1 Part 2 monotherapy dose expansion study in the first quarter of 2026. In December 2025, a dose cap was implemented for high body weight patients. Based on internal pharmacokinetic (PK) simulation modeling indicating that MICVO exposures with dose capping and adjusted ideal bodyweight (AIBW) dosing are expected to be comparable, dose capping was prioritized due to its operational simplicity and speed of implementation. The updated results reported focus on patients treated at 5.4 mg/kg Q3W with a dose cap. Efficacy Data: Confirmed objective response rate (cORR), % (n/N): 36% (12/33). Disease control rate (DCR), % (n/N): 94% (31/33). Responders achieving response by the first scan at six weeks, %: 75%. Responders achieving >50% tumor reduction from baseline, %: 83%. Median progression-free survival (mPFS), months, (95% CI): 6.2 (4.8-8.8). 12-month overall survival (OS) probability, %, (95% CI): 79% (58.1,90.3). Median overall survival (OS), months: NR (NR-NR). Efficacy Data Across Key Patient Subgroups: HPV+ oropharyngeal: N=17, Confirmed ORR: 35%, Median PFS: 6.2 months. HPV-unrelated: N=16, Confirmed ORR: 38%, Median PFS: 5.9 months. Prior EGFRi: Yes: N=18, Confirmed ORR: 28%, Median PFS: 5.0 months. No: N=15, Confirmed ORR: 47%, Median PFS: 8.8 months. Prior Novel EGFRi: Yes: N=5, Confirmed ORR: 40%, Median PFS: 5.8 months. Prior Taxane: Yes: N=23, Confirmed ORR: 35%, Median PFS: 6.2 months. No: N=10, Confirmed ORR: 40%, Median PFS: 4.9 months. Safety Data: No new safety signals were observed with MICVO. The tolerability data was consistent with that of other ADCs with auristatin payloads and was generally manageable. Adverse events of interest, including peripheral neuropathy, generally occurred after patients had received evidence of benefit, and after prolonged duration of treatment. Safety Data Summary – 5.4 mg/kg Dose Cap Population (N=35): Treatment duration – median days (range): 120 (21-470). All TRAEs, n (%): 32 (91.4%). TRAEs of CTCAE Grade = 3, n (%): 19 (54.3%). Non-Hematologic TRAEs of CTCAE Grade = 3, n (%): 15 (42.9%). Serious TRAEs, n (%): 5 (14.3%). TRAEs leading to treatment discontinuation, n (%): 5 (14.3%). TRAEs leading to treatment discontinuation days, median (min-max): 162 (104-212). TRAEs leading to dose reduction, n (%): 14 (40.0%). Treatment related deaths (Grade 5): 0. ADC Payload TRAEs of Interest: Cutaneous, n (%): Gr1/2: 17 (48.6%), Gr3: 2 (5.7%). Peripheral Neuropathy, n (%): Gr1/2: 14 (40.0%), Gr3: 6 (17.1%). Peripheral Neuropathy days to onset, median (min-max): Gr1/2: 82 (3-151), Gr3: 166 (85-197). Ocular, n (%): Gr1/2: 10 (28.6%), Gr3: 2 (5.7%). Pneumonitis, n (%): Gr1/2: 4 (11.4%), Gr3: 0. Pyxis Oncology is advancing the clinical development of MICVO through Project Optimus, a U.S. Food and Drug Administration (FDA) initiative focused on dose optimization and dose selection in oncology drug development. An End of Phase 2 meeting with the FDA to align on dose selection is anticipated in the first quarter of 2027. Updated overall survival data from the MICVO monotherapy study are expected in the first half of 2027. The Company has aligned with the feedback from the FDA and the European Medicines Agency (EMA) on the design of the planned pivotal Phase 3 monotherapy study of MICVO in patients with second- or third-line R/M HNSCC who have progressed following treatment with both a platinum-based therapy and an anti-PD-1 therapy. The randomized, open-label, 2-arm study will enroll approximately 500 patients who will be randomized 1:1 to receive MICVO or investigators’ choice of cetuximab, docetaxel, or methotrexate. The co-primary endpoints of the study will be overall response rate and overall survival. Pyxis Oncology plans to initiate the study in mid-2027 following alignment with the FDA on dose selection. Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for 1L R/M HNSCC patients in the fourth quarter of 2026. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025. Additional data evaluating initial durability and selection of the recommended Phase 3 dose (RP3D) for the 1L combination are expected in the second half of 2027.

Ankündigung • Nov 21

Pyxis Oncology, Inc. Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data

Pyxis Oncology, Inc. announced positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors. PYX-201, the Company’s lead clinical drug candidate, is a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (ECM). In this ongoing open-label, multicenter, dose-escalation Phase 1 trial of PYX-201, 80 patients have been enrolled and dosed across multiple solid tumor types to receive doses of PYX-201 ranging from 0.3 mg/kg up to 8.0 mg/kg. The trial's main objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. The current identified dose range for PYX-201 is 3.6 mg/kg to 5.4 mg/kg. The number of prior lines of cancer therapies for patients enrolled is a median of 4 lines and up to 10 lines in some patients. The data cutoff date for this data announcement was October 4, 2024. Preliminary Phase 1 Clinical Response Data in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC): Significant clinical responses were observed in HNSCC. Among evaluable HNSCC patients treated at an identified dose range of PYX-201 from 3.6 – 5.4 mg/kg (n=6), a confirmed 50% objective response rate (ORR) was observed, including one confirmed complete response (CR) and two confirmed partial responses (PR) by RECIST 1.1. Clinical Trial Collaboration Agreement with Merck’s KEYTRUDA® (pembrolizumab). The Company additionally announces that it has entered into a Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada), for a Pyxis Oncology-sponsored study of PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with 1L and 2L head and neck squamous cell carcinoma (HNSCC), HR+/HER2- breast cancer, and triple-negative breast cancer (TNBC) and sarcoma. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Pyxis Oncology and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies. PYX-201 Development Plans in Head and Neck Squamous Cell Carcinoma (HNSCC): The Company expects to initiate the following HNSCC Phase 1 expansion studies: PYX-201 and KEYTRUDA® combination dose escalation and expansion study in 1L and 2L HNSCC with preliminary clinical data readout expected in the second half of 2025; PYX-201 monotherapy study in 2L and 3L HNSCC patients who are platinum and PD-1 inhibitor experienced, with preliminary clinical data readout expected in the second half of 2025; and PYX-201 monotherapy study in 2L and 3L HNSCC patients who are EGFR and PD-1 inhibitor experienced, with preliminary clinical data readout expected in first half of 2026. Preliminary Phase 1 Clinical Response Data in Additional Solid Tumor Types: Encouraging confirmed and unconfirmed responses were observed in five additional solid tumor types: ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma. PYX-201 Development Plan in Additional Tumor Types: Exploratory PYX-201 Phase 1 monotherapy expansion cohorts are planned in ovarian cancer, NSCLC, HR+/HER2- breast cancer, TNBC, and sarcoma, with preliminary clinical data expected in the second half of 2025. The Company also expects to initiate the following clinical combination studies: PYX-201 and KEYTRUDA® combination study in HR+/HER2- breast cancer, TNBC, and sarcoma with preliminary clinical data expected in the second half of 2025 and the first half of 2026. Preclinical studies of PYX-201 in combination with other agents in ovarian cancer and NSCLC to commence in 2025 to be followed by clinical studies with preliminary clinical data expected in 2026. Summary of Preliminary Phase 1 Safety and Pharmacokinetics (PK) Data: PYX-201 demonstrated favorable preliminary tolerability profile data with low incidence of dose discontinuation, interruptions or delays due to treatment-related adverse events (TRAE). Low incidence of Grade 3 or Grade 4 payload-related TRAEs within the identified dose range reinforce PYX-201’s differentiated construct enabling enhanced molecular stability and differential expression of Extradomain-B (EDB) in tumor tissue with negligible expression in normal tissues. The low incidence of Grade 1 or Grade 2 adverse events points to an attractive safety, given that it has been well tolerated and suitable for both monotherapy and combination therapy development. With respect to PK data, PYX-201 demonstrated increased stability in circulation, which company believes is due to its proprietary design of site-specific conjugation chemistry as compared to certain approved val-cit-monomethyl auristatin E (MMAE) ADCs with non-site-specific conjugation chemistry.

Gesamte Aktionärsrendite	-4.0%
Zukünftige Dividendenrendite	n/a
Wachstum der Dividende	n/a
Nächster Dividendenzahlungstermin	n/a
Ex-Dividendendatum	n/a
Dividende pro Aktie	n/a
Ausschüttungsquote	n/a

Segment	Dividendenrendite
Unternehmen (PYXS)	n/a
Untere 25 % des Marktes (US)	1.4%
Markt Top 25 % (US)	4.1%
Branchendurchschnitt (Biotechs)	2.2%
Analystenprognose (PYXS) (bis zu 3 Jahre)	n/a

Daten	Zuletzt aktualisiert (UTC-Zeit)
Unternehmensanalyse	2026/09/14 23:15
Aktienkurs zum Tagesende	2026/09/14 00:00
Gewinne	2026/06/30
Jährliche Einnahmen	2025/12/31

Paket	Daten	Zeitrahmen	Beispiel US-Quelle ^*
Finanzdaten des Unternehmens	10 Jahre	Gewinn- und Verlustrechnung Kapitalflussrechnung Bilanz	SEC-Formular 10-K SEC-Formular 10-Q
Konsensschätzungen der Analysten	+3 Jahre	Finanzielle Vorausschau Kursziele der Analysten	Analysten Research Berichte Blue Matrix
Marktpreise	30 Jahre	Aktienkurse Dividenden, Splits und Aktionen	ICE-Marktdaten SEC-Formular S-1
Eigentümerschaft	10 Jahre	Top-Aktionäre Insiderhandel	SEC-Formular 4 SEC-Formular 13D
Verwaltung	10 Jahre	Das Führungsteam Direktorium	SEC-Formular 10-K SEC-Formular DEF 14A
Wichtige Entwicklungen	10 Jahre	Ankündigungen des Unternehmens	SEC-Formular 8-K

Analyst	Einrichtung
Tazeen Ahmad	BofA Global Research
Bradley Canino	Guggenheim Securities, LLC
Swayampakula Ramakanth	H.C. Wainwright & Co.

Pyxis Oncology Ausschüttungen und Rückkäufe

Zukünftiges Wachstum Kriterienprüfungen 0/6

Wichtige Informationen

Jüngste Updates zu Dividenden und Rückkäufen

Recent updates

Pyxis Oncology: Setbacks Costing Nearly 2 Years Of Recovery

Insufficient new directors

Price target increased by 14% to US$8.33

Pyxis Oncology Announces Positive Updated Data From Phase 1 Monotherapy Study Of Micvotabart Pelidotin (MICVO) In Second-Line And Beyond Recurrent/Metastatic Head And Neck Squamous Cell Carcinoma

Pyxis Oncology, Inc. Announces Appointment of Thomas Civik to Chief Executive Officer, Effective September 4, 2026

Consensus revenue estimates fall by 56%

New major risk - Shareholder dilution

New major risk - Revenue and earnings growth

Consensus revenue estimates increase by 14%

Pyxis Oncology, Inc. announced that it expects to receive $49.99999 million in funding from BVF Partners L.P., GordonMD Global Investments LP, RTW Investments, LP, Coastlands Capital LP

Pyxis Oncology Secures $114 Million Private Placement to Advance MICVO Clinical Milestones

Pyxis Oncology, Inc.(NasdaqGS:PYXS) dropped from Russell Microcap Value Benchmark Index

New major risk - Share price stability

New major risk - Revenue and earnings growth

Pyxis Oncology, Inc., Annual General Meeting, Jun 15, 2026

Pyxis Oncology Presents New Preclinical Data on MICVO Combination Therapy in HNSCC Model

New major risk - Financial position

Full year 2025 earnings: EPS and revenues exceed analyst expectations

Pyxis Oncology, Inc. Announces Chief Executive Officer Changes, Effective February 3, 2026

New minor risk - Market cap size

Pyxis Oncology, Inc. Announces Positive Preliminary Phase 1 Data for Micvotabart Pelidotin (MICVO) in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

New major risk - Share price stability

Pyxis Oncology, Inc. has filed a Follow-on Equity Offering in the amount of $150 million.

Price target increased by 10% to US$6.63

Pyxis Oncology, Inc. Appoints Alex Kane as Senior Vice President, Investor Relations & Capital Markets, Effective October 9, 2025

New major risk - Financial position

Pyxis Oncology, Inc. Announces Revisions to Patient Enrollment Participants Related to Phase 1 Monotherapy Clinical Trial

Pyxis Oncology, Inc. Announces CFO Changes, Effective July 1, 2025

Pyxis Oncology, Inc.(NasdaqGS:PYXS) dropped from Russell 2500 Value Index

Here's Why We're Watching Pyxis Oncology's (NASDAQ:PYXS) Cash Burn Situation

Pyxis Oncology, Inc., Annual General Meeting, Jun 18, 2025

Pyxis Oncology, Inc. Presents Promising Preclinical Results Providing Proof of Mechanism of Micvotabart Pelidotin, the First-In-Concept Extracellular-Targeting ADC

Pyxis Oncology, Inc. Reduces its Workforce by Approximately 20%

Pyxis Oncology, Inc. Grants Fast Track Designation for PYX-201 Monotherapy in Patients with Recurrent or Metastatic Head and Neck Cancer

Pyxis Oncology, Inc. Initiates New PYX-201 Combination Trial and Initiates Cohort Expansions of Ongoing Monotherapy Trial

New major risk - Shareholder dilution

Price target decreased by 17% to US$8.83

Pyxis Oncology, Inc. Announces Portfolio Prioritization, Focusing Resources on Its Lead Clinical Program, PYX-201

New minor risk - Market cap size

Pyxis Oncology: Speculative Buy Opportunity With Multiple Catalysts Ahead

New minor risk - Share price stability

Pyxis Oncology, Inc. Announces Favorable Preliminary PYX-201 Clinical Phase 1 Part 1 Data

Moment Of Truth Approaches For Pyxis Oncology

Pyxis Oncology, Inc. Appoints Michael A. Metzger to Its Board of Directors

Pyxis Oncology: Promising Research Amid Cash Constraints

Consensus revenue estimates increase by 258%, EPS downgraded

Pyxis Oncology, Inc. Appoints Stephen Worsley as its Senior Vice President

Price target increased by 11% to US$8.00

Pyxis Oncology, Inc., Annual General Meeting, Jun 11, 2024

Pyxis Oncology: Data Arriving Later Than Expected, But May Be Worth The Wait

New major risk - Shareholder dilution

Pyxis Oncology, Inc. Appoints Santhosh Palani to Its Board of Directors

Pyxis Oncology, Inc. announced that it expects to receive $49.999989 million in funding from Blue Owl Healthcare Opportunities, StemPoint Capital LP, Deep Track Capital, LP, Laurion Capital Management LP, Ridgeback Capital Management LLC and another investors

Pyxis Oncology: Making A Bold Acquisition Move, But It's Not A Convincing Thesis

Pyxis Oncology, Inc. Appoints Ken Kobayashi, M.D., F.A.C.P, as Chief Medical Officer

Price target decreased by 40% to US$6.00

CEO, President & Director recently sold US$63k worth of stock

Pyxis Oncology, Inc. (NasdaqGS:PYXS) completed the acquisition of Apexigen, Inc. (NasdaqCM:APGN) from entities associated with Pfizer Inc. (NYSE:PFE), Lincoln Park Capital, LLC, managed by Laurion Capital Management LP, Bayer World Investments B.V. and others.

Price target decreased by 19% to US$8.67

High number of new and inexperienced directors

Price target decreased by 19% to US$8.67

Chief Medical Officer notifies of intention to sell stock

New minor risk - Market cap size

Pyxis Oncology, Inc. Advances Pyx-106 and PYX-201 Clinical Programs

Pyxis Oncology, Inc. (NasdaqGS:PYXS) entered into a definitive agreement to acquire Apexigen, Inc. (NasdaqCM:APGN) for $15.9 million.

Pyxis Oncology, Inc. Announces Resignation of Jay M. Feingold as Chief Medical Officer, Effective June 15, 2023

Will Pyxis Oncology (NASDAQ:PYXS) Spend Its Cash Wisely?

Price target decreased to US$11.00

High number of new and inexperienced directors

Here's Why We're Watching Pyxis Oncology's (NASDAQ:PYXS) Cash Burn Situation

Pyxis Oncology, Inc. Appoints Rachel Humphrey to Its Board of Directors

Pyxis Oncology GAAP EPS of -$0.79 beats by $0.06

Pyxis Oncology, Inc. Appoints Jitendra Wadhane as Chief Accounting Officer and Principal Accounting Office

Pyxis Oncology, Inc.(NasdaqGS:PYXS) dropped from Russell 2500 Value Index

High number of new and inexperienced directors