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as of 11-09-2026 2:14pm EST

$1.73
+$0.08
+4.86%
Stocks Health Care Biotechnology: Pharmaceutical Preparations Nasdaq

Pyxis Oncology Inc is a clinical-stage oncology company focused on developing therapies for patients with solid tumors, with an initial emphasis on head and neck squamous cell carcinoma. Its product candidate, micvotabart pelidotin (MICVO, formerly PYX-201), is an investigational antibody-drug conjugate that targets extradomain-B fibronectin (EDB+FN), a component of the tumor extracellular matrix that is expressed in tumors and minimally present in normal tissues. MICVO consists of a fully human monoclonal antibody linked to a microtubule inhibitor payload, designed to bind within the tumor microenvironment and release its payload to kill cancer cells directly, affect nearby cells through a bystander effect, and induce immunogenic cell death, supporting enhanced anti-tumor activity.

Founded: 2018 Country:
United States
United States
Employees: N/A City: BOSTON
Market Cap: 141.3M IPO Year: 2021
Target Price: $8.22 AVG Volume (30 days): 797.9K
Analyst Decision: Strong Buy Number of Analysts: 10
Dividend Yield:
N/A
Dividend Payout Frequency: N/A
EPS: -0.98 EPS Growth: 3.03
52 Week Low/High: $1.03 - $5.55 Next Earning Date: 11-05-2026
Revenue: $13,858,000 Revenue Growth: -14.17%
Revenue Growth (this year): -99.86% Revenue Growth (next year): 14188.99%
P/E Ratio: -1.68 Index: N/A
Free Cash Flow: -63511000.0 FCF Growth: N/A

Earnings Transcripts

SEC 8-K filings with transcript text

View All
2026
Q3

Q3 2026 Earnings

8-K SELL

Nov 5, 2026 · 100% conf.

AI Prediction SELL

1D

-4.44%

$1.59

5D

-9.27%

$1.51

20D

-13.96%

$1.43

Price: $1.66 Prob +5D: 0% AUC: 1.000
0001193125-26-448604

EX-99.1

2 pyxs-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Pyxis Oncology Reports Third Quarter 2026 Financial Results and Highlights Progress Toward Pivotal Development of Micvotabart Pelidotin (MICVO)

Updated Phase 1 monotherapy results in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) showed compelling efficacy data with a manageable safety profile

FDA feedback on dose selection from the End-of-Phase 2 meeting expected in the first quarter of 2027; global Phase 3 HeadlinerSM trial initiation planned for mid-2027

Updated overall survival data from the MICVO Phase 1 monotherapy study expected in the first half of 2027

MICVO Phase 1 monotherapy data in previously treated R/M HNSCC to be presented in a late-breaking oral presentation and preclinical findings to be presented in two posters at the 38th EORTC-NCI-AACR Symposium

December 2026 corporate update to outline MICVO’s development strategy in R/M HNSCC, including updated data from the first-line pembrolizumab combination study

Quarter-end cash and net upfront proceeds from October public offering expected to fund operations into the first half of 2028

BOSTON, November 5, 2026 -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended September 30, 2026, and highlighted continued progress in the development of micvotabart pelidotin (MICVO).

“The September monotherapy data reinforce our confidence in MICVO’s potential to serve a significant population of patients with previously treated recurrent/metastatic head and neck cancer,” said Tom Civik, Chief Executive Officer and Chairman of Pyxis Oncology. “We have aligned with feedback received from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the design of the global Phase 3 HeadlinerSM trial and plan to initiate it in mid-2027, with FDA feedback on dose selection expected in the first quarter of 2027. We look forward to presenting MICVO monotherapy data, along with two preclinical posters, at the EORTC-NCI-AACR Symposium in November, and providing a comprehensive update on our head and neck cancer strategy in December, including updated efficacy and safety data from MICVO in combination with pembrolizumab in the first-line setting. Our strengthened balance sheet positions us to execute on these priorities, continue evaluating MICVO’s broader potential and advance toward becoming a pre-commercial organization.”

Pipeline Updates

• Pyxis Oncology has aligned with feedback from the FDA and the EMA on the design of the global pivotal Phase 3 HeadlinerSM trial, which the Company plans to initiate in mid-2027. The randomized, open-label, two-arm trial will evaluate MICVO monotherapy in patients with second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) who have progressed following treatment with both platinum-based chemotherapy and an anti-PD-1 therapy. Approximately 500 patients are expected to be randomized 1:1 to receive MICVO or investigator’s choice of cetuximab, docetaxel or methotrexate. The co-primary endpoints are overall response rate and overall survival.

• Pyxis Oncology expects to provide an update in the first quarter of 2027 on FDA feedback regarding dose selection following its End-of-Phase 2 meeting.

• Updated overall survival data from the ongoing MICVO monotherapy study are expected in the first half of 2027.

• Additional data from the Phase 1/2 combination study of MICVO and Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in first-line (1L) R/M HNSCC, including initial durability data to inform selection of the recommended Phase 3 dose, are expected in the second half of 2027.

Reported Updated Phase 1 Monotherapy Data in 2L+ R/M HNSCC

On September 9, 2026, Pyxis Oncology announced updated data from its ongoing global Phase 1 monotherapy study of MICVO in 2L+ R/M HNSCC, as of a data cutoff of August 18, 2026.

In the efficacy-evaluable population receiving MICVO at 5.4 mg/kg intravenously once every three weeks (IV Q3W) at or below a dose cap (N=33):

• Confirmed objective response rate was 36% (12/33), and disease control rate was 94% (31/33).

• Responses were rapid and deep, with 75% of responders responding by the first scan at six weeks and 83% of responders achieving greater than 50% tumor reduction.

• Median progression-free survival was 6.2 months (95% CI: 4.8–8.8), and the 12-month overall survival probability was 79% (95% CI: 58.1, 90.3). Median overall survival had not yet been reached.

• Clinical activity was observed across HPV status and prior-treatment subgroups.

In the safety-evaluable population (N=35), no new safety signals were observed. Dose capping reduced the frequency and severity of adverse events in high body weight patients.

Planned December 2026 Corporate Update

Pyxis Oncology plan

2026
Q2

Q2 2026 Earnings

8-K SELL

Aug 13, 2026 · 90% conf.

AI Prediction SELL

1D

-3.94%

$2.89

Act: +0.00%

5D

-8.82%

$2.74

20D

-13.29%

$2.61

Price: $3.01 Prob +5D: 5% AUC: 1.000
0001193125-26-347911

EX-99.1

2 pyxs-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Pyxis Oncology Reports Second Quarter 2026 Financial Results and Advances MICVO Toward Key 2026 Clinical Milestones

Updated data from the MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC on track to be reported in Fall 2026; update to include detailed analyses of patients treated at or below a dose cap

Updated data from the MICVO Phase 1/2 combination study with pembrolizumab in 1L R/M HNSCC on track to be reported in the fourth quarter of 2026

Completed private placement financing for up to $114 million, providing approximately $50 million in upfront gross proceeds to support additional patient follow-up

Upfront proceeds from the private placement, together with existing cash, extended the Company’s cash runway into the second quarter of 2027

BOSTON, August 13, 2026 (GLOBE NEWSWIRE)— Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended June 30, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development programs.

“The second quarter was marked by continued execution across the MICVO program and a financing that strengthened our balance sheet and extended our cash runway into the second quarter of 2027,” said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. “The additional capital gives us greater flexibility to incorporate longer patient follow-up and planned analyses into our next clinical updates. We expect to report updated monotherapy data in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) this fall, followed by updated first-line combination data with pembrolizumab in the fourth quarter. We remain focused on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer, regardless of HPV status or prior therapy.”

Pipeline & Corporate Updates

• Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in Fall 2026. The update is expected to include patients treated at 5.4 mg/kg IV Q3W with a dose equivalent to or below a dose cap, together with detailed analyses of the dose cap impact on safety, tolerability, efficacy and initial durability.

• The Company completed target enrollment in the Phase 1 Part 2 monotherapy dose expansion study in the first quarter of 2026.

• The ongoing MICVO Phase 1 monotherapy study 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, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025, supporting MICVO’s broad potential to address a significant unmet need for patients regardless of HPV status or prior therapy.

• The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post-platinum and anti-PD-(L)1-experienced patients (Arm 1) and post-EGFRi and anti-PD-(L)1-experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20.

• In December 2025, a dose cap was implemented for higher body weight patients. Based on internal 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 Fall 2026 monotherapy disclosure will remain focused on patients treated at or below the dose cap.

• Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for 1L R/M HNSCC patients in the fourth quarter of 2026.

• The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA® (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.

• In June 2026, Pyxis Oncology announced up to $114 million of private placement financing with new and existing healthcare-focused investors to advance MICVO through key clinical milestones.

• On July 2, 2026, the Company completed the private placement which resulted in upfront gross proceeds of approximately $50 million, before deducting placement agent fees and offering expenses, and anticipates up to an additional approximately $64 million of gross proceeds, before placement agent fees, if the accompanying warrants are exercised in full for cash.

• The upfront proceeds from the private placement, together with existing cash, extended the Company’s cash runway into the second quarter of

2026
Q1

Q1 2026 Earnings

8-K SELL

May 14, 2026 · 100% conf.

AI Prediction SELL

1D

-5.39%

$2.09

Act: +5.88%

5D

-8.90%

$2.01

Act: -12.22%

20D

-13.17%

$1.92

Act: -20.36%

Price: $2.21 Prob +5D: 0% AUC: 1.000
0001193125-26-222818

EX-99.1

2 pyxs-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Pyxis Oncology Reports First Quarter 2026 Financial Results and Advances MICVO Toward Key 2026 Clinical Milestones

Updated micvotabart pelidotin (MICVO) Phase 1 monotherapy data in 2L+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) on track for mid-year 2026; update to include analyses focused on patients treated at or below a dose cap

Completed target enrollment in Phase 1 monotherapy dose expansion study of MICVO in 2L+ R/M HNSCC in the first quarter of 2026

Updated data from MICVO Phase 1/2 dose escalation study in combination with pembrolizumab in 1L R/M HNSCC on track for the second half of 2026

Presented new preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026 that support the clinical development of MICVO as both a monotherapy and in combination with pembrolizumab for the treatment of R/M HNSCC

Announced the appointment of Nelson Azoulay as Chief Business Officer

Expected cash runway into the fourth quarter of 2026

BOSTON, May 14, 2026 (GLOBE NEWSWIRE) — Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended March 31, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development program.

“Our team’s exceptional clinical and operational execution in the first quarter of 2026, combined with growing investigator enthusiasm for MICVO’s potential to positively impact the lives of patients with cancer, has positioned us to deliver key milestones for the MICVO program this year,” said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. “We remain on track to share updated monotherapy data in mid-year 2026 and updated combination data in the second half of 2026. The mid-year 2026 monotherapy update will focus on 2L+ R/M HNSCC patients treated at or below a dose cap, which we implemented in December 2025. The goal of moving to a dose cap was to maintain MICVO’s strong efficacy profile while improving safety and tolerability. In the Phase 1/2 dose escalation combination study with pembrolizumab, we have refined our focus to 1L R/M HNSCC patients. We believe these two datasets will help establish MICVO’s broad potential as a novel ADC for patients with difficult-to-treat cancers and substantial unmet need.”

Pipeline & Corporate Updates

• Pyxis Oncology expects to report updated data from the ongoing MICVO Phase 1 monotherapy study for 2L+ R/M HNSCC in mid-year 2026. The mid-year 2026 update will focus on participants who were treated at 5.4 mg/kg IV Q3W, with a dose equivalent to or below a dose cap. Results will include detailed analyses of the impact of a dose cap on safety, tolerability and efficacy.

• The ongoing MICVO Phase 1 monotherapy study 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, a dose expansion study in 2L+ R/M HNSCC, is currently ongoing. Preliminary Phase 1 study results in 2L+ R/M HNSCC were shared in December 2025.

• The dose expansion study of the ongoing MICVO Phase 1 monotherapy study includes two arms: post platinum and anti-PD-(L)1 experienced patients (Arm 1) and post EGFRi and anti-PD-(L)1 experienced patients (Arm 2). Target enrollment for each arm of the study was n=~20. Total study target enrollment was completed in 1Q26.

• In December 2025, a dose cap was implemented for higher body weight patients. Based on internal 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.

• 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[i].

• A protocol amendment permitting AIBW has been approved, and AIBW dosing has begun. AIBW will be selected as a go-forward dose strategy only if it offers a superior profile to dose capping.

• Pyxis Oncology expects to report updated data from the ongoing Phase 1/2 combination dose escalation study of MICVO and Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for 1L R/M HNSCC patients in 2H26.

• The ongoing MICVO Phase 1/2 study evaluating MICVO in combination with KEYTRUDA® (pembrolizumab) is currently in dose escalation across multiple doses for the treatment of 1L R/M HNSCC. Preliminary positive results for the treatment of 1L/2L+ R/M HNSCC were shared in December 2025.

• The MICVO Phase 1/2 combination dose escalation study update in 2H26 will focus on 1L R/M HNSCC patients.

• In April 2026, Pyxis Oncology presented new preclinical data in a poster

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