UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR Pyxis Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 83-1160910 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 321 Harrison Avenue Boston, Massachusetts 02118 (Address of principal executive offices ...

– Phase 1 monotherapy expansion study of micvotabart pelidotin (MICVO) for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients progressing well with preliminary data in second half of 2025 and first half of 2026 – Phase 1/2 combination study of MICVO and KEYTRUDA® (pembrolizumab) progressing well with preliminary data in second half of 2025 – Received a $2.8 million, net of tax, milestone payment from Simcere Pharmaceutical Group Limited for approval of suvemcitug (BD0801) in ...

PYX-201 Mechanism and Target - PYX-201 is a first-in-concept extracellular-cleaving ADC targeting EDB+FN, a non-cellular component of the tumor extracellular matrix [6, 7] - EDB+FN is highly overexpressed in various solid tumors, releasing the payload extracellularly for direct tumor killing, bystander effect, and immunogenic cell death [10, 11] - PYX-201's unique mechanism of action (MOA) may address a primary cause of drug resistance by altering the ECM [16] Clinical Trial and Tolerability - Phase 1 dose escalation study included 80 patients with 10 solid tumor types [29] - PYX-201 demonstrated a favorable tolerability profile with a low treatment discontinuation rate of 1% [6, 39] - The identified dose range for further evaluation is 3.6 - 5.4 mg/kg [6, 34] Efficacy and Responses - An overall response rate (ORR) of 26% was observed in 6 responding tumor types (n=31) at the identified dose range of 3.6-5.4 mg/kg [6, 43] - In HNSCC patients within the 3.6 – 5.4 mg/kg dose range, a 50% ORR and 100% disease control rate (DCR) were observed [6, 54] - Median time on study in Phase 1 Part 1 was approximately 12 weeks [50, 51] Future Development and Catalysts - A clinical trial collaboration will evaluate PYX-201 in combination with KEYTRUDA® (pembrolizumab) [18] - Multiple clinical catalysts are expected in the next 6-18 months, including readouts from HNSCC monotherapy and early line combination studies [6, 65] - As of Q3 2024, the company has $146 million in cash, providing runway into 2H 2026 [87]

Summary of Pyxis Oncology Inc (PYXS) 2025 Conference Call Company Overview - **Company**: Pyxis Oncology Inc (PYXS) - **Focus**: Development of an antibody-drug conjugate (ADC) called Mycvotabart pelodotin, targeting extracellular domain B (EDB) of fibronectin, currently in phase one development [3][4] Core Points and Arguments ADC Development and Mechanism - **Differentiated Approach**: Pyxis Oncology's ADC targets the tumor extracellular matrix (ECM) rather than relying solely on internalization by tumor cells, allowing for payload release in the extracellular environment [6][7] - **Clinical Data**: The phase one study included 80 patients across nine tumor types, showing tumor regression in at least six types, particularly strong signals in head and neck cancer [9][10] - **Safety Profile**: No grade five adverse events reported, with a low incidence of grade three and above neuropathies and ocular toxicity, indicating a well-tolerated treatment [10][11] Clinical Trial Insights - **Head and Neck Cancer Focus**: The confirmed overall response rate (ORR) in the heavily pretreated head and neck cohort was 50%, with a 100% disease control rate [13][14] - **Patient Population**: The study targeted a very sick population with a median of four prior lines of therapy, indicating the drug's potential effectiveness in late-stage patients [13][14] - **Future Expectations**: Two upcoming data updates are anticipated in the second half of the year, focusing on monotherapy and combination therapy with Keytruda [19][20][23] Competitive Landscape - **Market Positioning**: The company aims to differentiate itself by demonstrating efficacy in both HPV positive and negative patients, potentially gaining a competitive advantage [29][30] - **Benchmarking Against Competitors**: The company is aware of the benchmarks set by competitors like Merus and BIKARA, with expectations of achieving ORRs of 65% or more for combination therapy and 37% for monotherapy [34][35] Financial Position and Future Outlook - **Cash Position**: The company reported a cash balance of approximately $105 million, providing a runway through the second half of 2026 [57][58] - **Key Events**: Investors are advised to monitor upcoming clinical data releases and translational work that may provide insights into the drug's mechanism and efficacy [58] Additional Important Insights - **Exploratory Work**: The company is conducting research to understand responder versus non-responder characteristics, focusing on the tumor microenvironment and potential biomarkers [55][56] - **Collaboration with Merck**: A supply agreement with Merck is in place, allowing for collaboration and data sharing, which may enhance the development strategy across multiple tumor types [51][53] This summary encapsulates the key points discussed during the conference call, highlighting the company's strategic focus, clinical developments, competitive positioning, and financial outlook.

Summary of Pyxis Oncology Inc (PYXS) 2025 Conference Call Company Overview - **Company**: Pyxis Oncology Inc (PYXS) - **Lead Asset**: MycVo, a first-in-class antibody-drug conjugate (ADC) targeting the extracellular domain b, a splice variant of fibronectin [3][4] Key Points and Arguments Product Development and Mechanism - MycVo was developed by Pfizer and optimized for better potency, stability, and permeability [3] - The ADC utilizes site-specific conjugation chemistry, which is crucial for the quality of the dataset [4] - MycVo targets EDB, which is highly expressed in various solid tumors but minimally in normal tissue, indicating a potential for high specificity and reduced side effects [4] Clinical Data and Efficacy - Initial clinical data from a dose escalation study involving 80 patients across 10 tumor types showed tumor regression in 6 out of 9 tumor types dosed [9] - A notable 50% confirmed response rate was observed in head and neck cancer patients, with some patients having multiple prior lines of therapy [10] - The company is transitioning to cohort expansion to validate initial findings with a larger patient population [9][11] Safety Profile - The safety profile of MycVo is considered well-tolerated, with no drug-related grade five adverse events reported [15] - Only one patient out of 77 discontinued due to adverse effects, indicating a low dose reduction rate [15] - The company compared its safety data favorably against FDA-approved ADCs, showing better or comparable results in various toxicity dimensions [16] Competitive Landscape - The company is aware of competing therapies in the head and neck space, such as those from Maris and Vicara, and aims to demonstrate superior overall response rates (ORR) [18][20] - Current ORR for Maris is 37%, while MycVo has shown a 50% response rate in a heavily pretreated population [20] Future Development Plans - The company is focusing on both monotherapy and combination therapy programs, with plans to generate data from 40 head and neck patients across two arms [28][29] - Preliminary data for the monotherapy is expected in the second half of the year, while combination therapy data is anticipated shortly thereafter [30][32] Research and Mechanism Insights - Ongoing research aims to better understand the mechanism of MycVo, including its direct tumor-killing effects and local immunostimulatory effects [25][27] - The company is also investigating gene signatures to identify responsive patient populations [27] Investigator Enthusiasm - There is significant enthusiasm from the physician community, with waiting lists for patient enrollment in both monotherapy and combination studies [41] - Investigators are optimistic about MycVo's potential to address resistance in various patient populations [41] Other Important Content - The company is constrained by resources but is strategically focusing on head and neck cancer while exploring signals in other tumor types like breast, sarcoma, ovarian, and lung cancers [22][24] - The development program is designed to allow for simultaneous data collection from monotherapy and combination therapy, enhancing the interpretability of results [33] This summary encapsulates the key insights and developments discussed during the Pyxis Oncology conference call, highlighting the company's strategic focus, clinical data, safety profile, and future plans in the oncology space.

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40881 Pyxis Oncology, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 83-1160910 | | --- | --- | | (State or other jurisdiction of | (I.R. ...

Core Insights - Pyxis Oncology is advancing its lead candidate micvotabart pelidotin (MICVO), demonstrating a unique three-pronged mechanism of action that includes direct tumor killing, bystander effect, and immunogenic cell death [1][5] - The company is on track to report preliminary data from Phase 1 trials for MICVO in various patient cohorts, with significant milestones expected in the second half of 2025 and early 2026 [1][5] - Financial results indicate a net loss of $21.2 million for Q1 2025, a significant increase from a net loss of $3.3 million in Q1 2024, primarily due to increased research and development expenses [10][13] Pipeline Updates - MICVO has shown broad anti-tumor activity across ten solid tumor indications in preclinical models, attributed to its unique targeting and cytotoxic payload [5] - The company is focusing on recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a key area of development, with ongoing Phase 1 studies evaluating MICVO as a monotherapy and in combination with pembrolizumab [7][5] - Preliminary data from the ongoing Phase 1 clinical trial is expected to be reported in the second half of 2025 for patients who have received prior platinum and PD-1 inhibitor therapy [5][1] Financial Overview - As of March 31, 2025, Pyxis Oncology reported cash and cash equivalents of $106.9 million, which is expected to fund operations into the second half of 2026 [4][6] - Research and development expenses increased to $17.0 million in Q1 2025 from $13.0 million in Q1 2024, reflecting heightened clinical trial activities [10] - General and administrative expenses decreased to $5.9 million in Q1 2025 from $8.2 million in Q1 2024, primarily due to lower stock-based compensation and corporate insurance costs [10]

Core Insights - Pyxis Oncology, Inc. announced robust preclinical data supporting the unique mechanism of action of micvotabart pelidotin (MICVO), an antibody-drug conjugate (ADC) targeting extradomain-B fibronectin (EDB+FN), which is highly expressed in various solid tumors [1][5] - MICVO demonstrated significant anti-tumor activity across multiple solid tumor indications, with 45% of models showing strong to very strong tumor growth inhibition (TGI) and complete responses observed in several tumor types [2][3] - The combination of MICVO with anti-PD-1 therapy showed enhanced tumor clearance and longer immunological memory compared to either treatment alone, reinforcing the potential for MICVO as both a monotherapy and in combination therapies [1][3] Preclinical Findings - Evaluation of MICVO in patient-derived xenograft (PDX) models identified gene signatures associated with anti-tumor activity, with 45% of models showing TGI between 70% and 90% or greater than 90% [2][3] - The preclinical studies indicated that MICVO is well-tolerated at a dosage of 3 mg/kg, with significant tumor regression responses confirmed in Phase 1 studies [2][4] - Upregulation of certain proteases may enhance linker cleavage, contributing to increased MICVO activity, supporting the hypothesis for its extracellular mechanism [3] Clinical Development - MICVO is currently being evaluated in Phase 1 studies as a monotherapy and in combination with KEYTRUDA® (pembrolizumab) for advanced solid tumors, particularly recurrent and metastatic head and neck squamous cell carcinoma [4][5][8] - The company has received Fast Track Designation from the U.S. FDA for MICVO in treating adult patients with recurrent and metastatic head and neck squamous cell carcinoma whose disease has progressed after prior treatments [8]

Industry Overview - The cancer market is experiencing significant growth due to rising demand for targeted and less toxic cancer medicines, with new cancer cases in the U.S. expected to exceed 2 million for the first time in 2024, leading to increased global spending on cancer treatments [1][3] - Innovative cancer treatments such as immunotherapy, targeted therapies, and personalized vaccines are emerging, utilizing the body's immune system and focusing on specific genetic mutations to provide more effective and less harmful alternatives to traditional chemotherapy [2][3] Company Developments - Major pharmaceutical companies like Novartis, AstraZeneca, Pfizer, AbbVie, and Eli Lilly are actively developing new cancer therapies, including antibody-drug conjugates and immune-oncology agents, while smaller biotech firms are also making significant advancements [4] - Verastem Oncology is seeking FDA approval for its combination regimen of avutometinib and defactinib for treating KRAS mutant recurrent low-grade serous ovarian cancer, with a decision expected by June 30, 2025 [6][7] - Relay Therapeutics has reported positive interim data for its RLY-2608 breast cancer program, leading to plans for a pivotal study in mid-2025 [9][10] - Pyxis Oncology is focused on developing next-generation therapeutics, with its lead candidate showing significant tumor regression in patients with recurrent and metastatic head and neck squamous cell carcinoma, and has received Fast Track Designation from the FDA [12][13][14]

Core Insights - Pyxis Oncology, Inc. is a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers [3] - The company will participate in the Stifel 2025 Virtual Targeted Oncology Forum on April 9, 2025, featuring a fireside chat with CEO Lara S. Sullivan [1] - The lead product candidate, micvotabart pelidotin (MICVO), is an antibody-drug conjugate targeting Extradomain-B Fibronectin, currently in Phase 1 clinical studies for various solid tumors [3] Company Overview - Pyxis Oncology is dedicated to creating differentiated mono and combination therapies for challenging cancers [3] - MICVO aims to combat difficult-to-treat cancers through multiple mechanisms, including direct cancer cell killing and enhancing anti-tumor immune response [3] - The company is focusing on recurrent and metastatic head and neck squamous cell carcinoma based on promising clinical signals [3] Event Participation - The company will hold one-on-one investor meetings during the Stifel 2025 Virtual Targeted Oncology Forum [1] - A live webcast of the fireside chat will be available on the company's Investor Relations website [2]