Pyxis Oncology Inc. (NASDAQ:PYXS) on Thursday released preliminary data from its ongoing Phase 1 studies of micvotabart pelidotin (MICVO) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).The update includes preliminary data from both the Phase 1 monotherapy study in second line (2L+) R/M HNSCC and the Phase 1/2 study evaluating MICVO in combination with Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab), in (first and second line) 1L/2L+ R/M HNSCC.The data reported below reflec ...

PresentationI would now like to turn the conference over to Alex Kane, Senior Vice President of Investor Relations and Capital Markets. Please go ahead.Ladies and gentlemen, thank you for standing by. Welcome to Pyxis Oncology MICVO Clinical Update Call. [Operator Instructions] Please be advised that today's conference is being recorded.Alex KaneSenior Vice President of Investor Relations & Capital Markets Hi, and good morning, everyone. My name is Alex Kane, and I'm the Senior Vice President of Investor Re ...

Pyxis Oncology (NasdaqGS:PYXS) Update / Briefing December 18, 2025 08:30 AM ET Company ParticipantsAlex Kane - SVP, IR and Capital MarketJeff La Rosa - Equity ResearchLara Sullivan - President, CEO and CMOConference Call ParticipantsAndy Hsieh - Biotechnology and Equity Research AnalystStephen Willey - MD and Senior Equity Research AnalystSwayampakula Ramakanth - MD and Senior Healthcare AnalystParsons Hack - AnalystSam Slutsky - Senior Research AnalystNone - AnalystBradley Canino - Biotechnology and Equity ...

MICVO Monotherapy Efficacy - MICVO monotherapy demonstrated a validated efficacy signal in 2L+ R/M HNSCC, with a 46% confirmed ORR and a 92% DCR (n=13, 5.4 mg/kg)[4] - In the Phase 1 monotherapy dose expansion study at 5.4 mg/kg, Arm 1 (post-PD1/post-Platinum) showed a 60% confirmed ORR (N=5)[32] - Arm 2 (post-PD1/post-EGFRi) in the monotherapy study showed a 25% confirmed ORR (N=4), exceeding the PI benchmark of 20%+[32] - MICVO monotherapy at 5.4 mg/kg demonstrated clear activity with deep responses and exceptional disease control[35] MICVO + KEYTRUDA® Combination Efficacy - MICVO combined with KEYTRUDA® showed a promising emerging efficacy profile in 1L/2L+ R/M HNSCC, with a 71% confirmed ORR and 100% DCR (n=7, 3.6 mg/kg & 4.4 mg/kg)[4] MICVO Safety and Tolerability - MICVO at 5.4 mg/kg in R/M HNSCC showed no Grade 4 or Grade 5 ADC payload TRAEs of interest[40] - Initial data supports a lack of overlapping toxicities observed between MICVO and KEYTRUDA®[52] Market and Clinical Development - FDA aligned on a 2L+ monotherapy pivotal trial design for MICVO[4] - The US R/M HNSCC market is large, growing, and relatively uncrowded, making it ripe for innovation[17] - Projected 2029 US market data shows a significant number of drug-treatable patients, with ~31K in 1L, ~21K in 2L, and ~8K in 3L[18]

46% confirmed objective response rate (ORR) and 92% disease control rate (DCR) observed with MICVO as monotherapy in 2L+ R/M HNSCC at 5.4 mg/kg 71% confirmed ORR and 100% DCR observed with MICVO in combination with KEYTRUDA® (pembrolizumab) in 1L/2L+ R/M HNSCC at 3.6 mg/kg and 4.4 mg/kgUpdated data from ongoing Phase 1 monotherapy study in 2L+ R/M HNSCC expected mid-2026; updated data from ongoing Phase 1/2 study evaluating MICVO in combination with KEYTRUDA®, including in 1L/2L+ R/M HNSCC and other tumor t ...

Summary of Pyxis Oncology Conference Call Company Overview - **Company**: Pyxis Oncology - **Focus**: ADC (Antibody-Drug Conjugate) development - **Lead Asset**: Novel ADC targeting extracellular domain B (EDB), a splice variant of fibronectin in the tumor microenvironment - **Mechanism**: Extracellular cleaving ADC that kills tumors through direct tumor killing, bystander effect, and immunogenic cell death - **Clinical Development**: Asset brought into the clinic in early 2023, with dose escalation data showing a confirmed overall response rate (ORR) of 50% in head and neck cancer [4][65] Clinical Data and Trials - **Basket Trial**: Conducted with 80 patients across nine tumor types, showing strong tumor regression in head and neck, breast, sarcoma, ovarian, and lung cancers [15][16] - **Efficacious Dose Range**: Identified as 3.6-5.4 mg/kg, with a well-tolerated safety profile [14][15] - **Combination Therapy**: Initiated trials combining the ADC with Pembrolizumab (Pembro) [66] Mechanistic Insights - **Differentiation from Conventional ADCs**: Unlike traditional ADCs that target cell surfaces, Pyxis's ADC cleaves in the extracellular matrix, allowing for direct tumor cell killing [7][8] - **Bystander Effect**: The ADC's mechanism includes a significant bystander effect, which has been validated through translational biology work [9][10] - **Translational Data**: Ten biology and translational posters presented at major conferences, supporting the proof of mechanism for the novel ADC [8][9] Safety and Tolerability - **Adverse Events (AEs)**: Modest AE profile with no grade three treatment-related ocular toxicity or neuropathy; manageable AEs include neutropenia and cutaneous lesions [15][24] - **Comparison with Other ADCs**: Safety profile appears favorable compared to other ADCs, with a stable drug-to-antibody ratio (DAR) of 4 [26][27] Market Position and Strategy - **Head and Neck Cancer**: Identified as an underserved market with significant unmet needs; ongoing trials aim to establish the ADC's role in both current and future treatment paradigms [28][29] - **Monotherapy and Combination Trials**: Two arms in monotherapy targeting platinum and PD-1 resistant patients, and a combination arm with PD-1 inhibitors [30][31] - **Competitive Landscape**: Aiming for an ORR of 35-45% in monotherapy to be competitive, and 60-65% in combination therapy [33][34] Future Directions - **Data Disclosure**: Preliminary data expected by year-end, with insights into market opportunities and regulatory strategies [52] - **Cash Position**: Current cash balance of $77 million, providing runway into the second half of 2026 [54] Additional Insights - **Biomarker Development**: No single biomarker expected to predict response; multiple factors such as protease concentration and tumor matrix characteristics are considered [47] - **Exploration of Other Tumor Types**: Ongoing studies in combination therapy may inform potential applications in other cancers beyond head and neck [48]

Summary of Pyxis Oncology FY Conference Call Company Overview - **Company**: Pyxis Oncology (NasdaqGS:PYXS) - **Lead Asset**: MICVO, an antibody-drug conjugate (ADC) targeting the extracellular domain B (EDB) in solid tumors [4][5] Key Points and Arguments Development Focus - **Target Indication**: Focus on head and neck cancers, with two ongoing programs: monotherapy for second and third line, and combination therapy with Pembrolizumab (Pembro) [5][18] - **Mechanism of Action**: MICVO utilizes a three-pronged mechanism involving direct tumor killing, bystander effect, and immunogenic cell death, allowing for broad applications across various solid tumors [4][12] Clinical Trial Insights - **Phase I Study**: Conducted as a basket dose escalation trial with 80 patients across 10 tumor types, identifying an efficacious dose range of 3.6-5.4 mg/kg [6][7] - **Efficacy Results**: Confirmed response rate of 50% in head and neck cancer patients, with tumor regression observed in six different tumor types [8][15] - **Safety Profile**: Minimal grade three adverse events reported, indicating broad tolerability, particularly in heavily pretreated end-of-life patients [7][10] Competitive Landscape - **Market Positioning**: Aiming to establish a foothold in the head and neck cancer market, competing against other therapies with a focus on both current and emerging treatment lines [16][22] - **Efficacy Expectations**: Minimum expected overall response rate (ORR) of 35% to be considered a credible competitor in the second and third line settings [22][23] Future Development Plans - **Data Updates**: Upcoming data disclosure will include preliminary results from both monotherapy arms and the combination therapy, aimed at shaping the understanding of the competitive landscape [19][20] - **Broader Applications**: While currently focused on head and neck cancers, the mechanism of MICVO suggests potential applications in other solid tumors over time [35][36] Translational Biology Work - **Supporting Mechanism**: Recent translational biology work has validated the mechanism of MICVO, including the identification of key proteases in the tumor microenvironment and T cell activation [12][13][14] Strategic Considerations - **Market Segmentation**: Plans to provide insights on market segmentation and competitive positioning in future updates, considering factors like HPV status and prior treatment history [33][34] Additional Important Insights - **Combination Therapy**: Ongoing combination therapy program with Keytruda, currently in dose escalation phase [18] - **Patient Cohorts**: Distinction between cohorts based on prior treatments (platinum and PD-1 vs. EGFR and PD-1) to assess the agent's efficacy in different treatment lines [16][17] This summary encapsulates the critical aspects of Pyxis Oncology's conference call, highlighting the company's strategic focus, clinical insights, and future development plans in the oncology space.

Core Insights - Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutics for difficult-to-treat cancers [2] - The company will participate in two upcoming investor conferences in November 2025, including the Guggenheim 2 Annual Healthcare Innovation Conference and the Stifel 2025 Healthcare Conference [1][3] Company Overview - Pyxis Oncology's lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody drug conjugate (ADC) targeting extradomain-B of fibronectin (EDB+FN), which is overexpressed in various solid tumors [2] - MICVO aims to treat solid tumors through a mechanism involving direct tumor cell killing, bystander effect, and immunogenic cell death [2] - The drug is currently in Phase 1 clinical studies for recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and other solid tumors, both as a monotherapy and in combination with Merck's KEYTRUDA® [2]

Product Development - Pyxis Oncology's product candidate micvotabart pelidotin (MICVO) targets EDB+FN, a component of the tumor extracellular matrix, aiming to destabilize tumor support while directly killing tumor cells[90]. - In the Phase 1 dose escalation study, micvotabart pelidotin achieved a 50% objective response rate (ORR) in six patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) at a dose range of 3.6 mg/kg – 5.4 mg/kg IV Q3W[96]. - The study also reported a disease control rate (DCR) of 100% among the six heavily pre-treated R/M HNSCC patients[96]. - Across six solid tumor types of interest, micvotabart pelidotin achieved a 26% ORR (n=31) at the same dose range[97]. - The FDA granted Fast Track Designation to micvotabart pelidotin for the treatment of adult patients with R/M HNSCC whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy[103]. - Pyxis Oncology plans to prioritize resources to further develop micvotabart pelidotin based on the promising efficacy signals observed in R/M HNSCC[104]. - A clinical trial collaboration with Merck has been established to study micvotabart pelidotin in combination with KEYTRUDA®[108]. - The company initiated a Phase 1/2 combination study with KEYTRUDA® to evaluate the safety and preliminary efficacy of micvotabart pelidotin in advanced solid tumors[109]. - Preliminary data from the ongoing studies are expected to be disclosed in the fourth quarter of 2025[111]. - The company is actively recruiting patients for two monotherapy expansion cohorts in the R/M HNSCC study, each expecting to enroll approximately 20 patients at the 5.4 mg/kg IV Q3W dose[111]. Financial Performance - For the nine months ended September 30, 2025, the company reported a net loss of $61.5 million, compared to a net loss of $41.8 million for the same period in 2024, representing an increase in losses of $19.8 million[115]. - Research and development expenses for the nine months ended September 30, 2025, increased by $7.3 million to $52.0 million, up from $44.7 million in the same period in 2024[136]. - The company recognized $2.8 million in milestone revenue related to regulatory approval of Suvemcitug in China during the nine months ended September 30, 2025, compared to $16.1 million in total revenues for the same period in 2024[133]. - The accumulated deficit as of September 30, 2025, was $425.1 million, with net equity of $68.8 million and cash and cash equivalents totaling $77.7 million[115]. - Research and development expenses for the three months ended September 30, 2025, were $17.8 million, a slight increase of $0.1 million from $17.7 million in the same period in 2024[126]. - The company expects to continue incurring significant operating losses and expenses in the foreseeable future, primarily due to ongoing clinical and preclinical activities[115]. - General and administrative expenses decreased by $0.4 million to $5.6 million for the three months ended September 30, 2025, compared to $6.0 million in the same period in 2024[130]. - Micvotabart pelidotin program-specific research and development costs increased by $2.0 million, primarily due to increased contract manufacturing and clinical trial expenses[127]. - The company has not generated any revenues from product sales and does not expect to do so in the foreseeable future[116]. - Other income, net for the three months ended September 30, 2025, was $1.4 million, down from $2.5 million in the same period in 2024, primarily due to decreased interest and investment income[131]. - Micvotabart pelidotin program-specific R&D costs increased by $9.1 million, driven by a $5.0 million rise in contract manufacturing costs and a $3.9 million increase in clinical trial expenses[137]. - PYX-106 program-specific R&D costs decreased by $3.9 million due to the pause in clinical development[138]. - General and administrative expenses decreased by $3.4 million, from $20.3 million in 2024 to $16.9 million in 2025, primarily due to lower stock-based compensation and professional fees[139]. - Other income decreased from $7.6 million in 2024 to $4.9 million in 2025, mainly due to reduced interest and investment income[140]. - As of September 30, 2025, the company had cash and short-term investments totaling $77.7 million, with net losses of $61.5 million for the nine months ended September 30, 2025[141]. - The company expects substantial increases in expenses related to ongoing clinical trials and may finance operations through equity offerings and collaborations[143]. - Net cash used in operating activities was $53.1 million for the nine months ended September 30, 2025, compared to $38.4 million in 2024[146][148]. - Net cash provided by investing activities was $42.6 million in 2025, primarily from the redemption of marketable debt securities[149]. - The company had $106.2 million of remaining capacity available under its ATM facility as of September 30, 2025[142]. - The company raised substantial doubt about its ability to continue as a going concern for the next 12 months due to insufficient cash resources[154].

Core Insights - Pyxis Oncology is advancing its lead candidate, micvotabart pelidotin (MICVO), targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) with preliminary data expected in Q4 2025 [1][5] Pipeline & Clinical Updates - Ongoing Phase 1 clinical studies of MICVO include monotherapy and combination approaches, with a focus on 2L/3L R/M HNSCC patients and a collaboration with Merck for combination therapy with KEYTRUDA® [4][5] - Preliminary data from the Phase 1 monotherapy dose expansion study and the Phase 1/2 combination dose escalation study will be presented, highlighting MICVO's unique mechanism of action and its potential to improve treatment outcomes [4][5] - Recent translational data presented at ESMO 2025 and AACR-NCI-EORTC provided insights into MICVO's pharmacodynamics and its effects on tumor microenvironment remodeling and immune activation [4][5] Financial Results - As of September 30, 2025, Pyxis Oncology reported cash and cash equivalents of $77.7 million, sufficient to fund operations into the second half of 2026 [11] - Research and development expenses for Q3 2025 were $17.8 million, slightly up from $17.7 million in Q3 2024, with a notable increase in MICVO program-specific costs [11] - The net loss for Q3 2025 was $22.0 million, consistent with the previous year, reflecting ongoing investment in clinical development [11][14]