Core Insights - The company has reported positive preliminary data from the Phase 1 dose escalation trial of micvotabart pelidotin (MICVO), achieving a confirmed 50% objective response rate in recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) [1][6] - MICVO has received Fast Track Designation from the U.S. FDA for treating adult patients with R/M HNSCC whose disease has progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][10] - The company has initiated monotherapy expansion cohorts for MICVO in 2L and 3L R/M HNSCC patients, with preliminary data expected in 2H25 and 1H26 [1][7] Pipeline Updates - The lead therapeutic candidate, micvotabart pelidotin, has shown significant tumor regression in multiple tumor types during the Phase 1 dose escalation study [4] - A combination study of MICVO with Merck's anti-PD-1 therapy, KEYTRUDA®, has been initiated, with preliminary data expected in 2H25 [5][7] - The company has streamlined its organization and reduced its workforce by approximately 20% to focus resources on the MICVO clinical program [5][8] Financial Overview - As of December 31, 2024, the company had cash and cash equivalents of $128.4 million, sufficient to fund operations into the second half of 2026 [11] - Research and development expenses increased to $58.7 million in 2024 from $49.6 million in 2023, primarily due to clinical trial-related expenses [11] - The net loss for the year ended December 31, 2024, was $77.3 million, or $1.32 per common share, compared to a net loss of $73.8 million, or $1.85 per common share, in 2023 [11][16]

Company Overview - Pyxis Oncology, Inc. is a clinical-stage company focused on developing next-generation therapeutics for difficult-to-treat cancers [3] - The company is working on PYX-201, an antibody-drug conjugate (ADC) targeting EDB+FN, which is currently in Phase 1 clinical studies for various solid tumors [3] Upcoming Events - Lara S. Sullivan, M.D., President and CEO of Pyxis Oncology, will participate in a fireside chat at the Leerink Partners Global Healthcare Conference on March 10, 2025, at 2:20 PM EST [1] - A live webcast and replay of the fireside chat will be available on the company's Investor Relations website [2]

Core Insights - Pyxis Oncology, Inc. has received Fast Track Designation from the FDA for its drug PYX-201, aimed at treating recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) in patients who have progressed after platinum-based chemotherapy and anti-PD-(L)1 therapy [1][2] Company Overview - Pyxis Oncology is a clinical-stage company focused on developing next-generation therapeutics for challenging cancers, with PYX-201 being its lead clinical candidate [8] - PYX-201 is an antibody-drug conjugate (ADC) that targets Extradomain-B Fibronectin (EDB+FN), a component of the tumor extracellular matrix, designed to kill cancer cells and address tumor microenvironment factors [5][8] Industry Context - Head and Neck Cancer (HNC) is the sixth most common cancer globally, with approximately 1,464,550 new cases and 487,993 deaths annually [3] - Nearly 50% of HNSCC cases progress to recurrent or metastatic stages post-initial treatment, with a median overall survival of less than one year [3] - The incidence of HNSCC is projected to increase by 30% annually by 2030, driven by factors such as tobacco use, alcohol consumption, and HPV infections [3]

Core Insights - Pyxis Oncology, Inc. is making significant progress in its clinical program for PYX-201, an antibody-drug conjugate (ADC) targeting Extradomain-B Fibronectin (EDB+FN), which is highly expressed in various tumor types [1][10] - The company is actively recruiting for two trials: one evaluating PYX-201 as a monotherapy for recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and another combining PYX-201 with Merck's KEYTRUDA® in patients with advanced solid tumors [2][3] Clinical Trials - The Phase 1/2 combination study, PYX-201-102, is set to initiate patient dosing in Q1 2025, focusing on the combination of PYX-201 with pembrolizumab across multiple indications [3][6] - The ongoing Phase 1 PYX-201-101 study has begun enrolling patients for its monotherapy expansion cohorts, targeting advanced solid tumors predicted to express EDB+FN [5][9] Treatment Potential - PYX-201 is designed to deliver its AUR-0101 payload specifically within the tumor microenvironment, potentially enhancing the efficacy of pembrolizumab by allowing T cells to infiltrate challenging tumor microenvironments [3][10] - The ongoing trials represent a critical step in advancing PYX-201 as a potential breakthrough treatment for a broad range of cancers, particularly for patients with limited treatment options [3][11]

Core Viewpoint - Pyxis Oncology is prioritizing its lead asset, PYX-201, a novel antibody-drug conjugate (ADC) targeting difficult-to-treat cancers, particularly head and neck squamous cell carcinoma (HNSCC) [1][8] Group 1: PYX-201 Development - PYX-201 has shown significant RECIST responses in HNSCC, with a confirmed 50% objective response rate (ORR) in a Phase 1 trial [2] - The drug achieved a disease control rate (DCR) of 100% in a small cohort of heavily pretreated patients [2] - Across six solid tumor types, PYX-201 achieved a 26% ORR, indicating potential for further development in both monotherapy and combination therapy settings [3] Group 2: Clinical Trials and Future Plans - The company plans to initiate patient dosing for both monotherapy and combination therapy trials in early 2025, including a frontline HNSCC study in combination with pembrolizumab [3][4] - Preliminary data from ongoing dose expansion studies is expected in the second half of 2025 and the first half of 2026 [4] Group 3: Financial Outlook - The current cash position is projected to fund the development of PYX-201 into the second half of 2026 [9] Group 4: Pipeline Prioritization - The company has deprioritized its second clinical program, PYX-106, to focus resources on advancing PYX-201 [6][8] - PYX-106 was observed to be generally safe and well-tolerated, but further clinical investment has been suspended [7][8]

Core Insights - Pyxis Oncology, Inc. released preliminary data from a Phase 1 clinical study of PYX-201, showing a 50% objective response rate in Head and Neck Squamous Cell Carcinoma patients [1] - The company has entered a Clinical Trial Collaboration Agreement with Merck to study PYX-201 in combination with Keytruda for various cancers [2] - Analysts have reduced the probability of success for PYX-201 to 10% from 35%, with an updated fair value of $250 million or approximately $4.25 per share [7] Group 1: Clinical Data and Studies - In the ongoing Phase 1 study, among 6 evaluable HNSCC patients treated with PYX-201 at doses of 3.6 – 5.4 mg/kg, there was a confirmed 50% objective response rate, including one complete response and two partial responses [1] - A combination study of PYX-201 and Keytruda is planned for 1L and 2L HNSCC, HR+/HER2- breast cancer, TNBC, and sarcoma, with preliminary data expected in the second half of 2025 [3][5] - Exploratory Phase 1 monotherapy expansion cohorts for PYX-201 are planned for ovarian cancer, NSCLC, HR+/HER2 breast cancer, TNBC, and sarcoma, with preliminary data also expected in the second half of 2025 [4] Group 2: Market and Analyst Insights - William Blair analysts noted that PYX-201 shows limited effectiveness outside of head-and-neck cancer, with only 8.7% of patients responding to the drug at tolerable doses [6] - The stock is expected to trade around $2.80 per share soon, reflecting a valuation of $1.77 per share for PYX-201 and $1.07 for remaining cash by late 2025 [8] - Pyxis has been downgraded to Market Perform due to challenges in differentiating head-and-neck cancer results and modest activity in other solid tumor types [8]

Core Insights - Pyxis Oncology's lead drug candidate, PYX-201, has shown promising preliminary data with a confirmed 50% objective response rate (ORR) in heavily pretreated head and neck squamous cell carcinoma (HNSCC) patients, including one complete response and a 100% disease control rate in a small cohort [1][3] - The overall ORR across six solid tumor types of interest is 26%, indicating dose-dependent responses and supporting the first-in-concept mechanism of the novel extracellular targeting antibody-drug conjugate (ADC) [1][2] - A new clinical trial collaboration agreement with Merck will evaluate the combination of PYX-201 and Merck's anti-PD-1 therapy, KEYTRUDA®, in various cancer types, with dosing expected to begin in the first quarter of 2025 [1][5] Clinical Trial Details - The ongoing Phase 1 clinical trial has enrolled 80 patients across multiple solid tumor types, with doses ranging from 0.3 mg/kg to 8.0 mg/kg, focusing on safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy [2][4] - The identified dose range for PYX-201 is currently between 3.6 mg/kg and 5.4 mg/kg, with a median of four prior lines of cancer therapies for enrolled patients [2][4] Safety and Pharmacokinetics - PYX-201 has demonstrated a favorable safety profile, with a low incidence of treatment-related adverse events (TRAE) and minimal Grade 3 or Grade 4 TRAEs, indicating its potential for both monotherapy and combination therapy [11][12] - The drug's design allows for increased stability in circulation, attributed to its proprietary site-specific conjugation chemistry [12] Future Development Plans - The company plans to initiate expansion studies for PYX-201 in HNSCC and other solid tumors, with preliminary clinical data expected in the second half of 2025 and early 2026 [7][9][10] - Additional exploratory cohorts are planned for ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma [9][10] Investor Engagement - Pyxis Oncology will host an investor event to discuss the preliminary Phase 1 data, featuring insights from key physician thought leaders [15][16]

Financial Performance - Pyxis Oncology reported a net loss of $41.8 million for the nine months ended September 30, 2024, compared to a net loss of $58.2 million for the same period in 2023, indicating a reduction in losses year-over-year [59]. - Net loss for the three months ended September 30, 2024, was $21.20 million, a decrease of $1.85 million compared to a net loss of $23.05 million for the same period in 2023 [65]. - Total revenues for the nine months ended September 30, 2024, were $16.1 million, compared to $0 for the same period in 2023, primarily due to a settlement agreement with Novartis [69]. - Other income increased to $7.6 million for the nine months ended September 30, 2024, compared to $6.2 million in 2023, primarily due to higher sublease income [73]. - Other income, net for the three months ended September 30, 2024, was $2.55 million, an increase of $0.25 million compared to $2.30 million for the same period in 2023 [65]. Cash and Investments - As of September 30, 2024, Pyxis Oncology had an accumulated deficit of $328.0 million and cash, cash equivalents, and short-term investments totaling $144.8 million [59]. - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $144.8 million, with net losses of $21.2 million and $41.8 million for the three and nine months ended September 30, 2024, respectively [74]. - Net cash used in operating activities was $38.4 million for the nine months ended September 30, 2024, compared to $55.5 million in the same period of 2023 [78]. - Net cash used in investing activities was $18.5 million for the nine months ended September 30, 2024, primarily due to purchases of marketable debt securities [79]. - Net cash provided by financing activities was $59.3 million for the nine months ended September 30, 2024, compared to $6.0 million in 2023 [80]. - The company expects existing cash resources to fund operations into the second half of 2026, including clinical development for PYX-201 [80]. Research and Development - The company has not generated any revenues from product sales and does not expect to do so in the foreseeable future, relying instead on research and development agreements for revenue [60]. - Pyxis Oncology's research and development expenses are expected to increase substantially due to ongoing and planned clinical activities [62]. - Research and development expenses increased by $6.7 million, from $37.98 million for the nine months ended September 30, 2023, to $44.72 million for the same period in 2024 [71]. - PYX-201 program-specific research and development costs increased by $12.6 million, primarily due to a $3.2 million increase in clinical trial expenses and a $7.6 million increase in contract manufacturing costs [71]. - Total program costs for the three months ended September 30, 2024, were $11.16 million, significantly up from $4.13 million for the same period in 2023 [66]. Clinical Trials and Product Development - The Phase 1 trial of PYX-201 has dosed 80 subjects, focusing on difficult-to-treat cancers such as head and neck squamous cell carcinoma and non-small cell lung cancer [55]. - PYX-201 received Orphan Drug Designation from the FDA for the treatment of pancreatic cancer, with a starting dose of 0.3 mg/kg in the Phase 1 trial [55]. - The acquisition of Apexigen added PYX-107 to the pipeline, which has shown a 15.2% partial response rate in melanoma patients refractory to anti-PD-(L)1 therapy [59]. - The Phase 1 trial of PYX-106 has dosed 45 subjects, with a starting dose of 0.5 mg/kg and a focus on solid tumors [58]. - The company anticipates announcing preliminary data from the Phase 1 trial of PYX-201 in November 2024 [55]. Expenses and Obligations - General and administrative expenses decreased by $4.7 million, from $10.67 million for the three months ended September 30, 2023, to $6.01 million for the same period in 2024 [68]. - General and administrative expenses decreased by $6.1 million, from $26.5 million in the nine months ended September 30, 2023, to $20.3 million in the same period of 2024 [72]. - Unallocated research and development costs decreased by $8.6 million from $28.2 million for the nine months ended September 30, 2023, to $19.6 million for the same period in 2024 [71]. - The company has contractual lease obligations totaling $27.1 million over the remaining term of its office and laboratory space lease [82].

Core Insights - Stephens has initiated coverage on Pyxis Oncology Inc, emphasizing the company's technology platform for next-gen antibody-drug conjugates (ADCs) with improved potency, stability, and tolerability [1] - The lead drug, PYX-201, targets Extradomain-B Fibronectin (EDB+FN) in tumor stroma and delivers a toxic payload into the tumor microenvironment [1] - The analyst has given an Overweight rating with a price target of $13 [1] ADC Technology Potential - The ADC technology has demonstrated strong potential, with recent successes enhancing confidence in market growth [2] - Pyxis has shown that proteases and acidic conditions in the tumor stroma can effectively break down the payload linker, similar to cellular absorption processes [2] Clinical Trial Updates - The company is set to announce results from the first phase of its human clinical trial for PYX-201, which targets various solid tumors, with updates expected this month [3] - Positive results, including partial or complete responses and a favorable safety profile at doses above 3.6 mg/kg, are anticipated [3] Financial Position - As of June 30, 2024, Pyxis Oncology reported cash and cash equivalents of $157.2 million, which includes restricted cash and short-term investments [4] - The current financial resources are projected to fund operations into the second half of 2026 [4] - The stock price of PYXS was noted at $4.42, reflecting a 12.2% change at the last check [4]

NEW YORK, Sept. 25, 2024 /PRNewswire/ -- Levi & Korsinsky announces that it has commenced an investigation of Pyxis Oncology, Inc. (NASDAQ:PYXS) concerning possible breaches of fiduciary duty. To obtain additional information, go to: https://zlk.com/compensation2/pyxis-oncology-inc-lawsuit-submission-form or contact Joseph E. Levi, Esq. either via email at [email protected] or by telephone at (212) 363-7500. There is no cost or obligation to you. Levi & Korsinsky is a nationally recognized firm with offices ...