BOSTON, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers, today announced the appointment of Alex Kane, MBA, as Senior Vice President, Investor Relations & Capital Markets, effective immediately. Mr. Kane brings 20 years of experience and a proven track record in investor relations, strategic communications, and equity capital markets across the life sciences sector. He joins P ...

Technical Analysis - Pyxis Oncology, Inc. (PYXS) has reached a key level of support, indicating potential for upward movement [1] - The 50-day simple moving average has crossed above the 200-day simple moving average, forming a "golden cross," which is a bullish signal for traders [1] - A golden cross typically suggests a bullish breakout is on the horizon, as it indicates a positive trend reversal [2] Performance Metrics - Over the past four weeks, PYXS has gained 48%, suggesting strong momentum [3] - The stock currently holds a 2 (Buy) rating on the Zacks Rank, further indicating potential for a breakout [3] - Positive earnings outlook for the current quarter supports the bullish case, with three revisions higher and no downward revisions in earnings estimates over the past two months [3] Investment Consideration - Investors are encouraged to consider adding PYXS to their watchlist due to the significant technical indicator and positive movement in earnings estimates [5]

Summary of Pyxis Oncology FY Conference Call Company Overview - **Company**: Pyxis Oncology (NasdaqGS:PYXS) - **Focus**: Clinical-stage oncology company targeting head and neck cancer and advanced solid tumors - **Lead Candidate**: Micutorbopilidotin (MICO), investigated for monotherapy and combination therapy with pembrolizumab [1][2] Core Points and Arguments Business Strategy - Pyxis Oncology's strategy centers on MICO, an antibody-drug conjugate (ADC) licensed from Pfizer, which has a strong development history [2] - Initial data indicated a strong signal in head and neck cancer among nine solid tumor types [2] - Two ongoing programs: - Monotherapy program with two arms targeting different patient populations - Combination program with pembrolizumab [3][4] Upcoming Catalysts - Major catalysts expected in the next 12 to 18 months: - Monotherapy trial results for PD-1 plus platinum-resistant population in the second half of the year - Results for EGFR-resistant population in the first half of next year [4][10] - Combo trial data from dose escalation involving multiple tumor types [10][11] Mechanism of Action - MICO targets EDB, a novel extracellular domain B splice variant of fibronectin, which is expressed across various tumor types [6][8] - The ADC mechanism involves cleavage in the extracellular matrix, contributing to a bystander effect, which is becoming recognized as significant in ADC efficacy [9] Efficacy Expectations - Efficacy benchmarks set by competitors: - Monotherapy: 36% overall response rate (ORR) from Merus - Combination therapy: 63% ORR from Merus - Pyxis aims for competitive efficacy in the 30s for monotherapy and 60s for combination therapy [12] Safety Profile - Safety concerns include neutropenia, neuropathy, ocular toxicity, and pneumonitis, with Pyxis showing comparable or better safety profiles than existing ADCs [16][17] Market Opportunity - The EGFR-resistant population is seen as a distinct market opportunity, with potential for patients who do not respond to existing therapies [18][19] - The company is cautious about quantifying market sizes until more data is available [19] Future Indications - Pyxis is currently focused on head and neck cancer but sees potential for MICO in other tumor types due to its broad applicability [24][25] Financial Position - Current cash position is approximately $90 million, providing a runway through the second half of next year, allowing the company to fund upcoming catalysts without immediate need for additional capital [28][29] Additional Important Points - The company is prioritizing head and neck cancer due to strong signals observed, while remaining open to exploring other indications in the future [25] - The global market for cetuximab varies, with different standards of care in the U.S. and Europe [34]

Summary of Pyxis Oncology (PYXS) 2025 Conference Call Company Overview - **Company**: Pyxis Oncology - **Focus**: Development of antibody-drug conjugates (ADCs) - **Lead Asset**: Nykbo, targeting extracellular domain b (EDB), a splice variant of fibronectin, expressed in various solid tumors with minimal expression in normal tissues [2][3] Clinical Development and Data - **Clinical Trials**: Nykbo is currently in clinical trials for both monotherapy and combination therapy with pembrolizumab (Keytruda), particularly in head and neck cancers [3][30] - **Phase 1 Data**: - Significant tumor regression observed in six out of nine tumor types tested, with a confirmed overall response rate (ORR) of 50% and a 100% disease control rate in head and neck cancer [4][5] - The data was based on a cohort of six patients at a therapeutic dose range of 3.6 to 5.4 mg/kg [4] - The median time on therapy for head and neck patients was approximately 16 weeks, compared to the average of 65-70 days typically seen in Phase 1 studies [13] Competitive Landscape - **Market Dynamics**: The head and neck cancer treatment landscape has become competitive with the introduction of bispecific antibodies targeting EGFR, such as those from Merus and Vicara [5][6] - **Comparative Efficacy**: - Pyxis's 50% confirmed ORR in head and neck cancer is higher than Merus's 37% and Vicara's 0% in their respective Phase 1 trials [5][6] - Pyxis has observed responses in patients resistant to prior treatments, indicating a potential niche for Nykbo [6][7] Patient Enrollment and Characteristics - **Enrollment Criteria**: The expansion cohort is focusing on second and third-line treatment patients, contrasting with the heavily pretreated patients in the initial Phase 1 trial [16][18] - **Patient Characteristics**: The median number of prior treatment lines for the initial cohort was four, while the current expansion targets patients with fewer prior treatments [16][18] Safety Profile - **Adverse Events**: The safety profile of Nykbo appears favorable compared to other ADCs, with no significant grade 3 or 4 neuropathies or ocular toxicities observed [25][40] - **Grade 5 Event**: A grade 5 non-treatment-related event occurred in a patient with multiple comorbidities, which was not attributed to the drug [28] Future Data Expectations - **Upcoming Data Releases**: - Data from the monotherapy cohort is expected in the second half of the year, focusing on 20 patients in two arms: one for PD-1 and platinum-resistant patients and another for EGFR and PD-1 resistant patients [30][31] - Preliminary data from the combination study with pembrolizumab is also anticipated in the second half of the year [32][45] Strategic Priorities - **Execution Focus**: The company emphasizes execution in patient enrollment, data generation, and analytics as its top priorities [56] Additional Insights - **Mechanism of Action**: The ADC's mechanism includes direct tumor killing, bystander effects, and immunogenic cell death, which may synergize well with pembrolizumab [43] - **Market Positioning**: Pyxis aims to carve out a niche in the evolving treatment landscape, particularly in segments not fully addressed by current competitors [31][55]

Company Overview - Pyxis Oncology, Inc. is a clinical-stage company focused on developing antibody-drug conjugate (ADC) therapeutics for difficult-to-treat cancers [1][2] - The company is building therapeutics that have potential for both monotherapy and combination indications [2] Lead Candidate - The lead candidate, micvotabart pelidotin (MICVO), is currently being evaluated in ongoing Phase 1 clinical studies targeting multiple types of solid tumors [2] - The development focus is on treating patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) due to promising signals observed in this area [2] - A Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), has been initiated for patients with R/M HNSCC and other advanced solid tumors [2] Upcoming Conferences - Lara S. Sullivan, M.D., President and CEO, will participate in several upcoming investor conferences, including: - 2025 Cantor Global Healthcare Conference on September 3, 2025, featuring a fireside chat and investor one-on-one meetings [4] - H.C. Wainwright 27th Annual Global Investment Conference on September 8, 2025, also including a fireside chat and investor one-on-one meetings [4] - 2nd Annual ADC and Novel Conjugates Partnering and Investment Summit on September 9, 2025, with a company presentation [1][4]

[Summary Risk Factors](index=3&type=section&id=Summary%20Risk%20Factors) [Summary of Key Risks](index=3&type=section&id=Summary%20Risk%20Factors) The company identifies several material risks, including its history of significant losses, the need for substantial additional capital, heavy dependence on its primary product candidate, micvotabart pelidotin, and the inherent uncertainties of clinical development and regulatory approval - The company is a clinical-stage entity with a history of significant losses and anticipates continued losses for the next several years, with no guarantee of achieving profitability[7](index=7&type=chunk) - Operations are heavily dependent on the success of a single product candidate, micvotabart pelidotin, which is in the early stages of clinical development; failure in clinical trials or regulatory approval would materially harm the business[7](index=7&type=chunk) - The company relies on third parties for manufacturing its product candidate and for critical intellectual property through licensing agreements, such as the one with Pfizer; failure to comply with these agreements could result in the loss of necessary IP rights[7](index=7&type=chunk) [PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited condensed consolidated financial statements for the period ended June 30, 2025, show a decrease in cash and marketable securities, an accumulated deficit of $403.1 million, and a net loss of $39.5 million for the first six months of 2025, reflecting the company's financial position as a clinical-stage entity with no product revenue and significant ongoing research and development expenses [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, the company's total assets were $123.2 million, a decrease from $157.2 million at year-end 2024, primarily due to a reduction in cash and marketable securities, while total liabilities remained relatively stable at $35.6 million and the accumulated deficit grew to $403.1 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,733 | $19,473 | | Marketable debt securities, short-term | $78,211 | $107,458 | | Total current assets | $99,956 | $132,440 | | Total assets | $123,215 | $157,181 | | Total liabilities | $35,572 | $36,430 | | Accumulated deficit | $(403,068) | $(363,556) | | Total stockholders' equity | $87,643 | $120,751 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended June 30, 2025, the company reported a net loss of $39.5 million, compared to a net loss of $20.6 million for the same period in 2024, with the increase driven by higher R&D expenses and lower total revenues, as the prior year period included significant revenue from a sale of royalty rights, while Q2 2025 included a one-time milestone revenue of $2.8 million Statement of Operations Summary (in thousands, except per share data) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Total revenues | $2,820 | $16,146 | | Research and development | $34,177 | $26,982 | | General and administrative | $11,307 | $14,326 | | Loss from operations | $(42,664) | $(25,637) | | Net loss | $(39,512) | $(20,557) | | Net loss per share | $(0.64) | $(0.37) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was $39.8 million, a significant increase from $23.7 million in the prior year period, reflecting higher net loss and changes in working capital, while investing activities provided $31.1 million and financing activities used a nominal amount, resulting in a total cash, cash equivalents, and restricted cash decrease of $8.7 million during the period Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(39,798) | $(23,717) | | Net cash provided by (used in) investing activities | $31,125 | $(18,494) | | Net cash (used in) provided by financing activities | $(67) | $57,621 | | Net (decrease) increase in cash | $(8,740) | $15,410 | [Notes to Financial Statements](index=8&type=section&id=Notes%20to%20Financial%20Statements) Key notes to the financial statements detail the company's liquidity position, licensing agreements, and stock-based compensation, with existing cash of $88.9 million believed to fund operations for at least the next twelve months, and a significant event being the recognition of $2.8 million in milestone revenue from the Simcere agreement following regulatory approval of Suvemcitug in China, while stock-based compensation expense for the first six months of 2025 was $6.6 million - The company had an accumulated deficit of **$403.1 million** as of June 30, 2025, and expects its existing cash, cash equivalents, and short-term investments of **$88.9 million** to fund operations and capital requirements for at least the next twelve months[25](index=25&type=chunk)[27](index=27&type=chunk) - On June 30, 2025, the company became entitled to a **$3 million** regulatory approval milestone under its Simcere Agreement, recognizing **$2.8 million** in milestone revenue (net of withholding tax) in the second quarter[57](index=57&type=chunk) - Total stock-based compensation expense was **$6.6 million** for the six months ended June 30, 2025, compared to **$7.2 million** for the same period in 2024[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management's discussion focuses on the clinical development strategy for its lead product candidate, micvotabart pelidotin, particularly in head and neck squamous cell carcinoma (HNSCC), with the analysis of financial results highlighting a significant year-over-year increase in net loss for the first six months of 2025, driven by higher R&D spending on micvotabart pelidotin and a decrease in revenue compared to 2024, which benefited from a one-time royalty sale, and the company confirms its cash runway is expected to last into the second half of 2026 [Overview and Clinical Pipeline](index=18&type=section&id=Overview%20and%20Clinical%20Pipeline) Pyxis Oncology is a clinical-stage company focused on solid tumors, with its lead candidate, micvotabart pelidotin, an ADC targeting EDB+FN, prioritizing development in R/M HNSCC based on promising Phase 1 data, and in February 2025, the FDA granted Fast Track Designation for this indication, with preliminary data from several cohorts expected in the second half of 2025 and first half of 2026 - The company's lead product candidate is **micvotabart pelidotin**, an ADC targeting Extradomain-B Fibronectin (EDB+FN), with a primary development focus on head and neck squamous cell carcinoma (HNSCC)[92](index=92&type=chunk)[93](index=93&type=chunk) - The FDA granted **Fast Track Designation** to micvotabart pelidotin in February 2025 for treating adult patients with R/M HNSCC who have progressed after platinum-based chemotherapy and an anti-PD-(L)1 antibody[107](index=107&type=chunk) - Key upcoming milestones include preliminary data from the monotherapy expansion cohort (N=20) in **2H 2025** and from the combination therapy with KEYTRUDA® in **2H 2025**[108](index=108&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2025, revenue was $2.8 million from a single milestone, compared to $16.1 million in the prior year which included an $8.0 million sale of royalty rights and $8.1 million in royalty revenues, while R&D expenses increased by $7.2 million to $34.2 million, primarily due to higher manufacturing and clinical trial costs for micvotabart pelidotin, and G&A expenses decreased by $3.0 million to $11.3 million due to lower stock-based compensation and professional fees, consequently, net loss widened to $39.5 million from $20.6 million in the prior year period Comparison of Results for the Six Months Ended June 30 (in thousands) | Account | 2025 | 2024 | Change | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $2,820 | $16,146 | $(13,326) | -82.5% | | R&D Expenses | $34,177 | $26,982 | $7,195 | 26.7% | | G&A Expenses | $11,307 | $14,326 | $(3,019) | -21.1% | | Net Loss | $(39,512) | $(20,557) | $(18,955) | 92.2% | - The **$7.0 million** increase in program-specific costs for micvotabart pelidotin in the first half of 2025 was driven by a **$3.9 million** increase in manufacturing costs and a **$1.8 million** increase in clinical trial expenses[135](index=135&type=chunk) - Revenue in the first six months of 2024 included an **$8.0 million** one-time payment from Novartis for the transfer of future royalty rights to Beovu® and the recognition of **$8.1 million** in previously paid royalties[132](index=132&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $90.4 million in cash, cash equivalents, restricted cash, and short-term investments, which management believes are sufficient to finance operations into the second half of 2026, with net cash used in operating activities for the first six months of 2025 being $39.8 million, and the company having an effective shelf registration statement with $106.2 million of remaining capacity available under its ATM facility - The company's cash, cash equivalents, restricted cash, and short-term investments totaled **$90.4 million** as of June 30, 2025[140](index=140&type=chunk) - Management projects the current cash position is sufficient to fund operations into the **second half of 2026**[152](index=152&type=chunk) - Net cash used in operating activities was **$39.8 million** for the six months ended June 30, 2025, up from **$23.7 million** in the prior-year period[144](index=144&type=chunk)[145](index=145&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Pyxis Oncology is not required to provide the information for this item - The company is a "smaller reporting company" and is exempt from providing quantitative and qualitative disclosures about market risk[162](index=162&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and Principal Financial and Accounting Officer, evaluated the company's disclosure controls and procedures and concluded they were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The company's management concluded that disclosure controls and procedures were effective at a reasonable assurance level as of the end of the period[163](index=163&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[164](index=164&type=chunk) [PART II. OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[168](index=168&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section details the significant risks facing the company, with key areas including its financial position, marked by a history of losses and the need for future capital; the inherent uncertainties and high costs of clinical development, with heavy reliance on the success of its lead candidate, micvotabart pelidotin; the complex and lengthy regulatory approval process; dependence on third parties for manufacturing and clinical trials; challenges in protecting intellectual property; and risks associated with its common stock, including price volatility [Risks Related to Financial Position and Capital Needs](index=32&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Capital%20Needs) The company has a limited operating history, has incurred significant losses since inception ($403.1 million accumulated deficit as of June 30, 2025), and expects to continue incurring losses, with substantial additional capital required to fund operations, and the current cash runway estimated to last into the second half of 2026, an estimate based on assumptions that may prove wrong - The company has incurred significant operating losses, with a net loss of **$39.5 million** for the six months ended June 30, 2025, and an accumulated deficit of **$403.1 million**[171](index=171&type=chunk) - Substantial additional capital will be needed to finance operations; the current cash of approximately **$90.4 million** is expected to fund operations into the **second half of 2026**, but this estimate is subject to change[176](index=176&type=chunk) [Risks Related to Product Candidate Development](index=34&type=section&id=Risks%20Related%20to%20Product%20Candidate%20Development) The company's success is heavily dependent on its lead candidate, micvotabart pelidotin, as clinical development is a lengthy, expensive, and uncertain process with a high risk of failure, including potential for undesirable side effects, negative trial results, difficulties in patient enrollment, and intense competition from other biotechnology and pharmaceutical companies developing similar therapies - The company is heavily dependent on the success of its single clinical-stage product candidate, **micvotabart pelidotin**[192](index=192&type=chunk) - The company faces significant competition in HNSCC from other agents, including Merus's petosemtamab and Bicara's ficerafusp alfa (BCA101), which are targeting similar patient populations[226](index=226&type=chunk) [Risks Related to Regulatory and Legal Compliance](index=46&type=section&id=Risks%20Related%20to%20Regulatory%20and%20Legal%20Compliance) The regulatory approval process for new drugs is long, unpredictable, and subject to the discretion of authorities like the FDA, and even if approved, the company will face ongoing regulatory obligations, potential pricing pressures from healthcare legislation like the Inflation Reduction Act, and must comply with complex data privacy laws (e.g., GDPR, CCPA) - The regulatory licensure and approval processes of the FDA and other authorities are lengthy, time-consuming, and inherently unpredictable, and there is no guarantee of approval for the company's product candidate[232](index=232&type=chunk) - Enacted and future healthcare legislation, such as the **Inflation Reduction Act (IRA)**, may increase costs, affect pricing, and create additional hurdles for commercialization[273](index=273&type=chunk) [Risks Related to Dependence on Third Parties](index=63&type=section&id=Risks%20Related%20to%20Dependence%20on%20Third%20Parties) The company relies on third parties for critical functions, including manufacturing (with some operations in China), conducting clinical trials (CROs), and intellectual property through in-licensing agreements (e.g., Pfizer), and any failure by these third parties to perform, comply with regulations (like cGMP), or maintain agreements could significantly delay or impair development and commercialization - The company relies on third-party manufacturers and does not have its own manufacturing capabilities; a portion of this manufacturing occurs in China, which is subject to geopolitical and regulatory risks, including potential impacts from the **BIOSECURE Act**[321](index=321&type=chunk)[331](index=331&type=chunk) - The company relies on third-party CROs to conduct its clinical trials and is responsible for ensuring their compliance with GCP standards[339](index=339&type=chunk)[340](index=340&type=chunk) [Risks Related to Intellectual Property](index=68&type=section&id=Risks%20Related%20to%20Intellectual%20Property) The company's ability to compete depends on protecting its intellectual property through patents and trade secrets, but the patent process is uncertain, and issued patents may be challenged or circumvented, and the company also faces risks of infringing on third-party patents and must maintain compliance with its in-licensing agreements to retain rights to its product candidates - The company's success depends on its ability to obtain and maintain patent protection for its product candidates, a process that is expensive, time-consuming, and uncertain[343](index=343&type=chunk) - Failure to comply with obligations under its license agreement with Pfizer could result in the loss of intellectual property rights necessary for the development of micvotabart pelidotin[358](index=358&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section addresses the use of proceeds from the company's October 2021 Initial Public Offering (IPO), noting that its planned use of the $152.3 million in net proceeds has changed due to pipeline reprioritizations and will now be used to advance the clinical development of micvotabart pelidotin and for general corporate purposes - The company raised net proceeds of **$152.3 million** from its IPO in October 2021[400](index=400&type=chunk) - The planned use of IPO proceeds has been updated to prioritize the clinical development of micvotabart pelidotin following portfolio reprioritizations[401](index=401&type=chunk) [Item 5. Other Information](index=83&type=section&id=Item%205.%20Other%20Information) During the quarter, the company's President and CEO, Lara Sullivan, M.D., terminated a Rule 10b5-1 trading arrangement on June 24, 2025, and adopted a new one on the same day for the sale of up to 411,845 shares - On June 24, 2025, CEO Lara Sullivan, M.D., terminated an existing Rule 10b5-1 trading plan and adopted a new plan for the sale of up to **411,845 shares** of common stock[404](index=404&type=chunk) [Item 6. Exhibits](index=84&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including a separation agreement and various officer certifications required by the Sarbanes-Oxley Act

Core Insights - Pyxis Oncology is making significant progress in its Phase 1 clinical trials for micvotabart pelidotin (MICVO), targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) with preliminary data expected in the second half of 2025 and first half of 2026 [1][6] - The company has a cash runway that is expected to last through data milestones and into the second half of 2026, with cash and cash equivalents totaling $90.4 million as of June 30, 2025 [1][6] Pipeline Updates - The Phase 1/2 combination study of MICVO and KEYTRUDA® (pembrolizumab) is progressing well, with preliminary data anticipated in the second half of 2025 [5][6] - Preliminary data from the Part 2 monotherapy expansion cohorts of the ongoing Phase 1 clinical trial for R/M HNSCC patients is expected in the second half of 2025, with additional data from patients who have received prior EGFRi and PD-1 inhibitor therapy anticipated in the first half of 2026 [6] Financial Results - For the quarter ended June 30, 2025, Pyxis Oncology reported revenues of $2.8 million, a significant increase from $0 in the same quarter of 2024, primarily due to milestone revenue from the approval of suvemcitug in China [6][10] - Research and development expenses increased to $17.1 million for the quarter ended June 30, 2025, compared to $14.0 million for the same period in 2024, driven by increased manufacturing and clinical trial-related expenses [10] - The net loss for the quarter was $18.4 million, or ($0.30) per common share, compared to a net loss of $17.3 million, or ($0.29) per common share, for the same quarter in 2024 [10][12]

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.