Core Viewpoint - Pyxis Oncology, Inc. (PYXS) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based on changes in earnings estimates, which are tracked through the Zacks Consensus Estimate from sell-side analysts for the current and following years [2]. - The Zacks rating upgrade reflects an improvement in Pyxis Oncology's earnings outlook, which is expected to positively impact its stock price [4][6]. Impact of Earnings Estimate Revisions - There is a strong correlation between changes in earnings estimates and near-term stock price movements, largely due to institutional investors who adjust their valuations based on these estimates [5][7]. - Pyxis Oncology's rising earnings estimates and the subsequent rating upgrade suggest an improvement in the company's underlying business, likely leading to an increase in stock price [6][11]. Performance of Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [8]. - The upgrade of Pyxis Oncology to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10][11]. Current Earnings Estimates for Pyxis Oncology - For the fiscal year ending December 2025, Pyxis Oncology is expected to earn -$1.34 per share, with no year-over-year change; however, the Zacks Consensus Estimate has increased by 2.6% over the past three months [9].

Core Viewpoint - The drug and biotech sector is experiencing a recovery driven by a landmark drug-pricing deal between Pfizer and the Trump administration, which includes tariff exemptions and price cuts, alongside increased M&A activity in the sector [1]. Group 1: Industry Overview - The Zacks Medical-Drugs industry consists of small to medium-sized drug companies that primarily focus on developing medicines, often relying on collaborations with larger firms for revenue [3]. - The industry is currently ranked 68 in the Zacks Industry Rank, placing it in the top 28% of 243 Zacks industries, indicating strong prospects for growth [9]. Group 2: Market Performance - The Zacks Medical-Drugs industry has seen a year-to-date stock increase of 6.2%, outperforming the Zacks Medical sector, which decreased by 0.2%, but underperforming the S&P 500, which rose by 12.2% [11]. - The industry is trading at a trailing 12-month price-to-sales ratio of 2.37, lower than the S&P 500's 5.82 and the Zacks Medical sector's 2.45 [13]. Group 3: Key Trends and Innovations - There is a strong focus on innovation in areas such as rare diseases, next-generation oncology treatments, obesity, immunology, and neuroscience, which are attracting investor interest [5]. - Investment in technology and personalized medicine is crucial for smaller companies to adapt to the evolving healthcare landscape [7]. Group 4: Company Highlights - **Ironwood Pharmaceuticals**: The company is advancing its key pipeline candidate, apraglutide, for treating short bowel syndrome, with a stock increase of 115.5% in the past three months [16][17]. - **Pyxis Oncology**: The company is progressing with its lead candidate, micvotabart pelidotin, for treating head and neck cancer, with a stock increase of 197.4% in the past three months [20][21]. - **Plus Therapeutics**: Focused on targeted radiotherapeutics for CNS cancers, the company has seen its stock rise by 113.6% in the past three months [24][26]. - **Cardiol Therapeutics**: Developing CardiolRx for heart disease, the company has experienced an 18.6% decline in stock over the past three months [29][31]. - **Akebia Therapeutics**: The company launched Vafseo for anemia due to chronic kidney disease, but its stock has declined by 28.3% in the past three months [33][34].

Core Insights - Pyxis Oncology is advancing micvotabart pelidotin (MICVO), a first-in-concept antibody-drug conjugate (ADC) targeting extradomain-B of fibronectin, with promising translational data to be presented at ESMO 2025 and AACR-NCI-EORTC conferences [1][2][10] Mechanism of Action - MICVO operates through a three-pronged mechanism: direct tumor cell killing, bystander effect, and immunogenic cell death, which contributes to its potential effectiveness against solid tumors [1][2][12] - The ADC's unique extracellular-cleaving mechanism distinguishes it from traditional ADCs that target cell surfaces and internalize [2][12] Clinical Development - Ongoing clinical studies focus on head and neck squamous cell carcinoma (HNSCC), with a Phase 1/2 combination study of MICVO and pembrolizumab initiated for recurrent and metastatic cases [10][13] - Data from 37 clinical samples indicate a reduction in circulating tumor DNA tumor fraction after treatment with MICVO, particularly at a dose of 5.4 mg/kg, supporting its development in HNSCC [2][10] Presentation Details - At ESMO 2025, two posters will present histological biomarker analysis and longitudinal changes in circulating tumor DNA from the Phase 1 dose escalation study [4][5] - Six additional posters at the AACR-NCI-EORTC conference will further explore MICVO's mechanism of action and its impact on tumor microenvironment remodeling [5][6] Future Directions - The company aims to continue developing MICVO based on the positive signals observed in HNSCC and its potential as both a monotherapy and in combination with anti-PD1 therapy [2][10]

Core Insights - Pyxis Oncology, Inc. has appointed Alex Kane as Senior Vice President of Investor Relations & Capital Markets, effective immediately [1] - Kane has 20 years of experience in investor relations and capital markets, particularly in the life sciences sector [2] - His previous roles include Vice President at Guggenheim Securities and senior positions at Praxis Precision Medicines and PTC Therapeutics, where he managed IPOs and investor engagement [3] Company Overview - Pyxis Oncology is a clinical-stage company focused on developing antibody-drug conjugate (ADC) therapeutics for challenging cancers [1] - The lead candidate, micvotabart pelidotin (MICVO), is currently in Phase 1 clinical studies targeting recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) [5] - The company has initiated a Phase 1/2 combination study of MICVO with Merck's KEYTRUDA® in patients with R/M HNSCC and other advanced solid tumors [5]

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]