Sotigalimab

Third dose cohort initiated in Phase 1 trial of PYX-201, Pyxis Oncology's first ADC product candidate Preliminary data from two Phase 1 trials on track for late 2023 to early 2024 Apexigen transaction anticipated to close later in August Strong balance sheet with $144 million in cash (including restricted cash) and short-term investments supports operations into 1H 2025 BOSTON, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today reported financial results for the quarter ended June 30, 2023, and provided a corporate update. Pyxis Oncology ended the second quarter of 2023 with approximately $144.1 million in cash, cash equivalents, restricted cash and short-term investments, which is expected to provide a runway into the first half of 2025, enabling the Company to evaluate early signs of potential clinical activity for PYX-201 and PYX-106 and potentially allowing the Company to initiate tumor-specific expansion cohorts following dose selection. “During the second quarter, we announced our planned acquisition of Apexigen, Inc., which will bolster Pyxis Oncology’s position at the forefront of antibody-drug conjugate (ADC) innovation and will expand our clinical pipeline. We are on track to close the acquisition later in August. We remain financially disciplined while executing operationally on each of our two ongoing clinical trials of PYX-201 and PYX-106 and we are encouraged by the positive feedback we’ve received from investigators,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “We continue to anticipate preliminary data, including biomarker results and early signs of potential clinical activity, from our Phase 1 trials of PYX-106 in late 2023 and PYX-201 in early 2024.” Recent Corporate Updates Third dose level reached in Phase 1 trial of PYX-201: Dosing is ongoing at the third dose level in the PYX-201-101 trial, and three clinical sites have begun recruiting in Europe, along with sites in the U.S. Abstracts accepted for poster presentation at SITC: Abstracts for trial-in-progress (TIP) posters describing the PYX-106-101 and PYX-201-101 Phase 1 clinical trials were accepted for presentation at the Society for the Immunotherapy of Cancer (SITC) 38th Annual Meeting, to be held November 1-5, 2023, in San Diego. Upcoming Milestones Apexigen, Inc. transaction expected close, later in August 2023 Anticipated Yale presentation of investigator sponsored trial (IST) results describing an anti-siglec-15 compound’s activity and safety at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer, September 2023 Announce clinical development plan for sotigalimab​, Q4 2023 (assuming closing of the Apexigen transaction) Report pharmacokinetic/pharmacodynamic (PK/PD) data for sotigalimab​, Q4 2023 (assuming closing of the Apexigen transaction) Report preliminary data, including biomarker results and early signs of potential clinical activity from PYX-106-101​, late 2023 Report preliminary data, including biomarker results and early signs of potential clinical activity from PYX-201-101​​, early 2024 Q2 2023 Financial Results As of June 30, 2023, Pyxis Oncology had cash and cash equivalents (including restricted cash) and short-term investments of $144.1 million (preliminary, unaudited), which is expected to fund operations into the first half of 2025 and reflects continued financial discipline. Research and development expenses were $11.4 million for the three months ended June 30, 2023, compared to $17.2 million for the three months ended June 30, 2022. The period-over-period decline was primarily due to lower contract manufacturing and preclinical research costs, which were partially offset by increased clinical trial-related expenses for PYX-201 and PYX-106. General and administrative expenses were $6.7 million for the three months ended June 30, 2023, compared to $8.6 million for the three months ended June 30, 2022. The period-over-period decrease was primarily due to a reduction in stock-based compensation expense and lower professional and consultant fees. Net loss was $15.9 million, or $0.41 per common share, for the three months ended June 30, 2023, compared to $25.6 million, or $0.79 per common share, for the three months ended June 30, 2022. Net losses for the quarters ended June 30, 2023 and 2022 included $3.7 million and $4.0 million, respectively, related to non-cash stock-based compensation expense. As of June 30, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 39,376,941. About Pyxis Oncology, Inc. Pyxis Oncology, Inc. is a clinical-stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next-generation therapeutics that hold the potential for mono and combination therapies. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s antibody-drug conjugates (ADCs) and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit or follow us on Twitter and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Part II, Item 1A. of the Company’s Annual Report on Form 10-K filed with SEC on March 22, 2023, and in our other filings with the SEC. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date hereof and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Additional Information and Where to Find It This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933. The Company has filed with the Securities and Exchange Commission (the “SEC”) a Registration Statement on Form S-4 in connection with the transaction and Apexigen has filed with the SEC and mailed to its stockholders a proxy statement/prospectus in connection with the transaction. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ THE REGISTRATION STATEMENT, PROXY STATEMENT/PROSPECTUS AND ANY OTHER RELEVANT DOCUMENTS THAT MAY BE FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THESE DOCUMENTS, CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders are able to obtain free copies of the registration statement and the proxy statement/prospectus and other documents filed with the SEC by the Company and Apexigen through the website maintained by the SEC at In addition, investors and security holders are able to obtain free copies of the registration statement and the proxy statement/prospectus from the Company by contacting ir@pyxisoncology.com or from Apexigen by contacting ir@apexigen.com. Participants in the Solicitation The Company and Apexigen, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. Information regarding the Company’s directors and executive officers is contained in the Company’s proxy statement, filed with the SEC on April 28, 2023. Information regarding Apexigen’s directors and executive officers is contained in Apexigen’s Annual Report on Form 10-K, filed with the SEC on February 22, 2023. Additional information regarding the persons who may be deemed participants in the proxy solicitation and a description of their direct and indirect interests in the proposed business combination are available in the registration statement and the proxy statement/prospectus. Pyxis Oncology Contact Jennifer Davis Ruff VP, Investor Relations jdavisruff@pyxisoncology.com PYXIS ONCOLOGY, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 Operating expenses: Research and development $ 11,391 $ 17,170 $ 23,292 $ 37,241 General and administrative 6,730 8,556 15,783 19,874 Total operating expenses 18,121 25,726 39,075 57,115 Loss from operations (18,121 ) (25,726 ) (39,075 ) (57,115 ) Other income, net: Interest and investment income 1,656 164 3,329 173 Sublease income 564 — 602 — Total other income, net 2,220 164 3,931 173 Net loss $ (15,901 ) $ (25,562 ) $ (35,144 ) $ (56,942 ) Net loss per common share - basic and diluted $ (0.41 ) $ (0.79 ) $ (0.95 ) $ (1.76 ) Weighted average shares of common stock outstanding - basic and diluted 38,389,123 32,451,610 36,878,787 32,384,522 PYXIS ONCOLOGY, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share amounts) (Unaudited) June 30, 2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $ 25,898 $ 179,293 Marketable debt securities, short-term 116,765 — Restricted cash 1,472 1,472 Prepaid expenses and other current assets 5,169 5,847 Total current assets 149,304 186,612 Property and equipment, net 12,643 11,165 Operating lease right-of-use assets 13,283 13,602 Total assets $ 175,230 $ 211,379 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $ 1,305 $ 7,097 Accrued expenses and other current liabilities 7,393 24,537 Operating lease liabilities, current portion 527 — Total current liabilities 9,225 31,634 Operating lease liabilities, net of current portion 20,730 18,921 Total liabilities 29,955 50,555 Stockholders’ equity: Preferred stock — — Common stock 39 34 Additional paid-in capital 392,900 373,225 Accumulated other comprehensive loss (85 ) — Accumulated deficit (247,579 ) (212,435 ) Total stockholders’ equity 145,275 160,824 Total liabilities and stockholders’ equity $ 175,230 $ 211,379

The dynamics of the esophageal cancer market are predicted to grow owing to the increasing prevalence of cancer and the increase in research & development. In addition, the anticipated launch of emerging therapies will also propel the esophageal cancer market growth in the coming years. LAS VEGAS, July 6, 2023 /PRNewswire/ -- DelveInsight's Esophageal Cancer Market Insights report includes a comprehensive understanding of current treatment practices, esophageal cancer emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan]. Key Takeaways from the Esophageal Cancer Market Report As per DelveInsight analysis, the esophageal cancer market size in the 7MM was approximately USD 1,000 million in 2022. According to the assessment done by DelveInsight, the estimated total diagnosed incident esophageal cancer cases in the US were approximately 20K in 2022. Globally, leading esophageal cancer companies such as Zymeworks, Innovent Biologics, BeiGene, Apexigen, Shanghai Henlius Biotech, CStone Pharmaceuticals, Jiangsu HengRui Medicine Co., Ltd., AstraZeneca, Symphogen, Hoffmann-La Roche, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sinocelltech Ltd., Eli Lilly and Company, Ipsen, Jacobio Pharmaceuticals Co., Ltd., Shire, GlaxoSmithKline, Keythera Pharmaceuticals (Australia) Pty Ltd, Sunshine Lake Pharma Co., Ltd., Novartis Pharmaceuticals, Sanofi, Seagen Inc., Rapa Therapeutics LLC, Incyte Corporation, Atreca, Inc., Exelixis, Bayer, Lyell Immunopharma, Sichuan Baili Pharmaceutical, AP Biosciences., Leap Therapeutics, Inc., Adlai Nortye Biopharma Co., Ltd., Athenex, Inc., Pfizer, Genentech, Hangzhou Neoantigen Therapeutics, Janssen Pharmaceutical, Curis, Inc., Merck KGaA, Shenzhen Hornetcorn Bio-technology Company, LTD, MacroGenics, Bristol-Myers Squibb, Integral Molecular, CARTEXELL, EMD Serono, and others are developing novel esophageal cancer drugs that can be available in the esophageal cancer market in the coming years. The promising esophageal cancer therapies in the pipeline include Zanidatamab, Sintilimab, Tislelizumab, Sotigalimab (APX005M), and others. Discover which therapies are expected to grab the major esophageal cancer market share @ Esophageal Cancer Market Report Esophageal Cancer Overview Esophageal cancer arises when cancer cells originate in the esophagus, a tube-like tissue that connects the throat and stomach. The esophagus transfers food from the mouth to the stomach. The cancer develops in the inner layer of the esophagus and can spread to other layers of the esophagus and other organs of the body. Typically, signs of esophageal cancer do not develop until the tumor has grown large enough to obstruct eating, swallowing, or digesting food. The most common symptom of esophageal cancer is difficulty swallowing, specifically a sense that food is trapped in the throat; in some cases, choking on food occurs. These symptoms worsen with time, with increasing discomfort while swallowing as the esophagus narrows due to cancer growth. Indications or symptoms of esophageal cancer are frequently used to diagnose it. Exams, testing, and a biopsy will be required to confirm the diagnosis; if cancer is found, additional tests will be performed to determine the extent. Esophageal Cancer Epidemiology Segmentation DelveInsight estimates that there were approximately 20K diagnosed incident cases of esophageal cancer in the US in 2022. In 2022, as per the age-specific cases, the 65 and above segment accounted for the highest number of cases of esophageal cancer. In contrast, the <45 age group accounted for the least number of cases in the United States. The esophageal cancer market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into: Total Esophageal Cancer Diagnosed Incident Cases Esophageal Cancer Age-specific Cases Esophageal Cancer Histology-specific Cases Esophageal Cancer Gender-specific Cases Esophageal Cancer Mutation-specific Cases Esophageal Cancer Stage-specific Cases Esophageal Cancer Line-wise Treated Cases Esophageal Cancer Treatment Market Everyone with esophageal cancer is treated in some way. The best course of therapy for each patient is determined by a number of criteria, including personal preferences, cancer stage, and overall health. Many medical specialists work together on a daily basis in cancer care to create a patient's comprehensive treatment plan, which includes a variety of treatments. Esophagectomy is the primary esophageal cancer treatment for early-stage esophageal cancer, while its precise role in superficial (T1A) malignancies remains unknown, owing to the introduction of endoscopic mucosal therapy. A multimodal strategy of neoadjuvant chemotherapy or combination chemoradiotherapy (CRT) followed by surgery is strongly recommended for treating locally advanced malignancies. Preoperative evaluation is the cornerstone of modern esophageal cancer management. The precision and specificity of the clinical staging evaluation will be dependent on the tumor board's recommendations on the use of multimodal therapy, thus preoperative staging accuracy is crucial. The standardized evaluation of a patient undergoing curative treatment for early-stage or advanced esophageal cancer includes upper endoscopy, high-resolution contrast CT scan, FDG-PET scan, and EUS. For a tumor that has not migrated beyond the esophagus and lymph nodes, doctors often recommend a combination of radiation treatment, chemotherapy, and surgery. Locally advanced esophageal cancer is typically treated with radiation therapy, chemotherapy, and surgery. Radiation treatment and chemotherapy are frequently combined in "chemoradiotherapy." Radiation therapy, chemotherapy, and other drug-based therapies are frequently used to treat metastatic esophageal cancer. To know more about esophageal cancer treatment, visit @ Esophageal Cancer Treatment Drugs Key Esophageal Cancer Therapies and Companies Zanidatamab: Zymeworks Sintilimab: Innovent Biologics Tislelizumab: BeiGene Sotigalimab (APX005M): Apexigen Nivolumab: Bristol-Myers Squibb Pembrolizumab: Merck Sharp & Dohme Learn more about the FDA-approved drugs for esophageal cancer @ Drugs for Esophageal Cancer Treatment Esophageal Cancer Market Dynamics The esophageal cancer market is expected to change in the coming years owing to expanding disease awareness and increased healthcare spending around the world, which will increase the size of the esophageal cancer market. The esophageal cancer companies and academics are working to assess challenges and seek opportunities that could influence esophageal cancer R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition. Esophageal cancer companies are involved in developing esophageal cancer therapies. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the esophageal cancer market in the 7MM. However, several factors are impeding the growth of the esophageal cancer market. The cost of newly approved drugs is typically exorbitant, so people avoid correct therapy or opt for off-label and low-priced medications. It has an impact on market access for newly released drugs, and reimbursement is critical. Market access and reimbursement options might vary depending on regulatory status, target population size, care environment, unmet requirements, the volume of extra benefit claims, and costs. Furthermore, the esophageal cancer market growth may be offset by failures and discontinuation of emerging therapies and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the esophageal cancer market growth. Scope of the Esophageal Cancer Market Report Therapeutic Assessment: Esophageal Cancer current marketed and emerging therapies Esophageal Cancer Market Dynamics: Attribute Analysis of Emerging Esophageal Cancer Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's Views, Analyst's Views, Esophageal Cancer Market Access and Reimbursement Discover more about esophageal cancer drugs in development @ Esophageal Cancer Clinical Trials Table of Contents Related Reports Esophageal Cancer Pipeline Esophageal Cancer Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key esophageal cancer companies, including BeiGene, AstraZeneca, CSPC ZhongQi Pharmaceutical Technology, Amgen, Jiangsu Hengrui Medicine, Oncolys Biopharma, Pfizer, Novartis, Luye Pharma, Eli Lilly and Company, ImmunoFrontier, Inc, Adaptimmune, Innovent Biologics (Suzhou) Co. Ltd., Genentech, Janssen Pharmaceuticals, Merck KGaA, Shenzhen Hornetcorn Biotechnology, Apexigen, Inc., Highlight Therapeutics, EMD Serono, HaiHe Biopharma, Lumicell, Jacobio Pharmaceuticals Co., Ltd., TESARO, Ascentage Pharma Group Inc., Adlai Nortye, Seagen, among others. Gastro-Esophageal Junction Neuroendocrine Tumor (GEJ-NET) Market Gastro-Esophageal Junction Neuroendocrine Tumor (GEJ-NET) Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key GEJ-NET companies, including Vedanta Biosciences, Inc., Bristol-Myers Squibb, Incyte Corporation, Xencor, Inc., ICON plc, Adaptimmune, Medicenna Therapeutics, Inc., Guangdong Zhongsheng Pharmaceutical Co., Ltd., among others. Esophageal Squamous Cell Carcinoma Pipeline Esophageal Squamous Cell Carcinoma Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key esophageal squamous cell carcinoma companies, including BeiGene, AstraZeneca, Ipsen, Shire, Sanofi, Seagen, among others. Esophageal Squamous Carcinoma Market Esophageal Squamous Carcinoma Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key esophageal squamous carcinoma companies, including BeiGene, AstraZeneca, Ipsen, Shire, Sanofi, Seagen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Expand your knowledge and gain valuable insights into personalized cancer care through DelveInsight's Conference Coverage Services Explore some of the conference coverage related case studies: Conference Coverage in Various Oncology Conferences Conference Coverage Intelligence of Asthma and COPD assets across the Respiratory Therapy Area Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP