UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 24, 2023 |
Pyxis Oncology, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-40881 |
83-1160910 |
||
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
321 Harrison Avenue |
|
|||
Boston, Massachusetts |
|
02118 |
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: 617-221-9059 |
|
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
|
|
Trading |
|
|
Common Stock, par value $0.001 per share |
|
PYXS |
|
The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 7.01 Regulation FD Disclosure.
On May 24, 2023, Pyxis Oncology, Inc. (the "Company") and Apexigen, Inc. ("Apexigen") held a conference call to discuss the proposed transaction (the "Joint Conference Call"). A copy of the investor presentation of the Joint Conference Call is furnished herewith as Exhibit 99.1.
The information contained in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any of the Company’s filing with the SEC made by the Company, regardless of any general incorporation language in such filings, except to the extent expressly set forth by reference in such filing.
Additional Information and Where to Find It
This Current Report on Form 8-K 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. Pyxis Oncology plans to file with the SEC a Registration Statement on Form S-4 in connection with the transactions and Apexigen plans to file with the SEC and mail to Apexigen stockholders a Proxy Statement/Prospectus in connection with the transactions. 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 will be able to obtain free copies of the Registration Statement and the Proxy Statement/Prospectus and other documents filed with the SEC by Pyxis Oncology and Apexigen through the web site maintained by the SEC at www.sec.gov. In addition, investors and security holders will be able to obtain free copies of the Registration Statement and the Proxy Statement/Prospectus from Pyxis Oncology by contacting ir@pyxisoncology.com or from Apexigen by contacting ir@apexigen.com.
Participants in the Solicitation
Pyxis Oncology and Apexigen, and their respective directors and executive officers, may be deemed to be participants in the solicitation of proxies in respect of the transactions contemplated by the merger agreement. Information regarding Pyxis Oncology’s directors and executive officers is contained in Pyxis Oncology’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 will be available in the Registration Statement and the Proxy Statement/Prospectus.
Forward Looking Statements
This Current Report on Form 8-K 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 Pyxis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2022, Pyxis Oncology’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, Apexigen’s Annual Report on Form 10-K for the year ended December 31, 2022, and Apexigen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, each of which is on file with the SEC. Among other things, there can be no guarantee that the proposed business combination will be completed in the anticipated timeframe or at all, that the conditions required to complete the proposed business combination will be met, that the combined company will realize the expected benefits of the proposed business combination, if any, that the clinical stage assets will progress on anticipated timelines or at all, or that the combined company will be successful in progressing its pipeline through development and the regulatory approval process. 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits |
||
Exhibit No. |
|
Description |
99.1 |
|
Investor Presentation of Pyxis Oncology, Inc. and Apexigen, Inc. dated May 24, 2023 |
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
Pyxis Oncology, Inc. |
|
|
|
|
Date: |
May 24, 2023 |
By: |
/s/ Pam Connealy |
|
|
|
Pam Connealy |
Pyxis Oncology Acquisition of Apexigen Nasdaq: PYXS May 24, 2023 Exhibit 99.1
This presentation 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. All statements other than statements of historical facts contained in this presentation, including without limitation statements regarding our future results of operations and financial position, execution of the company’s vision and growth strategy, including with respect to the proposed transaction, M&A activity, future revenue, timing and progress of our current clinical trials and the pre-clinical studies and clinical trials of Apexigen, Inc. (Apexigen), the expected results of such trials, business strategy, prospects, research and development costs, timing and likelihood of success, the size of the market opportunities, as well as plans and objectives of management for future operations, are forward looking statements. These statements involve known and unknown risks, uncertainties and other important factors that are in some cases beyond our control and may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward looking statements. The words “ may,” “would,” “expects,” “plans,” “target,” “believes,” “estimates,” ”potential,” “probable,” “opportunity,” “future,” “promising,” “likely” or “continue” or the negative of these terms or other similar expressions are intended to identify forward looking statements, although not all forward looking statements contain these identifying words. The forward looking statements in this presentation are only predictions and represent our views as of the date of this presentation. Although we believe the expectations reflected in such forward looking statements are reasonable, we cannot guarantee that the future results, advancements, discoveries, levels of activity, performance or events and circumstances reflected in the forward looking statements will be achieved or occur. Except as set forth in the definitive merger agreement or in any proxy solicitation materials, Pyxis Oncology makes no representations or warranties regarding the proposed transaction discussed in this presentation. The forward looking statements are subject to a number of risks, uncertainties and assumptions including, but not limited to, the outcome of any legal proceedings that may be instituted against us or Apexigen following the announcement of the proposed transaction, the inability to complete the proposed transaction due to failure to obtain approval of Apexigen’s shareholders, delays in obtaining, adverse conditions contained in, or the inability to obtain necessary regulatory approvals or complete regular reviews required to complete the proposed transaction, the inability to recognize the anticipated benefits of the proposed transaction, which may be affected by, among other things, competition or the ability of the combined company to grow and successfully execute on its business plan, costs related to the proposed transaction, changes in the applicable laws or regulations, the possibility that the combined company may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, which are more fully described in Pyxis Oncology’s periodic and other reports filed with the Securities and Exchange Commission (SEC). Any forward looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward looking statement, whether as a result of new information, future events or otherwise. Accordingly, readers should not rely upon forward looking statements as predictions of future events. Except as required by applicable law, we undertake no obligation to update publicly or revise any forward looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward looking statements. We operate in a very competitive and rapidly changing environment. New risks emerge from time to time, and it is not possible for our management to predict all risks, 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 we may make. In light of these risks, uncertainties and assumptions, the forward looking events and circumstances described in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements contained in this presentation. Market & Industry Data This presentation contains estimates, projections and other information concerning our industry, our business and the markets for our product candidates. This information is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, assumptions and limitations, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we are not aware of any misstatements regarding any third party information in this presentation, their estimates, in particular, as they relate to projections, involve numerous assumptions and limitations, are subject to risks and uncertainties and are subject to change. We have not independently verified any of the third-party information. You are cautioned not to give undue weight to any such information, projections and estimates. Trademarks This presentation contains references to trademarks and service marks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this presentation may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that the applicable licensor will not assert, to the fullest extent under applicable law, its rights to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies. No Offer or Solicitation This communication is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction 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 the Securities Act. Important Additional Information Will Be Filed with the SEC In connection with the proposed transaction between Apexigen and Pyxis Oncology, Pyxis Oncology intends to file with the U.S. Securities and Exchange Commission (the “SEC”) a registration statement on Form S-4 that will include a proxy statement of Apexigen and that also constitutes a prospectus of Pyxis Oncology. Each of Apexigen and Pyxis Oncology may also file other relevant documents with the SEC regarding the proposed transaction. This document is not a substitute for the proxy statement/prospectus or registration statement or any other document that Apexigen or Pyxis Oncology may file with the SEC. The definitive proxy statement/prospectus (if and when available) will be mailed to stockholders of Apexigen. 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 WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Investors and security holders will be able to obtain free copies of the registration statement and proxy statement/prospectus (if and when available) and other documents containing important information about Apexigen, Pyxis Oncology and the proposed transaction, once such documents are filed with the SEC through the website maintained by the SEC at http://www.sec.gov. Copies of the documents filed with the SEC by Apexigen will be available free of charge on Apexigen’s website at https://ir.apexigen.com/ or by contacting Apexigen’s Investor Relations department by email at IR@apexigen.com. Copies of the documents filed with the SEC by Pyxis Oncology will be available free of charge on Pyxis Oncology’s website at https://ir.pyxisoncology.com/ or by contacting Pyxis Oncology’s Investor Relations department by email at ir@pyxisoncology.com. Participants in the Solicitation Apexigen, Pyxis Oncology, their respective directors and certain of their executive officers and other employees may be deemed to be participants in the solicitation of proxies from Apexigen’s stockholders in connection with the proposed transaction. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of Apexigen’s stockholders in connection with the proposed transaction, including a description of their direct or indirect interests, by security holdings or otherwise, will be set forth in the proxy statement/prospectus when it is filed with the SEC. Information about the directors and executive officers of Apexigen, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in Apexigen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, which was filed with the SEC on February 22, 2023. Information about the directors and executive officers of Pyxis Oncology, including a description of their direct or indirect interests, by security holdings or otherwise, is set forth in Pyxis Oncology’s proxy statement for its 2023 annual meeting of shareholders, which was filed with the SEC on April 28, 2023. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction when such materials become available. Investors should read the proxy statement/prospectus carefully when it becomes available before making any voting or investment decisions. You may obtain free copies of these documents from Apexigen or Pyxis Oncology using the sources indicated above. Forward-Looking Statements
Transaction Equips Pyxis Oncology with Promising Clinical Asset and Antibody Discovery Platform mPFS: median progression free survival DDLPS: dedifferentiated liposarcoma LPS: liposarcoma ASCO: American Society of Clinical Oncology FACT: flexible antibody conjugation technology PFS: progression free survival ADC: antibody-drug conjugate Commercially and clinically validated APXiMAB antibody discovery platform provides backbone to FACT platform for ADC creation Sotigalimab is a potential best-in-class CD40 agonist Licensing income/revenue stream from 5 licensed antibodies, one approved in 2019 and marketed by Novartis Cash runway remains into 1H 2025 PYXS executive team to lead combined entity PYX-201 and PYX-106 programs remain on track Updated duration of response/PFS data for sotigalimab in DDLPS anticipated at ASCO Potential to significantly improve median progression-free survival (mPFS) in patients with LPS
Note: As of May 10, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 38,245,287. Overview Definitive merger agreement wherein Pyxis Oncology will acquire Apexigen in an all-stock transaction For each share of Apexigen, Pyxis Oncology will issue 0.1725 shares of common stock at a fixed exchange ratio Total of 4.4 million PYXS shares expected to be issued Pyxis Oncology shareholders to own approximately 90% of the combined company / Apexigen shareholders to own approximately 10% Implied valuation of $0.64 per Apexigen share for total consideration of approximately $16 million Pyxis Oncology executive team to lead the combined company Financial Impact to Pyxis Oncology Cash runway anticipated to remain into 1H 2025 upon closing Royalty streams from 5 out-licensed APXiMAB assets Conditions & Timing Closing subject to customary conditions, including the approval by a majority of Apexigen outstanding common shares Closing anticipated mid-2023 Transaction Details
Complementary APXiMAB and FACT Platforms Accelerate Efficient Development of Next Generations ADCs FACT Conjugation Chemistry Site specific conjugation enables more consistent drug antibody ratio (DAR) Improved plasma stability, limiting payload release in circulation FACT Optimized Payload Next-generation AUR-0101 payload with enhanced bystander activity Potentially increased potency and improved permeability across cell membrane Addition of humanized antibody capability enables end-to-end ADC development in-house FACT Linker Library Expanded library of linkers with high stability in circulation Enable selective release at target side via enzymatic cleavage APXiMAB Targeting Antibody Platform Enables generation of novel antibodies against a library of targets with high affinity and unique binding epitopes
APXiMAB Platform Facilitates In-House Development of Antibodies to Support Novel ADC Generation via FACT Platform
Patient treated with sotigalimab achieved a durable partial response and resolution of all lesions when treated with sotigalimab-nivolumab After surgery and radiation, a 54-year-old patient received ipilimumab-nivolumab but discontinued ipilimumab after 3 cycles because of poor tolerability 10 months later, the patient developed rapid disease progression in multiple sites while on nivolumab alone Patient had highly progressed, metastatic disease with poor prognosis and limited effective treatment options remaining with discussions about hospice as next step Compelling CASE STUDY Patient enrolled in Phase 2 trial and dosed with sotigalimab 0.3 mg/kg and nivolumab 360mg IV Q3W Q3W: dosed once every 3 weeks
Patient Achieved a Durable Partial Response (PR) and Resolution of All Lesions on Sotigalimab-nivolumab, a Combination that Was Well Tolerated 2 months Baseline Sotigalimab-Nivo Strong activity: patient responded only 2 months after starting sotigalimab-nivolumab (3 cycles of treatment) Good tolerability: patient completed ~11 months (15 cycles) of therapy Lasting durability: patient maintained a PR for 25+ months on study after treatment concluded At 45.9+ months, the patient maintained their response, as observed by the PI Reduced/ resolved lesions Metastatic liver lesions Mesenteric lesion PI: principal investigator
CD40 Activation Triggers Immune Responses from Both the Innate and Adaptive Arms of the Immune System to Potentially Optimize Anti-tumor Activity Activation leads to the conversion of a “cold” TME to a “hot” TME and could potentially enhance the efficacy of ICIs CD40 Cascade Why Activate CD40? Multiple paths to induce tumor cell death Innate response (e.g., macrophages) Adaptive response (T-cell responses) Antigen-presenting cells (APCs) support priming and activation of T-cells, creating a pro-inflammatory tumor microenvironment (TME) Activates dendritic cells, the most important antigen-presenting cells (APC) Induces IL-12 to activate naïve T-cells ICI: immune checkpoint inhibitor
Sotigalimab is Unlike Any Other CD40 Agonist in Development Because of Its Novel Design that Aims to Optimize Potency and Improve Tolerability Unique binding site to enhance immune response Sotigalimab mimics physiologic CD40 activation by binding to the same region as its natural ligand Potently induces IL-12 to activate naïve T-cells more effectively than others in class Modified Fc region boosts potency and improves tolerability Modified Fc region maximizes activity through receptor clustering Fc region engineered to eliminate antibody-dependent cellular cytotoxicity (ADCC) on APC Fab: Binding site region Fc: Immune System Modulator Region 2 key modifications enable sotigalimab to elicit a robust anti-tumor response with an acceptable tolerability profile 1 2 1 2
Sotigalimab-Nivolumab Demonstrates Activity and Prolonged Responses in PD-1 Blockade Refractory Melanoma Patients in Phase 2 Trial Duration of Response with Sotigalimab+Nivolumab in Patients who Progressed on Prior PD-1/PD-L1 Blockade Therapy Change in Tumor Size (%) Time from Baseline Assessment (Months) 5 PRs (15%) PR DoR (months): 4.2+ | 11+ | 13.3+ | 18.7 | 24.7+ SD DoR (months): Up to 14+ 10 SDs (30%) 18 PDs (55%) Background Patients (n=33) with relapsed/refractory metastatic melanoma with confirmed PD on anti-PD-1 mAb 24% received prior anti-CTLA-4 Results Summary Strong activity: 15.2% achieved partial responses (PR) and 30.3% showed stable disease (SD) Well tolerated Grade >3 related TEAEs reported in two patients: transient increases of alanine aminotransferase (2 patients) and aspartate aminotransferase (2 patients) Rapid, deep and durable responses SD up to 14+ months 4/5 patients had ongoing PRs; median duration of response (DoR) not reached
Results Demonstrate Favorable Tolerability Profile of Sotigalimab Abbreviations: C = cohort, DL = dose level, N = number of subjects enrolled, SAE= serious adverse event: TEAE = treatment-emergent adverse event a Regardless of the relatedness to nivolumab b All 3 subjects from DL3 from phase 1b were also included in phase 2 C1 (1) and C2 (2) Number (%) of subjects with related grade ≥3 TEAEs (in ≥2 subjects) Study APX005M-002 Phase 1b Phase 2 (0.3 mg/kg) Total (N=139) Melanoma Patient Cohort Relateda Grade > 3 TEAE Preferred Term DL1 (0.03 mg/kg) (N=3) DL2 (0.1 mg/kg) (N=3) DL3b (0.3 mg/kg) (N=3) C1b (N=53) C2b (N=38) C3A (N=l4) C3B (N=28) Alanine Aminotransferase Increased 0 0 0 1 ( 1.89%) 2 (5.26%) 0 2 (7.14%) 5 (3.60%) Hypertension 0 0 0 4 (7.55%) 0 0 1 (3.57%) 5 (3.60%) Gamma-glutamyltranferase Increased 0 0 0 2 (3.77%) 1 (2.63%) 0 1 (3.57%) 4 (2.88%) Aspartate Aminotransferase Increased 0 0 0 1 (1.89%) 2 (5.26%) 0 0 3 (2.16%) Dyspnoea 0 0 0 3 (5.66%) 0 0 0 3 (2.16%) Amylase Increased 0 0 0 1 ( 1.89%) 1 (2.63%) 0 0 2 (1.44%) Blood Bilirubin Increased 1 (33.33%) 0 0 1 (1.89%) 0 0 0 2 (1.44%) Colitis 0 0 0 2 (3.77%) 0 0 0 2 (1.44%) Cytokine Release Syndrome 0 0 0 0 0 0 2 (7.14%) 2 (1.44%) Diarrhoea 0 0 0 2 (3.77%) 0 0 0 2 (1.44%) Fatigue 0 0 0 1 ( 1.89%) 0 1 (7.14%) 0 2 (1.44%) Hyperglycaernia 0 0 0 1 (1.89%) 0 0 1 (3.57%) 2 (1.44%) Lipase Increased 0 0 0 1 (1.89%) 1 (2.63%) 0 0 2 (1.44%) Pyrexia 0 0 0 0 1 (2.63%) 1 (7.14%) 0 2 (1.44%)
BRAF Testing Patients with Melanoma Who Do Not Respond or Stop Responding to Immune Checkpoint Inhibitors (ICIs) Are a Rapidly Growing Population Where Sotigalimab Has Shown Response Majority of metastatic melanoma patients get treated frontline (1L) with an anti-PD1 and/or anti-CTLA-4 agent resulting in a growing ICI refractory population starting as early as 2L 60–70% of patients do not experience an objective response to anti-PD1 therapy1 Of those who respond, 20–30% demonstrate eventual tumor relapse1 There are an estimated 9,000+ patients in the U.S. with 2L+(PD1 refractory) melanoma2 No approved standard of care exists for patients who have failed both PD1 and CTLA4 therapy, a population that is rapidly growing and difficult to treat *Treatment paradigm reflects US population 2Cancer MPact TE Melanoma 2021, Globaldata, SEER 1Bagchi et al., Annual review of pathology, 16, 223–249 (2021) Figure source: NCCN guidelines, PI for all agents and GlobalData Clinical Trials Chemotherapy 3L ICI refractory population 2L PD-1 Mono / Combo Ipilimumab Mono Chemotherapy BRAFi + MEKi +/- Atezo (BRAFmt only) 1L PD-1 Mono PD-1 + CTLA-4 Combo Opduolag BRAFi + MEKi +/- Atezo (BRAFmt only) ICI Mono / Combo Treatment Paradigm BRAFwt BRAFmt Metastatic Melanoma Patient addressable
All STS subtypes1 (n=20) Sotigalimab-Doxorubicin Demonstrates Robust Responses and Encouraging Tolerability Profile Across STS Subtypes 1All subtypes excluding Kaposi sarcoma (KS) and gastroesophageal intestinal stromal tumor (GIST) plus 10 patients each with LPS, LMS or MFS/undifferentiated pleomorphic sarcoma (UPS) 2One of 10 patients remains unclassified STS: soft tissue sarcoma DDLPS: dedifferentiated liposarcoma Potential to significantly improve median progression-free survival (mPFS) in patients with LPS 4 PDs (20%) Time from Baseline Assessment (Months) Change in Tumor Size (%) 12 SDs (60%) 4 PRs (20%) 0 6 12 18 24 Time from Baseline Assessment (Months) Change in Target Lesions from Baseline (%) PR DoR: 1.3-11 months SD DoR: 1.4-23.4 months DDLPS2 sub-analysis (n=10) mPFS: 12.45 months (historically 2-5 months on dox alone) PR SD PD SD, Ongoing response SD, Withdrew to go to Surgery Data snapshot as of Sept/Oct 2022 Data snapshot from Jan 2022: N=20 enrolled and evaluable
Sarcoma Has Seen Few Novel Advancements and Patients Need Improved Treatments with Fewer Side Effects 1Kim, et al., BMC Cancer 9, 205 (2009) 2Chamberlain et al., Future oncology, 17(20), 2659–2670 (2021) 3Resag et al., Cancers, 14(19), 4578 (2022) Single agent doxorubicin remains SOC despite dose-limiting cardiac toxicity Incidence of liposarcoma in the U.S. is ~3k1 Of the 4 major LPS subtypes, dedifferentiated (DD) LPS is difficult to treat and represents great unmet need Response rate to chemotherapy in patients with DDLPS/well-differentiated (WD) LPS is ~11–24%2 Metastases can be observed in 20–30% of cases and typically develop in the lungs, which is associated with poor outcomes3 Most therapies are chemo-based with significant side effects and clinically poor mPFS (2-5 months) As patients progress, survival rapidly declines, highlighting the need for greatest impact at the earliest line of therapy 43% 28% 23% 5% 45% 30% 10% 10% 5% *Pyxis Oncology Internal Data Pie Chart Source: Rizer, M et al, Skeletal Radiol, 45, 1193–1204
Sotigalimab Demonstrated Strong Activity, Durable Responses, and Encouraging Tolerability Profile Across Multiple Difficult-to-Treat Tumor Types Cumulative clinical data highlight sotigalimab franchise potential Sotigalimab in Melanoma Demonstrated rapid, deep and durable responses in difficult-to-treat population Evidence supporting its potential to rescue lack of IO responsiveness Opportunity to address a growing population of patients with limited treatment options Sotigalimab in LPS Demonstrated durable activity across multiple STS subtypes Potential to significantly improve mPFS in LPS patients Opportunity to provide an innovative treatment to patients with limited treatment options and implement a faster to patient approach Sotigalimab Across Multiple Tumor Types Powerful mechanism that can synergize with multiple classes of therapeutics Tolerability profile ideal for combination treatment regimens Opportunity to partner to drive development in additional indications
Immuno-oncology (IO); Antibody-Drug Conjugate (ADC) Multi-modality portfolio with broad potential Program Class Potential Indications Discovery Preclinical Phase 1 Phase 2 Phase 3 Next Milestone Sotigalimab (CD40 agonist) IO melanoma Begin Phase 2 dose-finding study in 2L melanoma in 2024 Dedifferentiated liposarcoma (DDLPS) data anticipated in 2023 liposarcoma (LPS) PYX-201 (anti-EDB) ADC e.g., breast, head and neck, lung, and thyroid cancer Preliminary data in early 2024 PYX-106 (anti-siglec-15) IO e.g., bladder, cholangio-carcinoma, colorectal, and kidney cancer First subject dosing 2Q23 Internal Discovery ADC solid and heme tumors Orphan Drug Designation (ODD) received for PYX-201 in pancreatic cancer and sotigalimab in soft tissue sarcoma Post-close Pipeline Focuses on Multiple Difficult-to-Treat Tumors
Lara Sullivan, MD CEO Xiaodong Yang, MD, PhD Founder & CEO, Apexigen Supporting R&D Transition Martina Molsbergen CBO (Interim) Jan Pinkas, PhD CSO Pam Connealy, MBA CFO & COO Charlie Gombar, PhD SVP, Portfolio & Project Management Pyxis Oncology has strategically formulated a diverse leadership team with a proven track record of success, that strongly positions the organization to deliver meaningful impact to the industry and clinical oncology landscape. Balu Balasubramanian, PhD CTO (Interim) Pyxis Oncology Executive Team to Lead Combined Entity Xiaodong Yang, CEO of Apexigen to support R&D transition at business combination closing
Pyxis Oncology Organization with Proven Drug Development Experience 152 Total prior drug approvals/ launches 64 Prior Oncology drug approvals/launches 232 Number of prior biotech/ pharma companies >104 Decades of biotech/ pharma experience Onboarding Survey of Pyxis Oncology employees Pharma-trained, Biotech-seasoned Significant Industry Contributions
Current Cash Runway Provides Meaningful Mid- to Near-Term Catalysts DATA Poster presentation of Phase 2 sotiga data in advanced soft tissue sarcoma at upcoming ASCO Preliminary data expected in late 2023 / early 2024 for PYX-201 and PYX-106 CLINICAL PYX-201 planned expansion cohort initiation in 2Q23 PYX-106 first subject, first dose in 2Q23 PYX-106 planned expansion cohort initiation in 3Q23 UPCOMING PRESENTATIONS June: Jefferies Healthcare Conference presentation and 1x1s August: BTIG 7th Annual Global Biotechnology Conference September: Wells Fargo Healthcare Conference September: H.C. Wainwright 25th Annual Global Investment Conference Acquisition of Apexigen Anticipated to Close Mid-2023
Q&A
Thank you
Appendix
Sotigalimab vs. Other Advanced Clinical Stage CD40 Agonists (Not Exhaustive) sotigalimab1 CDX-11402 selicrelumab3 ABBV-9271 SEA-CD404 dacetuzumab BNT-3125 (GEN1042) mitazalimab1 ADC-1013 YH0036 (Biocytogen) Format IgG1 humanized mAB IgG2 fully human mAB IgG2 fully human mAB IgG1 IgG1 DuoBody-CD40x4-1BB IgG1 IgG2 humanized mAB Fc engineering Modified to eliminate ADCC (S267E): Reduced FcgRIIIa binding No No Modified to eliminate ADCC (V273Y): Reduced FcgRIIIa binding Modified to increase ADCC (afucosylated): Increased FcgRIIIa binding Modified to eliminate binding to Fcg receptors No CD40 epitope Competes with CD40L (binds cysteine-rich domain 2 [CRD2]) CRD1; not competing with CD40L CRD1; not competing with CD40L CRD1; not competing with CD40L CRD1; not competing with CD40L Not known CRD1; not competing with CD40L CRD1; not competing with CD40L Requires cross-linking Yes No No Yes Yes No Yes FcγR dependent Yes (FcgIIbR) No No Yes (FcgIIbR) yes No Yes In-vitro activity High Weak High High High High In-vivo activity No binding to mouse CD40 Yes Yes, not tolerated Yes Yes, crosslinks CD40-expressing APC with 4-1BB-expressing T cells Yes Development status Phase 2 Ph 2 (De-prioritized by company Phase 2 Phase 1/2 Phase 2 Celldex Roche AbbVie Seagen BioNTech Alligator Bioscience Eucure Sources: 1. Smith, Karin, et al,Expert Opinion on Biological Therapy 21.12 (2021): 1635-1646; 2. Vitale, Laura A., et al. Cancer Immunology, Immunotherapy 68 (2019): 233-245; 3. Djureinovic, et al, Cancers 13.6 (2021): 1302; 4. Gardai, Shyra J., et al. Cancer Research 75.15_Supplement (2015): 2472-2472.; 5. Muik, Alexander, et al. Cancer Research 81.13_Supplement (2021): 1846-1846; 6. Coward, Jermaine, et al. (2022): 2603-2603.
PYX-201 Roadmap: Focus on Select EDB-FN Tumors Susceptible to Next-Generation Microtubule Inhibition Synergizing Translational Research with Clinical Evidence to Enhance: Indication Selection: Utilizing a deep dive approach of evaluating tumor profiles to tubulin inhibitor sensitivity to select across a range of indications based on EDB-FN expression – early focus on low incidence and highly underserved tumors for rapid PoC generation Subject Selection: Robust biomarker strategy and early biopsy analysis to confirm preclinical data suggesting correlation of high EDB-FN expression to response and appropriate subject selection Label Expansion: Repurposing PoC and early indication data to expand subject reach in more prevalent cancers FDA IND approval, Nov ‘22 Dose escalation completion, Q1 ‘24 Ph 1 initiation, Q1 ‘23 Ph 1 expansion into select tumors Early biomarker data for subject selection Preclinical Evidence Early Clinical Evaluation Translational Exploration First subject dosing Q1 ‘23 2022 2023 2024 Preliminary data, including biomarker results and potential signs of early clinical activity
PYX-201-101 Study Overview NSCLC: Non-small cell lung cancer; HNSCC: head and neck squamous cell carcinomas; PDAC: Pancreatic ductal adenocarcinoma; TNBC: Triple negative breast cancer. * The expansion phase will be triggered by a protocol amendment. The indications, dosing schedules, and assessment timepoints planned for the expansion phase will be determined based on clinical safety, efficacy, biomarker, and pharmacokinetic (PK) data obtained during the dose escalation phase. First-in-Human, Open-label, Multicenter Study Evaluating PYX-201 in Subjects with Advanced Solid Tumors Select Tumor Types Dose Escalation Analysis Phase 1 expansion cohort in select tumor types Regular follow-ups Analysis of paired biopsies from a subset of subjects pre/post treatment Determine maximum tolerated dose (MTD) using Bayesian optimal interval (BOIN) design Evaluate safety, tolerability and pharmacokinetics of PYX-201 Objectives: Determine recommended dose(s) of PYX-201 Evaluate safety and tolerability Characterize the pharmacokinetic profile Evaluate ORR, DOR, DCR, PFS, and OS Evaluate immunogenicity of PYX-201 Ovarian Cancer NSCLC HR+ Breast Cancer Thyroid Cancer HCC Soft Tissue Sarcoma PDAC TNBC HNSCC Renal Cancer Expansion*
PYX-106 Roadmap: Focus on a “Faster to Patient” Approach Innovating through applied learnings, translational explorations and symbiosis between research and development Synergizing Translational Research with Clinical Evidence to Enhance: Indication Identification: PoC generating/lean/fast to market high unmet need cancers that may respond to anti-Siglec-15 therapy Subject Selection: Robust biomarker strategy to better characterize target expression in tumor cells and macrophages and the immune landscape to identify subject segments likely to derive the most benefit from therapy Label Expansion: Repurposing PoC and early indication data to expand subject reach in more prevalent cancers Combination Strategy: Expand subject response and impact through additive efficacy Preclinical Evidence Early Clinical Evaluation Translational Exploration FDA IND approval, Nov ‘22 Dose escalation likely completion, Q4 ‘23 Ph 1 initiation, Q1 ‘23 Ph 1 expansion into select tumors Early biomarker data for potential subject selection First subject dosing Q2 ‘23 2022 2023 2024 Preliminary data, including biomarker results and potential signs of early clinical activity
PYX-106-101 Study Overview * The expansion phase will be triggered by a protocol amendment. The indications, dosing schedules, and assessment timepoints planned for the expansion phase will be determined based on clinical safety, efficacy, biomarker, and pharmacokinetic (PK) data obtained during the dose escalation phase. First-in-Human, Open-label, Multicenter Study Evaluating PYX-106 in Subjects with Advanced Solid Tumors Phase 1 expansion cohort in select tumor types Select Tumor Types Part 1:Dose Escalation Regular follow-ups Analysis of paired biopsies from a subset of subjects pre/post treatment Analysis Determine maximum tolerated dose (MTD) using Bayesian optimal interval (BOIN) design Evaluate safety, tolerability and pharmacokinetics of PYX-106 Thyroid Cancer NSCLC Endomet. Carcinoma HNSCC HR+ Breast Cancer Cholangio-carcinoma Colorectal Carcinoma Kidney Cancer Bladder Carcinoma Objectives: Determine the recommended dose for Part 2 Evaluate safety and tolerability Characterize the pharmacokinetic profile Evaluate ORR, DOR, DCR, PFS, and OS Evaluate immunogenicity of PYX-106 Part 2: Expansion*