Pyxis Oncology Reports First Quarter 2025 Financial Results and Provides Business Update

- Announced robust preclinical data supporting the unique three-pronged mechanism of action of micvotabart pelidotin (MICVO, formerly PYX-201), driving anti-tumor activity via direct tumor killing, bystander effect and immunogenic cell death

- On track to report preliminary data from Phase 1 monotherapy expansion cohorts of MICVO for 2L/3L R/M HNSCC patients who have received prior platinum-based chemotherapy and prior PD-(L)1 inhibitor therapy in second half of 2025, and 2L/3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor therapy in first half of 2026

- On track to report preliminary data from Phase 1 trial of MICVO in combination with pembrolizumab targeting multiple tumor types including 1L/2L HNSCC patients in second half of 2025

- Expected cash runway through data milestones and into second half of 2026

BOSTON, May 15, 2025 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation ADC therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended March 31, 2025, and provided a business update.

"We are enthusiastic about the progress we are making with micvotabart pelidotin, particularly our recent preclinical data that validate its unique three-pronged mechanism of action and indicate that MICVO monotherapy may be eliciting immune responses in previously unresponsive tumors," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "Our focus remains on delivering durable and efficacious therapies for patients with recurrent or metastatic head and neck squamous cell carcinoma and other advanced solid tumors, building on the tremendous potential of our next generation ADC. We look forward to reporting data from our ongoing Phase 1 trials evaluating MICVO as a monotherapy and in combination with pembrolizumab later this year."

Pipeline Updates

   -- Pyxis Oncology presented promising preclinical data at the 2025 American 
      Association for Cancer Research Annual Meeting supporting the unique 
      three-pronged mechanism of action of MICVO driving anti-tumor activity 
      via direct tumor killing, bystander effect and immunogenic cell death. 
      These data further reinforce the potential patient benefit of MICVO as a 
      monotherapy and in combination with an anti-PD-1 therapy. 
 
          -- MICVO demonstrated broad anti-tumor activity across ten solid 
             tumor indications in PDX models, attributed to EDB+FN target 
             expression, proteolytic activity for MICVO linker cleavage and 
             tumor responsiveness to the cytotoxic Auristatin0101 payload. 
 
          -- Differential gene expression analysis enabled identification of 
             gene signatures associated with anti-tumor activity. 
 
          -- Upregulation of certain proteases may contribute to increased 
             linker cleavage and subsequent increased MICVO activity, 
             supporting hypothesis for extracellular mechanism. 
 
          -- Combining a mouse analog of MICVO with anti-PD-1 therapy inhibited 
             EMT6 tumor growth and improved survival. 
 
   -- The Company expects to report preliminary data from the Part 2 
      monotherapy expansion cohorts of the ongoing Phase 1 clinical trial 
      evaluating MICVO in 2L and 3L R/M HNSCC patients who have received prior 
      platinum and PD-1 inhibitor therapy in the second half of 2025 and 2L and 
      3L R/M HNSCC patients who have received prior EGFRi and PD-1 inhibitor 
      therapy in the first half of 2026. R/M HNSCC continues to be an area of 
      high medical need despite improvements in treatment options. 
 
   -- Pyxis Oncology anticipates selecting a dose of MICVO in the ongoing Phase 
      1/2 combination study of micvotabart pelidotin and Merck's anti-PD-1 
      therapy, KEYTRUDA$(R)$ (pembrolizumab), in patients with R/M HNSCC and 
      other advanced solid tumors by mid-year 2025 and reporting preliminary 
      data from the trial in the second half of 2025. 

First Quarter 2025 Financial Results

   -- As of March 31, 2025, Pyxis Oncology had cash and cash equivalents, 
      including restricted cash, and short-term investments, of $106.9 million. 
      The Company believes that its current cash, cash equivalents, and 
      short-term investments will be sufficient to fund its operations into the 
      second half of 2026. 
 
   -- Research and development expenses were $17.0 million for the quarter 
      ended March 31, 2025, compared to $13.0 million for the quarter ended 
      March 31, 2024. The increase was primarily due to increased clinical 
      trial-related expenses related to monotherapy and combination therapy of 
      micvotabart pelidotin, increase in preclinical and translation work to 
      support clinical development of micvotabart pelidotin and increased 
      manufacturing of drug product and drug substance. 
 
   -- General and administrative expenses were $5.9 million for the quarter 
      ended March 31, 2025, compared to $8.2 million for the quarter ended 
      March 31, 2024. The decrease was primarily due to lower stock-based 
      compensation costs, lower corporate insurance costs and decrease in legal, 
      professional and consulting fees. 
 
   -- Net loss was $21.2 million, or ($0.35) per common share, for the quarter 
      ended March 31, 2025, compared to $3.3 million, or ($0.06) per common 
      share, for the quarter ended March 31, 2024. Net loss for the quarter 
      ended March 31, 2024 included total revenues of $16.1 million related to 
      the settlement agreement with Novartis for sale of royalty rights of 
      Beovu(R) for a one-time amount of $8.0 million and Novartis agreed to 
      forgo its right to reclaim royalties previously paid of $8.1 million to 
      us and Apexigen. Excluding non-cash stock-based compensation expense, the 
      net loss for the quarter ended March 31, 2025 was $17.5 million, compared 
      to net income of $1.1 million for the quarter ended March 31, 2024. 
 
   -- As of May 14, 2025, the outstanding number of shares of Common Stock of 
      Pyxis Oncology was 61,947,665. 

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 monotherapy and combination indications. Its lead candidate, micvotabart pelidotin (MICVO, formerly PYX-201), has been evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors with a go-forward development focus on treating patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) based on the strength of the HNSCC signal that emerged. Additionally, the Company initiated a Phase 1/2 combination study of MICVO and Merck's anti-PD-1 therapy, KEYTRUDA(R) (pembrolizumab), in patients with R/M HNSCC and other advanced solid tumors.

To learn more, visit www.pyxisoncology.com or follow us on X (formerly known as 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 Quarterly Report on Form 10-Q filed with SEC on May 15, 2025, and our other filings, each of which is on file with the Securities and Exchange Commission. 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.

Pyxis Oncology Contact

Pamela Connealy

CFO and COO

ir@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 March 31, 
                                   -------------------------------- 
                                         2025             2024 
                                   ----------------   ------------- 
Revenues 
   Royalty revenues                 $            --   $       8,146 
   Sale of royalty rights                        --           8,000 
                                       ------------    ------------ 
     Total revenues                              --          16,146 
Costs and operating expenses 
   Cost of revenues                              --             475 
   Research and development                  17,044          13,029 
   General and administrative                 5,870           8,247 
     Total costs and operating 
      expenses                               22,914          21,751 
                                       ------------    ------------ 
Loss from operations                        (22,914)         (5,605) 
Other income, net: 
   Interest and investment income             1,241           1,550 
   Sublease income                              515             799 
                                       ------------    ------------ 
     Total other income, net                  1,756           2,349 
                                       ------------    ------------ 
Net loss                            $       (21,158)  $      (3,256) 
                                       ============    ============ 
Net loss per common share - basic 
 and diluted                        $         (0.35)  $       (0.06) 
                                       ------------    ------------ 
Weighted average shares of common 
 stock outstanding - basic and 
 diluted                                 61,048,948      51,289,284 
                                       ============    ============ 
 
 
 
                          PYXIS ONCOLOGY, INC. 
                  Condensed Consolidated Balance Sheets 
                        (In thousands, Unaudited) 
 
                                March 31, 2025     December 31, 2024 
                               ----------------   ------------------- 
Assets 
Current assets: 
   Cash and cash equivalents    $        12,759    $           19,473 
   Marketable debt 
    securities, short-term               92,673               107,458 
   Restricted cash                        1,472                 1,472 
   Prepaid expenses and other 
    current assets                        4,967                 4,037 
                                   ------------       --------------- 
     Total current assets               111,871               132,440 
Property and equipment, net               9,403                 9,899 
Intangible assets, net                    2,544                 2,600 
Operating lease right-of-use 
 asset                                   12,049                12,242 
                                   ------------       --------------- 
Total assets                    $       135,867    $          157,181 
                                   ============       =============== 
Liabilities and 
Stockholders' Equity 
Current liabilities: 
   Accounts payable             $         2,846    $            4,859 
   Accrued expenses and other 
    current liabilities                  10,076                11,371 
   Operating lease 
    liabilities, current 
    portion                               1,508                 1,450 
     Total current 
      liabilities                        14,430                17,680 
Operating lease liabilities, 
 net of current portion                  18,254                18,650 
Financing lease liabilities, 
 net of current portion                      80                   100 
     Total liabilities                   32,764                36,430 
                                   ------------       --------------- 
Commitments and 
contingencies 
Stockholders' equity: 
   Preferred stock                           --                    -- 
   Common stock                              62                    60 
   Additional paid-in capital           487,706               484,077 
   Accumulated other 
    comprehensive income                     49                   170 
   Accumulated deficit                 (384,714)             (363,556) 
                                   ------------       --------------- 
     Total stockholders' 
      equity                            103,103               120,751 
                                   ------------       --------------- 
Total liabilities and 
 stockholders' equity           $       135,867    $          157,181 
                                   ============       =============== 
 

(END) Dow Jones Newswires

May 15, 2025 07:00 ET (11:00 GMT)