PYXS 8-K
Pyxis Oncology, Inc. (PYXS)
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): |
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
||
|
|
|
|
|
|
||||
|
||||
(Address of Principal Executive Offices) |
|
(Zip Code) |
||
Registrant’s Telephone Number, Including Area Code: |
(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 |
|
|
|
|
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 2.02 Results of Operations and Financial Condition.
On August 13, 2026, Pyxis Oncology, Inc. (“the Company”) issued a press release announcing its financial results for the quarter ended June 30, 2026 and provided a corporate update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
The information contained in Item 2.02 of this Current Report, 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 other filing with the U.S. Securities and Exchange Commission made by the Company, regardless of any general incorporation language in such filings.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits |
||
Exhibit No. |
|
Description |
99.1 |
|
|
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: |
August 13, 2026 |
By: |
/s/ Jitendra Wadhane |
|
|
|
Jitendra Wadhane |
Exhibit 99.1
Pyxis Oncology Reports Second Quarter 2026 Financial Results and Advances MICVO Toward Key 2026 Clinical Milestones
Updated data from the MICVO Phase 1 monotherapy study in 2L+ R/M HNSCC on track to be reported in Fall 2026; update to include detailed analyses of patients treated at or below a dose cap
Updated data from the MICVO Phase 1/2 combination study with pembrolizumab in 1L R/M HNSCC on track to be reported in the fourth quarter of 2026
Completed private placement financing for up to $114 million, providing approximately $50 million in upfront gross proceeds to support additional patient follow-up
Upfront proceeds from the private placement, together with existing cash, extended the Company’s cash runway into the second quarter of 2027
BOSTON, August 13, 2026 (GLOBE NEWSWIRE)— Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, today reported financial results for the quarter ended June 30, 2026, and highlighted continued advancement of the micvotabart pelidotin (MICVO) clinical development programs.
“The second quarter was marked by continued execution across the MICVO program and a financing that strengthened our balance sheet and extended our cash runway into the second quarter of 2027,” said Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology. “The additional capital gives us greater flexibility to incorporate longer patient follow-up and planned analyses into our next clinical updates. We expect to report updated monotherapy data in second-line and beyond recurrent/metastatic head and neck squamous cell carcinoma (2L+ R/M HNSCC) this fall, followed by updated first-line combination data with pembrolizumab in the fourth quarter. We remain focused on generating the clinical evidence needed to evaluate MICVO’s potential to address the significant unmet need in head and neck cancer, regardless of HPV status or prior therapy.”
Pipeline & Corporate Updates
Second Quarter 2026 Financial Results
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is a clinical-stage biopharmaceutical company developing therapeutics for difficult-to-treat cancers. The Company’s lead candidate, micvotabart pelidotin (MICVO), is a first-in-concept antibody-drug conjugate (ADC) that targets extradomain-B of fibronectin (EDB+FN), a non-cellular structural component of the tumor extracellular matrix (ECM). EDB+FN is selectively overexpressed in the tumor microenvironment of a wide range of solid tumors and largely absent from normal adult tissues. MICVO is designed to treat solid tumors through a three-pronged mechanism of action: direct cancer cell killing, bystander effect and immunogenic cell death. MICVO is currently being evaluated as monotherapy in a Phase 1 clinical study in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) and in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in a Phase 1/2 clinical study in patients with R/M HNSCC and other solid tumors. Pyxis Oncology is focused on advancing MICVO, with the goal of improving outcomes for patients living with R/M HNSCC and contributing to meaningful progress in cancer treatment.
MICVO received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of adult patients with R/M HNSCC whose disease has progressed following treatment with platinum-based chemotherapy and an anti-PD-(L)1 therapy.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
To learn more, visit www.pyxisoncology.com or follow us on 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 the SEC on August 13, 2026, 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
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, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Milestone revenue |
|
$ |
— |
|
|
$ |
2,820 |
|
|
$ |
— |
|
|
$ |
2,820 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
|
16,057 |
|
|
|
17,133 |
|
|
|
36,040 |
|
|
|
34,177 |
|
General and administrative |
|
|
9,933 |
|
|
|
5,437 |
|
|
|
14,310 |
|
|
|
11,307 |
|
Total operating expenses |
|
|
25,990 |
|
|
|
22,570 |
|
|
|
50,350 |
|
|
|
45,484 |
|
Loss from operations |
|
|
(25,990 |
) |
|
|
(19,750 |
) |
|
|
(50,350 |
) |
|
|
(42,664 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest and investment income, net |
|
|
255 |
|
|
|
995 |
|
|
|
712 |
|
|
|
2,236 |
|
Sublease income |
|
|
389 |
|
|
|
684 |
|
|
|
1,020 |
|
|
|
1,199 |
|
Total other income, net |
|
|
644 |
|
|
|
1,679 |
|
|
|
1,732 |
|
|
|
3,435 |
|
Loss before income taxes |
|
|
(25,346 |
) |
|
|
(18,071 |
) |
|
|
(48,618 |
) |
|
|
(39,229 |
) |
Income tax expense |
|
|
— |
|
|
|
283 |
|
|
|
— |
|
|
|
283 |
|
Net loss |
|
$ |
(25,346 |
) |
|
$ |
(18,354 |
) |
|
$ |
(48,618 |
) |
|
$ |
(39,512 |
) |
Net loss per common share - basic and diluted |
|
$ |
(0.40 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.76 |
) |
|
$ |
(0.64 |
) |
Weighted average shares of common stock outstanding - basic and diluted |
|
|
63,991,609 |
|
|
|
61,918,826 |
|
|
|
63,695,177 |
|
|
|
61,486,290 |
|
Other comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net unrealized loss on marketable debt securities |
|
|
(4 |
) |
|
|
(54 |
) |
|
|
(57 |
) |
|
|
(175 |
) |
Other comprehensive loss |
|
|
(4 |
) |
|
|
(54 |
) |
|
|
(57 |
) |
|
|
(175 |
) |
Comprehensive loss |
|
$ |
(25,350 |
) |
|
$ |
(18,408 |
) |
|
$ |
(48,675 |
) |
|
$ |
(39,687 |
) |
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share amounts)
(Unaudited)
|
|
June 30, 2026 |
|
|
December 31, 2025 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
18,855 |
|
|
$ |
15,422 |
|
Marketable debt securities |
|
|
14,141 |
|
|
|
51,435 |
|
Restricted cash |
|
|
1,472 |
|
|
|
1,472 |
|
Prepaid expenses and other current assets |
|
|
2,266 |
|
|
|
3,776 |
|
Total current assets |
|
|
36,734 |
|
|
|
72,105 |
|
Property and equipment, net |
|
|
7,237 |
|
|
|
7,997 |
|
Operating lease right-of-use asset |
|
|
10,951 |
|
|
|
11,418 |
|
Total assets |
|
$ |
54,922 |
|
|
$ |
91,520 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
3,269 |
|
|
$ |
10,885 |
|
Private placement advance liability |
|
|
10,000 |
|
|
|
— |
|
Accrued expenses and other current liabilities |
|
|
12,381 |
|
|
|
8,554 |
|
Operating lease liabilities, current portion |
|
|
1,824 |
|
|
|
1,692 |
|
Total current liabilities |
|
|
27,474 |
|
|
|
21,131 |
|
Operating lease liabilities, net of current portion |
|
|
16,008 |
|
|
|
16,958 |
|
Financing lease liabilities, net of current portion |
|
|
— |
|
|
|
23 |
|
Total liabilities |
|
|
43,482 |
|
|
|
38,112 |
|
Commitments and contingencies |
|
|
|
|
|
|
||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
63 |
|
|
|
63 |
|
Additional paid-in capital |
|
|
503,176 |
|
|
|
496,469 |
|
Accumulated other comprehensive (loss) income |
|
|
(4 |
) |
|
|
53 |
|
Accumulated deficit |
|
|
(491,795 |
) |
|
|
(443,177 |
) |
Total stockholders’ equity |
|
|
11,440 |
|
|
|
53,408 |
|
Total liabilities and stockholders’ equity |
|
$ |
54,922 |
|
|
$ |
91,520 |
|