UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
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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 November 1, 2022, Pyxis Oncology, Inc., or the Company, issued a press release announcing its financial results for the third quarter and nine months ended September 30, 2022 and providing corporate updates. 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 this Item 2.02, 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 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 |
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Exhibit No. |
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Description |
99.1 |
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104 |
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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.
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Pyxis Oncology, Inc. |
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Date: |
November 1, 2022 |
By: |
/s/ Pamela Connealy |
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Pamela Connealy |
Exhibit 99.1
Pyxis Oncology Reports Financial Results for the Quarter Ended September 30, 2022 and Provides Corporate Update
CAMBRIDGE, Mass., November 1, 2022 – Pyxis Oncology, Inc. (Nasdaq: PYXS) today reported financial results for the third quarter and nine months ended September 30, 2022 and provided a corporate update.
“The expansion of our exclusive in-licensing agreement with Pfizer continues to strengthen our development and partnership capabilities through exclusive access to Pfizer’s ADC technology platform and toolkit with first right of access to all available Pfizer ADC targets and associated technology,” said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “As Pfizer’s exclusive sublicensing agent for its ADC technology, our team has already concluded the first multi-target sublicensing agreement with a stealth ADC company demonstrating the durable value of this platform as well as industry interest in the technology. We look forward to further collaborating with other industry partners to fully leverage the potential of this intellectual property.”
Jeff Settleman, Ph.D., Senior Vice President and Chief Scientific Officer for Oncology Research and Development at Pfizer, added, “We are proud to strengthen our agreement with Pyxis Oncology. Pyxis Oncology has assembled a talented team, and we are confident in their ability to fully realize the platform’s clinical potential.”
Corporate Development Highlights
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“Our team believes in the potential of marrying internal and external development strategies to accelerate promising therapeutics for patients with difficult-to-treat cancers,” continued Dr. Sullivan. “In addition to strengthening our current partnerships, we see a significant opportunity to leverage our strong balance sheet and our team’s extensive industry networks to explore new avenues of scientific and therapeutic advancement.”
Financial Update for Quarter Ended September 30, 2022
About Pyxis Oncology, Inc.
Pyxis Oncology, Inc. is an oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients. By leveraging our fully integrated research, development and commercial capabilities, our expert team is efficiently building a diversified portfolio of next-generation therapeutics. 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. Since its launch in 2019,
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Pyxis Oncology has developed a broad portfolio of novel antibody-drug conjugate, or ADC, immuno-oncology, or IO, product candidates, and monoclonal antibody, or mAb, preclinical discovery programs that it is developing as monotherapies and in combination with other therapies. To learn more about Pyxis Oncology, visit www.pyxisoncology.com.
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 November 1, 2022 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.
Pyxis Oncology Contact
Pamela Connealy
Chief Financial Officer
(617) 453-3596
ir@pyxisoncology.com
Investor Contact
Ashley Robinson
LifeSci Advisors, LLC
arr@lifesciadvisors.com
---tables to follow---
3
PYXIS ONCOLOGY, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts) (Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses: |
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Research and development |
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$ |
19,034 |
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$ |
7,849 |
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$ |
56,275 |
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$ |
43,828 |
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General and administrative |
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9,359 |
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3,772 |
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29,233 |
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9,463 |
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Total operating expenses |
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28,393 |
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11,621 |
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85,508 |
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53,291 |
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Loss from operations |
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(28,393 |
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(11,621 |
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(85,508 |
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(53,291 |
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Other income (expense): |
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Interest income |
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719 |
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6 |
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892 |
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16 |
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Service fee income from related party |
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— |
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— |
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— |
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181 |
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Change in fair value of derivative liability |
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— |
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(2,560 |
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— |
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(5,821 |
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Total other income (expense) |
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719 |
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(2,554 |
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892 |
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(5,624 |
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Loss from equity method investment in joint venture |
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— |
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— |
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— |
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(231 |
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Net loss and comprehensive loss |
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$ |
(27,674 |
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$ |
(14,175 |
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$ |
(84,616 |
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$ |
(59,146 |
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Net loss per common share - basic and diluted |
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$ |
(0.85 |
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$ |
(8.96 |
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$ |
(2.61 |
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$ |
(40.27 |
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Weighted average shares of common stock outstanding - basic and diluted |
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32,561,228 |
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1,581,610 |
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32,444,072 |
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1,468,777 |
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4
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(In thousands) (Unaudited)
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September 30, 2022 |
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December 31, 2021 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
198,538 |
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$ |
274,735 |
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Restricted cash |
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1,472 |
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1,472 |
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Prepaid expenses and other current assets |
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2,798 |
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2,466 |
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Total current assets |
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202,808 |
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278,673 |
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Property and equipment, net |
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6,391 |
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1,007 |
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Operating lease right-of-use assets |
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14,696 |
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232 |
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Other assets, noncurrent |
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— |
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109 |
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Total assets |
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$ |
223,895 |
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$ |
280,021 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
5,509 |
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$ |
11,951 |
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Accrued expenses and other current liabilities |
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13,586 |
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6,592 |
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Operating lease liabilities, current portion |
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— |
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165 |
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Total current liabilities |
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19,095 |
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18,708 |
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Operating lease liabilities, net of current portion |
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16,053 |
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— |
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Total liabilities |
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35,148 |
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18,708 |
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Commitments and contingencies |
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Stockholders’ equity: |
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Preferred stock |
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— |
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— |
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Common stock |
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32 |
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32 |
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Additional paid-in capital |
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365,049 |
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352,999 |
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Accumulated deficit |
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(176,334 |
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(91,718 |
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Total stockholders’ equity |
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188,747 |
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261,313 |
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Total liabilities and stockholders’ equity |
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$ |
223,895 |
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$ |
280,021 |
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5