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
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 15, 2022, Pyxis Oncology, Inc., or the Company, issued a press release announcing its financial results for the second quarter and six months ended June 30, 2022 and providing business 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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On August 11, 2022, Pyxis Oncology, Inc. appointed Rachel Humphrey, M.D., to its Board of Directors and to serve on the Board’s Nominating and Corporate Governance Committee and Compensation Committee. Dr. Humphrey will be eligible for compensation under the Company’s director compensation plan, and the Board granted Dr. Humphrey stock options to purchase 236,220 shares of common stock with an exercise price of $2.91. These stock options vest in three equal annual instalments, subject to Dr. Humphrey’s continued service through the applicable vesting date.
Dr. Humphrey has no family relationships with any director or executive officer of the Company. There are no arrangements or understandings between Dr. Humphrey and any other persons pursuant to which she was selected as a Director of the Company, and there are no transactions in which Dr. Humphrey has an interest requiring disclosure under Item 404(a) of Regulation S-K.
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 15, 2022 |
By: |
/s/ Pamela Connealy |
|
|
|
Pamela Connealy |
Exhibit 99.1
Pyxis Oncology Reports Financial Results for the Second Quarter Ended June 30, 2022 and Provides Pipeline Update
CAMBRIDGE, Mass., August 15, 2022 – Pyxis Oncology, Inc. (Nasdaq: PYXS), a diversified oncology company focused on developing an arsenal of next-generation therapeutics to target difficult-to-treat cancers and improve quality of life for patients, today reported financial results for the second quarter and six months ended June 30, 2022 and provided a corporate update.
“Our strong balance sheet and cash runway will allow us to fund the Company through the second half of 2024, solidifying our position to potentially capitalize on multiple expected near-term catalysts and advance our programs to clinical development,” said Lara Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “We have elected to sharpen our near-term focus on the clinical execution of our two most advanced programs, anti-EDB Antibody Drug Conjugate (ADC), PYX-201, and anti-Siglec-15 monoclonal antibody (mAb), PYX-106. We also look forward to leveraging our team’s extensive industry network in identifying and facilitating opportunities where we can forge strategic partnerships to efficiently advance therapies that might change the treatment paradigm for patients with cancer.”
Corporate Development Highlights
1
Jay Feingold, M.D., Ph.D., Chief Medical Officer of Pyxis Oncology, commented, “We believe that our therapeutic candidates have distinct advantages and are ideally suited for targeting difficult-to-treat tumors. PYX-201 represents a potentially first-in-class ADC with a novel mechanism of action, and PYX-106 has a differentiated activity profile with the potential to help patients who don’t respond or have stopped responding to current PD-1 targeted therapies. We look forward to progressing these two most advanced programs towards the clinic and filing INDs in the second half of this year.”
Addition to Board of Directors
Pyxis Oncology has appointed Rachel Humphrey, M.D., to its Board of Directors. Dr. Humphrey brings over 20 years of experience in oncology drug development and extensive experience in product development from pre-IND to commercialization of small molecules, cytotoxics and biologics in oncology and immuno-oncology. She currently serves as President and Chief Executive Officer of Normunity, an innovative immuno-oncology company. She was previously Chief Medical Officer at Black Diamond Therapeutics, a precision oncology medicine company, and was a member of the Board of Directors at Xilio Therapeutics. Prior to that, she served as Chief Medical Officer and a member of the Board of Directors of CytomX Therapeutics, a clinical stage oncology company, where she was responsible for the clinical development of Probody™ Therapeutics for the treatment of cancer. She oversaw the early and late-stage clinical development of two new oncology molecular entities, ipilimumab (Yervoy®) while serving as Vice President, Clinical Development at Bristol-Myers Squibb, and sorafenib (Nexavar®) at Bayer.
Dr. Sullivan commented, “We are excited to welcome Rachel to our Board of Directors. Her experience and successful track record in oncology drug development spanning across large pharmaceutical and small biotechnology companies will add incredible value to our already deep bench of industry leaders as we near the clinic with two promising oncology therapeutic candidates.”
Financial Update for Quarter Ended June 30, 2022
2
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, 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 August 15, 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
3
obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.
Pyxis Oncology Contact:
Courtney Dugan
Vice President, Head of Investor Relations & Corporate Communications
(617) 500-8872
ir@pyxisoncology.com
---tables to follow---
4
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, |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
17,170 |
|
|
$ |
3,205 |
|
|
$ |
37,241 |
|
|
$ |
35,979 |
|
General and administrative |
|
|
8,556 |
|
|
|
2,736 |
|
|
|
19,874 |
|
|
|
5,691 |
|
Total operating expenses |
|
|
25,726 |
|
|
|
5,941 |
|
|
|
57,115 |
|
|
|
41,670 |
|
Loss from operations |
|
|
(25,726 |
) |
|
|
(5,941 |
) |
|
|
(57,115 |
) |
|
|
(41,670 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
164 |
|
|
|
6 |
|
|
|
173 |
|
|
|
10 |
|
Service fee income from related party |
|
|
— |
|
|
|
181 |
|
|
|
— |
|
|
|
181 |
|
Change in fair value of derivative liability |
|
|
— |
|
|
|
(2,161 |
) |
|
|
— |
|
|
|
(3,261 |
) |
Total other income (expense) |
|
|
164 |
|
|
|
(1,974 |
) |
|
|
173 |
|
|
|
(3,070 |
) |
Loss from equity method investment in joint venture |
|
|
— |
|
|
|
(231 |
) |
|
|
— |
|
|
|
(231 |
) |
Net loss and comprehensive loss |
|
$ |
(25,562 |
) |
|
$ |
(8,146 |
) |
|
$ |
(56,942 |
) |
|
$ |
(44,971 |
) |
Net loss per common share - basic and diluted |
|
$ |
(0.79 |
) |
|
$ |
(5.54 |
) |
|
$ |
(1.76 |
) |
|
$ |
(31.86 |
) |
Weighted average shares of common stock outstanding - basic and diluted |
|
|
32,451,610 |
|
|
|
1,471,447 |
|
|
|
32,384,522 |
|
|
|
1,411,428 |
|
5
PYXIS ONCOLOGY, INC.
Condensed Consolidated Balance Sheets
(In thousands) (Unaudited)
|
|
June 30, 2022 |
|
|
December 31, 2021 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
223,355 |
|
|
$ |
274,735 |
|
Restricted cash |
|
|
1,472 |
|
|
|
1,472 |
|
Prepaid expenses and other current assets |
|
|
1,768 |
|
|
|
2,466 |
|
Total current assets |
|
|
226,595 |
|
|
|
278,673 |
|
Property and equipment, net |
|
|
965 |
|
|
|
1,007 |
|
Operating lease right-of-use assets |
|
|
15,003 |
|
|
|
232 |
|
Other assets, noncurrent |
|
|
— |
|
|
|
109 |
|
Total assets |
|
$ |
242,563 |
|
|
$ |
280,021 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
7,820 |
|
|
$ |
11,951 |
|
Accrued expenses and other current liabilities |
|
|
7,096 |
|
|
|
6,592 |
|
Operating lease liabilities, current portion |
|
|
— |
|
|
|
165 |
|
Total current liabilities |
|
|
14,916 |
|
|
|
18,708 |
|
Operating lease liabilities, net of current portion |
|
|
15,681 |
|
|
|
— |
|
Total liabilities |
|
|
30,597 |
|
|
|
18,708 |
|
Commitments and contingencies |
|
|
|
|
|
|
||
Stockholders’ equity: |
|
|
|
|
|
|
||
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
32 |
|
|
|
32 |
|
Additional paid-in capital |
|
|
360,594 |
|
|
|
352,999 |
|
Accumulated deficit |
|
|
(148,660 |
) |
|
|
(91,718 |
) |
Total stockholders’ equity |
|
|
211,966 |
|
|
|
261,313 |
|
Total liabilities and stockholders’ equity |
|
$ |
242,563 |
|
|
$ |
280,021 |
|
6