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): November 27, 2023 |
Pyxis Oncology, Inc.
(Exact name of Registrant as Specified in Its Charter)
Delaware |
001-40881 |
83-1160910 |
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(State or Other Jurisdiction |
(Commission File Number) |
(IRS Employer |
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321 Harrison Avenue |
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Boston, Massachusetts |
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02118 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s Telephone Number, Including Area Code: 617-221-9059 |
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(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:
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Trading |
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Common Stock, par value $0.001 per share |
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PYXS |
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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. ☒ On November 28, 2023, Pyxis Oncology, Inc. (the “Company”) announced the appointment of Ken Kobayashi, M.D., F.A.C.P, as Chief Medical Officer, effective as of November 27, 2023 (the “Effective Date”).
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Chief Medical Officer
Dr. Kobayashi, age 63, brings extensive leadership experience in oncology clinical development and regulatory affairs. Dr. Kobayashi has a deep background as a clinician-scientist, regulator, scientific diplomat, and drug developer across the US, Europe, Latin America, and Japan/Asia. From September 2022 until joining the Company, Dr. Kobayashi served as President at Small Woods Biopharma Consulting, LLC. Additionally, from June 2021 to September 2022, Dr. Kobayashi served as Senior Vice President, Clinical Development, at Kinnate Biopharma (Nasdaq: KNTE), a precision oncology company focused on the discovery, design and development of small molecule kinase inhibitors for difficult-to-treat, genomically defined cancers. Additionally, from March 2019 to June 2021, Dr. Kobayashi served as Vice President, Early Oncology Development and Clinical Research, at Pfizer (NYSE: PFE), a pharmaceutical company. Additionally, from October 2016 to March 2019, Dr. Kobayashi served as Executive Director, Global Oncology Research and Development, at Daiichi Sankyo, Inc. (TSE: DSNKY), a pharmaceutical company. As a senior executive in top-tier pharmaceutical companies, including Pfizer, Daiichi Sankyo, AstraZeneca, Janssen, and Novartis, Dr. Kobayashi has successfully overseen the introduction of more than 28 investigational agents into the clinic and has been directly involved with 60 programs across multiple solid tumor and hematologic malignancy indications, including small molecules, antibody-drug conjugates (“ADCs”), monoclonal antibodies, and tumor vaccines. He has early and late-stage experience, including filing and regulatory review of both investigational new drugs (“INDs”), and new drug applications (“NDAs”). His experience also includes roles at the National Cancer Institute and the Food and Drug Administration. Dr. Kobayashi holds an AB from Washington University in St. Louis, Missouri and a M.D. from Northwestern University Medical School in Chicago, Illinois.
There are currently no arrangements or understandings between Dr. Kobayashi and any other person pursuant to which Dr. Kobayashi will be appointed as Chief Medical Officer of the Company and there are no family relationships between Dr. Kobayashi and any of the Company’s directors or executive officers. There are currently no transactions in which Dr. Kobayashi has an interest requiring disclosure under Item 404(a) of Regulation S-K.
In connection with his appointment as Chief Medical Officer, Dr. Kobayashi entered into an employment agreement with the Company (the “Employment Agreement”) effective as of the Effective Date. Pursuant to the Employment Agreement, Dr. Kobayashi will be paid an annual base salary of $500,000. Following the end of each calendar year, Dr. Kobayashi will be eligible to receive a discretionary annual performance bonus with a target of 40% of his then annual base salary based upon the Board of Directors’ assessment of the Company’s achievement of its performance goals and Dr. Kobayashi’s continued employment with the Company.
Under the terms of the Employment Agreement, in the event that Dr. Kobayashi is terminated by the Company for any reason other than for “Cause” or he terminates his employment for “Good Reason” (each as defined in the Employment Agreement), he will be entitled to receive, upon execution and effectiveness of a release of claims, base salary for a period of nine (9) months and up to nine (9) months of continued health insurance coverage at the Company’s expense.
As an inducement to Dr. Kobayashi's employment, the Company will grant Dr. Kobayashi an option to purchase 1.25% of the Company’s common stock outstanding as of the Effective Date (the "Inducement Grant"). The stock options have a ten-year term. Subject to the approval of the Company’s Board of Directors or it’s Compensation Committee, the Inducement Grant will be granted on or before January 1st, 2024, at the fair market value as determined on the date of the grant based on the closing price of the Company’s common stock on The Nasdaq Global Market. The option to purchase 1.00% of the Company’s common stock outstanding will vest over four years with 25% vesting on the first anniversary of the Effective Date and the remaining shares vesting monthly over the 36-month period thereafter, subject to continued employment with the Company through the applicable vesting dates. The remaining option to purchase 0.25% of the Company’s common stock outstanding will vest upon Dr. Kobayashi’s achievement of negotiated milestones. The Inducement Grant will be issued pursuant to the Company’s 2022 Inducement Plan, and in accordance with Nasdaq Listing Rule 5635(c)(4).
The foregoing summary of certain terms of the Employment Agreement are qualified in their entirety by the terms of the Employment Agreement, a copy of which is attached to this Current Report on Form 8-K as Exhibit 10.1.
In addition, Dr. Kobayashi will enter into an indemnification agreement with the Company, the form of which was filed with the Securities and Exchange Commission (the "SEC") as Exhibit 10.2 to the Company’s Registration Statement on Form S-1/A (File No. 333-259627) on October 4, 2021, pursuant to which the Company may be required, among other things, to indemnify Dr. Kobayashi for certain expenses (including reasonable attorneys’ fees), judgments, fines, penalties, excise taxes and settlement amounts actually and reasonably incurred by his in any action or proceeding arising out of his service as an officer of the Company.
A copy of the Company’s press release announcing Dr. Kobayashi’s appointment as Chief Medical Officer attached hereto as Exhibit 99.1 and shall be deemed furnished and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) 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 |
10.1*^+ |
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Employment Agreement between Pyxis Oncology, Inc. and Ken Kobayashi, M.D. |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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Portions of this exhibit have been redacted in accordance with Item 601(b)(10) of Regulation S-K. The omitted information is not material and is the type that the registrant treats as private or confidential. |
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Certain of the exhibits and schedules to this exhibit have been omitted in accordance with Regulation S-K Item 601(a)(5). The Registrant agrees to furnish a copy of all omitted exhibits and schedules to the SEC upon its request. |
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Indicates management contract or compensatory plan. |
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 28, 2023 |
By: |
/s/ Pamela Connealy |
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Pamela Connealy |
Exhibit 10.1
[***] CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN EXCLUDED PURSUANT TO REGULATION S-K, ITEM 601(B)(10). SUCH EXCLUDED INFORMATION IS BOTH NOT MATERIAL AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
Pyxis Oncology, Inc.
November 21, 2023
Via Email Only
Ken Kobayashi [***]
RE: EXECUTIVE EMPLOYMENT AGREEMENT
Dear Dr. Kobayashi:
On behalf of Pyxis Oncology, Inc. (“Pyxis”, or the “Company”), it is my pleasure to confirm the terms and conditions of your employment as Pyxis’s Chief Medical Officer, with such duties and responsibilities as commensurate with such position, as disclosed in the position description and as directly by the Company or the Board. You shall report during your employment to the Company’s Chief Executive Officer (the “CEO”), commencing on November 27, 2023 (the “Start Date”). During your employment with Pyxis, you will devote substantially all of your professional efforts to the business of Pyxis, except that you may engage in the business activities described on Appendix A of this employment agreement (this “Agreement”), and other activities that may be approved in advance by the Company’s Chief Executive Officer, with advice from the Board (which together with the activities set forth on Appendix A may include one for-profit board membership(s)), in each case, so long as these activities do not interfere or conflict with your obligations to the Company. Your employment under the terms of this Agreement shall continue until it terminates in accordance with Section 5 below.
This Agreement supersedes, amends, and restates in all respects all prior agreements and understandings between you and the Company regarding the subject matter herein.
This Agreement is intended to summarize some of the terms and conditions of your employment.
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The remaining Initial Options to purchase 0.25% of the Pyxis’s common stock outstanding will vest upon your achievement of negotiated milestone, which we expect to finalize immediately after commencement of your employment with the Company and prior to actual grant of stock options. In the event of a conflict between the terms of this Agreement and the terms of the 2022 Inducement Plan and the underlying Stock Option Agreement, the terms of the 2022 Inducement Plan and the Stock Option Agreement shall prevail.
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would cause you to incur any additional tax or interest under Code Section 409A and Pyxis concurs with such belief or Pyxis independently makes such determination, Pyxis shall, after consulting with you, reform such provision to try to comply with Code Section 409A through good faith modifications to the minimum extent reasonably appropriate to conform with Code Section 409A. To the extent that any provision hereof is modified in order to comply with Code Section 409A, such modification shall be made in good faith and shall, to the maximum extent reasonably possible, maintain the original intent and economic benefit to you and Pyxis of the applicable provision without violating the provisions of Code Section 409A.
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The costs of obtaining such determination and all related fees and expenses (including related fees and expenses incurred in any later audit) shall be borne by Pyxis. Notwithstanding the foregoing, if (i) Pyxis is not publicly traded prior to the occurrence of a change in control such that the private company exception pursuant to Q & A #7 of the regulations promulgated under Section 280G of the Code is applicable and (ii) you request that Pyxis seek shareholder approval of the portion of any payments to be made to you which are parachute payments under Section 280G and exceed 2.99 times your “base amount” (as such term is defined in Section 280G) in order that, upon obtaining such approval, all of the payments will be exempt from the excise taxes imposed under Sections 280G and 4999 of the Code, Pyxis shall use its reasonable best efforts to obtain such approval.
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If the foregoing is acceptable, please indicate your agreement by signing below and returning the original signed Agreement (keeping a copy for your own records) to me on or before November 27, 2023. If you have any further questions or require additional information, please feel free to contact me.
Sincerely,
PYXIS ONCOLOGY, INC.
By: |
/s/ Lara Sullivan |
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Lara S. Sullivan, M.D. |
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President & Chief Executive Officer |
ACCEPTED AND AGREED:
By: |
/s/ Ken Kobayashi |
Date: |
11/21/2023 |
Appendices:
Appendix A - |
Approved Activities |
Appendix B - |
Separation Agreement and General Release |
Appendix C - |
Proprietary Information, Inventions and Non-Solicitation Agreement |
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Exhibit 99.1
Pyxis Oncology Announces Appointment of Ken Kobayashi, M.D., F.A.C.P as Chief Medical Officer
November 28, 2023
Dr. Kobayashi brings over 25 years of experience in oncology drug development, including Antibody Drug Conjugates (ADCs) and other oncology modalities
BOSTON, Nov. 28, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced the appointment of Ken Kobayashi, M.D., F.A.C.P, as Chief Medical Officer (CMO), effective November 27, 2023. Dr. Kobayashi brings extensive leadership experience in oncology clinical development and regulatory affairs. As CMO, Dr. Kobayashi will lead the Company’s clinical and regulatory operations, drive strategic growth, and play a key role in advancing Pyxis Oncology’s clinical pipeline.
“I am thrilled to welcome Ken to the Pyxis Oncology team, and I look forward to working closely with him to advance our clinical programs,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “Ken’s depth and breadth of experience in oncology drug development will be invaluable as we work to bring forward new therapies to patients.”
Dr. Kobayashi has a deep background as a clinician-scientist, regulator, scientific diplomat, and drug developer across the US, Europe, Latin America, and Japan/Asia. Most recently, he served as Senior Vice President, Clinical Development at Kinnate Biopharma. As a senior executive in top-tier pharmaceutical companies, including Pfizer, Daiichi Sankyo, AstraZeneca, Janssen, and Novartis, he has successfully overseen the introduction of more than 28 investigational agents into the clinic and has been directly involved with 60 programs across multiple solid tumor and hematologic malignancy indications, including small molecules, ADCs, monoclonal antibodies, and tumor vaccines. He has early and late-stage experience, including filing and regulatory review of both INDs and NDAs. His experience also includes roles at the National Cancer Institute and the Food and Drug Administration. Dr. Kobayashi received his M.D. from Northwestern University Medical School, Chicago, IL, and his AB from Washington University, St. Louis, MO.
“Pyxis Oncology has an exciting clinical pipeline and is advancing a first-in-class and first-in-concept ADC against the stromal EDB-fibronectin target, which could have a significant impact on patients with difficult-to-treat tumors, as targets in the stroma have been overlooked to date as an area of focus in the industry,” said Dr. Kobayashi. “I am excited about the potential for the PYX-201 program, and I look forward to working with the Company’s experienced team of drug developers in this important phase of Pyxis Oncology.”
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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 mono and combination therapies. 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. Pyxis Oncology’s antibody-drug conjugates (ADCs) and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit www.pyxisoncology.com or follow us on 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 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, Pyxis Oncology’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, Pyxis Oncology’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 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
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