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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):
September 22, 2026
Tempest Therapeutics, Inc.
(Exact name of Registrant as Specified in Its
Charter)
| Delaware |
|
001-35890 |
|
45-1472564 |
(State or Other Jurisdiction
of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
| 2000 Sierra Point Parkway, Suite 400 |
|
|
| Brisbane, California |
|
94005 |
| (Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including
Area Code: (415)
798-8589
(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:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on
which registered |
| Common Stock, $0.001 par value |
|
TPST |
|
The Nasdaq Stock Market LLC |
| Series A Junior Participating Preferred Purchase Rights |
|
N/A |
|
The Nasdaq Stock Market LLC |
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 1.01 Entry into a Material Definitive Agreement.
On September 22, 2026, Tempest Therapeutics, Inc. (“Tempest”)
entered into a Master Services Agreement (the “MSA”) with Factor Bioscience Inc. (“Factor”). The MSA establishes
the terms under which Factor will provide research and development services requested by Tempest pursuant to mutually agreed work orders.
The MSA supports Tempest’s development activities, including its obligations under the Amended and Restated License and Collaboration
Agreement between Tempest and Factor Bioscience Limited, Factor’s Irish subsidiary, dated November 19, 2025 and effective as of
August 6, 2025. Concurrently with the MSA, Tempest and Factor entered into Work Order No. 1, relating to the development of in vivo
CAR-T therapies.
The MSA continues until terminated by either party upon 30 days’
prior written notice. Work Order No. 1 may similarly be terminated by either party upon at least 30 days’ prior written notice.
Work orders that remain in effect when the MSA is terminated will continue to be governed by the MSA until their expiration or termination.
Tempest may also suspend the services under Work Order No. 1 for one calendar month by providing at least 14 days’ prior written
notice before the end of the then-current calendar month. Tempest may exercise this suspension right up to three times and remains responsible
for services performed and authorized, non-cancellable costs and expenses incurred in connection with the suspended services.
Dr. Matt Angel, Ph.D., Tempest’s
President and Chief Executive Officer and a member of its Board of Directors (the “Board”), is the majority owner, Chief Executive Officer, and
chairman of Factor Bioscience LLC. Factor is a wholly-owned subsidiary of Factor Bioscience LLC. As of May 28, 2026, Dr. Angel owned
34.2% of the outstanding shares of common stock of Tempest, which includes shares of common stock held by Factor. As the majority
stockholder and Chairman of the Board of Directors of Factor, Dr. Angel exercises voting and investment power over the shares held
by Factor Biosciences Inc.
Because Factor is a related person, the
Board and its Audit Committee believe that the MSA constitutes a related person transaction under the Company’s Related Party
Transaction Policy. The MSA was reviewed and approved by the Audit Committee with Dr. Angel not
participating in the deliberations or vote. In evaluating the MSA, the Audit Committee considered, among other factors, whether the
terms are no less favorable to the Company than terms generally available from an unaffiliated third party under the same or similar
circumstances.
The Company currently expects that aggregate fees payable to Factor
under the MSA will be $5.0 million per year, payable in equal monthly installments of $416,667, subject to proration for the first and
last months of service. Tempest will additionally reimburse Factor for materials, equipment, reagents and third-party services incurred
in furtherance of the services or on Tempest’s behalf, together with a 10% project management fee on those amounts. Factor is obliged
to provide quarterly reports summarizing the services performed.
The foregoing description is only a summary and is qualified in its
entirety by reference to the full text of the agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and
incorporated by reference herein.
Item 5.02 Departure of Directors or Certain Officers; Election
of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Appointment of Director and Chair of Audit Committee
Effective September 22, 2026, the Board appointed Ms. Nancy Freda-Smith
as Class III director to fill a vacancy on the Board. Ms. Freda-Smith will serve until the Company’s 2027 annual meeting of stockholders
and until her successor is duly elected and qualified, or until her earlier death, resignation or removal. Ms. Freda-Smith has been appointed
to serve as the Chair of the Audit Committee.
Nancy Freda-Smith, age 54, served as the
Chief Audit Executive and Global Head of Asset Protection at Ralph Lauren Corporation, a global leader in the design, marketing, and
distribution of premium lifestyle products from 2017 to August 2026. At Ralph Lauren, she led various strategic functions, including
internal audit, enterprise risk management, and asset protection where her primary responsibility is to identify and assess key
business risks relating to cybersecurity, internal controls, and business continuity. From 2011 to 2017, Ms. Freda-Smith also served
in various vice president positions at Ralph Lauren. She has also served as an Independent Director and Audit Committee Member of
Chuy’s Holdings, providing oversight during its acquisition by Darden Restaurants. Earlier in her career, she was a Managing
Director at Deloitte providing accounting, audit and business-advisory services working in the New York Metro and London offices,
from September 1994 until November 2011. Ms. Freda-Smith is a Certified Public Accountant as well as a Certified Fraud Examiner. She
holds a Bachelor of Science in Accounting from Boston College. The board concluded that Ms. Freda-Smith should serve as a director
based upon her experience as an executive and her extensive professional accounting, financial and risk management expertise.
As a non-employee director, Ms. Freda-Smith
will be compensated in accordance with the Company’s Non-Employee Director Compensation Policy. Pursuant to the
Company’s Non-Employee Director Compensation Policy, Ms. Freda-Smith will receive compensation in connection with her service
as a non-employee director, including an initial option award to purchase 25,000 shares of the Company’s common stock under
the Company’s 2023 Equity Incentive Plan, subject to the terms and conditions of the applicable award agreement and the
Compensation Policy. Ms. Freda-Smith has entered into the Company’s standard form of indemnification agreement, the form of
which was previously filed by the Company.
There are no arrangements or understandings between Ms. Freda-Smith
and any other person pursuant to which she was appointed as a director of the Company, there are no family relationships between Ms. Freda-Smith
and any of the Company’s directors or executive officers, and there are no transactions involving Ms. Freda-Smith requiring disclosure
under Item 404(a) of Regulation S-K.
Previously, on May 22, 2026, Nasdaq had notified the Company that,
as a result of resignations from the Board, the Company was no longer in compliance with the Nasdaq Listing Rules due to more than one
vacancy on its Board and board committees. As a result, Nasdaq advised the Company that it was not eligible for the cure periods set forth
in Nasdaq Listing Rules 5605(b)(1)(A) and 5605(c)(4) and that the Company is required to submit a plan of compliance within the timeframe
prescribed by Nasdaq.
Following the appointment of Ms. Freda-Smith, as well as the prior
appointments of Dr. Yee and Mr. Richey on June 4, 2026, the Board has reconstituted its membership and committees as part of its efforts
to regain compliance with the applicable Nasdaq Listing Rules, and believes it is now in full compliance with the applicable Nasdaq requirements
related to its Board.
Departure of Chief Financial Officer and Principal Financial Officer
On September 22, 2026, Mr. Nicholas Rossettos confirmed to Tempest
Therapeutics, Inc. (the “Company”) that he would be resigning from his position as Chief Financial Officer of the Company
and from any and all other positions he holds with the Company, effective immediately.
Appointment of Principal Financial and Accounting Officer
On September 22, 2026, the Board of
Directors of the Company (the “Board”) appointed Ms. Constance Ames as Chief Financial Officer Principal Financial and
Accounting Officer, Treasurer, and Corporate Secretary of the Company, effective immediately.
Ms. Ames is an experienced financial executive
with more than 15 years of experience working with public and private biopharma companies. Since 2017, she has been an independent consultant
assisting companies with corporate finance and accounting services. Prior to consulting, from February 2015 to August 2017, Ms. Ames was
the Vice President of Finance at Axsome Therapeutics, Inc., where she was instrumental in the company’s initial public offering
and other financings. From November 2010 to February 2015, she served in a variety of positions at Keryx Biopharmaceuticals, Inc., where
she played a critical role in growing the finance and accounting department through Keryx’s transition from a development-stage
company to a fully integrated commercial organization. Prior to joining Keryx, Ms. Ames started her career in public accounting at Deloitte
and Touche, LLP. Ms. Ames received a B.S. in Accounting from Ithaca College.
Ms. Ames will enter into the Company’s standard form of indemnification
agreement, the form of which was previously filed by the Company.
There are no family relationships between Ms. Ames and any of the Company’s
directors or executive officers, and there are no arrangements or understandings between Ms. Ames and any other person pursuant to which
she was appointed as an officer of the Company and designated as its Principal Financial and Accounting Officer. There are no transactions
involving Ms. Ames requiring disclosure under Item 404(a) of Regulation S-K.
Item 7.01. Regulation FD Disclosure.
On September 23, 2026, the Company issued a press release entitled
“Tempest Appoints Global Finance Leader Nancy Freda-Smith to Board of Directors.” A copy of the press release is furnished
as Exhibit 99.1 to this Current Report on Form 8-K.
The information furnished in this Item 7.01 (including Exhibit 99.1)
shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under
the Securities Act or the Exchange Act, except as expressly provided by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Number |
|
Description |
| 10.1 |
|
Master Services Agreement, dated September 22, 2026, between Factor Bioscience Inc. and Tempest Therapeutics, Inc. |
| |
|
|
| 99.1 |
|
Press Release, dated September 23, 2026, furnished herewith. |
| |
|
|
| 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 hereunto duly authorized.
| |
|
TEMPEST THERAPEUTICS, INC. |
| |
|
|
| Date: September 28, 2026 |
By: |
/s/ Matthew Angel |
| |
Name: |
Matthew Angel |
| |
Title: |
President and Chief Executive Officer |
Exhibit 99.1
Tempest Appoints Global Finance
Leader Nancy Freda-Smith to Board of Directors
September 23, 2026
Accomplished finance and enterprise
executive with over 20 years of global leadership in multinational and Fortune 500 companies
BRISBANE, Calif., Sept. 23, 2026 (GLOBE
NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing in
vivo CAR-T therapies designed to reset dysfunctional immunity in cancer and autoimmune disease, today announced that Nancy
Freda-Smith has been appointed to its board of directors and will serve as Chair of the Audit Committee.
“We are
delighted to welcome Nancy to our board,” said Matt Angel, Ph.D., President and Chief Executive Officer of Tempest. “As an
experienced board director and C-suite executive who has both led and advised global Fortune 500 companies, Nancy brings deep expertise
in corporate governance, global finance, enterprise risk management, and large-scale transformation. Her strategic and operational acumen,
along with experience spearheading financial and governance frameworks to support corporate objectives, will bring significant value to
Tempest.”
Ms. Freda-Smith is a seasoned public
company board director and senior finance and audit executive with more than 30 years of experience advancing corporate governance, financial
reporting, enterprise risk management, and regulatory compliance across global organizations. She most recently served as Chief Audit
and Risk Officer at Ralph Lauren where she led internal audit, Sarbanes-Oxley Act compliance, enterprise risk management, asset protection,
cybersecurity resilience, and global control transformation across operations spanning over 30 countries and more than $7 billion in revenue.
Previously, she served as an Independent Director and Audit Committee Member of Chuy’s Holdings, providing oversight during its
acquisition by Darden Restaurants, including M&A execution, cybersecurity response, SEC disclosure, and financial risk management.
Earlier, as Managing Director at Deloitte & Touche LLP, Ms. Freda-Smith advised Fortune 500 companies on SEC reporting, capital markets
transactions, complex U.S. GAAP and IFRS matters, and audit quality. Her clients included companies across the pharmaceutical and life
sciences sector among other industries. She is a Certified Public Accountant and Certified Fraud Examiner. Ms. Freda-Smith also holds
a Bachelor of Science in Accounting from Boston College.
Ms. Freda-Smith added, “Tempest’s
science and its differentiated approach to in vivo CAR-T are genuinely
compelling, and I’m encouraged by the company’s efforts to broaden its pipeline and strategic partnerships, creating additional avenues
for value creation. I look forward to bringing rigorous financial oversight and governance discipline to the board as Tempest works to
execute on this next chapter, and to supporting the team in pursuit of that potential.”
About Tempest Therapeutics
Tempest is a clinical-stage biotechnology
company developing next-generation in vivo CAR-T therapies for
cancer and autoimmune disease. Tempest’s lead product candidate, TPST-4003, combines a clinically supported dual-targeting CD19/BCMA
CAR structure with an advanced CD7-targeting delivery system to support broad immune reset across multiple indications. Tempest envisions
a world in which immune reset therapies bring safe, effective, and broadly accessible therapeutic options to patients in need. For additional
information, visit Tempest’s website at https://www.tempesttx.com.
Forward-Looking Statements
This press release
contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and
Section 27A of the Securities Act of 1933, as amended, concerning Tempest. These statements may discuss goals, intentions, and expectations
as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management
of Tempest, as well as assumptions made by, and information currently available to, management of Tempest. Forward-looking statements
generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words
such as “may,” “will,” “should,” “would,” “could”, “expect,” “anticipate,”
“plan,” “likely,” “believe,” “estimate,” “project,” “intend,”
“goal”, “suggest”, “target” and other similar expressions. All statements that are not historical
facts are forward-looking statements, including but not limited to, statements regarding: the potential applicability of Tempest’s
platform and product candidates across autoimmune and oncology indications; and Tempest’s ability to achieve its operational plans.
All forward-looking statements in this press release are based on Tempest’s current expectations, estimates and projections about
its industry as well as management’s current beliefs and expectations of future events only as of today and are subject to a number
of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such
forward-looking statements. These risks and uncertainties include, but are not limited to Tempest’s need for additional capital
to fund its planned programs and operations and to continue to operate as a going concern; unexpected safety or efficacy data observed
during preclinical or clinical trials; the possibility that results from prior clinical trials and preclinical studies may not necessarily
be predictive of future results; past results may not be indicative of future results; clinical trial site activation or enrollment rates
that are lower than expected; loss of key personnel; changes in expected or existing competition; changes in the regulatory environment;
risks relating to volatility and uncertainty in the capital markets for biotechnology companies; and unexpected litigation or other disputes.
These and other factors that may cause actual results to differ from those expressed or implied are discussed in greater detail in the
“Risk Factors” section of Tempest’s Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities
and Exchange Commission (“SEC”) on March 30, 2026, and in other documents filed by Tempest from time to time with the SEC.
Except as required by applicable law, Tempest undertakes no obligation to revise or update any forward-looking statement, or to make any
other forward-looking statements, whether as a result of new information, future events or otherwise. These forward-looking statements
should not be relied upon as representing Tempest’s views as of any date subsequent to the date of this press release and should
not be relied upon as prediction of future events. In light of the foregoing, investors are urged not to rely on any forward-looking statement
in reaching any conclusion or making any investment decision about any securities of Tempest.
Investor Contacts:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com