– Transaction to advance Tempest’s targeted
oncology pipeline –
- Concurrent $30M PIPE financing expected to
close with merger -
- Companies to host conference call today at
8:30 a.m. ET -
Tempest Therapeutics, Inc. (“Tempest”), a privately-held
clinical-stage oncology company developing potentially
first-in-class therapeutics that combine both targeted and
immune-mediated mechanisms, and Millendo Therapeutics, Inc.
(Nasdaq: MLND) (“Millendo”), announced today that they have entered
into a definitive agreement under which Millendo will merge with
Tempest in an all-stock transaction. The combined company will
focus on advancing Tempest’s oncology pipeline of small molecule
therapeutics that have the potential to address a wide range of
tumors. Upon shareholder approval, the combined company is expected
to operate under the name Tempest Therapeutics and trade on the
Nasdaq Capital Market under the ticker symbol TPST.
In support of the merger, Tempest has secured commitments from a
premier syndicate of healthcare investors comprised of Versant
Ventures, Rock Springs Capital, F-Prime Capital, Monashee
Investment Management, Quan Capital, Lyfe Capital, Maven Investment
Partners US, Lilly Asia Ventures and Eight Roads Ventures for a $30
million PIPE financing that is expected to close concurrent with
the completion of the merger. Together with the cash expected from
both companies at closing, the net proceeds of the merger and
financing are expected to fund the further development of Tempest’s
three oncology programs and operate the company into early 2023.
The financing and merger are expected to close in the first half of
2021.
“We are very pleased to announce this proposed merger with
Millendo Therapeutics, which will facilitate the advancement of our
broad pipeline of targeted oncology programs, including TPST-1495
and TPST-1120, which are both progressing in the clinic with
encouraging early signs of clinical benefit,” said Tom Dubensky,
Ph.D., chief executive officer of Tempest. “Together with our
recently announced clinical collaboration with Roche to investigate
TPST-1120 in a randomized frontline hepatocellular carcinoma study,
this has been a highly productive quarter for Tempest that sets the
stage for additional potential catalysts from our proprietary
oncology programs. The transition of Tempest to a public company
enhances our ability to fund these potentially important product
candidates, as well as consider additional programs with exciting
new targets.”
Tempest’s oncology pipeline is led by two clinical programs,
TPST-1495 and TPST-1120, with broad potential across multiple tumor
types. TPST-1495 is an antagonist selective for two receptors in
the prostaglandin (PGE2) pathway, EP2 and EP4, which promote both
tumor growth and the proliferation of suppressive immune cell
populations. Tempest is currently evaluating the safety,
tolerability, pharmacokinetics, pharmacodynamics, and preliminary
anti-tumor activity of TPST-1495 in a multicenter Phase 1a/1b dose
and schedule optimization study in patients with advanced solid
tumors, with a focus on known prostaglandin-driven tumors such as
colorectal cancer, lung adenocarcinoma and urothelial cancer.
Tempest expects to report topline data from this study prior to the
end of 2021, as well as data from planned monotherapy dose
expansion and combination studies in 2022. TPST-1120 is designed to
be a selective antagonist of proliferator-activated receptor alpha
(PPAR⍺) which is a transcription factor that regulates the
expression of target genes that promote angiogenesis and enable a
cellular metabolic pathway known as fatty acid oxidation. TPST-1120
has completed monotherapy dose escalation and is progressing
through a combination dose escalation study with nivolumab. This
summer, Tempest expects F. Hoffmann-La Roche Ltd to initiate a
global, randomized Phase 1b/2 clinical study in combination with
the standard-of-care first-line regimen of atezolizumab and
bevacizumab in patients with advanced or metastatic HCC not
previously treated with systemic therapy, pursuant to a recently
announced collaboration between the companies. Tempest expects to
report topline data from this study by year-end 2022.
“Millendo Therapeutics’ strategic review was a thorough and
thoughtful process. We believe we have found a partner that offers
not only the greatest value for our existing shareholders but also
promising targeted oncology product candidates for patients living
with cancer,” said Louis Arcudi, chief executive officer of
Millendo.
About the Proposed Merger
Millendo stockholders are expected to own approximately 18.5% of
the combined company and pre-merger Tempest stockholders will own
approximately 81.5% of the combined company. The percentage of the
combined company that Millendo’s stockholders will own as of the
close of the transaction is subject to adjustment based on the
amount of Millendo’s net cash at the closing date.
Upon closing of the transaction, Millendo will be renamed
Tempest Therapeutics, Inc. and will be headquartered in South San
Francisco, CA. Stephen Brady and Tom Dubensky, Ph.D., will serve as
chief executive officer and president, respectively, of the
combined company. The merger agreement provides that the Board of
Directors of the combined company will be comprised of seven
members. The merger agreement has been approved by the Board of
Directors of each company, and the transaction is expected to close
in the first half of 2021, subject to approvals by the stockholders
of each company, the effectiveness of a registration statement
filed with the U.S. Securities and Exchange Commission to register
the shares of Millendo common stock to be issued in connection with
the merger, the completion of a PIPE financing, and other customary
closing conditions.
SVB Leerink is serving as the exclusive financial advisor to
Millendo and WilmerHale is serving as legal counsel. Piper Sandler
is serving as the exclusive financial advisor to Tempest and Sidley
Austin is serving as legal counsel.
Conference Call Information
Millendo and Tempest will host a conference call today, March
29, 2021, at 8:30 a.m. ET, to discuss the merger. The conference
call may be accessed by dialing 1-(678) 302-3550 or 1-(866)
939-3921 internationally and referencing conference ID number
50135737. A live webcast of the presentation will be available on
the Investors & Media section of Millendo’s website at
http://investors.millendo.com and Tempest’s website at
www.tempesttx.com. A replay of the webcast will be archived on both
company’s websites for 30 days following the presentation.
About Millendo Therapeutics, Inc.
Millendo Therapeutics is a biopharmaceutical company previously
primarily focused on developing novel treatments for endocrine
diseases where current therapies do not exist or are insufficient.
Millendo seeks to create distinct and transformative treatments
where there is a significant unmet medical need. For more
information, please visit www.millendo.com.
About Tempest Therapeutics
Tempest Therapeutics is a clinical-stage oncology company
advancing small molecules that combine both targeted and
immune-mediated mechanisms with the potential to treat a wide range
of tumors. The company’s two novel clinical programs are TPST-1495
and TPST-1120, antagonists of EP2/EP4 and PPARα, respectively. Both
TPST-1495 and TPST-1120 are advancing through Phase 1 studies
designed to study both agents as monotherapies and in combination
with other approved agents. Tempest is also developing an inhibitor
of TREX-1, a double-stranded DNA exonuclease that is designed to
control activation of the cGAS/STING pathway, which is an innate
immune response pathway that induces the production of IFN-β, a
cytokine that is well-established to trigger the development of
anti-tumor immunity. Oral delivery of a TREX-1 small molecule
inhibitor is intended to selectively activate STING in tumors,
leading to anti-tumor immunity. Tempest is headquartered in South
San Francisco and supported by notable healthcare investors. More
information about Tempest can be found on the company’s website at
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 (the “Securities Act”)) concerning
Millendo, Tempest, the proposed transaction and other matters.
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 Millendo, as well as assumptions made by, and information
currently available to, management of Millendo. 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,” “expect,”
“anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,”
“intend,” and other similar expressions. Statements that are not
historical facts are forward-looking statements. Forward-looking
statements are based on current beliefs and assumptions that are
subject to risks and uncertainties and are not guarantees of future
performance. Actual results could differ materially from those
contained in any forward-looking statement as a result of various
factors, including, without limitation: the risk that the
conditions to the closing of the transaction are not satisfied,
including the failure to obtain stockholder approval for the
transaction or to complete the financing in a timely manner or at
all; uncertainties as to the timing of the consummation of the
transaction and the ability of each of Millendo and Tempest to
consummate the transaction, including the PIPE financing; risks
related to Millendo’s continued listing on the Nasdaq Stock Market
until closing of the proposed transaction; risks related to
Millendo’s and Tempest’s ability to correctly estimate their
respective operating expenses and expenses associated with the
transaction, as well as uncertainties regarding the impact any
delay in the closing would have on the anticipated cash resources
of the combined company upon closing and other events and
unanticipated spending and costs that could reduce the combined
company’s cash resources; the ability of Millendo or Tempest to
protect their respective intellectual property rights; competitive
responses to the transaction; unexpected costs, charges or expenses
resulting from the transaction; potential adverse reactions or
changes to business relationships resulting from the announcement
or completion of the transaction; and legislative, regulatory,
political and economic developments. The foregoing review of
important factors that could cause actual events to differ from
expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and
elsewhere, including the risk factors included in Millendo’s most
recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q
and Current Reports on Form 8-K filed with the SEC. Millendo can
give no assurance that the conditions to the transaction will be
satisfied. Except as required by applicable law, Millendo
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.
No Offer or Solicitation
This press release is not intended to and does not constitute an
offer to sell or the solicitation of an offer to subscribe for or
buy or an invitation to purchase or subscribe for any securities or
the solicitation of any vote in any jurisdiction pursuant to the
proposed transaction or otherwise, nor shall there be any sale,
issuance or transfer of securities in any jurisdiction in
contravention of applicable law. No offer of securities shall be
made except by means of a prospectus meeting the requirements of
the Securities Act. Subject to certain exceptions to be approved by
the relevant regulators or certain facts to be ascertained, the
public offer will not be made directly or indirectly, in or into
any jurisdiction where to do so would constitute a violation of the
laws of such jurisdiction, or by use of the mails or by any means
or instrumentality (including without limitation, facsimile
transmission, telephone and the internet) of interstate or foreign
commerce, or any facility of a national securities exchange, of any
such jurisdiction.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transaction between Millendo and
Tempest, Millendo intends to file relevant materials with the SEC,
including a registration statement on Form S-4 that will contain a
proxy statement/prospectus of Millendo and information statement of
Tempest. MILLENDO URGES INVESTORS AND STOCKHOLDERS TO READ THESE
MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT
MILLENDO, TEMPEST, THE PROPOSED TRANSACTION AND RELATED MATTERS.
Investors and shareholders will be able to obtain free copies of
the proxy statement/prospectus/information statement and other
documents filed by Millendo with the SEC (when they become
available) through the website maintained by the SEC at
www.sec.gov. In addition, investors and shareholders will be able
to obtain free copies of the proxy statement/prospectus/information
statement and other documents filed by Millendo with the SEC by
contacting Stern IR. Investors and stockholders are urged to read
the proxy statement/prospectus/information statement and the other
relevant materials when they become available before making any
voting or investment decision with respect to the proposed
transaction.
Participants in the Solicitation
Millendo and its directors and executive officers may be deemed
to be participants in the solicitation of proxies in connection
with the proposed transaction. Information about Millendo’s
directors and executive officers is included in Millendo’s most
recent Annual Report on Form 10-K, including any information
incorporated therein by reference, as filed with the SEC, and the
proxy statement for Millendo’s 2020 annual meeting of stockholders,
filed with the SEC on April 24, 2020. Additional information
regarding these persons and their interests in the transaction will
be included in the proxy statement/prospectus/information statement
relating to the transaction when it is filed with the SEC. These
documents can be obtained free of charge from the sources indicated
above.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210329005356/en/
Millendo Investor Contact: Jack Hildick-Smith Stern
Investor Relations 212-698-8690 Jack.Hildick-Smith@Sternir.com
Millendo Media Contact: Julie Bane MacDougall
617-821-1089 jbane@macbiocom.com
Tempest Investor Contacts: Sylvia Wheeler Wheelhouse Life
Science Advisors swheeler@wheelhouselsa.com
Alex Santos Wheelhouse Life Science Advisors
asantos@wheelhouselsa.com
Millendo Therapeutics (NASDAQ:MLND)
Historical Stock Chart
From Nov 2024 to Dec 2024
Millendo Therapeutics (NASDAQ:MLND)
Historical Stock Chart
From Dec 2023 to Dec 2024
