Full Press Release Details
Tempest and Millendo Announce Proposed Merger
- Transaction to advance Tempest's
targeted oncology pipeline -
- Concurrent $30M PIPE financing expected to
- Companies to host conference call today at
South San Francisco, CA, and Ann Arbor, Mich.
March 29, 2021 -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 Capital Partners, 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 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
PPAR , 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- , 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