Combination will create a company with a
diverse product development pipeline led by a planned new global
Phase 2 clinical trial evaluating eganelisib in head and neck
squamous cell carcinoma (HNSCC)
Projected ~$100M cash balance of combined
company expected to fund operations through mid-2025 and to
clinical data over the next 12 to 24 months
Companies to host conference call and webcast
today at 8:00 a.m. ET
MEI Pharma, Inc. (Nasdaq: MEIP) (“MEI”), a clinical-stage
pharmaceutical company focused on advancing new therapies for
cancer, and Infinity Pharmaceuticals, Inc. (Nasdaq: INFI)
(“Infinity”), a clinical-stage biotechnology company developing
eganelisib, a first-in-class, oral, immuno-oncology macrophage
reprogramming drug candidate, announced today that the companies
entered into a definitive merger agreement for an all-stock
transaction forming a company combining the expertise and resources
of MEI and Infinity to advance a robust pipeline of three
clinical-stage oncology drug candidates. All three clinical-stage
development programs have the potential, in combination with
current therapies, to overcome known resistance mechanisms and
meaningfully improve patient outcomes.
The combined company’s clinical-stage oncology development
pipeline consists of three differentiated programs:
- Eganelisib, an oral immuno-oncology macrophage reprogramming
product candidate, which is planned to be evaluated in combination
with the PD-1 targeted checkpoint inhibitor pembrolizumab
(KEYTRUDA®) in patients with head and neck squamous cell carcinoma
(HNSCC);
- Voruciclib, an oral CDK9 inhibitor, currently being studied in
combination with venetoclax (VENCLEXTA®) in patients with
hematologic malignancies; and
- ME-344, a novel tumor selective mitochondrial inhibitor
targeting the OXPHOS pathway, to be evaluated in combination with
bevacizumab (AVASTIN®) in patients with relapsed colorectal
cancer.
“We are very excited to enter into this agreement with Infinity
given the strength of a combined organization that builds on each
company’s potential. The combined organization will have three
differentiated clinical-stage oncology assets, expected funding
into mid-2025 to reach clinical data in all three programs, and a
team with extensive oncology clinical development expertise. I
believe these ingredients place the merged organization in a strong
position to create value for all our stakeholders,” said Daniel
Gold, Ph.D., President and Chief Executive Officer of MEI Pharma.
“The new company’s lead program, eganelisib, has already been
tested in over 350 patients with demonstrated clinical activity in
multiple settings, including in combination therapy with immune
checkpoint inhibitors. Along with voruciclib and ME 344, this gives
us three promising clinical-stage programs that we believe have
significant potential to deliver improved therapeutic options for
patients.”
“With this planned merger, we are creating a company that is
well capitalized to advance a differentiated clinical-stage
therapeutic development pipeline leveraging an experienced drug
development and leadership team,” said Adelene Perkins, Chief
Executive Officer and Chair of Infinity. “With data supporting
multiple potential development paths for eganelisib, we have
prioritized head and neck cancer based on our ability to leverage
encouraging progression free survival data from this patient
population in MARIO-1. Unfortunately, head and neck cancer remains
an area of high unmet medical need with a relatively short PFS and
overall survival in patients treated with checkpoint inhibitor
monotherapy. Because of this, we prioritized the initiation of a
randomized, controlled Phase 2 clinical study combining eganelisib
with pembrolizumab in head and neck cancer patients which is
intended to demonstrate improved clinical benefit.”
“I am looking forward to leading the combined company which,
beyond the promising clinical-stage pipeline, leverages the
capabilities and resources of two organizations sharing a
commitment to developing new oncology therapeutics. The combined
company is built around extensive small molecule development
experience based on solid science and backed by promising data,”
said David Urso, J.D., Chief Operating Officer and General Counsel
of MEI Pharma, and the Chief Executive Officer of the combined
company upon closing of the merger. “At closing, the combined
company is projected to have a strong balance sheet of
approximately $100 million which is expected to fund planned
studies for our clinical candidates through mid-2025 with the
potential to deliver near and long-term value for patients and
shareholders.”
About the Combined Clinical Pipeline Drug Candidates
The combined company’s pipeline includes three differentiated,
clinical-stage, small molecule oncology therapeutic candidates:
- Eganelisib: A potential
first-in-class, oral, once-daily, immuno-oncology development
candidate that selectively inhibits phosphoinositide-3-kinase
gamma. Eganelisib has demonstrated encouraging clinical results and
tolerability across a broad range of solid tumors in over 350
patients, including head and neck squamous cell carcinoma (HNSCC),
metastatic triple-negative breast cancer (mTNBC), as well as
urothelial, ovarian and melanoma cancers. The combined company
plans to initiate in Q3 2023, subject to U.S. Food and Drug
Administration review, a global, randomized, controlled Phase 2
clinical trial of eganelisib plus pembrolizumab vs pembrolizumab
for the potential treatment of first line relapsed/metastatic head
and neck squamous cell carcinoma. The primary endpoint of the Phase
2 study will be overall survival. In the second half of 2024 we
plan to have initial data on safety and progression free
survival.
- Voruciclib: An orally administered
Cyclin-Dependent Kinase 9 (CDK9) inhibitor being clinically
investigated for hematological malignancies. CDK9 has important
functions in cell cycle regulation, including the modulation of two
therapeutic targets in cancer: myeloid leukemia cell
differentiation protein (MCL1) and the MYC proto-oncogene protein,
which regulate cell proliferation and growth. Voruciclib is
currently being evaluated in a Phase 1b trial exploring dose and
schedule in patients with acute myeloid leukemia (AML) and B-cell
malignancies as a single-agent and in combination with venetoclax.
The ongoing Phase 1b trial is expected to report initial results
from the combination regimen around the end of 2023.
- ME-344: A novel, parenteral, tumor
selective mitochondrial inhibitor drug candidate targeting the
OXPHOS pathway involved in the production of adenosine. Clinical
investigation of ME-344 is focused on use in combination with the
VEGF inhibitor bevacizumab (Avastin®). Data reported from an
investigator-initiated, multi-center, randomized study of ME-344 in
combination with the VEGF inhibitor bevacizumab (Avastin®)
demonstrated biologic activity supporting further clinical
investigation. Initiation of a Phase 1b trial is planned to
evaluate ME-344 plus bevacizumab in patients with relapsed
colorectal cancer in the first half of 2023. Data from the Phase 1b
trial to support opening enrollment in an expansion cohort are
expected to be reported around the end of 2023.
About the Proposed Merger
Under the terms of the merger agreement, Infinity will become a
wholly owned subsidiary of MEI Pharma. Pursuant to an exchange
ratio set forth in the merger agreement, the pre-merger MEI Pharma
shareholders are expected to own approximately 58.0% and pre-merger
Infinity shareholders are expected to own approximately 42.0% of
the outstanding equity of the combined company immediately
following the merger.
Subject to shareholder approval and the subsequent closing of
the merger, the combined company is expected to be renamed and
trade on the Nasdaq Stock Market. The combined company would be
headquartered in San Diego, California and led by a team with
extensive industry and oncology drug development expertise,
including David Urso, Chief Executive Officer, Robert Ilaria, Jr.,
M.D., Chief Medical Officer, and Stéphane Peluso, Ph.D., Chief
Scientific Officer. Daniel Gold, Ph.D., and Adelene Perkins, the
current chief executive officers of MEI and Infinity, respectively,
would serve on the Board of Directors of the combined company. The
Board of Directors is expected to be composed of eight members,
consisting of Mr. Norman C. Selby, currently Infinity’s Lead
Independent Director, who will Chair the Board, Mr. Urso, Dr. Gold,
Ms. Perkins, two additional members designated by MEI Pharma, one
additional member designated by Infinity and one member mutually
agreed upon by MEI Pharma and Infinity.
The merger agreement has been approved by the Boards of
Directors of both companies. The merger is expected to close in
mid-2023, subject to approvals by MEI Pharma and Infinity
shareholders, respectively, and other customary closing
conditions.
Torreya Capital, LLC is serving as financial advisor to MEI
Pharma, and Morgan, Lewis & Bockius LLP is serving as legal
counsel to MEI Pharma. Aquilo Partners, L.P. is serving as
financial advisor to Infinity, and WilmerHale is serving as legal
counsel to Infinity.
Conference Call and Webcast Information
MEI Pharma and Infinity Pharmaceuticals will host a conference
call and webcast today at 8:00 a.m. ET to discuss the merger. To
access the live call, please dial 1-833-974-2378 (United States) or
1-412-317-5771 (International). Please ask to join the MEI and
Infinity merger conference call.
The conference call will also be webcast live here, as well as
from the Events Calendar page in the Investors section of MEI
Pharma’s website at www.meipharma.com and the Events &
Presentations page in the Investors/Media section of Infinity’s
website at www.infi.com. All participants are encouraged to join 10
minutes prior to the start time. An archived version of the webcast
will be available on each company’s website for 30 days following
the event.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a pharmaceutical company
focused on developing potential new therapies for cancer. MEI
Pharma’s portfolio of drug candidates includes clinical stage
candidates with differentiated mechanisms of action intended to
address unmet medical needs and deliver improved benefit to
patients, either as standalone treatments or in combination with
other therapeutic options. For more information, please visit
www.meipharma.com. Follow us on Twitter @MEI_Pharma and on
LinkedIn.
About Infinity Pharmaceuticals
Infinity Pharmaceuticals, Inc. (Nasdaq: INFI) is a
clinical-stage biotechnology company developing eganelisib
(IPI-549), a potential first-in-class, oral, immuno-oncology
macrophage reprogramming therapeutic which is designed to address a
fundamental biologic mechanism of immune suppression in cancer in
multiple clinical studies. For more information on Infinity, please
refer to Infinity’s website at www.infi.com.
Important Information about the Merger and Where to Find
It
This communication relates to a proposed transaction between
Infinity Pharmaceuticals, Inc. (“Infinity”) and MEI Pharma, Inc.
(“MEI”). In connection with the proposed merger, MEI and Infinity
plan to file with the SEC a registration statement on Form S-4 that
will include a joint proxy statement of MEI and Infinity that also
constitutes a prospectus of Infinity. Each of MEI and Infinity also
plan to file other relevant documents with the SEC regarding the
proposed merger. Any definitive joint proxy statement/prospectus
regarding the proposed merger (as amended or supplemented from time
to time, the “Joint Proxy Statement/Prospectus”), if and when
available, will be mailed to stockholders of MEI and Infinity.
INVESTORS AND MEI’S AND INFINITY’S RESPECTIVE STOCKHOLDERS ARE
URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS IN ITS ENTIRETY
WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED BY EACH OF
MEI AND INFINITY WITH THE SEC IN CONNECTION WITH THE PROPOSED
MERGER OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED MERGER AND THE
PARTIES TO THE PROPOSED MERGER. Investors and stockholders will be
able to obtain a free copy of the Joint Proxy Statement/Prospectus
and other documents containing important information about MEI and
Infinity, once such documents are filed with the SEC, from the
SEC’s website at www.sec.gov. MEI and Infinity make available free
of charge at www.meipharma.com and www.infi.com, respectively (in
the “Investors” and “Investors/Media” sections, respectively),
copies of materials they file with, or furnish to, the SEC.
Participants in the Solicitation
MEI, Infinity and their respective directors, executive officers
and certain employees and other persons may be deemed to be
participants in the solicitation of proxies from the stockholders
of MEI and Infinity in connection with the proposed merger.
Securityholders may obtain information regarding the names,
affiliations and interests of MEI’s directors and executive
officers in MEI’s Annual Report on Form 10-K for the fiscal year
ended June 30, 2022, which was filed with the SEC on September 8,
2022, and its definitive proxy statement for the 2022 annual
meeting of stockholders, which was filed with the SEC on October
27, 2022. Securityholders may obtain information regarding the
names, affiliations and interests of Infinity’s directors and
executive officers in Infinity’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2021, which was filed with the SEC
on March 29, 2022, and its definitive proxy statement for the 2022
annual meeting of stockholders, which was filed with the SEC on
April 25, 2022. Additional information regarding the interests of
such individuals in the proposed merger will be included in the
Joint Proxy Statement/Prospectus relating to the proposed merger
when it is filed with the SEC. These documents (when available) may
be obtained free of charge from the SEC’s website at www.sec.gov,
MEI’s investor website at https://www.meipharma.com/investors and
Infinity’s investor website at https://investors.infi.com/.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor shall there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such jurisdiction.
No offering of securities shall be made except by means of a
prospectus meeting the requirements of Section 10 of the U.S.
Securities Act of 1933, as amended.
Cautionary Statement Regarding Forward-Looking
Statements
Certain statements contained in this filing may be considered
forward-looking statements within the meaning of the federal
securities law. Such statements are based upon current plans,
estimates and expectations of the management of MEI and Infinity
that are subject to various risks and uncertainties that could
cause actual results to differ materially from such statements. The
inclusion of forward-looking statements should not be regarded as a
representation that such plans, estimates and expectations will be
achieved. Words such as “anticipate,” “expect,” “project,”
“intend,” “believe,” “may,” “will,” “should,” “plan,” “could,”
“continue,” “target,” “contemplate,” “estimate,” “forecast,”
“guidance,” “predict,” “possible,” “potential,” “pursue,” “likely,”
and words and terms of similar substance used in connection with
any discussion of future plans, actions or events identify
forward-looking statements. All statements, other than historical
facts, including statements regarding: the expected timing of the
closing of the proposed merger; the ability of the parties to
complete the proposed merger considering the various closing
conditions; the expected benefits of the proposed merger, including
estimations of anticipated cost savings and cash runway; the
competitive ability and position of the combined company; the
potential, safety, efficacy, and regulatory and clinical progress
of the combined company’s product candidates, including the
anticipated timing for initiation of clinical trials and release of
clinical trial data and the expectations surrounding potential
regulatory submissions, approvals and timing thereof; the
sufficiency of the combined company’s cash, cash equivalents and
short-term investments to fund operations; and any assumptions
underlying any of the foregoing, are forward-looking statements.
Important factors that could cause actual results to differ
materially from MEI’s and Infinity’s plans, estimates or
expectations could include, but are not limited to: (i) the risk
that the proposed merger may not be completed in a timely manner or
at all, which may adversely affect MEI’s and Infinity’s businesses
and the price of their respective securities; (ii) uncertainties as
to the timing of the consummation of the proposed merger and the
potential failure to satisfy the conditions to the consummation of
the proposed merger, including obtaining stockholder and regulatory
approvals; (iii) the proposed merger may involve unexpected costs,
liabilities or delays; (iv) the effect of the announcement,
pendency or completion of the proposed merger on the ability of MEI
or Infinity to retain and hire key personnel and maintain
relationships with customers, suppliers and others with whom MEI or
Infinity does business, or on MEI’s or Infinity’s operating results
and business generally; (v) MEI’s or Infinity’s respective
businesses may suffer as a result of uncertainty surrounding the
proposed merger and disruption of management’s attention due to the
proposed merger; (vi) the outcome of any legal proceedings related
to the proposed merger or otherwise, or the impact of the proposed
merger thereupon; (vii) MEI or Infinity may be adversely affected
by other economic, business, and/or competitive factors; (viii) the
occurrence of any event, change or other circumstances that could
give rise to the termination of the merger agreement and the
proposed merger; (ix) restrictions during the pendency of the
proposed merger that may impact MEI’s or Infinity’s ability to
pursue certain business opportunities or strategic transactions;
(x) the risk that MEI or Infinity may be unable to obtain
governmental and regulatory approvals required for the proposed
merger, or that required governmental and regulatory approvals may
delay the consummation of the proposed merger or result in the
imposition of conditions that could reduce the anticipated benefits
from the proposed merger or cause the parties to abandon the
proposed merger; (xi) risks that the anticipated benefits of the
proposed merger or other commercial opportunities may otherwise not
be fully realized or may take longer to realize than expected;
(xii) the impact of legislative, regulatory, economic, competitive
and technological changes; (xiii) risks relating to the value of
MEI shares to be issued in the proposed merger; (xiv) the risk that
integration of the proposed merger post-closing may not occur as
anticipated or the combined company may not be able to achieve the
benefits expected from the proposed merger, as well as the risk of
potential delays, challenges and expenses associated with
integrating the combined company’s existing businesses; (xv)
exposure to inflation, currency rate and interest rate
fluctuations, as well as fluctuations in the market price of MEI’s
and Infinity’s traded securities; (xvi) the impact of the COVID-19
pandemic on MEI’s and Infinity’s industry and individual companies,
including on counterparties, the supply chain, the execution of
clinical development programs, access to financing and the
allocation of government resources; (xvii) final data from
pre-clinical studies and completed clinical trials may differ
materially from reported interim data from ongoing studies and
trials; (xviii) costs and delays in the development and/or U.S.
Food and Drug Administration (“FDA”) approval, or the failure to
obtain such approval, of the combined company’s product candidates;
(xix) uncertainties or differences in interpretation in clinical
trial results; (xx) the combined company’s inability to maintain or
enter into, and the risks resulting from dependence upon,
collaboration or contractual arrangements necessary for the
development, manufacture, commercialization, marketing, sales and
distribution of any product candidates; and (xxi) the ability of
MEI or Infinity to protect and enforce intellectual property
rights; and (xxii) the unpredictability and severity of
catastrophic events, including, but not limited to, acts of
terrorism or outbreak of war or hostilities, as well as MEI’s and
Infinity’s response to any of the aforementioned factors.
Additional factors that may affect the future results of MEI and
Infinity are set forth in their respective filings with the United
States Securities and Exchange Commission (the “SEC”), including
each of MEI’s and Infinity’s most recently filed Annual Reports on
Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other filings with the SEC, which are
available on the SEC’s website at www.sec.gov. See in particular
MEI’s Annual Report on Form 10-K for the fiscal year ended June 30,
2022 in Part I, Item 1A, “Risk Factors,” and Infinity’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2021 in
Part I, Item 1A, “Risk Factors,” as updated by Infinity’s Quarterly
Reports on Form 10-Q for the quarters ended March 31, 2022, June
30, 2022, and September 30, 2022, in Part I, Item 1A, “Risk
Factors.” The risks and uncertainties described above and in the
SEC filings cited above are not exclusive and further information
concerning MEI and Infinity and their respective businesses,
including factors that potentially could materially affect their
respective businesses, financial conditions or operating results,
may emerge from time to time. Readers are urged to consider these
factors carefully in evaluating these forward-looking statements,
and not to place undue reliance on any forward-looking statements.
Any such forward-looking statements represent management’s
reasonable estimates and beliefs as of the date of this press
release. While MEI and Infinity may elect to update such
forward-looking statements at some point in the future, they
disclaim any obligation to do so, other than as may be required by
law, even if subsequent events cause their views to change.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230223005433/en/
Infinity Contact Luke Heagle Real Chemistry Tel:
910-619-5764 lheagle@realchemistry.com
MEI Pharma Contacts David A. Walsey Tel: 858-369-7104
investor@meipharma.com
Jason I. Spark Canale Communications for MEI Tel: 619-849-6005
jason.spark@canalecomm.com
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