Enliven Therapeutics, Inc. (Enliven), a clinical-stage precision
oncology company focused on the discovery and development of
next-generation small molecule kinase inhibitors, and Imara Inc.
(Nasdaq: IMRA) (Imara) today announced that they have entered into
a definitive merger agreement to combine the companies in an
all-stock transaction. The combined company will focus on advancing
Enliven’s pipeline of precision oncology product candidates.
Enliven is advancing two parallel lead product candidates:
ELVN-001, a highly selective small molecule BCR-ABL inhibitor
designed to address the challenges that limit the efficacy,
tolerability and convenience of currently available adenosine
triphosphate (ATP)-competitive tyrosine kinase inhibitors (TKIs) in
the treatment of chronic myeloid leukemia (CML), and ELVN-002, a
potent, selective and irreversible HER2 and pan-HER2 mutant kinase
inhibitor for the treatment of HER2 mutant lung cancer and other
HER2-driven tumor types. Upon completion of the merger, which is
subject to approval by Imara’s and Enliven’s stockholders, the
combined company is expected to operate under the name Enliven
Therapeutics, Inc. and trade on the Nasdaq Global Select Market
under the ticker symbol ELVN.
In support of the merger, Enliven also intends
to raise approximately $165 million in a concurrent private
financing co-led by new investors Fairmount and Venrock Healthcare
Capital Partners, with participation from additional new investors,
which include Fidelity Management & Research Company, RA
Capital Management, Frazier Life Sciences and Commodore Capital.
All of Enliven’s existing investors will participate in the
financing, including OrbiMed, 5AM Ventures, Surveyor Capital (a
Citadel company), Cormorant Asset Management, Roche Venture Fund,
Sheatree Capital, Boxer Capital, Logos Capital and Janus Henderson
Investors. The financing was oversubscribed and new investor
allocations account for over 60% of the total size of the
financing, which is expected to close immediately prior to the
completion of the merger.
With the cash expected from both companies at
closing and the proceeds of the planned concurrent financing, the
combined company is currently expected to have approximately $300
million of cash and cash equivalents at closing, after transaction
expenses. The cash resources are expected to be used to advance
Enliven’s pipeline through multiple clinical milestones and provide
runway into early 2026. The merger and financing are expected to
close in the first quarter of 2023, subject to stockholder approval
of both companies, the effectiveness of a registration statement to
be filed with the U.S. Securities and Exchange Commission (SEC) to
register the shares of Imara common stock to be issued in
connection with the merger, and the satisfaction of customary
closing conditions.
“We are excited to announce this merger with
Imara, which comes at a pivotal moment for Enliven. We recently
initiated our Phase 1 clinical trial for ELVN-001, which is being
evaluated in adults with CML, and expect to file our IND for
ELVN-002 by the end of the year. We expect this transaction to
provide Enliven with capital to fund us through multiple key
milestones and allow us to explore the potential of our pipeline.
We look forward to helping people with cancer to not only live
longer, but live better,” said Sam Kintz, MBA, Enliven’s Co-founder
and Chief Executive Officer.
“Following an extensive and thoughtful review of
several strategic alternatives, it became clear that the proposed
merger with Enliven was a compelling option for our stockholders,”
said Rahul Ballal, Ph.D., President and Chief Executive Officer of
Imara. “Enliven has a differentiated pipeline, an experienced team
and we expect the combined company to be well financed by top-tier
investors to execute on its clinical mission. We look forward to
the company’s continued progress in the clinic.”
About Enliven’s Precision Oncology
Portfolio
Enliven is a clinical-stage precision oncology
company focused on the discovery and development of potentially
best-in-class or first-in-class precision oncology therapies.
Enliven’s programs are designed to address issues such as
tolerability, combinability, resistance and disease escape through
brain metastases. Enliven is advancing two parallel lead product
candidates:
ELVN-001: Enliven’s most advanced candidate,
ELVN-001, is a potent, highly selective, small molecule kinase
inhibitor designed to specifically target the BCR-ABL gene fusion,
the oncogenic driver for patients with CML. Although the approval
of BCR-ABL TKIs has improved the life expectancy of patients with
CML significantly, tolerability, safety, resistance and patient
convenience concerns have become more prominent as patients can now
expect to live on therapy for decades. These issues can result in
the loss of molecular response and disease progression for many
patients and drive approximately 20% of patients to switch therapy
within the first year and approximately 40% to switch in the first
5 years. Enliven’s preclinical studies showed that ELVN-001 does
not meaningfully interfere with the activity of kinases that we
believe limit efficacy and tolerability of approved ATP-competitive
TKIs. Additionally, given ELVN-001's mechanism of action, it
potentially represents a complementary option to allosteric BCR-ABL
inhibitors, which may play an increasingly important role in the
standard of care. ELVN-001 was also designed to be efficacious
against the T315I mutation, the most common BCR-ABL mutation, which
confers resistance to nearly all approved TKIs. Importantly,
ELVN-001 was designed to be a more attractive option for patients
with comorbidities, on concomitant medications or desiring more
freedom from stringent administration requirements. ELVN-001 is
currently being evaluated in a Phase 1 clinical trial in adults
with CML. To learn more, please visit
www.clinicaltrials.gov (NCT05304377).
ELVN-002: Enliven’s second product candidate,
ELVN-002, is a potent, selective and irreversible HER2 inhibitor
with activity against various HER2 mutations, including Exon 20
insertion mutations (E20IMs) in non-small cell lung cancer (NSCLC),
for which there are currently no approved small molecule
inhibitors. ELVN-002 is designed to inhibit HER2 and key mutations
of HER2, while sparing wild-type EGFR and avoiding EGFR-related
toxicities. Enliven believes that if ELVN-002 achieves this
profile, it will be able to achieve an improved therapeutic index
compared to current approved and investigational TKIs as well as
provide a meaningful therapeutic option to patients with brain
metastases, a key mechanism of resistance to current therapies in
patients with NSCLC and other HER2 driven diseases. While the
initial focus for this program is for HER2 mutant NSCLC, Enliven
intends to seek to expand the opportunity to patients with other
HER2 mutations as well as HER2 amplified tumors including breast,
colorectal and gastric cancers.
In addition to its two lead programs, Enliven is
pursuing several additional research stage opportunities that align
with its development approach. Enliven is in the process of
screening and optimizing the chemistry for multiple programs and
expects to make a product candidate nomination for its third
program in the first half of 2023.
About the Proposed Merger
Under the terms of the merger agreement, Imara
will issue to pre-merger Enliven stockholders shares of Imara
common stock as merger consideration in exchange for the
cancellation of shares of capital stock of Enliven and Enliven will
become a wholly-owned subsidiary of Imara. Pre-merger Imara
stockholders are expected to own approximately 16% of the combined
company and pre-merger Enliven stockholders (including those
purchasing Enliven shares in the private financing discussed above)
are expected to own approximately 84% of the combined company. The
percentage of the combined company that pre-merger Enliven
stockholders and pre-merger Imara stockholders will own as of the
close of the proposed transaction is subject to certain adjustments
as described in the merger agreement, including the amount of
Imara’s net cash at closing. Immediately prior to the closing of
the proposed merger, pre-merger Imara stockholders will be issued
contingent value rights representing the right to receive certain
payments received by the combined company, if any, related to the
previously announced pending sale of tovinontrine (IMR-687) or
related to any potential sale or license of IMR-261.
Upon closing of the proposed transaction, Imara
Inc. will be renamed Enliven Therapeutics, Inc. The combined
company will be led by Sam Kintz, Co-founder and Chief Executive
Officer of Enliven, and other members of the Enliven management
team. The combined company’s board of directors will be comprised
of all of the directors of Enliven’s board of directors and one
director designated from Imara’s board of directors, who is
expected to be Rahul Ballal, Imara’s President and Chief Executive
Officer.
The merger agreement has been approved by the
board of directors of each company and the proposed transaction is
expected to close in the first quarter of 2023, subject to
approvals by the stockholders of each company, the effectiveness of
a registration statement to be filed with the SEC to register the
shares of Imara common stock to be issued in connection with the
merger, and other customary closing conditions.
Goldman Sachs & Co., LLC, Jeffries and
Cowen are serving as financial advisors and placement agents
to Enliven. Wilson Sonsini Goodrich & Rosati is serving as
legal counsel to Enliven, and Cooley is serving as legal counsel to
the placement agents. SVB Securities is serving as the exclusive
financial advisor and WilmerHale is serving as legal counsel to
Imara.
Conference Call Information
Enliven and Imara will host a conference call
today, October 13, 2022, at 5:00 p.m. E.T., to discuss the proposed
merger. The conference call may be accessed by dialing (800)
715-9871 (United States and Canada) or (646) 307-1963
(international) and asking to join the Enliven and Imara conference
call (conference ID 3259480). A live webcast of the presentation
will be available on the Events & Presentations section of
Imara’s website at https://imaratx.com. A replay of the webcast
will be archived on the Imara website following the
presentation.
About Enliven Therapeutics
Enliven Therapeutics is a clinical-stage
biopharmaceutical company focused on the discovery and development
of small molecule inhibitors to help patients with cancer live not
only longer, but better. Enliven aims to address existing and
emerging unmet needs with a precision oncology approach that
improves survival and enhances overall patient well-being.
Enliven’s discovery process combines deep insights from clinically
validated biological targets and differentiated chemistry to design
potentially first-in-class or best-in-class therapies. Enliven is
based in Boulder, Colorado.
Cautionary Note Regarding 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 (Securities Act)) concerning Enliven,
Imara, the proposed transactions 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 Imara and Enliven, as well as assumptions made by, and
information currently available to, management of Imara and
Enliven. 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 or the negative or plural of these words, or other
similar expressions that are predictions or indicate future events
or prospects, although not all forward-looking statements contain
these words. Statements that are not historical facts are
forward-looking statements. Forward-looking statements in this
communication include, but are not limited to, expectations
regarding the proposed merger and financing transactions; the
potential benefits and results of such transactions; the
sufficiency of the combined company’s capital resources; the
combined company’s cash runway; the expected timing of the closing
of the proposed transactions; statements regarding the potential
of, and expectations regarding, Enliven’s programs, including
ELVN-001, ELVN-002 and its research stage opportunities; the
expected timing of Enliven’s filing of an IND for ELVN-002; the
expected timing to make a product candidate nomination for
Enliven’s third program; statements by Imara’s President and Chief
Executive Officer; and statements by Enliven’s Co-founder and Chief
Executive Officer. 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 limited operating history of each company; the
significant net losses incurred since inception; the ability to
raise additional capital to finance operations; the ability to
advance product candidates through preclinical and clinical
development; the ability to obtain regulatory approval for, and
ultimately commercialize, Enliven’s product candidates; the outcome
of preclinical testing and early clinical trials for Enliven’s
product candidates, including the ability of those trials to
satisfy relevant governmental or regulatory requirements; Enliven’s
limited experience in designing clinical trials and lack of
experience in conducting clinical trials; the ability to identify
and pivot to other programs, product candidates, or indications
that may be more profitable or successful than Enliven’s current
product candidates; the substantial competition Enliven faces in
discovering, developing, or commercializing products; the negative
impacts of the COVID-19 pandemic on operations, including ongoing
and planned clinical trials and ongoing and planned preclinical
studies; the ability to attract, hire, and retain skilled executive
officers and employees; the ability of Imara or Enliven to protect
their respective intellectual property and proprietary
technologies; reliance on third parties, contract manufacturers,
and contract research organization; the risk that the conditions to
the closing of the proposed transactions are not satisfied,
including the failure to obtain stockholder approval for the
proposed transactions from both Imara and Enliven’s stockholders or
to complete the transactions in a timely manner or at all;
uncertainties as to the timing of the consummation of the proposed
transactions and the ability of each of the parties to consummate
the proposed transactions; risks related to Imara’s continued
listing on the Nasdaq Stock Market until closing of the proposed
transactions; risks related to Imara’s and Enliven’s ability to
correctly estimate their respective operating expenses and expenses
associated with the proposed transactions, 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 occurrence of any event,
change or other circumstance or condition that could give rise to
the termination of the merger agreement or the financing
transaction; competitive responses to the proposed transactions;
unexpected costs, charges or expenses resulting from the proposed
transactions; the outcome of any legal proceedings that may be
instituted against Imara, Enliven or any of their respective
directors or officers related to the merger agreement, the
financing transaction, or the proposed transactions contemplated
thereby; the effect of the announcement or pendency of the
transactions on Imara’s or Enliven’s business relationships,
operating results and business generally; and legislative,
regulatory, political and economic developments and general market
conditions. 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 Imara’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 as well as the registration statement on
Form S-4 to be filed with the SEC by Imara. Imara and Enliven can
give no assurance that the conditions to the proposed transactions
will be satisfied. Except as required by applicable law, Imara and
Enliven undertake 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.
This press release contains hyperlinks to information that is
not deemed to be incorporated by reference into this press
release.
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, 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 Imara and
Enliven, Imara intends to file relevant materials with the SEC,
including a registration statement on Form S-4 that will contain a
proxy statement/prospectus of Imara and information statement of
Enliven. IMARA AND ENLIVEN URGE INVESTORS AND STOCKHOLDERS TO READ
THESE MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT
IMARA, ENLIVEN, THE PROPOSED TRANSACTION AND RELATED MATTERS.
Investors and stockholders will be able to obtain free copies of
the proxy statement/prospectus/information statement and other
documents filed by Imara with the SEC (when they become available)
through the website maintained by the SEC at www.sec.gov. In
addition, investors and stockholders will be able to obtain free
copies of the proxy statement/prospectus/information statement and
other documents filed by Imara with the SEC by contacting Imara
Inc. at 116 Huntington Ave., 6th Floor, Boston, MA 02116. 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
Imara, Enliven and their respective directors and executive
officers may be considered participants in the solicitation of
proxies in connection with the proposed transaction. Information
about Imara’s directors and executive officers is included in
Imara’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 Imara’s 2022 annual meeting of
stockholders, filed with the SEC on April 22, 2022. Additional
information regarding the persons who may be deemed participants in
the solicitation of proxies will be included in the proxy
statement/prospectus/information statement relating to the proposed
transaction when it is filed with the SEC. These documents can be
obtained free of charge from the sources indicated above.
Contacts:
Enliven Investors & Media:Argot
PartnersEnliven@argotpartners.com
Imara Investors:Michael
Gray617-835-4061mgray@imaratx.com
Imara Media:Wendy RyanTen Bridge
Communicationswendy@tenbridgecommunications.com781-316-4424
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