Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN),
a clinical-stage precision oncology company focused on the
discovery and development of next-generation small molecule kinase
inhibitors, today announced that it has entered into a securities
purchase agreement for a private investment in public equity (PIPE)
financing that is expected to result in gross proceeds of
approximately $90 million, before deducting offering expenses. The
financing includes participation from new and existing
investors, including Commodore Capital, Fairmount, Venrock
Healthcare Capital Partners, a biotech investor, a large
mutual fund, Rock Springs Capital, Logos Capital,
Woodline Partners LP and Acuta Capital Partners.
“We appreciate the support from our existing and
new high-quality investors and their confidence in our clinical
programs,” said Sam Kintz, MBA, Enliven’s Co-founder and Chief
Executive Officer. “The additional funding further strengthens our
balance sheet and enables us to achieve critical, longer-term
clinical milestones as we advance our parallel lead programs,
ELVN-001 and ELVN-002. We are particularly excited to share initial
proof of concept data for ELVN-001 at our KOL event in a few
weeks.”
Recent Research and Development Updates
and Upcoming Milestones
ELVN-001, a highly selective, small molecule
kinase inhibitor designed to specifically target the BCR-ABL gene
fusion
- The Company is currently enrolling
patients in its Phase 1 clinical trial evaluating ELVN-001 in
adults who failed or are intolerant to available therapies known to
be active for the treatment of their CML (NCT05304377), and will
host a key opinion leader (KOL) event with CML Investigators
Professor Michael Mauro of Memorial Sloan-Kettering Cancer Center
and Professor Fabian Lang of Goethe University Hospital, on April
11, 2024, to discuss initial proof of concept data from the trial.
More details of the event will be announced soon.
- In the ongoing Phase 1a dose
escalation, 10-120mg once daily (QD), ELVN-001 has been well
tolerated with anti-CML activity at and above 20mg QD, including
both achievement and maintenance of major molecular responses (MMR)
by three months in late line patients, and in patients with prior
asciminib experience.
- A maximum tolerated dose (MTD) has
not been reached, and there have been no dose reductions. Of note,
there have been no ≥ Grade 3 non-hematologic treatment-related
adverse events (TRAEs) and of the Grade 1/2 non-hematologic
TRAE, none > 11%.
- At above 20mg QD, ELVN-001 achieved
superior target coverage compared to 2nd Generation TKIs.
- More detailed ELVN-001 data will be
presented at the April 11th KOL event.
ELVN-002, a potent, highly selective, central
nervous system (CNS) penetrant and irreversible HER2 inhibitor with
activity against wild type HER2 and various HER2 mutations
- Following the U.S. Food and Drug
Administration’s approval of its Investigational New Drug (IND)
application, the Company recently activated its first site to
evaluate ELVN-002 in combination with trastuzumab +/-
chemotherapeutic agents in adults with HER2+ metastatic breast
cancer (MBC) and colorectal cancer (CRC). Dosing of the first
patient in the combination study is expected in Q2 2024.
- The combination trial in patients
with HER2+ cancers is supported by the initial data from the
ongoing monotherapy trial, which includes:
- Investigator reported responses
(including unconfirmed) in both HER2+ and HER2 mutant tumors,
including in patients who have progressed on Enhertu and patients
with brain metastases, at doses that have been well tolerated.
- At the clinically predicted optimal
monotherapy dose (n=30), based on current Phase 1a data:
- The most common reported (>10%)
treatment-related adverse events (AEs) were headache, nausea,
vomiting and diarrhea. Of note, no Grade 3 diarrhea (0%) and
only Grade 1/2 AST/ALT (3%/0%) and rash (3%).
- Compared to tucatinib, ELVN-002 had
>10x target coverage based on pharmacokinetics in cancer
patients and preclinical HER2+ efficacy.
- Phase 1 data and initial proof of
concept combination data in HER2+ cancers are expected in
2025.
Details of the PIPE
Financing
Pursuant to the terms of the securities purchase
agreement, Enliven has agreed to sell an aggregate of 5,357,144
shares of its common stock at a price of $14.00 per share,
representing a premium of approximately 11% to Enliven’s closing
price on March 18, 2024, and pre-funded warrants to purchase
1,071,505 shares of its common stock at a price per pre-funded
warrant of $13.999. Enliven anticipates the gross proceeds from the
private placement to be approximately $90 million, before deducting
offering expenses. The PIPE financing is expected to close on or
about March 21, 2024, subject to satisfaction of customary closing
conditions.
Enliven intends to use the net proceeds from the
proposed financing to fund research and development of its
clinical-stage product candidates, other research programs, working
capital and general corporate purposes. The proceeds from this
financing, combined with current cash, cash equivalents and
marketable securities, are expected to fund current operations into
late 2026 and through the following additional key milestones for
the Company’s two clinical programs:
- ELVN-001:
- In 2025, Phase 1b data including
between approximately 60-100 patients across various lines of
therapy with significant follow-up
- By the end of 2025, initial
regulatory interactions with the aim of achieving regulatory path
clarity regarding the first head-to-head pivotal trial
- ELVN-002:
- In 2025, Phase 1 monotherapy data,
Phase 1a/b Herceptin combination data in HER2+ CRC, and initial
Phase 1a combination data in HER2+ MBC
The offer and sale of the foregoing securities
are being made in a transaction not involving a public offering and
the securities have not been registered under the Securities Act of
1933, as amended (Securities Act), and may not be reoffered or
resold in the United States except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements of the Securities Act. Enliven has agreed
to file a registration statement with the Securities and Exchange
Commission registering the resale of the shares of common stock and
the shares of common stock issuable upon exercise of the pre-funded
warrants sold in the PIPE financing. Any offering of the securities
under the resale registration statement will only be made by means
of a prospectus.
This press release shall not constitute an offer
to sell or a solicitation of an offer to buy these securities, nor
shall there be any sale of these securities in any state or other
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to the registration or qualification under the
securities laws of any such state or other jurisdiction.
About Enliven Therapeutics
Enliven Therapeutics is a clinical-stage
biopharmaceutical company focused on the discovery and development
of small molecule inhibitors to help people with cancer not only
live longer, but live better. Enliven aims to address existing and
emerging unmet needs with a precision oncology approach that
improves survival and enhances overall well-being. Enliven’s
discovery process combines deep insights in clinically validated
biological targets and differentiated chemistry to design
potentially first-in-class or best-in-class therapies. Enliven is
based in Boulder, Colorado.
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 Enliven 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 Enliven, as well as assumptions made
by, and information currently available to, management of 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 press release
include, but are not limited to, statements regarding the potential
of, and plans and expectations regarding, Enliven’s programs,
including ELVN-001 and ELVN-002; Enliven’s pipeline of product
candidates; expected milestones for ELVN-001 and ELVN-002,
including the expected timing of dosing of ELVN-002 in combination
and of data from the clinical trials of ELVN-001 and ELVN-002;
statements relating to Enliven’s expected cash runway; the timing
and expectation of the closing of the PIPE financing; the
satisfaction of customary closing conditions related to the PIPE
financing and the anticipated use of proceeds therefrom; 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 risks and uncertainties, including, without
limitation: whether the conditions for the closing of the PIPE
financing will be satisfied; the limited operating history of
Enliven; the ability to advance product candidates through
preclinical and clinical development; the ability to obtain
regulatory approval for, and ultimately commercialize, product
candidates; the outcome of preclinical testing and early clinical
trials for product candidates and the potential that the outcome of
preclinical testing and early clinical trials may not be predictive
of the success of later clinical trials; Enliven’s limited
resources; the risk of failing to demonstrate safety and
efficacy of product candidates; Enliven’s limited experience as a
company in designing and conducting clinical trials; potential
delays or difficulties in the enrollment or maintenance of patients
in clinical trials; developments relating to Enliven’s competitors
and its industry, including competing product candidates and
therapies; the decision to develop or seek strategic collaborations
to develop Enliven’s current or future product candidates in
combination with other therapies and the cost of combination
therapies; the ability to attract, hire, and retain highly skilled
executive officers and employees; the ability of Enliven to protect
its intellectual property and proprietary technologies; the scope
of any patent protection Enliven obtains or the loss of any of
Enliven’s patent protection; reliance on third parties, including
contract manufacturing organizations, contract research
organizations and strategic partners; general market or
macroeconomic conditions; Enliven’s ability to obtain additional
capital to fund Enliven’s general corporate activities and to fund
Enliven’s research and development; and other risks and
uncertainties, including those more fully described in Enliven’s
filings with the Securities and Exchange
Commission (SEC), which may be found in the section titled
“Risk Factors” in Enliven’s Annual and Quarterly Reports on Form
10-K and 10-Q filed with the SEC and in Enliven’s future reports to
be filed with the SEC. Except as required by applicable law,
Enliven 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.
This press release contains hyperlinks to
information that is not deemed to be incorporated by reference into
this press release.
Contact:
Enliven Investors &
Media:Investorsir@enliventherapeutics.com
MediaMedia@enliventherapeutics.com
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