- Merger to create Nasdaq-listed, clinical-stage biopharmaceutical firm targeted on advancing Enliven’s portfolio of precision oncology applications
- Combined firm is predicted to have a money steadiness of roughly $300 million at shut, which is predicted to supply money runway by way of a number of medical milestones and into early 2026
- Planned concurrent financing of roughly $165 million co-led by new traders Fairmount and Venrock Healthcare Capital Partners, with participation from further new traders together with Fidelity Management & Research Company, RA Capital Management, Frazier Life Sciences and Commodore Capital and assist from all current Enliven traders
- Companies to host convention name right now at 5:00 p.m. E.T.
Boulder, CO and Boston, MA, Oct. 13, 2022 (GLOBE NEWSWIRE) — Enliven Therapeutics, Inc. (Enliven), a clinical-stage precision oncology firm targeted on the invention and improvement of next-generation small molecule kinase inhibitors, and Imara Inc. (Nasdaq: IMRA) (Imara) right now introduced that they’ve entered right into a definitive merger settlement to mix the businesses in an all-stock transaction. The mixed firm will deal with advancing Enliven’s pipeline of precision oncology product candidates. Enliven is advancing two parallel lead product candidates: ELVN-001, a extremely selective small molecule BCR-ABL inhibitor designed to deal with the challenges that restrict the efficacy, tolerability and comfort of at present obtainable adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitors (TKIs) within the remedy of continual myeloid leukemia (CML), and ELVN-002, a potent, selective and irreversible HER2 and pan-HER2 mutant kinase inhibitor for the remedy of HER2 mutant lung most cancers and different HER2-driven tumor varieties. Upon completion of the merger, which is topic to approval by Imara’s and Enliven’s stockholders, the mixed firm is predicted to function beneath the identify Enliven Therapeutics, Inc. and commerce on the Nasdaq Global Select Market beneath the ticker image ELVN.
In assist of the merger, Enliven additionally intends to lift roughly $165 million in a concurrent personal financing co-led by new traders Fairmount and Venrock Healthcare Capital Partners, with participation from further new traders, which embrace Fidelity Management & Research Company, RA Capital Management, Frazier Life Sciences and Commodore Capital. All of Enliven’s current traders will take part within the financing, together with OrbiMed, 5AM Ventures, Surveyor Capital (a Citadel firm), 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 entire dimension of the financing, which is predicted to shut instantly previous to the completion of the merger.
With the money anticipated from each firms at closing and the proceeds of the deliberate concurrent financing, the mixed firm is at present anticipated to have roughly $300 million of money and money equivalents at closing, after transaction bills. The money sources are anticipated for use to advance Enliven’s pipeline by way of a number of medical milestones and present runway into early 2026. The merger and financing are anticipated to shut within the first quarter of 2023, topic to stockholder approval of each firms, the effectiveness of a registration assertion to be filed with the U.S. Securities and Exchange Commission (SEC) to register the shares of Imara frequent inventory to be issued in reference to the merger, and the satisfaction of customary closing circumstances.
“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,” mentioned 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,” mentioned 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 firm targeted on the invention and improvement of doubtless best-in-class or first-in-class precision oncology therapies. Enliven’s applications are designed to deal with points equivalent to tolerability, combinability, resistance and illness escape by way of mind metastases. Enliven is advancing two parallel lead product candidates:
ELVN-001: Enliven’s most superior candidate, ELVN-001, is a potent, extremely selective, small molecule kinase inhibitor designed to particularly goal the BCR-ABL gene fusion, the oncogenic driver for sufferers with CML. Although the approval of BCR-ABL TKIs has improved the life expectancy of sufferers with CML considerably, tolerability, security, resistance and affected person comfort considerations have change into extra distinguished as sufferers can now count on to stay on remedy for many years. These points may end up in the lack of molecular response and illness development for a lot of sufferers and drive roughly 20% of sufferers to modify remedy inside the first 12 months and roughly 40% to modify within the first 5 years. Enliven’s preclinical research confirmed that ELVN-001 doesn’t meaningfully intrude with the exercise of kinases that we consider restrict efficacy and tolerability of authorized ATP-competitive TKIs. Additionally, given ELVN-001’s mechanism of motion, it doubtlessly represents a complementary choice to allosteric BCR-ABL inhibitors, which can play an more and more essential function in the usual of care. ELVN-001 was additionally designed to be efficacious in opposition to the T315I mutation, the most typical BCR-ABL mutation, which confers resistance to just about all authorized TKIs. Importantly, ELVN-001 was designed to be a extra enticing possibility for sufferers with comorbidities, on concomitant medicines or wanting extra freedom from stringent administration necessities. ELVN-001 is at present being evaluated in a Phase 1 medical trial in adults with CML. To be taught extra, please go to www.clinicaltrials.gov (NCT05304377).
ELVN-002: Enliven’s second product candidate, ELVN-002, is a potent, selective and irreversible HER2 inhibitor with exercise in opposition to numerous HER2 mutations, together with Exon 20 insertion mutations (E20IMs) in non-small cell lung most cancers (NSCLC), for which there are at present no authorized small molecule inhibitors. ELVN-002 is designed to inhibit HER2 and key mutations of HER2, whereas sparing wild-type EGFR and avoiding EGFR-related toxicities. Enliven believes that if ELVN-002 achieves this profile, it will likely be capable of obtain an improved therapeutic index in comparison with present authorized and investigational TKIs in addition to present a significant therapeutic choice to sufferers with mind metastases, a key mechanism of resistance to present therapies in sufferers with NSCLC and different HER2 pushed ailments. While the preliminary focus for this program is for HER2 mutant NSCLC, Enliven intends to hunt to increase the chance to sufferers with different HER2 mutations in addition to HER2 amplified tumors together with breast, colorectal and gastric cancers.
In addition to its two lead applications, Enliven is pursuing a number of further analysis stage alternatives that align with its improvement strategy. Enliven is within the means of screening and optimizing the chemistry for a number of applications and expects to make a product candidate nomination for its third program within the first half of 2023.
About the Proposed Merger
Under the phrases of the merger settlement, Imara will concern to pre-merger Enliven stockholders shares of Imara frequent inventory as merger consideration in alternate for the cancellation of shares of capital inventory of Enliven and Enliven will change into a wholly-owned subsidiary of Imara. Pre-merger Imara stockholders are anticipated to personal roughly 16% of the mixed firm and pre-merger Enliven stockholders (together with these buying Enliven shares within the personal financing mentioned above) are anticipated to personal roughly 84% of the mixed firm. The proportion of the mixed firm that pre-merger Enliven stockholders and pre-merger Imara stockholders will personal as of the shut of the proposed transaction is topic to sure changes as described within the merger settlement, together with the quantity of Imara’s internet money at closing. Immediately previous to the closing of the proposed merger, pre-merger Imara stockholders will likely be issued contingent worth rights representing the suitable to obtain sure funds acquired by the mixed firm, if any, associated to the beforehand introduced pending sale of tovinontrine (IMR-687) or associated to any potential sale or license of IMR-261.
Upon closing of the proposed transaction, Imara Inc. will likely be renamed Enliven Therapeutics, Inc. The mixed firm will likely be led by Sam Kintz, Co-founder and Chief Executive Officer of Enliven, and different members of the Enliven administration staff. The mixed firm’s board of administrators will likely be comprised of the entire administrators of Enliven’s board of administrators and one director designated from Imara’s board of administrators, who is predicted to be Rahul Ballal, Imara’s President and Chief Executive Officer.
The merger settlement has been authorized by the board of administrators of every firm and the proposed transaction is predicted to shut within the first quarter of 2023, topic to approvals by the stockholders of every firm, the effectiveness of a registration assertion to be filed with the SEC to register the shares of Imara frequent inventory to be issued in reference to the merger, and different customary closing circumstances.
Goldman Sachs & Co., LLC, Jeffries and Cowen are serving as monetary advisors and placement brokers to Enliven. Wilson Sonsini Goodrich & Rosati is serving as authorized counsel to Enliven, and Cooley is serving as authorized counsel to the location brokers. SVB Securities is serving because the unique monetary advisor and WilmerHale is serving as authorized counsel to Imara.
Conference Call Information
Enliven and Imara will host a convention name right now, October 13, 2022, at 5:00 p.m. E.T., to debate the proposed merger. The convention name could also be accessed by dialing (800) 715-9871 (United States and Canada) or (646) 307-1963 (worldwide) and asking to affix the Enliven and Imara convention name (convention ID 3259480). A stay webcast of the presentation will likely be obtainable on the Events & Presentations part of Imara’s web site at https://imaratx.com. A replay of the webcast will likely be archived on the Imara web site following the presentation.
About Enliven Therapeutics
Enliven Therapeutics is a clinical-stage biopharmaceutical firm targeted on the invention and improvement of small molecule inhibitors to assist sufferers with most cancers stay not solely longer, however higher. Enliven goals to deal with current and rising unmet wants with a precision oncology strategy that improves survival and enhances total affected person well-being. Enliven’s discovery course of combines deep insights from clinically validated organic targets and differentiated chemistry to design doubtlessly first-in-class or best-in-class therapies. Enliven relies in Boulder, Colorado.
Cautionary Note Regarding Forward-Looking Statements
This press launch incorporates forward-looking statements (together with inside the that means 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)) regarding Enliven, Imara, the proposed transactions and different issues. These statements might talk about objectives, intentions and expectations as to future plans, developments, occasions, outcomes of operations or monetary situation, or in any other case, based mostly on present beliefs of the administration of Imara and Enliven, in addition to assumptions made by, and data at present obtainable to, administration of Imara and Enliven. Forward-looking statements usually embrace statements which are predictive in nature and rely on or confer with future occasions or circumstances, and embrace phrases equivalent to “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and different related expressions or the damaging or plural of those phrases, or different related expressions which are predictions or point out future occasions or prospects, though not all forward-looking statements comprise these phrases. Statements that aren’t historic info are forward-looking statements. Forward-looking statements on this communication embrace, however will not be restricted to, expectations concerning the proposed merger and financing transactions; the potential advantages and outcomes of such transactions; the sufficiency of the mixed firm’s capital sources; the mixed firm’s money runway; the anticipated timing of the closing of the proposed transactions; statements concerning the potential of, and expectations concerning, Enliven’s applications, together with ELVN-001, ELVN-002 and its analysis stage alternatives; the anticipated timing of Enliven’s submitting of an IND for ELVN-002; the anticipated 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 mostly on present beliefs and assumptions which are topic to dangers and uncertainties and will not be ensures of future efficiency. Actual outcomes may differ materially from these contained in any forward-looking assertion on account of numerous components, together with, with out limitation: the restricted working historical past of every firm; the numerous internet losses incurred since inception; the flexibility to lift further capital to finance operations; the flexibility to advance product candidates by way of preclinical and medical improvement; the flexibility to acquire regulatory approval for, and finally commercialize, Enliven’s product candidates; the result of preclinical testing and early medical trials for Enliven’s product candidates, together with the flexibility of these trials to fulfill related governmental or regulatory necessities; Enliven’s restricted expertise in designing medical trials and lack of expertise in conducting medical trials; the flexibility to establish and pivot to different applications, product candidates, or indications which may be extra worthwhile or profitable than Enliven’s present product candidates; the substantial competitors Enliven faces in discovering, growing, or commercializing merchandise; the damaging impacts of the COVID-19 pandemic on operations, together with ongoing and deliberate medical trials and ongoing and deliberate preclinical research; the flexibility to draw, rent, and retain expert govt officers and staff; the flexibility of Imara or Enliven to guard their respective mental property and proprietary applied sciences; reliance on third events, contract producers, and contract analysis group; the danger that the circumstances to the closing of the proposed transactions will not be happy, together with the failure to acquire stockholder approval for the proposed transactions from each Imara and Enliven’s stockholders or to finish the transactions in a well timed method or in any respect; uncertainties as to the timing of the consummation of the proposed transactions and the flexibility of every of the events to consummate the proposed transactions; dangers associated to Imara’s continued itemizing on the Nasdaq Stock Market till closing of the proposed transactions; dangers associated to Imara’s and Enliven’s skill to accurately estimate their respective working bills and bills related to the proposed transactions, in addition to uncertainties concerning the influence any delay within the closing would have on the anticipated money sources of the mixed firm upon closing and different occasions and unanticipated spending and prices that might scale back the mixed firm’s money sources; the incidence of any occasion, change or different circumstance or situation that might give rise to the termination of the merger settlement or the financing transaction; aggressive responses to the proposed transactions; surprising prices, prices or bills ensuing from the proposed transactions; the result of any authorized proceedings which may be instituted in opposition to Imara, Enliven or any of their respective administrators or officers associated to the merger settlement, the financing transaction, or the proposed transactions contemplated thereby; the impact of the announcement or pendency of the transactions on Imara’s or Enliven’s business relationships, working outcomes and business usually; and legislative, regulatory, political and financial developments and common market circumstances. The foregoing evaluate of essential components that might trigger precise occasions to vary from expectations shouldn’t be construed as exhaustive and must be learn along side statements which are included herein and elsewhere, together with the danger components included in Imara’s most up-to-date Annual Report on Form 10-Okay, Quarterly Reports on Form 10-Q and Current Reports on Form 8-Okay filed with the SEC in addition to the registration assertion on Form S-4 to be filed with the SEC by Imara. Imara and Enliven may give no assurance that the circumstances to the proposed transactions will likely be happy. Except as required by relevant regulation, Imara and Enliven undertake no obligation to revise or replace any forward-looking assertion, or to make every other forward-looking statements, whether or not on account of new data, future occasions or in any other case.
This press launch incorporates hyperlinks to data that’s not deemed to be integrated by reference into this press launch.
No Offer or Solicitation
This press launch just isn’t supposed to and doesn’t represent a suggestion to promote or the solicitation of a suggestion to subscribe for or purchase or an invite to buy or subscribe for any securities or the solicitation of any vote in any jurisdiction pursuant to the proposed transaction or in any other case, nor shall there be any sale, issuance or switch of securities in any jurisdiction in contravention of relevant regulation. No provide of securities shall be made besides via a prospectus assembly the necessities of the Securities Act. Subject to sure exceptions to be authorized by the related regulators or sure info to be ascertained, the general public provide is not going to be made straight or not directly, in or into any jurisdiction the place to take action would represent a violation of the legal guidelines of such jurisdiction, or by use of the mails or by any means or instrumentality (together with with out limitation, phone and the web) of interstate or international commerce, or any facility of a nationwide securities alternate, of any such jurisdiction.
Important Additional Information Will be Filed with the SEC
In reference to the proposed transaction between Imara and Enliven, Imara intends to file related supplies with the SEC, together with a registration assertion on Form S-4 that can comprise a proxy assertion/prospectus of Imara and data assertion 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 capable to acquire free copies of the proxy assertion/prospectus/data assertion and different paperwork filed by Imara with the SEC (after they change into obtainable) by way of the web site maintained by the SEC at www.sec.gov. In addition, traders and stockholders will be capable to acquire free copies of the proxy assertion/prospectus/data assertion and different paperwork filed by Imara with the SEC by contacting Imara Inc. at 116 Huntington Ave., sixth Floor, Boston, MA 02116. Investors and stockholders are urged to learn the proxy assertion/prospectus/data assertion and the opposite related supplies after they change into obtainable earlier than making any voting or funding determination with respect to the proposed transaction.
Participants within the Solicitation
Imara, Enliven and their respective administrators and govt officers could also be thought-about individuals within the solicitation of proxies in reference to the proposed transaction. Information about Imara’s administrators and govt officers is included in Imara’s most up-to-date Annual Report on Form 10-Okay, together with any data integrated therein by reference, as filed with the SEC, and the proxy assertion for Imara’s 2022 annual assembly of stockholders, filed with the SEC on April 22, 2022. Additional data concerning the individuals who could also be deemed individuals within the solicitation of proxies will likely be included within the proxy assertion/prospectus/data assertion regarding the proposed transaction when it’s filed with the SEC. These paperwork will be obtained freed from cost from the sources indicated above.
Contacts:
Enliven Investors & Media:
Argot Partners
[email protected]
Imara Investors:
Michael Gray
617-835-4061
[email protected]
Imara Media:
Wendy Ryan
Ten Bridge Communications
[email protected]
781-316-4424
