Full Press Release Details
Nuvation Bio to Acquire AnHeart Therapeutics in All-Stock
Acquisition transforms Nuvation Bio into late-stage global oncology company with potential to become a commercial
organization by the end of 2025
Acquisition adds taletrectinib, a next-generation, potentially best-in-class ROS1 inhibitor with Breakthrough Therapy Designations currently completing two pivotal studies for the treatment of patients with ROS1-positive non-small
cell lung cancer (NSCLC)
Acquisition also adds safusidenib, a potentially best-in-class mutant IDH1 inhibitor currently being evaluated in a global Phase 2 study of patients with grades 2 and 3 IDH1-mutant glioma
All-stock transaction preserves Nuvation Bio s robust cash balance and enables development of
both new assets and current pipeline without a need to raise capital in the near term
New York, NY, March 25, 2024 Nuvation Bio
Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, and AnHeart Therapeutics Ltd. (AnHeart), a global clinical-stage biopharmaceutical
company developing novel precision therapies for people with cancer, today announced that the companies have entered into a definitive agreement for Nuvation Bio to acquire AnHeart in an all-stock transaction
(the Acquisition). Immediately following the closing of the Acquisition, the former shareholders of AnHeart will own approximately 33% and the current stockholders of Nuvation Bio will own approximately 67% of Nuvation Bio on a fully diluted basis.
The Acquisition, which has been approved by the board of directors of each company and is subject to approval by AnHeart s shareholders and other customary closing conditions, will position Nuvation Bio as a late-stage global oncology company
with multiple programs in clinical development. The Acquisition is expected to close in the second quarter of 2024.
This transaction represents a
significant milestone for our company and reflects Nuvation Bio s continued commitment to developing therapies for patients with the most difficult-to-treat
cancers, said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. AnHeart s lead asset, taletrectinib, which will become our lead asset as it completes two pivotal studies, is a differentiated,
next-generation ROS1 inhibitor with a potentially best-in-class profile that may overcome the significant limitations of existing therapies. We are impressed by what the
AnHeart team has done to develop this asset and intend to build on the progress made to date.
Dr. Hung added, Nuvation Bio is well
capitalized, and this all-stock transaction maintains our robust cash balance and removes any need for near-term financing to develop both new assets and our current pipeline. With our combined talented teams
and resources, we will continue to focus on executing the development strategy for our differentiated pipeline. We expect this deal will bring Nuvation Bio much closer to realizing our goal of delivering novel cancer therapies to patients, and we
look forward to this exciting next chapter together with the AnHeart team.
AnHeart, named for our deep sense of service to patients, has worked tirelessly over the past five
years to advance our pipeline of next-generation precision oncology medicines. We are excited to continue our mission as part of Nuvation Bio given their shared vision to improve the lives of people with cancer, said Junyuan Jerry Wang, Ph.D.,
Co-Founder and Chief Executive Officer of AnHeart. We believe the pipeline and financial strength of the combined company have the potential to create a market leader, and we look forward to working with
David and the Nuvation Bio team to bring new cancer therapies to patients in need of better options.
Management and Organization
Nuvation Bio will continue to be led by its current management team, including David Hung, M.D., its Founder, Chief Executive Officer, and President, and
expects AnHeart s employees in China and the United States to join the Nuvation Bio team. Following the closing of the Acquisition, Min Cui, Ph.D., Founder and Managing Director of Decheng Capital, an investor in AnHeart, and Junyuan Jerry
Wang, Ph.D., Co-Founder and Chief Executive Officer of AnHeart, will join the Nuvation Bio board of directors.
At the closing of the Acquisition,
Nuvation Bio will issue to the AnHeart securityholders, in exchange for all outstanding AnHeart shares, options, and other securities, approximately 43,590,197 shares of Nuvation Bio s Class A common stock (inclusive of the shares of
Class A common stock underlying the AnHeart equity awards to be assumed by Nuvation Bio), 851,212 shares of Nuvation Bio s Series A Non-Voting Convertible Preferred Stock, and warrants
collectively exercisable for 2,893,731 shares of Nuvation Bio s Class A common stock at an exercise price of $11.50 per share.
approval by the Nuvation Bio stockholders (the Nuvation Bio Stockholder Approval), each share of Series A Non-Voting Convertible Preferred Stock issued by Nuvation Bio in the Acquisition will initially be
convertible into 100 shares of Class A common stock. Additionally, the warrants issued in the Acquisition will be restricted until receipt of the Nuvation Bio Stockholder Approval. Any shareholders of AnHeart who are not accredited investors
will receive cash for their AnHeart shares in lieu of receiving Nuvation Bio securities.
The holders of approximately 90% of AnHeart s outstanding
shares have entered into voting agreements, pursuant to which they have agreed to, among other matters, vote in favor of the Acqusition.
with the execution of the definitive merger agreement, Dr. Hung entered into a voting agreement, pursuant to which he agreed to vote his shares of Nuvation Bio stock, representing approximately 27% of Nuvation Bio s outstanding shares, for
the Nuvation Bio Stockholder Approval. The closing of the Acquisition does not require the approval of the Nuvation Bio stockholders.
AnHeart intend that the Acquisition will qualify as a tax-free reorganization. As AnHeart s parent company after the Acquistion, Nuvation Bio will own all of AnHeart s assets, including
AnHeart s intellectual property.
For further information regarding the terms and conditions contained in the definitive transaction agreement,
please see Nuvation Bio s current report on Form 8-K, which will be filed with the U.S. Securities and Exchange Commission (the SEC) in connection with the Acquisition.
Nuvation Bio will schedule a conference
call to discuss the acquisition after it has closed.
Evercore is acting as Nuvation Bio s exclusive financial advisor and Cooley LLP is acting as legal counsel, alongside Morrison & Foerster LLP as
intellectual property counsel, Haiwen & Partners as Chinese legal counsel, and Conyers as Cayman Islands legal counsel. Davis Polk & Wardwell LLP is acting as legal counsel for AnHeart, alongside Fangda Partners as Chinese legal
counsel and Walkers (Cayman) LLP as Cayman Islands legal counsel.
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic
candidates. Nuvation Bio s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most
difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which
brought to patients one of the world s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com and
About AnHeart Therapeutics
AnHeart Therapeutics is a global clinical-stage biopharmaceutical company developing novel precision therapies for people with cancer. AnHeart s lead
investigational therapy, taletrectinib, is a next-generation ROS1-inhibitor currently in pivotal Phase 2 trials for ROS1-positive non-small cell lung cancer (NSCLC). Taletrectinib
has been granted Breakthrough Therapy Designations by both the U.S. Food and Drug Administration (FDA) and the China National Medical Products Administration (NMPA). China s NMPA has accepted and granted Priority Review Designations to New Drug
Applications for taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC who either have or have not previously been treated with ROS1 TKIs. AnHeart s second investigational therapy,
safusidenib, is a mIDH1-inhibitor being evaluated in a Phase 2 trial for IDH1-mutant glioma.
AnHeart owns global rights to taletrectinib, except in Greater China, Japan and Korea, where AnHeart
licensed commercial rights to Innovent Biologics, Nippon Kayaku and NewG Lab, respectively. AnHeart owns global rights to safusidenib excluding Japan, where Daiichi Sankyo retains development and commercial rights. AnHeart s mission is to
improve the lives of people with cancer. AnHeart is supported by leading life sciences investors and has built an organization with deep oncology drug discovery and development expertise, with offices in New York and Shanghai. For more information,
Forward Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor
provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as believe, may, will, estimate,
continue, anticipate, intend, expect, should, would, plan, predict, potential, seem, seek, future,
outlook and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, those under the captions
Management and Organization and Transaction Details above and statements regarding the anticipated closing of the Acquisition, expected timing of establishing a commercial organization, potential therapeutic benefit of
Nuvation Bio and AnHeart s product candidates, advancement of clinical studies for such product candidates, and the sufficiency of Nuvation Bio s current cash balance to fund ongoing activities. These statements are based on various
assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and
uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the risk that the Acquisition may not close due to the failure of closing conditions to be satisfied or
other reasons and the challenges associated with conducting drug discovery and initiating or conducting clinical trials due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring
necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and
uncertainties facing Nuvation Bio are described more fully in its Form 10-K filed with the SEC on February 29, 2024, under the heading Risk Factors, and other documents that Nuvation Bio has
filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or
revise any forward-looking statements contained in this press release.
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