• 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.

TRANSACTION DETAILS

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.

Subject to 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.

In connection 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.

Nuvation Bio and 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.

PIPELINE UPDATES

• Taletrectinib is being evaluated for the treatment of patients with ROS1-positive NSCLC in two pivotal Phase 2 studies, TRUST-I (NCT04395677) in China and TRUST-II (NCT04919811), a global pivotal study. Nuvation Bio will continue to advance both studies.
• Taletrectinib has been granted Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration (NMPA) for the treatment of advanced or metastatic ROS1-positive NSCLC.
• The NMPA has accepted and granted Priority Review Designation 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.
• Nuvation Bio will continue to develop safusidenib, a novel, selective, potent, oral mIDH1 inhibitor being evaluated by AnHeart in a global Phase 2 study (NCT05303519) in patients with grades 2 and 3 IDH1-mutant glioma.
• Nuvation Bio will continue to advance all clinical studies for its internally discovered pipeline candidates, including the Phase 1b studies of NUV-868 and the recently initiated Phase 1/2 study of NUV-1511.

CONFERENCE CALL

Nuvation Bio will schedule a conference call to discuss the acquisition after it has closed.

ADVISORS

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.

ABOUT NUVATION BIO

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 https://www.linkedin.com/company/nuvationbio/.

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, visit https://www.anhearttherapeutics.com/ and https://www.linkedin.com/company/anheart-therapeutics-official/.

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.

NUVATION BIO INVESTOR CONTACT:

ir@nuvationbio.com

NUVATION BIO MEDIA CONTACT:

nuvation@argotpartners.com

AMSTERDAM, the Netherlands, January 08, 2024 / B3C newswire / — Calypso Biotech BV (‘Calypso’), a leader in the development of Interleukin15 (IL-15) targeted therapies, announced today that it has entered into an agreement to be acquired by Novartis AG (‘Novartis’). Calypso’s shareholders will receive an upfront payment of $250 million upon closing and are eligible to receive development milestones of up to $175 million based on the achievement of certain predetermined milestones.

Calypso, a spin-out from Merck, is focused on the research and development of monoclonal antibodies for an array of autoimmune indications, with an expertise in IL-15 biology. IL-15 is a broad, untapped immune axis that controls barrier function and downstream immune cascades in many chronic autoimmune diseases. Calypso’s lead product candidate, CALY-002, is a potential best-in-class therapeutic antibody that binds to and neutralizes Interleukin-15.

The acquisition gives Novartis full rights to CALY-002. Novartis intends to further explore CALY-002 across a wide variety of autoimmune indications with high unmet medical need. CALY-002 is currently evaluated in a Phase 1b trial in patients with Celiac Disease and Eosinophilic Esophagitis.

We are excited for this transaction with Novartis, a company with relentless commitment to the development of innovative therapies for autoimmune conditions. As part of the Novartis portfolio, CALY-002 is in the best position to be developed effectively, so that it can promptly address unmet medical needs in multiple indications

The transaction with Novartis constitutes the high point in the development path of CALY-002 for the Calypso team. Calypso has established a significantly de-risked profile for CALY-002 as a potential best-in-class therapeutic anti-IL-15 antibody

Novartis is committed to bringing innovative treatment options forward for patients living with immunological diseases. We’re thrilled to add Calypso’s potential best-in-class antibody to our Immunology pipeline and explore it in a spectrum of autoimmune indications.

Lazard acted as financial advisor and Goodwin Procter LLP acted as legal counsel to Calypso.

About Calypso Biotech BV
Calypso is a private biotechnology company focused on the research and development of novel biologics to address unmet medical need in autoimmune and inflammatory diseases.

Calypso is developing a novel anti-IL-15 monoclonal antibody to treat a broad range of chronic autoimmune diseases by blocking Interleukin-15 (IL-15) and its wide-ranging functions at many levels of the immune response cascade. CALY-002, a highly potent monoclonal antibody, neutralizes all forms of IL-15 through a uniquely effective molecular mode of action to reduce inflammation and prevent tissue destruction.

Calypso was founded by M Ventures, the corporate strategic venture arm of Merck, and is headquartered in Amsterdam, The Netherlands, with offices and laboratories in Geneva, Switzerland. Investors include M Ventures, Inkef Capital, Gilde Healthcare, Fountain Healthcare Partners and Johnson & Johnson Innovation – JJDC, Inc.

For more information see www.calypsobiotech.com.

Our planet’s natural resources are increasingly under strain due to climate change and overconsumption. Novel and more eco-friendly solutions to how we produce food and essential everyday items are urgently needed to sustain a growing global population.

This is why we are excited to back twig, a UK-based bioengineering company that harnesses an AI-first approach to develop eco-friendly alternatives to everyday ingredients in consumer goods, and replace environmentally harmful chemicals and ingredients (e.g. acetone, palm oil, or isoprene), which are typically produced from fossil fuels, or hyper-intensive farming.

Founded by Dr. Russ Tucker (who previously founded UK cultivated meat pioneer Ivy Farm), Dr. James Allen, and Dr. Satnam Surae, twig is on a mission to radically improve the speed and efficacy of lab-based bioengineering, creating affordable, scalable, and dependable ingredients that producers can use in the everyday items the world relies on.

Dr. Russ Tucker, co-founder of twig highlights: 

“Many of the biggest little ingredients that go into the products we use in our daily lives are hugely damaging for the planet. This needs to change, and this needs to happen fast. (…) through the right combination of  AI and automation, we can deliver a step-change in bioengineering, driving a global transition from unsustainably resourced ingredients to bio-fermented ingredients in a way that benefits everyone – people, producers, and the planet.” 

twig’s new approach fundamentally reduces the time and costs of conventional bioengineering processes for developing potential ingredient strains. Combining AI and SynBio (synthetic biology), twig relies on three distinct tech pillars:

1) Bio:Builder: a best-in-class biological tool that allows it to create the building blocks to develop its new sustainable ingredients.

2) Grow:Bot: a dependable, programmable, and scalable robotics, enabling the manipulating and analysis of tens of thousands of bacteria variations each month.

3) ML:Bridge: twig’s AI connects the dots across the ever-growing standardised and formatted data library generated by Bio:Builder and Grow:Bot. ML:Bridge reviews production yields against target thresholds and recommends pathway improvements.

Since its beginnings in late 2022, twig has already tested thousands of strains through their automated platform in just five short months in the lab.

On why we invested, our Partner Tom Wilson comments:

“We believe the timing is perfect for seeing a real breakthrough in bioengineered products due to advancements in AI and automation. The Twig team have the perfect combination of technical and domain expertise to make their vision a reality and we’re thrilled to have the opportunity to partner with them.“

We are excited to participate in twig’s £3 million seed round, alongside Project A, Zero Carbon Capital, UK Innovation and Science Seed Fund, Gaingels, and expert angels.

For more information, visit twig.bio.

Thompson Street Capital Partners (TSCP), a private equity firm based in St. Louis, today announced the acquisition of Quanta BioDesign, the inventor of discrete polyethylene glycol (dPEG®) technology for advanced bioconjugate and payload delivery design for life science and biopharma applications, by Vector Laboratories, a portfolio company of TSCP and the pioneer of innovative proteomic and glycomic research solutions. This acquisition further expands Vector Laboratories’ portfolio of bioconjugation linkers and dyes and builds on its manufacturing and bioconjugation capabilities to better serve partners across biopharma and the life sciences. Terms of the transaction were not disclosed.

“This acquisition supports Vector Laboratories’ long-term strategic vision of accelerating the pace of scientific discovery for life science companies and transformational treatments and approaches for biopharma companies,” said Lisa V. Sellers, PhD, CEO of Vector Laboratories. “It also builds on our recent acquisition of Click Chemistry Tools and Fluoroprobes and goes beyond standard linker capabilities to serve broader industrial segments, expanding what’s possible for customers in manufacturing components for their end products. It truly demonstrates a new level of flexibility in what they can accomplish with our offerings.”

Quanta BioDesign develops patented and innovative cross-linking and labeling chemistries that incorporate and are uniquely enabled by their dPEG® technology, allowing for new approaches in the areas of therapeutic and diagnostic development. The Plain City, OH-based company was founded for the purpose of developing and commercializing an extensive line of dPEG® based products for companies involved in drug discovery and diagnostic development programs.

J.C. Wetzel, TSCP Managing Director, said, “We’re excited about the opportunity to continue executing against Vector Laboratories’ long-term growth strategy by bringing cutting-edge technology to an expanding customer base, increasing its range of products and services, and ultimately impacting the important work of biopharmaceutical companies developing the next generation of treatment options.”

Vector Laboratories acquired Click Chemistry Tools, a manufacturer of click chemistry linkers and labeling reagents, and Fluoroprobes, a leader in fluorescent probes and dyes earlier this year. Vector was the first company to commercialize avidin-biotin enzyme complex kits for immunohistochemistry and antifade mounting media for immunofluorescence. Since then, it has introduced more than 600 reliable reagents and kits through four decades of leadership in labeling and detection technologies.

We’re happy to welcome Guard Therapeutics, a Swedish biotech company that develops new therapies for acute kidney injury, to our portfolio. The company just announced they’ve raised 120 million SEK in new capital from a syndicate led by Industrifonden and including Swedbank Robur Fonder, Strand Kapitalförvaltning and Arctic Asset Management.

Guard Therapeutics develops novel therapies for diseases with a large medical need for more effective treatments. The company’s investigational drug RMC-035 recently received FDA Fast Track designation and is being developed as a kidney protective treatment in connection with open heart surgery. The newly raised capital will be used to secure the completion of the ongoing global phase 2 study (AKITA) and to finance selected preparatory phase 3 activities including CMC development.

Tobias Agervald, CEO at Guard Therapeutics, says: “We’re thrilled by the interest and response from a broad range of specialist and institutional investors. The capital provided by the syndicate led by Industrifonden will significantly broaden our investor base and enables us to run the phase 2 study in cardiac surgery to completion and initiate targeted preparatory activities for a subsequent registrational study.”

Fredrik Lehmann, Venture Partner at Industrifonden, says: “We are excited to support Guards’ mission to provide breakthrough treatment for patients with acute kidney injury.” 

Peter Wolpert, CEO at Industrifonden, adds: “Our investment focus is on private companies, but we’re truly impressed by the progress of Guard Therapeutics under Dr Agervalds leadership during the last years.”