TSL Express Daily News

NEW YORK--(BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today announced non-dilutive financings of up to $250 million with Sagard Healthcare Partners (Sagard). The transaction comprises a royalty interest financing of $150 million and a senior term loan of up to $100 million. These financings strengthen Nuvation Bio’s balance sheet to fully fund commercialization of taletrectinib in the U.S., if approved, and development of the Company’s current clinical-stage pipeline. The transaction also provides Nuvation Bio with a path to potential profitability without the need to raise additional capital.

“This transaction is a significant milestone for Nuvation Bio as we prepare to bring taletrectinib to the U.S. market, subject to FDA approval, in mid-2025,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “With these financings, we are well positioned to launch taletrectinib and drive continued development of our clinical-stage pipeline—all without the need for additional fundraising. This also improves our flexibility to pursue strategic opportunities to deploy our capital . We are thrilled to have support from Sagard and appreciate their shared confidence in taletrectinib and Nuvation Bio as we continue toward our goal of improving outcomes for patients with cancer.”

Subject to the approval of taletrectinib by the U.S. Food and Drug Administration (FDA) on or prior to September 30, 2025, Sagard will provide Nuvation Bio with an upfront cash payment of $150 million. In return, Sagard will receive tiered royalties on U.S. net sales of taletrectinib, including 5.5% of annual U.S. net sales up to $600 million and 3.0% of annual U.S. net sales between $600 million and $1 billion. Nuvation Bio will retain all annual U.S. net sales above $1 billion. Payments to Sagard will cease upon the earliest occurrence of total royalties reaching 1.6 times its investment by June 30, 2031, 1.75 times its investment by June 30, 2034, or 2.0 times its investment thereafter.

“We are excited to partner with Nuvation Bio, an organization with deep oncology expertise and a commitment to delivering transformative therapies,” said Raja Manchanda, Partner at Sagard Healthcare Partners. “We believe taletrectinib has the potential to redefine the treatment landscape for patients with ROS1-positive non-small cell lung cancer, and we are pleased to provide a structured financing that supports both potential near-term commercialization and long-term growth.”

In addition to the royalty financing, Sagard has committed to a 5-year, senior secured term loan of up to $100 million, with $50 million to be funded upon U.S. FDA approval of taletrectinib on or prior to September 30, 2025. The second tranche of $50 million is available at Nuvation Bio's option until June 30, 2026, as long as Nuvation Bio has achieved first U.S. commercial sale of taletrectinib. The term loan will bear interest at SOFR + 6.00%, subject to a 4.00% SOFR floor. There are no scheduled amortization payments associated with the term loan, with all outstanding principal due at maturity.

TD Cowen served as financial advisor and Cooley LLP served as legal advisor to Nuvation Bio. Sidley Austin LLP served as legal advisors to Sagard.

About Sagard

Sagard is a multi-strategy alternative asset management firm with over US$25B under management, 150 portfolio companies, and 400 professionals. Sagard invests in venture capital, private equity, private credit, and real estate. Sagard delivers flexible capital, an entrepreneurial culture, and a global network of investors, commercial partners, advisors, and value creation experts. Sagard’s dynamic and supportive ecosystem gives its partners the advantage they need to learn, grow and win at every stage. The firm has offices in Canada, the United States, Europe and the Middle East.

About Nuvation Bio

Nuvation Bio is a global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel product candidates. Nuvation Bio’s programs include taletrectinib (ROS1), safusidenib (mIDH1), NUV-1511 (DDC), and NUV-868 (BET). 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, San Francisco, Boston, and Shanghai. For more information, please visit www.nuvationbio.com or follow the Company on LinkedIn and X (@nuvationbioinc).

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, our expectations regarding U.S. FDA approval and commercial launch of taletrectinib, and the timing thereof, receipt and use of proceeds from the financings to fully fund U.S. commercial launch of taletrectinib and development of Nuvation Bio’s current clinical-stage pipeline, the path to potential profitability without need to raise additional capital, and the potential of taletrectinib to redefine the treatment landscape for patients with ROS1-positive non-small cell lung cancer. 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 challenges associated with conducting drug discovery and initiating or conducting clinical studies 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-Q filed with the SEC on November 6, 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.