Nuvation Bio Provides Corporate Update and Highlights Key 2022 Milestones

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) provided a corporate update ahead of the J.P. Morgan Healthcare Conference on January 11, 2022. The company anticipates multiple trial initiations and IND filings in 2022, including Phase 2 studies for NUV-422 and a Phase 1 study for NUV-868. Nuvation Bio reported a strong balance sheet with approximately $765 million in cash as of December 31, 2021. The CEO, David Hung, emphasized continued advancements in oncology therapeutics to address unmet patient needs in challenging cancer types.

Positive

• Strong cash position of approximately $765 million as of December 31, 2021.
• Multiple trials planned for NUV-422, including Phase 2 studies for high-grade glioma, advanced breast cancer, and prostate cancer.
• Fast Track Designation received for NUV-422 by the FDA.

Negative

• None.

David Hung, M.D., founder, president, and chief executive officer, to present virtually at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022 at 7:30 a.m. ET 

Multiple trials anticipated to initiate in 2022 as well as additional IND filings - 

•     Phase 2 monotherapy cohorts and Phase 1b combination studies for NUV-422
•     Phase 1 study of NUV-868 in advanced solid tumors
•     IND filing for NUV-569 in solid tumors

Strong balance sheet with cash, cash equivalents, and marketable securities of approximately $765 million as of December 31, 2021

NEW YORK, Jan. 10, 2022 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today provided a corporate update and highlighted key 2022 milestones in anticipation of its presentation at the 40^th Annual J.P. Morgan Healthcare Conference being held virtually January 10 – 13, 2022.

"We are proud of the significant strides Nuvation Bio made in 2021, including the ongoing progress of our Phase 1/2 study of NUV-422 in patients with high-grade glioma, hormone receptor-positive metastatic breast cancer, and metastatic castration-resistant prostate cancer. Since the trial initiated, the FDA has cleared three INDs for NUV-422 and granted it Fast Track Designation for the treatment of high-grade glioma, demonstrating the therapy's broad potential to address the significant unmet needs of patients with a variety of cancer types," said David Hung, M.D., founder, president, and chief executive officer of Nuvation Bio. "We look forward to building upon this momentum in 2022 with advancements across our deep pipeline of treatments for the most difficult-to-treat cancers." 

In 2022, Nuvation Bio seeks to achieve the following milestones across its broad pipeline of potential product candidates:

NUV-422, CDK 2/4/6: High-grade glioma, aBC, mCRPC

• Identify a recommended Phase 2 dose and initiate Phase 2 monotherapy dose expansion cohorts for NUV-422 in glioblastoma multiforme, advanced breast cancer (aBC), and metastatic castration-resistant prostate cancer (mCRPC)
• Initiate Phase 1b combination studies for NUV-422 in aBC and mCRPC
• Present safety data from NUV-422 Phase 1 dose escalation study

NUV-868, BD2 Selective BETi: Solid tumors

• Receive clearance from U.S. Food and Drug Administration (FDA) on an Investigational New Drug (IND) application for NUV-868 and initiate a Phase 1 study in patients with advanced solid tumors

NUV-569, Wee1i: Solid tumors

• File an IND for NUV-569 with the FDA for the treatment of patients with solid tumors

A2A and DDC Programs

• Select clinical candidates

Presentation at J.P. Morgan Healthcare Conference

David Hung, M.D., founder, president, and chief executive officer, will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 7:30 a.m. ET. The presentation will be webcast live and can be accessed under "Events & Presentations" in the "Investors" section of Nuvation Bio's website at www.nuvationbio.com.

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 six novel and 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.

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, statements regarding the potential therapeutic benefit of Nuvation Bio's product candidates and the expected timing of regulatory filings and clearance and clinical trial dose selection, initiation and data presentation. 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. Actual events and circumstances, many of which are beyond Nuvation Bio's control, are difficult or impossible to predict and may cause actual results to differ materially from those anticipated by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, the inherent uncertainty associated with pharmaceutical product development and clinical trials; the risk of unexpected emergence of adverse events or other undesirable side effects; delays in clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; disruptions to normal business operations relating to the COVID-19 pandemic; and developments in the competitive landscape. The risks and uncertainties facing Nuvation Bio are discussed more fully  in its Quarterly Report on Form 10-Q filed with the SEC on November 10, 2021, under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. There may be additional risks that Nuvation Bio does not presently know, or that Nuvation Bio currently believes are immaterial, that could also cause actual results to differ from those anticipated by the forward-looking statements. In addition, forward-looking statements reflect Nuvation Bio's expectations, plans or forecasts of future events and views only as of the date of this press release. Nuvation Bio anticipates that subsequent events and developments will cause its assessments to change. However, while Nuvation Bio may elect to update these forward-looking statements at some point in the future, Nuvation Bio specifically disclaims any obligation to do so.

Nuvation Bio Investor Contact:

ir@nuvationbio.com 

Nuvation Bio Media Contact:

Argot Partners
Leo Vartorella
leo@argotpartners.com 

View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-provides-corporate-update-and-highlights-key-2022-milestones-301456635.html

SOURCE Nuvation Bio, Inc.

FAQ

What key milestones are anticipated for Nuvation Bio in 2022?

Nuvation Bio plans to initiate multiple trials for its product candidates, including Phase 2 studies for NUV-422 and a Phase 1 study for NUV-868.

When will Nuvation Bio present at the J.P. Morgan Healthcare Conference?

Nuvation Bio will present virtually on January 11, 2022, at 7:30 a.m. ET.

What is the financial status of Nuvation Bio as of December 31, 2021?

As of December 31, 2021, Nuvation Bio had approximately $765 million in cash, cash equivalents, and marketable securities.

What is the significance of Fast Track Designation for NUV-422?

Fast Track Designation by the FDA indicates the potential of NUV-422 to address unmet medical needs in high-grade glioma and supports its expedited development.