• Roivant will develop RVT-2001 for the treatment of transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes
• Roivant JPM presentation scheduled for Monday, January 10, at 2:15 p.m. ET

Roivant Sciences (Nasdaq: ROIV), a next-generation biopharmaceutical company dedicated to improving the delivery of healthcare to patients, today announced that it has entered into a licensing agreement with Eisai Co., Ltd. for exclusive global rights to the investigational agent RVT-2001 (also known as H3B-8800), which will provide the lead program for a new subsidiary Vant.

RVT-2001 is an orally available small molecule modulator of splicing factor 3B subunit 1 (SF3B1) with over 80 human subjects exposed to date. Under the terms of the agreement, Eisai will receive an upfront payment, development and regulatory milestone payments, and royalties on sales revenue for RVT-2001.

Roivant plans to develop RVT-2001 as a first-in-class therapy for transfusion-dependent anemia in patients with lower-risk myelodysplastic syndromes (MDS). The company intends to conduct a robust open-label expansion of an ongoing clinical trial for RVT-2001 (ClinicalTrials.gov Identifier: NCT02841540) this year.

Additional details on RVT-2001 and the company’s development plan will be provided during Roivant’s presentation at the 40^th Annual J.P. Morgan Healthcare Conference. The presentation by Roivant’s chief executive officer, Matthew Gline, is scheduled for Monday, Jan. 10, 2021, at 2:15 p.m. ET. A livestream of the presentation will be accessible from the “Events & Presentations” page of Roivant’s website at https://investor.roivant.com/news-events/events and an archived recording of the presentation will be available for 30 days.

About Anemia in Lower-Risk MDS

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematologic malignancies characterized by cytopenias and abnormal blood cells. For patients with lower-risk MDS, anemia due to ineffective erythropoiesis leads to fatigue, dizziness, shortness of breath, and other symptoms which disrupt daily life. Time-consuming repeat red blood cell transfusions can result in iron overload and end-organ damage and current treatment options are ineffective for many patients.

About Roivant Sciences

Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch "Vants" – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.com.

Forward-Looking Statements

This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the "Securities Act"), and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), which are usually identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "would" and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team's expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. All product candidates referenced in this press release are investigational and subject to health authority approval.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.