Immunovant Receives $200 Million Strategic Investment from Roivant Sciences

On August 2, 2021 Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage biopharmaceutical company focused on enabling normal lives for people with autoimmune diseases, reported that it has received a $200 million strategic investment from Roivant Sciences (Press release, Roivant Sciences, AUG 2, 2021, https://investors.immunovant.com/news-releases/news-release-details/immunovant-receives-200-million-strategic-investment-roivant [SID1234585515]). Immunovant intends to use the proceeds from this investment to advance the development of IMVT-1401 in multiple indications.

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Roivant has purchased 17,021,276 shares of Immunovant’s common stock at a price of $11.75 per share, which purchase has been approved by a special committee of Immunovant directors not affiliated with Roivant. This represents approximately a 15% premium to Immunovant’s 20 trading day volume weighted average price. After giving effect to the investment, Immunovant has a pro forma cash balance of approximately $600 million and Roivant has increased its ownership stake in Immunovant from 57.5% to 63.8%, based on Immunovant’s cash balance and share count as of March 31, 2021.

"We are excited to announce this significant investment by Roivant, which will expedite our development of IMVT-1401 for a wide range of autoimmune disorders," said Dr. Pete Salzmann, Chief Executive Officer of Immunovant. "Over the next 12 months, we plan to initiate a pivotal trial for myasthenia gravis, resume our trials in WAIHA and TED and initiate at least two additional clinical studies, including another pivotal trial in 2022."

"Roivant and Immunovant explored a range of possible transactions over the past few months, including a potential acquisition by Roivant of the minority interest in Immunovant, and ultimately agreed on this significant investment in order to support a robust development plan for IMVT-1401 and increase our stake in the company," said Matt Gline, Chief Executive Officer of Roivant Sciences. "We are incredibly excited about the prospects for IMVT-1401, and we are eager to support Immunovant through this investment. We look forward to continuing to work closely with Dr. Salzmann and the Immunovant management team to help develop IMVT-1401 to maximize benefit for patients with high levels of unmet medical need."

Oncternal Therapeutics to Participate in the BTIG Virtual Biotechnology Conference

On August 2, 2021 Oncternal Therapeutics (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that management will participate in the BTIG Virtual Biotechnology Conference being held August 9-10, 2021 (Press release, Oncternal Therapeutics, AUG 2, 2021, View Source [SID1234585536]).

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BTIG Virtual Biotechnology Conference – August 9-10, 2021

James Breitmeyer, President and Chief Executive Officer will present a corporate overview on Monday, August 9th at 12:00pm (ET), and the company will be available for one-on-one meetings.

Personalis, Inc. Publishes New Data Demonstrating a Novel Composite Biomarker NEOPS™ for Predicting Response to Cancer Immunotherapy in Late-Stage Melanoma Patients

On August 2, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced translational genomics and diagnostics for cancer, reported the publication of its study "Prediction of immunotherapy response in melanoma through combined modeling of neoantigen burden and immune-related resistance mechanisms,"(1) in Clinical Cancer Research, a journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Personalis, AUG 2, 2021, View Source [SID1234585551]).

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The study details the development of the Personalis Neoantigen Presentation Score (NEOPS), a novel composite biomarker for predicting response to cancer immunotherapy. Enabled by comprehensive tumor immunogenomic profiling from the Personalis NeXT Platform, NEOPS simultaneously models both neoantigen burden and immune-related resistance mechanisms to better predict immunotherapy response in a cohort of late-stage melanoma patients. In this study, NEOPS was more strongly predictive of therapy response than other standard single analyte and investigational biomarkers tested, including tumor mutational burden. Performance of this composite biomarker was initially tested on a cohort of late-stage melanoma patients receiving immune checkpoint blockade therapies and later validated on an independent dataset of similarly treated late-stage melanoma patients.

"Given the varied response to immunotherapy as well as the potential toxicities associated with treatment, there is a need for improved biomarker approaches to better predict which patients will respond to therapy," said Richard Chen, MD, Personalis CMO. "Our findings suggest that integrative, multi-omic biomarkers like NEOPS can be stronger predictors of response than simpler, single-analyte approaches, especially in the setting of new cancer therapies where the underlying biological mechanisms governing response are highly complex. We feel that NEOPS and other composite biomarkers will be important, sharper tools for enabling precision oncology."

NEOPS utilizes technology that Personalis has been developing since 2015 to better predict neoantigens and identify associated escape mechanisms such as HLA LOH. Our ImmunoID NeXT, and clinical NeXT Dx tests make this advanced capability, including NEOPS, available to pharmaceutical researchers and clinicians for clinical trials and investigational use, and additional clinical studies with other tumor types are planned.

Xencor to Present at Upcoming Investor Conferences

On August 2, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate in the following upcoming investor events and conferences (Press release, Xencor, AUG 2, 2021, View Source [SID1234585569]):

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Bernstein CD28 Day
Presentation: Monday, August 9, 1:00 p.m. ET (10:00 a.m. PT)
2021 Wedbush PacGrow Healthcare Virtual Conference
Panel: Tuesday, August 10, 1:10 p.m. ET (10:10 a.m. PT)
BTIG Virtual Biotechnology Conference 2021
Presentation: Tuesday, August 10, 3:30 p.m. ET (12:30 p.m. PT)
Canaccord Genuity 41st Annual Growth Conference
Presentation: Wednesday, August 11, 4:30 p.m. ET (1:30 p.m. PT)
Piper Sandler Virtual West Coast Bus Tour
Presentation: Thursday, August 12, 4:00 p.m. ET (1:00 p.m. PT)
A webcast of the presentation at the Canaccord conference will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Following the webcast, a replay will be archived on the website approximately for at least 30 days.

Evotec SE Announces Confidential Submission of Draft Registration Statement on Form F-1 with the U.S. Securities and Exchange Commission for a Proposed Offering of American Depositary Shares

On August 1 2021 Evotec SE (Frankfurt Stock Exchange; EVT, MDAX/TecDAX, ISIN: DE0005664809, WKN 566480) reported that it confidentially submitted a Registration Statement on Form F-1 ("Registration Statement") with the U.S. Securities and Exchange Commission ("SEC") for a proposed offering and sale in the United States of shares of Evotec represented by American Depositary Shares ("ADSs") (Press release, Evotec, AUG 1, 2021, View Source;announcements/ad-hoc-releases/p/evotec-se-announces-confidential-submission-of-draft-registration-statement-on-form-f-1-with-the-us-securities-and-exchange-commission-for-a-proposed-offering-of-american-depositary-shares-6080 [SID1234585507]). The Registration Statement has not yet become effective and the final number of ADSs to be offered and their price have not yet been determined.

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Evotec’s shares are listed on the regulated market of the Frankfurt Stock Exchange in Germany with additional admission obligations of the Prime Standard Segment. Evotec will seek a secondary listing of the ADSs on the Nasdaq Global Select Market in the United States under the ticker symbol "EVO". The new shares underlying the ADSs will be issued from Evotec’s authorized capital. The first day of trading of the ADSs is expected to occur during the second half of 2021, however, this timing remains subject to change.

The ADSs referred to in this announcement are to be offered only by means of a registration statement on Form F-1 approved by the SEC. In accordance with applicable capital markets requirements, Evotec will announce when the registration statement has been approved by the SEC, including further details, such as final number and price of ADS.

This announcement does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offers, solicitations, or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the U.S. Securities Act of 1933, as amended ("Securities Act"), and other applicable securities laws. This announcement is being issued in accordance with Rule 135 under the Securities Act and other applicable securities laws. This public disclosure of inside information does not constitute a prospectus.