On February 19, 2021 Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM) (Press release, Immunocore, FEB 19, 2021, View Source [SID1234575332]).

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Bahija Jallal, Chief Executive Officer of Immunocore, said: "We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020. There is an urgent need for an approved treatment for this rare and aggressive form of melanoma and we look forward to continuing to work with regulators to bring tebentafusp to patients as quickly as possible."

In an initial pre-planned interim analysis of a randomized Phase 3 clinical trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, tebentafusp demonstrated superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved when the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).

The Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

Tebentafusp has also been granted Fast Track Designation and orphan drug designation from the FDA for uveal melanoma and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme. Immunocore will be working with the FDA to facilitate submission of a BLA for tebentafusp. If approved, Immunocore believes tebentafusp would be the first new therapy for the treatment of metastatic uveal melanoma in 40 years.

On February 19, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its fourth quarter and full-year 2020 financial results on Thursday, February 25, 2021 (Press release, Gossamer Bio, FEB 19, 2021, View Source [SID1234575331]).

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In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 8:30 a.m. ET on Thursday, February 25, 2021, to discuss the Company’s financial results and provide a corporate update.

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

On February 19, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biopharmaceutical company engaged in the discovery and development of novel cell therapies for oncology and other indications, in conjunction with an announcement to be issued by Legend Biotech’s majority parent company, GenScript Biotech Corporation, pursuant to the rules of The Stock Exchange of Hong Kong Limited, reported preliminary, unaudited financial results for the year ended December 31, 2020 (Press release, Legend Biotech, FEB 19, 2021, View Source [SID1234575330]).

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For the year ended December 31, 2020, Legend Biotech expects to record a loss for the year of approximately US$292.2 million to US$324.9 million and an adjusted loss for the year of approximately US$202.4 million to US$234.4 million, in each case, including research and development expenses of approximately US$220.7 million to US$255.6 million, which was mainly caused by the continuous investment into its lead product candidate, ciltacabtagene autoleucel, and other product candidates in Legend Biotech’s pipeline. See "Use of Non-IFRS Financial Measures" for a reconciliation of Loss for the year to Adjusted loss for the year.

In addition, Legend Biotech expects to report a one-time non-cash fair value loss of approximately US$80.0 million caused by the changes of fair value of Legend Biotech’s Series A convertible redeemable preferred shares ("Series A Preferred Shares"), which was derived from the automatic conversion of all outstanding Series A Preferred Shares (plus dividends accrued but unpaid on the Series A Preferred Shares) into ordinary shares, par value $0.0001 per share, of Legend Biotech ("Ordinary Shares") upon Legend Biotech’s listing on the Nasdaq Global Select Market. The details of the automatic conversion of the Series A Preferred Shares into Ordinary Shares are described in Legend Biotech’s prospectus filed with the Securities and Exchange Commission on June 8, 2020. The changes in fair value led to an increase of share premium, which had no material impact on the net assets of Legend Biotech and its subsidiaries.

As of December 31, 2020, Legend Biotech had approximately US$455.7 million of cash and cash equivalents and approximately US$50.0 million in time deposits.

The financial information contained in this press release is preliminary and is based on the latest estimated unaudited management accounts for the year ended December 31, 2020. Because Legend Biotech has not yet completed its financial closing procedures for the year ended December 31, 2020, Legend Biotech has provided a range for the preliminary results described above. Such information is not a comprehensive statement of Legend Biotech’s results for, and as of, this year, and are subject to the completion of management’s and Legend Biotech’s audit committee’s reviews and other financial closing processes and potential adjustments. Accordingly, Legend Biotech’s actual results as of, and for, the year ended December 31, 2020 may differ materially from the preliminary estimated data presented in this press release. As a result, it is possible that Legend Biotech’s final results will not be within the ranges presented.

The information contained in this press release has not been, and is not based on information that has been, audited, or reviewed by Legend Biotech’s independent auditor. Investors are cautioned not to place undue reliance on these preliminary estimates.

This preliminary estimated data should not be considered a substitute for the audited financial results for the year ended December 31, 2020, to be filed with the Securities and Exchange Commission (the "SEC") on Form 20-F, which Legend Biotech expects to occur before the end of April 2021.

Use of Non-IFRS Financial Measures

The following table provides a reconciliation of Legend Biotech’s Loss for the year to Adjusted loss for the year:

Adjusted loss for the year is a non-IFRS financial measure. Legend Biotech is reporting Adjusted loss for the year because this financial measure is to be reported as part of a Profit Warning announcement issued by Legend Biotech’s majority parent company, GenScript Biotech Corporation, pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited. Adjusted loss for the year has limitations in that it does not reflect all expense items that affect Legend Biotech’s results.

Non-IFRS measures are not meant to be considered in isolation or as a substitute for financial information presented in accordance with IFRS and should be viewed as supplemental and in addition to Legend Biotech’s financial information presented in accordance with IFRS.

About Ciltacabtagene autoleucel (cilta-cel)

Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 outside of China and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed and/or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. to develop and commercialize cilta-cel.

In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020.

On February 19, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the commencement of a registered underwritten public offering of up to $100 million in shares of its common stock (Press release, Y-mAbs Therapeutics, FEB 19, 2021, View Source [SID1234575329]). All shares in the offering are expected to be offered by the Company. In addition, the Company intends to grant the underwriters a 30-day option to purchase up to $15 million in shares of its common stock.

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J.P. Morgan, Morgan Stanley, and BofA Securities are acting as the joint book-running managers for the proposed offering. The offering is subject to market and other customary closing conditions, and there can be no assurance as to whether or when the offering may be completed.

A shelf registration statement relating to the shares of common stock being offered in the public offering described above was filed on Form S-3 (Reg. No. 333-234034) which was declared effective by the Securities and Exchange Commission (SEC) on October 15, 2019. The securities may be offered only by means of a written prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: J.P. Morgan, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, or by telephone at (866) 803-9204; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, Second Floor, New York, New York 10014 or BofA Securities, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by emailing [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 19, 2021 Calyxt, Inc. (NASDAQ: CLXT), a plant-based technology company, reported that the Board of Directors has appointed Yves Ribeill, Ph.D., to the new role of Executive Chair of the Board effective immediately (Press release, Cellectis, FEB 19, 2021, View Source [SID1234575327]). Dr. Ribeill will serve in this role while Calyxt initiates a search for a new Chief Executive Officer to replace Jim Blome, who is leaving to pursue other opportunities. Calyxt has retained a premier executive search firm to lead the search. Based on his long experience in the biotech and innovation fields, Dr. Ribeill will help guide the CEO search on behalf of the Board and support the transition once the incoming CEO is selected.

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"On behalf of the Board, we want to thank Jim for guiding Calyxt to a streamlined business model that can capitalize on delivering disruptive, plant-based innovations, said Yves Ribeill, Ph.D., Chair of the Calyxt Board. "He led Calyxt to a strong 2020, redirected Calyxt’s innovation engine to new and high-value opportunities and built a team with the right talent mix to drive Calyxt’s go-to-market strategies. Jim has positioned Calyxt for future growth and success, and we wish Jim all the best in his future pursuits." This action represents a continuing step to focus Calyxt on significant innovation opportunities beyond commodity-based agriculture," concluded Dr. Ribeill.

"I am proud of what Calyxt has been able to accomplish during my tenure as CEO and I am honored to have had the opportunity to lead the talented Calyxt team to this important level," said Mr. Blome. "I believe Calyxt is poised to capitalize on the unlimited possibilities that can be created with its plant-based innovations and have confidence that the Calyxt team will continue to leverage and expand Calyxt’s position as a global leader in plant gene editing."

Dr. Ribeill has served as a member of the Calyxt board since July 2018 and as Calyxt’s interim Chief Executive Officer from August 2018 until October 2018. Since January 2018, he has served as the Chief Executive Officer of Ribogenics, Inc., which is a private biotechnology company working on RNA biology. Dr. Ribeill was also a founder of SCYNEXIS, Inc. (NASDAQ: SCYX), served as its Chief Executive Officer from November 1999 until April 2015. Dr. Ribeill has more than 35 years of experience in the healthcare industry, with an expertise in anti-infective diseases. Prior to moving to the U.S. 21 years ago, Dr. Ribeill held several management positions during his international career with Rhône-Poulenc and Aventis in France and in the UK. Dr. Ribeill was a member of the Scientific Advisory Committee of the World Health Organization and the Medicines for Malaria Venture in Geneva.