Curocell announces Korean FDA clearance of the IND for CRC01, a first in kind immune checkpoint receptors downregulated CD19 CAR-T therapy

On February 22, 2021 Curocell, Inc., a clinical-stage biotech developing next-generation CAR-T (OVIS) therapies, reported that the Ministry of Food and Drug Safety (MFDS) of Korea has approved its Phase 1/2 clinical study application for CRC01, CD19 CAR-T cell therapy in patients with relapsed/refractory diffuse large B-cell lymphoma(DLBCL) (Press release, Curocell, FEB 22, 2021, View Source [SID1234575408]). This study is expected to be initiated in the first half of 2021.

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"We are excited to receive Korea’s first IND clearance for a CAR-T therapy," said Gunsoo Kim, CEO of Curocell. "OVIS is a unique CAR-T platform that combines CAR-T with immune checkpoint receptor inhibition. This unique technology can be a breakthrough for patients who are difficult to treat with conventional CD19 CAR-T."

About CRC01

CRC01, recognized CD19 and is based on OVIS, a first in class CAR-T platform co-developed with KAIST. OVIS downregulates PD1 and TIGIT in the same viral vector, designed to express a CAR protein, allowing cost-effective and simple manufacturing. Curocell holds the global development and commercial rights for CRC01 and OVIS.

Acacia Pharma Group plc – Results of Placing – EUR 27 million Raised to Invest Further in US Launch and Commercialization Activities

On February 19, 2021 Acacia Pharma Group plc ("Acacia Pharma" or the "Company") (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or chemotherapy, reported the successful completion of the placing announced yesterday (the "Placing") (Press release, Acacia Pharma, FEB 19, 2021, View Source [SID1234575310]).

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Capitalized terms not otherwise defined in this announcement have the meanings given to them in the announcement made by the Company at 13:15 CET yesterday afternoon.

Pursuant to the Placing, Placees have agreed to subscribe for 10,000,000 New Ordinary Shares at a price of EUR 2.70 per share (the "Placing Price"), which represents a 6.9 % discount to the last trading share price on 18 February 2021. The Placing will raise gross proceeds of approximately EUR 27,000,000. The New Ordinary Shares issued pursuant to the Placing represent 11.1% of the Company’s issued share capital prior to the Placing.

Trading of Acacia Pharma shares was temporarily suspended as a result of the Bookbuild and shall resume today, as of the start of trading.

Bank Degroof Petercam SA/NV ("Degroof Petercam") is acting as Sole Bookrunner and Listing Agent (the "Sole Bookrunner" or the "Bank") in connection with the Placing.

Following issuance of the New Ordinary Shares, the total number of ordinary shares in issue in the Company will be 99,689,451.

Mike Bolinder, CEO of Acacia Pharma, commented: "We are very pleased with the rapid and successful completion of this Placing, which will provide us with the financial resources to support the continued launch and roll out of BARHEMSYS and BYFAVO in the US. As we reported in yesterday’s announcement, early progress in gaining formulary access for BARHEMSYS has been very promising, exceeding our expectations, and comparing very favorably with recent comparable US hospital product launches. Gaining formulary acceptance is a crucial step to driving sales longer term, and we are delighted with the very positive early market reception to the US launch of BARHEMSYS. We would like to thank our existing and new shareholders for their support and look forward to providing a further update on our progress at the time of our full year results in late March."

Acacia Pharma intends to use the net proceeds of the Placing:
(i) To meet its sales force and marketing costs relating to BARHEMSYS and BYFAVO including brand development and engagement with key opinion leaders, healthcare professionals and medical conference and speaker programs; NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, INTO OR WITHIN THE UNITED STATES, AUSTRALIA, CANADA, JAPAN OR SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE IT IS UNLAWFUL TO DISTRIBUTE THIS ANNOUNCEMENT 2
(ii) To continue implementing post-approval research and development commitments including pediatric studies for BARHEMSYS and BYFAVO and a renal study for BARHEMSYS;
(iii) To satisfy interest and principal payments under existing loan agreements; and
(iv) For general corporate purposes relating to ongoing commercial activities.

In connection with the Placing, the Company has agreed to a lock-up undertaking, not to issue additional shares for a period of 90 days following settlement of the Placing. In addition, in connection with the Placing, senior managers and directors of the Company as well as Cosmo Technologies Limited ("Cosmo"), a substantial shareholder in the Company, have agreed not to sell any shares in Acacia Pharma for a period of 90 days following the settlement of the Placing, subject to customary exceptions. Application has been made to Euronext Brussels for admission of the New Ordinary Shares issued pursuant to the Placing to trading on the regulated market of Euronext Brussels ("Admission"). It is expected that Admission will take place on or around 08:00 CET on 23 February 2021 (or such later time or date as the Bank may agree with the Company) and that unconditional dealings in the New Ordinary Shares issued pursuant to the Placing will commence at the same time. The Placing is conditional upon, inter alia, Admission becoming effective and the placing agreement between the Company and the Bank not being terminated in accordance with its terms.

The payment and delivery of the New Ordinary Shares is expected to take place on 23 February 2021. The New Ordinary Shares to be issued pursuant to the Placing will have the same rights and benefits as, and rank pari passu in all respects with, the Existing Ordinary Shares.

Y-mAbs to Announce 2020 Financial and Operating Results on February 25, 2021

On February 19, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the fiscal year ended December 31, 2020 on Thursday, February 25, 2021, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, FEB 19, 2021, View Source [SID1234575334]). The announcement will be followed by a conference call and webcast with the investment community on Friday, February 26, 2021, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

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Citius Pharmaceuticals Announces Closing of $76.5 Million Registered Direct Offering Priced At-the-Market under Nasdaq Rules

On February 19, 2021 Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, reported that it has closed its previously announced sale of an aggregate of 50,830,566 shares of its common stock and accompanying warrants to purchase up to an aggregate of 25,415,283 shares of its common stock, at a purchase price of $1.505 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules (Press release, Citius Pharmaceuticals, FEB 19, 2021, View Source [SID1234575335]).

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The warrants have an exercise price of $1.70 per share, are immediately exercisable, and will expire five years from the issue date.

The aggregate gross proceeds to the Company from the offering are approximately $76.5 million, before deducting the placement agent fees and other offering expenses payable by the Company. Citius currently intends to use the net proceeds from the offering for general corporate purposes, including pre-clinical and clinical development of our product candidates and working capital and capital expenditures.

The securities described above were offered pursuant to a "shelf" registration statement (File No. 333-248748) filed with the Securities and Exchange Commission (SEC) and declared effective on September 25, 2020, and an additional registration statement on Form S-3 (File No. 333-253179) filed on February 16, 2021 pursuant to Rule 462(b), which became effective automatically upon filing. The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the securities that were offered has been filed with the SEC and is available at the SEC’s website at www.sec.gov. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the securities in the offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

Fate Therapeutics to Webcast Conference Call Reporting Fourth Quarter and Full Year 2020 Financial Results

On February 19, 2021 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer, reported that the Company will host a conference call and live audio webcast on Wednesday, February 24, 2021 at 5:00 p.m. ET to report its fourth quarter and full year 2020 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 19, 2021, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-6 [SID1234575318]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 6368962. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.