On February 19, 2021 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that it will announce fourth quarter and full year 2020 financial results on Thursday, February 25, 2021 (Press release, Cyclacel, FEB 19, 2021, View Source [SID1234575333]). The company will host a conference call and live webcast at 4:30 p.m. Eastern Standard Time on the same day.

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For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.

On February 19, 2021 Octapharma reported that New expert consensus guidelines on the use of immunoglobulin replacement therapy (IgRT) in patients with haematological malignancy and secondary antibody deficiencies (SAD) were recently published in the European Journal of Haematology (Press release, Octapharma, FEB 19, 2021, View Source [SID1234575392]).

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The publication, sponsored by Octapharma, marks the first pan-European consensus guidance on the use of IgRT in patients with hypogammaglobulinaemia secondary to haematological malignancies and aims to support harmonisation of clinical practice across Europe.

Octapharma has a longstanding commitment to improving the management of patients with secondary immunodeficiencies (SID) and in 2020 launched PRO-SID, a phase III clinical trial investigating primary infection prophylaxis with intravenous immunoglobulin (IVIg) in patients with chronic lymphocytic leukaemia (CLL). These efforts address the need for both robust clinical data and unified guidance on managing infection risk in patients with SID.

Absence of guidance leaves patients at risk

SAD is a common complication in patients with haematological malignancies such as CLL and multiple myeloma (MM). Up to 85% of CLL patients and up to 83% of patients with smouldering MM have low immunoglobulin levels, which leaves patients more susceptible to infections1,2. Infections are the likely cause of death in 22% of patients with MM and up to 50% of patients with CLL3,4. IgRT is effective at reducing the risk of infections in patients with haematological malignancies5.

In 2019, the EMA approved an expanded use of IVIg in patients with SID6. However, detailed European guidelines on the use of IgRT in patients with haematological malignancies and SAD were lacking. Differences in treatment approaches to reduce the infection burden remain significant across Europe, including different strategies for initiation, dosing and discontinuation of IgRT.

Stephen Jolles, lead author of the publication and Professor at the Immunodeficiency Centre for Wales in Cardiff, UK, commented: "Developing consensus guidelines for the use of IgRT in secondary antibody deficiency (SAD) aims to address a major need for treatment recommendations for patients with haematological malignancies and SAD. IgRT can reduce morbidity and mortality in a selected group of these patients and it is important that physicians have consistent guidance on defining this group and managing infection risk."

A Task Force of eight experts in immunology and haemato-oncology developed statements on key aspects of IgRT, which were reviewed by a panel of 32 European experts. This Delphi consensus exercise developed clear recommendations for SAD due to haematological malignancies such as: measurement of IgG levels at the beginning of anti-cancer treatment; initiation of IgRT in patients who have received appropriate anti-infective therapy during or after a single severe infection or during recurrent or persistent infections when IgG levels are <4 g/l or if test immunization has failed; initiation of IgRT with a minimum IgG dose of 0.4 g/kg bodyweight every 3-4 weeks or stopping IgRT after at least 6 months without infections and concomitant evidence of immunological recovery. The 21 consensus statements emphasise the importance of IgRT for patients with SAD who experience severe, recurrent or persistent infections and provide guidance on initiation, dosing and discontinuation of IgRT, as well as measurement of IgG levels and the use of subcutaneous immunoglobulin (SCIg) therapy. The publication is available through open access at "Treating Secondary Antibody Deficiency in Patients with Haematological Malignancy: European Expert Consensus".

More information on SID in patients with haematological malignancies, including detailed information on the recent consensus guidelines, can be found at View Source

Patient recruitment continues for the PRO-SID study

Recruitment for the phase III PRO-SID study (NCT04502030) of IVIg in patients with CLL and SID is underway, in 22 sites across 7 countries. The PRO-SID study is investigating the efficacy and safety of IVIg (Panzyga) as primary prophylaxis in patients with CLL and SID. Secondary prophylaxis with IVIg is an established approach to reduce the rate of infections in patients with haematological malignancies and SAD, but there is a need for robust data on IVIg as primary infection prophylaxis, i.e. before a major infection occurs7.

Commenting on Octapharma’s involvement in the field of SID, Olaf Walter, Board Member at Octapharma, said that: "Infections remain a serious concern for patients with haematological malignancies and SID, and at Octapharma we continue to strive for a better understanding of how to minimise the risk of such potentially life-threatening complications."

About the PRO-SID study

The PRO-SID study (NCT04502030) is a prospective, double-blind, randomised, multi-centre, placebo-controlled, interventional, phase III study investigating the efficacy and safety of Panzyga in patients with chronic lymphocytic leukaemia (CLL) and hypogammaglobulinaemia (IgG < 5 g/L) who are receiving antineoplastic treatment. The study is conducted at multiple sites across Europe (Italy, Poland, Denmark, Hungary, Germany and Russia) and the USA and plans to recruit at least 240 patients.

About Panzyga

Panzyga is a 10% human normal immunoglobulin solution ready for intravenous administration. Panzyga is approved for use in treatment of primary immunodeficiency and idiopathic thrombocytopenic purpura in the USA, Europe and Canada. It is also approved for secondary immunodeficiencies and Guillain Barré syndrome in Europe and Canada and for Kawasaki disease, chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) in Europe.

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.

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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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.