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Announcement of Consolidated Financial Results Fiscal 2021

On February 7, 2022 Kyowa Hakko Kirin reported that Consolidated Financial Summary (IFRS)Fiscal 2021 (Press release, Kyowa Hakko Kirin, FEB 7, 2022, View Source [SID1234607779])

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1. Consolidated Financial Results for the Fiscal Year Ended December 31, 2021 (from January 1, 2021 to December 31, 2021)

(1) Consolidated operating results
(2) Consolidated financial position
(3) Consolidated cash flows

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2022 (from January 1, 2022 to December 31, 2022) Non-Consolidated Results for the Fiscal Year Ended December 31, 2021 (Japanese GAAP) (from January 1, 2021 to December 31, 2021)
(1) Non-consolidated operating results
(2) Non-consolidated financial position

These financial results reports are exempt from audit conducted by certified public accountants or an audit corporation.

* Notice regarding the appropriate use of the earnings forecasts and other special comments
The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.

For more information regarding our suppositions that form the assumptions for the earnings forecasts, please see pages 17 and 18 of the attachment, "(5) Outlook for Fiscal 2022" in "
1. Summary of Business Performance and Financial Position."

Notice Regarding Recording of Extraordinary Income in Non-consolidated Finacial Statements

On February 7, 2022 Kyowa Kirin Co., Ltd. (hereinafter, the "Company") reported that it has recorded extraordinary income in the non-consolidated financial statements for Fiscal 2021 (January 1, 2021 to December 31, 2021) (Press release, Kyowa Hakko Kirin, FEB 7, 2022, View Source [SID1234607778]). The details are as follows.

1. Details of extraordinary income The Company had provided an allowance for doubtful accounts for bonds issued by FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd., which is an associate accounted for using the equity method of the Company, that the Company had underwritten. However, given the fact that the bonds have started to be repaid and in consideration of the repayment schedule going forward, etc., the Company recorded extraordinary income of ¥29,834 million as reversal of allowance for doubtful accounts for subsidiaries and associates in the non-consolidated financial statements for the fiscal year ended December 31, 2021.

2. Impact on consolidated financial results Because the reversal of allowance for doubtful accounts for subsidiaries and associates was eliminated in the consolidated financial statements, there is no impact on the consolidated financial results.

Invitation to Presentation of Herantis Pharma’s 2H and Full Year Report 2021

On February 7, 2022 Herantis Pharma Plc ("Herantis"), developing disease modifying therapies for Parkinson’s disease, reported that the company will report 2H and Full Year report 2021 and hold a live webinar (in English) for investors, analysts and media on (Press release, Herantis Pharma, FEB 7, 2022, View Source,c3499761 [SID1234607777]):

Thursday, March 3rd, 2022, at 10:00 EET / 9:00 CET.

Herantis will publish the company’s 2H and Full Year 2021 report on March 3, 2022, at 8:00 EET /7:00 CET.

The management will present Herantis and comment on the 2H and Full Year 2021 Report followed by a live Q&A session. Please join the webinar a few minutes in advance.

US FDA Study May Proceed letter for Clarity’s Cu-64 SAR-bisPSMA trial in prostate cancer

On February 7, 2022 Clarity Pharmaceuticals (ASX: CU6) ("Clarity"), a clinical-stage radiopharmaceutical company developing next-generation products to address the growing needs in oncology, reported that it has received a confirmation from the US Food and Drug Administration (FDA) that the diagnostic 64Cu SAR-bisPSMA trial (COBRA) may proceed (Press release, Clarity Pharmaceuticals, FEB 7, 2022, View Source [SID1234607769]).

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are excited to be progressing this stand-alone diagnostic trial following a Study May Proceed letter from the US FDA as we head towards registering this product in the US. Following this exciting news, we are now planning to commence recruitment in the trial in the second quarter of CY2022."

COBRA (Copper-64 SAR-BisPSMA in Biochemically Recurrent prostAte cancer) is a Phase I/II Positron Emission Tomography (PET) trial of participants with biochemical recurrence (BCR) of prostate cancer following definitive therapy. It is a multi-centre, single arm, non-randomised, open-label trial of 64Cu-labelled SAR-bisPSMA in up to 50 participants. The primary objectives of the trial are to investigate safety and tolerability of 64Cu-SAR-bisPSMA as well as its ability to correctly detect recurrence of prostate cancer.

Prostate cancer is a key focus of Clarity’s Targeted Copper Theranostics (TCT) program where COBRA is the third clinical trial of the optimised SAR-bisPSMA agent in prostate cancer. The US-based theranostic 64Cu/67Cu SAR-bisPSMA trial, SECuRE (NCT04868604)1, has already demonstrated utility in patients with metastatic castrate resistant prostate cancer with imaging from 1 hour to 72 hours post-injection. The diagnostic 64Cu SAR-bisPSMA trial in Australia, PROPELLER (NCT04839367)2, is well underway, having reached its 50% recruitment milestone in untreated, confirmed prostate cancer patients (i.e. pre-radical prostatectomy) in December 2021. Clarity has previously received advice from the FDA that its prostate diagnostic clinical program with 64Cu SAR-bisPSMA is addressing the two relevant patient populations for registration: pre-prostatectomy/pre-definitive treatment as well as patients with suspected biochemical recurrence.

Dr Alan Taylor further commented, "The preliminary data from our SAR-bisPSMA trials in Australia and the US look very promising and the high uptake and retention of SAR-bisPSMA shown in preclinical and clinical trials to date may lead to improved detection in patients with prostate cancer, particularly those with low PSA levels. Our team and our collaborators are excited to commence the COBRA trial, generating more data to progress the development of SAR-bisPSMA as we move this product closer to registration in the US.

"We also look forward to further validating our on-demand distribution model as the trial sites will be supplied with ready-to-use cGMP 64Cu-SAR-bisPSMA product. Clarity’s vision is to move the diagnostic field towards centrally manufactured products that can be delivered on demand, shifting away from the supply constraints of the first generation of PET agents such as gallium-68 and fluorine-18 and the burdensome challenges of short-lived radionuclides. But most importantly, on-demand central manufacture of radiopharmaceuticals could potentially improve patient care by focusing on the needs of patients and their treating staff, delivering critical treatments that are safe and efficacious, on time and at any treatment centre with a PET camera."

Dr Neal Shore MD, FACS (CMO – Urology/Surgical Oncology, GenesisCare, US and the Medical Director of Carolina Urologic Research Centre), Principal Investigator in the COBRA trial, commented, "I am impressed by the images seen to date and look forward to working together with Clarity on the COBRA trial, exploring the clinical benefits of 64Cu SAR-bisPSMA in patients with BCR of prostate cancer. Higher uptake of the product in tumours may offer improvements in diagnosis of disease, which is particularly relevant for patients with suspected recurrence of prostate cancer. The ability to diagnose the disease earlier offers the potential to provide better treatment options earlier. When these benefits are combined with the ability to supply the products on demand and in large scale, this may be a game changer for prostate cancer management."

This announcement has been authorised for release by the Executive Chairman.

Statera Biopharma Announces Pricing of $2.0 Million Registered Direct Offering

On February 6, 2022 Statera Biopharma, Inc. (NASDAQ: STAB) (the "Company" or "Statera Biopharma"), a leading biopharmaceutical company creating next-generation immune therapies that focus on immune restoration and homeostasis, reported that it entered into a securities purchase agreement with a certain institutional investor to purchase approximately $2.0 million worth of its common stock and warrants in a registered direct offering (Press release, Cleveland BioLabs, FEB 6, 2022, View Source [SID1234607784]).

Under the terms of the securities purchase agreement, the Company has agreed to sell approximately 2.0 million shares of its common stock and warrants to purchase approximately 2.0 million shares of common stock. The warrants will be exercisable immediately, have an exercise price of $1.00 per share, and will expire five years from the initial exercise date. The purchase price for one share of common stock and one warrant will be $1.00.

The gross proceeds to the Company from the registered direct offering are estimated to be approximately $2.0 million, before deducting the placement agent’s fees and other estimated offering expenses. The offering is expected to close on or about February 9, 2022, subject to the satisfaction of customary closing conditions.

EF Hutton, division of Benchmark Investments, LLC, is acting as exclusive placement agent for the offering. Bridgeway Capital Partners is acting as the Company’s financial advisor.

Anthony L.G., PLLC is acting as legal counsel to Statera Biopharma, Inc. and Carmel, Milazzo & Feil LLP is acting as legal counsel to EF Hutton for the offering.

The proposed offering of the common stock and warrants described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238578) filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on May 29, 2020, and the accompanying prospectus contained therein.

The offering is being made only by means of a prospectus supplement and accompanying prospectus. A prospectus supplement describing the terms of the public offering will be filed with the SEC and will form a part of the effective registration statement.

Copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, on the SEC’s website at View Source or by contacting EF Hutton, division of Benchmark Investments, LLC Attention: Syndicate Department, 590 Madison Avenue, 39th Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 404-7002.

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 registration or qualification under the securities laws of any such state or jurisdiction.