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Intention to Grant Notice – EU Patent for SDC-1802

On December 15, 2021 Sareum Holdings plc (AIM: SAR), the specialist drug development company delivering targeted small molecule therapeutics to improve the treatment of cancer and autoimmune diseases, reported that the European Patent Office has issued an Intention to Grant notice for a patent in respect of an invention associated with Sareum’s proprietary SDC-1802 TYK2/JAK1 Kinase Inhibitor Programme (Press release, Sareum, DEC 15, 2021, View Source [SID1234597211]).

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The patent (EPO Patent Application no. 17787186.0) will protect the SDC-1802 molecule and pharmaceutical preparations thereof as a therapeutic to treat TYK2-dependent T-cell acute lymphoblastic leukaemia (T-ALL – a cancer of a particular type of white blood cell called a T lymphocyte) by inhibiting TYK2 kinase. This programme is in preclinical development.

The Company expects that the patent will be formally granted within four months, subject to certain formalities being completed.

Sareum’s CSO, Dr John Reader, commented:

"Our aim is to build broad robust patent protection for our proprietary TYK2/JAK1 inhibitor candidates as they advance through their respective development programmes, to ensure that Sareum retains full value in these programmes as part of its business development discussions. We are pleased therefore to receive this ‘Intention to Grant’ notice from EPO around our patent application for SDC-1802 as a potential treatment for T-ALL. We expect to complete the formalities that would lead to a full grant of this patent in due course."

RedHill Biopharma Announces Additional Insider Buying

On December 15, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that members of its board of directors and senior management, including the Company’s Chairman & CEO, Mr. Dror Ben-Asher, collectively purchased approximately an additional 66,000 American Depositary Shares (ADSs) of RedHill since mid-October, 2021, in open-market transactions (Press release, RedHill Biopharma, DEC 15, 2021, View Source [SID1234597209]).

Pulmatrix Announces $6.75 Million Registered Direct Offering

On December 15, 2021 Pulmatrix, Inc. (Nasdaq: PULM) ("Pulmatrix" or the "Company"), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE technology, reported that it has entered into a definitive agreement with certain institutional investors for the issuance and sale of an aggregate of 6,745 shares of convertible preferred stock and warrants to purchase up to an aggregate of 5,620,834 shares of common stock for gross proceeds of $6.75 million in a registered direct offering (Press release, Pulmatrix, DEC 15, 2021, View Source [SID1234597208]). The shares of preferred stock will have a stated value of $1,000 per share and are convertible into an aggregate of 11,241,668 shares of common stock at a conversion price of $0.60 per share at any time. The warrants have an exercise price of $0.70 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the date of issuance. The closing of the offering is expected to occur on or about December 17, 2021, subject to the satisfaction of customary closing conditions.

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

The gross proceeds from the offering are expected to be approximately $6.75 million before deducting placement agent fees and other offering expenses. The Company currently intends to use the net proceeds from the offering for general corporate and working capital purposes.

The Company expects to call a special meeting of stockholders for the approval of a proposal to effect a reverse split of the common stock. The preferred stock has voting rights, with the common stock as a single class, equal to 5,000 votes per share of common stock underlying the preferred stock on the proposal, that, in accordance with Nasdaq listing rules, any votes cast by the preferred stock with respect to the proposal to effect a reverse split of the common stock must be counted by the Company in the same proportion as the aggregate shares of common stock voted on such proposal.

The securities described above are being offered and sold by Pulmatrix in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-256502), including a base prospectus previously filed with the Securities and Exchange Commission (the "SEC") on May 26, 2021, and became effective on June 9, 2021. The offering of such securities is being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at . Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (212) 856-5711 or e-mail at .

This press release shall 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.

Oncolytics Biotech® Announces the Presentation of Preclinical Data Demonstrating the Synergistic Anti-Leukemic Effects of Pelareorep Combined with Azacitidine at the 2021 American Society of Hematology Annual Meeting

On December 15, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported preclinical data demonstrating the synergistic anti-leukemic effects of pelareorep combined with the chemotherapeutic agent azacitidine (Press release, Oncolytics Biotech, DEC 15, 2021, View Source [SID1234597204]). The data were featured in a poster presentation at the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which took place from December 11-14, 2021, in Atlanta, Georgia.

Preclinical studies featured in the poster evaluated pelareorep in combination with azacitidine in acute myeloid leukemia (AML) cells in vitro and in a leukemia xenograft mouse model. Key data and conclusions from the poster include:

•Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant reduction (p<0.01) in tumor burden in a leukemia xenograft mouse model

•Compared to either treatment alone, treatment with pelareorep plus azacitidine led to a statistically significant (p<0.001) synergistic enhancement of anti-leukemic activity against AML cell lines, a benefit that was confirmed in AML patient samples in vitro

•The combination of pelareorep and azacitidine dramatically upregulated multiple genes known to drive anti-cancer immune responses such as IFNβ1, BATF2, IL-12β, CCL2, TLR3, and PD-L1

"These compelling preclinical findings, together with previously reported data demonstrating clinical proof-of-concept in multiple myeloma, indicate that pelareorep’s immunotherapeutic effects extend across multiple hematological malignancies. They also further highlight pelareorep’s potential to enhance the efficacy of a wide range of cancer therapeutics and have stimulated interest in investigator-sponsored clinical studies of pelareorep in leukemia," said Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics. "Given its ability to be administered intravenously without special handling procedures, pelareorep exerts a systemic effect that is uniquely suited to address liquid tumors compared to other oncolytic viruses. We look forward to leveraging collaborative relationships to continue evaluating pelareorep in hematological malignancies, which will allow us to potentially broaden its therapeutic impact while maintaining our primary focus on our lead breast cancer program."

A copy of the ASH (Free ASH Whitepaper) poster titled, "The Clinical Oncolytic Reovirus Formulation Reolysin Synergistically Augments the Anti-Leukemic Activity of Azacitidine," is available on the Posters & Publications page of Oncolytics’ website (LINK).

Navidea Biopharmaceuticals Terminates Stock Purchase Agreement

On December 15, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it has terminated the Stock Purchase Agreement that was executed on August 30, 2020 (Press release, Navidea Biopharmaceuticals, DEC 15, 2021, View Source [SID1234597201]).

On August 30, 2020, the Company entered into a Stock Purchase Agreement with each of the investors named therein (the "Investors"), pursuant to which the Investors agreed to purchase from the Company up to $25.0 million in shares of the Company’s common stock, par value $0.001 per share ("Common Stock"). The initial closings of the sale and purchase of the Common Stock (collectively, the "Initial Closing") were to occur within forty-five (45) business days after the date on which the Company’s application to the NYSE American for the listing of the Common Shares for trading thereon was approved by the NYSE American. The Investors agreed to purchase an aggregate of 1,000,000 shares of Common Stock at the Initial Closing at a purchase price of $5.00 per share. To date, we have received only $25,000 of the $5.0 million that was due at the Initial Closing. On December 14, 2021, the Company notified the Investors that it was terminating the Stock Purchase Agreement in accordance with its terms.