ARCA BIOPHARMA ANNOUNCES $9.4 MILLION REGISTERED DIRECT OFFERING

On June 1, 2020 ARCA biopharma, Inc. (Nasdaq: ABIO) a late stage biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported that it has entered into a definitive securities purchase agreement with certain institutional and accredited investors to purchase, in a registered direct offering, 348,000 shares of ARCA’s common stock, at a purchase price of $9.00 per share, and pre-funded warrants to purchase 694,222 shares of common stock at a purchase price of $8.999 per warrant (Press release, Arca biopharma, JUN 1, 2020, View Source [SID1234560717]). The gross proceeds to ARCA, before deducting placement agent fees and other offering expenses, are expected to be approximately $9.4 million. Subject to customary closing conditions, the transaction is expected to close on Wednesday, June 3, 2020.

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JonesTrading Institutional Services LLC is acting as the exclusive placement agent for the offering.

ARCA anticipates that the net proceeds from this offering will be used to initiate its clinical trial of AB201 and for working capital and general corporate purposes.

The shares of common stock are being offered pursuant to a "shelf" registration statement on Form S-3 (File No. 333-238067), which was declared effective by the Securities and Exchange Commission (SEC) on May 20, 2020. A prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may be obtained, when available, from JonesTrading Institutional Services LLC by calling (212) 907-5332, or by e-mailing [email protected], or at the SEC’s website at View Source

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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

BioLineRx Announces $4.39 Million Registered Direct Offering

On June 1, 2020 BioLineRx Ltd. (Nasdaq: BLRX) (TASE: BLRX), a late clinical-stage biopharmaceutical company focused on oncology, reported that it has entered into definitive agreements with several healthcare-focused, institutional and accredited investors for the purchase and sale of 2,510,286 of the Company’s American Depositary Shares (ADSs), at a purchase price of $1.75 per ADS, in a registered direct offering (Press release, BioLineRx, JUN 1, 2020, View Source [SID1234558793]). BioLineRx has also agreed to issue and sell to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 2,510,286 ADSs. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The offering is expected to close on or about June 3, 2020, subject to satisfaction of customary closing conditions.

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

The warrants will have an exercise price of $2.25 per ADS and will be exercisable at any time upon issuance and will expire two and one-half years from the date of issuance.

The gross proceeds from the offering (without taking into account any proceeds from any future exercises of warrants issued in the concurrent private placement), before deducting the placement agent’s fees and other estimated offering expenses payable by the Company, are expected to be $4.39 million. BioLineRx intends to use the net proceeds for general corporate purposes, which may include but are not limited to working capital and funding clinical trials.

The ADSs (but not the warrants or the ADSs underlying the warrants) are being offered by BioLineRx pursuant to a "shelf" registration statement on Form F-3 (File No. 333-222332) originally filed with the U.S. Securities and Exchange Commission (the "SEC") on December 28, 2017 and declared effective by the SEC on January 19, 2018. The offering of the ADSs will be 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 ADSs being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the ADSs underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying ADSs may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

RedHill Biopharma to Present at BIO Digital

On June 1, 2020 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that Mr. Adi Frish, RedHill’s Senior Vice President Business Development and Licensing, will present a corporate overview at BIO Digital, taking place June 8-12, 2020 (Press release, RedHill Biopharma, JUN 1, 2020, View Source [SID1234558792]).

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The presentation will be available during the conference on-demand via View Source, as well as on the Company’s website, View Source for 30 days.

DelMar Pharmaceuticals to Present Updates of Two Phase 2 Clinical Trials of VAL-083 at the 2020 American Association for Cancer Research Virtual Annual Meeting II

On June 1, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported that two posters updating results from the company’s two Phase 2 clinical trials of VAL-083 will be presented at the 2020 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II to be held June 22-24, 2020 (Press release, DelMar Pharmaceuticals, JUN 1, 2020, View Source [SID1234558791]).

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Details regarding the posters to be presented in the Phase 2 Trials in Progress session are as follows:

Title: "Phase 2 trial of dianhydrogalactitol (VAL-083) in patients with newly diagnosed MGMT-unmethylated glioblastoma"
Lead Author: Dr. Zhong-Ping Chen, Sun Yat-sen University Cancer Center
Poster Number: CT273
Summary: This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at Sun Yat-sen University Cancer Center as a first line therapy, and includes updates on enrollment, safety and efficacy.

Title: "Phase 2 study of dianhydrogalactitol (VAL-083) in patients with MGMT-unmethylated, bevacizumab-naïve glioblastoma in the recurrent or adjuvant setting"
Lead Author: Dr. Barbara O’Brien, M.D. Anderson Cancer Center
Poster Number: CT272
Summary: This poster will include data from the company’s ongoing Phase 2 trial of VAL-083 being conducted at M.D. Anderson Cancer Center as a treatment in the recurrent and adjuvant settings, and includes updates on enrollment, safety and efficacy.

Additional posters relevant to VAL-083 to be available from the conference include:

Session: Mechanisms of DNA Damaging Therapeutics
Title: "Dianhydrogalactitol (VAL-083) synergizes with topoisomerase inhibitors to overcome homologous recombination repair activity in glioblastoma and prostate cancer cells"
Poster Number: 1369

Session: DNA-reactive Agents and Other
Title: "Dianhydrogalactitol (VAL-083) exhibits strong efficacy in GBM tumors with different (epi)genetic background and treatment history"
Poster Number: 5231

All abstracts can be accessed via View Source!/9045.

About VAL-083
VAL-083 (dianhydrogalactitol) is a "first-in-class", bifunctional DNA-targeting agent that introduces inter-strand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cancer cell death. VAL-083 has demonstrated clinical activity against a range of cancers including GBM and ovarian cancer in historical clinical trials sponsored by the U.S. National Cancer Institute (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity is unaffected by common mechanisms of chemoresistance, including MGMT, in cancer cell models and animal studies. Further details regarding these studies can be found at:

View Source

Compugen Announces FDA Clearance of IND Application for Phase 1/2 Triple Combination Study of COM701 with Bristol Myers Squibb’s Opdivo® (Nivolumab) and TIGIT Inhibitor

On June 1, 2020 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported that the U.S. Food and Drug Administration has cleared the investigational new drug (IND) application for its Phase 1/2 study evaluating the triple combination of COM701, Compugen’s first-in-class anti-PVRIG antibody, Opdivo (nivolumab), Bristol Myers Squibb’s PD-1 immune checkpoint inhibitor and BMS-986207, Bristol Myers Squibb’s investigational anti-TIGIT antibody, in patients with advanced solid tumors (Press release, Compugen, JUN 1, 2020, View Source [SID1234558790]).

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The triple combination study is designed to evaluate the simultaneous blockade of three immune checkpoint pathways, PVRIG, TIGIT and PD-1, and will accelerate the clinical evaluation of Compugen’s DNAM axis hypothesis and biomarker-driven approach in patients with advanced
solid tumors, including those that may be refractory or non-responsive to standard-of-care immune checkpoint inhibitors. The study is expected to commence in the second half of 2020.

"This study complements our clinical strategy designed to evaluate the blockade of PVRIG as a monotherapy and in combination with intersecting DNAM axis components to fully elucidate the role of this potentially foundational axis for cancer immunotherapy," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The encouraging clinical data from the ongoing COM701 Phase 1 study evaluating our discovered target PVRIG, and the emerging clinical validation of the TIGIT pathway, leave us increasingly enthusiastic about our science-driven clinical approach evaluating these two complementary yet distinct pathways in combination with PD-1. Importantly, as the only company with wholly-owned clinical candidates against both PVRIG and TIGIT, we are uniquely positioned to address the role of the DNAM axis."

Henry Adewoye, M.D., Senior Vice President and Chief Medical Officer of Compugen, added, "This study evaluating COM701 in combination with BMS-986207 and nivolumab fits our overall clinical development strategy of advancing novel therapies in cancers with high unmet medical need. We have previously reported partial responses with COM701 as monotherapy and in combination with nivolumab in patients with extremely challenging to treat cancer types, such as MSS platinum resistant primary peritoneal cancer and MSS-CRC. These preliminary clinical data support our preclinical work indicating that PVRIG and PD-1 are distinct pathways and that inhibition of the two may result in clinical benefit to patients. The triple combination will further test our science-driven hypothesis that PVRIG, TIGIT, and PD-1 are non-redundant inhibitory pathways and that their simultaneous blockade is expected to further enhance anti-tumor immune responses and broaden the patient population responsive to cancer immunotherapies. We look forward to collaborating with Bristol Myers Squibb on this important study."

Under this IND, the Company intends to initiate an open-label Phase 1/2 trial designed to evaluate the safety, tolerability and preliminary antitumor activity of COM701 in combination with Opdivo and BMS-986207 during dose escalation, as well as anti-tumor activity in selected tumor types in the expansion cohorts. Dose levels for Opdivo and BMS-986207 combinations have already been determined through prior testing by Bristol Myers Squibb, allowing for dose escalation of COM701 with fixed doses of Opdivo and BMS-986207.

About COM701
COM701 is a humanized antibody that binds with high affinity to PVRIG, a novel immune checkpoint discovered computationally by Compugen, and blocks the interaction with its ligand, PVRL2. TIGIT, an immune checkpoint discovered computationally by Compugen in 2009, and PVRIG constitute parallel immune checkpoint pathways that counteract DNAM, a costimulatory receptor on T cells and NK cells. Preclinical data suggest that the blockade of PVRIG induces a robust anti-tumor immune response and demonstrates synergistic activity when used in combination with inhibitors of TIGIT and/or PD-1. Currently, COM701 is being evaluated in a Phase 1 clinical study. Data from the ongoing study have shown that COM701 is well-tolerated and demonstrated preliminary signals of anti-tumor activity in a heavily pretreated patient population.