On January 6, 2025 BioLineRx Ltd. (Nasdaq: BLRX) (TASE: BLRX) ("BioLineRx" or the "Company"), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has entered into definitive agreements for the purchase of an aggregate of 50,000,000 of the Company’s American Depositary Shares (ADSs) (or ADS equivalents) and accompanying warrants to purchase up to an aggregate of 50,000,000 ADSs, at a purchase price of $0.20 per ADS (or per ADS equivalent) and accompanying warrant in a registered direct offering (Press release, BioLineRx, JAN 6, 2025, View Source [SID1234649423]). The warrants will have an exercise price of $0.20 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date. Each ADS represents fifteen (15) ordinary shares, par value NIS 0.10 per share, of BioLineRx. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.

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

The aggregate gross proceeds to the Company from the offering are expected to be approximately $10 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering for research and development activities, the expansion of the Company’s pipeline of potential drug candidates, and working capital and general corporate purposes.

The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-276323) filed with the Securities and Exchange Commission ("SEC") on December 29, 2023 and declared effective on January 5, 2024. The offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the securities being offered will be filed with the SEC and be available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at [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.

On January 6, 2025 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC) (Press release, Tempest Therapeutics, JAN 6, 2025, View Source [SID1234649440]).

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"Receiving orphan drug designation for amezalpat to treat HCC underscores the critical need for new treatment options for patients suffering from this historically hard to treat disease," said Sam Whiting, M.D., Ph.D., chief medical officer and head of R&D of Tempest. "Tempest is dedicated to developing groundbreaking cancer treatments that will improve patients’ lives, and with broad agreement in hand from both the FDA and EMA, the team continues to prepare for a pivotal phase 3 study for amezalpat in first-line HCC patients."

This important regulatory designation follows positive data across multiple key study efficacy and safety endpoints in a global randomized Phase 1b/2 clinical study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic HCC. Notable positive outcomes of the randomized comparison include a six-month improvement in median overall survival (OS) with a hazard ratio (HR) of 0.65 for patients receiving the amezalpat combination therapy and an objective response rate (ORR) of 30% vs 13% favoring the amezalpat arm. In addition, survival benefit from the addition of amezalpat was preserved in key sub-populations including PD-L1 negative disease and b-catenin mutated disease, which is consistent with amezalpat’s proposed mechanism of action to target both the tumor cells directly and the patient’s immune system.

About Hepatocellular Carcinoma

HCC is an aggressive cancer with rising mortality and is projected to become the third leading cause of cancer death by 2030.2 Every year, more than 900,000 people worldwide are diagnosed with HCC.3 Incidence and mortality are highest in East Asia and are increasing in parts of Europe and the US. In the US, HCC represents the fastest-rising cause of cancer-related death.

Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.

Even if diagnosed in the early stage, an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.6 Early recurrence is associated with poorer prognosis and shorter survival.5,7 Tumor size, number of tumors, and portal vein invasion are associated with an increased risk of recurrence.

About Amezalpat

Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist. Data suggest that amezalpat treats cancer by targeting tumor cells directly and by modulating immune suppressive cells and angiogenesis in the tumor microenvironment. In a global randomized phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab in first-line patients with advanced HCC, the amezalpat arm showed clinical superiority across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to atezolizumab and bevacizumab alone, the standard of care. These randomized data were supported by additional positive results observed in the Phase 1 clinical trial in patients with heavily pretreated advanced solid tumors, including renal cell carcinoma and cholangiocarcinoma.

About Orphan Drug Designation

The FDA’s Orphan Drug Designation program provides orphan status to therapies intended for the treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the United States. This designation provides certain benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees and seven years of market exclusivity, if approved.

On January 6, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Verastem Oncology issued a press release on December 30, 2024 that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), who received at least one prior systemic therapy and have a KRAS mutation (Press release, Chugai, JAN 6, 2025, View Source [SID1234649424]). The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of June 30, 2025. In addition, the FDA has stated that it is not currently planning to hold an advisory committee meeting to discuss the application. Avutometinib was created by Chugai, and its clinical development is being conducted by Verastem Oncology.

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On January 6, 2025 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that Emil D. Kakkis, M.D., Ph.D., the company’s chief executive officer and president, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 10:30 AM PT (Press release, Ultragenyx Pharmaceutical, JAN 6, 2025, View Source [SID1234649441]).

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The live and archived webcast of the presentation will be accessible from the company’s website at View Source The replay of the webcast will be available for 30 days.

On January 6, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) reported that Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics, reported that it will present at the 43rd Annual J.P. Morgan Healthcare Conference being held in San Francisco, CA on Tuesday, January 14, 2025 at 4:30 p.m. Pacific Time (Press release, Crinetics Pharmaceuticals, JAN 6, 2025, View Source [SID1234649425]).

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To access the live webcast, click here. The archived webcast will also be accessible on the Events & Presentations page in the Investors section of the Crinetics’ website at www.crinetics.com/events.

If you are interested in arranging a 1×1 meeting with management, please contact your conference representative.