On July 17, 2023 Evogene Ltd. ("Evogene") (Nasdaq: EVGN) (TASE: EVGN), a leading computational biology company aiming to revolutionize life-science-based product discovery and development utilizing cutting-edge computational biology technologies across multiple market segments, reported that it has entered into securities purchase agreements with institutional investors (including SilverArc Capital Management, Altium Capital Management, LP and CVI Investments, Inc.) for the purchase and sale of 8,500,000 ordinary shares in a registered direct offering at a purchase price of $1.00 per ordinary share (the "offering") (Press release, Evogene, JUL 17, 2023, View Source [SID1234633260]).

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The closing of the offering is expected to occur on or about July 19, 2023, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $8,500,000 before deducting placement agent fees and other offering expenses. Evogene intends to use the net proceeds of this offering to further develop its and its subsidiaries’ product pipelines, to further enhance and expand its CPB (Computational Predictive Biology) platform and technological engines and for working capital and general corporate purposes.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

The ordinary shares will be issued in a registered direct offering pursuant to an effective shelf registration statement on Form F-3 (File No. 333-253300) previously filed with the U.S. Securities and Exchange Commission (the "SEC"), under the Securities Act of 1933, as amended (the "Securities Act"), and was declared effective by the SEC on March 3, 2021. A prospectus supplement describing the terms of the proposed registered direct offering will be filed with the SEC and once filed, will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

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.

On July 17, 2023 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. And a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported that the U.S. Food and Drug Administration (FDA) accepted a new drug application (NDA) for its investigational drug rivoceranib, an oral TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line treatment option for unresectable hepatocellular carcinoma (uHCC) (Press release, Elevar Therapeutics, JUL 17, 2023, View Source [SID1234633259]). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 16, 2024.

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"Rivoceranib plus camrelizumab has demonstrated the potential to improve the lives of those confronted with unresectable hepatocellular carcinoma," said Saeho Chong, Elevar chief executive officer. "With the FDA’s acceptance of our new drug application, we are pleased to reach another milestone in the development of this combination therapy. We look forward to working closely with the FDA during this review process and are focused on making the combination commercially available as quickly as possible should we gain approval."

The NDA is supported by clinical data from the Phase 3 CARES 310 study (NCT03764293), in which rivoceranib plus camrelizumab demonstrated statistically significant and clinically meaningful prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate versus sorafenib, a standard first-line treatment for uHCC.

Results from the randomized, open-label, international trial, which included 543 patients and was conducted at 95 study sites across 13 countries/regions, demonstrated median OS for camrelizumab + rivoceranib of 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5] for sorafenib; hazard ratio 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001. Median PFS for camrelizumab + rivoceranib was 5.6 mos. [95% CI 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; HR 0.52 [95% CI 0.41-0.65]); 1-sided p<0.0001, and confirmed objective response rate for camrelizumab + rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib.

With efficacy results generally consistent across all subgroups, the data suggested the combination confers a benefit in a global uHCC population. Also, it demonstrated efficacy among those with hepatitis C virus-based etiology and non-viral etiology, which comprises the majority of U.S. HCC cases1.

In February 2023, the combination therapy of rivoceranib and camrelizumab was approved by the National Medical Products Administration (NMPA) as a first-line treatment for liver cancer in China.

Elevar is also developing rivoceranib as a monotherapy treatment option for adenoid cystic carcinoma (ACC), and as mono and combination therapies in other tumor cell types.

To learn more, visit ElevarTherapeutics.com.

1Ghouri YA, Mian I, Rowe JH. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog. 2017 May 29;16:1. doi: 10.4103/jcar.JCar_9_16. PMID: 28694740; PMCID: PMC5490340.

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Rivoceranib

Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression.

Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China as a first-line treatment for uHCC (February 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.).

Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) and treatment settings.

Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021.

On July 17, 2023 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncology, inflammatory and liver diseases, reported its abstract titled "A novel approach for the treatment of advanced hepatocellular carcinoma (HCC)" is one of the highest scoring abstracts and has won the prestigious Breakthrough Abstract Award from Conquer Cancer, the ASCO (Free ASCO Whitepaper) Foundation, and the 2023 ASCO (Free ASCO Whitepaper) Breakthrough Program Committee (Press release, Can-Fite BioPharma, JUL 17, 2023, View Source [SID1234633258]).

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Can-Fite’s Chief Scientific Officer, Founder, and Executive Chairman, Dr. Pnina Fishman, will present the poster at the ASCO (Free ASCO Whitepaper) Breakthrough Meeting which will take place August 3 – 5, 2023 in Yokohama, Japan.

Namodenoson has received significant acknowledgment in the scientific and medical community, as evidenced by the numerous peer-reviewed publications and conferences in which it has been published and presented. Currently being evaluated in a pivotal Phase 3 multinational registration trial for the treatment of HCC and underlying Child Pugh B7, Namodenoson has also completely cleared cancer in an HCC patient who was enrolled in Can-Fite’s Phase 2b HCC trial. The patient continues to be treated through a compassionate use program in Romania, where she remains cancer-free more than six years following her first dose of Namodenoson.

"We are honored to receive this prestigious award from Conquer Cancer and ASCO (Free ASCO Whitepaper)," Dr. Fishman stated. "Our Phase 3 registration trial is designed to treat patients who have tried, yet not benefitted from the few other FDA-approved HCC treatments on the market today. We are hopeful that Namodenoson, with its liver-protective properties, can safely prolong life for advanced liver cancer patients."

About Namodenoson

Namodenoson was evaluated in Phase 2 trials for two indications, as a second line treatment for hepatocellular carcinoma (HCC), and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). It is currently in a Phase 2b trial for NASH and a pivotal Phase 3 for HCC. Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

On July 17, 2023 C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science to develop a new generation of small-molecule medicines and transform how disease is treated, reported that the independent directors serving on the Organization, Leadership and Compensation Committee of the Company’s Board of Directors approved the grant of non-qualified stock options to purchase an aggregate of 351,000 shares of the Company’s common stock to two new employees (the "Inducement Grants"), with grants made on July 10 and July 17, 2023 (the "Grant Dates") (Press release, C4 Therapeutics, JUL 17, 2023, View Source [SID1234633257]). The Inducement Grants were granted as inducements material to these individuals entering into employment with C4T in accordance with Nasdaq Listing Rule 5635(c)(4).

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The Inducement Grants have an exercise price per share that is equal to the closing price of C4T’s common stock on their respective Grant Dates. The Inducement Grants will vest over a four-year period, with 25% of the shares vesting on the first-year anniversary of the employee’s start date, and thereafter the remainder of the shares vesting in twelve equal quarterly installments, subject to each employee’s continued employment with C4T through each vesting date.

On July 17, 2023 Theradiag a company specializing in in vitro diagnostics of autoimmune diseases and theranostics, reported its half-revenue and cash position on June 30, 2023, data that is currently being audited (Press release, Theradiag, JUL 17, 2023, View Source [SID1234633256]).

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H1 2023 revenue of €6.7 million

Over the six monthsto June 30, 2023, Theradiag generated revenue of €6.7 million, compared with €6.3 million in the first half of 2022, representing growth of 6.8%. Growth accelerated slightly in the second quarter of 2023 thanks to strong sales performance in Theradiag two core businesses: +9.4% for Theranostics and +5.3% for In Vitro Diagnostics (IVD). Theranostics business recorded another semester of strong growth, with sales up 18.0% to almost €3.6 million at June 30, 2023. This strong growth was driven by very good export performance and solid growth in France, offsetting the decline in sales to the US market. As a reminder, this downturn on the US market is the consequence of the implementation of the Company’s new strategic plan to improve profitability. IVD recorded a slight decline in revenue of-3.7% to around €3.1 million at the end of June 2023. Business contracted in France, compared with an exceptional first-half of 2022 figure linked to non-recurring commercial opportunities. This slowdown on the domestic market is partly offset by commercial In thousands of euros Q2 2022 Q2 2023 Change H1 2022 H1 2023 Change Revenue 3,150 3,383 7.4% 6,264 6,688 6.8% Of which Theranostics revenue 1,578 1,727 9.4% 3,024 3,569 18.0% Of which IVD revenue 1,572 1,656 5.3% 3,240 3,119-3.7% developments in the main European markets. Theradiag recently extended its strategic partnership with Quotient, which will support the growth trajectory of this activity. Cash position At 30 June 2023, Theradiag had a net cash position of €5.7 million, above the company’s business plan, compared with €6.4 million at December 31, 2022. Simon Davière, CEO of Theradiag, commented: "During the first half 2023, Theradiag has maintained a solid sales momentum, particularly for its internally developed products, thanks to its technological lead in its two fast-growing markets. The deliberate slowdown in the United States has been offset by market share gains in new countries, mainly the major European markets. On the strength of our comfortable cash position, we intend to pursue the development and accelerate the marketing of our high-margin inhouse products over the coming months." Christian Policard, Chairman of the Board of Directors, added: "In addition to its strong commercial momentum, over the past few months Theradiag has been working to strengthen the collaboration with its shareholder and partner Biosynex. While synergies in purchasing are already underway, commercial synergies will need to become operational over the next six months in order to improve the performance of both companies. " Next financial press release :-2023 first-half results, on Monday 18, September 2023, before market open