On November 18, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported an underwritten public offering of American Depositary Shares ("ADSs") (Press release, RedHill Biopharma, NOV 18, 2021, View Source [SID1234595788]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs to be sold in the offering will be offered by RedHill. RedHill has granted the underwriter a 30-day option to purchase up to an additional 15 percent of the number of ADSs offered in the public offering.

Cantor Fitzgerald & Co. is acting as sole bookrunner for the proposed offering.

RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.

The securities described above will be offered by RedHill pursuant to a shelf registration statement on Form S-3 (No. 333-232777) declared effective by the Securities and Exchange Commission (the "SEC") on August 8, 2019.

The securities will be offered only by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at View Source Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained from Cantor Fitzgerald & Co., 499 Park Avenue, 4th Floor, New York, New York 10022, Attn: Capital Markets Department, or by email 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 registration or qualification under the securities laws of any such state or jurisdiction.

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On November 18, 2021 BAKX Therapeutics reported it closed $25 million in a Series A fundraising led by AB Magnitude Ventures Group with Ipsen Pharma SA and Sherpa Healthcare Partners (Press release, Bakx Therapeutics, NOV 18, 2021, View Source [SID1234595805]). The new funding will enable the company to drive its BAKX Activator Program into the clinic in hematologic malignancies and solid tumors and to advance additional targets for solid tumors and prevention of resistance. The financing comes on the heels of the company’s recent announcement of a partnership comprising up to $852 million in upfront and potential milestone payments with Ipsen, a global biopharmaceutical company, to research, develop, manufacture and commercialize the company’s lead candidate, BKX-001, as a potential treatment for leukemia, lymphoma and solid tumors.

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Sree Kant, founder and CEO of BAKX Therapeutics, said, "BAKX brings together the world’s most comprehensive knowledge of the mitochondrial apoptosis pathway with industry leading structure-based drug design and computational drug discovery techniques. Our pro-apoptotic programs were developed on the innovative work of our scientific co-founders, Loren D. Walensky of Dana-Farber Cancer Institute and Evripidis Gavathiotis of Albert Einstein College of Medicine, who are the world’s leading experts in pro-apoptotic BAX/BAK activation pathway. Together they uncovered novel methods for solving the unique challenges of exploiting conformationally dynamic proteins to induce cancer cell death while sparing healthy cells."

Kant added, "Following on our collaboration with Ipsen announced in July, the new capital will support more rapid advancement into the clinic of our pipeline of novel therapeutic candidates for solid tumors and turbocharge the deployment of our computational platform to drug conformationally dynamic proteins in the mitochondrial apoptosis pathway. We are grateful to our investors who share our vision and are singularly focused on our aim to develop new therapeutics that successfully address for the first time high-value, well validated, apoptosis targets."

"Many companies have focused on targeting the pro-survival proteins, Bcl-2, Bcl-xl and Mcl-1, which have been effective for treatment of certain leukemias. Unfortunately, they have limitations like resistance in hematological malignancies and inability to achieve dosing efficacy in solid tumors," said Yibing Shan, Ph.D., founding managing director of AB Magnitude Ventures Group, who has also joined BAKX in the role of chief computational scientist. "BAKX instead is successfully activating pro-apoptotic proteins such as BAX and BAK using a combination of unsurpassed target and pathway knowledge, deep expertise in conformationally dynamic protein interactions, and new, highly innovative computational methodologies for identifying cryptic sites and simulating protein interactions in the membrane. I am excited to support the company in this round as well as drive the deployment of the BAKX computational drug discovery platform in the field of apoptosis."

Philippe Lopes-Fernandes, executive vice president and chief business officer at Ipsen, said, "At Ipsen we believe great partnerships create great possibilities and our collaboration with BAKX is an example of this with our investment in the future of BAKX, alongside our collaboration on the BKX-001 program. We support and congratulate BAKX on raising additional capital as we work together to advance BKX-001 in what is a groundbreaking approach to inducing cancer cell death. We share BAKX’s ambition to bring this innovation to people living with cancer around the world."

On November 18, 2021 Lunit, a leading medical AI provider, reported that the US Food and Drug Administration (FDA) 510(k) has cleared its AI solution for breast cancer detection, ‘Lunit INSIGHT MMG’ (Press release, Lunit, NOV 18, 2021, View Source [SID1234595824]). Along with its chest x-ray triaging solution ‘Lunit INSIGHT CXR Triage’, the company’s AI solution for both chest x-ray and mammography is now commercially available across the United States.

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"I am delighted to deliver the great news and to introduce Lunit INSIGHT MMG to healthcare professionals and institutions across the US," said Brandon Suh, CEO of Lunit. "With our AI solution, we hope to increase the efficiency and accuracy of mammography screening as well as chest x-ray triaging. We can assist radiologists diagnose diseases at an earlier stage, helping patients be treated at the right time."

Lunit INSIGHT MMG is one of the company’s most mature radiology products which analyzes mammography images with high accuracy. It provides the location of lesions suspicious of breast cancer and an abnormality score that reflects the AI’s confidence of the existence of detected lesions.

The product is trained with a large-scale data of more than 240,000 mammography cases that include up to 50,000 breast cancer cases, and is known to show excellent performance in finding breast cancer at an earlier stage.

According to a study published in JAMA Oncology in 2020, Lunit INSIGHT MMG showed the best accuracy among three commercialized AI to identify breast cancer. It was found to have around 15% higher sensitivity compared to the other two algorithms. The FDA-cleared AI solution has been previously CE marked and approved for commercial sales in more than 35 countries worldwide.

"This is a huge milestone and business opportunity for us, as the US is one of the largest and most important markets that covers more than 45% of the global breast imaging market," added Suh. "Based on the FDA clearance, we will not only bring diagnostic value to medical professionals and patients in the US, but leverage our business to be a leading global provider of breast AI solution."

Lunit INSIGHT MMG will be showcased at RSNA 2021, scheduled to be held on 28 Nov – 2 Dec 2021, in Chicago. Lunit booth will be located in AI Showcase, booth #4545.

On November 18, 2021 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, reported that company management will participate in a fireside chat and one-on-one investor meetings at the 4th Annual Evercore ISI HealthCONx Conference, which is taking place virtually November 30, 2021 through December 2, 2021 (Press release, Crinetics Pharmaceuticals, NOV 18, 2021, https://crinetics.com/crinetics-presents-at-evercore-isi-healthconx-111821/ [SID1234595773]).

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Details on the fireside chat can be found below.

Date: December 2, 2021
Time: 12:35 PM ET
Webcast Link: View Source
A webcast of the fireside chat will also be accessible on the Events & Presentations page in the Investors section of the Crinetics website. A replay of the fireside chat will be available at the same location following its conclusion and will be archived for 90 days.

On November 18, 2021 Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic "off-the-shelf" gene-edited iNK (NK cells derived from iPSC) and CAR (Chimeric Antigen Receptor) Natural Killer (NK) cells derived from induced pluripotent stem cells (iPSCs) and Flex-NK cell engager multifunctional antibodies, and Cellectis (Euronext Growth: ALCLS – Nasdaq: CLLS), a clinical-stage gene-editing company employing its core technology to develop products based on gene-editing with a portfolio of allogeneic chimeric antigen receptor (CAR-)T cells in the field of immuno-oncology and gene-edited hematopoietic stem cells in other indications, reported that they have expanded their collaboration of TALEN gene-edited iPSC-derived NK and CAR-NK cells to include new CAR target and development in China by Cytovia’s joint venture entity, CytoLynx Therapeutics (Press release, Cellectis, NOV 18, 2021, View Source [SID1234595789]).

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The amended financial terms include an equity stake totaling $20 million in Cytovia stock as well as up to $805 million of development, regulatory, and sales milestones and single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia.

"We are pleased to expand the collaboration with Cellectis to enable Cytovia to develop iNK products that will leverage the high-precision of TALEN to perform gene-editing to minimize the risk of off-target effects and unlock the full potential of NK cells as a first line of defense against cancer. Cytovia’s internal research and development, and manufacturing teams are actively developing multiple gene-edited therapeutic candidates and optimizing our technology platform towards next generation products," said Dr. Daniel Teper, Chairman & CEO of Cytovia Therapeutics.

Cellectis is developing custom TALEN, which Cytovia uses to edit iPSCs. Cytovia is responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and is conducting the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis is granting Cytovia a worldwide license under the patent rights over which Cellectis has the control in this field, including in China, enabling Cytovia to modify NK cells to address multiple gene-targets for therapeutic use in several cancer indications.

"We are thrilled at the progress Cytovia has accomplished in the past year," said Dr. André Choulika, CEO of Cellectis. "Cytovia has attracted a world-class scientific team and is advancing its clinical candidates in areas of significant unmet medical need, sharing Cellectis’ mission to provide life-saving off-the-shelf allogeneic cell therapy to patients."