Celyad Oncology Announces $32.5 Million Private Placement with Fortress Investment Group

On December 3, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD) ("Celyad" or the "Company"), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer, reported that it has entered into a subscription agreement with an affiliate of Fortress Investment Group (such affiliate "Fortress") for the private placement of 6,500,000 ordinary shares for gross proceeds of USD 32.5 million (about EUR 28.7 million) (Press release, Celyad, DEC 3, 2021, View Source [SID1234596436]). The subscription will take place within the framework of the authorized capital and it is expected to close on or about December 8, 2021, subject to satisfaction of customary closing conditions.

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Pursuant to the terms of the private placement, the Company will issue the ordinary shares at a price of USD 5.00 (about EUR 4.42) per share, which represents a 18.5% premium to the 30-day volume weighted average price ("VWAP"). The Company intends to use net proceeds from the private placement to fund research and development expenses, including the clinical development of its allogeneic CAR T candidates CYAD-101 and CYAD-211, to advance the current pipeline of preclinical CAR T candidates, to discover and develop additional preclinical product candidates using its proprietary non-gene edited short hairpin RNA (shRNA) technology platform, as well as for working capital, other general corporate purposes, and the enhancement of the Company’s intellectual property.

As a result of the transaction, Fortress will hold 28.8% of the Company’s shares.

Filippo Petti, CEO of Celyad Oncology, commented, "This transformative investment provides an important springboard for the Company and further strengthens our corporate initiatives to advance our novel allogeneic CAR T product candidates. In addition, Fortress’s expertise in the intellectual property domain further validates our robust patent portfolio and emphasizes our position within the allogeneic CAR T field. The growth financing will be essential for us to expand our current allogeneic CAR T pipeline by continuing to exploit our differentiated, non-gene edited technologies and armored CAR T franchise."

"Celyad Oncology offers a unique optionality around its technology and intellectual property," said Christopher LiPuma, Director at Fortress. "In particular, the Company’s strong IP position around allogeneic CAR T stands out as a key asset that we believe will provide the foundation for the Company to strategically develop both novel cell therapy candidates and potential partnerships within the exciting off-the-shelf cell therapy landscape."

SVB Leerink acted as the exclusive placement agent for the private placement, Goodwin Procter LLP and Harvest acted as legal counsel to the Company. Skadden, Arps, Slate, Meagher & Flom LLP and Eubelius acted as legal counsel to Fortress.

The Company believes that following the close of the private placement, its existing cash and cash equivalents combined with access to the equity purchase agreement established with Lincoln Park Capital Fund, LLC should be sufficient, based on the current scope of activities, to fund operating expenses and capital expenditure requirements into the first half of 2023.

In the framework of this investment, Fortress and the Company have entered into a shareholders’ rights agreement. Pursuant to this agreement, Fortress will be subject to a customary lock-up obligation and standstill obligation, in each case for nine months following the closing of the private placement. Furthermore, as long as Fortress holds 10% of the shares of the Company, it will benefit from a right of first offer on any new indebtedness to be incurred by Celyad and on any new equity securities to be issued, pro-rata its shareholding, as well as of the right to nominate two individuals to Celyad’s board of directors. In addition, as long as Fortress holds 15% or more of the outstanding shares of the Company, certain intellectual property transactions will be subject to a 90% board majority for approval. Celyad will propose an amendment to its articles of association to reflect this qualified right.

The securities to be issued in the private placement have not been registered under the Securities Act of 1933 or applicable state securities laws and may not be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration requirements. The Company has agreed to customary registration rights covering the resale of the ordinary shares (in the form of American Depositary Shares) sold in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Regeneron to Participate in H.C. Wainwright & Co. Virtual Event

On December 3, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that is scheduled to participate in a virtual fireside chat at the H.C. Wainwright & Co. event – Unlocking the Full Potential of RNAi With World-Class Novel Target Identification: Regeneron Genomics and Alnylam’s RNAi Platform Collaboration Update – at 2:00 p.m. ET on Monday, December 6, 2021 (Press release, Regeneron, DEC 3, 2021, https://investor.regeneron.com/news-releases/news-release-details/regeneron-participate-hc-wainwright-co-virtual-event [SID1234596437]).

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Aris Baras, M.D., Senior Vice President at Regeneron and Head of the Regeneron Genetics Center, will participate on behalf of Regeneron.

The session may be accessed from the "Investors & Media" page of Regeneron’s website at View Source A replay of the webcast will be archived on the Company’s website for at least 30 days.

Shattuck Labs to Present at TIGIT Therapies Digital Summit 2021

On December 2, 2021 Shattuck Labs, Inc. (Shattuck) (NASDAQ: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease with three ongoing Phase 1 clinical trials, reported its presentation at the TIGIT Therapies Digital Summit 2021 being held virtually December 7 – 9, 2021 (Press release, Shattuck Labs, DEC 2, 2021, View Source [SID1234596402]).

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Presentation Details
Presentation Title: LIGHTing the Way for TIGIT Blockade in CPI Refractory Tumors
Presenter: Taylor Schreiber, M.D., Ph.D., Shattuck’s Chief Executive Officer
Date: December 9, 2021
Time: 9:30 a.m. EST
Location: View Source

The presentation will be available for download on the Events & Presentations section of the company’s website and also will be available to registered participants of the TIGIT Therapies Digital Summit 2021.

IceCure Medical’s Interim Results of the ICE3 Clinical Trial for Early-Stage Breast Cancer Cryoablation featured at the 2021 Annual Meeting of the Radiological Society of North America

On December 2, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense System, that destroys tumors by freezing as an alternative to surgical tumor removal, reported that interim data from the ICE3 Clinical Trial on cryoablation of small, low-risk breast cancer was featured by Co-Primary Investigator, Dr. Kenneth Tomkovich at the Radiologists Society of North America (RSNA), which was held from November 29th through December 2nd (Press release, IceCure Medical, DEC 2, 2021, View Source [SID1234596420]). Dr. Tomkovich’s presentation, "Primary Treatment of Low Risk Breast Cancers Using Image-Guided Cryoablation: A 6 Year Update of the ICE3 Trial" was selected to be featured in a daily bulletin by RSNA, the largest radiology society in the world with over 48,000 members in the United States, representing 31 radiologic sub-specialties sharing state-of-the-art radiological innovations.

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Dr. Tomkovich featured the ICE3 interim results on Tuesday, November 30th as part of the larger "Breast Imaging (Breast Intervention and PET/Breast Imaging in Neoadjuvant Chemotherapy" session.

Eyal Shamir, Chief Executive Officer of IceCure, noted, "We are proud that our data was recognized by the Radiology Society of North America,(RSNA), the largest radiology society in the world and a highly regarded medical association. We believe this recognition by this prestigious society is further supportive of the ICE3 data."

Dr. Tomkovich commented, "The acceptance of cryoablation as a treatment for breast cancer is becoming more wide-spread in the radiological medical community and the interim ICE3 trial results continue to validate this approach. It is an option that could be much more convenient than a mastectomy or lumpectomy surgery, in terms of requiring less office time, as well as less stress and a quick recovery for the patient."

HUYABIO Announces the Exclusive License of the KRAS Inhibitor from Shanghai Jemincare Pharmaceutical

On December 2, 2021 HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, reported it had licensed exclusive worldwide ex-China rights to the KRAS inhibitor, JMKX1899, from Shanghai Jemincare Pharmaceutical Co., Ltd. Jemincare will retain the relevant rights in the greater China area (Press release, HUYA Bioscience, DEC 2, 2021, View Source [SID1234596454]).

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Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, "We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program outlicensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs."

KRAS is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of KRAS in the switch-II region, which has made KRAS druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare filed the IND with the NMPA in October 2021. The parties will work closely to file the IND with the US FDA in 2021 to move towards clinical development.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, "We are excited to have added the clinical stage KRAS inhibitor to our oncology pipeline especially to test in combination with our SHP2 inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide."