Cogent Biosciences Announces Pricing of Upsized Public Offering of Shares of Common Stock and Pre-funded Warrants

On June 14, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the pricing of an underwritten public offering of 15,169,698 shares of its common stock, offered at a public offering price of $8.25 per share (Press release, Cogent Biosciences, JUN 14, 2022, View Source [SID1234615953]). In addition, in lieu of issuing common stock to certain investors, Cogent is offering pre-funded warrants to purchase 3,030,302 shares of its common stock at a purchase price of $8.24 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The aggregate gross proceeds to Cogent from this offering are expected to be approximately $150 million, before deducting underwriting discounts and commissions and other estimated offering expenses, upsized from $125 million. In addition, Cogent has granted the underwriters a 30-day option to purchase up to an additional 2,730,000 shares of its common stock at the public offering price less underwriting discounts. All of the shares of common stock and pre-funded warrants in the offering are being sold by Cogent. The offering is expected to close on or about June 16, 2022, subject to customary closing conditions.

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Cogent intends to use the net proceeds from the offering for development, regulatory and commercial preparation activities relating to bezuclastinib and other product candidates, as well as for working capital and general corporate purposes.

Jefferies, Piper Sandler & Co. and Guggenheim Securities, LLC are acting as joint book-running managers for the offering. LifeSci Capital is also acting as lead manager for the offering.

The securities described above are being offered pursuant to a shelf registration statement (File No. 333-264773) filed with the Securities and Exchange Commission (SEC), which became effective on May 24, 2022.

A final prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. The offering can be made only by means of a prospectus supplement and accompanying base prospectus, copies of which may be obtained at the SEC’s website at www.sec.gov, or by request to Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, or by telephone at (800) 747-3924, or by email at [email protected]; or Guggenheim Securities, LLC: Attention: Equity Syndicate Department, 330 Madison, New York, New York 10017, by telephone at 212-518-9544, or by email at [email protected].

InventisBio Bags NMPA Breakthrough Therapy Designation for D-1553

On June 13, 2022 InventisBio reported that the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) of China has granted Breakthrough Therapy Designation (BTD) to KRAS G12C inhibitor, D-1553, (Press release, InventisBio, JUN 13, 2022, View Source [SID1234633495]).

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InventisBio launched an international multi-center clinical study of D-1553 in October 2020, with several trials carried out since in non-small cell lung cancer (NSCLC), colorectal cancer, and others.

In preclinical studies, D-1553 has demonstrated tumor inhibitory effect, noted the company.

Specifically in NSCLC harboring KRAS G12C mutation, D-1553 led to patients achieving an objective response rate (ORR) of 40.4%, with a disease control rate of 90.4%, according to InventisBio at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April 2022.

D-1553 has become China’s first homegrown breakthrough drug for the treatment of KRAS G12C mutant tumors.

Conclusion of contract with additional institutes and first dosing of CBA-1205 in the second part of Phase 1 study

On June 13, 2022 Chiome Bioscience Inc. reported that new contract with additional institutes had been finalized and the first patient has been dosed CBA-1205, the first-in-class antibody, in the second part (expansion part) of Phase I study(Press release, Chiome Bioscience, JUN 13, 2022, View Source jp/xcontents/45830/87891347/f845/469b/96ae/2719ff6df264/20220613150323815s.pdf [SID1234625710]).

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In the first part of Phase I study, CBA-1205 exhibited good safety and tolerability. In the second part, two doses will be given to the patients with hepatocellular carcinoma to evaluate safety and to determine the optimum dose for further development. Also, the exploratory efficacy and pharmacokinetics will be investigated.

The study will be conducted at National Cancer Center Hospital, National Cancer Center Hospital East. Additional institutes will be at Kanagawa Cancer Center and Niigata University Medical and Dental Hospital.

We hope that CBA-1205 exhibits good safety and efficacy profile in the second part that is key for early licensing deal. We will announce the progress in a timely manner.

There is no impact on the financial performance in the fiscal period ending December 31, 2022.

<About CBA-1205>

CBA-1205 is a humanized IgG1 afucosylated monoclonal antibody targeting cell surface antigen "DLK-1 (Delta-like 1 homolog)" which expresses on hapatocellular carcinoma and other solid cancers. CBA-1205 exhibits potent and specific anti-tumor activity in various DLK1 expressing cancer models by increasing ADCC (antibody-dependent cellular cytotoxicity). DLK-1 is known to control the proliferation and differentiation of stem cells, progenitor cells,
and other immature cells. CBA-1205 is expected to offer a new therapeutic option for the treatment of DLK-1 expressing cancer such as hepatocellular carcinoma. The present phase I clinical study is the first trial all over the world and CBA-1205 exhibited safety and tolerability.

BlueSphere Bio to Present a Corporate Overview at the 2022 BIO International Convention

On June 13, 2022 BlueSphere Bio, a T-cell receptor (TCR) T-cell therapy company developing a powerful TCR discovery platform and novel therapeutic candidates for patients with hematologic malignancies and solid tumors, reported that David Apelian, M.D., Ph.D., MBA, Chief Executive Officer of BlueSphere Bio, will provide a corporate overview at the 2022 BIO International convention on June 13, 2022 at 3:45 p.m. PT in company presentation theater 2 (Press release, BlueSphere Bio, JUN 13, 2022, View Source [SID1234616066]).

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The presentation will highlight the company’s latest data supporting future clinical development of their adoptive TCR T-cell therapies and novel high-throughput TCXpress and NEOXpress platforms designed to target some of the most challenging cancers. The TCXpress platform has enabled the discovery of BlueSphere’s first clinical candidate, a TCR T-cell therapy directed against the minor histocompatibility antigen (miHA) HA-1. The company anticipates filing its first IND by the end of 2022. The TCXpress platform has also enabled the discovery of four new TCRs reactive against other relevant miHAs, in addition to HA-1. BlueSphere plans to announce details on these other targets later this year.

BlueSphere’s management will be available to participate in one-on-one meetings with industry executives and investors registered for the conference. To schedule a meeting with the Company, please reach out through the BIO partnering system.

Brain tumor therapy – A new indication for Hamlet Pharma

On June 13, 2022 Hamlet Pharma reported that signed a joint development agreement with Neurochase Limited, founded by Professor Steven Gill, a world leading expert in the area of neurosurgery, to develop novel technology and methods to treat Central Nervous System (CNS) tumors with Alpha1H (Press release, HAMLET Pharma, JUN 13, 2022, View Source;utm_medium=rss&utm_campaign=brain-tumor-therapy-a-new-indication-for-hamlet-pharma [SID1234615967]).

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Alpha1H is effective against a range of solid and haematological tumor cells that commonly metastasize to the CNS. Early studies in rats have shown that infusion of HAMLET into the brain markedly delayed the progression of glioblastomas. Glioblastomas are highly invasive and malignant brain tumours with a poor prognosis, accounting for about 60% of all primary brain tumors. At the time of diagnosis, the tumors are mostly inaccessible to complete surgical removal due to spread of tumor cells from the primary tumor site and there is a lack if efficient, alternative treatments.

As a pioneer in this field, Professor Gill has invented new technologies for drug delivery into the brain and used them successfully in the treatment of neurological diseases and cancers. In this collaboration between Neurochase and Hamlet Pharma, new technology will be developed for delivery of Alpha1H to the leptomeninges for treatment of primary and secondary CNS tumors. The collaboration will primarily explore infusion of Alpha1H in an animal model in preparation for clinical trials.

Steven Gill said "We are delighted to be collaborating with Hamlet Pharma on this programme. Alpha 1H has shown very promising results to date as a potential treatment for CNS tumors. I am hopeful that by working together we can improve the otherwise poor outcome for patients with CNS tumors".

" Combining this novel technology with Alpha1H to explore the treatment of brain tumors is a very exiting prospect", says Catharina Svanborg, Professor and Chairman of Hamlet Pharma AB.