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Accutar Biotechnology Announces First Patient Dosed in China with AC0176 in Phase 1 Study in Prostate Cancer

On February 23, 2023 Accutar Biotechnology, Inc., a clinical stage biotechnology company focusing on artificial intelligence (AI)-empowered drug discovery, reported the dosing of the first patient in China in a Phase 1 study of AC0176, an orally bioavailable chimeric degrader molecule designed to target Androgen Receptor (AR) protein with high potency and selectivity (Press release, Accutar Biotechnology, FEB 23, 2023, View Source [SID1234627650]).

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"The initiation of this study marks the second program from our chimeric degrader portfolio to enter the clinic in China, after the initiation of AC0176 Phase 1 study in the US and the IND clearance by the China National Medical Products Administration (NMPA) last year," said Jie Fan, Ph.D., Chief Executive Officer of Accutar Biotechnology, Inc. "Prostate cancer is one of the most common cancers among men in China, and the increase in its incidence and death ranks highest in China. We look forward to accelerating the development of AC0176 globally to bring transformative medicines to patients worldwide."

The Phase 1 study in China will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of AC0176 treatment in Chinese patients with metastatic Castration Resistant Prostate Cancer (mCRPC). Additional information on this clinical trial can be found on www.clinicaltrials.gov (NCT05673109).

About AC0176

AC0176 is an investigational orally bioavailable, chimeric degrader of androgen receptor (AR) for the potential treatment of prostate cancers. AR is a hormonal transcription factor, and plays important roles during prostate cancer onset and progression. In preclinical studies, AC0176 has demonstrated potent and selective AR protein degradation with broad coverage of AR mutants, favorable pharmacological properties, as well as promising anti-tumor activities in animal models.

SELLAS Life Sciences Announces Proposed Underwritten Public Offering

On February 23, 2023 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that it has commenced an underwritten public offering of shares of its common stock and warrants to purchase shares of its common stock (Press release, Sellas Life Sciences, FEB 23, 2023, View Source [SID1234627649]). All of the securities in the offering will be sold by SELLAS.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The public offering will be made pursuant to a shelf registration statement on Form S-3 (File No. 333-255318) that was previously filed with the Securities and Exchange Commission (the "SEC") on April 16, 2021 and declared effective on April 29, 2021. A preliminary prospectus supplement and accompanying base 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 located at View Source The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained, when available, from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, NY 10022, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Termination of a Material Definitive Agreement

On February 23, 2023 Pliant Pharmaceuticals, Inc. (the "Company") received notice from Novartis Institutes for BioMedical Research, Inc. ("Novartis") that Novartis has elected to exercise its right to terminate the Collaboration and License Agreement by and between the Company and Novartis, dated October 17, 2019 (the "Collaboration Agreement"), as amended by Amendment No. 1 to the Collaboration and License Agreement between the Company and Novartis, dated as of November 15, 2022 ("Amendment No. 1") (Filing, 8-K, Pliant Therapeutics, FEB 23, 2023, View Source [SID1234627648]). Novartis informed the Company of its decision, as part of its new strategy focusing on a limited number of therapeutic areas, to divest clinical NASH assets and, as a result, to discontinue the development of PLN-1474, a small molecule selective inhibitor of integrin αvß1, being developed for the treatment of liver fibrosis associated with NASH. The termination will take effect on April 18, 2023.

The Collaboration Agreement provided for an early research program for up to three additional integrin targets (the "Research Targets"). The research term, as amended by Amendment No. 1, is scheduled to conclude in the first quarter of 2023. During the research term, the Company collaborated with Novartis to biologically validate certain Research Targets and identify and synthesize potential research compounds for each Research Target in accordance with the applicable research plan. In the second quarter of 2022, the Company successfully validated one of the Research Targets and synthesized multiple potential development candidates.

Pursuant to the Collaboration Agreement, the Company received an upfront, non-refundable license fee of $50.0 million and was eligible to receive contingent payments of up to $416.0 million, of which $29.0 million has been received by the Company. Effective upon the termination of the Collaboration Agreement, all rights and licenses granted thereunder, including development candidates targeting the validated Research Target, PLN-1474 and the related IND, will revert back to the Company. The payment obligations of Novartis with respect to future milestones, royalties and research and development funding will also terminate.

The foregoing description of the terms of the Collaboration Agreement and Amendment No. 1 are qualified in their entirety by reference to (i) the Collaboration Agreement, which is filed as Exhibit 10.15 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on May 11, 2020 and (ii) Amendment No. 1, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.

Entry into a Material Definitive Agreement

On February 23, 2023 Oncocyte Corporation ("Oncocyte" or the "Company") completed its sale of 3,188,181 shares of common stock of its wholly-owned subsidiary Razor Genomics, Inc. ("Razor"), which constitutes approximately 70% of the issued and outstanding equity interests of Razor on a fully-diluted basis, pursuant to the previously reported Stock Purchase Agreement (as amended by the First Amendment to Stock Purchase Agreement, the "Agreement") with Dragon Scientific, LLC, a Delaware limited liability company ("Buyer"), and Razor, a Delaware corporation (the "Closing") (Filing, Oncocyte, FEB 23, 2023, View Source [SID1234627647]).

In connection with the Closing, Oncocyte transferred to Razor all of the assets and liabilities related to DetermaRxTM, a test used to predict a patient’s risk of cancer recurrence following surgery and response to chemotherapy in early-stage lung cancer. While no monetary consideration was received for the sale of 70% of the equity interests of Razor, the transaction allows the Company to eliminate all development and commercialization costs with respect to DetermaRx. Following the Closing, Oncocyte continues to own 1,366,364 shares of common stock of Razor, which constitutes approximately 30% of the issued and outstanding equity interests of Razor on a fully-diluted basis. The unaudited pro forma consolidated financial information included as Exhibit 99.1 to this report reflects the Closing.

On February 16, 2023, in connection with the Closing, the Company, Buyer and Razor entered into a Second Amendment to Stock Purchase Agreement (the "Second Amendment"), pursuant to which, (i) in lieu of a transition services agreement, Razor entered into certain transitional consulting agreements with two employees of Oncocyte, (i) the Company entered into a Records Custody and Services Agreement with Razor and Buyer, and (ii) certain representations, warranties and covenants were modified. No other provisions of the Agreement were otherwise amended or waived by the Second Amendment, and the Agreement remains in full force and effect.

The foregoing description of the Second Amendment does not purport to be complete and is qualified in its entirety by reference to the complete text of the Second Amendment, which is filed as Exhibit 2.1 to this Current Report on Form 8-K and incorporated herein by reference.

Item 7.01 Regulation FD Disclosure.

On February 22, 2023, Oncocyte issued a press release announcing the completion of the Razor transaction, a copy of which is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

The information under this Item 7.01 and the accompanying Exhibit 99.2 shall be deemed "furnished" and not "filed" under Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any filings made by Oncocyte under the Securities Act of 1933, as amended, or the Exchange Act except as may be expressly set forth by specific reference in such filing.

Entry into a Material Definitive Agreement

On February 23, 2023 Omega Therapeutics, Inc. (the "Company") reported that it has entered into a Securities Purchase Agreement (the "Purchase Agreement") with the purchasers named therein (collectively, the "Purchasers") (Filing, 8-K, Omega Therapeutics, FEB 23, 2023, View Source [SID1234627646]). Pursuant to the Purchase Agreement, the Company agreed to issue and sell in a registered direct offering (the "Offering") an aggregate of 6,920,415 shares of the Company’s common stock, par value $0.001 per share (the "Common Stock"), at a purchase price of $5.78 per share (the "Purchase Price") to the Purchasers, for aggregate gross proceeds to the Company of approximately $40.0 million pursuant to an effective shelf registration statement on Form S-3 (File No. 333-268254) and a related prospectus supplement filed with the Securities and Exchange Commission. The closing of the Offering is expected to occur on or about February 27, 2023, subject to the satisfaction of customary closing conditions.

The Company expects to receive net proceeds from the Offering of approximately $39.7 million, after deducting estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering, together with its existing cash, to advance its ongoing MYCHELANGELO I clinical trial, further develop its OMEGA platform, continue to advance its preclinical pipeline, and for general corporate and working capital purposes. The Company believes that its existing cash, cash equivalents and marketable securities, together with the net proceeds from the Offering, will fund its operations into the second half of 2024.

The Purchase Agreement contains customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company and the Purchasers, including for liabilities under the Securities Act of 1933, as amended, other obligations of the parties and termination provisions.

The foregoing description of the Purchase Agreement is not complete and is qualified in its entirety by reference to the full text of the Purchase Agreement, a form of which is filed as Exhibit 10.1 to this Current Report on Form 8-K ("Form 8-K") and is incorporated by reference herein.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated February 23, 2023, regarding the validity of the shares of Common Stock to be issued and sold in the Offering. A copy of the opinion is filed as Exhibit 5.1 to this Form 8-K.

This Form 8-K shall not constitute an offer to sell or the solicitation of any offer to buy the securities discussed herein, nor shall there be any offer, solicitation or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

Forward-Looking Statements Disclaimer

This Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the completion of the Offering, anticipated proceeds from the Offering, and the use of such proceeds from the Offering. These forward-looking statements are based on the Company’s management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions relating to the Offering. These and other important factors discussed under the caption "Risk Factors" in the Company’s most recent Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, and the Company’s other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this Form 8-K. Any such forward-looking statements represent management’s estimates as of the date of this Form 8-K. While the Company may elect to update such forward-looking statements