Entry into a Material Definitive Agreement

On August 23, 2024, Guardant Health, Inc. (the "Company") reported to have entered into an Open Market Sale AgreementSM (the "Sales Agreement") with Jefferies LLC (the "Agent") with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of the Company’s common stock, par value $0.00001 per share (the "Common Stock"), having aggregate gross proceeds of up to $400.0 million (the "Shares") through the Agent, acting as sales agent (Filing, 8-K, Guardant Health, AUG 23, 2024, View Source [SID1234646068]).

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Any Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to the Company’s shelf registration statement on Form S-3, which was filed with the U.S. Securities and Exchange Commission (the "SEC") on May 22, 2023 and became effective immediately upon filing (File No. 333-272121). The Company filed a prospectus supplement with the SEC on August 23, 2024 in connection with the offer and sale of the Shares pursuant to the Sales Agreement, which supplements the base prospectus included in the Registration Statement.

The Company will designate the maximum amount of Shares to be sold through the Agent in any placement under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, the Agent has agreed to use its commercially reasonable efforts to sell on the Company’s behalf all of the Shares requested to be sold by the Company. Upon delivery of a placement notice and subject to the terms and conditions of the Sales Agreement, the Agent may sell the Shares by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"). The Company may instruct the Agent not to sell Shares if the sales cannot be effected at or above a price designated by the Company in a placement notice. The Company or the Agent may suspend the offering of Shares upon proper notice to the other party. The Company and the Agent each have the right, by giving written notice as specified in the Sales Agreement, to terminate the Sales Agreement in each party’s sole discretion at any time.

The Sales Agreement provides that the Agent will be entitled to aggregate compensation for its services of up to 3.0% of the gross sales price per share of all Shares sold through the Agent under the Sales Agreement. The Company has no obligation to sell any Shares under the Sales Agreement. The Company has agreed in the Sales Agreement to provide indemnification and contribution to the Agent against certain liabilities, including liabilities under the Securities Act.

The foregoing description of the Sales Agreement is not complete and is qualified in its entirety by reference to the full text of such agreement, a copy of which is filed as Exhibit 1.1 to this Current Report on Form 8-K (the "Current Report") and is incorporated herein by reference.

The legal opinion of Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP relating to the validity of the Shares is filed as Exhibit 5.1 to this Current Report.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

Bectas Therapeutics Awarded $2.75M CPRIT Product Development Seed Grant

On August 22, 2024 Bectas Therapeutics reported the company was awarded a $2.75M product development seed grant from the Cancer Prevention Research Institute of Texas (CPRIT) (Press release, Bectas Therapeutics, AUG 22, 2024, View Source [SID1234656652]).

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These funds will support the pre-clinical development of Bectas’ first-in-class precision antibody and patient selection biomarker that together are designed to overcome resistance to existing cancer treatments for over 200,000 patients per year.

Bectas received the top score amongst their cohort of applicants following rigorous diligence review of Bectas science, business and intellectual property, providing independent confirmation of the value we are creating for cancer patients and our investors.

Upfront payment received under the license and collaboration agreement with SynBioTx for IMM2510 and IMM27M

On August 22, 2024 ImmuneOnco Biopharmaceuticals reported on a voluntary basis to inform shareholders and potential investors of the Company about the latest business development of the Group (Press release, ImmuneOnco Biopharma, AUG 22, 2024, View Source [SID1234655702]).

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Reference is made to the announcement of the Company dated August 1, 2024, in relation to the entry into a license and collaboration agreement (the "License and Collaboration Agreement") dated August 1, 2024, between the Company and SynBioTx Inc.("SynBioTx").

The board (the "Board") of directors ("Directors", and each a "Director") of the Company is pleased to announce that the Company has received an upfront payment of US$10 million from SynBioTx in line with the License and Collaboration Agreement. Pursuant to the License and Collaboration Agreement, the Company expects to receive potential nearterm payments of up to US$40 million in the future, the earliest of which is expected to be received in September of 2024. Furthermore, the Company and SynBioTx have established a joint Clinical Development & Operations Committee and will actively advance the development of the IMM2510 and IMM27M.

ABOUT IMM2510
IMM2510, independently developed by the Group, is a bispecific molecule with a mAbTrap structure targeting vascular endothelial growth factor (VEGF) and programmed cell death ligand 1 (PD-L1). IMM2510 can inhibit angiogenesis, leading to tumor shrinkage, and sensitize tumor cells to immune responses, while activating T cells, NK cells, and macrophages via the blockade of PD-L1/programmed cell death protein 1 (PD-1) interaction and the induction of Fc-mediated antibody-dependent cellular cytotoxicity (ADCC)/antibody-dependent cellular phagocytosis (ADCP) activity.

ABOUT IMM27M
IMM27M is a new generation cytotoxic T-lymphocyte-associated protein 4 (CTLA-4)antibody with enhanced ADCC activity. It can induce potent immune responses targeting CTLA-4 overexpressed immune-suppressive Treg cells and promote Treg depletion from the tumor microenvironment (TME), thus enhancing T-cell antitumor response.

Hanmi Pharmaceutical-Novomedicine, Technology Transfer Agreement Following Joint Development of ‘Poseltinib’

On August 22, 2024 Hanmi Pharmaceutical reported the company has signed a technology transfer agreement with domestic research and development company Novomedison for the BTK inhibitor ‘Poseltinib’ (Press release, Hanmi, AUG 22, 2024, View Source [SID1234649253]).

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On the 14th, Hanmi Pharmaceutical announced in its ‘Semi-Annual Report’ that it had transferred Poseltinib to Novomedison on June 3rd through major contracts and research and development activities.

The technology transfer target region is the entire world. The total contract amount and the amount received were not disclosed under the agreement of both companies.

Novomedison is the new name of Genome Opinion, which signed a joint development agreement with Hanmi Pharmaceutical for Poseltinib in October 2021.

After signing the joint development agreement, Hanmi Pharmaceutical and Novomedison have signed a technology transfer agreement.

After signing the joint development agreement, Novomedison has been conducting an investigator-led clinical trial with a three-drug combination therapy using Poseltinib.

Poseltinib is a drug that Hanmi Pharmaceutical has been developing since 2010 for the indication of diffuse large B-cell lymphoma. It was exported to Eli Lilly in 2015, but the rights were returned in 2019 as its efficacy was not proven in phase 2 for patients with rheumatoid arthritis.

Since then, Hanmi Pharmaceutical has been conducting phase 2 domestic trials for follow-up development.

Simcere Zaiming’s novel molecule targeting the synthetic lethal pathway Pol θ has obtained approval for clinical trials in China

On August 22, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), reported that SIM0508, a DNA polymerase θ (Pol θ) small molecule inhibitor developed independently by the company, has received Clinical Trial Approval from the National Medical Products Administration of China (Press release, Jiangsu Simcere Pharmaceutical Company, AUG 22, 2024, View Source [SID1234648427]). This approval allows for the commencement of clinical trials to evaluate the efficacy of SIM0508 in treating locally advanced/metastatic solid tumor.

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Homologous recombination is a vital cellular process for repairing DNA double-strand breaks. When homologous recombination deficiency (HRD) occurs, genomic instability can lead to tumor development. HRD tumors rely on an alternative repair pathway called microhomology-mediated end joining (MMEJ), where Pol θ plays a crucial role. Interestingly, Pol θ is rarely expressed in normal tissues but highly expressed in various malignant tumor cells. By blocking Pol θ, we can disrupt the MMEJ pathway, precisely targeting HRD tumor cells while sparing normal cells.

SIM0508, a potent small molecule inhibitor, selectively targets and inhibits Pol θ, effectively blocking MMEJ repair and precisely inhibiting the proliferation of HRD tumor cells. SIM0508 also has potential synergy when used in combination with poly (ADP-ribose) polymerase (PARP) inhibitors or chemotherapeutic agents. Preclinical studies of SIM0508 revealed favorable oral pharmacokinetics and safety, with no evident hematologic toxicities. These findings suggest that combining SIM0508 with PARP inhibitors or chemotherapeutic agents carries a low risk of additive toxicity. The preclinical data were presented at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Simcere Zaiming’s pipeline currently includes 13 innovative drug projects either in the clinical study stage or with clinical approval.