Entry into a Material Definitive Agreement

On October 1, 2021, Cue Biopharma, Inc., a Delaware corporation (the "Company"), reported that it entered into an Open Market Sale Agreement (the "Sales Agreement") with Jefferies LLC, as agent (the "Agent"), pursuant to which the Company may offer and sell shares of its common stock, $0.001 par value per share, having an aggregate offering price of up to $80,000,000 (the "Shares") from time to time through the Agent (the "Offering") (Filing, 8-K, Cue Biopharma, OCT 1, 2021, View Source [SID1234590633]). The Company is filing a prospectus supplement with the Securities and Exchange Commission (the "SEC") in connection with the Offering (the "Prospectus Supplement") under the Company’s existing shelf Registration Statement on Form S-3 (File No. 333-239357), as amended by Post-Effective Amendment No. 3, which became effective on May 21, 2021 (the "Registration Statement").

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Upon delivery of a placement notice to the Agent and subject to the terms and conditions of the Sales Agreement, the Agent may sell the Shares by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) under the Securities Act of 1933, as amended, including sales made directly on or through the Nasdaq Capital Market or on any other existing trading market for the Company’s common stock.

The Company or the Agent may suspend or terminate the offering of Shares upon notice to the other party, subject to certain conditions. The Agent will act as sales agent on a commercially reasonable efforts basis consistent with its normal sales and trading practices.

The Company has agreed to pay the Agent commissions for its services of acting as agent of 3.0% of the gross proceeds from the sale of the Shares pursuant to the Sales Agreement. The Company has also agreed to provide the Agent with customary indemnification and contribution rights.

A copy of the Sales Agreement is attached as Exhibit 1.1 hereto and is incorporated herein by reference. The foregoing description of the material terms of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to such exhibit.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued a legal opinion relating to the Shares. A copy of such legal opinion, including the consent included therein, is attached as Exhibit 5.1 hereto.

The Shares will be sold pursuant to the Registration Statement, and offerings of the Shares will be made only by means of the Prospectus Supplement. This Current Report on Form 8-K shall not constitute an offer to sell or solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of such state or jurisdiction.

CRISPR Therapeutics to Present Preclinical Data at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

On October 1, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported two poster presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting, to be held both virtually and at the Walter E. Washington Convention Center in Washington, D.C., from November 10 to 14, 2021 (Press release, CRISPR Therapeutics, OCT 1, 2021, View Source [SID1234590631]). The Company also announced an oral presentation at the SITC (Free SITC Whitepaper) 2021 Pre-Conference Program, The Evolution of Immunotherapy: An Exploration of Immunity Beyond T cells, CAR T in Solid Tumors and Novel Combinations, which will be held from 2:00 p.m. – 6:00 p.m. ET on November 10, 2021.

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CRISPR Therapeutics presentation:

Title: CRISPR/Cas9 gene-edited allogeneic CAR-T cells targeting CD33 show high preclinical efficacy against AML without long-term hematopoietic toxicity
Abstract Number and Type: 133, poster
Date and Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. ET
Location: Walter E. Washington Convention Center, Hall E, or View Source

Presented jointly with Nkarta:

Title: A combined strategy of CD70 CAR co-expression with membrane-bound IL-15 and CISH knockout results in enhanced NK cytotoxicity and persistence
Abstract Number and Type: 16439, oral
Date and Time: Wednesday, November 10, 2021, 2:40 p.m. ET
Location: Walter E. Washington Convention Center, or View Source

Title: CISH gene-knockout anti-CD70-CAR NK cells demonstrate potent anti-tumor activity against solid tumor cell lines and provide partial resistance to tumor microenvironment inhibition
Abstract Number and Type: 113, poster
Date and Time: Friday, November 12, 2021, 7:00 a.m. – 8:30 p.m. ET
Location: Walter E. Washington Convention Center, Hall E, or View Source

Rubius Therapeutics Announces Preclinical Data for RTX-224, a Broad Immune Costimulatory Agonist, to be Presented at the Society for Immunotherapy of Cancer’s Annual Meeting

On October 1, 2021 Rubius Therapeutics, Inc. (Nasdaq: RUBY), a clinical-stage biopharmaceutical company that is genetically engineering red blood cells to create an entirely new class of cellular medicines called Red Cell Therapeutics for the treatment of cancer and autoimmune diseases, reported it will present preclinical data for RTX-224, a broad immune costimulatory agonist for the treatment of cancer, at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 36th Annual Meeting which is being held from November 10-14, 2021, in Washington, D.C., and virtually (Press release, Rubius Therapeutics, OCT 1, 2021, View Source [SID1234590630]).

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RTX-224 is an allogeneic cellular therapy that is engineered to express hundreds of thousands of copies of 4-1BB ligand (4-1BBL) and interleukin-12 (IL-12) on the cell surface. RTX-224 is designed as a broad immune agonist of both adaptive and innate responses, activating CD8+ and CD4+ T cells, promoting antigen presentation and activating and expanding NK cells. It is expected to produce a broad and potent anti-tumor T cell response, an innate immune response and have anti-tumor activity in those tumor types with known sensitivity to T cell killing, including tumor types with high mutational burden, PD-L1 expression and prior responsiveness to checkpoint inhibitors.

"At SITC (Free SITC Whitepaper), we plan to present preclinical data indicating that RTX-224 activates immune cells in the spleen and blood, leading to their trafficking into the tumor microenvironment to deliver an anti-tumor effect in our preclinical models," said Laurence Turka, M.D., chief scientific officer of Rubius Therapeutics. "The combination of IL-12 and 4-1BB ligand has the potential to broadly induce an immune response in patients with solid tumors and may serve as the bridge between the innate and adaptive immune systems. These preclinical data are encouraging, and we plan to submit an Investigational New Drug application to the FDA by year end."

Details of the poster are as follows:

Poster Title: RTX-224, An Engineered Allogeneic Red Cell Therapeutic Expressing 4-1BBL and IL-12, Activates Immune Cells in Blood and Spleen to Promote Tumor Growth Inhibition in Mice
Abstract Number: 208 (ePoster)
Date, Time and Location: Friday, November 12, 2021, at 7 a.m. EST through Sunday, November 14, 2021, at 5 p.m. EST on the SITC (Free SITC Whitepaper) website: www.sitcancer.org/2021

Bristol Myers Squibb to Hold Investor Event on November 16

On October 1, 2021 Bristol Myers Squibb (NYSE: BMY) reported that the company will hold an Investor Event in New York City on Tuesday, November 16, 2021 at 9:30 a.m. ET. Giovanni Caforio, M.D., Board Chair and Chief Executive Officer, will be joined by members of the company’s leadership team to discuss the Company’s strategy, pipeline and business opportunities (Press release, Bristol-Myers Squibb, OCT 1, 2021, View Source [SID1234590628]).

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The event will also be simultaneously webcast at View Source, with materials related to the presentation available at the start of the live webcast. A replay and archived edition of the presentation will be available following the event.

Cogent Biosciences to Present Preclinical Data on Bezuclastinib at AACR-NCI-EORTC Conference

On October 1, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that the Company will present preclinical data on bezuclastinib at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) held October 7-10, 2021 (Press release, Cogent Biosciences, OCT 1, 2021, View Source [SID1234590627]).

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Poster Presentation Details for Bezuclastinib:
Title: Preclinical data identifies bezuclastinib as a differentiated KIT inhibitor with unique selectivity to KIT D816V and minimal evidence of brain penetration
Virtual Poster Number: P257
Date/Time: All poster presentations are made available by the conference at the opening of the meeting on October 7, 2021, at 9:00 am ET.

The presentation will be available on October 7, 2021 shortly after 9:00 am ET on the Cogent Biosciences website at View Source