Entry into a Material Definitive Agreement

On July 29, 2022, Shattuck Labs, Inc. (the "Company") reported that it entered into a sales agreement (the "Sales Agreement") with SVB Securities LLC (the "Agent"), pursuant to which the Company may offer and sell from time to time shares of the Company’s common stock, $0.0001 par value per share (the "Shares"), through the Agent (Filing, 8-K, Shattuck Labs, JUL 29, 2022, View Source [SID1234617136]). The offering and sale of up to $75,000,000 of the Shares has been registered under the Securities Act of 1933, as amended, (the "Securities Act") pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-263553) (the "Registration Statement"), which was originally filed with the Securities and Exchange Commission ("SEC") on March 15, 2022 and declared effective by the SEC on July 29, 2022, the base prospectus contained within the Registration Statement, and a prospectus supplement that was filed with the SEC on July 29, 2022.

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Sales of the Shares, if any, pursuant to the Sales Agreement may be made in sales deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act, including sales made directly on or through the Nasdaq Global Select Market or on any other existing trading market for our common stock. The Company has no obligation to sell any of the Shares under the Sales Agreement, and may at any time suspend offers under the Sales Agreement or terminate the Sales Agreement. The Agent will act as sales agent and will use commercially reasonable efforts to sell on the Company’s behalf all of the Shares requested to be sold by the Company, consistent with its normal trading and sales practices, on mutually agreed terms between the Agent and the Company. The Company intends to use the proceeds of the offering for pipeline development, working capital, and other general corporate purposes.

The Sales Agreement contains customary representations, warranties and agreements by the Company, as well as indemnification obligations of the Company for certain liabilities under the Securities Act. Under the terms of the Sales Agreement, the Company will pay the Agent a commission of up to 3.0% of the gross sales price of the Shares sold through it under the Sales Agreement. In addition, the Company has agreed to reimburse certain expenses incurred by the Agent in connection with the offering. The Sales Agreement may be terminated by the Agent or the Company at any time upon notice to the other party, as set forth in the Sales Agreement, or by the Agent at any time in certain circumstances, including the occurrence of any material adverse effect, or any development that could reasonably be expected to result in a material adverse effect, that, in the judgment of the Agent, may materially impair the ability of the Agent to sell the Shares.

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

Gibson, Dunn & Crutcher LLP, counsel to the Company, has issued an opinion to the Company, dated July 29, 2022, regarding the validity of the Shares. A copy of the opinion is filed herewith as Exhibit 5.1.

The description of the material terms of the Sales Agreement is not intended to be complete and is qualified in its entirety by reference to the Sales Agreement, which is filed herewith as Exhibit 1.1 and incorporated herein by reference.

Leidos Holdings, Inc. Declares Quarterly Cash Dividend

On July 29, 2022 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, JUL 29, 2022, View Source [SID1234617135]). The cash dividend is payable on September 30, 2022, to stockholders of record as of the close of business on September 15, 2022.

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Fresenius Kabi launches IV Drug in the U.S.

On July 29, 2022 Fresenius Kabi reported that Thiotepa Injection, a cancer therapeutic, is now available in the United States (Press release, Fresenius, JUL 29, 2022, View Source [SID1234617133]). It has multiple indications, including for the treatment of patients with adenocarcinoma of the breast or ovary. This is the newest addition to the company’s portfolio of generic IV oncology products – the largest such portfolio in the U.S.

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Anaveon to present new data from the Phase I/II study of ANV419 at the ESMO Congress 2022

On July 29, 2022 Anaveon reported that it will present new clinical data from the ongoing Phase I/II study of ANV419 in patients with solid tumors, as well as new pre-clinical data further elucidating the mode of action of this powerful and selective interleukin-2 (IL-2) agonist, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, taking place in Paris, September 9 – 13, 2022 (Press release, Anaveon, JUL 29, 2022, View Source [SID1234617132]). Abstracts will be available online starting 00.05 CEST on Monday, September 5, 2022.

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Details of the poster presentations are:

Abstract Title: "ANV419, a selective IL-2R-beta-gamma targeted antibody-IL-2 fusion protein, in patients with advanced solid tumors, a phase I/II study"

Presentation Number: 479P
Location: Poster Area Hall 4

Authors: H. Läubli, G. Alonso, J. Lopez, E. Calvo, M. Jörger, V. Sanchez, D. Di Blasi, A. Nair, K. Richter, Ch Huber, J Mouton, S. Costanzo, S. Jethwa, Ch Bucher and E. Garralda
Date/Time: 12 September 2022 at 9:00 CEST – 18:30 CEST

Abstract Title: "ANV419 is a novel CD122-biased IL-2/anti-IL-2 fusion protein with potent CD8 T cell and NK cell stimulating capacity that shows additive efficacy in combination with checkpoint inhibitors and treatments acting through antibody dependent cellular cytotoxicity"

Presentation Number: 39P
Location: Poster Area Hall 4

Authors: K. Richter, N. Egli, L. Petersen, P. Murer, A. Katopodis and Ch. Huber
Date/Time: 11 September 2022 at 9:00 CEST – 18:30 CEST

Please visit the ESMO (Free ESMO Whitepaper) website here for more information.

Anaveon is undertaking a Phase I/II study to evaluate the safety, dosing and clinical activity of its lead program, ANV419, a powerful and selective interleukin-2 (IL-2) agonist in patients with solid tumors. The Company is pursuing multiple parallel Phase II programs in order to explore the full therapeutic potential of ANV419. In addition, Anaveon continues its work in developing follow-on compounds to expand on the success of ANV419 by delivering the IL-2 agonist to tumor fighting cells and thus expand the therapeutic potential into less immunogenic tumors. Alongside this, the Company is building on its cytokine engineering expertise with preclinical-stage programs harnessing the power of cytokines for therapeutic purposes.

New NSF awards will advance theoretical foundations of data science research through interdisciplinary collaborations

On July 29, 2022 National Science Foundation reported that Data science is an expanding field that requires the expertise of computer scientists, engineers, mathematicians, and statisticians to handle the complex analysis of ever-larger data sets (Press release, National Science Foundation, JUL 29, 2022, View Source [SID1234617130]). Data affect how industry, academia and government operate. The U.S. National Science Foundation is committed to leading the nation in foundational data science research.

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As part of this effort, NSF announces two new Transdisciplinary Research in Principles of Data Science, or TRIPODS, Phase II awards totaling $20 million that bring together scientists and engineers from different research communities to further the theoretical foundations of data science through integrated research and training activities. TRIPODS is tied to NSF’s Harnessing the Data Revolution Big Idea, which aims to accelerate discovery and innovation in data science algorithms, data infrastructure, and education and workforce development.

Phase II of the program will continue to support the development of collaborative institutes to delve deeper into foundational issues in data science, such as design of algorithms for analyzing large, complex, noisy and changing data sets; data that includes historical biases and elements influenced by self-interested and possibly malicious parties; and the need for fair, ethical and understandable results from complex data-driven decision-making processes.

"The NSF TRIPODS Institutes will bring advances in data science theory that improve health care, manufacturing, and many other applications and industries that use data for decision-making," said NSF Division Director for Electrical, Communications and Cyber Systems Shekhar Bhansali.

TRIPODS awards aim to achieve these goals and other long-term major impacts in areas ranging from basic science to commerce and law by bringing together electrical engineering, mathematics, statistics, and theoretical computer science communities in synergistic and mutually beneficial ways to develop a unified foundation for data science.

NSF is supporting two new teams over five years focused on these topics, bringing the total number of TRIPODS Phase II Institutes to four. Previous TRIPODS Institutes were announced in 2020.

The Institute for Emerging CORE Methods in Data Science, or EnCORE, is led by the University of California San Diego in collaboration with the University of California, Los Angeles; University of Pennsylvania; and The University of Texas at Austin. EnCORE brings together scientists from multiple disciplines such as statistics, mathematics, electrical engineering, theoretical computer science, machine learning and health science, among others.

EnCORE’s team will focus on the four CORE pillars of data science: C for complexities of data, O for optimization, R for responsible learning, and E for education and engagement. The institute is fostering a plan for outreach and broadening participation by engaging students of diverse backgrounds at all levels, from K-12 to postdocs and junior faculty. The project aims to reach a wide demography of students by offering collaborative courses across its partner universities and a flexible co-mentorship plan for multidisciplinary research.

To bring theoretical development into practice, EnCORE will work with industry partners and domain scientists and will forge strong connections with other NSF Harnessing the Data Revolution Institutes across the nation.

Institute for Emerging CORE Methods in Data Science awards: UC San Diego, UCLA, University of Pennsylvania, and The University of Texas at Austin.

The Institute for Data, Econometrics, Algorithms, and Learning, or IDEAL, is a multi-institution and transdisciplinary institute led by the University of Illinois Chicago in collaboration with Northwestern University; Toyota Technological Institute at Chicago; the University of Chicago; and Illinois Institute of Technology, in partnership with members of the Learning Theory team at Google. The institute involves more than 50 researchers working on key aspects of the foundations of data science across computer science, electrical engineering, mathematics, statistics, and fields such as economics, operations research and law.

Research will center around the foundations of machine learning, high-dimensional data analysis and inference, and data science and society. Topics include foundations of deep learning, reinforcement learning, machine learning and logic, network inference, high-dimensional data analysis, trustworthiness and reliability, fairness, and data science with strategic agents.

The institute will broaden research and education participation from underrepresented groups by organizing activities that engage diverse communities of students at all levels, including high school and undergraduate students, as well as teachers (through a partnership with Math Circles of Chicago) and the public (via lectures in partnership with the Museum of Science and Industry).

Institute for Data, Econometrics, Algorithms, and Learning awards: UIC, Toyota Technological Institute, The University of Chicago, IIT, Northwestern University.

"The new 2022 TRIPODS awards address foundational challenges in data science at the core of data-driven discovery and decision making," said NSF Division Director for Computing and Communication Foundations (CCF) Dilma Da Silva. "CCF is pleased to be able to support these impactful projects."