Number of shares and votes in Calliditas Therapeutics

On July 29, 2022 Calliditas Therapeutics AB (publ) reported that it has issued 51,399 ordinary shares as part of the company’s long-term incentive program for certain members of the board of directors issued in 2019, Board LTIP 2019, and converted 5,908,018 class C-shares to 5,908,018 ordinary shares as part of the establishment of the company’s at-the-market program (Press release, Calliditas Therapeutics, JUL 29, 2022, View Source [SID1234617137]). Thus, as of July 29, 2022, the number of shares and votes in the company amounts to 59,157,587 shares and 59,157,587 votes.

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The information in the press release is such that Calliditas Therapeutics AB (publ) is required to disclose pursuant to the Swedish Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact persons set out above, at 12:00 CEST on July 29, 2022.

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.