On June 1, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported that its management team will present at the Jefferies Healthcare Conference on June 8, 2022 at 1:00 pm ET in New York City (Press release, Savara, JUN 1, 2022, View Source [SID1234615446]). A live webcast of the presentation will be available on Savara’s website at www.savarapharma.com/investors/events-presentations/ and will be archived for 90 days.

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On June 1, 2022 Histogen Inc. (NASDAQ: HSTO), a clinical-stage therapeutics company focused on developing both restorative therapeutics and pan-caspase and caspase selective inhibitors focused on treatments for infectious and inflammatory diseases, reported that its Board of Directors has approved a 1-for-20 reverse stock split of the Company’s issued and outstanding common stock (the "Reverse Stock Split") (Press release, Conatus Pharmaceuticals, JUN 1, 2022, View Source [SID1234615427]). The Reverse Stock Split will be effective at 4:01 p.m. Eastern Time on June 2, 2022. The Company’s common stock is expected to begin trading on The Nasdaq Capital Market on a split-adjusted basis on June 3, 2022.

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On June 1, 2022, the Company’s Board of Directors approved the Reverse Stock Split at the ratio of 1-for-20 shares. Also on June 1, 2022, the Company’s stockholders approved the Reverse Stock Split at the annual meeting of stockholders held on June 1, 2022 at a ratio ranging from 1-for-5 up to a ratio of 1-for-20, such ratio and the implementation and timing of such Reverse Stock Split to be determined by the Company’s Board of Directors.

The principal purpose of the Reverse Stock Split is to decrease the total number of shares of common stock outstanding and proportionately increase the market price of the common stock in order to meet the continuing listing requirements of The Nasdaq Capital Market. In connection with the Reverse Stock Split, the Company’s CUSIP number will change to 43358Y202 as of June 3, 2022. The Company’s common stock will continue to trade under the symbol "HSTO."

As a result of the Reverse Stock Split, every 20 shares of the Company’s common stock issued and outstanding will be automatically reclassified into one new share of common stock. The Reverse Stock Split will not modify any rights or preferences of the shares of the Company’s common stock. Proportionate adjustments will be made to the exercise prices and the number of shares underlying the Company’s outstanding equity awards, as applicable, and warrants, as well as to the number of shares issued and issuable under the Company’s equity incentive plans. The common stock issued pursuant to the Reverse Stock Split will remain fully paid and non-assessable. The Reverse Stock Split will not affect the number of authorized shares of common stock or the par value of the common stock nor will it change the authorized shares of Preferred Stock or the relative voting power of such holders of our outstanding common stock and Preferred Stock.

No fractional shares will be issued in connection with the Reverse Stock Split. Stockholders who would otherwise be entitled to receive fractional shares as a result of the Reverse Stock Split will be entitled to a cash payment in lieu thereof at a price equal to the fraction to which the stockholder would otherwise be entitled multiplied by the closing trading price per share of the common stock (as adjusted for the reverse stock split) on the Nasdaq Capital Market on the trading day immediately preceding the effective time of the reverse stock split.

American Stock Transfer & Trust Company, LLC has been appointed by the Company to act as its exchange agent for the reverse stock split. Stockholders owning pre-split shares via a bank, broker or other nominee will have their positions automatically adjusted to reflect the Reverse Stock Split and will not be required to take further action in connection with the Reverse Stock Split, subject to brokers’ particular processes. Similarly, registered stockholders holding pre-split shares of the Company’s common stock electronically

in book-entry form are also not required to take further action in connection with the Reverse Stock Split. Holders of certificated shares will be contacted by the Company or its exchange agent with further details about how to surrender old certificates.

Additional information about the Reverse Stock Split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission (the "SEC") on April 21, 2022, which is available free of charge at the SEC’s website, www.sec.gov, and on the Company’s website at www.histogen.com.

On June 1, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported a corporate reorganization to extend its cash runway through 2023, including a workforce reduction of more than 25% (Press release, Atreca, JUN 1, 2022, View Source [SID1234615417]). Atreca will remain focused on the development of ATRC-101, ATRC-301, and its other preclinical oncology programs, and will continue efforts to generate new lead antibodies against tumor specific targets utilizing its proprietary discovery platform.

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"While we are taking steps to significantly streamline our operations, we remain committed to the development of ATRC-101 and ATRC-301, the advancement of earlier-stage assets, and the discovery of additional novel tumor-targeting lead antibodies using our platform," said John Orwin, Chief Executive Officer of Atreca. "We look forward to sharing additional monotherapy and combination data from the ongoing Phase 1b clinical trial of ATRC-101, as well as key preclinical toxicology data from the ATRC-301 program, later this year. While it is difficult to part with so many talented and valued members of our team, we view this as a necessary step to ensure we have the capital required to execute on our mission to deliver novel therapeutics to patients in need. I’d like to thank those leaving Atreca for their important contributions to the Company."

Corporate Updates and Revised Guidance

Atreca has extended its guidance on cash runway through the end of 2023 as a result of revisions to its operating plan and a workforce reduction of more than 25%, including both current employees and open positions.
Atreca still plans to present updated monotherapy and pembrolizumab combination data from the Phase 1b clinical trial of ATRC-101 in the second half of 2022.
Initial non-human primate toxicology data in the ATRC-301 development program remains expected in the second half of 2022.
Based on the efficiency of its discovery platform, Atreca continues to target one additional investigational new drug, or IND, filing per year beginning with ATRC-301 in 2023.
The chemotherapy combination arm of the ATRC-101 Phase 1b clinical trial is no longer expected to initiate enrollment in 2022.
"In 2022 so far, we’ve not only named our next clinical candidate, ATRC-301, an antibody drug conjugate targeting EphA2, but we’ve disclosed multiple lead-stage oncology programs, all generated via our discovery platform," said Tito A. Serafini, Ph.D., Chief Strategy Officer and Founder of Atreca. "Given the productivity of our platform, and the validation provided by ATRC-101 clinical activity reported earlier this year, we remain committed to leveraging the platform for the continued growth of our pipeline, while also supporting the development of existing programs. We sincerely thank our team, including those who are leaving Atreca, for working so creatively and diligently to build a highly efficient and scalable platform in service of delivering potential medicines to patients with unmet needs."

On June 1, 2022 Regeneron Pharmaceuticals, Inc., a New York corporation ("Regeneron" or the "Company"), and Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France ("Sanofi Biotechnology"), reported that entered into the Amended and Restated Immuno-Oncology License and Collaboration Agreement (the "A&R IO LCA"), which amends the Immuno-Oncology License and Collaboration Agreement, dated as of July 1, 2015 and executed as of July 27, 2015 (as amended), by and between the Company and Sanofi Biotechnology (the "Original IO LCA") (Filing, 8-K, Regeneron, JUN 1, 2022, View Source [SID1234615411]). The A&R IO LCA is subject to and will become effective on the first day of the first month following receipt of all necessary authorizations and expiration of all necessary waiting periods applicable to the consummation of the A&R IO LCA (such date, the "A&R Effective Date").

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The Original IO LCA provides for Regeneron and Sanofi Biotechnology to collaborate on the development and commercialization of certain immuno-oncology products, including Libtayo (cemiplimab). From and after the A&R Effective Date, Regeneron will have the sole right to develop and commercialize Libtayo worldwide and no other products will be subject to the A&R IO LCA; and Regeneron will also obtain a license under certain intellectual property rights of Sanofi Biotechnology to develop and commercialize Libtayo worldwide and Sanofi Biotechnology will transfer to Regeneron certain regulatory, promotional, and other rights relating to the commercialization of Libtayo outside the United States. The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi Biotechnology will perform for Regeneron certain transition, distribution, and manufacturing services, respectively.

Under the A&R IO LCA, the quarterly period ended March 31, 2022 is the last quarter for which Sanofi Biotechnology and Regeneron share net profits and losses for Libtayo under the Original IO LCA. From and after April 1, 2022 (after giving effect to certain true-up payments as set forth in the A&R IO LCA), Regeneron will be entitled to all profits from Libtayo and will pay Sanofi Biotechnology an 11% royalty on net product sales of Libtayo through March 31, 2034. In addition, the A&R IO LCA provides for the following payments by Regeneron to Sanofi Biotechnology: (i) a $900 million upfront payment, payable within 10 business days after the A&R Effective Date; (ii) a $100 million development milestone payment upon the first marketing approval from the U.S. Food and Drug Administration or the European Commission of Libtayo in non-small cell lung cancer in combination with chemotherapy; and (iii) sales milestone payments of up to $100 million in the aggregate upon achieving certain amounts of worldwide net product sales of Libtayo in 2022 or 2023.

Under the A&R IO LCA, the amount of development costs incurred under the Original IO LCA for which Regeneron is obligated to reimburse Sanofi Biotechnology is $35 million. Regeneron will reimburse Sanofi Biotechnology for such development costs by paying Sanofi a 0.5% royalty on Regeneron’s net product sales of Libtayo until Regeneron has reimbursed Sanofi Biotechnology for all such development costs.

Fifth Amendment to Antibody LCA. On June 1, 2022, Regeneron, Sanofi Biotechnology, and Sanofi, a société anonyme organized under the laws of France ("Sanofi Parent"), entered into the Fifth Amendment to Amended and Restated License and Collaboration Agreement (the "Fifth Amendment"), which amends the Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009 (as amended), by and between the Company, Sanofi Biotechnology (as successor in interest to Aventis Pharmaceuticals Inc.) and Sanofi Parent (the "Antibody LCA") and will become effective on the A&R Effective Date. Pursuant to the Fifth Amendment, the parties amended the Antibody LCA, among other matters, to, from and after April 1, 2022, increase from 10% to 20% the percentage of Regeneron’s share of profits used to reimburse Sanofi Biotechnology for the remaining development costs incurred under the Antibody LCA subject to reimbursement by Regeneron.

The foregoing description of the A&R IO LCA and the Fifth Amendment is qualified in its entirety by reference to the full text of the A&R IO LCA and the Fifth Amendment, a copy of each of which will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending June 30, 2022.

On June 1, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT) reported entry into agreements that include a $25 million investment by G42 Investments AI Holding RSC Ltd ("G42 Investments") (Press release, vTv Therapeutics, JUN 1, 2022, View Source [SID1234615402]). Under the terms of the agreements, G42 Investments acquired 10,386,274 shares of Class A Common Stock of vTv at an issue price of $2.407 per share, with $12.5 million paid in cash at closing, and the remaining amount of $12.5 million payable on May 31, 2023. The agreements also provide for the potential issuance of $30 million in additional shares of Class A Common Stock to G42 Investments (or cash in lieu of such issuance at the option of G42 Investments) if the United States Food and Drug Administration (the "FDA") approves the marketing and sale of a pharmaceutical product containing TTP399, a liver selective glucokinase activator, as the active ingredient for treatment of type 1 diabetes in the United States. The agreements set forth the terms under which vTv and an affiliate of G42 plan to collaborate on clinical trials for pharmaceutical products that contain TTP399, including G42’s affiliate funding a portion of the Phase 3 clinical trials for TTP399, and vTv granting G42’s affiliate an exclusive license to develop and commercialize pharmaceutical products containing TTP399 in certain territories outside of the United States and the European Union.

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"We have focused substantial energy and resources on TTP399 since obtaining Breakthrough Therapy designation from the FDA in April 2021 and are thrilled to welcome a partner to work with us to accelerate the development and potential approval and commercialization of this treatment. G42 Healthcare brings a unique combination of strong commitment to the development of new impactful drugs and treatments, as demonstrated by their success and their leadership on COVID-19 testing and other product and service offerings in the healthcare spectrum, and substantial resources, making them an ideal partner for this program. This investment into vTv will fund a substantial portion of our Phase 3 clinical trials for TTP399 in the United States and the collaboration with G42 will fund certain of the Phase 3 clinical trials that will be conducted in other territories. We are excited to partner with the G42 Healthcare team as we launch our Phase 3 clinical trials and work together towards approval and commercialization of this treatment for type 1 diabetes," said Rich Nelson, Interim Chief Executive Officer of vTv.

Dr. Fahed Al Marzooqi, the Chief Operating Officer of G42 Healthcare, noted that "We have a deep commitment to collaborating with international organizations to share our knowledge and expertise in the consumer and clinical health spectrum and we look forward to working together with vTv to further develop and commercialize this important treatment. As we move ahead, we will continue to join forces with the world’s best to innovate and invest in science and create the next wave of medicines to future-proof the health of nations."

A more detailed description of the agreements is set forth in vTv’s Current Report on Form 8-K filed with the SEC. The Stock Purchase Agreement is attached to the Current Report on Form 8-K and the Collaboration and License Agreement will be filed with vTv’s Quarterly Report on Form 10-Q for the second quarter.

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

About TTP399

TTP399 is a novel, oral, small molecule, liver selective glucokinase activator being developed as an adjunct therapy to insulin in patients with type 1 diabetes. In a recent phase 2 clinical trial, TTP399 showed a 40% reduction in hypoglycemic episodes compared to placebo. In April 2021, the FDA granted Breakthrough Therapy designation to TTP399 for the treatment of type 1 diabetes. This past October, vTv announced results of a mechanistic study of TTP399 in patients with type 1 diabetes demonstrating no increased risk of ketoacidosis. TTP399 has now been tested in almost 600 subjects. TTP399 is still in the development phase; the FDA has not reviewed or approved TTP399 for use in the United States.