vTv Therapeutics Announces Investment by CinRx Pharma

On July 25, 2022 vTv Therapeutics Inc. (Nasdaq: VTVT) reported that entry into agreements that include a $10 million investment by CinPax, LLC ("CinPax"), a subsidiary of CinRx Pharma, LLC ("CinRx") (Press release, vTv Therapeutics, JUL 25, 2022, View Source [SID1234616908]). Under the terms of the agreements, CinPax acquired 4,154,549 shares of Class A Common Stock of vTv at an issue price of approximately $2.41 per share, with $6 million paid in cash at closing, and the remaining amount of $4 million payable on November 22, 2022. The agreements also provide for the issuance of 1.2 million warrants to CinRx to acquire additional shares of Class A Common Stock that become exercisable upon agreed vesting triggers (including FDA approval of TTP399 ("FDA Approval")). In addition to the investment, the agreements set forth the terms under which vTv will leverage the CinRx team’s industry experience to collaborate on the oversight of the clinical trials for pharmaceutical products that contain TTP399.

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"We have been hard at work on TTP399 since obtaining Breakthrough Therapy Designation from the FDA in April 2021 and are thrilled to welcome another partner to work with us to accelerate the development and potential approval and commercialization of this treatment. In addition to the $10 million investment, the CinRx team brings exceptional industry experience in developing therapeutics. On top of last month’s announcement of G42 Healthcare’s $25 million investment into vTv, this investment provides additional funding towards our Phase 3 clinical trials for TTP399," said Rich Nelson, Interim Chief Executive Officer of vTv.

Dr. Jon Isaacsohn, Chief Executive Officer of CinRx, who has been involved in the clinical development of countless therapeutics, is expected to join the vTv Board of Directors. Dr. Isaacsohn noted "CinRx values the new partnership with the team at vTv. We believe that TTP399 has the potential to reduce the frequency of hypoglycemic events in type 1 diabetics, thus easing the burden of managing their disease and allowing for tighter long-term diabetic control."

A more detailed description of the agreements is set forth in vTv’s Current Report on Form 8-K filed with the SEC. The Common Stock and Warrant Purchase Agreement is attached to the Current Report on Form 8-K.

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 a potential 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, and a Breakthrough Therapy designation does not mean a product has been, or will be, approved for use in the United States.

Supernus Pharmaceuticals to Announce Second Quarter 2022 Financial Results and Host Conference Call on August 4, 2022

On July 25, 2022 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company expects to report financial and business results for the second quarter of 2022 after the market closes on Thursday, August 4, 2022 (Press release, Supernus, JUL 25, 2022, View Source [SID1234616907]).

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Jack Khattar, President and CEO, and Tim Dec, Senior Vice President and CFO, will host a conference call to present the second quarter 2022 financial and business results on Thursday, August 4, 2022 at 4:30 p.m. ET. Following management’s prepared remarks and discussion of business results, the call will be open for questions.

A live webcast will be accessible in the Events & Presentation section of the Company’s Investor Relations website www.supernus.com/investors.

Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.

Following the live call, a replay will be available on the Company’s Investor Relations website www.supernus.com/investors. The webcast will be available on the Company’s website for 60 days following the live call.

OPKO Health to Report Second Quarter 2022 Financial Results on August 4, 2022

On July 25, 2022 OPKO Health, Inc. (NASDAQ: OPK) reported that operating and financial results for the three and six months ended June 30, 2022 after the close of the U.S. financial markets on Thursday, August 4, 2022 (Press release, Opko Health, JUL 25, 2022, View Source [SID1234616906]). OPKO’s senior management will provide a business update and discuss financial results as well as financial guidance during a conference call and live audio webcast on August 4th beginning at 4:30 p.m. Eastern time.

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CONFERENCE CALL & WEBCAST INFORMATION

OPKO encourages participants to pre-register for the conference call using this link. Callers who pre-register will be given a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing (833) 630-0584 (U.S.) or (412) 317-1815 (International). A webcast of the call may also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until August 11, 2022 by dialing (877) 344-7529 (U.S.) or (412) 317-0088 (International) and providing the passcode 5775821. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

MacroGenics Announces Date of Second Quarter 2022 Financial Results Conference Call

On July 25, 2022 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the second quarter of 2022 after the market closes on Monday, August 8, 2022 (Press release, MacroGenics, JUL 25, 2022, View Source [SID1234616905]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Monday, August 8, 2022, at 4:30 pm ET.

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Conference Call Information

To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

FDA accepts HOOKIPA’s Investigational New Drug Application for HB-300 for the treatment of metastatic castration-resistant prostate cancer

On July 25, 2022 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapies based on its proprietary arenavirus platform, reported that it has received U.S. Food and Drug Administration (FDA) acceptance of its Investigational New Drug (IND) application for HB-300, a novel arenaviral immunotherapy for the treatment of metastatic castration-resistant prostate cancer (Press release, Hookipa Pharma, JUL 25, 2022, View Source [SID1234616904]).

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"FDA acceptance of our IND application for HB-300 is a key milestone as we expand and diversify our oncology pipeline and arenavirus platform from viral antigens to self-antigens," said Joern Aldag, Chief Executive Officer at HOOKIPA. "With the concurrent acceptance of the Drug Master File, we have reduced cycle time between completion of preclinical studies and clinical entry of our pipeline projects."

About HB-300
HB-300 is an alternating, 2-vector replicating arenaviral immunotherapy for metastatic castration-resistant prostate cancer. It uses the Lymphocytic Choriomeningitis Virus and Pichinde Virus as arenaviral backbones, with each expressing two well-defined antigens of prostate cancer, PAP and PSA. Subsequent clinical development may include addition of arenaviral therapeutics expressing a third antigen, PSMA. HOOKIPA’s approach is designed to focus the immune response against the target antigens. The technology has demonstrated the ability to induce potent antigen-specific T cell responses and anti-tumor activity in preclinical tumor models.

About the Drug Master File
A Drug Master File (DMF) is a voluntary submission to the FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support additional INDs and other submissions. The FDA accepted HOOKIPA’s submission of a Type II Master File to the FDA’s Center for Biologics Evaluation and Research to present data specific to HOOKIPA’s proprietary replicating arenavirus platform.

About prostate cancer
Prostate cancer is the most diagnosed cancer and fifth leading cause of death from cancer in men. There are several stages of prostate cancer, and prostate cancer cells usually need androgen hormones, such as testosterone, to grow. Treatment for early-stage prostate cancer often aims to lower testosterone levels to stop or slow growth. Metastatic castration-resistant prostate cancer is when the cancer has spread, or metastasized, to other parts of the body including the lymph nodes, bones, rectum, liver and lungs. Metastatic castration-resistant prostate cancer does not respond to hormone therapy. Currently, there are limited treatment options for people with metastatic castration-resistant prostate cancer and only 30 percent will survive beyond five years.