Bausch Health Companies Inc. Will Release Second-Quarter 2021 Financial Results On August 3

On July 6, 2021 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its second-quarter 2021 financial results on Tuesday, Aug. 3, 2021 (Press release, Bausch Health, JUL 6, 2021, View Source [SID1234584634]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.

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Novavax to Host Conference Call to Discuss Second Quarter Financial Results and Operational Highlights on August 5, 2021

On July 6, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported it will report its second quarter 2021 financial results and operational highlights on Thursday, August 5, 2021, following the close of U.S. financial markets (Press release, Novavax, JUL 6, 2021, https://www.prnewswire.com/news-releases/novavax-to-host-conference-call-to-discuss-second-quarter-financial-results-and-operational-highlights-on-august-5-2021-301325648.html [SID1234584633]). Details of the event and replay are as follows:

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Biocytogen/Eucure Biopharma’s CTLA-4 and CD40 mAbs Approved for Phase II Clinical Trials by the FDA

On July 6, 2021 Eucure Biopharma, a wholly owned subsidiary of Biocytogen dedicated to developing antibody drugs with independent intellectual property rights, reported that the U.S. Food and Drug Administration (FDA) has approved two phase II clinical trials for YH001 (anti-CTLA-4) and YH003 (anti-CD40) in the United States (Press release, Eucure, JUL 6, 2021, View Source [SID1234584632]).

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A phase II, non-randomized, multi-center clinical study will evaluate the use of YH001 in combination with Junshi Biosciences’ anti-PD-1 monoclonal antibody (Toripalimab) for the treatment of advanced non-small cell lung cancer (NSCLC) and hepatocellular carcinoma (HCC). A phase II, open-label, multi-center study will evaluate the safety and efficacy of YH003 combined with Toripalimab for the treatment of PD-1-resistant unresectable/metastatic melanoma and pancreatic ductal adenocarcinoma (PDAC). Both trials are multi-regional clinical trials, and will be conducted in the United States, Australia and China. The YH003 phase II clinical trial in Australia was approved by the Australian regulatory agency in May 2021 following a phase I dose-escalation study launched in May 2020.

Dr. Yuelei Shen, Chairman and CEO of Biocytogen and Eucure Biopharma, said that the approvals signify "a milestone" for Eucure Biopharma. "In just one year, both products advanced from Australian phase I clinical trials to the FDA approvals of phase II trials. This is not only an affirmation of the clinical safety and preliminary efficacy of these two products, but also an affirmation of Biocytogen’s drug discovery platform and in vivo drug efficacy screening model. I am very pleased to see that the Eucure team was able to advance clinical development so efficiently. We will continue to actively promote the clinical trials of YH001 and YH003 in China and around the world. With our RenMice HiTS Platform, Eucure’s clinical pipeline will continue to expand with potentially novel best-in-class and first-in-class mAbs for oncologic, viral and autoimmune diseases."

About YH001

YH001 is a humanized IgG1 monoclonal antibody targeting CTLA-4. YH001 enhances the immune response against tumor cells and promotes removal of regulatory T cells from the tumor microenvironment. In phase I first-in-human dose-escalation studies in patients with advanced solid tumors conducted in Australia and China, YH001 has shown best-in-class potential with an improved safety profile compared to Ipilimumab (Yervoy), and promising preliminary efficacy when used in combination with Toripalimab.

About YH003

YH003 is a humanized IgG2 agonistic antibody targeting CD40, a receptor that promotes the activation of antigen-presenting cells and the effector activity of anti-tumor T cells. CD40 activation is a key regulatory point in tumor immunotherapy, effectively transforming cold tumors lacking immune cell infiltration into hot tumors that respond well to tumor immunotherapy. Whether used as a single agent or in combination with anti-PD-1 monoclonal antibody drugs, YH003 demonstrated strong anti-tumor effects against multiple tumor models in Biocytogen’s humanized CD40 mice. Pharmacodynamic studies in mice indicates that YH003 significantly increased the infiltration of anti-tumor T cells into tumors. Available clinical data from the YH003 phase I dose-escalation trial indicates a desirable safety profile when combined with Toripalimab, and a potential breakthrough treatment for PD-1-refractory melanoma.

IDEAYA Announces Proposed Public Offering of Common Stock

On July 6, 2021 IDEAYA Biosciences, Inc. (Nasdaq:IDYA) reported that it intends to offer and sell up to $80 million of shares of its common stock in an underwritten public offering (Press release, Ideaya Biosciences, JUL 6, 2021, View Source [SID1234584631]). In addition, IDEAYA intends to grant the underwriters a 30-day option to purchase up to $12 million of shares of its common stock. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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IDEAYA intends to use the net proceeds of the offering, along with its existing cash, cash equivalents and short-term and long-term marketable securities to fund (i) clinical development of IDE397, its MAT2A inhibitor development candidate, (ii) preclinical and clinical development of other product candidates in its research pipeline targeting poly (ADP-ribose) glycohydrolase, or PARG, a MTAP synthetic lethality target (other than MAT2A), and DNA damage targets, as well as its share of costs for targeting WRN under the Company’s Collaboration, Option and License Agreement with GSK, (iii) ongoing early clinical development of darovasertib (IDE196), its PKC inhibitor, in metastatic uveal melanoma, or MUM, and other solid tumors having GNAQ/11 hotspot mutations, including as monotherapy and as combination therapies with binimetinib, a MEK inhibitor, and independently with crizotinib, in each case pursuant to a clinical trial and drug supply agreement with Pfizer, (iv) synthetic lethality target and biomarker research and development activities and (v) working capital and other general corporate purposes.

J.P. Morgan, Citigroup, Jefferies and Guggenheim Securities are acting as joint book-running managers for the offering.

The securities described above are being offered by IDEAYA pursuant to a shelf registration statement on Form S-3 that was previously filed with and declared effective by the U.S. Securities and Exchange Commission (the "SEC"). The offering will be made only by means of a written prospectus and a prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to these securities may also be obtained by request from: J.P. Morgan, by mail at J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 866-803-9204, or by email at [email protected]; Citigroup, by mail at Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146, or by email at [email protected]; Jefferies, by mail at Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or 877-821-7388, or by email at [email protected]; or Guggenheim Securities, by mail at Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017, or by telephone at (212) 518-5548 or by email at [email protected].

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

OncoSec Enters into a Collaboration Agreement with Merck for a Pivotal Global Phase 3 Study, KEYNOTE-C87, of TAVO™ Combined with KEYTRUDA® for Late-Stage Metastatic Melanoma

On July 6, 2021 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec") reported it has entered into a Clinical Trial Collaboration and Supply Agreement ("Agreement") with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s DNA-plasmid interleukin-12 (IL-12) TAVO (tavokinogene telseplasmid) with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a global Phase 3 randomized clinical trial, KEYNOTE-C87 (Press release, OncoSec Medical, JUL 6, 2021, View Source [SID1234584630]). The planned clinical trial will evaluate the overall survival of patients treated with the TAVO in combination with KEYTRUDA versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.

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TAVO has received Fast Track designation from the U.S. Food and Drug Administration (FDA), as a potentially first-in-class, intratumoral anti-cancer gene therapy that expresses IL-12 for the treatment of metastatic melanoma, following progression on KEYTRUDA or OPDIVO (nivolumab). KEYNOTE-C87 is intended to support accelerated approval by the U.S. FDA and/or serve as a pivotal study to support a full licensure. Under the terms of the Agreement, Merck will provide KEYTRUDA , while OncoSec will provide the investigational drug, TAVO. Each party will be responsible for its own internal costs, with OncoSec covering third party costs. Eligible patients must have Stage III or IV unresectable, metastatic melanoma, and must be refractory to prior checkpoint therapy. KEYNOTE-C87 intends to enroll approximately 400 patients and is planned to be conducted in the U.S., Canada, EU, and Australia.

"We are thrilled to enter into this collaboration and supply agreement with Merck – one of the world’s leading immuno-oncology companies – to help bring TAVO to patients with metastatic melanoma whose disease did not respond to initial checkpoint inhibitor therapy or who have developed progressive disease and therefore do not have additional treatment options available," said Brian Leuthner, Interim Chief Executive Officer of OncoSec. "This Phase 3 collaboration represents a crucial milestone for OncoSec as we advance TAVO through the clinic and toward potential approval globally, and expands upon our initial 2017 clinical collaboration and supply agreement with Merck. We look forward to our continued work and progress with Merck and its experienced team of immuno-oncology leaders as we continue to explore TAVO in combination with KEYTRUDA with the goal of helping more patients with cancer."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A. OPDIVO is a registered trademark of Bristol Myers Squibb.

About TAVO
OncoSec’s gene therapy technology combines TAVO (tavokinogene telseplasmid), a DNA plasmid-based interleukin-12 (IL-12), with an intra-tumoral electroporation gene delivery platform to achieve endogenous IL-12 production in the tumor microenvironment that enables the immune system to target and attack tumors throughout the body. TAVO has demonstrated a local and systemic anti-tumor response in several clinical trials, including the pivotal Phase 2b trial KEYNOTE-695 for metastatic melanoma and the KEYNOTE-890 Phase 2 trial in triple negative breast cancer (TNBC). TAVO has received both Orphan Drug and Fast-Track Designation by the U.S. Food & Drug Administration for the treatment of metastatic melanoma.