Epizyme Announces Pricing of Public Offering of Common Stock

On January 27, 2022 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported the pricing of an underwritten public offering of 56,666,667 shares of its common stock at a price to the public of $1.50 per share, before underwriting discounts (Press release, Epizyme, JAN 27, 2022, View Source [SID1234607451]). In addition, Epizyme has granted the underwriters a 30-day option to purchase up to an additional 8,500,000 shares of common stock at the public offering price, less the underwriting discount. All of the shares in the offering are to be sold by Epizyme.

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Epizyme anticipates the total gross proceeds from the offering (before deducting underwriting discounts and offering expenses) will be approximately $85.0 million, excluding any exercise of the underwriters’ options to purchase additional shares.

Epizyme anticipates using the net proceeds from the offering, together with its existing cash, cash equivalents and marketable securities, to fund global development and commercialization costs of tazemetostat outside of Japan, including the costs of conducting the Company’s ongoing and planned clinical trials of tazemetostat, including the Company’s confirmatory Phase 1b/3 trials in epithelioid sarcoma and follicular lymphoma (FL), the Company’s clinical trials of tazemetostat in additional FL populations and the Company’s clinical trials of tazemetostat across multiple types of hematological malignancies and solid tumors; to fund the Company’s Phase 1/1b trial of its SETD2 inhibitor, EZM0414 and the discovery and identification of additional product candidates to expand the Company’s pipeline of novel epigenetic therapies; to fund initiatives to accelerate commercial adoption of TAZVERIK; and for working capital and other general corporate purposes, which may include the acquisition of companies or businesses or licensing of other products, businesses or technologies, and repayment and refinancing of debt.

Jefferies and Barclays are acting as joint bookrunning managers for the offering. Wedbush PacGrow and H.C. Wainwright & Co. are acting as co-lead managers. The offering is expected to close on January 31, 2022, subject to the satisfaction of customary closing conditions.

The shares are being offered by Epizyme pursuant to a shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission ("SEC") on May 6, 2021 and declared effective by the SEC on May 13, 2021. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement relating to and describing the terms of the offering was filed with the SEC on January 26, 2022 and copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at [email protected] or by telephone at (888) 603-5847. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, the securities being offered 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.

Provectus Biopharmaceuticals Provides Update on Research into PV-10® Immunotherapy as an Immune Adjuvant for Making Vaccines Work Better

On January 27, 2022 Provectus (OTCQB: PVCT) reported an update on research of its investigational immunotherapy PV-10 (rose bengal sodium, a halogenated xanthene small molecule) as an immune adjuvant in vaccines for cancer and viruses to improve immune response upon vaccination, in conjunction with the Company’s ongoing efforts to expand its intellectual property (Press release, Provectus Biopharmaceuticals, JAN 27, 2022, View Source [SID1234607450]).

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On January 20, 2022, the U.S. Patent and Trademark Office (USPTO) published Provectus’ patent application entitled "Halogenated Xanthenes as Vaccine Adjuvants" (publication no. US 2022/0016242 A1), which contained among other things:

In vitro data that showed PV-10 was able to significantly increase numbers of interferon (IFN) gamma-producing CD8 cells (compared to controls) for peptides representing various antigenic regions of the Hepatitis B virus (HBV) core protein (HBcAg). These peptides were selected for their capability to raise CD4 and CD8 T cells against HBV.
Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "Immune adjuvants can help vaccines generate quicker, more efficacious and durable immune responses. This new research further supports the multi-faceted immunogenicity of Provectus’ small molecule medical science platform, which is the foundation of our work to develop transformative, accessibly-priced immunotherapy medicines."

Beyond Air® Schedules Third Fiscal Quarter 2022 Financial Results Conference Call and Webcast

On January 27, 2022 Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that it will report financial results for its third fiscal quarter ended December 31, 2021 on Thursday, February 10, 2022 (Press release, Beyond Air, JAN 27, 2022, View Source [SID1234607449]). The Company’s management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day.

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Conference Call & Webcast
Thursday, February 10th @ 4:30 PM ET
Domestic: 877-407-0784
International: 201-689-8560
Passcode: 13726696
Webcast: View Source;tp_key=78e079398f

Enveric Biosciences to Participate in Upcoming Investor Conferences in February 2022

On January 27, 2022 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-centric biotechnology company developing next-generation mental health and oncology treatments by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric Biosciences, will participate in two upcoming investor conferences (Press release, Enveric Biosciences, JAN 27, 2022, View Source [SID1234607447]):

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Citi’s Psychedelic Drug Call Series
Tuesday, February 8th at 10:00 a.m. ET
A fireside chat hosted by Neena Bitritto-Garg, Citi’s Biotech analyst.

Aegis Capital Corp. Virtual Conference
Friday, February 25th at 3:00 p.m. ET
To access the event, please download and import the following iCalendar (.ics) files to your calendar system: Aegis Virtual Conference Calendar.

For more information about the events, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate Citi or Aegis representative, respectively, or send an email to KCSA Strategic Communications at [email protected].

Adagene Announces First Patient Dosed with Novel, Proprietary Combination of Anti-CD137 Agonist, ADG106, and Anti-CTLA-4 Monoclonal Antibody, ADG116

On January 27, 2022 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, reported the first patient has been dosed in a combination cohort of its anti-CD137 agonist, ADG106, with its anti-CTLA-4 monoclonal antibody (mAb), ADG116, in patients with advanced/metastatic solid tumors (Press release, Adagene, JAN 27, 2022, View Source [SID1234607446]). The dose escalation cohort will evaluate the safety and tolerability of this novel, proprietary combination in patients with advanced/metastatic solid tumors.

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"Existing cancer therapies that target CD137 and CTLA-4 are associated with safety concerns, creating a significant unmet need and high threshold for agents that are both safe and potent. With ADG106 and ADG116, we now have two promising agents to test the therapeutic potential of these two potent pathways together to safely inhibit tumor growth," said Anthony W. Tolcher, M.D., FRCPC, FACP, co-founder of NEXT Oncology and study investigator. "While the oncology community has long known of the compelling preclinical rationale for this intriguing combination, safety has been a barrier to further exploration. Given the encouraging individual safety profiles of both ADG 106 and ADG116 in patients so far, we finally have the rare and exciting opportunity to be the first to move this combination into clinic and improve patient care."

The combination is part of an open-label, global phase 1b/2 clinical trial (ADG116-1003) at multiple sites in the U.S. and Asia Pacific (APAC). The combination part begins with dose-escalation, followed by dose expansion once a recommended dose is established.

"Published research in preclinical models underscores the potential synergistic effect of combining these two potent pathways. We are proud to pioneer exploration of this novel combination, which also demonstrates the translational power of our NEObody platform — targeting unique epitopes with novel mechanisms of action by species cross reactive antibodies that can move directly from preclinical syngeneic mouse models to clinical studies," said Peter Luo, Ph.D., Co-founder, Chief Executive Officer and Chairman of Adagene. "This innovative clinical research will establish the safety and potential complementary effects of ADG106 and ADG116 against two challenging but orthogonal pathways for T-cell priming by anti-CTLA-4 and proliferation by anti-CD137, respectively, building on the promising preclinical and clinical data on safety and preliminary efficacy from our global trials. This pursuit aligns with our goal to transform the development paradigm of antibody-based immunotherapies for global cancer care."

As single agents, both ADG106 and ADG116 have demonstrated robust safety profiles and early signals of efficacy. In monotherapy trials in 98 patients, ADG106 was well tolerated at doses of 3 mg/kg and 5 mg/kg and at 300mg and 400mg flat doses, with limited liver toxicity or hematologic abnormalities observed. Results showed evidence of efficacy and a potential biomarker associated with tumor shrinkage was identified.

In monotherapy evaluation, ADG116 demonstrated a strong safety profile at doses up to 10 mg/kg, and showed early signals of efficacy, including in treatment-resistant "cold" and "warm" tumors such as ovarian and pancreatic cancers. ADG116 has achieved the recommended dosing range as a single agent and for evaluation in combination therapy.

About ADG116

ADG116 is a fully human ligand-blocking anti-CTLA-4 mAb generated using Adagene’s proprietary NEObody technology and being developed for the treatment of advanced/metastatic solid tumors. ADG116 is designed to enhance efficacy by potent Treg depletion in the tumor microenvironment (TME) and to maintain its physiological function by soft ligand blocking thereby addressing safety concerns associated with existing CTLA-4 therapeutics.

About ADG106

ADG106, is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb generated using Adagene’s proprietary NEObody technology and being developed for the treatment of advanced solid tumors and non-Hodgkin’s lymphoma. CD137 stimulates the immune system to attack cancer cells and is a key driver for long-lasting T-cell proliferation and survival. Clinical trials of ADG106 as monotherapy have been conducted in the U.S. and China, and combination trials are underway with multiple anti-PD-1 therapies.