Fate Therapeutics Announces Proposed Public Offering of Common Stock

On June 8, 2020 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that it has commenced an underwritten public offering of its common stock (Press release, Fate Therapeutics, JUN 8, 2020, View Source [SID1234560898]). Fate Therapeutics intends to use the net proceeds from the offering to fund clinical trials and nonclinical studies, the manufacture of its clinical product candidates, the expansion of its cGMP compliant manufacturing operations, including the construction, commissioning and qualification of its new facility, the conduct of preclinical research and development, and for general corporate purposes. In connection with the offering, Fate Therapeutics expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All shares of common stock to be sold in the offering will be offered by Fate Therapeutics. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.

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Subject to the completion of the offering and the expiration or early termination of applicable waiting periods relating to certain antitrust filings under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, the Company also expects to sell to Johnson & Johnson Innovation-JJDC, Inc. in a private placement, a number of shares of common stock in an aggregate purchase price of up to $50.0 million, at a price per share equal to the price to the public in the underwritten public offering.

Jefferies, SVB Leerink and Barclays are acting as joint book-running managers for the offering.

The securities described above are being offered by Fate Therapeutics pursuant to an automatic shelf registration statement on Form S-3 (File No. 333-228513) that was previously filed by Fate Therapeutics with the Securities and Exchange Commission (the "SEC") and automatically became effective upon filing on November 21, 2018.

A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source A copy of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 547-6340; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525 ext. 6218 or by email at [email protected]; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (888) 603-5847 or by email at [email protected].

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

Agios Announces FDA Orphan Drug Designation Granted to Mitapivat for Treatment of Thalassemia

On June 8, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s first-in-class pyruvate kinase-R (PKR) activator mitapivat for the treatment of patients with thalassemia (Press release, Agios Pharmaceuticals, JUN 8, 2020, View Source [SID1234560897]). Mitapivat is an investigational, oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes.

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"Receiving orphan drug designation is an important milestone as we continue to advance mitapivat for patients with thalassemia, a serious hemolytic anemia with limited treatment options," said Chris Bowden, M.D., chief medical officer at Agios. "We look forward to presenting updated data from our Phase 2 study of mitapivat in both alpha- and beta-thalassemia patients at the virtual European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress later this week."

The FDA’s Office of Orphan Drug Products grants orphan status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including market exclusivity upon regulatory approval if received, exemption of FDA application fees and tax credits for qualified clinical trials.

Mitapivat was previously granted orphan drug designation by the FDA and the European Medicines Agency for pyruvate kinase (PK) deficiency, a rare, debilitating, hemolytic anemia.

Mitapivat Clinical Development
Agios is conducting a Phase 2 study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of treatment with mitapivat in adults with non-transfusion-dependent β- and α-thalassemia (NTDT). The trial is fully enrolled, and the primary endpoint is hemoglobin response. Preliminary Phase 2 data establishing proof-of-concept for mitapivat in thalassemia were disclosed at the end of 2019, and updated data from this trial will be presented at the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, which is being held virtually on June 11-14, 2020.

In addition, Agios has two ongoing global, pivotal trials in adults with PK deficiency that are fully enrolled.

ACTIVATE: A placebo-controlled trial with a 1:1 randomization evaluating patients who do not receive regular transfusions. The primary endpoint of the trial is the proportion of patients who achieve a sustained hemoglobin increase of ≥1.5 g/dL.
ACTIVATE-T: A single arm trial of regularly transfused patients with a primary endpoint of reduction in transfusion burden over six months compared to individual historical transfusion burden over prior 12 months.
Mitapivat is also being studied in sickle cell disease under a Cooperative Research and Development Agreement (CRADA) with the U.S. National Institutes of Health.

Mitapivat is not approved for use by any regulatory authority.

Lilly to Participate in Goldman Sachs Global Healthcare Conference

On June 8, 2020 Eli Lilly and Company (NYSE:LLY) reported that it will participate in the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10, 2020 (Press release, Eli Lilly, JUN 8, 2020, View Source [SID1234560896]). Joshua Smiley, senior vice president and Lilly’s chief financial officer, will participate in a virtual fireside chat at 2:10 p.m. EDT.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay will be available for approximately 90 days.

Xenetic Biosciences, Inc. to Present at the Virtual Investor Fireside Chat Series

On June 8, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported that Jeffrey Eisenberg, Chief Executive Officer of Xenetic, will present at the Virtual Investor Fireside Chat Series on Tuesday, June 16, 2020 at 12:00 PM ET (Press release, Xenetic Biosciences, JUN 8, 2020, View Source [SID1234560895]).

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A live video webcast of the fireside chat will be available on the IR Calendar page of the Investors section of the Company’s website (xeneticbio.com). Immediately following the fireside chat, management will participate in an interactive Q&A session with interested parties, allowing participants to type in questions and receive live responses. A webcast replay will be available two hours following the live presentation and will be accessible for one year.

To schedule a one-on-one call with management, please submit a request through the conference website vifiresidechat.com, or contact the conference at [email protected]. For more information about the event, please visit vifiresidechat.com.

Can-Fite Participating in BIO Digital International Convention and One-on-One Partnering Meetings on June 8-12, 2020

On June 8, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported that the Company’s VP of Business Development, Dr. Sari Fishman, is conducting one-on-one meetings with pharmaceutical companies for potential distribution and partnerships for the Company’s drug candidates, Piclidenoson and Namodenoson, at the BIO International Convention 2020 which is taking place digitally on June 8-12, 2020 (Press release, Can-Fite BioPharma, JUN 8, 2020, View Source [SID1234560894]).

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"Namodenoson’s highly encouraging Phase II data showing it substantially resolved all cases of NASH, in addition to the drug’s advancement towards a global pivotal Phase III study in liver cancer underscores its value for potential partnership agreements. Likewise, we expect interim data for Piclidenoson on Phase III studies in psoriasis and rheumatoid arthritis by the end of this year. With our advanced stage clinical pipeline, this is very opportune timing for us to engage in discussions with potential pharma partners seeking safe and effective drugs for autoimmune and liver diseases," stated Can-Fite CEO Dr. Pnina Fishman.

Can-Fite currently has out-licensing agreements for its Namodenoson and Piclidenoson drug candidates in several territories and has received approximately $18 million in upfront and milestone payments to date.