GT Biopharma Announces Dosing Of New Patient In GTB-3550 TriKE(TM) Phase I/II Clinical Trial

On May 27, 2020 GT Biopharma, Inc. (OTCQB:GTBP) (GTBP.PA) an immuno-oncology company focused on NK cell engager (TriKE) technology. GT reported that the second patient of the lowest dose of an ascending dose finding study has begun treatment of the GTB-3550 TriKE (Press release, GT Biopharma, MAY 27, 2020, View Source [SID1234558535]). The patient will be evaluated following completion of the third cycle of GTB-3550 TriKE therapy. The clinical trial is being conducted at the University of Minnesota’s Masonic Cancer Center in Minneapolis. Additional clinical trial sites are now being processed.

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The first patient of the Phase I/II study achieved stable disease and increased NK cell production with no adverse side effects. The first patient elicited an encouraging initial efficacy marker response.

The TRIKE clinical trial evaluates GTB-3550 in patients with acute myeloid leukemia or advanced systemic mastocytosis, and will determine safety and tolerability as well as the pharmacologically active dose and maximum tolerated dose of GTB-3550.

TriKE is a multi-targeted immuno-oncology protein-based therapeutic drug. The TriKE addresses the patient delivery and administration issues of liquid tumor cell therapies and NK engagers. Pre-clinical data shows that The TriKE platform technology works in both liquid and solid tumors.

About GTB-3550 Trispecific NK cell Engager (TriKE)

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. The Company is currently in a clinical trial with GTB-3550 in CD33 positive leukemia for acute myeloid leukemia (AML), and is studying myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies along with other solid tumor candidates.

Bicycle Therapeutics to Present at Upcoming Investor Conferences

On May 27, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that management will participate in fireside chats at the following virtual investor conferences in June (Press release, Bicycle Therapeutics, MAY 27, 2020, View Source [SID1234558570]):

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Jefferies Global Healthcare Conference on Wednesday, June 3, 2020 at 3:00 p.m. ET
Goldman Sachs 41st Annual Global Healthcare Conference on Thursday, June 11, 2020 at 1:20 p.m. ET
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at www.bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.

Seneca Biopharma Announces the Closing of its $5 Million Registered Direct Offering

On May 27, 2020 Seneca Biopharma, Inc. (Nasdaq:SNCA), a clinical-stage biopharmaceutical company developing novel treatments for various diseases of high unmet medical need, reported the closing of its previously announced $5 million registered direct offering (Press release, Seneca Biopharma, MAY 27, 2020, View Source [SID1234558587]). Pursuant to the terms of the offering, Seneca sold an aggregate of 5 million shares of its common stock at a sales price $1.00 per share. Seneca intends to use the net proceeds from the offering for general working capital.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The shares of common stock are registered pursuant to a registration statement on Form S-3 (File No. 333-218608) which became effective by the Securities and Exchange Commission (SEC) on June 23, 2017. The offering was made by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy 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 the registration or qualification under the securities laws of any such state or jurisdiction.

Geron Corporation Announces the Closing of its Public Offering of Common Stock and Warrants

On May 27, 2020 Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 107,049,375 shares of its common stock and pre-funded warrants to purchase 8,335,239 shares of common stock, together with accompanying warrants to purchase 57,692,307 shares of common stock (Press release, Geron, MAY 27, 2020, View Source [SID1234558626]). The common stock and pre-funded warrants were sold in combination with an accompanying warrant to purchase 0.5 of a share of common stock issued for each share of common stock or pre-funded warrant sold. The combined offering price to the public of each share of common stock and accompanying warrant was $1.30. The combined offering price to the public of each pre-funded warrant and accompanying warrant was $1.299.

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The estimated net proceeds to Geron from the public offering are expected to be approximately $140 million, after deducting the underwriting discount and estimated offering expenses payable by Geron. Geron intends to use the net proceeds from this public offering to fund its ongoing IMerge Phase 3 clinical trial in lower risk myelodysplastic syndromes to top-line results, its planned Phase 3 clinical trial in refractory myelofibrosis to complete patient enrollment, and for working capital and general corporate purposes.

Stifel and MTS Health Partners acted as joint book-running managers for the offering. Needham & Company, BTIG and H.C. Wainwright & Co. acted as co-managers for the offering.

A shelf registration statement on Form S-3 relating to the public offering of the shares of common stock and accompanying warrants described above was previously filed with the Securities and Exchange Commission (SEC) and subsequently declared effective by the SEC. A final prospectus supplement relating to the offering has been filed with the SEC and is available on the SEC’s web site at www.sec.gov. Copies of the final prospectus supplement may also be obtained from Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at 415-364-2720 or by email at [email protected]; or MTS Securities, LLC, 623 Fifth Avenue, 14th Floor, New York, New York 10022, by telephone at 646-975-6548 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy any of these securities, nor will 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.

Moleculin Announces Common Stock Will Resume Trading on the NASDAQ on May 28, 2020

On May 27, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that it has received notification from Nasdaq that trading in the Company’s common stock will resume on Thursday, May 28, 2020 (Press release, Moleculin, MAY 27, 2020, View Source [SID1234558552]).

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