On June 18, 2021 Protagonist Therapeutics, Inc. (Nasdaq:PTGX), a clinical stage biopharmaceutical company, reported the closing of its previously announced underwritten public offering of 3,503,311 shares of its common stock, including 456,953 shares sold pursuant to the underwriters’ exercise in full of their "green shoe" option to purchase additional shares, at a price to the public of $37.75 per share (Press release, Protagonist, JUN 18, 2021, View Source [SID1234584140]). Aggregate gross proceeds to Protagonist from the offering were approximately $132.2 million, before deducting underwriting discounts and commissions and offering expenses.

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J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler acted as joint book-running managers for the offering. JMP Securities LLC and H.C. Wainwright & Co., LLC acted as co-lead managers for the offering.

A shelf registration statement relating to the offered shares of common stock was filed with the Securities and Exchange Commission (SEC) on December 10, 2020. A final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and is available on the SEC’s website, located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus related to the offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at 866-803-9204, or by email at [email protected]; Jefferies LLC (Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022; telephone: 877-821-7388; email: [email protected]); or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924 or by email 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 registration or qualification under the securities laws of any such state or jurisdiction.

On June 17, 2021 Cleveland BioLabs, Inc. (NASDAQ: CBLI), an innovative biopharmaceutical company developing novel approaches to activate the immune system, announced that its registration statement on SEC Form S-4 (the "Registration Statement") filed with U.S. Securities and Exchange Commission (the "SEC") in connection with its previously reported merger with Cytocom Inc. ("Cytocom") was declared effective by the SEC on June 10, 2021(Press release, Cytocom, JUN 18, 2021, https://www.cytocom.com/2021/06/18/cleveland-biolabs-inc-and-cytocom-announce-registration-statement-and-proxy-statement-for-previously-announced-merger-declared-effective-by-sec/ [SID1234584123]). Cytocom is a leading biopharmaceutical company creating next-generation immune therapies that deliver immune homeostasis.

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A special meeting of the Cleveland BioLabs stockholders to approve the proposals related to the merger (the "Special Meeting") will be held virtually. Details of the meeting are as follows:

Date:

Tuesday, July 6, 2021

Time:

10:00 a.m. ET

Registration:

www.virtualshareholdermeeting.com/CBLI2021SM

The Registration Statement includes a definitive proxy statement and a prospectus. Notice of the Special Meeting and the definitive proxy statement/prospectus was mailed to stockholders of the Company as of June 9, 2021.

ubsequent to the closing of the merger, the new combined company will be named "Cytocom Inc.", and its common stock is expected to trade on the Nasdaq Capital Market under the symbol "CYTO". The closing of the merger, which is expected to occur during the third quarter of 2021, is subject to approval by Cleveland BioLabs’ stockholders, the approval of the application for listing of the combined company’s stock on the Nasdaq Capital Market and the satisfaction of other customary closing conditions.

On June 18, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a clinical stage biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported that the Company is expected to join the small cap Russell 2000 Index and the broad-market Russell 3000 Index at the conclusion of this year’s reconstitution of the Russell stock indexes, effective after the U.S. stock market opens on Monday, June 28, 2021, accordingly to a preliminary list of additions posted on June 4, 2021 (Press release, Ampio, JUN 18, 2021, View Source [SID1234584141]).

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Michael Macaluso, the Company’s President and Chief Executive Officer, stated, "Inclusion in the Russell Indexes is an important milestone and will increase the overall awareness and exposure of our Company within the investment community."

Annual Russell indexes reconstitution captures the 4,000 largest U.S. stocks as of May 7, 2021, ranking them by total market capitalization. Membership in the U.S. all-cap Russell 3000 Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective market-capitalization rankings and style attributes.

Russell U.S. Indexes are part of the FTSE Russell, a leading global index provider, and are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies. FTSE Russell reports approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. indexes. For more information on the Russell 3000 Index and Russell 2000 Index and the Russell U.S. Indexes reconstitution, visit the "Russell Reconstitution" section at FTSE Russell website.

On June 18, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported data from two presentations evaluating TG-1701, the Company’s investigational once-daily, oral BTK inhibitor, presented today during the 16th International Congress on Malignant Lymphoma (ICML)(Press release, TG Therapeutics, JUN 18, 2021, View Source [SID1234584125]). One presentation evaluated TG-1701 preclinically and the other included Phase 1 data evaluating TG-1701 as a monotherapy and as a triple therapy in combination with ublituximab, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ (umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The Phase 1 data presented today were previously presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting and the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) annual meeting.

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PRESENTATION HIGHLIGHTS:

Poster Presentation Title: Antitumoral activity of the novel BTK inhibitor TG-1701 is associated with disruption of Ikaros signaling and improvement of anti-CD20 therapy in B-cell non-Hodgkin lymphoma

TG-1701 is a novel irreversible BTK inhibitor currently in Phase 1 clinical development, as monotherapy or in combination with ublituximab and UKONIQ (umbralisib).
In patient samples from a Phase 1 clinical trial of TG-1701, phosphoproteomic analysis differentiated early and late CLL responders to TG-1701 therapy.
Disruption of an active Ikaros pathway is a signature of early responders, while absence of Ikaros modulation upon TG-1701 therapy is a signature of non-/late responders.
TG-1701 did not impair FcγR-driven ADCC and ADCP and cooperated with U2 in in vitro and in vivo models of BTKi-sensitive and BTKi-resistant B-NHL.
Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-cell Malignancies

A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or TG-1701 in combination with U2 in the dose escalation cohort (n=19).
TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD.
Adverse Events (AEs) of special interest in patients treated with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3 hypertension (4.9%), atrial fibrillation (1.2%), and no instances of major bleeding observed. Grade 3 AEs occurring in ≥10% of patients treated with U2+1701 included diarrhea (11%), neutropenia (11%), ALT increase (16%), and AST increase (16%), and Grade 4 AEs occurring in ≥10% of patients treated with U2+1701 included neutropenia (11%).
At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates (ORR) were: 95% (19/20) in CLL, 65% (13/20) in mantle cell lymphoma (MCL), and 95% (19/20) in Waldenstrom macroglobulinemia (WM).
100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort (n=19).
At a median follow up of 15.6 months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=19).
Data presented at ICML 2021 is available on the Publications page of the Company’s website at View Source

On June 18, 2021 InnoCare (HKEX: 09969), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, reported the company presented the latest clinical data of the Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib at the 16th International Conference on Malignant Lymphoma (ICML) (Press release, InnoCare Pharma, JUN 18, 2021, View Source [SID1234584142]). Orelabrutinib showed a significant higher rate of complete response (CR) with the extended time of treatment.

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Updated Efficacy and Safety Results of Orelabrutinib in the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Cell lymphoma.

Abstract Number: 131

Orelabrutinib is a novel and highly selective irreversible BTK inhibitor. According to the previous reported data, orelabrutinib had high bioavailability with near 100% BTK occupancy at 24 hours at 150 mg daily dosing regimen and had demonstrated excellent safety and efficacy profiles in a phase II trial of r/r CLL/SLL. The median follow-up time was 25.6 months.

The efficacy results were evaluated by both IRC and investigators, with the ORR of 93.8% with 21.3% CR/CRi, 61.3% PR, and 11.3% PR-L by investigators, and the ORR of 92.5% with 16.3% CR/CRi, 65.0% PR and 11.3% PR-L by IRC. These results revealed high concordance rate for overall response assessments between IRC and investigator. Median time for achieving first response was 1.87 months. The median DOR and PFS were not reached. Orelabrutinib showed a significant higher CR/CRi rate in r/r CLL/SLL comparing to other BTK inhibitors at a similar median follow-up period.

Extended follow-up analysis did not reveal new safety concerns. Similar to the previous reported safety results, most AEs were mild to moderate.

Professor Wei Xu, deputy director of the Department of Hematology, Jiangsu Provincial People’s Hospital, said, "This updated study result further confirms that orelabrutinib is efficacious in treating r/r CLL patients with a significant higher CR rate, durable response and improved safety profiles. Orelabrutinib provides a favorable therapeutic choice for patients with r/r CLL/SLL and a potential best candidate for the combination therapy."

The ICML is held online from June 18 to 22, 2021, which is organized every two years. The ICML meeting represented a high level of lymphoma research and treatment, which not only gathered international experts in the field of lymphoma, but also demonstrated the trend of malignant lymphoma treatment.