On November 4, 2021 Aprea Therapeutics, Inc. (NASDAQ: APRE), a biopharmaceutical company focused on developing and commercializing novel cancer therapeutics that reactivate mutant tumor suppressor protein p53, reported that investigators will present data from clinical trials evaluating eprenetapopt at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH) (Free ASH Whitepaper) (Press release, Aprea, NOV 4, 2021, View Source [SID1234594429]).

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Oral presentations are as follows:

Title: Long-Term Follow-up and Combined Phase 2 Results of Eprenetapopt (APR-246) and Azacitidine (AZA) in Patients with TP53 Mutant Myelodysplastic Syndromes (MDS) and Oligoblastic Acute Myeloid Leukemia (AML)
Date & Time: Saturday, December 11, 2021 at 3:15 pm ET
Oral Abstract Session: 637. Myelodysplastic Syndromes—Clinical and Epidemiological: Treatment of High Risk Myelodysplastic Syndrome
Abstract: 246
Location: Georgia World Congress Center, B207-B208
Presenter: David Sallman, M.D., H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida

Title: Phase II Trial of Eprenetapopt (APR-246) in Combination with Azacitidine (AZA) As Maintenance Therapy for TP53 Mutated AML or MDS Following Allogeneic Stem Cell Transplantation (SCT)
Date & Time: Sunday, December 12, 2021 at 9:30 am ET
Oral Abstract Session: 723. Allogeneic Transplantation: Long-term Follow-up and Disease Recurrence
Abstract: 409
Location: Georgia World Congress Center, B304-B305
Presenter: Asmita Mishra, M.D., H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida

Poster presentation is as follows:

Title: Phase I and Expansion Study of Eprenetapopt (APR-246) in Combination with Venetoclax (VEN) and Azacitidine (AZA) in TP53-Mutant Acute Myeloid Leukemia (AML)
Date & Time: Monday, December 13, 2021, 6:00 – 8:00 pm ET
Poster Abstract Session: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Abstract: 3409
Location: Georgia World Congress Center, Hall B5
Presenter: Guillermo Garcia-Manero, M.D., The University of Texas MD Anderson Cancer Center, Houston, Texas

On November 4, 2021, Fate Therapeutics, Inc. (the "Company") reported that filed a registration statement on Form S-3ASR (the "Registration Statement") under Rule 415 of the Securities Act of 1933, as amended (the "Securities Act") (Press release, Fate Therapeutics, NOV 4, 2021, View Source [SID1234594445]). Pursuant to such Registration Statement, the Company may issue and sell from time to time securities consisting of (i) the Company’s common stock, par value $0.001 per share (the "Common Stock"), (ii) the Company’s preferred stock, par value $0.001 per share (the "Preferred Stock" together with the Common Stock, the "Equity Securities"), (iii) debt securities ("Debt Securities"), which may be either senior debt securities, subordinated debt securities, senior convertible debt securities or subordinated convertible debt securities, (iv) warrants or other rights to purchase Common Stock ("Warrants"), and (v) units comprised of shares of Common Stock, shares of Preferred Stock, Debt Securities and Warrants in any combination.

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In addition, on November 4, 2021, the Company entered into an Open Market Sale AgreementSM (the "Agreement") with Jefferies LLC ("Jefferies") with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its Common Stock having an aggregate offering price of up to $350,000,000 (the "Placement Shares"), through Jefferies as its sales agent. The issuance and sale, if any, of the Placement Shares may be by any method permitted by law deemed to be an "at-the-market offering" as defined in Rule 415 of the Securities Act, including, without limitation, sales made directly on the Nasdaq Global Market ("Nasdaq"), or on any other existing trading market for the Common Stock.

The Company is not obligated to make any sales of Common Stock, and Jefferies is not required to sell any specific number or dollar amount of shares of the Common Stock, under the Agreement. The Company or Jefferies may suspend or terminate the offering of Placement Shares upon notice to the other party and subject to other conditions.

Subject to the Company’s request to sell Placement Shares, Jefferies will act as the Company’s sales agent on a best efforts basis and use commercially reasonable efforts to sell on the Company’s behalf, from time to time consistent with its normal sales practices and applicable state and federal laws, rules and regulations and Nasdaq rules, such Placement Shares based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay Jefferies a commission equal to 3.0 percent (3.0%) of the gross proceeds of any Placement Shares sold through Jefferies under the Agreement, and also has provided Jefferies with customary indemnification and contribution rights.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed herewith and incorporated herein by reference.

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the securities discussed herein, nor shall there be any offer, solicitation, or sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

On November 4, 2021 Aptose Biosciences Inc. (Nasdaq: APTO; TSX: APS), reported that it has entered into an exclusive license agreement with Hanmi Pharmaceutical, a South Korean pharmaceutical company, to develop and commercialize HM43239, an oral, highly potent, clinical-stage myeloid kinome inhibitor (MKI), designed to target a distinct constellation of kinases operative in myeloid malignancies, including SYK, FLT3, and others (Press release, Aptose Biosciences, NOV 4, 2021, View Source [SID1234594478]). HM43239 has demonstrated significant genotype-agnostic anti-leukemic activity in an ongoing Phase 1/2 clinical trial, including multiple complete responses in patients with relapsed or refractory acute myeloid leukemia (AML).

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Under the terms of the agreement, Hanmi has granted Aptose exclusive worldwide rights to HM43239 for all indications. Hanmi will receive an upfront payment of $12.5 million, including $5 million in cash and $7.5 million in Aptose shares. Hanmi will also receive up to $407.5 million in future milestone payments contingent upon the achievement of certain clinical, regulatory and sales milestones across several potential indications, as well as tiered royalties on net sales.

"Our deep experience with kinase inhibitors has led us to appreciate and develop agents covering constellations of kinases associated with specific malignancies. HM43239 is a well-tolerated, once-daily oral agent with validated anti-leukemic activity in a highly challenging and heterogeneous malignancy like AML. We believe that HM43239 has a clear development and commercial path, while being a natural fit with our strategic focus, technical expertise, and clinical experience," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer.

"We believe that the myeloid kinome inhibitor HM43239 furthers our leadership in leukemia and lymphoma therapeutics, alongside our dual lymphoid and myeloid kinome inhibitor luxeptinib. We believe that today’s agreement brings significant value to our company and shareholders, and we are pleased to add this novel clinical compound to our evolving pipeline," said Jotin Marango, M.D., Ph.D., Senior Vice President, Chief Financial Officer and Chief Business Officer.

"We view HM43239 as a promising drug for the treatment of myeloid hematologic malignancies, which can specifically target mutations that are commonly found in AML patients, while overcoming drug resistance observed with currently approved drugs. We are thrilled to establish a partnership with Aptose, who has strong expertise in the field of hematology, to enhance the quality of life of patients suffering from refractory hematologic tumors," said Se-Chang Kwon, Ph.D., Chief Executive Officer at Hanmi Pharmaceutical.

Aptose has scheduled a conference call and webcast today, Thursday, November 4, 2021:

Conference Call & Webcast Details

About HM43239
HM43239 is an oral genotype agnostic small molecule inhibitor of a constellation of kinases operative in myeloid malignancies and known to be involved in tumor proliferation, resistance to therapy, and differentiation. Preclinical in vitro and in vivo studies suggest that HM43239 may be an effective monotherapy and combination therapy in patients with hematologic malignancies including AML. An international Phase 1/2 clinical trial in patients with relapsed or refractory AML is ongoing. The dose escalation portion of this study thus far has delivered multiple complete responses in a diverse set of patients with various disease genotypes, and no toxicity trends that prevent further dose escalation to date. HM43239 was granted Orphan Drug Designation (ODD) in AML in the US in October 2018. For more information, please visit clinicaltrials.gov (NCT03850574).

On November 4, 2021 DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, reported that its third quarter 2021 financial results will be released after the markets close on Wednesday, November 10th (Press release, DiaMedica, NOV 4, 2021, View Source [SID1234594497]). DiaMedica will host a live conference call on Thursday, November 11th at 7:00 AM Central Time to discuss its business update and financial results.

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Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on our website, under investor relations – events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until November 18, 2021, by dialing (800) 770-2030 (US Toll Free) and entering the replay passcode: 4814247.

On November 4, 2021 Epizyme, Inc. (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to EZM0414, the Company’s novel, first-in-class, oral SETD2 inhibitor, as an investigational agent for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Press release, Epizyme, NOV 4, 2021, View Source [SID1234594514]). In addition, the Company has initiated a Phase 1/1b study to evaluate safety and determine the optimal dose of EZM0414. Following this dose-ranging phase, the study will be expanded to evaluate EZM0414 in three patient cohorts: t(4;14) multiple myeloma, non t(4;14) multiple myeloma, and DLBCL.

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"Today we are excited to announce an important milestone for Epizyme, as we prepare to bring another investigational candidate into the clinic with the initiation of this first-in-human clinical trial of our SETD2 inhibitor, EZM0414," said Grant Bogle, President and Chief Executive Officer at Epizyme. "As leaders in pioneering therapies against novel epigenetic targets, bringing EZM0414 to the clinic is an important advancement as we strive to fulfill our vision of making transformative therapies a reality for patients living with cancer."

SETD2 is a histone methyltransferase, similar to EZH2, which plays multiple important roles in oncogenesis. Epizyme recently shared data demonstrating potent preclinical in vitro and in vivo activity for a selective inhibitor of the SETD2 histone methyltransferase at the 2021 European Hematology Association (EHA) (Free EHA Whitepaper) meeting. The Company plans to share additional preclinical data and the Phase 1/1b trial design as a trial in progress at an upcoming medical meeting.

"The receipt of Fast Track designation underscores the urgent need for innovative therapies that may significantly improve the lives of patients living with devastating diseases such as DLBCL," said Dr. Shefali Agarwal, Executive Vice President and Chief Medical and Development Officer at Epizyme. "Additionally, through the initiation of our Phase 1/1b study, we look forward to evaluating the safety and efficacy of EZM0414 in both DLBCL and multiple myeloma, including high-risk t(4;14) multiple myeloma. Multiple myeloma patients with this high-risk mutation often have a poorer prognosis and is an area of high unmet medical need. We believe the inhibition of SETD2 may play an important role in treating these patients."

The FDA Fast Track program is designed to facilitate the development of important new drugs and to provide patients access to those drugs more quickly. The designation enables early and frequent communication between FDA and a product sponsor throughout the drug development and review process. Through the Fast Track program, a product may be eligible for priority review at the time of a new drug application (NDA) filing and may also be eligible to submit completed sections of the NDA on a rolling basis before the complete application is submitted. These expedited processes can potentially reduce development time and cost associated with bringing a drug to market.