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.

On November 4, 2021 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on sickle cell disease, prostate cancer and other rare hematologic diseases and cancers, reported that four abstracts have been accepted for presentation – including three oral presentations and one poster presentation – at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place Dec. 11-14, 2021 (Press release, Forma Therapeutics, NOV 4, 2021, View Source [SID1234594532]).

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Two oral presentations will feature clinical data on a Phase 1 trial of etavopivat, the company’s oral, once-daily, selective pyruvate kinase-R (PKR) activator for the treatment of sickle cell disease (SCD). One abstract evaluates the ability of etavopivat to improve anemia and decrease intravascular hemolysis. A second abstract shows the effects of etavopivat on improving red blood cell health and lifespan, as well as reduction in systemic markers of inflammation and hypercoagulability. A third abstract highlights clinical data from the Phase 2 trial of olutasidenib, the company’s selective inhibitor for cancers with mutations in isocitrate dehydrogenase 1 (IDH1m) being evaluated in patients with relapsed/refractory acute myeloid leukemia (R/R AML).

"We’re pleased that these abstracts were selected for oral and poster presentation at the ASH (Free ASH Whitepaper) annual meeting," said Patrick Kelly, M.D., chief medical officer of Forma Therapeutics. "We look forward to sharing updated data at the meeting on the profile of etavopivat in sickle cell patients to not only increase hemoglobin but also to improve markers of hemolysis, as well as red blood cell health and red blood cell lifespan. In addition, the new olutasidenib results indicate potential for use as a single agent and in combination therapy with azacytidine to provide benefit in patients with relapsed/refractory AML."

The abstracts are currently available on the ASH (Free ASH Whitepaper) website: View Source

Oral Presentations:
Title: FT-4202, Activation of Pyruvate Kinase-R with Etavopivat (FT-4202) Is Well Tolerated, Improves Anemia, and Decreases Intravascular Hemolysis in Patients with Sickle Cell Disease Treated for up to 12 Weeks
Date/Time: Saturday, Dec. 11, at 9:45 AM ET
Session: 114
Abstract: 147091
Presenter: R. Clark Brown, MD, PhD

Title: FT-4202, Etavopivat, an Allosteric Activator of Pyruvate Kinase-R, Improves Sickle RBC Functional Health and Survival and Reduces Systemic Markers of Inflammation and Hypercoagulability in Patients with Sickle Cell Disease: An Analysis of Exploratory Studies in a Phase 1 Study
Date/Time: Saturday, Dec. 11, at 10:00 AM ET
Session: 114
Abstract: 147078
Presenter: Theodosia A. Kalfa, MD, PhD

Title: FT-2102, Olutasidenib (FT-2102) in Combination with Azacitidine Induces Durable Complete Remissions in Patients with mIDH1 Acute Myeloid Leukemia
Date/Time: Monday, Dec. 13, at 3:00 PM ET
Session: 616
Abstract: 144905
Presenter: Jorge E. Cortes, MD

Poster Presentation:
Title: FT-2102, Molecular Characteristics of Response to Olutasidenib (FT-2102) in Patients with Relapsed/Refractory mIDH1 Acute Myeloid Leukemia
Date/Time: Sunday, December 12th at 6:00-8:00 PM ET
Session: 616
Abstract: 144912
Presenter: Stéphane de Botton, MD, PhD

About Etavopivat
Etavopivat is an investigational, once-daily, selective red blood cell (RBC) pyruvate kinase-R (PKR) activator designed to be a disease-modifying therapy for the treatment of sickle cell disease (SCD). Employing a multimodal approach, etavopivat is designed to work by activating the RBCs’ natural PKR activity to decrease 2,3-DPG levels, which leads hemoglobin to hold on to oxygen molecules longer to reduce polymerization and RBC sickling. Etavopivat-mediated PKR activation also increases ATP levels, the fuel that provides energy to cells, to improve RBC health and survival. Together, these effects are anticipated to increase hemoglobin levels and decrease painful vaso-occlusive crises. In preclinical safety studies, etavopivat did not inhibit aromatase activity or affect steroidogenesis, important biological processes responsible for sexual development. Etavopivat has been granted Fast Track, Rare Pediatric Disease and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), and Orphan Drug Designation from the European Commission based on a positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency for the treatment of patients with SCD.

About Olutasidenib
Olutasidenib is an oral, potent, small-molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. With the conclusion of the Phase 2 R/R AML trial, Forma has begun preparing a new drug application (NDA) for submission to the U.S. Food and Drug Administration (FDA).

IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.