Pulse Biosciences, Inc. Announces Commencement of Rights Offering

On November 19, 2018 Pulse Biosciences, Inc. (Nasdaq: PLSE) ("Pulse Biosciences" or the "Company"), a novel medical therapy company bringing to market its proprietary CellFX Nano-Pulse Stimulation (NPS) platform, reported that it has commenced its previously announced rights offering of $45,000,000 of its common stock (Press release, Pulse Biosciences, NOV 19, 2018, View Source [SID1234531448]). The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on Thursday December 6, 2018 (the "Expiration Date").

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Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase up to $45,000,000 of shares of its common stock at a subscription price per share equal to the lesser of (i) $13.33 per share (the "Initial Price") or (ii) the volume weighted average price (the "Alternate Price") of the Company’s common stock as calculated for the five-trading day period through and including the Expiration Date.

Stockholders wishing to exercise subscription rights must timely pay $13.33 per share, the Initial Price, for the number of shares of common stock they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional shares in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional shares that are not purchased by other stockholders, on a pro rata basis and subject to availability and ownership limitations.

A registration statement relating to the shares of common stock was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on November 6, 2018. A prospectus relating to the offering was filed with the SEC on November 19, 2018 and is available on the SEC’s website.

Stockholders may exercise their subscription rights by delivering documentation of their subscription and payment in the manner specified in the prospectus relating to the rights offering. Beneficial stockholders (i.e. stockholders whose shares are in a brokerage account), should exercise their subscription rights as indicated in the instructions provided by their broker-dealer. Procedures and dates set-forth by broker-dealers may differ from those in offering documents. Investors wishing to participate in the Company’s offering are encouraged to contact their broker-dealer for further information.

Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information and subscription agent for the rights offering, after the Record Date by calling (888) 789-8409 (toll-free) or by emailing [email protected].

This press release shall 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 other 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 other jurisdiction. Any offer will be made only by means of the prospectus forming a part of the effective registration statement.

City of Hope Doctors Present New Research on CAR T Cell Therapy, Bone Marrow Transplants and Other Treatments for Blood Cancers

On November 19, 2018 City of Hope reported that it will present data on new findings on immunotherapies, including CAR T cell therapy, bone marrow transplants and other treatments for blood cancers, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting Dec. 1-4 in San Diego (Press release, City of Hope, NOV 19, 2018, View Source [SID1234531447]).

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City of Hope is addressing some of the hardest-to-treat cancers by accelerating innovative clinical research approaches. The institution was a pioneer in bone marrow and stem cell transplants — and the transplantation program is now one of the largest, most successful programs of its kind in the U.S. Its CAR T therapy program was the first to treat patients with CAR T cells targeting the IL13Rα2 antigen in glioblastomas, and the first to offer CAR T trials targeting CD123 in acute myeloid leukemia.

City of Hope doctors will make special presentations at the ASH (Free ASH Whitepaper) conference. Joseph Alvarnas, vice president for government affairs and associate clinical professor of hematology and hematopoietic cell transplantation, will chair an ASH (Free ASH Whitepaper) Practice Partnership Lunch titled "How to Incorporate Palliative Care Into Practice: Addressing Barriers and Solutions," which addresses how patients with hematologic malignancies often have difficulty accessing high-quality symptom management and palliative care because of preconceived perceptions as well as limited reimbursement, and discusses solutions. The lunch takes place Sunday, Dec. 2, 2018, 11:15 a.m.-12:30 p.m., in the Marina Ballroom G (Marriott Marquis San Diego Marina).

City of Hope researchers will also make presentations on the following data:

610: CD19-CAR Therapy Using Naive/Memory or Central Memory T Cells Integrated into the Autologous Stem Cell Transplant Regimen for Patients with B-NHL
Type: Oral
Session: 731. Clinical Autologous Transplantation
Session Date and Time: Monday, Dec. 3, 2018: 7:45 a.m.
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Presenter: Leslie Popplewell, M.D., associate clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

965: The Cerebroventricular Environment Reprograms Locally Infused CAR T Cells for Superior Activity Against Both CNS and Systemic B Cell Lymphoma
Type: Oral
Session: 703. Adoptive Immunotherapy: Preclinical Studies to Improve Safety and Efficacy of CAR-T Cells
Session Date and Time: Monday, Dec. 3, 2018: 5:30 p.m.
Location: San Diego Ballroom B (Marriott Marquis San Diego Marina)
Presenter: Xiuli Wang, Ph.D., research professor, Department of Hematology & Hematopoietic Cell Transplantation

399 Mosunetuzumab, a Full-Length Bispecific CD20/CD3 Antibody, Displays Clinical Activity in Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (NHL): Interim Safety and Efficacy Results from a Phase 1 Study
Type: Oral
Session: 626. Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas)
Session Date and Time: Sunday, Dec. 2, 2018: 12:30 p.m.
Location: Pacific Ballroom 20 (Marriott Marquis San Diego Marina)
Presenter: Elizabeth Lihua Budde, M.D., Ph.D., assistant professor, Department of Hematology & Hematopoietic Cell Transplantation

300 Rapid MRD-Negative Responses in Patients with Relapsed/Refractory CLL Treated with Liso-Cel, a CD19-Directed CAR T-Cell Product: Preliminary Results from Transcend CLL 004, a Phase 1/2 Study Including Patients with High-Risk Disease Previously Treated with Ibrutinib
Type: Oral
Session: 642. CLL: Therapy, excluding Transplantation
Session Date and Time: Sunday, Dec. 2, 2018: 8:45 a.m.
Location: Pacific Ballroom 20 (Marriott Marquis San Diego Marina)
Presenter: Tanya Siddiqi, assistant clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

620: Muscle Depletion Is an Important and Clinically Relevant Predictor of Outcomes after Autologous Hematopoietic Cell Transplantation
Type: Oral
Session: 904. Outcomes Research—Malignant Conditions: Outcomes in Lymphoid Malignancies and Stem Cell Transplant
Session Date and Time: Monday, Dec. 3, 2018: 7:15 a.m.
Location: Room 24B (San Diego Convention Center)
Presenter: Alex Iukuridze, clinical research assistant, Department of Population Sciences

611: Phase I Study of Yttrium-90 Labeled ANTI-CD25 (aTac) Monoclonal Antibody PLUS BEAM for Autologous Hematopoietic CELL Transplantation (AHCT) in Patients with Mature T-CELL NON-Hodgkin Lymphoma, the "a-TAC-BEAM Regimen"
Type: Oral
Session: 731. Clinical Autologous Transplantation
Session Date and Time: Monday, Dec. 3, 2018: 8 a.m.
Location: Grand Hall B (Manchester Grand Hyatt San Diego)
Presenter: Jasmine M. Zain, M.D., associate clinical professor, Department of Hematology & Hematopoietic Cell Transplantation, and director, T cell Lymphoma Program

4016 Adult Patients with ALL Treated with CD62L+ T Naïve/Memory-Enriched T Cells Expressing a CD19-CAR Mediate Potent Antitumor Activity with a Low Toxicity Profile
Type: Poster
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation
Session Date and Time: Monday, Dec. 3, 2018, 6-8 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Samer K. Khaled, M.D. assistant clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

2181: Clinical Outcomes of MDS Patients Who Were Allogeneic Hematopoietic Stem Cell Transplant Candidates but Did Not Proceed with Transplantation
Type: Poster
Session: 732. Clinical Allogeneic Transplantation
Session Date and Time: Saturday, Dec. 1, 2018, 6:15-8:15 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Rohan Gupta, clinical resident/fellow, Department of Medical Oncology & Therapeutics Research

1411: Novel BAFF-R CAR T-Cell Therapy for CD19 Antigen-Loss Relapsed B Cell Tumors
Type: Poster
Session: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation
Session Date and Time: Saturday, Dec. 1, 2018, 6:15-8:15 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Hong Qin, Ph.D., associate research professor, Department of Hematology & Hematopoietic Cell Transplantation

3967: Disease Burden Subgroup Analysis of Health-Related Quality of Life of Blinatumomab Versus Standard-of-Care Chemotherapy in Patients with Relapsed or Refractory Philadelphia Chromosome-Negative B-Cell Precursor Acute Lymphoblastic Leukemia in a Randomized, Open-Label Phase 3 Study (TOWER)
Type: Poster
Session: 612. Acute Lymphoblastic Leukemia
Session Date and Time: Monday, Dec. 3, 2018, 6-8 p.m.
Location: Hall GH (San Diego Convention Center)
Presenter: Anthony Stein, M.D., co-director, Gehr Family Center for Leukemia Research, clinical professor, Department of Hematology & Hematopoietic Cell Transplantation

Sensei Biotherapeutics to Present at the 30th Annual Piper Jaffray Healthcare Conference

On November 19, 2018 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported that John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics, will present a company overview at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday, November 27, 2018 at 1:30 p.m. ET in New York, NY (Press release, Sensei Biotherapeutics, NOV 19, 2018, View Source [SID1234531446]).

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GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia

On November 19, 2018 GlycoMimetics, Inc. (NASDAQ: GLYC) reported dosing of the first patient in the company’s Phase 3 clinical trial of uproleselan (GMI-1271) in relapsed/refractory AML (Press release, GlycoMimetics, NOV 19, 2018, View Source [SID1234531445]). The trial’s protocol provides for administration of the investigational drug in combination with MEC (mitoxantrone, etoposide and ara-C) or in combination with FAI (fludarabine, ara-C and idarubicin), both of which are standard of care for this indication in the United States. In 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to GlycoMimetics for uproleselan in this patient population. The company anticipates the initiation of two complementary Phase 2/3 trials from two leading clinical consortia in early 2019.

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"The dosing of the first patient in our pivotal Phase 3 trial for uproleselan is an important milestone for GlycoMimetics," said Helen Thackray, M.D., FAAP, Senior Vice President, Clinical Development, and Chief Medical Officer of GlycoMimetics. "This is a rigorously designed Phase 3 trial that has the potential to bring us one step closer to meeting the significant unmet needs of individuals living with relapsed/refractory AML. The trial is an important component of our comprehensive late-stage development program for uproleselan that positions us to evaluate the use of our product candidate across the spectrum of AML. It is the first of three randomized, controlled trials for uproleselan in AML, which we believe should provide clear efficacy and safety outcome measures in each of the settings being assessed."

"Our clinical development pipeline sets us up for multiple, value-creating clinical data readouts," added Rachel K. King, GlycoMimetics Chief Executive Officer. "During 2019, we anticipate topline data from the Phase 3 study of rivipansel being conducted by Pfizer in patients with sickle cell disease. Then, beginning at the end of 2020, we expect to generate topline data from the several trials that we will have underway in AML."

GlycoMimetics plans to enroll approximately 380 adult patients worldwide in the single pivotal randomized, double-blind, placebo-controlled Phase 3 AML trial, which is designed to align with guidance received from regulatory agencies. The primary endpoint is overall survival, and censoring for transplant in the primary efficacy analysis will not be required. Key secondary endpoints include incidence of severe mucositis and remission rate, which will be assessed in a hierarchical fashion for potential inclusion in the product labeling. The majority of the study sites will be in the United States, with meaningful participation from leading clinical centers in other strategic countries to support regulatory filings in major markets.

More information on the clinical trial can be found at www.clinicaltrials.gov.

About Uproleselan (GMI-1271)

Uproleselan (yoo’ pro le’sel an) is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment. In a Phase 1/2 clinical trial, uproleselan was evaluated in both newly diagnosed elderly and relapsed/refractory patients with AML. In both populations, patients treated with uproleselan together with standard chemotherapy achieved better than expected remission rates and overall survival, as well as lower than expected induction-related mortality rates, as compared to historical controls which have been derived from results from third party clinical trials evaluating standard chemotherapy The U.S. Food and Drug Administration (FDA) has granted uproleselan Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed/refractory (R/R) disease. GlycoMimetics is currently implementing a comprehensive development program across the clinical spectrum of AML. This includes a company sponsored Phase 3 trial in R/R AML and two consortia-sponsored trials in newly diagnosed patients. One consortium trial is being sponsored by the NCI and will enroll newly diagnosed patients fit for intensive chemotherapy. The other trial is sponsored by the HOVON group in Europe and will enroll newly diagnosed patients unfit for intensive chemotherapy.

FLX Bio to Present at Evercore ISI HealthCONx Conference

On November 19, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target immune drivers of cancer and other immune-related disorders, reported that Brian Wong, M.D., Ph.D., CEO and Rekha Hemrajani, COO will participate in an analyst-led fireside chat at the Evercore ISI HealthCONx on Tuesday, November 27 at 12:30 p.m. EST, in Boston, MA (Press release, FLX Bio, NOV 19, 2018, View Source [SID1234531444]).

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A live webcast and audio archive of the presentation may be accessed here or on the FLX Bio website at View Source Please connect to the website 10 minutes prior to the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast.