Mirati Therapeutics Announces Closing Of Public Offering Of Common Stock And Full Exercise Of Underwriters’ Option To Purchase Additional Shares

On October 30, 2020 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported the closing of its previously announced underwritten public offering of 4,985,706 shares of its common stock at a public offering price of $202.00 per share, which consists of 4,585,706 shares sold by Mirati and 400,000 shares sold by a selling stockholder (Press release, Mirati, OCT 30, 2020, View Source [SID1234569530]). This includes the exercise in full by the underwriters of their option to purchase up to 625,309 additional shares of common stock from Mirati and up to 25,000 additional shares of common stock from the selling stockholder. The aggregate gross proceeds to Mirati from this offering were approximately $926.3 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by Mirati.

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Goldman Sachs & Co. LLC, SVB Leerink LLC, Cowen and Company, LLC and Evercore Group, L.L.C. acted as joint book-running managers in the offering. Barclays Capital Inc., Credit Suisse Securities (USA) LLC and Piper Sandler & Co. also acted as book-running managers in the offering.

The shares of common stock described above were offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A final prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by email at [email protected]; or from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or from Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (833) 297-2926, or by email at [email protected]; or from Evercore Group, L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, or by telephone at (888) 474-0200, or by email at [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 the registration or qualification under the securities laws of any such state or other jurisdiction.

Genprex Unveils New Branding for Upcoming Combination Clinical Trials in Non-Small Cell Lung Cancer

On October 30, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported the launch of new branding for its upcoming oncology clinical trials combining its lead drug candidate, REQORSA (quaratusugene ozeplasmid), with AstraZeneca’s Tagrisso (osimertinib), which received U.S. Food and Drug Administration (FDA) Fast Track Designation earlier this year, and for the combination of REQORSA with Merck’s Keytruda (pembrolizumab), for the treatment of non-small cell lung cancer (NSCLC) (Press release, Genprex, OCT 30, 2020, View Source [SID1234569525]).

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These trials will use the trial brand "Acclaim," which the Company believes evokes its enthusiasm and the hope these trials represent for NSCLC patients and the oncology community. Acclaim-1 will be used to identify the REQORSA and Tagrisso combination clinical trial, and Acclaim-2 will be used to identify the REQORSA and Keytruda combination clinical trial.

"We are enthusiastically preparing for our upcoming clinical trials and are excited to launch the adoption of this branding," said Rodney Varner, President and Chief Executive Officer of Genprex. "We believe the Acclaim brand communicates our passion for providing hope to NSCLC patients for important new treatment options in the fight against this devastating disease and aligns us with the clinical, medical and patient communities."

The trial brand was developed in order to encourage early exposure of the Company’s clinical programs to the broad audience that Genprex’s business addresses, including patients, healthcare practitioners, clinical investigators, investors, employees and others. Genprex plans to initiate the Acclaim-1 clinical trial and the Acclaim 2 clinical trial in the first-half of 2021. Acclaim-1 is a Phase 1/2 clinical trial using a combination of REQORSA with Tagrisso in patients with late stage NSCLC with mutated epidermal growth factor receptors ("EGFRs") whose disease progressed after treatment with Tagrisso. Acclaim-2 is a Phase 1/2 clinical trial using a combination of REQORSA with Keytruda in NSCLC patients who are low expressors (1 to 49%) of the protein, programmed death-ligand 1 (PD-L1).

Epizyme Announces Date of Third Quarter 2020 Financial Results

On October 30, 2020 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that management will host a conference call and webcast to discuss its third quarter 2020 financial results and other business highlights on Friday, Nov. 6, 2020 at 8:00 a.m. ET (Press release, Epizyme, OCT 30, 2020, View Source [SID1234569523]).

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To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 9556565. A live webcast will be available in the investor section of the company’s website at www.epizyme.com, and will be archived for 60 days following the event.

BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization

On October 30, 2020 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients (Press release, BioLineRx, OCT 30, 2020, View Source [SID1234569521]).

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At a meeting of the study’s independent Data Monitoring Committee (DMC), a planned interim analysis of the study’s primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.

In accordance with the DMC’s recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.

"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company’s most efficient path to registration for motixafortide," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."

The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize ≥ 6×106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

Iovance Biotherapeutics to Host Third Quarter 2020 Financial Results Conference Call and Webcast on Thursday, November 5, 2020

On October 30, 2020 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, reported that it will report its third quarter 2020 financial results on Thursday, Nov. 5, 2020 (Press release, Iovance Biotherapeutics, OCT 30, 2020, View Source [SID1234569519]). Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. EST.

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To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 1190777. The live webcast can be accessed in the Investors section of the Company’s website at www.iovance.com. The archived webcast will be available for one year.