On October 9, 2019 Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), a clinical stage, antibody-centric biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases, reported the closing of its previously announced registered direct offering of 10,869,566 shares of its common stock and warrants to purchase up to 10,869,566 shares of its common stock, at a combined purchase price of $2.30 per share and related warrant (Press release, Sorrento Therapeutics, OCT 9, 2019, View Source [SID1234540950]). The net proceeds to Sorrento from this offering are expected to be approximately $23.3 million, after deducting the placement agent’s fees and other estimated offering expenses. Sorrento currently intends to use the net proceeds from the offering for the continued clinical development of its RTX and CD38 CAR-T programs and general research and development, working capital and general corporate purposes.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The securities described above were offered by Sorrento pursuant to a "shelf" registration on Form S-3 (File No. 333-221443) previously filed with the Securities and Exchange Commission (the "SEC") on November 9, 2017, amended on December 1, 2017 and declared effective by the SEC on December 6, 2017. The offering of the securities was made only by means of a prospectus supplement that forms a part of the registration statement. A prospectus supplement and accompanying base prospectus relating to the securities being offered were filed with the SEC on October 8, 2019. Electronic copies of the prospectus supplement and accompanying base prospectus may be obtained on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On October 9, 2019 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM), reported that it will release the financial results for its third quarter ended September 30, 2019 on Thursday, October 31, 2019 after the market closes (Press release, Select Medical, OCT 9, 2019, View Source [SID1234540137]).

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Select Medical will host a conference call regarding its third quarter results, as well as its business outlook, on Friday, November 1, 2019, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 9264899. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, November 8, 2019. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 9264899. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

On October 10, 2019 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported the launch of VANFLYTA (quizartinib), an oral FLT3 inhibitor, in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, OCT 10, 2019, View Source [SID1234540951]).

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Marketing approval of VANFLYTA by Japan’s Ministry of Health, Labor and Welfare (MHLW) in June 2019 was based on the results of the global pivotal phase 3 QuANTUM-R study and a phase 2 study of VANFLYTA in Japanese patients with relapsed/refractory FLT3-ITD AML. Results of QuANTUM-R were published in The Lancet Oncology.[1] Results from the phase 2 study in Japan patients were recently published in the International Journal of Hematology.[2]

"We are proud to launch VANFLYTA in Japan making it available to both physicians and patients as an important new therapeutic option with a survival benefit over salvage chemotherapy for the treatment of patients with relapsed/refractory FLT3-ITD AML," said Takashi Ikegami, PhD, Vice President, Head of Specialty Marketing in Japan, Daiichi Sankyo. "Now patients have access to a treatment that targets FLT3-ITD, a driver mutation in AML linked to poor prognosis and aggressive disease that results in increased relapsed rate and reduced overall survival for patients compared to those without this mutation."

About FLT3-ITD AML
AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.[3] AML is the most common adult leukemia in Japan,[4] with approximately 5,500 new cases diagnosed each year. The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.3
FLT3 gene mutations are one of the most common genetic abnormalities in AML.[5] FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.[6] FLT3-ITD is a driver mutation that presents with high leukemic burden and has poor prognosis and a significant impact on disease management for patients with AML.[7] Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse, and a higher likelihood of relapse following hematopoietic stem cell transplantation, as compared to those without this mutation.[8],[9]

About QuANTUM-R and Phase 2 Japan Study
In the QuANTUM-R study, a statistically significant improvement in overall survival was demonstrated when comparing VANFLYTA to salvage chemotherapy. The hazard ratio for VANFLYTA was 0.76 [95% CI: 0.58, 0.98], and the median overall survival was 6.2 months [95% CI: 5.3, 7.2] in patients receiving VANFLYTA compared to 4.7 months [4.0, 5.5] salvage chemotherapy. The most common treatment-related adverse drug reactions in those receiving VANFLYTA were nausea (33.2%, 80/241 patients), electrocardiogram QT prolonged (24.9%, 60/241 patients), anemia (24.9%, 60/241 patients), and thrombocytopenia (21.2%, 51/241 patients) in the Japanese labeling.

The open-label, single-arm phase 2 study evaluating VANFLYTA in Japanese patients with relapsed/refractory FLT3-ITD AML met its primary endpoint of achieving a pre-determined composite complete remission rate at interim analysis, triggering an early stop of the study due to efficacy. The efficacy and safety profile of VANFLYTA observed in the phase 2 study in Japan appears consistent with that of QuANTUM-R.

About VANFLYTA
VANFLTYA, an oral FLT3 inhibitor, is the lead product in the AML Franchise of Daiichi Sankyo. VANFLYTA currently is only approved for use in Japan for the treatment of adult patients with relapsed/refractory FLT3-ITD AML, as detected by an MHLW-approved test.

Ongoing studies include QuANTUM-First, a pivotal phase 3 study evaluating VANFLYTA in combination with standard chemotherapy in newly diagnosed FLT3-ITD AML in the U.S., Europe and Japan; and phase 1/2 development for pediatric and young adult relapsed/refractory FLT3-ITD AML in North America and Europe; and phase 1 development in combination with milademetan, an investigational MDM2 inhibitor, for relapsed/refractory FLT3-ITD AML and newly-diagnosed FLT3-ITD AML unfit for intensive chemotherapy in the U.S. Milademetan is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

On October 9, 2019 Targovax ASA (OSE: TRVX), reported that clinical data on the company’s lead product candidate ONCOS-102, a genetically modified oncolytic adenovirus which has been engineered to selectively infect and replicate in cancer cells, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting being held November 6-10, 2019, in Maryland, USA (Press release, Targovax, OCT 9, 2019, View Source [SID1234540119]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Title:

A pilot study of engineered adenovirus ONCOS-102 in combination with pembrolizumab in checkpoint inhibitor refractory advanced or unresectable melanoma

Authors:

Alexander N. Shoushtari, MD; Anthony J. Olszanski, MD, RPh; Thomas J. Hornyak, MD; Jedd D. Wolchok, MD, PhD; Sylvia Vetrhus; Karianne Risberg Handeland; Lukasz Kuryk, PhD; Magnus Jaderberg, MD;

Date:

9 November 2019

Time:

5:30 pm – 5:45 pm

Presenter:

Dr. Alexander Shoushtari, Principal Investigator, MSKCC, NYC

For further information, please contact:
Renate Birkeli, Investor Relations
Phone: +47-922-61-624
Email: [email protected]

Media and IR enquires:
Andreas Tinglum – Corporate Communications (Norway)
Phone: +47-9300-1773
Email: [email protected]

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On October 9, 2019 Valens GroWorks Corp. (TSXV: VGW) (OTCQX: VGWCF) (the "Company" or "Valens"), a vertically integrated provider of industry leading extraction products and services, including a diverse suite of extraction methodologies, next generation cannabinoid delivery formats and an ISO 17025 accredited analytical lab, is reported it will issue its third-quarter financial results, for the period ended August 31, 2019 on Tuesday, October 15, 2019 after markets close (Press release, Valens Therapeutics, OCT 9, 2019, View Source [SID1234540138]).

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CONFERENCE CALL DETAILS

The Company will host a conference call the following day Wednesday, October 16, 2019 at 11am Eastern Time / 8am Pacific Time to discuss the financial results and business outlook.

Participant Dial-In Numbers:
Toll-Free: 1-877-407-0792
Toll / International: 1-201-689-8263
*Participants should request the Valens GroWorks Earnings Call or provide confirmation code 13695323

The call will be webcast on the Valens Investor page of the Company website at View Source or at this link. Please visit the website at least 15 minutes prior to the call to register, download, and install any necessary audio software. A replay of the call will be available on the Valens Investor page approximately two hours after the conference call has ended.

Tyler Robson, Chief Executive Officer, Chris Buysen, Chief Financial Officer, Jeffrey Fallows, President, and Everett Knight, Executive Vice President of Strategy & Investments will be conducting a question and answer session following the prepared remarks.