VBI Vaccines Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On September 26, 2019 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI or the Company), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the closing of its previously announced underwritten public offering and the exercise in full of the underwriters’ option to purchase additional shares (Press release, VBI Vaccines, SEP 26, 2019, View Source [SID1234539810]). The gross proceeds from the offering, before deducting the underwriting discounts and commissions and estimated offering expenses payable by VBI, are US$40.3 million. 80,500,000 common shares at a public offering price of US$0.50 per share were issued and sold in this offering, which includes 10,500,000 shares issued upon the exercise of the underwriters’ option to purchase additional shares.

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Immediately following the closing of the underwritten public offering, the number of outstanding common shares of the Company is 178,257,199.

Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. acted as joint book-running managers, and National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), acted as lead manager for the underwritten public offering.

VBI intends to use the net proceeds from the offering to progress its pipeline programs including the completion of the global CONSTANT Phase 3 lot-to-lot consistency study, regulatory submissions, and pre-commercialization activities for Sci-B-Vac, a trivalent hepatitis B vaccine, and for the continued clinical development of VBI-1901, a vaccine immunotherapeutic candidate for recurrent glioblastoma (GBM); VBI-2601, an immunotherapeutic candidate for chronic hepatitis B infection; and VBI-1501, a cytomegalovirus (CMV) vaccine candidate. The net proceeds will also be used for general corporate purposes, including working capital and capital expenditures.

A shelf registration statement relating to the common shares was previously filed with the Securities and Exchange Commission (SEC) and declared effective on July 30, 2018. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering was filed with the SEC on September 18, 2019. A final prospectus supplement and accompanying prospectus, dated September 19, 2019, relating to the offering was filed with the SEC on September 20, 2019, and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may be obtained from Raymond James & Associates, Inc., Attention: Equity Syndicate, 880 Carillon Parkway, St. Petersburg, Florida 33716, by telephone at (800) 248-8863, by e-mail at [email protected], or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004 or by e-mail 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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

OncoSec to Present at the Cantor 2019 Global Healthcare Conference

On September 26, 2019 OncoSec Medical Incorporated (OncoSec) (NASDAQ: ONCS), a company developing late-stage intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, President and Chief Executive Officer of OncoSec, will present a company overview at the Cantor 2019 Global Healthcare Conference on Thursday, October 3, 2019, at 7:45 a.m. Eastern Time in New York, NY (Press release, OncoSec Medical, SEP 26, 2019, View Sourcenews/detail/2008/oncosec-to-present-at-the-cantor-2019-global-healthcare-conference" target="_blank" title="View Sourcenews/detail/2008/oncosec-to-present-at-the-cantor-2019-global-healthcare-conference" rel="nofollow">View Source [SID1234539809]).

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A live audio webcast of the presentation will be available on the Investors section of OncoSec’s website at View Source, where it will be archived for approximately 30 days.

Patient recruitment in the Pivotal Phase 2-Study HORIZON completed

On September 26, 2019 Oncopeptides AB (Nasdaq Stockholm: ONCO) reported that the last patient has been included in the OP-106 HORIZON pivotal phase 2 clinical study evaluating melflufen with dexamethasone in patients with relapsed/refractory multiple myeloma (RRMM) (Press release, Oncopeptides, SEP 26, 2019, View Source [SID1234539808]). Oncopeptides has previously communicated a target enrollment of 150 patients in the study before the end of September, which now has been achieved.

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Oncopeptides is engaged in preparations for submitting a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for accelerated market approval in the United States based on available data from the HORIZON study. The objective is to submit the application in the first quarter of 2020. This could then potentially lead to the first market approval for melflufen in the U.S. in 2020.

"The HORIZON study was initially intended as an exploratory study in late-stage patients with relapsed and/or refractory multiple myeloma when started in January 2017. As positive efficacy and safety data were generated, the study was expanded to include 150 patients and now forms the basis of our planned application for accelerated market approval in the United States. We are encouraged that the data to-date support the potential for melflufen to offer a new treatment option in this important setting, especially for patients with severe and widespread multiple myeloma. This is an important milestone in Oncopeptides’ history and signifies that we are on track for submitting our NDA in the U.S. as planned, which will completely transform the company if approved," says Jakob Lindberg, CEO of Oncopeptides.

About the OP-106 HORIZON study
Patient recruitment in the pivotal HORIZON study is now completed. The patients in the study are refractory to pomalidomide and/or daratumumab after failing on immunomodulatory drugs (IMiDs) and proteasome inhibitors (PIs). The interim data presented at IMW 2019 was based on a data cut-off dated July 30, 2019, with 136 patients treated. The goal is to present updated data at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December, pending abstract acceptance.

More information on the IMW 2019 presentation can be found at:
View Source

More information can be found at:
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For further information, please contact:
Jakob Lindberg, CEO of Oncopeptides
E-mail: [email protected]
Telephone: +46 8 615 20 40

Rein Piir, Head of Investor Relations at Oncopeptides
E-mail: [email protected]
Cell phone: +46 70 853 72 92

This information was submitted for publication at 15.00 CET September 26, 2019.

About melflufen
Melflufen is a lipophilic peptide-conjugated alkylator that rapidly delivers a highly cytotoxic payload into myeloma cells through peptidase activity. It belongs to the novel class Peptidase Enhanced Cytotoxics (PEnC), which is a family of lipophilic peptides that exhibit increased activity via peptidase cleavage and have the potential to treat many cancers. Peptidases play a key role in protein homeostasis and feature in cellular processes such as cell-cycle progression and programmed cell death. Melflufen is rapidly taken up by myeloma cells due to its high lipophilicity and immediately cleaved by peptidases to deliver an entrapped hydrophilic alkylator payload. In vitro, melflufen is 50-fold more potent in myeloma cells than the alkylator payload itself due to the peptidase cleavage, and induces irreversible DNA damage and apoptosis. Melflufen displays cytotoxic activity against myeloma cell lines resistant to other treatments, including alkylators, and has also demonstrated inhibition of DNA repair induction and angiogenesis in preclinical studies.

MannKind Corporation to Present at the 2019 Cantor Global Healthcare Conference

On September 26, 2019 MannKind Corporation (NASDAQ: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension, reported that it will be featured as a presenting company at the 2019 Cantor Global Healthcare Conference on Thursday, October 3, 2019 at 9:30 am (ET) at the InterContinental New York Barclay Hotel in New York City (Press release, Mannkind, SEP 26, 2019, View Source [SID1234539807]). Presenting from the Company will be its Chief Executive Officer, Michael Castagna .

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The presentation will be webcast live. Interested parties can access a link to the live webcast of the presentation from the News & Events section of the Company’s website at View Source The webcast replay will remain available for 14 days following the live presentation.

Lineage Cell Therapeutics to Present at 2019 Cantor Global Healthcare Conference on October 4, 2019

On September 26, 2019 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, reported that Brandi L. Roberts, Chief Financial Officer, will be presenting at the 2019 Cantor Global Healthcare Conference on October 4th, 2019 at 1:45pm Eastern Time at the InterContinental Barclay Hotel in Grand Ballroom 1 in New York, NY (Press release, Lineage Cell Therapeutics, SEP 26, 2019, View Source [SID1234539806]).

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