VBI Vaccines Announces Closing of Public Offering of Common Stock and Partial Exercise of Underwriter’s Option to Purchase Additional Shares for Aggregate Gross Proceeds of $42.9 Million

On December 18, 2018 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported the closing of its previously announced underwritten public offering of 26,800,000 common shares at a public offering price of US$1.40 per share, and the partial exercise by the underwriters of their option to purchase an additional 4,020,000 common shares, with 3,865,304 additional common shares purchased at US$1.40 per share (Press release, VBI Vaccines, DEC 18, 2018, View Source [SID1234532184]). As a result, the company has issued a total of 30,665,304 common shares in the offering and has received aggregate gross proceeds, before deducting the underwriting discounts and commissions and estimated offering expenses, of approximately US$42.9 million.

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Immediately following the closing of the underwritten public offering, the number of outstanding common shares of the company is 97,343,777.

BMO Capital Markets, Canaccord Genuity LLC, and Oppenheimer & Co. Inc. acted as joint book-runners for the underwritten public offering. National Securities Corporation acted as a financial advisor to VBI in connection with the offering.

VBI intends to use the net proceeds from the offering to progress its research and development programs, which include, among other things, funding the continued clinical development of Sci-B-Vac, including the ongoing Phase 3 clinical program in the United States, Europe and Canada; the Phase 1/2a clinical study of the therapeutic vaccine candidate, VBI-1901, for glioblastoma (GBM); the prophylactic vaccine candidate, VBI-1501, for cytomegalovirus (CMV); and the immuno-therapeutic candidate, VBI-2601, for hepatitis B. 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 (the "SEC") and declared effective on June 8, 2017. A preliminary prospectus supplement and accompanying prospectus relating to the underwritten public offering was filed with the SEC on December 12, 2018. A final prospectus supplement and accompanying prospectus relating to the offering was filed with the SEC on December 17, 2018, 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 BMO Capital Markets Corp., Attention: Equity Syndicate Department, 3 Times Square, 25th Floor, New York, NY 10036 or by e-mail at [email protected], or from Canaccord Genuity LLC, Attention: Equity Syndicate Department 99 High Street, 12th Floor, Boston, MA 02110 or 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.

Phio Pharmaceuticals to Present at Biotech Showcase™ 2019 in San Francisco

On December 18, 2018 Phio Pharmaceuticals Corp. (NASDAQ: PHIO) (formerly RXi Pharmaceuticals Corporation), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that Dr. Gerrit Dispersyn, President and Chief Operating Officer, will present at Biotech Showcase 2019, to be held January 7 – 9, 2019 at the Hilton San Francisco Union Square (Press release, Phio Pharmaceuticals, DEC 18, 2018, View Source [SID1234532115]).

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Dr. Gerrit Dispersyn will present an overview of the Company’s novel self-delivering RNAi (sd-rxRNA) technology and the multiple business development and commercial opportunities available with this proprietary platform on:

Date: Monday, January 7, 2019
Time: 9:00 a.m. PST
Room: Yosemite C (Ballroom Level)

He will also be available for investor and executive meetings throughout the conference. The presentation will be webcast and available on the "Investors – Events and Presentations" section of the Company’s website, www.phiopharma.com.

About Biotech Showcase
Now in its eleventh year, Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and executives in one place during the course of one of the industry’s largest annual healthcare investor conferences, J.P. Morgan Annual Healthcare Conference.

LIGAND INTRODUCES 2019 FINANCIAL OUTLOOK AND RAISES 2018 FINANCIAL GUIDANCE

On December 18, 2018 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported its financial outlook for 2019 (Press release, Ligand, DEC 18, 2018, View Source [SID1234532150]). Ligand expects revenue in 2019 to be at least $212 million, with up to an additional $40 million of potential milestone and license payments. Approximately two thirds of the $212 million of revenue is expected to be royalty revenue, and the remainder is expected to consist of contract payments and material sales. With projected revenue of $212 million, adjusted earnings per diluted share for 2019 is estimated to be approximately $5.50. So far during the fourth quarter of 2018, Ligand has repurchased over 420,000 shares under its authorized share repurchase plan, and will potentially continue to execute additional repurchases going forward.

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Ligand is also raising its previous guidance for 2018, mostly due to higher material sales, and now expects revenue to be approximately $244 million, including royalties of approximately $123 million, material sales of approximately $28 million and license fees and milestones of approximately $93 million. Revenue for 2018 includes a milestone payment of $47 million from WuXi Biologics. With projected revenue of approximately $244 million, adjusted earnings per diluted share for 2018 is estimated to be approximately $6.63. This compares with previous guidance for 2018 revenue of approximately $240 million, and adjusted earnings per diluted share for 2018 which was previously estimated to be $6.52.

Oncology Venture receives positive feed-back from the FDA on approval pathway for LiPlaCis and DRP in the US

On December 18, 2018 Oncology Venture A/S ("OV" or the Company) reported that the US Food and Drug Administration, FDA has responded positively on questions posed by the company in a Pre-IND/IDE package for the approval pathway for LiPlaCis and its companion diagnostic DRP – Drug Response Predictor – in metastatic breast cancer (Press release, Oncology Venture, DEC 18, 2018, View Source [SID1234532169]).

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The FDA agreed that the 505(b)(2) pathway is an acceptable registration route for LiPlaCis and that no further toxicology studies are needed. Based on current good data the number of patients to be treated is in line with previous guidance in the upcoming pivotal phase 3 trial of LiPlaCis and its DRPÒ for the treatment of patients with advanced breast cancer.
The FDA accepts objective response rate (ORR) as the primary endpoint but asked for further characterization of sub-groups in the breast cancer population aimed for treatment with LiPlaCis.
LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at tumor site. The specific LiPlaCis DRP selects the patients whom are expected to benefit from the treatment. LiPlaCis has shown very promising results in an ongoing phase 2 trial, a study that will continue as planned. Recruitment timelines of the pivotal phase 3 study will be updated following the FDA approval of the Investigational New Drug Application (IND) and the Investigational Device Exemption (IDE) expectedly in H1 2019.

"Oncology Venture in-licensed LiPlaCis as a phase 1 project in 2016. The 505(b)(2) strategy allows us to refer to data for a listed drug and will save us important time and resources. Our team has done a remarkable job by moving this project from an early stage to a late stage project in only two years. The discussions with the FDA gave no barrier for proceeding with our pivotal development plans for a fast route to commercialization and we can now increase our partnering activities with pharma," comments Peter Buhl Jensen, M.D., CEO of Oncology Venture.

Data from the ongoing Phase 2 LiPlaCis study in patients with metastatic breast cancer shows a
50% objective response rate (five out of ten patients) in the upper one third of DRP selected patients and a 24% objective response rate (6 out of 25 patients) in the upper two thirds of DRP selected patients. These data should be compared with historical response rates to the established cancer drugs in metastatic breast cancer with a 10-12% objective response rate of eribulin, vinorelbine and gemcitabine and 10% of conventional cisplatin.

If the ongoing phase 2 study will continue to show strong efficacy data, Oncology Venture aims for a Break through designation. This application is planned for filing shortly after the IND and its IDE application for LiPlaCis.

Oncology Venture’s regulatory strategy is to first obtain approval in the US. The aim is then to run randomized pivotal studies in Europe and Asia.

CTI BioPharma Provides Program Update Following Regulatory Feedback from the U.S. FDA on Pacritinib Development

On December 18, 2018 CTI BioPharma Corp. (NASDAQ:CTIC) reported that it has received input from the U.S. Food and Drug Administration (FDA) at a recent Type C meeting on key elements of the design of a new randomized Phase 3 study of pacritinib in adult patients with myelofibrosis (primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis) and who have severe thrombocytopenia (as defined by patients with platelet counts of less than 50,000 per microliter), an indication that has been recognized by the medical community as an important unmet medical need (Press release, CTI BioPharma, DEC 18, 2018, View Source [SID1234532119]).

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The planned Phase 3 study is designed to evaluate the effects of pacritinib as compared to physician’s choice of treatment. The primary efficacy endpoint will be the proportion of patients achieving a greater than or equal to 35% spleen volume reduction (SVR) between baseline and Week 24. Secondary efficacy endpoints of the study include total symptom score reduction and overall survival.

Before commencing the Phase 3 study, CTI plans to meet with the FDA to discuss the final optimal dose analysis from the PAC203 Phase 2 study. To expedite the transition to Phase 3, CTI intends to amend the PAC203 protocol to include a Phase 3 component. The PAC203 Phase 3 component is designed to enroll approximately 200 patients with enrollment expected to commence in the third quarter of 2019. The anticipated cost of the Phase 3 study is approximately $25 million. Taking into account the impact of recently-announced cost saving efforts and the anticipated cost of the new Phase 3 trial, the current CTI financial analysis projects a cash runway that extends into 2020.