Genocea Announces Private Placement Financing of Up to $39 Million

On February 12, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported that it has entered into a private placement with certain existing and new investors providing for the purchase of up to approximately $39.2 million of its common stock and warrants to purchase shares of Genocea common stock, in two closings (Press release, Genocea Biosciences, FEB 12, 2019, View Source [SID1234533283]).

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In the first closing, Genocea will offer 25.6 million shares of common stock and 4.25 million pre-funded warrants to purchase common stock, along with accompanying warrants to purchase 0.25 shares of common stock for each share of common stock or pre-funded warrant purchased by an investor, for expected aggregate gross proceeds to Genocea of approximately $15.0 million (before deducting fees to the placement agents and other offering expenses payable by Genocea). The warrants will be exercisable immediately upon issuance, in whole or in part, at an exercise price of $0.5656 per share and will have a five-year term. The first closing of the private placement is expected to occur on or about February 14, 2019, subject to customary closing conditions.

Contingent on satisfactory top-line immunogenicity results from the ongoing Phase 1/2a clinical trial for GEN-009, Genocea’s neoantigen vaccine candidate, expected in late second quarter or early third quarter of this year, Genocea will have the option to conduct a second closing and sell up to an additional $24.2 million of shares of common stock to the investors who participated in the first closing at a purchase price per share equal to the greater of $0.4713 per share and a per share price that is derived from the volume weighted average price of the common stock for the period between the public release of the Phase 1/2a data and Genocea’s exercise of its option to proceed with the second closing. An investor in the first closing that does not purchase at least 50% of the shares that it specified it would purchase in the second closing will forfeit any unexercised warrant purchased in the first closing.

Genocea intends to use the net proceeds from the offering to support the ongoing clinical study of GEN-009, advancing GEN-011, a neoantigen adoptive T cell therapy candidate for the treatment of cancer, toward an Investigational New Drug Application with the U.S. Food and Drug Administration, and for working capital and other general corporate purposes.

The securities sold in the offering have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Genocea has agreed to file a resale registration statement with the Securities and Exchange Commission (the "SEC") within 60 days of the closing of the offering for purposes of registering the resale of the shares of common stock issued or issuable in connection with the offering.

This notice is issued pursuant to Rule 135c under the Securities Act and does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Yuhan Corp and Sorrento Therapeutics Announce Closing of a $40m USD Financing for Joint Venture ImmuneOncia to Support Advancement of Immuno-Oncology Program

On February 12, 2019 Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics (Nasdaq: SRNE) reported that ImmuneOncia, a joint venture formed in September 2016, has completed a private equity financing of $40 million USD at a pre-money valuation of $95 million USD, which was led by Paratus SP (Private Equity Fund) (Press release, Sorrento Therapeutics, FEB 12, 2019, View Source [SID1234533284]).

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The proceeds of the transaction will be utilized to advance ImmuneOncia’s Phase I and II clinical studies of IMC-001, a PD-L1 monoclonal antibody, as well as to support its earlier stage programs. As a result of this financing, ImmuneOncia is expected to be sufficiently funded in preparation for an initial public offering, which is expected to occur in 2021.

This investment from Paratus SP was made in recognition of ImmuneOncia’s R&D capabilities, strong management team and its growth potential based on the market trends in the global immuno-oncology landscape.

"Our R&D and clinical studies have been progressing on schedule. This cash infusion allows us to move IMC-001 forward to the next stage of development," said Yun Jeong Song, M.D., CEO of ImmuneOncia Therapeutics, Inc.

"We are pleased with the continued progress made by our joint venture over the past year," added Dr Henry Ji, Chairman and CEO of Sorrento Therapeutics. "This latest $40 million USD investment by Paratus SP validates the potential of our antibody therapies in international markets."

As of the closing of the financing, equity stakes in ImmuneOncia include Yuhan at 36.1%, Sorrento at 34.6% and Paratus SP at 29.3%.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody.

Dynavax Technologies to Report Fourth Quarter and Full Year 2018 Financial Results and Host Conference Call on February 26

On February 12, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that will report its fourth quarter and full year 2018 financial results on Tuesday, February 26, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 12, 2019, View Source [SID1234533267]).

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Dynavax will host a conference call and live audio webcast on Tuesday, February 26, 2019, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events &Presentations" page in the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial (877) 423-9813 (domestic) or (201) 689-8573 (international) and refer to conference ID 13687416.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

First production and administration of Axumin® (fluciclovine (18F)) in Italy.

On February 12, 2019 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in Italy occurred recently, with the first Italian patients being dosed (Press release, Blue Earth Diagnostics, FEB 12, 2019, View Source [SID1234533250]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

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Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth is committed to maximizing access to Axumin to clinicians and their patients across Europe. Today’s announcement is key milestone towards our goal."

LSKB Announces that the ANGEL Study Has Reached its Primary Completion Date

On February 12, 2019 BioPharma (LSKB, Company) reported it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global Phase III clinical trial, which is evaluating the safety and efficacy of rivoceranib (also known as apatinib) in patients with advanced or metastatic gastric cancer (Press release, LSK BioPharma, FEB 12, 2019, View Source [SID1234533268]).

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"Reaching the primary completion date in our global pivotal trial is an important milestone in the development of rivoceranib" said Scott Houston, Vice President of Clinical Development, "Outside of China, where apatinib is marketed, there is no small-molecule angiogenesis inhibitor approved for gastric cancer. We believe it will be the first such drug available for these patients worldwide."

The Company, which has conducted pre-submission meetings with FDA and EMA in the last month, will now focus on completion of database lock activities and subsequent data analysis with an expectation that the top-line, unblinded safety and efficacy data will be reported in the middle of this year. LSKB further expects to complete preparations in the second half of this year for filing marketing authorizations applications in several territories worldwide, including the US.

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.