Xspray Pharma proposes a directed issue of 1,350,000 shares corresponding to approximately SEK 88 million to expand the product portfolio

On January 30, 2018 Xspray Pharma reported its board of directors has resolved to propose a directed share issue of 1,350,000 shares at a subscription price of SEK 65 per share, representing a discount of 2 percent compared to the volume weighted average price during the last five trading days (Press release, Xspray, JAN 30, 2018, View Source [SID1234650101]). The share issue will provide Xspray Pharma with approximately SEK 88 million before transaction costs.
The objective of the proposal and the reasons for the deviation from the shareholders’ preferential rights are to strengthen the institutional shareholder base in the company and in a timely manner enable the company to finance the development of additional product candidates, relying on positive research data published on 24 October 2017. Shareholders representing approximately 67.2 per cent of the shares of Xspray Pharma have undertaken to vote in favour of the issue, including the company’s largest shareholder Östersjöstiftelsen who will not participate in the issue. The directed issue will be fully subscribed by a number of selected investors in accordance with separate agreements, including Robur Ny Teknik, Niclas Ericsson&family, Unionen and Nyenburgh. The board of directors will convene an extraordinary general meeting to be held on 20 February to resolve on the share issue.

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NOT FOR DISTRIBUTION OR PUBLIC RELEASE, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR ANY OTHER JURISDICTION IN WHICH SUCH MEASURES WOULD BE IN VIOLATION OF APPLICABLE REGULATIONS. THIS PRESS RELEASE DOES NOT CONSTITUTE AN OFFER, OR A SOLICITATION OF ANY OFFER, TO BUY OR SUBSCRIBE FOR ANY SECURITIES IN XSPRAY PHARMA IN ANY JURISDICTION.

"Our research results have proven that the tools we have developed are working for developing bioequivalent PKI-drugs based on our HyNap-platform. This reduces the development risk and enables us to develop additional drug candidates, efficiently and faster than anticipated by the time of the IPO last year. To be able to develop more drug candidates fast will increase our options as well as the value of the company’s product pipeline," comments Per Andersson, CEO of Xspray Pharma.

Background and reasons

The company intends to use the proceeds from the directed rights issue for financing the development of up to four new drug candidates, based on the company’s HyNap-platform. The new drug candidates will be selected out of a group of six potential drug candidates currently under evaluation. All of them have a similar profile to that of the company’s three current main candidates, i.e. they are all new versions of established cancer drugs based on protein kinase inhibitors – "PKI:s". The primary patents of the original drugs will expire between 2024-2026. The total annual sales of these original drugs in 2022 is estimated to exceed USD 7.3 billions in the US alone. The proceeds will in an efficient and timely manner enable Xspray to broaden its product portfolio of clinically proven drug candidates.

The issue

The board of directors has resolved to propose an extraordinary general meeting to resolve on a directed share issue of not more than 1,350,000 shares. The subscription price for the issue is SEK 65 per share, which, in total, will provide the company with approximately SEK 88 million before transaction costs. The subscription price for the issue has been determined through a so-called private placement procedure and represents a discount of 2 percent compared to the volume weighted average price during the last five trading days. The directed issue will be fully subscribed by a number of selected investors in accordance with separate agreements, including Robur Ny Teknik, Niclas Ericsson&family, Unionen and Nyenburgh.

Shareholders representing approximately 67.2 per cent of the shares in Xspray Pharma, including the company’s largest shareholder Östersjöstiftelsen who will not participate in the issue, have undertaken to vote in favour of the issue at the extraordinary general meeting.

The reasons for the deviation from the shareholders’ preferential rights are to strengthen the institutional shareholder base of the company, whilst in an efficiently managed and timely manner raise capital for the development of additional drug candidates. Through the issue, the share capital will increase with SEK 1,350,000 to SEK 13,706,460, which entails a dilution effect of approximately 9.8 per cent of both the number of shares and votes.

Investor Presentation dated January 29, 2018.

On January 29, 2018 KaloBios presented Investor Presentation (Presentation, KaloBios, JAN 29, 2018, View Source [SID1234523605]).

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China Oncology Focus Limited Receives Approval by Chinese Authorities to Begin Clinical Trials in Three Separate Cancer Indications Using Sorrento’s Anti-PD-L1 Monoclonal Antibody

On January 29, 2018 Lee’s Pharm and Sorrento Therapeutics reported that the Chinese authorities have approved China Oncology Focus Limited (COF, an affiliate of Lee’s Pharmaceutical Holdings Limited, Hong Kong Stock Symbol: 0950.HK) to proceed with the clinical trials for ZKAB001, an anti-PD-L1 monoclonal antibody exclusively licensed to COF for Greater China territories, by Sorrento Therapeutics (Press release, Sorrento Therapeutics, JAN 29, 2018, View Source [SID1234532252]).

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The investigation sites will be:

Beijing Cancer Hospital
The Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Wuhan Union Hospital
Shanghai Sixth People’s Hospital
The trials will be anticipated to use a 3+3 design with 5mg/kg, 10mg/kg and 15mg/kg dosing regimens. Once the Maximum Tolerated Dose (MTD) has been established, additional patients are expected to be recruited in an expanded Phase 1 protocol. Clinical data from these studies could be available by the end of the year 2019, and positive results could lead to conditional approval of the antibody prior to a confirmatory Phase 3 study.

"We are proud to announce the acceptance of the IND for our anti-PD-L1 antibody ZKAB001. It’s further evidence for COF continued commitment to addressing high unmet oncology needs by bringing new effective immuno-oncology therapies to the Chinese market. Throughout the IND-enabling activities and the extensive IND review process by the Chinese FDA, the COF team has worked closely and efficiently with Sorrento colleagues. In the landscape of anti-PD-L1 therapies in China, we believe our program is part of the first wave of immune checkpoint inhibitors. Encouraged by our impressive preclinical data, we are excited about evaluating our immunotherapy and addressing unmet medical needs of cancer patients in the Greater China region. Based on this highly productive first joint project, we look forward to potentially expanding our partnership with Sorrento," said Dr. Xiaoyi (Benjamin) Li, Chief Executive Officer and Executive Director of COF.

"We believe COF’s progress in the development of cancer therapeutics for the Greater China market utilizing our G-MAB library of fully human antibodies is a testimony of the value of Sorrento’s comprehensive portfolio of immuno-oncology platform technologies and products acquired and developed over the years," stated Dr. Henry Ji, Chairman and CEO. "Although our own internal resources are currently focused on the development of CAR-T platforms and programs, we think we have shown success in collaborations and out-licensing of other therapeutic assets to a number of strategic partners. COF’s success in developing ZKAB001 could lead to milestone and royalty payments to Sorrento."

About ZKAB001 (anti-PD-L1 monoclonal antibody)

ZKAB001 is a fully human anti-PD-L1 monoclonal antibody (mAb), an immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PD-1/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 potentially further strengthening the anti-tumor effect of the antibody. It was licensed from Sorrento Therapeutics, Inc. (SRNE) to COF in Q4 2014.

Supplementary Financial Data for the Third Quarter of the Year Ending March 31, 2018

On January 29, 2018 Sumitomo Dainippon Pharma reported its Supplementary Financial Data
for the Third Quarter of the Year Ending March 31, 2018 (Press release, Dainippon Sumitomo Pharma, JAN 29, 2018, View Source [SID1234523624]).

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DiaMedica to Present at the 14th Annual Noble Investor Conference

On January 29, 2018 DiaMedica Therapeutics Inc. (TSXV:DMA) (OTCQB:DMCAF), reported that Mr. Rick Pauls, its President and CEO, will present at Noble Capital Markets’ Fourteenth Annual Investor Conference at the W Hotel, Fort Lauderdale, Florida on Tuesday, January 30th at 01:30 pm EST – Studio 1 (Press release, DiaMedica, JAN 29, 2018, View Source [SID1234523653]).

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