MATEON ENTERS INTO MERGER AGREEMENT WITH POINTR DATA TO LEVERAGE DISRUPTIVE AI TECHNOLOGY IN ITS INNOVATION-DRIVEN QUEST FOR A CURE OF CANCER

On August 19, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) ("Mateon") and PointR Data Inc. (PointR), a privately-held, developer of high performance cluster computer and artificial intelligence company, reported that they have entered into a definitive agreement with respect to a merger, creating a publicly traded artificial intelligence ("AI") driven immuno-oncology company with a robust pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma (Press release, Mateon Therapeutics, AUG 19, 2019, View Source [SID1234538861]).

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"We believe that the merger of Mateon and PointR will create a combined company that can generate shareholder value through a promising pipeline of next generation immunotherapies leveraging high performance, personalized and secure cluster computer for AI driven drug development and personalized healthcare deliveries," said Vuong Trieu, Ph.D., Chairman and Chief Executive Officer of Mateon. "This is culmination of over a year of working together on disruptive technologies for drug development and healthcare."

"We are thrilled at the opportunity of vertically integrating AI and drug development capabilities under one roof. We expect to quickly identify promising new therapeutic opportunities for various diseases delivering compelling business value," said Saran Saund, PointR’s Chief Executive Officer. "The prospect of interdisciplinary teams from biotech and technology sectors can significantly accelerate drug candidates towards the clinic while expanding our proprietary datasets."

"The integration of AI and machine learning algorithms in new drug discovery and lead optimization, design of biomarker-driven clinical studies as well as identification of biomarker-enriched patient populations most likely to respond to new anti-cancer drug candidates are potentially paradigm-shifting initiatives with a very high scientific merit. AI-based cognitive technologies have the potential to streamline our clinical development strategy for the portfolio drug candidates, including our lead compound OT101, by amplifying our knowledge and understanding of the target cancers, their biology as well as structural and pharmacologic characteristics of the lead compounds," said Dr. Fatih Uckun, MD, PhD, the Chief Medical Officer of Mateon. "Furthermore, the combined use of AI and the Blockchain technology supported by the PointR AI computing platform has a very high impact potential for better cancer care and especially patient-tailored cancer treatments," he added. Dr. Uckun explained: "Blockchain technology-powered clinical development platforms for the anti-cancer drug candidates in our pipeline, including our lead compound OT101 could (i) expedite multi-stakeholder collaboration via optimized peer-to-peer data sharing for success of R&D efforts aimed at a cure for difficult-to-treat forms of cancer, (ii) amplify data management capabilities that are critical for the clinical development of the most promising drug candidates, and (iii) enable rapid identification of best clinical study sites and investigators as well as optimized clinical protocol designs to ensure high quality clinical trials with streamlined feasibility checks and very short study start-up and rapid completion times.

Merger Terms

Under the terms of the merger agreement, PointR will be merged into and become a wholly owned subsidiary of Mateon. Holders of PointR common stock prior to the merger will be entitled to $15,000,000 payable in shares of Mateon common stock, calculated at of $0.18 per share. The merger agreement also provides for two additional tranches of merger consideration based on: (1) PointR’s achievement of proof of concept and (2) licensing deal for AI based asset for minimum of $100 million in life-time license fees of which at least $10 million has been received. Each tranche is for $7,500,000 in value of additional Mateon common stock, based on the market price at the time of payment, subject to a minimum value of $0.18 per share.

The merger is subject to customary conditions to closing. In addition, Mateon’s obligation to close is conditioned on PointR providing audited financial statements that would be required for Mateon to comply with the SEC’s filing requirements. PointR’s obligation to close is conditioned on Mateon raising a minimum of $10 million in an equity financing transaction or $5 million in a commercial agreement. In addition, PointR’s obligation is conditioned upon Mateon to grant a license to allow the former shareholders of PointR to use elements of the technology in fields outside of pharmaceutical development. Mateon and PointR intend to actively seek additional capital to support the combined business, no additional equity financing or commercial agreement is in place at this time. The merger is not expected to close until such financing is secured.

Horizon Therapeutics plc to Participate in the Morgan Stanley 17th Annual Global Healthcare Conference

On August 19, 2019 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the company will participate in the following conference in September (Press release, Horizon Therapeutics, AUG 19, 2019, View Source [SID1234538860]):

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Morgan Stanley 17th Annual Global Healthcare Conference

Date: Sept. 10, 2019
Presentation Time: 10 a.m. ET
Location: New York
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for the event.

PharmaMar will submit NDA for lurbinectedin under accelerated approval in SCLC in the USA

On August 19, 2019 PharmaMar (MSE: PHM) reported that the FDA (Food and Drug Administration) agreed with PharmaMar’s proposal to file for accelerated approval its New Drug Application (NDA) for lurbinectedin monotherapy for the treatment of second-line SCLC (Press release, PharmaMar, AUG 19, 2019, View Source [SID1234538859]).

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The FDA’s accelerated approval program allows the submission of the registration dossier for evaluation based on investigational drug results of a Phase II study for serious conditions that satisfy an unmet medical need.

The application will be based on data from the SCLC cohort of the lurbinectedin Phase II monotherapy basket trial that enrolled a total of 105 patients at 39 centers in more than 9 countries in Western Europe and the United States. The primary endpoint of Overall Response Rate (ORR), was achieved by both the investigator and the Independent Review Committee (IRC) assessment. Secondary endpoints included Duration of Response (DOR), Progression-Free Survival (PFS), Overall Survival (OS), and safety.

PharmaMar anticipates that the NDA filing will take place in the fourth quarter of 2019.

Legal warning
This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

Deciphera Pharmaceuticals Announces Closing of Public Offering of Common Stock

On August 19, 2019 Deciphera Pharmaceuticals, Inc. (Nasdaq:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported the closing of its previously announced registered underwritten public offering (Press release, Deciphera Pharmaceuticals, AUG 19, 2019, View Source [SID1234538857]). 10,810,810 shares of the Company’s common stock at a price to the public of $37.00 per share were issued and sold in the offering. The gross proceeds to Deciphera from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $400.0 million. In addition, the Company has granted the underwriters a 30-day option to purchase up to 1,621,621 additional shares of its common stock.

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J.P. Morgan, Piper Jaffray and Jefferies acted as joint book-running managers for the offering. Guggenheim Securities acted as lead manager for the offering. SunTrust Robinson Humphrey acted as co-manager for the offering.

Deciphera intends to use the net proceeds of the offering to fund: clinical trials for ripretinib, including the expansion stage of its current Phase 1 clinical trial, its ongoing pivotal Phase 3 clinical trials, and additional clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material, and pre-commercialization manufacturing process development and validation; clinical trials for DCC-3014, including the expansion stage of its current Phase 1 clinical trial, as well as clinical research outsourcing and manufacturing of clinical trial material; clinical trials for rebastinib, including its current Phase 1b/2 clinical trials, as well as clinical research outsourcing and manufacturing of clinical trial material; Investigational New Drug-enabling studies and the potential development of DCC-3116; new and ongoing research activities for future drug candidates using its proprietary kinase switch control inhibitor platform; continued growth of its commercial and medical affairs capabilities to support its transition from a development-stage company toward a commercial-stage company; and working capital purposes, including general operating expenses.

The offering was made only by means of a prospectus supplement and accompanying prospectus forming part of a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) and declared effective by the SEC on October 12, 2018. The final prospectus supplement and the accompanying prospectus was filed with the SEC and is available on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from J.P. Morgan Securities LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Piper Jaffray & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota, 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected]; and Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected].

This press release does 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 offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Dr. Reddy’s Laboratories announces the launch of Versavo® (bevacizumab biosimilar) in India

On August 19, 2019 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) reported that it has launched Versavo (bevacizumab), a biosimilar of Roche’s Avastin in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer) (Press release, Dr Reddy’s, AUG 19, 2019, View Source [SID1234538855]).

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Dr. Reddy’s Versavo is available in strengths of 100mg and 400mg single use vials.

Commenting on the launch, MV Ramana, CEO – India and Emerging Markets, Dr. Reddy’s Laboratories, said, "We regard the good health of our patients as our responsibility and are committed to ensure that they always have access to the medicines they need. The launch of Versavo is another step in that journey and helps strengthen our Oncology portfolio."

Dr. Raymond De Vré, Global Head, Biologics, Dr. Reddy’s Laboratories added "Versavo will help improve access to high quality therapy at an affordable cost, addressing the needs of patients with different cancers in India."

Avastin and its biosimilars had India sales of approximately INR 223 Crore MAT for the most recent twelve months ending in December 2018, according to Ipsos*.

Dr. Reddy’s now has six biosimilar products commercialized in India and various emerging markets and an active development pipeline of several biosimilar products in the oncology and immunology space.

*Ipsos India Tandem Oncology Monitor 2018

About Biosimilars

Biosimilarity means1:

That the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and,

There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.