On May 18, 2020 Turning Point Therapeutics, Inc. (Nasdaq: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, reported the pricing of its previously announced underwritten public offering of 5,416,667 shares of its common stock at a price to the public of $60.00 per share (Press release, Turning Point Therapeutics, MAY 18, 2020, View Source [SID1234564373]). The gross proceeds to Turning Point from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Turning Point, are expected to be approximately $325.0 million. In addition, Turning Point has granted the underwriters a 30-day option to purchase up to an additional 812,500 shares of common stock. The offering is expected to close on or about May 21, 2020, subject to satisfaction of customary closing conditions.

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Goldman Sachs & Co. LLC, SVB Leerink and Guggenheim Securities are acting as joint bookrunning managers for the offering. Wedbush PacGrow is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the offering.

The shares of common stock described above are being offered by Turning Point pursuant to a shelf registration statement on Form S-3, including a base prospectus, that was previously filed with and became effective by rule of the Securities and Exchange Commission (the "SEC") on May 15, 2020. A preliminary prospectus supplement and accompanying prospectus relating to the offering were filed with the SEC and are available on the SEC’s website located at View Source A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC’s website located at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from: Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, New York 10282, via telephone: 1-866-471-2526, or via email: [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218 or by email at [email protected]; or Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at 212-518-5548, or by email 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On May 18, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported its cash position as of March 31, 2020 and revenues for the first three months of 2020 (Press release, Genfit, MAY 18, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2020-financial-information-genfit [SID1234561498]).

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Cash position

As of March 31, 2020, the Company’s cash and cash equivalents amounted to €252.0 million compared with €314.1 million as of March 31, 2019 and €276.7 million as of December 31, 2019.

Revenues

Revenues for the first three months of 2020 amounted to €102 thousand compared to €1 thousand for the same period in 2019. Revenues mainly consisted of revenues from services provided to Terns Pharmaceuticals pursuant to the collaboration and license agreement in relation to their clinical trials.

Additional Information

Following the May 11, 2020 announcement of the interim results from the RESOLVE-IT Phase 3 clinical trial evaluating elafibranor in adults with NASH and fibrosis, GENFIT outlines the main operational and financial implications of this announcement:

Operational implications

Elafibranor did not show a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis, and therefore the top-line results do not support an application for accelerated approval by the FDA (U.S. Food and Drug Administration) under Subpart H or conditional approval by the EMA (European Medicines Agency).

However, before taking a final decision regarding the discontinuation, amendment or continuation of the RESOLVE-IT trial, GENFIT will review in detail the full dataset and will conduct additional analyses in order to:

Understand why the placebo response rate was higher than what was observed in other late stage clinical trials using similar protocols;
Determine whether there is still a potential for elafibranor in specific subpopulations.
GENFIT will then engage with the FDA and the EMA, and will take a decision regarding the discontinuation, amendment or continuation of the RESOLVE-IT trial following its discussions with regulatory authorities.

GENFIT remains fully committed to developing NIS4, its non-invasive diagnostic technology, to identify at-risk NASH patients.

With regards to PBC (Primary Biliary Cholangitis), given elafibranor’s activity in Phase 2, and its safety profile confirmed by the RESOLVE-IT interim data, and because PBC is an autoimmune disease unrelated to the metabolic origins of NASH, GENFIT is confident in its Phase 3 development program evaluating elafibranor in this indication.

Finally, GENFIT remains open to opportunities that could create value for the Company, whether through forging new strategic partnerships or new scientific collaborations.

GENFIT plans to share its updated corporate strategy in the Fall 2020, once a decision regarding the RESOLVE-IT trial is taken, including potential decisions regarding its product pipeline.

Financial implications

GENFIT is reviewing all non-essential expenses and a first series of measures includes terminating all marketing and commercialization readiness activities for elafibranor in NASH.
However, since no immediate decision can be taken regarding the future of the RESOLVE-IT trial, the trial will continue and its associated costs will continue , including those related to:
Contract Research Organization activities; and
patient monitoring, which cannot be interrupted abruptly due to ethical and regulatory concerns.
In the event a decision is taken to discontinue the RESOLVE-IT trial in the Fall 2020, given the size and complexity of the study, residual costs are to be expected and the full impact of the decision on the Company’s cash burn will not be noticeable until several months following the termination of the trial.

On May 18, 2020 Celleron reported the launch of the University of Oxford-Sichuan University Huaxi Joint Centre for Gastrointestinal Cancer, led by Prof. David Kerr (Radcliffe Department of Medicine, University of Oxford) and Prof. Li Yang (Sichuan University) (Press release, Celleron, MAY 18, 2020, View Source [SID1234560784]).

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Over the next 5 years, this new international collaboration seeks to develop an integrated cancer plan with a focus on gastrointestinal cancer, underpinned by high quality basic, translational and clinical cancer research.

The intention is to develop one team based across two sites, with an operating and governance system that will drive the exchange of ideas, which is crucial to academic development and alleviating the burden that cancer places on society across the world.

The Centre will seek to build a portfolio of multi-disciplinary teams drawing from both organizations. These teams and their projects will enable scientists and clinicians to learn from each other and apply their expertise for the benefit of cancer patients in both nations. The establishment of a bilateral researcher exchange program will drive the delivery of these.

Professor David Kerr, Co-Director of the University of Oxford-Sichuan University Huaxi Joint Centre for Gastrointestinal Cancer and CMO of Celleron Therapeutics, commented,

"The idea behind personalised cancer medicine is both simple and powerful: delivering the right treatment to the right patient at the right time. Our aim is to radically alter the way cancer is managed, saving lives by focusing on the individual"

Professor Nick La Thangue, CEO of Celleron Therapeutics, commented,

"Cancer remains a devastating and clinically unmet disease. It is very pleasing that our leadership team can contribute to international partnerships between leading universities and hospitals aiming to improve treatment of the disease".

On May 18, 2020 AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare solutions company targeting oncological and cannabinoid research, reported its oncology-focused subsidiary, Sapphire Biotech, Inc. ("Sapphire"), filed a utility patent application relating to a novel biomarker for the detection of cancer in blood serum and urine (Press release, AXIM Biotechnologies, MAY 18, 2020, View Source;utm_medium=rss&utm_campaign=axim-biotechnologies-files-for-patent-for-unique-biomarker-for-early-detection-of-cancer-in-blood [SID1234558661]).

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"Sapphire’s diagnostics products have the potential to change the way in which cancer is detected and treated, not only by enabling detection with a simple blood test but also by providing an important tool for oncologists to assess the treatment protocol for patients," said AXIM Biotech CEO John W. Huemoeller II.

The patent application is based on Sapphire’s discovery of the long splice variant of the enzyme, quiescin sulfhydryl oxidase (QSOX1-L), as a biomarker in bladder cancer patients’ sera that was highly specific for the presence of cancer and was low or non-existent in normal donors’ sera. This is the first time that a clinically relevant QSOX1-L splice variant has been identified as a unique biomarker of bladder cancer and other cancers in serum.

Sapphire scientists have generated a novel antibody that selectively detects only this splice variant and have used the biomarker to develop a prototype rapid and cost-effective diagnostic test for bladder and other cancers non-invasively. On August 21, 2019, a one-year clinical trial began to evaluate Sapphire’s test to detect the QSOX1 biomarker in patients with or at risk for pancreatic cancer.

"Sapphire’s objective is to address the large mortality cancer rate by developing products using its proprietary biomarker, QSOX1, that can potentially detect cancer earlier than blood biopsy tests," said Catalina Valencia, Chief Executive Officer of Sapphire Biotech.

Sapphire’s Diagnostics Product Portfolio includes:

Universal Companion Diagnostic Test: Sapphire scientists have developed proprietary assays to detect QSOX1 levels in patients undergoing cancer treatment. The universal companion diagnostic test is intended to measure the response to treatment and to monitor post-treatment recurrence by tracking QSOX1 levels in blood. Animal studies are expected to commence imminently.
Immunohistochemistry (IHC) Diagnostic Test: The Company is developing an IHC test, using proprietary anti-QSOX1 antibodies for diagnosis of cancer. The Company’s goal is to complete the development of a commercial prototype in the first quarter of 2021.
Universal Cancer Biomarker: The Company has been studying QSOX1 levels in the blood of cancer patients to make the correlation between QSOX1 levels with various cancer stages. The ultimate goal is to validate QSOX1 as a blood biomarker for the presence of cancer in asymptomatic individuals. Breast, lung and pancreatic cancer-focused validation studies are planned.

On May 18, 2020 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical-stage targeted oncology company, reported that Joseph Leveque, M.D. has been named Chief Medical Officer effective May 18, 2020 (Press release, Mirati, MAY 18, 2020, View Source [SID1234558276]). Isan Chen, M.D., will step down as Chief Medical and Development Officer to lead an early-stage biotech company, however, Dr. Chen will continue to act as an advisor to Mirati.

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"Isan’s leadership over the last seven years has been central to the advancement of our programs," said Dr. Charles Baum, M.D., Ph.D., President and Chief Executive Officer at Mirati Therapeutics. "We appreciate his dedicated service which brought Mirati from a small oncology company to where we are today. We wish him well and know he will be successful in this new opportunity."

"Joe’s experience with world class clinical development teams that have brought several novel oncology therapies to patients will have an important impact as we prepare for Mirati’s next phase of growth," said Dr. Baum. "We are thrilled to have him join Mirati as we rapidly advance our registration-enabling clinical trials for both sitravatinib and MRTX849, as well as advance our preclinical pipeline including the KRAS G12D inhibitor program."

Dr. Leveque joins Mirati following his successful tenure as Chief Medical Officer at Synthorx, which was acquired by Sanofi in late 2019. Prior to Synthorx, he served as Chief Medical Officer at ARMO Biosciences, a late-stage immuno-oncology company that was acquired by Eli Lilly in May 2018. Prior to these roles, Dr. Leveque was Chief Medical Officer of EMD Serono, the North American subsidiary of Merck KGaA, and Vice President and Head of U.S. Medical Oncology at Bristol-Myers Squibb, where he led the development and commercialization of the first generation of immuno-oncology therapeutics. He has also held key medical leadership positions at Onyx Pharmaceuticals, Cephalon Oncology and Amgen.

Dr. Leveque earned a Medical Doctorate from The University of Texas School of Medicine in Houston, TX and completed his post-graduate medical training in internal medicine at the Cedars-Sinai Medical Center, a teaching affiliate of the University of California, Los Angeles (UCLA). In addition, Dr. Leveque holds a Master of Business Administration from the Wharton School of the University of Pennsylvania.

In connection with his employment, the Compensation Committee of Mirati’s Board of Directors granted Dr. Leveque an inducement award consisting of a non-qualified stock option to purchase shares of common stock with a grant date fair value equal to $3,500,000 and restricted stock units with a grant date fair value equal to $2,500,000 ("RSUs"). The stock option has an exercise price per share equal to the closing price of the Company’s common stock on the Nasdaq Global Select Market on May 18, 2020 and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the vesting commencement date and 1/48th of the underlying shares vesting monthly thereafter over 36 months subject to Dr. Leveque’s continued service relationship with Mirati through the applicable vesting dates. The RSUs vest over four years, with 25% of the underlying shares vesting on each of the four anniversaries of the vesting commencement date, subject to Dr. Leveque’s continued service relationship with Mirati through the applicable vesting dates. The Compensation Committee of Mirati’s Board of Directors approved the awards as inducement material to Dr. Leveque’s employment in accordance with NASDAQ Listing Rule 5635(c)(4).