On September 9, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will present an overview and update, as well as host investor meetings, at the Morgan Stanley 18th Annual Global Healthcare Conference on Wednesday, September 16, 2020, at 2:00 p.m. ET (Press release, Supernus, SEP 9, 2020, View Source [SID1234564825]).

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Investors interested in arranging a virtual meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company’s website after the conference.

On September 9, 2020 Varian (NYSE: VAR) reported the German Cancer Research Center (DKFZ) in Heidelberg has ordered Germany’s first Ethos therapy, an Adaptive Intelligence solution (Press release, Varian Medical Systems, SEP 9, 2020, View Source [SID1234564824]). This artificial intelligence (AI)-driven holistic solution is designed to increase the capability, flexibility, and efficiency of radiotherapy. Ethos therapy delivers an entire adaptive treatment in a typical 15-minute timeslot, from patient setup through treatment delivery. The first Ethos therapy in Germany is scheduled to be installed and start treating patients by early 2021.

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"Adaptive therapy is one of the most important developments in the field of radiotherapy," said Prof. Dr. Michael Baumann, CEO and scientific director at DKFZ. "At DKFZ, cancer researchers and oncologists are closely cooperating to get the latest research findings rapidly from bench to bedside, as well as transfer the insights gained from the treatment back from clinic to the lab. Ethos therapy will complement both our research and treatment activities at DKFZ, and we are looking forward to applying adaptive radiotherapy in this context."

"We are very proud that DKFZ, the largest biomedical research center in Germany, has selected Ethos to conduct both research into adaptive radiotherapy and to put this research directly into practice," said Chris Toth, president, Varian Oncology Systems. "Since its introduction in September 2019, Ethos therapy has been recognized by leading clinics around the world as a game changer that is unlocking a new era of personalized adaptive radiation therapy."

DKFZ is among the most renowned cancer research facilities in the world, with 3,000 employees working tirelessly to gain a better understanding of cancer and putting their research findings to medical use for patients. Located on the Heidelberg biomedical campus, DKFZ scientists are engaged in a large number of national and international partnerships and research alliances and cooperate closely with several university hospitals in translational networks. The DKFZ Ethos therapy was financed by the Dieter Morszeck Foundation.

Ethos Therapy

The streamlined workflow of Ethos therapy is enabled by its AI-driven planning and contouring capabilities. Physicians define their clinical intent from predefined templates and the initial treatment plan is generated based on the physician’s pre-defined clinical objectives. The treatment is adapted in response to changes in the patient’s anatomy and the tumor’s shape and position, at the time of treatment. The ability of Ethos to deliver on-couch adaptive treatment puts the patient at the center of care.

Ethos therapy offers the use of multimodality images (MR, PET, CT) registered with daily iterative CBCT images at the console. By providing an up-to-date view of the patient’s anatomy, Ethos therapy provides clinicians the confidence to make more informed adaptive treatment decisions. The solution is built on Varian’s latest treatment delivery technology and provides fast imaging and treatment delivery without compromising quality.

Ethos therapy has obtained CE mark, as well as 510(k) clearance. Its availability is rapidly expanding across multiple markets worldwide. For more information on Ethos, visit www.varian.com/ethos.

On September 9, 2020 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its fiscal year ended June 30, 2020 (Press release, MEI Pharma, SEP 9, 2020, View Source [SID1234564823]).

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"This past year was marked by progress on multiple fronts, particularly for zandelisib, formerly called ME-401, which is our PI3K delta inhibitor in the Phase 2 TIDAL study intended to support an accelerated approval marketing application with FDA," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "The progress on zandelisib this past year includes entering a global license, development and commercialization agreement with Kyowa Kirin Company, maturing Phase 1b study data that continues to support best-in-class potential, as well as obtaining Fast Track designation from FDA."

Dr. Gold continued: "With about $183 million in cash at the start of our fiscal year, we believe we have an operational runway at least through 2023 and are well positioned to advance our ongoing clinical programs. In particular, we look forward to completing TIDAL enrollment as we initiate additional clinical studies to fully explore zandelisib’s potential to benefit patients with B-cell malignancies while we continue our staged build-out of a commercial infrastructure to optimally capture value from the program."

Fiscal Year 2020 Zandelisib (ME-401) and Corporate Highlights

Zandelisib (formerly called ME-401), an oral, once-daily, investigational drug-candidate selective for phosphatidylinositol 3-kinase delta (PI3Kδ), for B-Cell Malignancies

The World Health Organization approved "zandelisib" as the International Nonproprietary Name, or INN, for ME-401, the Company’s investigational cancer treatment being developed as an oral, once-daily, selective PI3Kδ inhibitor for the treatment of B-cell malignancies.
In May 2020, the Company and Kyowa Kirin Co. presented updated data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Virtual Scientific Program from a Phase 1b study of zandelisib (ME-401) for the treatment of B-cell malignancies. These data evaluating patients on an intermittent dosing schedule of zandelisib showed that treatment was generally well tolerated and demonstrated an 83% overall response rate in patients with relapsed or refractory follicular lymphoma (n=36). The responses were durable with no median yet reached (median follow-up of 13.2 months: range: 3.0-27.6).
In April 2020, the Company entered into a global license, development and commercialization agreement with Kyowa Kirin Co. to further develop and commercialize MEI’s zandelisib:
MEI and Kyowa Kirin will co-develop and co-promote zandelisib in the U.S.
MEI to book U.S. sales on 50-50 profit and cost sharing.
$100 million upfront cash payment to MEI.
$582.5 million in potential development, regulatory and commercial milestones
Kyowa Kirin obtains exclusive commercialization rights ex-U.S.
MEI to receive escalating tiered royalty payments starting in the teens on ex-U.S. sales.
In March 2020, the Company was granted Fast Track designation by the U.S. FDA for zandelisib for the treatment of adult patients with relapsed or refractory follicular lymphoma.
Corporate Highlights

In April 2020, Cheryl L. Cohen, former chief commercial officer of Medivation, Inc. and a product launch and commercialization veteran with over 25 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
In December 2019, the Company closed an underwritten public offering of 32,343,750 shares of its common stock for total gross proceeds of approximately $51,750,000. Additionally, during the year ended June 30, 2020, MEI sold 5,471,684 shares under the ATM Sales Agreement for net proceeds of $20.8 million.
In July 2019, Tamar Howson, M.S., MBA, a highly experienced business development executive with over 30 years of service in the pharmaceutical and biotechnology industry, joined the Board of Directors.
Fiscal Year 2020 Financial Results

As of June 30, 2020, MEI had $182.6 million in cash, cash equivalents, and short-term investments with no outstanding debt. Additionally, MEI has a receivable of $20.4 million that is expected to be received from the Japanese taxing authorities in fiscal year 2021 that was withheld from the $100 million paid by Kyowa Kirin Co. under the terms of April 2020 global license, development and commercialization agreement. The withholding was a result of the US Internal Revenue Service being closed because of the COVID pandemic, resulting in an inability to provide the necessary documentation to support an exemption from the required foreign withholding.
For the year ended June 30, 2020, cash used in operations was $45.3 million compared to $39.4 million for 2019.
Research and development expenses were $34.1 million for the year ended June 30, 2020, compared to $32.3 million for 2019. The increase was primarily related to increased development costs associated with zandelisib, as well as increased personnel costs to support our clinical trial activities.
General and administrative expenses were $16.7 million for the year ended June 30, 2020, compared to $14.6 million for 2019. The increase primarily relates to personnel costs and general corporate expenses incurred during the year ended June 30, 2020.
MEI recognized revenues of $28.9 million for the year ended June 30, 2020, compared to $4.9 million for the year ended June 30, 2019. Revenues resulted from the recognition of license revenue associated with the Kyowa Kirin license agreement as well as fees allocated to research and development activities related to the Kyowa Kirin and Helsinn license agreements.
Net loss was $46.0 million, or $0.51 per share, for the fiscal year ended June 30, 2020, compared to net loss of $16.8 million, or $0.24 per share for 2019. The Company had 111,513,689 shares of common stock outstanding as of June 30, 2020, compared with 73,544,576 shares as of June 30, 2019.
The adjusted net loss for the fiscal year ended June 30, 2020, excluding non-cash expenses related to changes in the fair value of the warrants issued in connection with the May 2018 financing (a non-GAAP measure), was $23.1 million.
Conference Call and Webcast

MEI Pharma will host a conference call with simultaneous webcast today, September 9, 2020, at 5:00 p.m. Eastern time to provide a corporate update. To access the live call, please dial (866) 939-3921 (United States) or (678) 302-3550 (International), conference ID 49919899. The conference call will also be webcast live and can be accessed at www.meipharma.com. A replay of the webcast will be available approximately one hour after the conclusion of the call.

On September 9, 2020 Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company, reported that it has closed its previously announced registered direct offering to certain institutional investors of 8,865,000 shares of common stock at a price of $0.79 per share (Press release, Apricus Biosciences, SEP 9, 2020, View Source [SID1234564822]). The Company also closed its previously announced concurrent private placement to the investors of unregistered warrants to purchase up to 6,648,750 shares of common stock. The warrants have an exercise price of $0.84 per share of common stock, will be exercisable six months from the date of issuance and will expire five years following the initial date of exercise.

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After deducting the placement agent’s fees and offering expenses, the Company received net proceeds of approximately $6.2 million. Seelos intends to use the net proceeds from the offering for general corporate purposes and to advance the development of its product candidates.

Roth Capital Partners acted as the sole placement agent for the offering.

A shelf registration statement on Form S-3 (File No. 333-221285) relating to the shares of common stock issued in the registered direct offering was previously filed with the Securities and Exchange Commission (the "SEC") on November 2, 2017, amended on December 1, 2017 and declared effective by the SEC on December 7, 2017. Such shares were offered only by means of a prospectus. A prospectus supplement and the accompanying prospectus relating to and describing the terms of the registered direct offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Newport Beach, California 92660, by calling (800) 678-9147 or by e-mail at [email protected].

The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

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 the registration or qualification under the securities laws of any such state or jurisdiction.

On September 9, 2020 Constellation Pharmaceuticals, Inc. (Nasdaq: CNST), a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that the Company will participate in upcoming virtual investor conferences (Press release, Constellation Pharmaceuticals, SEP 9, 2020, View Source [SID1234564821]). Jigar Raythatha, CEO, will present at:

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The H.C. Wainwright Global Investment Conference at 1:00 PM EDT on September 14
The Cantor Global Healthcare Conference at 1:20 PM EDT on September 17
Live audio webcasts of Mr. Raythatha’s presentations and archives for replay will be available on the Investor Relations section of Constellation’s website at View Source The audio webcast replays will be available for 30 days following the live presentation.