On July 25, 2017 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, reported its financial results for the quarter ended June 30, 2017 (Press release, RedHill Biopharma, JUL 25, 2017, View Source [SID1234519868]).

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The Company will host a conference call on Tuesday, July 25, 2017 at 9:00 am EDT to review the financial results and business highlights. Dial-in details are included below.

Financial highlights for the quarter ended June 30, 20172
Net Revenues for the second quarter of 2017 were approximately $0.5 million, compared to immaterial Net Revenues in the second quarter of 2016 and in the first quarter of 2017. The increase was due to the initiation, in mid-June 2017, of the U.S. promotional activities of Donnatal (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)3 and the sale of EnteraGam (serum-derived bovine immunoglobulin/protein isolate, SBI)4.

Cost of Revenues for the second quarter of 2017 were $0.3 million, reflecting costs related to the initiation of the sale of EnteraGam in mid-June 2017.

Research and Development Expenses for the second quarter of 2017 were $8.4 million, an increase of $2.4 million or 40% compared to the second quarter of 2016. The increase was mainly due to the ongoing Phase III and Phase II studies with BEKINDA (RHB-102) for gastroenteritis and IBS-D, respectively, the ongoing Phase III study with RHB-104 for Crohn’s disease, the ongoing and planned studies with YELIVA (ABC294640) for multiple indications, and the initiation of the ongoing confirmatory Phase III study with TALICIA (RHB-105)5 for H. pylori infection. Research and Development Expenses for the second quarter of 2017 increased by $0.3 million or 4% compared to the first quarter of 2017.

General and Administrative Expenses for the second quarter of 2017 were $1.9 million, an increase of $1.2 million compared to the second quarter of 2016. General and Administrative Expenses for the second quarter of 2017 increased by $0.6 million or 48% compared to the first quarter of 2017. The increase from the comparable periods was mainly due to the establishment and advancement of the Company’s U.S. commercial operations in the first quarter of 2017 and enhanced professional services.

Selling, Marketing and Business Development Expenses for the second quarter of 2017 were $3.4 million, an increase of $3.0 million compared to $0.4 million in the second quarter of 2016, comprised only of Business Development Expenses. The increase was mainly due to the establishment and advancement of the Company’s U.S. commercial operations. The Company recognized Selling and Marketing Expenses in 2017 for the first time.

Operating Loss for the second quarter of 2017 was $13.5 million, an increase of $6.3 million or 88% compared to the second quarter of 2016. The increase was mainly due to an increase in Research and Development Expenses and Selling, Marketing and Business Development Expenses, as detailed above. Operating Loss for the second quarter of 2017 increased by $3.4 million or 34% compared to the first quarter of 2017. The increase was mainly due to an increase in Selling, Marketing and Business Development Expenses, as detailed above.

Financial Income, net for the second quarter of 2017 was $2.5 million, an increase of $1.9 million compared to the second quarter of 2016. Financial Income, net for the second quarter of 2017 increased by $1.0 million or 67% compared to the first quarter of 2017. The increase from the comparable periods was mainly due to a fair value gain on derivative financial instruments.

Net Cash Used in Operating Activities for the second quarter of 2017 was $9.7 million, an increase of $4 million or 70% compared to the second quarter of 2016. The increase was mainly due to the increase in Operating Loss, as detailed above. Net Cash Used in Operating Activities for the second quarter of 2017 decreased by $0.6 million or 6% compared to the first quarter of 2017.

Net Cash Used in Investing Activities for the second quarter of 2017 was $4.9 million, an increase of $1.9 million or 67% compared to the second quarter of 2016. Net Cash Used in Investing Activities for the second quarter of 2017 decreased by $13.7 million compared to the first quarter of 2017. The decrease was mainly due to change in short-term investments.

Cash Balance6 as of June 30, 2017, was $51 million, a decrease of $15 million, compared to $66 million as of December 31, 2016, and a decrease of $10 million compared to March 31, 2017. The decrease was a result of the ongoing operations, mainly related to research and development activities and the establishment of the U.S. commercial operations.

Micha Ben Chorin, RedHill’s CFO, said: "We are pleased with the important milestones achieved during the second quarter, including positive top-line results from the Phase III GUARD study with BEKINDA 24 mg for acute gastroenteritis, initiation of the confirmatory Phase III study with TALICIA for the treatment of H. pylori infection, and the initiation of promotional activities in the U.S. by our GI-focused sales force with Donnatal and EnteraGam, which generated encouraging initial net revenues of approximately $0.5 million in the second half of June alone. Our cash position of $51 million at the end of the second quarter should allow us to continue to execute our strategic plans, diligently advance our late-stage clinical programs and pursue the acquisition of additional commercial GI products in the U.S."

On July 25, 2017 Oxis International Inc. (OTCQB: OXIS and Euronext Paris: OXI.PA) reported that provides additional detail about its agreement to acquire Georgetown Translational Pharmaceuticals Inc. (GTP) and how the deal will add value to Oxis. Further, Oxis International Inc. has initiated a name change to GT Biopharma Inc. as part of its acquisition and 14C filing (Press release, OXIS International, JUL 25, 2017, View Source [SID1234539563]).

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On June 26, Oxis announced that it had executed a binding LOI agreement to acquire GTP, a move that will deliver new management and a class of close-to-market Central Nervous Systems (CNS) products to Oxis.

Oxis agreed to pay 33 percent of its outstanding shares to GTP to complete the transaction, which is expected to close before Sept. 30.

The slide deck (www.oxis.com) highlights several benefits of the acquisition for Oxis and its shareholders, including:

The acquisition of GTP’s leading candidate, Pain Brake, a pain-relief drug expected to be submitted to the FDA as a New Drug Application in 15 to 18 months.
The acquisition of drug candidate GTP-004 for the treatment of myasthenia gravis, a rare muscular disease. The only approved drug for this disease carries significant GI side effects, limiting the tolerable dose. GTP-004 combines the existing drug with an approved treatment of GI disease, reducing side effects and allowing patients to tolerate a more effective dose.
The acquisition of GTP-011, a treatment for motion sickness. This is a repurposed version of an existing drug. It was designed to reduce or eliminate side effects in some elderly patients, allowing them to treat motion sickness without side effects that resembled symptoms of Alzheimer’s Disease.
A new management team at Oxis (soon to be GT Biopharma). GTP co-founder Dr. Kathleen Clarence-Smith, a respected and experienced leader in the pharmaceutical industry, will become CEO of the combined companies. Additionally, a Chief Medical Officer, who formerly served as CMO with Pfizer, will join Oxis under the deal.
Prior to founding GTP, Dr. Clarence-Smith co-founded Chase Pharmaceuticals Corporation in Washington D.C. and served as Chairman of the company’s Board from 2008 to 2014. Chase Pharmaceuticals was acquired by Allergan, PLC (AGN) in 2016 in a deal that, with milestones, could reach $1 billion.

Dr. Clarence-Smith also held executive management positions with Sanofi, Roche, Otsuka Pharmaceutical and Prestwick Scientific Capital. She is co-founder and a managing member of KM Pharmaceutical Consulting in Washington, D. C.

Dr. Clarence-Smith’s vast experience will be extremely beneficial to Oxis’ development of drugs in its pipeline, including OXS-1550, which is in an FDA Phase 2 clinical trial, and its highly valued TriKE platform oncology assets, which are set to go into FDA clinical trials soon.

Oxis’ lead drug candidate, OXS-1550 (DT2219ARL), is a novel drug that binds to targets and destroys cancer cells, due to the action of the drug’s cytotoxic payload. OXS-1550 has demonstrated success in early human clinical trials in patients with relapsed/refractory B-cell lymphoma or leukemia. It is currently in an FDA-approved Phase 2 trial at the University of Minnesota.

Anthony J. Cataldo, who is Oxis’ Chief Executive Officer, will become Executive Chairman of the combined companies after the deal closes. He said, "Dr. Clarence-Smith’s leadership will be extremely valuable to Oxis. There are not many Biotech executives that have successfully sold their company to big pharma and have navigated several drugs through FDA approval like Dr. Clarence-Smith."

"I am excited by the prospect of joining Tony’s (Anthony J Cataldo) team following his highly successful creation of Lion Biotechnologies, Inc. (now Iovance Biotherapeutics, Inc: Trading – IOVA). As founder of Oxis Biotech, it appears he has delivered again with oncology assets that are well positioned to be in the forefront of the next generation of targeted immunotherapies," said Dr. Clarence-Smith.

"Our existing oncology products (FDA Phase 2 OXS 1550 clinical trial and upcoming FDA TriKE phase 1 clinical trial) have now reached the point where Dr. Clarence-Smith’s experience in taking drugs through FDA approvals and into the market, will bring significant value to our shareholders," Mr. Cataldo said.

The agreement to acquire GTP marks another major value-added inflection point for the shareholders of Oxis. The company continues to progress with recently announced partnership and milestone accomplishments.

On July 25, 2017 Celgene Corporation (NASDAQ:CELG) reported that it has reached a civil settlement with Relator Brown, the Department of Justice, 28 States, the District of Columbia, and the City of Chicago to resolve the previously disclosed False Claims Act litigation pending in the United States District Court for the Central District of California (Press release, Celgene, JUL 25, 2017, View Source [SID1234519881]). The litigation related primarily to allegations that Celgene promoted Thalomid (thalidomide) for off-label uses before its 2006 FDA approval for newly diagnosed multiple myeloma. The Department of Justice, the States, the District of Columbia, and the City of Chicago declined to intervene in the litigation.

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Under the settlement, Celgene will pay a total of $280 million to the United States, 28 States, the District of Columbia, and the City of Chicago to resolve the litigation. This final settlement includes the resolution of all allegations the Relator made with respect to Thalomid and Revlimid (lenalidomide). Before the parties reached a settlement, the Court dismissed a significant part of the case on a motion for summary judgment, including allegations that Celgene illegally paid doctors to induce them to promote and/or prescribe Thalomid and Revlimid. Celgene is not required to enter into a Corporate Integrity Agreement as part of the settlement.

Celgene has denied any wrongdoing in this matter, but is settling to avoid the uncertainty, distraction, and expense of protracted litigation. Celgene contends, and has contended throughout the litigation, that Thalomid and Revlimid are medical breakthrough medicines that have benefitted patients with serious illnesses; that physicians prescribed these medicines based on their independent medical judgment; and that Celgene’s relationships with physicians have been appropriate, and have helped to advance patient care and science.

On July 24, 2017 Spherix Incorporated ("Spherix" or the "Company") (NASDAQ: SPEX), an intellectual property development company committed to fostering of technology, reported that it has closed its previously announced firm commitment underwritten public offering of 1,250,000 shares of its common stock at a price to the public of $2.00 per share (Press release, Spherix, JUL 24, 2017, View Source [SID1234538992]).

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The total gross proceeds of the offering are approximately $2.5 million. After deducting the underwriter’s discount and other offering expenses payable by Spherix, the net proceeds to the Company are approximately $2.1 million.

Anthony Hayes, the Chief Executive Officer of Spherix, stated, "One of the purposes of this offering is to raise capital to explore potential acquisition opportunities. Looking beyond our recent investment in Hoth Therapeutics, we hope to use these proceeds to find other similar opportunities."

Laidlaw & Company (UK) Ltd. acted as the sole underwriter for the offering.

The shares were offered pursuant to a registration statement on Form S-1 (File No. 333-218216) that was declared effective by the Securities and Exchange Commission (SEC) on July 18, 2017. The securities were offered only by means of a prospectus. A final prospectus supplement related to the offering has been filed with the SEC, and is available on the SEC’s website at www.sec.gov and may also be obtained from Laidlaw & Company (UK) Ltd., Attention: Syndicate Department, 546 Fifth Avenue, 5th Floor, New York, New York 10036, telephone (212) 953-4900, email: [email protected].

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor may there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On July 24, 2017 Novocure (NASDAQ:NVCR) reported a new arm for a phase 1b study to evaluate the safety of marizomib and temozolomide in combination with Optune, Novocure’s Tumor Treating Fields (TTFields) delivery system, as adjuvant treatment for patients with newly diagnosed glioblastoma (GBM) following radiation therapy with concurrent temozolomide (Press release, NovoCure, JUL 24, 2017, View Source [SID1234519860]). The trial is the first to study Optune in combination with an investigational drug.

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Marizomib is a novel, brain-penetrant proteasome inhibitor developed by Triphase Accelerator Corporation and acquired by Celgene Corporation. Celgene is responsible for marizomib’s development.

"This collaboration marks an important first step toward testing Optune with a promising new investigational compound for the treatment of GBM," said Principal Investigator Dr. Roger Stupp, Associate Director for Strategic Initiatives at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. "Optune is the first treatment in over a decade to improve survival in GBM. I believe that combining Optune with new pharmacologic treatments in clinical trials, like this phase 1b study, will help advance our understanding of how to treat this devastating disease."

Celgene and Triphase modified their current phase 1b multicenter, open-label study of marizomib in combination with temozolomide and radiotherapy in patients with grade IV malignant gliomas to include Optune. A cohort of 12 GBM patients will be treated with Optune in combination with marizomib and temozolomide after initial treatment with radiation and temozolomide has been completed.

The primary objective for the Optune portion of the study is to determine the safety of the combination of marizomib and temozolomide with the addition of Optune in patients entering the adjuvant treatment phase. Secondary objectives for the Optune portion of the study include assessing preliminary clinical activity of the combination of Optune, marizomib and temozolomide in patients entering adjuvant therapy, progression-free survival and overall survival. The protocol has been submitted to an institutional review board, and this arm of the trial is expected to open in the third quarter of 2017.

"We believe TTFields has the potential to be an excellent development candidate in combination with other solid tumor cancer treatments," said Dr. Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "As innovators in cancer treatment, we know collaboration is essential to improve patient outcomes. We hope this is the first collaboration of many."
Tumor Treating Fields in combination with temozolomide and marizomib is experimental for the treatment of glioblastoma. Limited by law to investigational use only.