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OXIS RELEASES ADDITIONAL DETAILS ABOUT ACQUISITION OF GEORGETOWN TRANSLATIONAL PHARMACEUTICALS, OXIS TO CHANGE NAME TO "GT BIOPHARMA, INC."

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.

HedgePath Pharmaceuticals Receives Clarity From FDA Regarding Pathway to Potential Regulatory Submission

On July 25, 2017 HedgePath Pharmaceuticals, Inc. (OTCQX:HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) has provided further guidance regarding HPPI’s ongoing, open-label Phase 2(b) clinical trial studying the effect of SUBA-Itraconazole (SUBA-Cap) oral capsules in patients with Basal Cell Carcinoma Nevus Syndrome (BCCNS), also known as Gorlin Syndrome (Press release, HedgePath Pharmaceuticals, JUL 25, 2017, View Source [SID1234519943]).

The FDA’s guidance came in the form of a written response by FDA to HPPI’s Type-C meeting background package. Such a meeting is a standard element of the regulatory review process leading to a potential New Drug Application (NDA) to FDA.

Nicholas Virca, President and CEO of HPPI, stated that, "We are pleased with the FDA’s guidance, since we believe it adds clarity to our regulatory and clinical road going forward for the BCCNS indication of SUBA-Cap. FDA confirmed that we may follow the more streamlined 505(b)(2) regulatory pathway, which will allow us to reference safety data from previous third-party itraconazole trials, to be supplemented by our own safety database. The acceptability of this combined safety database will then be determined by the FDA during the course of its review of the future NDA. FDA also agreed that no additional nonclinical toxicology studies appear necessary to support filing an NDA for SUBA-Itraconazole under the 505(b)(2) pathway."

Importantly, FDA also indicated that it "[w]ould accept a single study to support an NDA if results show a significant effect on a clinically meaningful endpoint. The results of the single trial must be sufficiently robust and so compelling that it would be unethical to repeat the study . . . [e]vidence of an objective reduction in tumor burden that is durable is important in order to demonstrate antitumor effects of SUBA-Itraconazole in patients with BCCNS and these data should be collected and independently reviewed."

Mr Virca further stated that, "In light of FDA’s additional guidance on what might constitute a clinically significant response, we are now undertaking further detailed analyses of individual tumor responses from our ongoing trial seeking to verify the robustness of our therapy in reducing the tumour burden in BCCNS patients. We intend to present the results of this additional analysis to FDA and continue discussions with them about the utility of such results in a potential NDA submission."

Readers are cautioned that no assurances can be given that (i) the final study results will match the results previously reported on May 30, 2017 or (ii) the study, when and if completed, will achieve its primary and secondary endpoints or (iii) that the study results will be found by FDA to be sufficient for the filing of a NDA, or that one or more additional studies will not be required or (iv) if an NDA is filed, that it will be approved by FDA. Further, HPPI is not committing to providing further interim updates prior to the reporting of the final study results.

About BCCNS
BCCNS results from a genetic mutation which causes the Hedgehog pathway (a major regulator of processes in cells) to function improperly, leading to the chronic formation of basal cell tumors, including potentially disfiguring lesions on the face. Industry sources estimate that there are approximately 10,000 patients in the United States with BCCNS, which has qualified SUBA-Itraconazole under the FDA’s Orphan Drug Designation Program.

About SUBA-Itraconazole
SUBA-Itraconazole is a patented and proprietary itraconazole formulation that enhances the absorption of itraconazole to improve the bioavailability of orally administered drugs that are poorly soluble. The U.S. rights to SUBA-Itraconazole for the treatment of cancer are exclusively licensed to HPPI by an affiliate of Mayne Pharma Group Limited. SUBA-Itraconazole was developed to improve absorption and significantly reduce variability compared to generic itraconazole. These benefits provide enhancements to patients and prescribers with reduced intra- and inter-patient variability, enabling a more predictable clinical response and a reduction in the active drug quantity to deliver the required therapeutic blood levels.

Celgene Corporation Announces Settlement of Civil Litigation

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.

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.

RedHill Biopharma Reports 2017 Second Quarter Financial Results

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]).

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."

Atossa Genetics Completes Enrollment in Endoxifen Phase 1 Study and Provides Update on Fulvestrant Microcatheter Phase 2 Study

On July 25, 2017 Atossa Genetics Inc. (NASDAQ:ATOS), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods for breast cancer and other breast conditions, reported it has now completed enrollment in its Phase 1 dose escalation study of Atossa’s proprietary Endoxifen (Press release, Atossa Genetics, JUL 25, 2017, View Source [SID1234519875]). Endoxifen is an active metabolite of the FDA-approved drug tamoxifen, which is currently used to treat breast cancer and for breast cancer prevention in high risk patients.

"We have now completed enrollment in both the oral and topical arms of our proprietary Endoxifen Phase 1 dose escalation study," commented Dr. Steven Quay, CEO and President of Atossa. "The speed at which this study fully-enrolled is a testament to the enthusiasm for potential new therapies in the breast cancer field, as well as the hard work and dedication of our CRO, CPR Pharma, and the personnel at Atossa. We hope to report initial top-line data before the end of the quarter and then, subject to favorable Phase 1 results and other regulatory requirements, proceed to one or more Phase 2 studies using both our oral and topical formulations," added Dr. Quay.

The objectives of this double-blinded, placebo-controlled, repeat dose study of 48 healthy female subjects is to assess the pharmacokinetics of proprietary formulations of both oral and topical Endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted in two parts based on route of administration.

Atossa has also now completed the transfer of its Fulvestrant Microcatheter Phase 2 study from Columbia University Medical Center Breast Cancer Programs, where the study was initiated, to Montefiore Medical Center, New York, NY.
"We are pleased to report that the study has been transferred to Montefiore, which is a nationally-ranked hospital," commented Dr. Quay. "While we cannot project the timing of completing enrollment in the study at this time, we look forward to providing updates as this clinical trial continues to advance," stated Dr. Quay.

The Fulvestrant Microcatheter Phase 2 study includes 30 women with ductal carcinoma in-situ (DCIS) or invasive breast cancer slated for mastectomy or lumpectomy. This study will assess the safety, tolerability and distribution of fulvestrant when delivered directly into breast milk ducts of these patients via microcatheters compared to those who receive the same product intramuscularly. The secondary objective of the study is to determine if there are changes in the expression of Ki67 as well as estrogen and progesterone receptors between a pre-fulvestrant biopsy and post-fulvestrant surgical specimen. Digital breast imaging before and after drug administration in both groups will also be performed to determine the effect of fulvestrant on any lesions as well as breast density of the participant. Six study participants will receive the standard intramuscular fulvestrant dose of 500 mg to establish the reference drug distribution, and 24 participants will receive fulvestrant by intraductal instillation utilizing Atossa’s proprietary microcatheter technology.