On December 22, 2016 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, reported results for its fourth quarter and fiscal year ended September 30, 2016 (Press release, Ohr Pharmaceutical, DEC 22, 2016, View Source [SID1234517168]).

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"Fiscal year 2016 was another highly productive year for Ohr, as we made significant progress in advancing both our lead candidate Squalamine for the treatment of wet AMD as well as our pipeline of sustained release drug candidates," said Jason Slakter, MD, Chief Executive Officer of Ohr. "Building off the Squalamine phase 2 results, we negotiated an SPA with the FDA in advance of commencing the pivotal phase 3 program. This comprehensive phase 3 program is now underway which, if successful, will position us to bring an innovative, meaningful treatment to market that has the potential to improve vision outcomes beyond current therapies and set a new standard of care in wet AMD."

Fiscal 2016 and Recent Corporate Highlights

Reached an agreement on a Special Protocol Assessment (SPA) with the US FDA on the design of Phase 3 trials for Squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102) for patients with wet AMD.
Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD.
Closed a public offering of shares of common stock and warrants resulting in net proceeds of approximately $6.9 million.
Fiscal 2016 Clinical and Development Program Highlights

In September, presented new data from the Phase 2 IMPACT study at the American Society of Retina Specialists (ASRS). Subjects with occult CNV <10mm2 achieved final mean visual acuity outcomes of 71.7 letters with Squalamine combination therapy compared to 67.4 letters with Lucentis monotherapy. The final mean visual acuity outcomes in the combination therapy group translates to approximately 20/40 vision (Snellen equivalent). This underscores the potential of Squalamine combination therapy to allow patients to reach higher levels of visual function and improve their overall quality of life.
In May, presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 sustained release in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference.
In April, commenced enrollment in the Phase 3 clinical development program investigating Squalamine as a treatment to improve visual acuity for patients with wet AMD.
The Phase 3 program includes two double-masked, placebo-controlled, multicenter, international studies of Squalamine administered topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
In November 2015, presented new data from the Phase 2 IMPACT Study in Wet-AMD at American Academy of Ophthalmology (AAO) Annual Meeting.
Data showed that the size of occult CNV at baseline, irrespective of a classic CNV component, was the most important factor in predicting treatment success with the combination of Squalamine plus Lucentis. This correlation was not seen in the Lucentis monotherapy group.
Also in November 2015, announced positive preclinical data in proprietary SKS sustained release technology.
In an animal model used to evaluate ophthalmic compounds, sustained supratherapeutic levels of active drug were achieved in target ocular tissues at all time points in the study.
The results serve as an important validation for the company’s SKS sustained release technology which holds the promise of improving the standard of care in a number of ocular conditions.
Financial Results for the Fiscal Year ended September 30, 2016

For the year ended September 30, 2016, the Company reported a net loss of approximately $25.8 million, or ($0.82) per share, compared to a net loss of approximately $15.2 million, or ($0.54) per share in the same period of 2015.
For the year ended September 30, 2016, total operating expenses were approximately $24.6 million, consisting of $7.7 million in general and administrative expenses, $16.5 million of research and development expenses, and $1.2 million in depreciation and amortization. This compares to total operating expenses of $17.8 million in the same period of 2015, comprised of approximately $7.5 million in general and administrative expenses, $8.8 million in research and development expenses, and $1.2 million in depreciation and amortization.
At September 30, 2016, the Company had cash and cash equivalents of approximately $12.5 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.
On December 7, 2016, the Company sold in a public offering, an aggregate of approximately 3,885,000 shares of its common stock, together with Series A common stock purchase warrants exercisable for up to an aggregate of approximately 1,942,500 shares of common stock and Series B common stock purchase warrants exercisable for up to an aggregate of approximately 3,885,000 shares of common stock. Net proceeds from the offering were approximately $6.9 million, after deducting placement agent fees and estimated offering expenses payable but excluding the proceeds, if any, from the exercise of the Series A and Series B Warrants issued in the offering.

On December 22, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative medicines and other technologies for targeting and treating cancer, reported that its independent Data Monitoring Committee (DMC) has completed review of an interim analysis of the Company’s ongoing Phase 3 clinical trial of its PSMA-targeted SPECT/CT imaging agent candidate, 99mTc-MIP-1404 (1404), and recommended that the trial continue (Press release, Progenics Pharmaceuticals, DEC 22, 2016, View Source [SID1234517186]).

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"The growing acceptance of active surveillance among men with lower-grade prostate cancer presents a significant opportunity for 1404 to enable clinicians and patients to accurately and non-invasively visualize and manage their disease," said Mark Baker, Chief Executive Officer of Progenics. "We are pleased that the DMC has determined that the trial should continue. The decision to undergo more invasive treatments, such as radical prostatectomy, is a difficult one for both patients and their families given the severity of potential side effects, and we look forward to the completion of this study as we work to introduce new and effective surveillance options."

This Phase 3 study enrolls patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. The study is designed to evaluate the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and sensitivity to identify patients with clinically significant disease.

Approximately 190 of a planned 450 patients have been enrolled in the trial to date.

A modification to the trial protocol has been proposed by the Company and agreed to by the U.S. Food and Drug Administration (FDA). The change permits patients with low to very low grade prostate cancer to participate in the trial without having to undergo a radical prostatectomy. In these patients, histopathology of tissues obtained from biopsies of those patients (rather than from radical prostatectomies) will be used as the truth standard in determining the specificity and sensitivity of 1404 imaging. The modification of the protocol was proposed in response to a lower percentage of patients enrolled in the trial having clinically insignificant disease, which is likely due to the emerging trend for more men with low-grade disease to use active surveillance for the management of their prostate cancer rather than undergo radical prostatectomy. The Company plans to monitor enrollment of patients based on the prevalence of clinical significant disease before determining whether any adjustment is needed to the sample size of the study.

Mr. Baker continued, "Our modification to the protocol reflects emerging trends among men with low grade disease to increasingly favor the use of active surveillance versus more aggressive measures, consistent with treatment guidelines. We believe that this shift underscores the potential for agents such as 1404 to address the growing active surveillance market. In addition, we expect that the protocol modification will allow for a better balance in the enrollment of subjects with clinically significant disease versus those with indolent disease, with the goal of evaluating the specificity of 1404 imaging to identify patients without clinically significant prostate cancer and the sensitivity of 1404 imaging to identify patients with clinically significant disease."

On December 22, 2016 Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, reported results for its fourth quarter and fiscal year ended September 30, 2016 (Press release, Ohr Pharmaceutical, DEC 22, 2016, View Source [SID1234517187]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"Fiscal year 2016 was another highly productive year for Ohr, as we made significant progress in advancing both our lead candidate Squalamine for the treatment of wet AMD as well as our pipeline of sustained release drug candidates," said Jason Slakter, MD, Chief Executive Officer of Ohr. "Building off the Squalamine phase 2 results, we negotiated an SPA with the FDA in advance of commencing the pivotal phase 3 program. This comprehensive phase 3 program is now underway which, if successful, will position us to bring an innovative, meaningful treatment to market that has the potential to improve vision outcomes beyond current therapies and set a new standard of care in wet AMD."

Fiscal 2016 and Recent Corporate Highlights

Reached an agreement on a Special Protocol Assessment (SPA) with the US FDA on the design of Phase 3 trials for Squalamine lactate ophthalmic solution, 0.2% ("Squalamine", also known as OHR-102) for patients with wet AMD.
Appointed David M. Brown, MD to serve as the chair of the Steering Committee for the Phase 3 clinical program of Squalamine in wet-AMD.
Closed a public offering of shares of common stock and warrants resulting in net proceeds of approximately $6.9 million.
Fiscal 2016 Clinical and Development Program Highlights

In September, presented new data from the Phase 2 IMPACT study at the American Society of Retina Specialists (ASRS). Subjects with occult CNV <10mm2 achieved final mean visual acuity outcomes of 71.7 letters with Squalamine combination therapy compared to 67.4 letters with Lucentis monotherapy. The final mean visual acuity outcomes in the combination therapy group translates to approximately 20/40 vision (Snellen equivalent). This underscores the potential of Squalamine combination therapy to allow patients to reach higher levels of visual function and improve their overall quality of life.
In May, presented two posters on the Squalamine Phase 2 IMPACT study and OHR3031 sustained release in vivo studies at the Association for Research in Vision and Ophthalmology (ARVO) Conference.
In April, commenced enrollment in the Phase 3 clinical development program investigating Squalamine as a treatment to improve visual acuity for patients with wet AMD.
The Phase 3 program includes two double-masked, placebo-controlled, multicenter, international studies of Squalamine administered topically twice a day in patients with newly diagnosed wet AMD, in combination with Lucentis injections.
The primary endpoint in both studies is a measurement of visual acuity gain at nine months, which is the most clinically meaningful endpoint for wet AMD patients. Subjects will be followed to two years for safety.
In November 2015, presented new data from the Phase 2 IMPACT Study in Wet-AMD at American Academy of Ophthalmology (AAO) Annual Meeting.
Data showed that the size of occult CNV at baseline, irrespective of a classic CNV component, was the most important factor in predicting treatment success with the combination of Squalamine plus Lucentis. This correlation was not seen in the Lucentis monotherapy group.
Also in November 2015, announced positive preclinical data in proprietary SKS sustained release technology.
In an animal model used to evaluate ophthalmic compounds, sustained supratherapeutic levels of active drug were achieved in target ocular tissues at all time points in the study.
The results serve as an important validation for the company’s SKS sustained release technology which holds the promise of improving the standard of care in a number of ocular conditions.
Financial Results for the Fiscal Year ended September 30, 2016

For the year ended September 30, 2016, the Company reported a net loss of approximately $25.8 million, or ($0.82) per share, compared to a net loss of approximately $15.2 million, or ($0.54) per share in the same period of 2015.
For the year ended September 30, 2016, total operating expenses were approximately $24.6 million, consisting of $7.7 million in general and administrative expenses, $16.5 million of research and development expenses, and $1.2 million in depreciation and amortization. This compares to total operating expenses of $17.8 million in the same period of 2015, comprised of approximately $7.5 million in general and administrative expenses, $8.8 million in research and development expenses, and $1.2 million in depreciation and amortization.
At September 30, 2016, the Company had cash and cash equivalents of approximately $12.5 million. This compares to cash and equivalents of approximately $28.7 million at September 30, 2015.
On December 7, 2016, the Company sold in a public offering, an aggregate of approximately 3,885,000 shares of its common stock, together with Series A common stock purchase warrants exercisable for up to an aggregate of approximately 1,942,500 shares of common stock and Series B common stock purchase warrants exercisable for up to an aggregate of approximately 3,885,000 shares of common stock. Net proceeds from the offering were approximately $6.9 million, after deducting placement agent fees and estimated offering expenses payable but excluding the proceeds, if any, from the exercise of the Series A and Series B Warrants issued in the offering.

On December 21, 2016 Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory and liver diseases, cancer, and sexual dysfunction, reported it has received its first payment of $500,000 from Chong Kun Dang Pharmaceuticals (CKD) (Korean Stock Exchange: 185750.KS) (Filing, 6-K, Can-Fite BioPharma, DEC 21, 2016, View Source [SID1234517146]). Can-Fite recently announced entering a distribution agreement with CKD for the exclusive right to distribute Namodenoson (CF102) for the treatment of liver cancer in South Korea, upon receipt of regulatory approvals, for up to $3,000,000 in upfront and milestone payments, plus royalties on net sales of 23%.

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"We are pleased to receive this upfront payment of $500,000 from CKD and look towards future potential milestone payments as we advance Namodenoson through completion of our current Phase II trial as a second line treatment for hepatocellular carcinoma and into Phase III," stated Can-Fite CEO Dr. Pnina Fishman.

Per the terms of the distribution agreement, Can-Fite will deliver finished product to CKD and CKD has a right of first refusal to distribute Namodenoson for other indications for which Can-Fite develops Namodenoson.

Can-Fite is currently conducting a global Phase II double-blind, placebo controlled study evaluating the efficacy of Namodenoson as a second-line treatment for advanced HCC. The primary endpoint is overall survival. In the coming quarters, Can-Fite intends to initiate a Phase II study of Namodenoson in the treatment of non-alcoholic fatty liver disease (NAFLD), the precursor to non-alcoholic steatohepatitis (NASH).

About Namodenoson (CF102)

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug. In Can-Fite’s pre-clinical and clinical studies, Namodenoson has demonstrated a robust anti-tumor effect via deregulation of the Wnt signaling pathway, resulting in apoptosis of liver cancer cells. Based on preclinical data showing Namodenoson has strong liver protective properties, Can-Fite intends to initiate a Phase II study in NASH. Can-Fite has received Orphan Drug Designation for Namodenoson in Europe and the U.S., as well as Fast Track Status in the U.S. as a second line treatment for hepatocellular carcinoma.

On December 21, 2016 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas" ) reported that it has completed the acquisition of Ganymed Pharmaceuticals AG ("Ganymed"), a biopharmaceutical company located in Mainz, Germany, and Ganymed has become a wholly owned subsidiary of Astellas as of CET December 20, 2016 (Press release, Astellas, DEC 21, 2016, View Source [SID1234517149]).

Under the agreement executed between Astellas and Ganymed’s shareholders, Astellas paid EUR 422 million to acquire 100% of the equity in Ganymed. In addition, Ganymed’s shareholders will become eligible to receive up to EUR 860 million in further contingent payments based on progress in the development of IMAB362, Ganymed’s most advanced clinical program.

Through the acquisition, Astellas will expand its oncology pipeline with antibody program in the late-stage to build upon its leading oncology franchise as a platform for sustainable growth.

Astellas is still reviewing the impact of the completion of the acquisition on its financial results for the fiscal year ending March 31, 2017.

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