On March 15, 2016 Diffusion Pharmaceuticals Inc. (OTCQX: DFFN), a clinical stage biotechnology company focused on the development of novel small molecule therapeutics for cancer, reported the online publication of a reviewed article on RES-529 ahead of print in Anti-Cancer Drugs (Press release, Diffusion Pharmaceuticals, MAR 15, 2016, View Source [SID:1234509556]).

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Diffusion Pharmaceuticals recently acquired RES-529, a novel PI3K/AKT/mTOR pathway inhibitor that targets both mTORC1 and mTORC2 through mTOR complex dissociation, from RestorGenex Corporation at the closing of its reverse merger on January 8, 2016. RES-529 is being developed for oncology and ophthalmology with a primary focus in the treatment of glioblastoma multiforme (GBM). Orphan drug designation has been granted by the FDA for this indication.

The article entitled "RES-529: a PI3K/AKT/mTOR pathway inhibitor that dissociates the mTORC1 and mTORC2 complexes," reviews the potential of RES-529 to inhibit tumorigenesis in glioblastoma, prostate cancer, and breast cancer. RES-529 treatment has been shown to be effective in preclinical models of glioblastoma as well as synergistic with radiation therapy in these models. In preclinical models of prostate cancer, RES-529 has been shown to be synergistic with all three common modalities of treatment: radiation therapy, chemotherapy, and hormonal therapy. The article was authored by Mark Weinberg, MD, MBA, who was previously Senior VP of Clinical Development at RestorGenex.

David Kalergis, Chairman and Chief Executive Officer of Diffusion Pharmaceuticals, said, "The acquisition of RES-529 has strengthened our oncology pipeline. Concurrent with our primary focus of advancing our lead candidate, trans sodium crocetinate (TSC), into a Phase III clinical program in GBM and a Phase II/III trial in pancreatic cancer, we are also assessing the future opportunities and plans for RES-529."

On March 15, 2016 Calithera Biosciences, Inc. (Nasdaq:CALA), a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported its financial results for the fiscal fourth quarter and year ended December 31, 2015 (Press release, Calithera Biosciences, MAR 15, 2016, View Source;p=RssLanding&cat=news&id=2148507 [SID:1234509553]). As of December 31, 2015, cash, cash equivalents and investments totaled $71.9 million.

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"In 2015, we made significant progress executing on our clinical development plan for CB-839, enrolling several monotherapy cohorts on our Phase 1 trials, while remaining on track with our IND-enabling studies for our immunotherapy arginase inhibitor, CB-1158, all while advancing internal preclinical programs," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "Looking forward to 2016, we expect to highlight new clinical data and scientific progress at oncology meetings, including CB-839 Phase 1b updates from our ongoing trials, dosing CB-839 in combination with other therapies. This is expected to occur initially in the second quarter of 2016, with further updates in the second half of the year. In addition, we plan on initiating a clinical trial of CB-839 in combination with a checkpoint inhibitor by mid-year. Our arginase inhibitor, CB-1158, is progressing towards the clinic with an IND filing expected mid-year."

Fourth Quarter 2015 and Recent Highlights

CB-839 clinical date presented at major medical meetings. The three phase I clinical trials with CB-839 in solid tumors and hematological malignancies continued to enroll throughout 2015, with 184 patients enrolled as of January 2016, across the three trials. New data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC meeting in November demonstrate stable disease across a variety of tumor types, as well as a single agent partial response in a renal cell carcinoma (RCC) patient. This patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases. Among the fifteen evaluable patients with RCC, nine (60%) had stable disease or better, with stable disease lasting three cycles (63 days). Among efficacy-evaluable patients across a range of tumor types treated on the current dosing schedule of twice-daily, 22 of 50 patients (44%) experienced stable disease or better. Five stable disease patients currently on study have been treated with CB-839 for over 8 months without progression (2 triple negative breast cancer, 1 RCC, 1 mesothelioma and 1 IDH1 mutant chondrosarcoma). In addition, the first results of CB-839 dosed in combination therapy were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December.

Arginase inhibitor CB-1158 preclinical data presented at the AACR (Free AACR Whitepaper)-NCI-EORTC Meeting. CB-1158, a highly selective, orally bioavailable, small molecule inhibitor of human arginase with nanomolar potency, demonstrated single agent efficacy in animal models. Inhibition of tumor growth was accompanied by a rapid increase in the local concentration of arginine, and the induction of multiple pro-inflammatory changes in the tumor microenvironment. CB-1158, when administered with anti-CTLA-4, increased CD8+ T-cell infiltrates in the tumor. The addition of CB-1158 to anti-CTLA-4 and anti-PD-1, significantly inhibited tumor growth in a mouse model that was resistant to dual checkpoint inhibitor therapy. CB-1158 was well tolerated as a single agent and in combination with checkpoint inhibitors in animal studies.

Selected Fourth Quarter and Year-end 2015 Financial Results

Cash, cash equivalents and investments totaled $71.9 million at December 31, 2015 compared with $102.0 million at December 31, 2014.

Research and development expenses for the full year 2015 were $23.7 million, compared with $16.4 million in the prior year. The increase of $7.4 million in 2015 was primarily attributed to higher expenses associated with Calithera’s arginase inhibitor program, including the selection of CB-1158 and its advancement through preclinical development, and continued enrollment of CB-839, Calithera’s first-in-class glutaminase inhibitor, in phase 1 clinical trials. Calithera expects to file an IND for the arginase inhibitor program mid-2016. Research and development expenses for the fourth quarter of 2015 were $5.8 million, compared to $5.0 million for the same period last year.

General and administrative expenses for the full year 2015 were $9.1 million, compared with $5.4 million in the prior year. The increase of $3.7 million in 2015 was primarily due to higher employment related expenses, including stock based compensation expense, and professional service fees relating to Calithera’s costs associated with operating as a publicly traded company. General and administrative expenses for the fourth quarter of 2015 were $2.3 million, compared to $1.9 million for the same period last year.

Loss from operations for the three months and year end ended December 31, 2015 was $8.1 million and $32.6 million, respectively.

Financial Guidance for 2016

Calithera expects that its cash, cash equivalents and investments will be at least $35 million at the end of 2016, exclusive of any funds arising from new collaborations or partnerships, equity financings or other new sources.

On March 15, 2016 Fortress Biotech, Inc. (NASDAQ: FBIO) announces its financial results for the fourth quarter and year ended December 31, 2015 (Filing, Q4/Annual, Fortress Biotech, 2015, MAR 15, 2016, View Source [SID:1234509552]).

Dr. Lindsay A. Rosenwald, Fortress Biotech’s Chairman, President and CEO, said, "2015 was a transformational year for Fortress Biotech both strategically and operationally. We continued to make progress executing our unique business plan of creating a portfolio of marketed and development-stage products under one umbrella. We believe this combination will enhance shareholder value. As a result of our aggressive efforts in 2015, Fortress Biotech now has several subsidiaries, or Fortress Companies, focused on a number of important, growing therapeutic areas. We plan to expand the number of Fortress Companies and expect to see continued advancement of our current pipeline as well as revenue growth in 2016 and beyond."

Financial Highlights:

· At December 31, 2015, Fortress Biotech’s consolidated cash and marketable securities totaled $98.2 million compared to $65.5 million at September 30, 2015 and $69.8 million at December 31, 2014, an increase of $32.7 million for the fourth quarter and an increase of $28.4 million for the year. This total excludes restricted cash of $14.6 million.
· Revenue totaled $0.9 million at December 31, 2015.
· License acquisitions totaled $11.4 million for the year ended December 31, 2015.
· Research and development expenses were $18.4 million for the year ended December 31, 2015, compared to $10.2 million for 2014. Noncash stock-based compensation expenses included in research and development were $5.8 million for the year ended December 31, 2015 and $1.1 million for 2014.
· General and administrative expenses were $21.6 million for the year ended December 31, 2015, compared to $10.4 million for 2014. Noncash stock-based compensation expenses included in general and administrative expenses were $8.5 million for the year ended December 31, 2015 and $4.4 million for 2014.
· For the year ended December 31, 2015, Fortress Biotech reported a net loss of $48.4 million, or $1.24 per share, compared to a net loss of $20.4 million, or $0.56 per share, for 2014.

Recent Corporate Events:

Avenue Therapeutics, Inc.
· In February 2015, Fortress Biotech purchased an exclusive license to an intravenous formulation of Tramadol for the U.S. market from Revogenex Ireland Limited. Fortress transferred the license and rights to Avenue during the first quarter of 2015.

Checkpoint Therapeutics, Inc.
· In March 2015, Checkpoint Therapeutics, Inc. ("Checkpoint") licensed a portfolio of fully human immuno-oncology targeted antibodies generated at the Dana-Farber Cancer Institute ("Dana Farber"). The portfolio includes antibodies targeting programmed-death ligand 1 ("PD-L1"), glucocorticoid-induced TNFR-related protein ("GITR") and carbonic anhydrase 9 ("CAIX"). Additionally, Fortress assigned its license from NeuPharma, Inc. for a small molecule inhibitor of epidermal growth factor receptor mutations to Checkpoint, effective March 2015.

· In connection with the license agreement with Dana-Farber, Checkpoint entered into a collaboration agreement with TG Therapeutics, Inc. ("TGTX") to develop and commercialize the Anti-PD-L1 and Anti-GITR antibody research programs in the field of hematological malignancies. Further, in connection with the NeuPharma license, Checkpoint entered into an option agreement with TGTX for a global collaboration in connection with the future development of the certain licensed compounds. Both programs are currently in preclinical development.
· In December 2015, Checkpoint licensed the exclusive worldwide rights to develop and commercialize a PARP (poly (ADP-ribose) polymerase) inhibitor from Teva Pharmaceutical Industries Ltd.’s subsidiary, Cephalon, Inc.
· Also in 2015, Checkpoint raised net proceeds of approximately $51.5 million from a series of private placement financings.

Escala Therapeutics, Inc.
· In July 2015, Escala Therapeutics, Inc. acquired from New Zealand Pharmaceuticals Limited a license from the National Institutes of Health and cooperative research and development agreements for the development of oral N-acetyl-D-mannosamine, a key compound in the sialic biosynthetic pathway for the treatment of hyposialylation disorders, including GNE myopathy and various forms of nephropathy.

Helocyte, Inc.
· In April 2015, Helocyte, Inc. ("Helocyte") entered into an agreement with the City of Hope National Medical Center ("COH") to secure exclusive worldwide rights for two T-cell immunotherapeutic vaccines, known as Triplex and PepVax, for controlling cytomegalovirus ("CMV") in allogeneic hematopoietic stem cell transplant ("HSCT") and solid organ transplant recipients. Triplex entered into a Phase 2 clinical study in February 2016 and PepVax is expected to enter Phase 2 clinical studies later this year. Both programs are supported by grants paid and payable to COH from the National Cancer Institute.
· In connection with the licensing of Triplex and PepVax, Helocyte further entered into an option agreement with COH for exclusive worldwide rights to Pentamer, a universal immunotherapeutic vaccine being developed for the prevention of CMV transmission in utero, and exercised this option on April 28, 2015.
· In December 2015, the results of the PepVax Phase 1b study in allogeneic HSCT CMV(+) recipients were published in Lancet Haematology.
· In February 2016, Helocyte entered into a Clinical Trial Agreement with the COH to support a Phase 2 Study of its Triplex vaccine for CMV control in allogeneic stem cell transplant recipients. The Phase 2 study is additionally supported by grants from the National Institutes of Health / National Cancer Institute. Helocyte expects data to emerge from this Phase 2 study in the first half of 2017.

Journey Medical Corporation
· In March 2015, Journey Medical Corporation ("JMC") entered into a license and supply agreement to acquire rights to distribute a dermatological product for the treatment of acne.
· In October 2015, JMC entered into a co-promotion agreement to sell a 2% topical lotion, Dermasorb HC, for the treatment of corticosteroid-responsive dermatoses.
· In January 2016, JMC entered into a product license and supply agreement with a third party to distribute a topical cream to promote wound healing for surgical treatments such as cryosurgery, Mohs surgery and biopsies.
· Additionally in January 2016, JMC entered into a distribution agreement with a third party to promote an emollient for the treatment of eczema.
· Both new products will be marketed under the Journey brand.

Mustang Bio, Inc.
· In March 2015, Fortress formed Mustang Bio, Inc. ("Mustang") to develop immunotherapies based on Chimeric Antigen Receptor T-Cells ("CAR-T") and Mustang entered into a license agreement with the COH to acquire such technology. In connection with the license agreement, Mustang also entered into a sponsored research agreement with COH in which Mustang will fund continued research at COH related to CAR-T.
· In the second half of 2015, Mustang entered the clinic with novel CAR-T studies for brain tumors and acute myeloid leukemia.

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On March 15, EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS), a pure-play biosimilar company focused on the global development and commercialization of biosimilar monoclonal antibodies (mAbs), reported financial results for the fourth quarter and fiscal year of 2015, and provided a business update (Press release, Epirus Biopharmaceuticals, MAR 15, 2016, View Source [SID:1234509549]).

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"During 2015, we made significant progress on our strategy of efficiently developing high quality biosimilars that will allow more people globally to benefit from biologic innovation," stated Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. "We added new product candidates to our pipeline, acquired the Bioceros technical platform, completed several early launch market regulatory submissions and, through partnerships, expanded our global commercial network which now enables us to access over 70 markets. EPIRUS is well positioned in the market as physicians, patients and payers look for innovative market-based solutions to address the problem of high drug costs."

"We are off to a strong start in 2016 with the initiation of UNIFORMi, the pivotal Phase 3 global registration study for BOW015 (infliximab, reference biologic Remicade) designed to support our filings anticipated in 2017 for marketing approval in Europe and North America. In 2016, we plan to continue to increase the number of patients treated with BOW015, which we expect will help support regulatory filings and provide valuable in-market experience as we continue to make BOW015 available globally. We will also focus on completing BOW050 (adalimumab, reference biologic Humira) process lock and initiating the global registration program, identifying our U.S. commercialization strategy and planning for management of cost of goods sold through efficient manufacturing and supply chain strategies."

Key Accomplishments

Initiated UNIFORM, a 58-week, double-blind, one-to-one randomized, comparator-controlled multi-center global study, to compare efficacy, safety and immunogenicity and demonstrate clinical equivalence of BOW015 with Remicade in active Rheumatoid Arthritis (RA) patients

Submitted regulatory applications for marketing authorization of BOW015 in multiple Southeast Asian and Latin American countries
Advanced programs for six product candidates, including preparing for pivotal Phase 3 global clinical study of BOW050 (adalimumab, reference biologic Humira)

Established distribution access to over 70 global markets through partnerships with Polpharma Group, mAbxience, Sun Pharma and Livzon

Expanded biosimilar pipeline, product development capabilities and experienced management team and staff through the acquisition of privately-held Bioceros Holdings B.V.

Summary Financial Results

Cash and cash equivalents and marketable securities, collectively "cash," totaled $31.5 million at December 31, 2015. The Company is in the process of evaluating various financing alternatives for operations, by raising additional capital through equity or debt financings or entering into collaboration agreements.

Fourth Quarter 2015 Financial Highlights

Revenue totaled approximately $285,000 for the fourth quarter of 2015, compared to $4,000 for the fourth quarter of 2014. The revenue in 2015 related to collaboration revenue under the Polpharma agreement of $185,000, royalties and milestones under the Sun Pharmaceutical agreement of $44,000, and $56,000 related to development service revenues from the recently acquired Bioceros subsidiary in the Netherlands.

Research and development (R&D) expenses totaled $10.6 million for the fourth quarter of 2015, compared to $4.8 million for the fourth quarter of 2014, an increase of $5.8 million. The increase was driven by increased development expenses, including headcount, related to BOW015 and BOW050.

General and administrative (G&A) expenses totaled $5.8 million for the fourth quarter of 2015, compared to $5.4 million for the fourth quarter of 2014, an increase of $0.4 million. The increase was primarily driven by increased headcount and related costs, offset in part by a gain of $0.6 million related to a change in the contingent consideration related to the Bioceros acquisition.

Other income and tax (expense), net totaled $0.7 million for the fourth quarter of 2015, compared to $(0.2) million for the fourth quarter of 2014, an increase of $0.9 million. The increase was driven by a gain of $1.0 million related to the sale of our Canadian subsidiary, offset in part by increased interest expense of $0.1 million.

Net loss was $15.4 million for the fourth quarter of 2015, compared to $10.4 million for the fourth quarter of 2014.

Fiscal 2015 Financial Highlights

Revenue totaled $576,000 in 2015, compared to $4,000 in 2014. The revenue in 2015 related to collaboration revenue under the Polpharma agreement of $235,000, royalties and milestones under the Sun Pharmaceutical agreement of $155,000 and $186,000 related to development service revenues from the recently acquired Bioceros subsidiary in the Netherlands.

Research and development (R&D) expenses totaled $31.0 million in 2015, compared to $16.3 million in 2014, an increase of $14.7 million. The increase was driven by increased development expenses, including headcount, related to BOW015 and BOW050, as well as an impairment charge related to the Z944 intangible asset of $1.7 million and a one-time $1.8 million commitment charge for commercial batches of BOW015.

General and administrative (G&A) expenses totaled $21.9 million in 2015, compared to $23.0 million in 2014, a decrease of $1.1 million. The decrease was primarily due to costs incurred in the third quarter of 2014 related to severance of former Zalicus employees of $1.8 million, professional fees related to becoming a public company of $2.1 million and a gain of $0.6 million related to a change in the contingent consideration related to the Bioceros acquisition, offset in part by increased headcount and related costs and a one-time settlement fee of $2.2 million related to the RLS Settlement Agreement recorded in the second quarter of 2015.

Other income and tax (expense), net totaled $0.1 million in 2015, compared to $(2.6) million in 2014, an increase of $2.7 million. The increase was primarily driven by reduced interest expense as a result of the conversion of convertible notes in March and April 2014 of $2.4 million, a gain of $1.0 million related to the sale of the Company’s Canadian subsidiary and an income tax benefit of $0.5 million resulting from the asset impairment and amortization of deferred taxes partially offset in part by interest on debt entered into in the third quarter of 2014 of $1.3 million.

Net loss was $52.2 million in 2015, compared to $41.8 million in 2014.

Pipeline Status Update

BOW015 (infliximab, reference biologic Remicade) — Global Phase 3 registration study initiated in February 2016 for BOW015 in active RA patients; harmonized global filing anticipated in 2017.

BOW050 (adalimumab, reference biologic Humira) — Harmonized global filing anticipated in 2018.

BOW070 (tocilizumab, reference biologic Actemra) — Harmonized global filing anticipated in 2019.

BOW080 (eculizumab, reference biologic Soliris) – Harmonized global filing anticipated in 2020.

BOW090 (ustekinumab, reference biologic STELARA) – Harmonized global filing anticipated in 2021.

BOW100 (golimumab, reference biologic SIMPONI) – Harmonized global filing anticipated in 2022.

On March 15, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported the results from the second pivotal clinical validation study for the myPath Melanoma test at the 2016 USCAP Annual Meeting in Seattle, Wash (Press release, Myriad Genetics, MAR 15, 2016, View Source [SID:1234509543]).

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"There is significant emotional distress associated with a melanoma diagnosis and doctors want to provide their patients with accurate information," said Loren Clarke, M.D., medical director, Myriad Genetic Laboratories. "We’re developing the myPath Melanoma test to help pathologists improve the diagnosis of melanoma, particularly for patients with difficult-to-diagnose skin lesions."

In the study with 736 patients, the myPath Melanoma test effectively diagnosed suspicious lesions with greater than 90 percent diagnostic accuracy, 91.5 percent sensitivity and 92.5 percent specificity. This second validation is consistent with the first validation study with 437 patients that demonstrated a diagnostic accuracy of greater than 90 percent.

"myPath Melanoma is an extremely robust diagnostic test with unmatched clinical validity data, having completed the largest clinical validation study for a melanoma diagnostic test," said Clarke. "We have now demonstrated in two pivotal validation studies that myPath Melanoma accurately differentiates patients with melanoma from those with benign moles."

The Company also announced that it will present new data on its myPlan Lung Cancer prognostic test at USCAP. Details about the featured Myriad presentations at USCAP are below. Follow Myriad on Twitter via @MyriadGenetics and stay up-to-date by using the hashtag #USCAP16.

myPath Melanoma Poster Presentation

Title: An independent validation of a gene expression signature to differentiate malignant melanoma from benign melanocytic nevi.
Date: Tuesday, March 15, 2016: 1:00 to 4:30 p.m. PT.
Location: Poster 84.
Presenter: Hillary Kimbrell, M.D., Myriad Genetic Laboratories.
In this clinical validation study, 736 melanocytic lesions, diagnosed as either benign or malignant by a panel of three expert dermatopathologists, were evaluated using the myPath Melanoma gene expression test. The results showed that the myPath Melanoma test differentiated malignant melanoma from benign nevi with a sensitivity of 91.5 percent and specificity of 92.5 percent. These findings were consistent across melanoma subtypes. There were several instances where the myPath test score differed from the pre-test diagnosis, causing the dermatopathologists to revise their initial diagnosis. These findings demonstrate the ability of the myPath Melanoma test to help diagnose cases of melanoma in samples representative of those seen in routine clinical practice.

myPlan Lung Cancer Poster Presentation

Title: Cell cycle progression score is a promising predictor of recurrence in primary lung carcinoid tumors.
Date: Monday, March 14: 1:00 to 4:30 p.m. PT.
Location: Poster 1874.
Presenter: Neda Kalhor, M.D., MD Anderson Cancer Center.
This exploratory study evaluated the cell cycle progression (CCP) score in pulmonary carcinoid tumors resected at the MD Anderson Cancer Center. The study cohort included 93 patients, including 79 with typical carcinoids (TC) and 14 with atypical carcinoids (AC). The results showed a significant association between the CCP score and recurrence free survival (RFS) in this cohort. These early findings suggest the CCP score may help in effective stratification of primary lung carcinoids to identify high-risk tumors that may require adjuvant therapy.

About myPath Melanoma
myPath Melanoma is a clinically validated gene expression test designed to differentiate malignant melanoma from benign nevi across all major melanoma subtypes. Myriad myPath Melanoma is a unique test of 23 genes that provides valuable, additive diagnostic information unavailable from any other method — information that can help physicians deliver a more confident diagnosis. View Source

About Myriad myPlan Lung Cancer
Myriad myPlan Lung Cancer is a molecular prognostic test that measures the expression levels of cell cycle progression genes to provide an accurate assessment of cancer aggressiveness in patients with early-stage non-small cell lung adenocarcinoma. For more information visit: View Source