Bristol-Myers Squibb Announces Dividend

On March 3, 2016 the Board of Directors of Bristol-Myers Squibb Company (NYSE:BMY) reported a quarterly dividend of thirty-eight cents ($0.38) per share on the $.10 par value Common Stock of the corporation (Press release, Bristol-Myers Squibb, MAR 3, 2016, View Source [SID:1234509367]). The next quarterly dividend will be payable on May 2, 2016, to stockholders of record at the close of business on April 1, 2016.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The directors also declared a quarterly dividend of fifty cents ($0.50) per share on the $2.00 Convertible Preferred Stock of the corporation, payable June 1, 2016 to stockholders of record at the close of business on May 10, 2016.

8-K – Current report

On March 3, 2016 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported business highlights and financial results for the fourth quarter and full year ended December 31, 2015 (Filing, Q4/Annual, Fate Therapeutics, 2015, MAR 3, 2016, View Source [SID:1234509372]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"During this past year, we significantly advanced our long-term corporate strategy, successfully building a ground-breaking preclinical pipeline of programmed adoptive immunotherapies, including a NK-cell therapy for solid tumors, a CD34+ cell therapy for autoimmune diseases and off-the-shelf cancer therapies derived from engineered pluripotent cell lines. We also formed a strategic research collaboration with Juno Therapeutics, leveraging our expertise in hematopoietic cell biology and ex vivo cell programming, to enhance the therapeutic function of Juno’s engineered T-cell immunotherapies," said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. "We have continued this momentum into 2016, having secured FDA clearance to conduct a Phase 1/2 clinical trial of ProTmune, and we look forward to safety and efficacy data from this trial during 2016. Finally, we will begin sharing data across our entire preclinical pipeline at industry-leading scientific conferences during the first half of 2016."
Recent Highlights

• FDA Clearance of IND Application for ProTmune Phase 1/2 Study. In January 2016, Fate Therapeutics announced that its Investigational New Drug (IND) application for ProTmune (FT1050-FT4145 programmed mobilized peripheral blood cells) was cleared by the U.S. Food and Drug Administration (FDA). The Company expects to commence enrollment of a multi-center, randomized, controlled Phase 1/2 clinical trial of ProTmune for the prevention of acute graft-versus-host disease (GvHD) and cytomegalovirus (CMV) infection in mid-2016, both of which are severe life-threatening immunological conditions with no approved FDA therapies.

• ProTmune Preclinical Data Highlighted at 2015 American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting (ASH) (Free ASH Whitepaper) and 2016 BMT Tandem Meetings. Fate Therapeutics presented ProTmune preclinical data demonstrating that FT1050-FT4145 programmed immune cells reduce acute GvHD and retain anti-tumor, or graft-versus-leukemia (GvL), activity in vivo. Acute GvHD is a leading cause of morbidity and mortality in patients undergoing allogeneic HCT, and therapeutic strategies aimed at addressing GvHD that suppress or deplete the immune system can compromise or eliminate T cells, often leading to severe infections and disease relapse. GvL activity is critical to eradicating residual cancer and realizing the curative potential of allogeneic HCT.
• Pluripotent Cell Platform for Off-the-Shelf NK- and T-Cell Cancer Immunotherapies Highlighted at 2015 ASH (Free ASH Whitepaper) Meeting. Fate Therapeutics presented the Company’s patent-protected, pluripotent cell platform, which combines genetic engineering of pluripotent cells with rapid and efficient generation of immune cells, for developing off-the-shelf engineered cancer immunotherapies without requiring patient-sourced cells. Highlighted features of this platform include the precise integration of multiple genetic modifications into pluripotent cells, the efficient expansion of engineered pluripotent cell clones, and the derivation of CD34+ cells, NK cells and T cells using well-defined, small molecule-driven protocols.

• Patent Position Covering Pluripotent Cell Platform Significantly Expanded. In 2015, Fate Therapeutics and its exclusive licensors were granted 21 patents covering induced pluripotent cell technology, extending its formidable position to include over 60 issued patents and 90 pending patent applications. Most notably, in October 2015, the U.S. Patent and Trademark Office issued U.S. Patent No. 9,169,490 providing broad protection for cell compositions expressing a sufficient amount of octamer-binding transcription factor 4 (Oct4) to enable pluripotency. The production of Oct4 protein within a cell is critical to generate highly-stable, genetically-modified, clonal pluripotent cell lines for use in the unlimited production of off-the-shelf engineered cell therapies.

• NK- and CD34+ Cell Immunotherapy Collaborations Formed with Leading Medical Institutions. In July 2015, Fate Therapeutics entered into a multi-year agreement with the University of Minnesota, under which the Company is advancing toward clinical development an Adaptive NK-cell cancer immunotherapy for solid tumors in collaboration with Dr. Jeffrey Miller, M.D., Professor of Medicine and Deputy Director, University of Minnesota Cancer Center. Additionally, in June 2015, the Company entered into a multi-year research agreement with Boston Children’s Hospital to develop an immuno-regulatory CD34+ cell therapy, which is currently being assessed in several preclinical models of T cell-mediated immune dysfunction.

• Juno Therapeutics Strategic Research Collaboration Formed to Program T-Cell Immunotherapies. In May 2015, the Company entered into a research collaboration and license agreement with Juno Therapeutics, Inc. to identify small molecule modulators that enhance the therapeutic function of genetically-engineered chimeric antigen receptor (CAR) T-cell and T-cell receptor (TCR) immunotherapies. Under the collaboration, Juno paid the Company an upfront fee of $5.0 million, purchased one million shares of the Company’s common stock at $8.00 per share, and agreed to fund all of the Company’s collaboration activities. For the first five therapies developed by Juno that incorporate modulators identified through the collaboration, the Company is eligible to receive approximately $500 million upon the achievement of various clinical, regulatory and commercial milestones, plus royalties on net sales.
Upcoming Anticipated Milestones

• First patient to be administered ProTmune in Phase 1 stage of Phase 1/2 clinical trial in mid-2016

• Adaptive NK Cell cancer immunotherapy program update (The Innate Killer Summit, May 16-18, 2016, San Diego, CA)

• Programmed CD34+ Cell immuno-regulatory program update (American Diabetes Association’s 76th Scientific Sessions, June 10-14, 2016, New Orleans, LA)

• Off-the-Shelf, pluripotent cell-derived NK- and T-Cell cancer immunotherapy program updates (International Society for Stem Cell Research, June 22-25, 2016, San Francisco, CA)
• First patient to be administered ProTmune in Phase 2 stage of Phase 1/2 clinical trial in the fourth quarter of 2016

• Data update from Phase 1/2 ProTmune clinical trial (American Society of Hematology, December 3-6, 2016, San Diego, CA)
Financial Results & Guidance

• Cash Position: Cash and cash equivalents as of December 31, 2015 were $64.8 million, compared to $49.1 million as of December 31, 2014. The increase is primarily driven by net proceeds from the Company’s public offering of common stock in May 2015 and cash generated from entering into a research collaboration and license agreement with Juno Therapeutics in May 2015, offset by cash used to fund operating activities.

• Total Revenue: Revenue was $1.1 million for the fourth quarter of 2015 and $2.4 million for the year ended December 31, 2015. All revenue was derived from the Company’s collaboration with Juno.

• Total Operating Expenses: Total operating expenses were $8.0 million for the fourth quarter of 2015 and $30.2 million for the year ended December 31, 2015, compared to $5.9 million and $24.9 million in the comparable periods in 2014. Operating expenses for the fourth quarter of 2015 include $0.5 million of stock compensation expense, compared to $0.6 million for the fourth quarter of 2014.

• R&D Expenses: Research and development expenses were $5.4 million for the fourth quarter of 2015 and $19.9 million for the year ended December 31, 2015, compared to $3.9 million and $16.4 million in the comparable periods in 2014. The increase in R&D expenses is primarily related to an increase in third-party professional consultant and service provider fees to support the clinical development of our product candidates, and an increase in personnel expenses, including stock-based compensation expense, resulting from additional headcount to support the conduct of research activities.

• G&A Expenses: General and administrative expenses were $2.6 million for the fourth quarter of 2015 and $10.4 million for the year ended December 31, 2015, compared to $2.1 million and $8.5 million in the comparable periods in 2014. The increase in G&A expenses is primarily related to an increase in personnel expenses, including stock-based compensation expense, and an increase in costs related to our intellectual property portfolio.

• Common Shares Outstanding: Common shares outstanding as of December 31, 2015 were 28.7 million compared to 20.6 million as of December 31, 2014. Common shares outstanding increased primarily as a result of the 6.9 million shares of the Company’s common stock issued pursuant to the May 2015 financing, and the 1.0 million shares of the Company’s common stock issued and sold to Juno pursuant to the collaboration.

• Financial Guidance: The Company expects 2016 net cash burn to be between $38 million and $42 million.

Autolus Limited secures £40 million funding

On March 3, 2016 UCLB spinout, Autolus Limited, a biopharmaceutical company focused on the development and commercialisation of next-generation engineered T-cell therapies for haematological and solid tumours, reported that it has raised £40 million of new capital in a Series B financing round (Press release, UCLB, MAR 3, 2016, View Source [SID:1234509353]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Woodford Investment Management LLP ("Woodford") and Perceptive Bioscience Investments Ltd ("Perceptive Bioscience") participated in the new investment, which augments the previous £30 million Seed and Series A investment from founding investor Syncona LLP ("Syncona").

The funds will enable Autolus to develop its proprietary pipeline of engineered T-cell products, and to further implement its industry-leading platform of T-cell programming technologies. In parallel with the financing, the Company’s technology platform was enhanced by a licence to additional technologies from UCLB, UCL’s technology transfer company.

In association with the financing, Dr Joe Anderson, Chief Executive Officer of Perceptive Bioscience, has joined the board of directors of Autolus.

Dr Christian Itin, Chairman of Autolus, said:
"We are pleased to welcome investors of the calibre of Woodford Investment Management and Perceptive Bioscience, which support our goal of building Autolus into a leading engineered T-cell company. The quality of Autolus’ technology and pipeline has allowed the company to raise £70m since its foundation in September 2014, and positions us to take multiple programmes into the clinic. We have also expanded the scope of our licence with UCLB to bring additional inventions from founder Dr Martin Pule’s group into the company adding to the suite of Autolus’ T-cell programming technologies."

Dr Joe Anderson, CEO of Perceptive Bioscience, added:
"We are delighted that Perceptive Bioscience’s first investment is in a company with the potential to transform cancer therapy. Autolus is at the cutting-edge of T-cell engineering to create a new generation of programmed T-cells acting as agents to kill tumour cells. Our investment in Autolus underlines our commitment to supporting emerging, innovative companies. Our flexible investment platform enables us to assist companies with finance and practical support whatever their stage of development."

Dr Martin Murphy, CEO of Syncona, said:
"We are excited that Woodford and Perceptive have invested in Autolus. The company is now funded by a group of investors that share our vision of creating sustainable standalone businesses that will develop products designed to deliver exceptional benefit to patients in areas of high unmet need."

Cengiz Tarhan, Managing Director of UCLB, commented:
"We are delighted to support this significant milestone in Autolus’ development. The licence and the commitment from Syncona, Woodford and Perceptive Bioscience provide a solid foundation to translate the licensed UCL technologies into healthcare benefits for patients."

Autolus is founded upon the work of Dr Martin Pule, an academic clinical haematologist at the UCL Cancer Institute and NIHR University College London Hospitals Biomedical Research Centre and a thought-leader in T-cell engineering. It is a next-generation engineered T-cell company, developing a series of T-cell products based on its proprietary targets, constructs and technologies.

Endocyte Reports Fourth Quarter and Year End 2015 Financial Results and Provides Clinical and Pipeline Update

On March 02, 2016 Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small molecule drug conjugates (SMDCs) and companion imaging agents for personalized therapy, reported financial results for the fourth quarter ended December 31, 2015, and provided a clinical update (Press release, Endocyte, MAR 2, 2016, View Source [SID:1234509345]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2015 laid the groundwork for what we expect to be an important year for Endocyte in 2016. After establishing strong proof of concept data with our first generation SMDC vintafolide, the advancements we’ve made with our second generation agents will be tested this year in patients selected by our companion imaging agents," said Ron Ellis, Endocyte’s president and chief executive officer. "These advancements include enhanced potency, higher dosing, extended drug circulation, and improved patient selection criteria enabled by more advanced imaging equipment now widely available. We look forward to providing updates on the efficacy and safety of these agents in targeted patients before the end of the year, as well as on exciting progress on the earlier-stage pipeline, including two new clinical development candidates."

"Having treated more than 60 patients with EC1456 and EC1169, we have been very pleased with the safety profile for both agents. Considering the potency of the warhead we are delivering, this speaks to the stability of the SMDCs and their specificity in targeting diseased cells," commented Alison Armour M.D., Endocyte’s Chief Medical Officer. "We are of course looking forward to reaching optimal dosing and begin evaluation of these agents in patients selected by our companion imaging agents. In the meantime, the imaging team has done some great work advancing the criteria for selecting patients."

EC1456 (Folate-targeted tubulysin) Development

Endocyte outlined the next phase of development for EC1456.

Dose escalation is underway, currently evaluating 2 schedules
Once maximum tolerated dose is determined, these schedules will be evaluated in up to 40 second-line non-small cell lung cancer (NSCLC) patients selected with EC20 imaging with all FR-positive disease
Response rates will be assessed after 15 patients enroll on each schedule to trigger the potential expansion of each cohort to 40
As the optimal schedule becomes evident, cohorts with new indications and combinations with other drugs may be initiated in preparation for randomized trials
In addition to NSCLC, triple-negative breast and ovarian cancers are priority target indications based on sensitivity to the drug payload and prominence of the FR
In NSCLC, the combination of EC1456 with approved PD1 inhibitors is among the most promising paths forward as pre-clinical models demonstrate the most compelling synergy observed by the company to date
EC1169 (PSMA-targeted tubulysin) Development

Endocyte also outlined the next phase of development for EC1169, which is currently in dose escalation with a once a week schedule. Once the maximum tolerated dose is determined, the drug will be evaluated as a single agent therapy in advanced prostate cancer patients previously treated with hormone therapy. The companion imaging agent, EC0652, has provided superior images of prostate-specific membrane antigen (PSMA) positive disease during dose escalation and will provide a valuable tool for patient selection.

Pipeline Programs Leverage SMDC Capability to Create Multiple New Opportunities

"We have been prudent to ensure our two lead programs have remained the priority for the company and that we have fully invested in the clinical activity required to optimize their success," commented Mike Sherman, Endocyte’s chief operating officer and chief financial officer. "With those programs well underway, we also want to make sure we take advantage of our unique SMDC capability and flexibility to extend this platform to include new mechanisms of action and new indications."

Upcoming Expected Milestones

Phase 1 dose escalation updates at ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) Annual meeting
EC1456 single agent efficacy data (tumor response) in NSCLC before year-end 2016
EC1169 single agent efficacy data in prostate cancer in late 2016 or 2017
Updates on plans for earlier stage programs
Fourth Quarter 2015 Financial Results

Endocyte reported a net loss of $9.8 million, or $0.23 per basic and diluted share, for the fourth quarter of 2015, compared to a net loss of $8.1 million, or $0.19 per basic and diluted share, for the same period in 2014.

Research and development expenses were $6.4 million for the fourth quarter of 2015, compared to $4.0 million for the same period in 2014. In the fourth quarter of 2014 there was a reduction in the PROCEED termination accrual. With no comparable adjustment in the fourth quarter of 2015, this led to an increase in expense. The increase was also driven by an increase in the expenses related to the EC1456 and EC1169 dose escalation trials which now have more active patients.

General and administrative expenses were $3.5 million for the fourth quarter of 2015, compared to $4.2 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in legal and professional fees in the fourth quarter of 2015 as compared to the same period in 2014.

Cash, cash equivalents and investments were $173.6 million at December 31, 2015, compared to $180.3 million at September 30, 2015, and $206.8 million at December 31, 2014.

Financial Expectations

The Company expects that its cash balance at the end of 2016 will be between $125 and $130 million. Spending is expected to increase from the first half of 2016 to the second half as the trials for EC1456 and EC1169 are expanded once the maximum tolerated doses are determined. The advancement of the pre-clinical programs is not expected to materially impact current levels of spending and are reflected in the 2016 cash guidance.

8-K – Current report

On February 25, 2016 La Jolla Pharmaceutical Company (NASDAQ: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, reported fourth quarter and full year 2015 financial results and highlighted 2015 corporate progress (Filing, Q4/Annual, La Jolla Pharmaceutical, 2015, MAR 2, 2016, View Source [SID:1234509952]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

2015 Corporate Progress

• The ATHOS (Angiotensin II for the Treatment of High-Output Shock) 3 trial, La Jolla’s multicenter, randomized, double-blind, placebo-controlled, Phase 3 clinical trial of LJPC-501, La Jolla’s proprietary formulation of angiotensin II, in catecholamine-resistant hypotension (CRH) was initiated in March 2015. The initiation of the ATHOS 3 trial followed the reaching of an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA), in which the agreed-upon primary efficacy endpoint in ATHOS 3 is increase in blood pressure. ATHOS 3 is enrolling as planned, and results are expected by the end of 2016.

• A multicenter, open-label, dose-escalation Phase 1 clinical trial of LJPC-401, the Company’s novel formulation of hepcidin, in patients at risk for iron overload due to conditions such as hereditary hemochromatosis, beta thalassemia, sickle cell disease and myelodysplastic syndrome was initiated in October 2015. Interim results, reported in January 2016, suggested a dose-dependent reduction in serum iron following a single dose of LJPC-401. Additionally, the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) designated LJPC-401 an orphan medicinal product for the treatment of beta thalassemia intermedia and major.

• La Jolla entered into exclusive worldwide license agreements with the Indiana University Research and Technology Corporation and the University of Alabama at Birmingham to acquire intellectual property rights covering LJPC-30Sa and LJPC-30Sb in May 2015. LJPC-30Sa and LJPC-30Sb are La Jolla’s next-generation gentamicin derivatives for the potential treatment of serious bacterial infections and rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy.

• La Jolla completed a public offering of common stock in September 2015, whereby La Jolla received approximately $104.6 million, net of issuance costs. La Jolla finished 2015 with $126.5 million in cash and cash equivalents and believes this is sufficient to fund operations into 2018.

"2015 was a very exciting year for La Jolla, highlighted by the initiation and continued progress of our Phase 3 clinical trial of LJPC-501 and encouraging interim data from our recently initiated Phase 1 clinical trial of LJPC-401," said George Tidmarsh, M.D., Ph.D., La Jolla’s President and Chief Executive Officer. "We look forward to a productive 2016, with the continued advancement of our exciting product candidates and results from our LJPC-501 Phase 3 clinical trial expected by the end of the year."

Results of Operations

As of December 31, 2015, La Jolla had $126.5 million in cash and cash equivalents, compared to $48.6 million as of December 31, 2014. The increase in cash and cash equivalents was primarily due to cash provided by our common stock offering that was completed in September 2015, which was partially offset by net cash used for operating activities. Based on current operating plans and projections, La Jolla believes that its current cash and cash equivalents are sufficient to fund operations into 2018.

La Jolla’s net cash used for operating activities for the three and twelve months ended December 31, 2015 was $8.5 million and $25.2 million, respectively, compared to net cash used for operating activities of $5.4 million and $12.9 million, respectively, for the same periods in 2014. La Jolla’s net loss for the three and twelve months ended December 31, 2015 was $11.8 million and $41.9 million, or $0.69 per share and $2.68 per share, respectively, compared to a net loss of $6.8 million and $21.3 million, or $0.45 per share and $2.00 per share, respectively, for the same periods in 2014. During the three and twelve months ended December 31, 2015, La Jolla recognized contract revenue of approximately $0.4 million and $1.1 million, respectively, which was pursuant to a services agreement initiated in 2015 under which La Jolla provides research and development services to a related party. The net loss includes non-cash, share-based compensation expense of $2.8 million and $13.1 million for the three and twelve months ended December 31, 2015, respectively, compared to $2.5 million and $9.1 million of noncash, share-based compensation expense, respectively, for the same periods in 2014.

The increases in net cash used for operating activities and net loss in 2015 as compared to 2014 were primarily due to increased development costs associated with the Phase 3 clinical trial of LJPC-501 in catecholamine-resistant hypotension and the costs associated with the initiation of the Phase 1 clinical trial of LJPC-401 in iron overload. In addition, there were increases in personnel and related costs, which were mainly due to the hiring of additional personnel and increased facility costs to support the increased development activities.