8-K – Current report

November 12, 2015 Cellectar Biosciences, Inc. (NASDAQ:CLRB), an oncology-focused biotechnology company, reported financial results for the third quarter of 2015 (Filing, 8-K, Cellectar Biosciences, NOV 12, 2015, View Source [SID:1234508216]).

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During the third quarter of 2015, the company reported a net loss of $1.9 million or ($0.25) per share versus net income of $0.3 million or $0.06 per share for the comparable period in 2014. The shift in profitability was attributable to a large non-cash gain on the revaluation of warrants that are classified as derivative liabilities in 2014. Research and development expenses for the quarter ended September 30, 2015 were $1.2 million, a reduction of $0.3 million from the year prior.

Cellectar’s general and administrative expenses for third quarter 2015 totaled $0.8 million, similar to the prior year period, while restructuring costs in the quarter just ended were $0.1 million. There were no restructuring costs in the third quarter last year.

The Company ended the third quarter with $2.5 million in cash and cash equivalents, compared to $9.4 million in cash and cash equivalents on December 31, 2014. This is exclusive of the $2.9 million, net of expenses, raised in the sale of stock and warrants that closed on October 1, 2015. The Company estimates that its available cash and cash equivalents should fund its planned operations into the second quarter of 2016. Additional capital will be required to complete Cellectar’s planned clinical and preclinical development.

"During the third quarter we implemented a corporate strategic shift for Cellectar Biosciences, repositioning the company around our Phospholipid Drug Conjugate (PDC) Delivery Platform and focusing resources on our therapeutic product portfolio, primarily CLR 131 for relapsed or refractory multiple myeloma and CLR CTX, our research and development program designed to identify new chemotherapeutic product candidates," said Jim Caruso, president and CEO of Cellectar Biosciences. "We believe we have made significant progress toward these goals and look forward to providing additional details during our conference call later today."

Cellectar will be holding a conference call at 5:00 PM ET today to review these results, as well as the company’s development plans. The call can be accessed by calling 888-646-8293. The call will also be webcast and replays will be available, both via the Investor Relations section of the company’s website: investor.cellectarbiosciences.com.

10-Q – Quarterly report [Sections 13 or 15(d)]

(Filing, 10-Q, Cellectar Biosciences, NOV 12, 2015, View Source [SID:1234508217])

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Cyclacel Pharmaceuticals Reports Third Quarter 2015 Financial Results

On November 12, 2015 Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) ("Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the third quarter ended September 30, 2015 (Press release, Cyclacel, NOV 12, 2015, View Source [SID:1234508218]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2015 was $2.8 million, or $0.08 per basic and diluted share, compared to a net loss applicable to common shareholders of $5.0 million, or $0.22 per basic and diluted share for the third quarter ended September 30, 2014. As of September 30, 2015, cash and cash equivalents totaled $22.7 million.

"SEAMLESS continues to progress towards final data read-out," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "There are now approximately 8% of events remaining to occur and we anticipate reporting top-line data during the first half of 2016. Following unblinding and analysis of the data, we will review the results to determine their suitability for submission to regulators. Our CDK2/9 programs made significant progress over the quarter. The CYC065 Phase 1 trial in solid tumor and lymphoma patients has started and the mechanistic rationale for CDK2/9 inhibition in targeted solid tumors and hematological malignancies is supported by multiple presentations at scientific conferences. Seliciclib was administered to the first patients with Cushing’s disease in an investigator-sponsored trial. We and our investigators are excited about the prospects of CDK2/9 inhibitors and we look forward to keeping you apprised as to our progress."

Business Highlights

Sapacitabine in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):

Continued follow-up with 8% of events remaining before analyzing mature data and reporting top-line results. The SEAMLESS study is powered at 90% to detect a 27.5% improvement of survival between the experimental and control arms.
Cyclin Dependent Kinase (CDK) Inhibitor Programs

Presented the molecular rationale for clinical development of CYC065 for the treatment of solid tumors at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics

Dosed the first patient in a first-in-human, Phase 1 trial of CYC065, the Company’s second-generation CDK2/9 inhibitor, in solid tumor and lymphoma patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065

Presented the molecular rationale for clinical development of CYC065 for the treatment of leukemias and lymphomas at the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting
Dosed the first patient in a Phase 2 investigator-sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

CYC065 data to be presented at the upcoming 2015 San Antonio Breast Cancer Symposium in Texas and at the 4th Neuroblastoma Symposium in Newcastle Upon Tyne, United Kingdom
Third Quarter 2015 Financial Results

Revenue

Revenue was $0.7 million for both the three months ended September 30, 2014 and 2015. Revenue is mainly related to grants from the European Union and the Biomedical Catalyst of the United Kingdom government. The Company recognized $0.3 million from its license and supply agreement with ManRos during the three months ended September 30, 2015.

Research and Development Expenses

Research and development expenses were $2.9 million for the three months ended September 30, 2015, compared to $5.0 million for the same period in the previous year. The decrease was primarily a result of reduced expenditures in study and site startup costs associated with the SEAMLESS Phase 3 study this quarter compared to the same period last year.

General and Administrative Expenses

General and administrative expenses for the three months ended September 30, 2015 were $1.2 million compared to $1.4 million for the same period in 2014. The decrease was primarily the result of lower patent-related and stock-based compensation costs.

Boehringer Ingelheim will invest 11 billion euros in Research and Development in the next five years to accelerate the discovery of next generation medical breakthroughs

On November 11, 2015 Boehringer Ingelheim reported that it is launching a new research and development (R&D) strategy and a five-year R&D investment programme (Press release, Boehringer Ingelheim, NOV 11, 2015, View Source [SID:1234508201]). This new plan was announced today at its R&D press conference in Berlin. The company pledges to invest a total of 11 billion euros in its new R&D programme over the next five years. Of the total investment, 5 billion euros will go to preclinical R&D with 1.5 billion euro thereof planned for collaborations with external partners. The company is aiming to develop the next generation of medical breakthroughs and maintain its excellent competitive position. The new R&D strategy embraces open innovation in the form of external collaborations to better leverage emerging science and Boehringer Ingelheim’s experience and capabilities for the discovery of new medicines.

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"With eleven new launches in 2014 and 2015, our R&D organisation is an example of Boehringer Ingelheim’s outstanding capability in this field," said Professor Andreas Barner, Chairman of the Board of Managing Directors of Boehringer Ingelheim. "The new programme and strategy reflect our corporate philosophy of long-term, sustainable growth. They will enable us to continue our excellent track record of bringing therapeutic innovations with high value for patients to the market."

A New R&D Strategy

A key element of the new strategy is an increased focus on collaborations with external partners, while maintaining strong internal R&D capabilities. This approach will enable the company to build on its long-term experience and strength in its core therapeutic areas while expanding its efforts to access the vast creative pool of global biomedical research through open innovation.

"Our new strategy embraces the trend towards more extensive open-innovation approaches between academia and industry in biomedical research. Our partners benefit by accessing our broad experience and capabilities and through establishment of long-term personal interactions with our R&D teams," explained Dr Michel Pairet, senior corporate vice president research and non-clinical development at Boehringer Ingelheim and designated Member of the Board of Managing Directors from January 2016 onwards. "The new strategy will foster our external collaboration efforts by enabling us to be faster and more flexible. This is of essence for research beyond the borders of our current focus areas, where we explore emerging science, new indications and new technology to expand opportunities."

Cooperation with Partners along the entire R&D value chain

Open innovation has become a fundamental part of drug discovery. The R&D organisation of Boehringer Ingelheim is working with the wider scientific world to embed a range of innovative opportunities in its R&D endeavours.

Firstly, bilateral collaboration agreements with academic investigators and biotechnology companies provide important starting points for drug discovery projects. Boehringer Ingelheim has entered into several new research collaborations in exciting areas of science with partners that are worldwide leaders in their fields.

Boehringer Ingelheim just announced new collaborations with four major scientific partners to enrich R&D with novel therapeutic approaches for patients suffering from inflammatory bowel disease (IBD), namely the Icahn School of Medicine at Mount Sinai, Massachusetts General Hospital, Scripps Research Institute and Weill Cornell Medicine. These four collaborations aim to identify and validate potential new therapeutic targets as well as identify biomarkers that offer the potential to address the significant unmet medical needs of patients suffering from IBD such as Crohn’s disease and ulcerative colitis. Boehringer Ingelheim has also recently signed exclusive agreements with Hanmi Pharmaceuticals in Korea to develop a third generation EGFR-targeted therapy for lung cancer and with Circuit Therapeutics, California to apply the technique of optogenetics to find new treatments for psychiatric disorders and cardiometabolic diseases.

Secondly, public-private partnerships, such as the Structural Genomics Consortium (SGC), Innovative Medicines Initiative (IMI) and the G-protein coupled receptor (GPCR) Consortium, are playing an increasingly important role in medicines discovery because of their ability to bring together the best academic and industrial scientists in an unrestricted precompetitive field. Boehringer Ingelheim is an active participant in all two of these successful public-private partnerships and recently joined the GPCR Consortium.

Thirdly, crowdsourcing initiatives with organisations such as InnoCentive and the BioMed X Innovation Center can be used to seek scientists with bright ideas to address important medical challenges. Boehringer Ingelheim and the BioMed X Innovation Center recently announced that they are bringing together outstanding scientists at an academic centre of excellence in Heidelberg and providing them with appropriate infrastructure and mentorship to work on new epigenetic approaches to chronic obstructive pulmonary disease.

In addition, Boehringer Ingelheim invests in the Institute for Molecular Pathology (IMP) in Vienna to support basic research, and a global network of scientists as essential elements of the creative endeavour. Finally, the Boehringer Ingelheim Venture Fund, founded in 2010 with an initial financial commitment of 100 million euro, is currently investing in a portfolio of 13 different start-up companies with exciting new therapeutic ideas.

The new R&D strategy is an important building block of Boehringer Ingelheim’s global strategy to be prepared for chances and challenges in the pharmaceutical market. "This is another decisive step to position Boehringer Ingelheim for long-term growth," said Professor Barner. "We are looking forward to addressing unresolved challenges in immunology, respiratory and cardiometabolic medicine, as well as in oncology, in diseases of the central nervous system and beyond."

NK-92: an ‘off-the-shelf therapeutic’ for adoptive natural killer cell-based cancer immunotherapy.

Natural killer (NK) cells are increasingly considered as immunotherapeutic agents in particular in the fight against cancers. NK cell therapies are potentially broadly applicable and, different from their T cell counterparts, do not cause graft-versus-host disease. Efficacy and clinical in vitro or in vivo expansion of primary NK cells will however always remain variable due to individual differences of donors or patients. Long-term storage of clinical NK cell lots to allow repeated clinical applications remains an additional challenge. In contrast, the established and well-characterized cell line NK-92 can be easily and reproducibly expanded from a good manufacturing practice (GMP)-compliant cryopreserved master cell bank. Moreover, no cost-intensive cell purification methods are required. To date, NK-92 has been intensively studied. The cells displayed superior cytotoxicity against a number of tumor types tested, which was confirmed in preclinical mouse studies. Subsequent clinical testing demonstrated safety of NK-92 infusions even at high doses. Despite the phase I nature of the trials conducted so far, some efficacy was noted, particularly against lung tumors. Furthermore, to overcome tumor resistance and for specific targeting, NK-92 has been engineered to express a number of different chimeric antigen receptors (CARs), including targeting, for example, CD19 or CD20 (anti-B cell malignancies), CD38 (anti-myeloma) or human epidermal growth factor receptor 2 (HER2; ErbB2; anti-epithelial cancers). The concept of an NK cell line as an allogeneic cell therapeutic produced ‘off-the-shelf’ on demand holds great promise for the development of effective treatments.

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