On March 14, 2016 Stemline Therapeutics, Inc. (Nasdaq:STML) reported financial results for the quarter ended December 31, 2015 (Press release, Stemline Therapeutics, MAR 14, 2016, View Source [SID:1234509512]).

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Ivan Bergstein, M.D., Stemline’s Chief Executive Officer, commented, "During the fourth quarter, we made significant progress across all three of our development programs. Key achievements included 1) generating and presenting data from our ongoing Phase 2 trial of SL-401 in blastic plasmacytoid dendritic cell neoplasm (BPDCN) which we have designed to support potential registration, 2) treating our first patient in the second stage of our Phase 2 program of SL-701 in advanced brain cancer, and 3) the opening of our IND for SL-801 on schedule. At the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December, we presented very strong data from our ongoing SL-401 trial in BPDCN, demonstrating a high overall response rate in BPDCN, with multiple complete responses. We are also very pleased with the pace of enrollment in BPDCN, and note that we are tracking in-line with our expectations. We look forward to sharing key clinical and regulatory updates on SL-401 throughout this year."

Dr. Bergstein continued, "We continue to evaluate SL-401 in several additional malignancies that overexpress IL-3R. Specifically, we have single agent trials enrolling AML patients with minimal residual disease and patients with advanced high-risk myeloproliferative neoplasms. We also expect our first clinical studies that combine SL-401 with other therapies will begin this year."

Dr. Bergstein concluded, "Our other pipeline candidates, SL-701 and SL-801, continue to advance. Our SL-701 trial is currently enrolling patients and we expect updates from this program in the second half of the year. The SL-801 IND is open, and we are on track to treat our first patient this quarter. With our strong cash position, we believe we have sufficient financial resources to achieve significant clinical and regulatory milestones this year and beyond."

Fourth Quarter 2015 Financial Results Review

Stemline ended the fourth quarter of 2015 with $97.5 million in cash, cash equivalents and investments, as compared to $104.0 million as of September 30, 2015, which reflects a cash burn of $6.5 million for the quarter. The company ended the fourth quarter of 2015 with 18.2 million shares outstanding.

For the fourth quarter of 2015, Stemline had a net loss of $10.2 million, or $0.58 per share, compared with a net loss of $6.9 million, or $0.53 per share, for the same period in 2014. The net loss for full year 2015 was $37.2 million, or $2.15 per share, as compared with a net loss of $28.8 million, or $2.23 per share, in the prior year.

Research and development expenses were $7.9 million for the fourth quarter of 2015, which reflects an increase of $2.8 million, or 56%, compared with $5.1 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to the ramp up in our clinical trial activities for SL-401 and SL-801.

General and administrative expenses were $2.6 million for the fourth quarter of 2015, which reflects an increase of $0.6 million, or 30%, compared with $2.0 million for the fourth quarter of 2014. The increase in expenses during the current quarter was primarily attributable to an increase in compensation expense relating to administrative employees.

On March 11, 2016 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported positive preclinical findings generated using the Company’s Immune Repertoire Capture technology, presented at the Keystone Symposia Conference "Antibodies as Drugs", which took place in Whistler, British Columbia, Canada, March 6-10, 2016 (Press release, Atreca, MAR 11, 2016, View Source [SID1234522968]). Atreca’s programs are advancing multiple therapeutic agents that have shown they can enhance elimination of cancer cells, based on the analysis of successful anti-tumor responses in patients .

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In a poster titled, "Expanded IgG Lineages in Lung Cancer Non-Progressors Reveal Anti-Tumor Antibodies" (Abstract No. X2 1014), a research team of scientists at Atreca and collaborators at leading institutions reported key preclinical research findings, including:

Immune Repertoire Capture technology generated the sequences of native antibodies from the active immune response of an individual with Stage 4 lung adenocarcinoma who had experienced long-term non-progression of disease.
Several of these antibodies have been shown to bind tumor tissue but not normal tissue, and some bind multiple tumor types beyond the cancer type of the original patient from which the antibodies were discovered.
Select antibodies demonstrated they can destroy tumor cells, as measured by antibody-dependent cellular cytotoxicity (ADCC) in in vitro assays.
Daniel Emerling, Ph.D., Atreca’s Senior Vice President, Research, stated, "By analyzing blood samples from one patient at the single cell level using Atreca’s Immune Repertoire Capture platform, we identified thousands of antibodies and were able to generate natively paired antibody heavy and light chain sequences from blood plasmablasts, which are activated B cells that play a critical role in immune responses. Analysis of these antibody sequences allowed us to select and express functional antibodies for further analysis. Multiple patient-derived antibodies were found to bind cells from multiple tumor types, which highlights the utility and efficiency of our approach."

Select antibodies discovered in Atreca’s research have progressed to preclinical testing in in vivo models of cancer, with the goal of selecting candidates to enter into more advanced preclinical studies, based on a detailed understanding of anti-tumor immune responses.

"The results disclosed at Keystone this week demonstrate the power of Atreca’s Immune Repertoire Capture platform and its ability to generate novel antibodies that can target cancer," commented Tito A. Serafini, Ph.D., Atreca’s President, Chief Executive Officer, and Co-Founder. "Our technology allows Atreca to mine the key phenomenon driving efficacious anti-cancer immune responses—a patient’s own anti-tumor immunity—with the goal of using this knowledge to help other patients fight their disease." Dr. Serafini added, "We are grateful to our collaborators for their dedication to this research and look forward to the continued progress of our lead efforts into the clinic."

On March 11, 2016 PharmaMar reported that the creation of a network of centres of reference and adopting measures that promote research and access to treatments are two key aspects for improving the prognosis of patients with soft tissue sarcoma (STS), an uncommon type of cancer that originates in the tissues that connect, support and surround other body structures, such as muscles, fat, blood vessels, nerves, tendons and lining of the joints (Press release, PharmaMar, MAR 11, 2016, View Source [SID:1234510444]).

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This is one of the conclusions of the renowned international oncologists during the presentation of the Soft Tissue Sarcoma: Evidence and Experience seminar. This meeting, organised by PharmaMar, will bring leading world experts in this disease to Barcelona on 11 and 12 March from, among other countries, the United Kingdom, France, Italy, Germany, Spain and the United States, to analyse the latest advances in its diagnosis and treatment.

"We are proud to lead this meeting, where the most influential oncologists in the world in sarcoma management share opinions, present new case reports, discuss the latest advances and the most effective treatments for these patients", explained Mr Luis Mora, General Manager of the PharmaMar Oncology Unit.

Incidence of sarcoma

According to figures quoted by Prof Jean-Yves Blay, Chair of the European Organisation for the Research and Treatment of Cancer (EORTC), STS represents less than 1% of adult cancersi. "There are more than 50 histological subtypes of soft tissue sarcoma. The most common are leiomyosarcoma and liposarcoma. In Europe, the incidence of this type of tumour in adults (not including gastrointestinal stromal tumour) is from 4 to 5 cases per 100,000 inhabitantsii and approximately 2 half of the patients diagnosed with soft tissue sarcoma have developed metastases or are expected to do so", said Prof Blay.

To prevent patients reaching the expert sarcoma team after having been operated on, measures are required to guarantee an appropriate diagnosis and treatment agreed upon by a multidisciplinary team. Dr Javier Martín Broto, Chair of the Spanish Sarcoma Research Group (GEIS), maintains that this coordination requires the creation of a network of centres of reference to guarantee that patients with suspected soft tissue sarcoma are diagnosed and treated by teams of experts in the disease. "Studies show that patients who are diagnosed and treated in a centre of reference specialising in soft tissue sarcoma survive for longer than those diagnosed and treated in a centre without such specialisation", he explained.

This is precisely one of the lines of research of the Spanish Sarcoma Research Group which, according to Dr Martin Broto, has been collaborating for years with the Ministry of Health for the recognition of sarcoma hospitals and CSUR (Centres, Services and Units of Reference) teams. In his opinion, "we are currently in the final phase and we expect these centres to be made official in the near future".

The Spanish Sarcoma Research Group was created in 1994 and has led 47 research projects that have included thousands of patients. In the last few years, it has sponsored a large number of international clinical trials and its protocols are used worldwide.

Advances in the treatment of soft tissue sarcoma

Professor George Demetri, Director of the Centre for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute (Boston), presented the latest research projects related to the treatment of sarcoma, including the study conducted with trabectedin (Yondelis) in the United States, in which the compound was shown to reduce the risk of disease progression versus conventional treatment. Yondelis is developed and marketed by PharmaMar in Europe, while Janssen Products, L.P. has the rights to develop and sell Yondelis in the rest of the world except Japan, where PharmaMar has signed a licensing agreement with Taiho Pharmaceutical. 3

"Since Yondelis was first approved in Europe in 2007, approximately 50,000 patients in 80 countries have benefited from this therapy in all its indications", said Prof. Demetri, who explained that "advanced soft tissue sarcoma is a complex set of uncommon diseases that are virtually always life-threatening for patients with advanced stage disease. Patients need new treatment options that are more effective and well tolerated, and renewed hope has come with new drug approvals in the past decade based on sophisticated scientific research".

According to the data provided by this expert, the Phase 3 multicentre trial in the United States, Brazil and Australia is one of the largest conducted to date in sarcoma patients. This study showed a significant improvement in disease control (called "progression-free survival") with trabectedin versus dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma (LMS) after failure of prior standard therapy with an anthracycline and at least one other chemotherapy.

All the experts present highlighted the importance of these advances in the treatment of sarcoma, a rapidly progressing form of cancer that requires new treatment options. "In soft tissue sarcoma, disease stabilisation is useful for evaluating the success of the treatment in advanced stage patients. The data from the latest clinical trials with Yondelis offer a more hopeful future for patients and a path forward for even more research to improve clinical outcomes", concluded Dr Demetri.

On March 11, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial and business results for the fourth quarter and full-year 2015 (Filing, Q4/Annual, Progenics Pharmaceuticals, 2015, MAR 11, 2016, View Source [SID:1234509494]).

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Key Business Highlights

RELISTOR, treatment for opioid-induced constipation (partnered with Valeant Pharmaceuticals, Inc., ("Valeant"))

· RELISTOR Net Sales for the Fourth Quarter 2015 Total $23.0 Million. Full year 2015 net sales totaled $43.8 million (as reported to us by our partner, Valeant).

· Oral RELISTOR Remains On-track for April 19, 2016 PDUFA. Progenics anticipates an FDA decision April 19, 2016 on the NDA submission for oral RELISTOR. If approved, Progenics would be entitled to a $50 million milestone payment and subsequent sales royalties and commercial milestones from Valeant.

· Subcutaneous RELISTOR Approved in Europe for All Opioid-Induced Constipation. In June 2015 the European Commission approved RELISTOR (methylnaltrexone bromide) Subcutaneous Injection for the treatment of opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older.

Progenics Announces Fourth Quarter and Full-Year 2015 Financial Results

AZEDRA, Ultra-orphan radiotherapeutic candidate

· AZEDRA Ultra-Orphan Cancer Therapeutic Receives FDA Breakthrough Designation. In July 2015 the U.S. Food and Drug Administration (FDA) designated AZEDRA as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma.

· AZEDRA Completes Enrollment of 68 Patients in Pivotal Trial. In December 2015, Progenics achieved target enrollment in its pivotal Phase 2b trial of AZEDRA. A total of 68 patients have been enrolled.

· AZEDRA Topline Results Expected Between December 2016 and March 2017. In late 2016 or early 2017, Progenics expects to report top-line results from its ongoing pivotal Phase 2b study of AZEDRA. If positive, the Company expects to submit an NDA to the FDA in 1H 2017.

PSMA-Targeted Prostate Cancer Pipeline

· Exclusive Worldwide License Signed With Johns Hopkins University for PyL, PSMA-Targeted PET/CT Imaging Agent. In August 2015, the Company announced an exclusive worldwide licensing agreement with the Johns Hopkins University for imaging agent PyL.

· Pivotal Phase 3 Study Underway of 1404, PSMA-Targeted SPECT/CT Imaging Agent. Progenics has commenced a pivotal Phase 3 study of PSMA-targeted imaging agent 1404 for prostate cancer. The Phase 3 clinical trial is expected to enroll approximately 450 patients with newly diagnosed low-grade prostate cancer patients who are candidates for active surveillance, but nonetheless are planning to undergo radical prostatectomy. During the second half of 2016, Progenics expects to perform an interim analysis of the Phase 3 clinical trial of its PSMA-targeted imaging agent, 1404, to assess futility and evaluate the need for a sample size re-estimation.

· Acquired EXINI Diagnostics AB, a Swedish Developer of Artificial Intelligence-Based Image Analysis Tools. In November 2015, Progenics acquired EXINI Diagnostics AB, a Swedish developer of artificial intelligence-based analytical tools to improve the management of prostate cancer. The acquisition enhances the Company’s proprietary prostate cancer imaging programs, 1404 and PyL.

· Announced Data Highlighting EXINI’s Lead Artificial Intelligence-Based Analytical Tool, the Bone Scan Index (BSI), was Published in the January 2016 Issue of the Journal of Nuclear Medicine. In the paper, researchers from Memorial Sloan Kettering Cancer Center in New York and Lund University in Sweden reported that BSI overcomes a number of key limitations of manual image assessment by human readers and can provide an accurate, precise and reproducible platform for quantifying changes in bone scans of prostate cancer patients.

· Phase 1 Study of 1095, PSMA-Targeted Therapeutic for Metastatic Prostate Cancer, Planned at Memorial Sloan Kettering. Initiation of a Phase 1 study of 1095 planned for 2H 2016 at Memorial Sloan Kettering Cancer Center.

"Over the past year, we have achieved significant progress across all three areas of our business – our partnered OIC therapy, RELISTOR, our ultra-orphan radiotherapeutic candidate, AZEDRA, and our prostate cancer pipeline," said Mark Baker, CEO of Progenics. "I expect 2016 to be a transformational year for our Company with a number of important milestones. We begin the year in a strong financial position, and Oral RELISTOR, if approved, will trigger a milestone payment and sales royalties that we can use to further advance AZEDRA toward commercialization while also developing our pipeline of therapeutic and imaging agents that we believe have the potential to change how prostate cancer is diagnosed and treated."
Page 3
Progenics Announces Fourth Quarter and Full-Year 2015 Financial Results
Fourth Quarter and Full-Year 2015 Financial Results
Net loss attributable to Progenics for the quarter was $7.1 million, or $0.10 per basic and diluted share, compared to a net loss of $12.2 million, or $0.18 per basic and diluted share in the 2014 period. Net loss attributable to Progenics for the full-year 2015 was $39.1 million, or $0.56 per basic and diluted share, compared to net income of $4.4 million, or $0.06 per basic and diluted share for the full-year 2014.

Progenics ended the year with cash and cash equivalents of $74.1 million, reflecting decreases of $16.3 million in the quarter and $45.2 million from 2014 year-end, primarily resulting from $40.1 million used in operating activities and $6.5 million used to acquire a majority interest in EXINI Diagnostics AB.

Total revenue for the fourth quarter increased $5.7 million over the fourth quarter of 2014, due primarily to $4.1 million higher RELISTOR royalty income and recognition of $1.5 million milestone payment from CytoDyn for dosing of the first patient in Phase 3 clinical trial for PRO 140. Current full-year revenues were $8.7 million, down from $44.4 million in the prior year, reflecting a decrease in collaboration revenue of $39.2 million. This resulted primarily from the recognition of a $40.0 million development milestone in the third quarter of 2014, for the U.S. marketing approval for subcutaneous RELISTOR in non-cancer pain patients, partially offset by an increase in RELISTOR royalty revenue to $6.6 million in 2015 from $3.1 million in 2014.

Fourth quarter research and development expenses increased by $1.7 million compared to the corresponding period in 2014, primarily due to higher AZEDRA and 1404 clinical trial expenses, partially offset by lower PSMA ADC-related expenses. Full-year research and development expenses decreased by $0.4 million compared to the corresponding period in 2014, primarily due to lower clinical trial expenses for PSMA ADC and lower share-based compensation expense, partially offset by higher AZEDRA-related expenses.

The fourth quarter 2015 general and administrative expenses decreased by $0.2 million compared to the corresponding period in 2014, primarily due to lower legal expenses. Full-year 2015 general and administrative expenses increased by $2.7 million compared to the prior year, primarily due to a legal reserve and expenses related to an action brought by a former employee and higher compensation expenses. Non-cash items for the quarter and year resulted from increased estimates for fair value of contingent consideration liability related to the 2013 acquisition of Molecular Insight.

On March 11, 2016 GenSpera, Inc. (OTC/QB: GNSZ), a biotech company developing a novel prodrug therapeutic for the treatment of cancer, reported that the Company’s board of directors has engaged FLG Partners, LLC and its partner Chris Lowe to provide strategic advice to further complement the Company’s efforts to strengthen its corporate and clinical development (Press release, GenSpera, MAR 11, 2016, View Source [SID:1234509501]). This includes aligning the Company’s long term-goals to optimize the clinical and regulatory development of mipsagargin, implement cost-efficient processes and advise on business development and funding initiatives.

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"We are delighted to engage the services of this highly regarded consultancy, which has a reputation for providing sound strategic and operational counsel to companies such as GenSpera. In particular, we will be calling upon Chris Lowe’s substantial expertise and proven abilities in assisting clinical-stage companies to develop well-conceived corporate and financial strategies. The full strategic review is designed with a view of enhancing shareholder value," commented the Board of Directors of GenSpera.

FLG Partners is a leading CFO consulting and services firm based in Silicon Valley and its partners have more than 500 years of collective CEO and CFO experience. Mr. Lowe is a partner at the firm and has more than 15 years of senior management experience that includes executive positions in publicly traded life sciences companies.

"It is an exciting time at GenSpera as we evaluate mipsagargin in our ongoing Phase 2 trial in patients with glioblastoma and finalize preparations to commence a Phase 2 trial in patients with prostate cancer," said Craig Dionne, Ph.D., GenSpera’s CEO. "The complementary operational and financial expertise of FLG partners and Chris Lowe will help guide us through this critical stage in our corporate development and support us in reaching our goal of commercializing an important new therapeutic for patients with cancer."

"GenSpera is ripe with opportunity and I look forward to using my experience as well as the shared expertise of my colleagues at FLG to develop a comprehensive plan that advances GenSpera’s clinical programs and puts forth financial options to provide a highly productive path forward for the Company and its shareholders," said Mr. Lowe.