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8-K – Current report

On November 4, 2015 Immunomedics, Inc. (Nasdaq:IMMU) reported financial results for the first quarter ended September 30, 2015. The Company also highlighted recent key developments and planned activities for its clinical pipeline (Filing, 8-K, Immunomedics, NOV 4, 2015, View Source [SID:1234507965]).

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First Quarter Fiscal 2016 Results

Total revenues for the first quarter of fiscal year 2016, which ended on September 30, 2015, were $0.7 million as compared to total revenues of $1.1 million for the same quarter last fiscal year. The decrease of $0.4 million in total revenues was primarily due to a $0.2 million reduction in research and development revenue from a decline in the number of government funded research grants and $0.1 million in reduced product sales due primarily to unfavorable currency rates on LeukoScan sales in Europe.

Total costs and expenses for the current quarter were $14.8 million as compared to $13.5 million for the same period in 2014, representing an increase of $1.3 million or 10%. This increase was driven primarily by $3.5 million higher research and development expenses for product development expenses related to the Phase 3 PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer and the Phase 2 antibody-drug conjugates’ clinical trials. The increase in cost and expenses this quarter was partially offset by the $2.1 million decrease in general and administrative expenses attributable primarily to reduced legal and professional fees, principally related to the arbitration proceedings with Takeda-Nycomed, which concluded during the 2015 fiscal year.

Interest expense this quarter related to the 4.75% Convertible Senior Notes was $1.4 million, including the amortization of $0.2 million debt issuance costs. There was no interest expense for the same quarter last fiscal year.

Net loss attributable to our stockholders this quarter was $15.4 million, or $0.16 per share, compared with a net loss attributable to our stockholders of $12.4 million, or $0.13 per share, for the same quarter in fiscal 2015. The $3.0 million increase in net loss this quarter was primarily due to $3.5 million increased clinical trial-related research and development costs and $1.4 million interest expense, partially offset by $2.1 million decreased legal and professional fees, as described above.

As of September 30, 2015, cash, cash equivalents, and marketable securities totaled $85.5 million.

"As presented by Dr. Goldenberg at the 2015 World ADC conference in San Diego, sacituzumab govitecan continues to show consistently encouraging results in patients with metastatic solid cancers. We are continuing to progress our regulatory activities regarding a Phase 3 registration trial in TNBC," commented Peter P. Pfreundschuh, Vice President Finance and Chief Financial Officer. "In addition, patient enrollment for the PANCRIT-1 trial has significantly increased in the last quarter, and we are on track to complete patient accrual during calendar year 2016," added Mr. Pfreundschuh.

The Company’s key clinical developments and future planned activities:

Sacituzumab Govitecan (IMMU-132)

At the 2015 World ADC San Diego conference, sacituzumab govitecan was reported to have produced durable responses that exceeded one year in some patients with metastatic triple-negative breast (TNBC), small-cell (SCLC) and non-small-cell lung (NSCLC) cancers. (For more information on the results, please refer to the Company’s press release at View Source).

Interim results in patients with advanced, metastatic lung cancers were also presented at the 16th World Conference on Lung Cancer.
(View Source)

A late-breaking abstract focusing on results in patients with TNBC has been accepted for presentation at the 2015 AACR (Free AACR Whitepaper)-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference, scheduled for Sunday, November 8, 2015, in Boston, Massachusetts.

Further update in TNBC will be provided in a poster discussion session at the 2015 San Antonio Breast Cancer Symposium in San Antonio, Texas, on Thursday, December 10, 2015.

Full updates on the sacituzumab govitecan Phase 2 study will be given at the Cambridge Healthtech Institute’s 15th Annual PepTalk: The Protein Science Week in San Diego, California, scheduled for Wednesday, January 20, 2016.
IMMU-114

Initial results of a Phase 1 first-in-man study of subcutaneous injections of IMMU-114 in hematologic malignancies will be presented at the 57th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in Orlando, Florida, on Sunday, December 6, 2015.

Roche showcases pharmaceuticals strategy and emerging new medicines

On November 5, 2015 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it is providing an update on its late-stage pipeline at an investor event in London, including promising investigational medicines for multiple sclerosis, asthma, haemophilia, eye disease and cancer (Press release, Hoffmann-La Roche , NOV 4, 2015, View Source [SID:1234507963]). In these and other areas, Roche expects as many as seven major read-outs from clinical trials with new molecular entities or line extensions for existing medicines up to the end of 2017, adding to the seven read-outs already achieved in 2015.

"Thanks to our diversified late-stage portfolio we are well positioned to maintain our leadership in oncology, expand further in the immunology and ophthalmology segments, and potentially offer new treatments to help improve the lives of people with multiple sclerosis and haemophilia," said Daniel O’Day, COO of Roche’s Pharmaceuticals Division. "And we are looking to harness the vast increase in molecular information as the next important step in our efforts to develop even better, more personalised treatment solutions."

In addition to presenting updates on Roche’s most advanced investigational medicines, executives will brief investors and analysts on the company’s strategy, R&D productivity, life-cycle management and approach to new market opportunities. Special breakout sessions will offer insights into Roche’s haematology portfolio, plans to exploit the growing depth and breadth of molecular information for drug discovery and development, and an assessment of the emerging biosimilar landscape.

The presentations will be available via live video webcast or conference call (details at the end of this release).

Addressing unmet need in melanoma, lung cancer and multiple sclerosis

Cotellic is currently undergoing regulatory review in the US and Europe for use in combination with Zelboraf for the treatment of BRAF mutation-positive unresectable metastatic melanoma. Decisions by the FDA and EMA are expected in November and December, respectively. Results from a phase III trial announced by Roche and Exelixis in October showed a statistically significant and clinically meaningful increase in overall survival for patients taking Cotellic plus Zelboraf compared to Zelboraf alone.
Alectinib is an investigational oral medicine for ALK-positive non-small cell lung cancer (NSCLC). After granting Breakthrough Therapy Designation in 2013, the FDA accepted Roche’s US marketing application in September 2015 for priority review, assigning a decision date in March 2016. Roche also filed an EU marketing application in September. A phase III study is comparing alectinib to crizotinib as initial treatment for advanced NSCLC identified as ALK-positive by a companion diagnostic test being developed by Roche.

Ocrelizumab is the first investigational medicine to show positive results in both primary progressive and relapsing forms of multiple sclerosis (PPMS, RMS). Based on pivotal study results, ocrelizumab has the potential to change the way MS is treated. Roche plans to submit data to global regulatory authorities in early 2016 to obtain marketing authorisation for ocrelizumab as a potential new treatment for RMS and first approved treatment for PPMS.

Cancer immunotherapy – preparing a multipronged attack on tumours

Roche’s industry-leading cancer immunotherapy pipeline currently includes eight new molecular entities and some 30 combinations of immunotherapies and targeted cancer medicines being tested in clinical trials.

Atezolizumab is an investigational monoclonal antibody designed to interfere with PD-L1, a protein expressed on tumour cells and tumour-infiltrating immune cells, preventing it from binding to PD-1 and B7.1 on the surface of T cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells, restoring their ability to detect and attack tumour cells. Roche has initiated a rolling FDA filing for atezolizumab and expects to finalise the data submissions from its phase II trials in the first quarter of 2016 under Breakthrough Therapy Designations for certain types of metastatic bladder and lung cancer. Roche currently has several ongoing phase III studies of atezolizumab alone or in combination with other medicines for various types of lung, bladder, kidney and breast cancer. All studies include the evaluation of a companion test developed by Roche Diagnostics to determine PD-L1 status.

Atezolizumab plus chemotherapy: Based on encouraging early-stage results, Roche is conducting a number of randomised phase III studies to evaluate the benefit of atezolizumab when added to standard chemotherapy in first-line NSCLC. First results are expected in 2017.

Atezolizumab combined with targeted therapies or other cancer immunotherapy agents: Roche is also investigating the potential benefit of combining atezolizumab with targeted medicines such as Avastin, Zelboraf, Cotellic, Tarceva, alectinib or Gazyva, as well as with other cancer immunotherapy agents such as anti-CD40, anti-CSF-1R, anti-OX40, IDO inhibitors or anti-CEA-IL2v FP in a range of cancers.

Aiming for treatment advances for blood cancers, asthma, haemophilia and age-related vision loss

Gazyva/Gazyvaro (obinutuzumab), a glycoengineered monoclonal antibody that binds to CD20 (a protein found only on B cells), is designed to attack and destroy targeted B cells directly and together with the immune system. It is currently approved in more than 50 countries in combination with chlorambucil for previously untreated chronic lymphocytic leukaemia. In October the US FDA accepted for priority review Roche’s supplemental Biologic License Application for Gazyva in the treatment of patients with follicular lymphoma who relapsed after or are refractory to a rituximab-containing regimen, based on results of the phase III GADOLIN study.
Venetoclax is a small-molecule Bcl-2 inhibitor designed to interfere with a process some cancer cells use to survive, thereby promoting programmed cell death, or apoptosis. Ongoing phase II and III studies are investigating venetoclax alone and in combination with other medicines in certain types of chronic lymphocytic leukaemia (CLL), non-Hodgkin’s lymphoma, acute myelogenous leukaemia and multiple myeloma. Earlier this year the US FDA awarded breakthrough designation for venetoclax in the treatment of relapsed or refractory CLL with 17p deletion. Roche’s partner AbbVie has completed a submission to the US FDA for approval of venetoclax, based on the results of a positive phase II trial; AbbVie also plans to submit these data to the EMA and other regulatory authorities around the world for approval consideration.

Lebrikizumab is a first-in-class anti-IL-13 monoclonal antibody under investigation for the treatment of severe uncontrolled asthma. Lebrikizumab has been shown in phase II studies to significantly reduce asthma exacerbation rates and improve lung function in patients with high levels of the biomarker periostin. Phase III trial results are expected in the first half of 2016, with global filings planned soon after. Roche is also investigating lebrikizumab as a potential treatment for other types of lung disease and atopic dermatitis.

ACE910 (factor IXa/X biMAb) is an investigational bispecific antibody specifically engineered to support the interaction between factors IXa and X and hence mimic factor VIII, a protein essential to blood clotting. It is being developed for use in people with haemophilia A, irrespective of inhibitor status. Following encouraging phase I results, Roche plans to initiate a phase III trial of ACE910 in patients with factor VIII inhibitors by the end of 2015, a phase III trial in patients without inhibitors in 2016, and a study in paediatric patients (0–12 years) in 2016.

Lampalizumab (anti-Factor D Fab) is a selective inhibitor of complement-mediated inflammation. It is potentially the first disease-modifying therapy for geographic atrophy (GA), an advanced form of age-related macular degeneration. There are currently no effective therapies approved for GA, a significant cause of irreversible vision loss and blindness in the elderly. A phase II study with lampalizumab was the first to show efficacy in reducing the progression of retinal cell death in GA. Patient recruitment for a phase III program is on track. In addition to efficacy and safety, the studies are assessing the prognostic and predictive roles of a complement factor I profile biomarker. Results are expected in 2017. The US FDA has granted fast-track status to lampalizumab for the treatment of GA secondary to age-related macular degeneration.

Participants at the event are also being briefed on Roche’s ongoing efficiency initiatives in areas such as clinical development, pharmaceutical production and commercialisation, part of the Group’s commitment to optimising use of resources. One result of these efforts has been a doubling of the number of projects in late-stage clinical development since 2010, with no increase in development spend.

Roche experts will also explain the challenges and opportunities of molecular information and its emerging role in drug development, diagnosis, patient selection and treatment monitoring. A key part of Roche’s R&D is directed towards developing new techniques and platforms that can exploit the wealth of molecular data now becoming available in clinical trials and real-world treatment settings. The aim is to use these increasingly detailed data in research and development to help select drug targets and develop new medicines. Molecular information will increasingly be used in routine clinical practice to match patients to the most appropriate treatment and monitor their progress on therapy.

Partners and collaborations
Cotellic (cobimetinib) is being developed in collaboration with Exelixis.
Zelboraf (vemurafenib) is developed in collaboration with Plexxikon, a member of the Daiichi Sankyo Group.
Alectinib (RG7853) is being developed in collaboration with Chugai, a member of the Roche Group.
Venetoclax (Bcl-2 inhibitor, GDC-0199, RG7601) is being developed in collaboration with AbbVie.
ACE910 (RG6013) is being co-developed with Chugai, a member of the Roche Group.

8-K – Current report

On November 04, 2015 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, provided a corporate progress update and reported financial results for the third quarter ended September 30, 2015 (Filing, 8-K, MacroGenics, NOV 4, 2015, View Source [SID:1234507959]).

"As we strive to create breakthrough biologics and life-changing medicines, the team at MacroGenics was proud to share our progress at our recent R&D Day in New York," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We reported encouraging initial clinical trial results from an ongoing Phase 1 study of enoblituzumab, our Fc-optimized monoclonal antibody that targets B7-H3. We also extended our B7-H3 franchise by advancing MGD009, a DART molecule directed against B7-H3 and CD3, into a Phase 1 study. Furthermore, we recently announced a collaboration with Merck to evaluate margetuximab in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, in patients with advanced gastric cancer. This combination of therapeutics could exploit complementary immune-based mechanisms for targeting tumors and provide an important alternative for patients who do not respond to currently available regimens."

Pipeline Update

Margetuximab is an Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2.

Recent highlights include:

· Phase 1b/2 Gastric Cancer Study in Collaboration with Merck: The Company recently announced a collaboration to evaluate the combination of margetuximab with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in a Phase 1b/2 clinical trial in patients with HER2-positive advanced gastric cancer. Trial startup activities are underway, and the Company expects to begin enrolling patients by the first quarter of 2016.

· SOPHIA Study Continues: The Company’s Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is continuing enrollment. This three-year study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy following progression after at least two lines of previous therapy in approximately 530 patients.
B7-H3 Franchise—MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company’s three programs target B7-H3 through complementary mechanisms of action and take advantage of this target’s broad expression across multiple solid tumor types.

Recent highlights include:

· Enoblituzumab (MGA271): The Company provided an overview of initial data from its ongoing Phase 1 monotherapy clinical study of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. To date, enoblituzumab has been well tolerated in patients and has shown encouraging, initial single-agent activity, including tumor regression in multiple, heavily pre-treated patients. In addition, evidence of T-cell immunomodulatory function has been observed in patients treated with enoblituzumab. The Company continues to enroll patients in additional monotherapy Phase 1 study cohorts as well as in two combination studies with either ipilimumab or pembrolizumab. Data from the ongoing monotherapy study will be presented in a late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting on November 7, 2015.

. Regains European and Other Regional Rights to Enoblituzumab: In October 2015, Les Laboratoires Servier, or Servier, provided notice that it would not be exercising its option under a 2011 agreement to develop and commercialize enoblituzumab in Europe and other countries. Accordingly, the agreement with Servier regarding enoblituzumab has expired and MacroGenics now controls worldwide development and commercialization rights to enoblituzumab. The agreement between MacroGenics and Servier for development of DART molecules is unaffected by this decision.

· MGD009 in Phase 1: MGD009, a Dual-Affinity Re-Targeting, or DART, molecule targeting B7-H3 and CD3, is being tested in a Phase 1 study in patients and is being evaluated across multiple solid tumor types.

· B7-H3 Antibody-Drug Conjugate: The Company continues to evaluate antibody drug conjugate (ADC) molecules to induce direct killing of B7-H3 positive tumor cells.

DART Product Candidates—There are currently five DART molecules in clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD011 (CD19 x CD3, also known as JNJ-64052781), MGD010 (CD32B x CD79B) and MGD009 (B7-H3 x CD3). Each of these DART molecules is being evaluated in a Phase 1 clinical study. At its R&D Day, the Company disclosed for the first time two DART molecules that it expects to advance into clinical development in the first half of 2017. These two product candidates include:

· MGD013: MacroGenics is developing an Fc-bearing DART molecule, MGD013, to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3. The company presented promising pre-clinical data demonstrating the activity of a DART molecule with these specificities and expects that this bi-specific combination may be useful for treatment of a wide range of solid tumors and hematological malignancies. Beyond MGD013, MacroGenics is generating and evaluating multiple other candidates that target a range of immune regulatory molecules using its DART platform as well as its Trident platform for generating tri-specific molecules.

· MGD014: MacroGenics presented pre-clinical data on MGD014, a DART molecule that is being developed to eliminate latent HIV infection. MGD014 will be developed under a contract recently awarded by the National Institute of Allergy and Infectious Diseases for up to $24.5 million. This is the first infectious disease DART program planned for clinical testing.

Corporate Update

· Equity Offering: In July, the Company completed an equity offering, raising $141 million in net proceeds, which included exercise of the underwriters’ over-allotment option in full. MacroGenics is using the proceeds of this offering to expand its manufacturing capacity and accelerate development of immune regulatory-based product candidates, including MGD013, advance other research and development programs, in-license or acquire other products or technologies, and for general corporate purposes.

· Partners’ DART Molecules Advance: As previously announced, MacroGenics’ collaboration partner, Janssen Biotech, Inc., paid the Company a $10 million milestone during the third quarter of 2015 after dosing a first patient in an open-label Phase 1 study of MGD011. Also, in October 2015, MacroGenics’ collaboration partner, Boehringer Ingelheim, selected a DART molecule for further pre-clinical development. This triggers a $5 million milestone payment to MacroGenics under an October 2010 agreement to discover, develop and commercialize DART therapeutics.

· Manufacturing Expansion: During the third quarter, the Company signed a lease for additional space with a focus on expanding its commercial manufacturing capabilities.

Third Quarter 2015 Financial Results

· Cash Position: Cash and cash equivalents as of September 30, 2015 were $365.8 million, compared to $157.6 million as of December 31, 2014. The Company expects that its cash balance should fund operations into 2018.

· Revenue: Total revenues, consisting primarily of revenue from collaborative research, were $14.7 million for the three-month period ended September 30, 2015 compared to $18.4 million for the three-month period ended September 30, 2014. Collaborative research revenue includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the quarter.

· R&D Expenses: Research and development expenses were $24.1 million for the three-month period ended September 30, 2015, compared to $18.6 million for the three-month period ended September 30, 2014. This increase was primarily due to preparations for and launch of the margetuximab SOPHIA Phase 3 study, increased activity to prepare for the MGD009 Investigational New Drug (IND) application submission, and costs of other ongoing clinical studies.

· G&A Expenses: General and administrative expenses were $6.0 million for the three-month period ended September 30, 2015, compared to $3.7 million for the three-month period ended September 30, 2014. This increase was primarily due to higher labor-related costs, including stock-based compensation expense and information technology-related expenses.

· Net Loss: Net loss was $15.4 million for the three-month period ended September 30, 2015, compared to net loss of $3.9 million for the three-month period ended September 30, 2014.

· Shares Outstanding: Shares outstanding as of September 30, 2015 were 34,248,240.

8-K – Current report

On November 4, 2015 Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, reported financial results for the three-month period ended September 30, 2015 (Filing, 8-K, Spectrum Pharmaceuticals, NOV 4, 2015, View Source [SID:1234507957]).

"The highest priority of the Company remains SPI-2012, which is a late-stage drug that could compete in the multi-billion dollar neutropenia market," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We had a productive meeting last week with the FDA and expect to finalize our SPA on SPI-2012 quickly. We have a meeting with the FDA this Friday to discuss EVOMELA’s Complete Response Letter and we feel confident in bringing EVOMELA to the market for patients. Before the end of this year, we look forward to filing the NDA for our bladder cancer drug apaziquone and initiating a Phase 2 breast cancer trial for poziotinib in the U.S. shortly. We believe the infrastructure that we have built over the years serves as a strong foundation for continued future growth."

Pipeline Update- Two Potential Blockbusters and One Near-term NDA Submission:

• SPI-2012, a novel long-acting GCSF: In a Phase 2 dose ranging study, SPI-2012 was shown to be superior at the higher dose tested and non-inferior at the middle dose in decreasing the duration of severe neutropenia compared to the blockbuster drug pegfilgrastim. SPI-2012 was also shown to have an acceptable safety profile with no significant dose-related or unexpected toxicities. The Phase 2 data will be presented at the San Antonio Breast Cancer Symposium. Spectrum has continued to have productive discussions with the FDA, expects to finalize the pivotal study design this year, and start the study shortly after reaching SPA agreement with the Agency. Over 80 study sites have already been qualified.

• Apaziquone, a potent tumor-activated pro-drug for non-muscle invasive bladder cancer: By year end, Spectrum expects to file the NDA based on the previous Phase 3 studies. The Company has also initiated enrollment in an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement, and treated the first patient in late October. This Phase 3 study has been specifically designed to address important lessons learned from the previous apaziquone Phase 3 studies, as well as recommendations made by the FDA.

• EVOMELA, a propylene-glycol free melphalan formulation with improved stability: Spectrum is actively addressing the non-clinical issues raised in the Complete Response Letter regarding the EVOMELA NDA. FDA has granted a Type A meeting for November 6, 2015 and the company believes these issues can be swiftly resolved. Spectrum plans to launch this drug with our existing sales force.

11500 S. Eastern Ave., Ste. 240 • Henderson, Nevada 89052 • Tel: 702-835-6300 • Fax: 702-260-7405 • www.sppirx.com • NASDAQ: SPPI

• Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: The Company plans to initiate a breast cancer program in the U.S., based on compelling Phase 1 efficacy data in breast cancer patients who had failed multiple other HER-2 directed therapies. In addition, multiple Phase 2 studies funded by our partner, Hanmi Pharmaceuticals, are currently ongoing in South Korea.

Three-Month Period Ended September 30, 2015 (All numbers are approximate)

GAAP Results
Total product sales were $28.5 million in the third quarter of 2015. Total product sales decreased 41% from $47.9 million in the third quarter of 2014.

Product sales in the third quarter included: FUSILEV (levoleucovorin) net sales of $11.1 million, FOLOTYN (pralatrexate injection) net sales of $8.7 million, ZEVALIN (ibritumomab tiuxetan) net sales of $4.8 million, MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $1.3 million and BELEODAQ (belinostat for injection) net sales of $2.6 million.

Spectrum recorded net loss of $18.7 million, or $(0.28) per basic and diluted share in the three-month period ended September 30, 2015, compared to net loss of $11.5 million, or $(0.18) per basic and diluted share in the comparable period in 2014. Total research and development expenses were $9.9 million in the quarter, as compared to $14.4 million in the same period in 2014. Selling, general and administrative expenses were $19.4 million in the quarter, compared to $24.1 million in the same period in 2014.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $7.9 million, or $(0.12) per basic share and diluted share in the three-month period ended September 30, 2015, compared to non-GAAP net income of $5.3 million, or $0.08 per basic and $0.07 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $9.4 million, as compared to $14.0 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $17.2 million, as compared to $21.3 million in the same period in 2014.

2015 Financial Guidance

Spectrum raises guidance on year-end cash to over $125 million, up from the Company’s previous guidance of $110 million excluding any new business development transactions.

8-K – Current report

On November 4, 2015 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, reported a corporate update and financial results for the third quarter ending September 30, 2015 (Filing, 8-K, Five Prime Therapeutics, NOV 4, 2015, View Source [SID:1234507956]).

"Our accomplishments since the second quarter have been transformational for Five Prime in many ways— highlighting our ability to discover and develop candidates and combinations to drive future immuno-oncology therapies, expanding our clinical programs and immuno-oncology pipeline, and strengthening our financial base going forward to augment and accelerate all of these activities," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "We recently announced an exciting license and collaboration agreement with Bristol-Myers Squibb (BMS) for our anti-CSF1R antibody, FPA008, which is a product of Five Prime’s proprietary discovery platform and our identification of IL-34, one of the ligands that FPA008 blocks. As this agreement illustrates, we are well equipped to identify new approaches for modulating the tumor microenvironment, and we will leverage this ability as we look internally and externally at opportunities to grow our pipeline. It also demonstrates the quality of our clinical capabilities, and we look forward to continuing development of FPA008 in certain areas alongside BMS, and advancing our FPA144 and GITR programs."

Business Highlights and Recent Developments

Clinical Pipeline:

• FPA008: FPA008 is an antibody that inhibits colony stimulating factor-1 receptor (CSF1R) and has been shown to block the activation and survival of monocytes and macrophages in vivo. In particular, inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment.

• Established Exclusive Worldwide License and Collaboration Agreement with Bristol-Myers Squibb (BMS) for FPA008. In October, Five Prime and BMS entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of FPA008. In addition to the $350 million upfront payment, Five Prime will be eligible to receive development and regulatory milestone payments for each anti-CSF1R antibody product as follows: up to $1.05 billion for combinations with OPDIVO (nivolumab) and other BMS or Five Prime oncology products and up to $340 million for therapeutic uses in pigmented villonodular synovitis (PVNS) and non-oncology indications. BMS will be responsible for manufacturing and global commercialization. FivePrime will be eligible to receive tiered royalty percentages ranging from the high teens to the low twenties on future worldwide net sales of FPA008 and other anti-CSF1R antibody products developed by BMS, and retains a U.S. co-promotion option for an additional low single-digit royalty. Importantly, Five Prime will lead and execute the three trials that are currently underway and has the ability to continue development of FPA008 in PVNS, in combination with its own oncology pipeline, and in non-oncology indications. The agreement is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act (HSR) and will become effective once clearance is received.

• Initiated Phase 1a/1b FPA008/OPDIVO Combination Trial. In September 2015, Five Prime initiated patient dosing in the Phase 1a/1b clinical trial evaluating the immunotherapy combination of FPA008 with OPDIVO, Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, in eight tumor settings. The trial is exploring the safety, tolerability and preliminary efficacy of the combination in patients with non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma and now includes two arms of anti-PD-1 resistant patients. The trial also was featured in a trial-in-progress poster at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September. Five Prime will continue to conduct the trial under the license agreement with BMS and expects to complete Phase 1a dose escalation and expand into Phase 1b with the selected dose of FPA008 in early 2016.

• Initiated Phase 1/2 Clinical Trial of FPA008 in Pigmented Villonodular Synovitis (PVNS). In July, Five Prime initiated patient dosing in its Phase 1/2 clinical trial of FPA008 in PVNS, a CSF1R-driven tumor and an orphan indication. During the Phase 1 dose escalation portion of the trial, Five Prime is assessing safety and pharmacodynamics of selected doses of FPA008 to determine the dose for expansion. During the Phase 2 expansion, the company will evaluate tumor response rate and duration, as well as measures of pain and joint function, in approximately 30 patients. Five Prime is entitled to continue independent development in PVNS under the BMS license agreement and expects to complete dose escalation and move into dose expansion in early 2016.

• Continued Dosing Rheumatoid Arthritis (RA) Patients in Open-Label Portion of Phase 1 Clinical Trial of FPA008. During the quarter, Five Prime continued to dose FPA008 in RA patients with active disease who are on methotrexate in its Phase 1 clinical trial. The company is scheduled to present preliminary open-label data from RA patients on November 10, 2015, at the American College of Rheumatology Annual Meeting. Five Prime plans to complete the open-label portion of the trial but does not intend to proceed with a randomized cohort or to conduct additional RA trials at this time in order to focus development of FPA008 in immuno-oncology and PVNS.

• Continued Enrollment in the Phase 1 Clinical Trial of FPA144. Five Prime continued to enroll the Phase 1a/1b clinical trial of FPA144, a selective ADCC-

enhanced antibody in development as a targeted therapy for tumors that over-express FGFR2b. By the end of 2015, the company expects to complete Phase 1a dose escalation in patients with solid tumors, including gastric cancer, and to begin the Phase 1b expansion at a selected dose in gastric cancer patients whose tumors over-express FGFR2b.

• Initial Data from Phase 1b Clinical Trial of FP-1039/GSK3052230 Presented at World Conference on Lung Cancer. Initial safety and efficacy data from GlaxoSmithKline’s ongoing Phase 1b clinical trial of FP-1039/GSK3052230, an FGF ligand trap, were featured in an oral presentation during the World Conference on Lung Cancer in September 2015. The three-arm study is still underway in patients with newly-diagnosed or recurrent FGFR1 gene-amplified squamous non-small cell lung cancer and malignant pleural mesothelioma.

Research Programs and Collaborations:

• Established New GITR Antibody Program. Five Prime established a research collaboration and license agreement for Inhibrx’s novel multivalent glucocorticoid-induced tumor necrosis factor receptor (GITR) antibodies. The program is currently at lead selection stage and the company is targeting an IND for 2017. Using its comprehensive protein library and proprietary in vivo screening technologies, Five Prime identified the GITR pathway as one of the most potent inhibitors of tumor growth and these agonist antibodies have the potential to be additive or synergistic with other immuno-oncology therapies and candidates in Five Prime’s portfolio. Five Prime paid an upfront fee of $10 million to Inhibrx in July 2015.

• GlaxoSmithKline (GSK) and UCB Pharma (UCB) Reserved Targets Discovered by Five Prime. In September, GSK exercised its option to reserve specific targets discovered by Five Prime under the respiratory diseases research collaboration between the companies, triggering a $300,000 payment. In September, UCB exercised its option to reserve certain targets discovered by Five Prime under its discovery collaboration with Five Prime in the area of fibrosis-related inflammatory diseases, triggering $140,000 in payments.

• Expanded Antibody Capabilities with License to Human Antibody Generation Platforms. The company continues to expand its antibody capabilities and internal expertise to capitalize on immuno-oncology targets identified using Five Prime’s discovery platform and to move candidates rapidly toward INDs. During October, Five Prime secured a license from Open Monoclonal Technology (OMT) to access mono- and bi-specific antibody platforms and antibody repertoire sequencing technology for the generation of novel therapeutic candidates. These platforms are designed to deliver human antibodies with high affinity, specificity, expression, solubility and stability and current OMT partners include leading pharmaceutical and biotech companies.
Summary of Financial Results and Guidance:

• Cash Position. Cash, cash equivalents and marketable securities totaled $183.4 million on September 30, 2015 compared with $149.1 million on December 31, 2014. The increase was primarily attributable to Five Prime’s January 2015 public offering of common stock, offset by cash used in operations. This does not include the $350 million upfront payment from BMS the company expects to receive under the FPA008 license and collaboration agreement.

• Revenue. Collaboration and license revenue for the third quarter of 2015 decreased by $0.2 million to $5.9 million from $6.1 million in the third quarter of 2014.

• R&D Expenses. Research and development expenses for the third quarter of 2015 increased by $14.9 million, or 152%, to $24.7 million from $9.8 million in the third quarter of 2014. This increase was primarily related to in-licensing GITR antibodies, advancing the FPA008 development program into additional indications and expanding the company’s internal immuno-oncology research and preclinical activities.

• G&A Expenses. General and administrative expenses for the third quarter of 2015 increased by $1.8 million, or 53%, to $5.2 million from $3.4 million in the third quarter of 2014. This increase was primarily due to increases in personnel related expenses, including stock-based compensation, and facility costs.

• Net Loss. Net loss for the third quarter of 2015 was $24.0 million, or $0.93 per basic and diluted share, compared with a net loss of $7.1 million, or $0.33 per basic and diluted share, for the third quarter of 2014. This increase in net loss was primarily related to in-licensing GITR antibodies, advancing the FPA008 development program into additional indications and expanding internal immuno-oncology research and preclinical activities.

Updated 2015 Guidance. Five Prime expects to have in excess of $500 million in cash, cash equivalents and marketable securities upon receipt of the $350 million upfront payment under the agreement with BMS for FPA008, which we expect to receive in 2015 after HSR clearance. Five Prime currently anticipates recognizing the $350 million upfront payment from BMS as revenue in the fourth quarter of 2015 and to be able to utilize substantially all of its existing net operating loss carryforwards to partially offset taxable income in 2015. Five Prime continues to expect full-year 2015 net cash used in operating activities to be between $65 and $70 million, without giving consideration to the $350 million upfront payment expected from BMS.