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Foundation Medicine Announces 2015 Third Quarter Results and Recent Highlights

On November 3, 2015 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its third quarter ended September 30, 2015 (Press release, Foundation Medicine, NOV 3, 2015, View Source [SID:1234507926]). Highlights for the quarter included:

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Third quarter revenue of $25.4 million, 54% year-over-year growth;
Third quarter revenue from biopharmaceutical customers of $11.7 million, 75% year-over-year growth;
Third quarter revenue from clinical testing of $13.7 million, 40% year-over-year growth;
8,012 clinical tests reported in the third quarter, 25% year-over-year growth;
Broadening molecular information solutions with the launch of GeneKit, a genomic solutions portal for pathologists, and expanding FoundationCORE to approximately 60,000 patient cases;
United Healthcare’s published medical policy for coverage of highly validated genomic profiling in patients with non-small cell lung cancer; and,

Launching the Precision Medicine Exchange Consortium(PMEC) with eight leading academic and community-based cancer centers, including The Cleveland Clinic’s Taussig Cancer Institute, Hackensack University Medical Center, and Sidney Kimmel Cancer Center at Thomas Jefferson University.

Foundation Medicine reported total revenue of $25.4 million in the third quarter of 2015, compared to $16.4 million in the third quarter of 2014 and $22.5 million in the second quarter of 2015. Revenue from clinical testing in the third quarter of 2015 was $13.7 million, compared to $9.8 million in the third quarter of 2014 and $12.4 million in the second quarter of 2015.

The company reported 8,012 clinical tests in the third quarter of 2015, a 25% increase from the same quarter last year. This number includes 7,000 FoundationOne tests and 1,012 FoundationOne Heme tests. The results of an additional 2,676 tests were also reported to biopharmaceutical customers in this year’s third quarter.

Revenue from biopharmaceutical customers grew to $11.7 million in the third quarter, a 75% increase from the same quarter last year and an increase of 17% from the second quarter of 2015. This growth underscores the diverse revenue streams generated by biopharmaceutical customers engaged with the company in clinical trial, molecular information data access, and companion diagnostic development activities.

"Foundation Medicine delivered 54% year-over-year revenue growth driven by particularly strong results from our biopharmaceutical business," said Michael Pellini, M.D., chief executive officer of Foundation Medicine. "While our third quarter clinical revenue and volume increased significantly year-over-year, these numbers also reflect that we have work to do in this nascent market. We believe we are well-positioned for continued growth over the near and long term with our fully integrated, diversified business, a growing pipeline of innovative products, a strong balance sheet and a global partner in Roche."

The company’s cancer knowledgebase, FoundationCORE, grew to approximately 60,000 clinical cases. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers. The increasing scale and breadth of a high quality, clinically relevant oncology data set derived from the company’s analytically validated testing platform continues to enhance clinical practice and enable improved outcomes for patients.

Total operating expenses for the third quarter of 2015 were approximately $35.6 million compared with $21.9 million for the third quarter of 2014. Net loss was approximately $20.6 million in the third quarter of 2015, or a $0.60 loss per share. At September 30, 2015, the company held approximately $250 million in cash and cash equivalents.

Recent Enterprise Highlights

At the end of October, Roche Pharmaceuticals (Israel) Ltd. commenced commercial activities in support of the company’s molecular information products in oncology. Roche Israel will act as the exclusive distributor of Foundation Medicine’s products and services.

United Healthcare published a medical policy for coverage of highly validated genomic profiling in patients with non-small cell lung cancer.

In September, Foundation Medicine launched the Precision Medicine Exchange Consortium (PMEC) to advance the integration of molecular information in clinical oncology and accelerate the adoption of precision care. PMEC brings together thought leaders from academic medical centers, regional hospital systems and community oncology networks to exchange molecular information and outcomes data.

In September, Foundation Medicine expanded its molecular decision support offerings with GeneKit, a genomic solutions portal for pathologists. GeneKit easily integrates into the pathologist’s workflow and expedites and improves the interpretation, analysis and reporting of genomic data for clinical use.

In September, Foundation Medicine successfully completed the migration of its physician customers to the newest version of Interactive Cancer Explorer, FoundationICE, which also includes the PatientMatch application that was launched commercially in May 2015.

2015 Outlook

The company anticipates 2015 revenue will be in the range of $85 to $95 million.
The company expects to report between 32,000 and 33,000 clinical tests in 2015.
The company expects operating expenses in the range of $128 to $138 million, plus an additional $14.4 million one-time expense during the second quarter related to advisor fees in connection with the closing of the Roche strategic collaboration.
The company expects to launch a circulating tumor DNA (ctDNA) test for its biopharmaceutical partners by year-end, and a commercial ctDNA assay for clinical testing in 2016.

8-K – Current report

On November 3, 2015 Fate Therapeutics, Inc. (NASDAQ: FATE), a biopharmaceutical company dedicated to the development of programmed cellular immunotherapeutics for the treatment of cancer and immune disorders, reported business highlights and financial results for the third quarter ended September 30, 2015 (Filing, 8-K, Fate Therapeutics, NOV 3, 2015, View Source [SID:1234507925]).

"We have firmly established a leadership position in a unique and broadly applicable strategy for cancer immunotherapy — the production of T cells and NK cells from pluripotent cells, bringing an off-the-shelf approach to the field of cell-based immunotherapies," said Scott Wolchko, Chief Operating and Financial Officer of Fate Therapeutics. "Additionally, our clinical experience with PROHEMA, preclinical studies with PROTMUNE and research collaborations with Juno Therapeutics and the University of Minnesota all provide compelling support that the administration of programmed immune cells to patients fighting cancer will serve as a cornerstone treatment paradigm."

Recent Highlights & Upcoming Milestones

· Off-the-Shelf Cancer Immunotherapy Strategy to be Presented at ASH (Free ASH Whitepaper) 2015 Annual Meeting. The Company’s patent-protected pluripotent cell platform combines genetic engineering of pluripotent cells with rapid and efficient generation of immune cells, enabling production of off-the-shelf engineered T- and NK-cell-based therapeutics without requiring patient-sourced cells. Fate plans to present its novel strategy for developing off-the-shelf cancer immunotherapies using its pluripotent cell platform during two poster sessions at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2015 Annual Meeting.

· NK-Cell Cancer Immunotherapeutic Undergoing Preclinical Development. In July 2015, Fate entered into a collaboration with the University of Minnesota to enable clinical development of a novel population of "adaptive" NK cells, which exhibit prolonged persistence and enhanced anti-tumor activity mediated through CD16 signaling in preclinical studies. The Company’s development strategy seeks to use "adaptive" NK cells in combination with solid tumor-targeting antibodies to induce potent killing of cancer cells.

· PROTMUNE IND Filing Planned. The Company expects to initiate a first-in-human clinical trial in 2016 to investigate the potential of PROTMUNE to prevent the life-threatening complications of acute graft-versus-host disease (GvHD) and severe infections in patients undergoing mobilized peripheral blood (mPB) transplantation. During an ASH (Free ASH Whitepaper) 2015 Annual Meeting poster session, Fate plans to present scientific findings showing that a single administration of programmed peripheral blood cells resulted in a statistically-significant reduction in GvHD score and improvement in survival as compared to vehicle-treated peripheral blood cells in preclinical models.

· PUMA Study Reaches 70% of Target Enrollment. Fate is currently preparing a second interim data-cut from its ongoing Phase 2 PUMA study of PROHEMA in adult patients undergoing double umbilical cord blood transplantation for the treatment of hematologic malignancies. The Company expects to report additional data on neutrophil engraftment and severe infection-related adverse events from the PUMA study during the 2015 ASH (Free ASH Whitepaper) Annual Meeting.

· Leadership Transition. On October 12, 2015, the Company announced that Scott Wolchko, a Fate founder and the Company’s Chief Operating & Financial Officer, will succeed Christian Weyer, M.D., M.A.S., as President and Chief Executive Officer, effective December 1. The Company also announced that Stewart Abbot, Ph.D. has been named Chief Development Officer after joining Fate earlier this year from Celgene Cellular Therapeutics, where he was instrumental in developing the company’s hematopoietic cell-based immuno-oncology programs and partnerships. Fate also announced the promotions of Daniel Shoemaker, Ph.D., who joined the Company in 2009, to Chief Scientific Officer, and Cindy Tahl, J.D., who joined the Company in 2009, to General Counsel.

Financial Results

· Cash Position: Cash and cash equivalents as of September 30, 2015 were $72.9 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 $1.0 million for the third quarter of 2015, which was derived from the Company’s collaboration with Juno.

· Total Operating Expenses: Total operating expenses were $7.4 million for the third quarter of 2015, compared to $6.0 million for the third quarter of 2014. Operating expenses for the third quarter of 2015 include $0.6 million of stock compensation expense, compared to $0.5 million for the third quarter of 2014.

· R&D Expenses: Research and development expenses were $5.0 million for the third quarter of 2015, compared to $4.1 million for the third quarter of 2014. The increase in R&D expenses is primarily related to an increase in third-party professional consultant and service provider expenses to support the clinical development of PROHEMA, and an increase in personnel expense, including stock-based compensation expense, resulting from additional headcount to support the conduct of research activities.

· G&A Expenses: General and administrative expenses were $2.4 million for the third quarter of 2015, compared to $1.9 million during the third quarter of 2014. The increase in G&A expenses is primarily related to an increase in personnel expense, including stock-based compensation expense.

· Common Shares Outstanding: Common shares outstanding as of September 30, 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.

Endocyte Reports Third Quarter 2015 Financial Results and Provides Update on Clinical Progress

On November 3, 2015 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 third quarter ending Sept. 30, 2015, and provided a clinical update (Press release, Endocyte, NOV 3, 2015, View Source [SID:1234507923]).

"Our Phase 1 dose escalation trials of the folate receptor (FR)- and prostate-specific membrane antigen (PSMA)-targeted tubulysin SMDCs, EC1456 and EC1169, continue to progress well. Both SMDCs are being dose escalated on two different schedules," said Ron Ellis, Endocyte’s president and chief executive officer. "Once we have determined the maximum tolerated dose and optimal schedule for each SMDC, we look forward to moving into expansion cohorts where we will evaluate these SMDCs specifically in receptor-positive patients among different tumor types, both as single agents and in combination with standard of care drugs."

Earlier in the third quarter, Endocyte announced the final results from the Phase 2b TARGET trial evaluating its SMDC vintafolide in combination with docetaxel in patients with FR positive recurrent non-small cell lung cancer (NSCLC) at the World Conference on Lung Cancer in Denver, Colorado. Vintafolide plus docetaxel improved overall survival (OS) by 2.7 months in NSCLC regardless of histology (Median OS 11.5 vs. 8.8 months, OS HR=0.86, 95% CI [0.58, 1.26]). In the predefined subset analysis of patients with adenocarcinoma, which expresses higher levels of FR, vintafolide plus docetaxel improved OS by 5.9 months (12.5 vs. 6.6 months, HR=0.72, 95% CI [0.44, 1.16]). This data is in line with earlier findings from the study of improved progression free survival and higher overall response rates. Final safety results were also consistent with those previously reported.

Third Quarter 2015 Financial Results

Endocyte reported a net loss of $10.0 million, or $0.24 per basic and diluted share, for the third quarter of 2015, compared to a net loss of $5.7 million, or $0.14 per basic share and diluted share, for the same period in 2014. The third quarter of 2014 included the recognition of $3.9 million of revenue related to the former collaboration with Merck.

Research and development expenses were $6.6 million for the third quarter of 2015, compared to $5.7 million for the same period in 2014. The increase in research and development expense was primarily attributable to an increase in expenses for the EC1456 and EC1169 dose escalation trials, the drug manufacturing expense of EC1456, and an increase in compensation expense, including noncash stock compensation, partially offset by the decrease in manufacturing expenses of etarfolatide, our folate-targeted companion molecular imaging agent to vintafolide and EC1456.

General and administrative expenses were $3.8 million for the third quarter of 2015, compared to $4.0 million for the same period in 2014. The decrease in expenses was primarily attributable to a reduction in legal and patent fees, slightly offset by an increase in compensation expense, including noncash stock compensation.

Cash, cash equivalents and investments were $180.3 million at September 30, 2015, compared to $211.1 million at September 30, 2014, and $206.8 million at December 31, 2014.

Financial Expectations

The Company updated its 2015 financial expectations and now anticipates that its 2015 year-end cash balance will be approximately $170 million.

Immune Design Presents Preclinical Data on G100 and ZVex(TM) in Combination With Check Point Inhibitors at the 2015 Society for Immunotherapy of Cancer Annual Meeting

On November 3, 2015 Immune Design (Nasdaq:IMDZ), a clinical-stage immunotherapy company focused on oncology reported new preclinical data showing that a dendritic-cell targeting lentiviral vector from its ZVex immunotherapy platform administered with G100, which contains a potent synthetic TLR4 agonist, synergize with immune check point inhibitors and demonstrate potent local and systemic anti-tumor activity in cancer models (Press release, Immune Design, NOV 3, 2015, View Source [SID:1234507922]). These data are being presented at the 30th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference, National Harbor, Maryland, November 4-8, 2015.

"These findings further illustrate the potential of ZVex-based product candidates and G100 to play an important role in the emerging field of cancer immunotherapy, especially in potential combination therapies with immune checkpoint inhibitors," said Jan ter Meulen, MD, PhD, Chief Scientific Officer at Immune Design. "Mechanistically, it is generally believed that the generation of tumor-specific CD8 T-cells can improve the clinical efficacy of checkpoint inhibitors, especially in patients with insufficient T-cell responses. These preclinical data provide a strong rationale for our ongoing and planned clinical trials which combine LV305, CMB305 and G100, agents from our ZVex and GLAAS discovery platforms, with KEYTRUDA and Atezolizumab."

In the presentations, Immune Design scientists present data showing that in the murine B16 melanoma model, intratumoral injection of G100 improves the trafficking of ZVex-induced antigen-specific CD8 T-cells into tumors and induces systemic anti-tumor immunity mediated by antigen spreading. This discovery that Immune Design’s two platforms appear to "pull" T cells (G100) that were "primed" (ZVex agent) into the tumor potentially opens up new possibilities of enhancing the immunotherapy of solid tumors by changing the tumor microenvironment. In addition, combining G100 or a ZVex agent with both anti-PD1 and anti-PDL1 antibodies demonstrated increased efficacy in this experiment. The presentations are entitled "Intratumoral Injections of G100 (synthetic TLR4 agonist) Increases Trafficking of Lentiviral Vector-induced Antigen-specific CD8 T Cells to the Tumor Microenvironment" and "Checkpoint Inhibitors Synergize with Therapeutic Platforms, ZVex and GLAAS by Enhancing Lentiviral Vector-induced Tumor-specific Immunity and Adjuvant-mediated Anti-tumor Efficacy."

These abstracts will be published in the Journal for ImmunoTherapy for Cancer on November 4, 2015, and the posters will be posted on the publications page of the Immune Design website following presentation at the conference.

About G100

G100 is a product candidate generated from the company’s GLAASTM discovery platform, and includes a specific formulation of Glucopyranosyl Lipid A (GLA), a synthetic, toll-like receptor-4 (TLR-4) agonist. G100 is part of Immune Design’s intratumoral immune activation, or ‘Endogenous Antigen’ approach to treating cancer, which leverages the activation of dendritic cells, T cells and other immune cells in the tumor microenvironment to potentially create a robust immune response against the tumor’s preexisting diverse set of antigens. Preclinical and clinical data have demonstrated the ability of G100 to activate dendritic cells in tumors and to increase antigen-dependent systemic humoral and cellular Th1 immune responses. A Phase 1 study of G100 in patients with Merkel cell carcinoma (MCC) recently completed enrollment, and Immune Design presented data at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In the first eight patients in MCC study, G100 had an acceptable safety profile and the combined therapy of G100 followed by radiation and/or surgery resulted in an objective response rate (ORR) of 50%. A second Phase 1 trial is planned to examine intratumoral administration of G100 with intravenous administration of KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with follicular non-Hodgkin’s lymphoma receiving local radiation. In addition to an evaluation of the safety of the combination, the study will assess the response in both injected and non-injected lesions.

About ZVex

ZVex is Immune Design’s discovery platform designed to activate and expand the immune system’s natural ability to create tumor-specific cytotoxic T cells (CTLs) in vivo.

The ZVex delivery system uses a re-engineered virus to carry genetic information of a tumor antigen selectively to dendritic cells (DCs) in the skin. This ultimately results in the creation of CTLs designed to kill tumor cells bearing that same specific tumor antigen.

Genmab Announces Financial Results for the First Nine Months of 2015 and Improves 2015 Financial Guidance

On November 3, 2015 Genmab reported Interim Report for the Nine Months Ended September 30, 2015 (Press release, Genmab, NOV 3, 2015, View Source [SID:1234507921]).

Daratumumab granted Priority Review by U.S. Food and Drug Administration (FDA) and accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)

Achieved USD 25 million in milestone payments from Janssen related to the regulatory applications submitted to the FDA and EMA for daratumumab

Regulatory submissions for ofatumumab (Arzerra) as maintenance therapy for relapsed chronic lymphocytic leukemia (CLL) submitted by Novartis to the EMA and FDA — Priority Review granted by FDA

Entered commercial license agreement with Novo Nordisk for DuoBody technology

Improved operating result by DKK 151 million over the first nine months of 2014

2015 financial guidance improved

"The third quarter was certainly a busy one in terms of regulatory filings for our antibody programs. We were very pleased that the FDA granted Priority Review and the EMA granted accelerated assessment to the regulatory applications for daratumumab in heavily pretreated or double refractory multiple myeloma patients. Regulatory submissions for ofatumumab as maintenance treatment for relapsed CLL were also submitted in the US and Europe and the US application received Priority Review. We also announced a new commercial agreement for the DuoBody technology with Novo Nordisk this quarter. With the end of the year coming up fast, we will continue to work towards our annual goals, while maintaining our focus on our vision of transforming cancer treatment," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months
Revenue was DKK 558 million in the first nine months of 2015 compared to DKK 635 million in the first nine months of 2014. The decrease of DKK 77 million or 12% was mainly driven by lower milestone and cost reimbursement revenue under our daratumumab collaboration with Janssen.

Operating expenses were DKK 380 million in the first nine months of 2015 compared to DKK 431 million in the first nine months of 2014. The decrease of DKK 51 million or 12% was primarily related to a decrease in costs associated with the ofatumumab and daratumumab programs, which was partly offset by increased investment in our research and development pipeline.
Operating income was DKK 355 million in the first nine months of 2015 compared to DKK 204 million in the first nine months of 2014. The improvement of DKK 151 million was driven by the positive effect from the reversal of the ofatumumab funding liability of DKK 176 million combined with lower expenses, which were partly offset by decreased revenue.

On September 30, 2015, Genmab had a cash position of DKK 3,206 million. This represented a net increase of DKK 545 million from December 31, 2014, which was driven primarily by the proceeds from exercise of warrants of DKK 598 million partly offset by the increased investment in our research and development activities to advance our pipeline of products.

Business Progress Third Quarter to Present

Daratumumab
September: The CHMP of the EMA granted accelerated assessment to the Marketing Authorization Application (MAA) for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma.

September: The MAA for daratumumab as a treatment for patients with relapsed and refractory multiple myeloma was submitted to the EMA by Janssen-Cilag International NV. The submission triggered a USD 10 million milestone payment to Genmab from Janssen.

September: The U.S. FDA granted Priority Review to the Biologics License Application (BLA) for daratumumab as a treatment for patients with double refractory multiple myeloma. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.

July: The rolling submission of a BLA to the U.S. FDA for daratumumab was completed by Janssen, triggering a USD 15 million milestone payment to Genmab.

Other
September: The U.S. FDA granted Priority Review to the sBLA for ofatumumab as maintenance therapy for patients with relapsed CLL. The FDA assigned a PDUFA target date of January 21, 2016.

August: Entered an agreement granting Novo Nordisk commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs.

July: Announced that Novartis submitted regulatory applications to the EMA and FDA for the use of ofatumumab as maintenance therapy for patients with relapsed CLL.

Q4 Events
October: Achieved five pre-clinical milestones under our DuoBody technology collaboration with Janssen, triggering total payments of USD 8.5 million to Genmab.

Outlook
Genmab is improving its 2015 financial guidance published on August 19, 2015, due to increased revenue and lower operating expenses resulting in increased operating income and cash position.