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8-K – Current report

On March 9, 2016 Mirati Therapeutics, Inc. (NASDAQ: MRTX) reported financial results for the fourth quarter and full year ended December 31, 2015 and provided an update on its drug development programs (Filing, Q4/Annual, Mirati, 2015, MAR 9, 2016, View Source [SID:1234509450]).

"We made significant progress across our entire pipeline in 2015, setting up a potentially transformative year for the Company in 2016," said Charles M. Baum, M.D., Ph.D., president and CEO of Mirati. "After reporting initial results in our Phase 1b dose expansion clinical trial for glesatinib last fall, which included two confirmed responses in non-small cell lung cancer patients, we have quickly moved into a Phase 2 clinical trial utilizing our diagnostic collaborations with Guardant Health and Foundation Medicine to help us identify which NSCLC patients we believe are most likely to respond."

"We expect to see updated data from both of those trials later this year, as well as data from our Phase 1b dose expansion clinical trial for sitravatinib, and we are looking forward to starting our Phase 2 combination trial in immuno-oncology for mocetinostat in the second quarter. Following our successful financing last September, we are now poised to capitalize on the significant potential of our targeted cancer therapies for patients in need of better treatment options."

2015 Operational Highlights

Glesatinib (MGCD265): Molecularly targeted kinase inhibitor

· In September 2015, presented data at the World Conference on Lung Cancer 2015 demonstrating the favorable tolerability and clinical efficacy of MGCD265 in a Phase 1b dose expansion clinical trial
· In December 2015, initiated a single arm, open-label Phase 2 clinical trial in NSCLC patients with driver alterations in MET — which occur in up to 7% of NSCLC patients
· In December 2015, announced a collaboration with Guardant Health to use the Guardant360 diagnostic tool in the Phase 2 clinical trial to screen NSCLC patients for certain genetic alterations to the MET pathway in order to identify those patients we believe are most likely to respond to MGCD265
· In December 2015, announced a separate collaboration with Foundation Medicine for the development of a companion diagnostic test for MGCD265 in NSCLC

Sitravatinib (MGCD516): Molecularly targeted kinase inhibitor

· In September 2015, presented interim clinical data from the ongoing Phase 1 dose escalation clinical trial of MGCD516 in patients with advanced solid tumors at the European Cancer Congress (ECC) 2015:
· Demonstrated that MGCD516 is well tolerated with a favorable pharmacokinetic profile
· Established recommended Phase 2 dose of 150 mg QD

· In December 2015, initiated the Phase 1b dose expansion clinical trial in genetically selected patients
· Initial focus on NSCLC in patients with genetic driver mutations, including RET, CHR4q12, CBL, Trk and DDR with exploratory cohorts in other solid tumors where the MGCD516 profile may provide benefit

Mocetinostat (MGCD103): Class I & IV HDAC inhibitor

· In August 2015, announced an immuno-oncology clinical trial collaboration with MedImmune, the global biologic research and development arm of AstraZeneca, to evaluate the safety and efficacy of mocetinostat in combination with durvalumab, an investigational anti-PD-L1 immune checkpoint inhibitor
· Phase 2 clinical trial will be conducted in patients with NSCLC including those who are PD-L1 low and who have failed prior checkpoint inhibitor treatment, two significant areas of unmet medical need

Corporate:

· Executed two successful financings in 2015, generating net proceeds of $143.3 million for the Company
· In February 2015, completed offering of 2.6 million shares of common stock at $20.00 per share
· In September 2015, completed offering of 2.3 million shares of common stock at $45.00 per share

2016 Milestones

· Update on Phase 1b dose expansion clinical trial of MGCD265 expected in the second quarter of 2016
· Initial data from Phase 2 clinical trial of MGCD265 in NSCLC patients with driver alterations in MET is expected by the end of 2016
· Preliminary data from the Phase 1b dose expansion clinical trial for MGCD516 in genetically selected patients is expected in the second half of 2016
· Phase 2 clinical trial for mocetinostat in combination with durvalumab in patients with NSCLC is expected to begin in the second quarter of 2016

Fourth Quarter and Fiscal Year 2015 Financial Results

Cash, cash equivalents, and short-term investments were $122.3 million at December 31, 2015, compared to $29.3 million at December 31, 2014. In September 2015, the Company completed a public offering of 2.3 million shares of its common stock, generating net proceeds of $94.9 million. In February 2015, the Company completed a public offering of 2.6 million shares of its common stock, generating net proceeds of $48.4 million.

Research and development expenses for the fourth quarter of 2015 were $14.9 million, compared to $7.1 million for the same period in 2014. Research and development expenses for the year ended December 31, 2015 were $49.0 million, compared to $26.1 million for the same period in 2014. The increases in research and development expenses primarily reflect costs to advance the clinical development of the Company’s three oncology development programs, MGCD265, MGCD516 and mocetinostat. General and administrative expenses for the fourth quarter of 2015 were $3.6 million, compared to $3.4 million for the same period in 2014. General and administrative expenses for the year ended December 31, 2015 were $15.8 million, compared to $12.7 million for

the same period in 2014. The increases in general and administrative expenses primarily reflect higher non-cash stock-based compensation expense.

Other income and expense, net, was income of $0.1 million for both the fourth quarter of 2015 and 2014. Other income and expense, net, for the year ended December 31, 2015 was income of $0.2 million compared to expense of $4.6 million for the same period in 2014. Other income and expense, net, for the year ended December 31, 2014 primarily reflects losses arising from the change in fair value of our warrant liability. During 2014, we amended the warrant agreements to allow for the warrants to be denominated in U.S. dollars. The amended warrants qualified for equity classification and were reclassified into stockholders’ equity.

Net loss for the fourth quarter of 2015 was $18.4 million, or $0.96 per share basic and diluted, compared to net loss of $10.4 million, or $0.77 per share basic and diluted for the same period in 2014. Net loss for the year ended December 31, 2015 was $64.5 million, or $3.82 per share basic and diluted, compared to net loss of $43.7 million, or $3.24 per share basic and diluted for the same period in 2014.

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Molecular Therapy Publication Highlights Sleeping Beauty Potential in Personalized TCR Gene Therapy

On March 09, 2016 ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on new cancer immunotherapies, reported the publication of an article describing the use of Sleeping Beauty non-viral gene transfer technology to modify T cells for the targeting of neoantigens present within solid tumors (Press release, Ziopharm, MAR 9, 2016, View Source [SID:1234509448]). This approach unlocks the potential for rapid and inexpensive personalized T-cell receptor (TCR) gene therapy aimed at the unique mutations within a patient’s cancer cells. The article, titled "Stable, non-viral expression of mutated tumor neoantigen-specific T-cell receptors using the Sleeping Beauty transposon/transposase system," was published in the journal Molecular Therapy (5 March 2016, doi:10.1038/mt.2016.51), and is available online.

"The DNA plasmids from the Sleeping Beauty platform provide a customizable solution to personalized TCR gene therapy, which is needed to open the door to safely target solid tumors," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of ZIOPHARM and an author of the paper. "There is growing consensus that a non-viral approach to gene therapy will be essential to targeting individual neoantigens. In Sleeping Beauty, we have the only clinically validated non-viral gene transfer platform. This compels us to bring this important technology to patients."

Neoantigens unique to each patient’s tumor can be recognized by autologous T cells through their T-cell receptors, but the low frequency and/or terminal differentiation of mutation-specific T cells may limit their utility as adoptive T-cell therapies. The publication describes how the Sleeping Beauty platform can be used to transfer and stably express TCR genes into T cells while retaining their proliferative potential. Indeed, the Sleeping Beauty gene transfer occurs without the need for cell division thus facilitating the genetic modification of minimally-differentiated T cells. The authors note that the Sleeping Beauty platform "can facilitate the use of personalized T cell therapy targeting unique neoantigens."

The Sleeping Beauty transposon-transposase system was exclusively licensed by Intrexon Corporation (NYSE:XON) through the University of Texas MD Anderson Cancer Center and accessed as part of ZIOPHARM’s collaboration with Intrexon.

8-K – Current report

On March 9, 2016 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 and year ended December 31, 2015 (Filing, Q4/Annual, Spectrum Pharmaceuticals, 2015, MAR 9, 2016, View Source [SID:1234509445]).

"We had solid operating performance this quarter and our pipeline has never been stronger with multiple drugs enrolling in late-stage trials," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer of Spectrum Pharmaceuticals. "We believe each of our late-stage drugs have demonstrated strong clinical data, and can be transformative to the Company. We just started enrolling the pivotal Phase 3 study for SPI-2012 and a Phase 2 study for poziotinib. We have two drugs lined up for FDA decision this year: Evomela in May, and EOquin in December. We remain focused on bringing innovative oncology medicines to the market."

Pipeline Update:

• SPI-2012, a novel long-acting GCSF: A pivotal Phase 3 study was initiated in Q1 2016 and will evaluate SPI-2012 as a treatment for chemotherapy-induced neutropenia in approximately 580 patients with breast cancer. In a Phase 2 dose ranging study, SPI-2012 was shown to have a shorter duration of severe neutropenia at the higher dose tested and comparable at the middle dose 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.

• Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: Spectrum initiated a Phase 2 breast cancer program in the U.S., based on promising Phase 1 efficacy data in breast cancer patients who had failed multiple other HER2-directed therapies. The Company submitted the Phase 2 protocol to the FDA as part of an Investigational New Drug (IND) application in November 2015. In addition, multiple Phase 2 studies are being conducted by Hanmi Pharmaceuticals and National OncoVenture in South Korea.

• EVOMELA, a propylene-glycol free melphalan formulation: After receiving a Complete Response Letter in October, Spectrum was granted a Type A meeting with the FDA on November 6, 2015. Within days, the company resubmitted the NDA and received a PDUFA date of May 9, 2016. If approved, we plan to launch Evomela with our existing sales force.

• EOquin, a potent tumor-activated drug for non-muscle invasive bladder cancer: Spectrum filed an NDA based on the previous Phase 3 studies. The FDA accepted the NDA and has given Spectrum a PDUFA date of December 11, 2016. The FDA also indicated that it plans to hold an advisory committee meeting regarding the NDA. The Company is actively enrolling an additional randomized, placebo-controlled Phase 3 trial under the SPA agreement. The Phase 3 study has been specifically designed to build on learnings from the previous EOquin Phase 3 studies, as well as recommendations from the FDA.

Three-Month Period Ended December 31, 2015 (All numbers are approximate)

GAAP Results

Total product sales were $34.8 million in the fourth quarter of 2015. Total product sales decreased 33% from $51.7 million in the fourth quarter of 2014.

Product sales in the fourth quarter included: FUSILEV (levoleucovorin) net sales of $15.1 million, FOLOTYN (pralatrexate injection) net sales of $10.3 million, ZEVALIN (ibritumomab tiuxetan) net sales of $3.7 million, BELEODAQ (belinostat) for injection net sales of $3.0 million, and MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $2.7 million. FUSILEV sales exceeded our expectations in the fourth quarter, however, we continue to expect significant declines in the future due to additional competition and pricing pressure.

Spectrum recorded net loss of $4.2 million, or $0.06 per basic and diluted share in the three-month period ended December 31, 2015, compared to net loss of $3.0 million, or $0.05 per basic and diluted share in the comparable period in 2014. Total research and development expenses were $15.4 million in the quarter, as compared to $14.4 million in the same period in 2014. Selling, general and administrative expenses were $21.2 million in the quarter, compared to $24.5 million in the same period in 2014.

Non-GAAP Results

Spectrum recorded non-GAAP net loss of $4.6 million, or $0.07 per basic share and diluted share in the three-month period ended December 31, 2015, compared to non-GAAP net income of $7.5 million, or $0.12 per basic and $0.09 per diluted share in the comparable period in 2014. Non-GAAP research and development expenses were $14.8 million as compared to $14.0 million in the same period of 2014. Non-GAAP selling, general and administrative expenses were $18.1 million, as compared to $21.4 million in the same period in 2014.

Twelve-Month Period Ended December 31, 2015 (All numbers are approximate)

GAAP Results

Total product sales were $136.9 million for the twelve months ended December 31, 2015. Total product sales decreased 27% from $186.5 million in the same period of 2014.

Product sales in 2015 included: FUSILEV (levoleucovorin) net sales of $60.7 million, FOLOTYN (pralatrexate injection) net sales of $40.6 million, ZEVALIN (ibritumomab tiuxetan) net sales of $17.5 million, BELEODAQ (belinostat) for injection net sales of $10.1 million, and MARQIBO (vinCRIStine sulfate LIPOSOME injection) net sales of $8.0 million.

Spectrum recorded net loss of $50.8 million, or $0.78 per basic and diluted share in the twelve-month period ended December 31, 2015, compared to net loss of $45.7 million, or $0.71 per basic and diluted share in the comparable period in 2014. Total research and development expenses were $50.8 million for the year, as compared to $69.7 million in the same period in 2014. Selling, general and administrative expenses were $86.5 million for the year, compared to $97.4 million in the same period in 2014.

Peregrine Pharmaceuticals Reports Financial Results for Third Quarter of Fiscal Year 2016 and Recent Developments

On March 09, 2016 Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) (NASDAQ:PPHMP), a biopharmaceutical company focused on developing therapeutics to stimulate the body’s immune system to fight cancer, reported financial results for the third quarter of fiscal year (FY) 2016 ended January 31, 2016, and provided an update on its advancing clinical pipeline and other corporate developments (Press release, Peregrine Pharmaceuticals, MAR 9, 2016, View Source [SID:1234509437]).

Highlights Since October 31, 2015

"Earlier this week, we announced the commissioning of our new commercial biomanufacturing facility, which gives us significant revenue growth potential over the short term. This represented a key corporate milestone and we are continuing to evaluate a number of additional opportunities to further expand this important, revenue-generating business," stated Steven W. King, president and chief executive officer of Peregrine. "On the drug development side, we unfortunately experienced a recent setback with the early discontinuation of our SUNRISE Phase III study evaluating the combination of bavituximab and chemotherapy. While we continue to collect patient follow-up data in the SUNRISE study and work to better understand the final trial outcome, we have made the decision to put a hold on our other chemotherapy combination trials so that we can make an informed decision on how to potentially proceed."

Mr. King continued, "In the meantime, we remain enthusiastic about the potential of combining bavituximab with other immuno-oncology ("I-O") agents based on a significant amount of translational and preclinical data demonstrating that bavituximab has the potential to enhance the activity of checkpoint inhibitors. These I-O combinations are based on completely different mechanistic synergies than the chemotherapy combinations and the interest in pursuing this development pathway remains high. We are in the process of engaging all of our collaborators to formulate a comprehensive clinical strategy for exploring the potential of bavituximab with immune checkpoint inhibitors, such as PD-L1 and PD-1 inhibitors. The overall goal of these efforts is to generate important clinical data that will guide the program toward the specific patient populations that can realize the biggest benefit from these I-O combination treatments."

Clinical Development Highlights

Peregrine is working closely with its collaborators and key opinion leaders ("KOLs") to transition the company’s clinical program to focus on bavituximab combinations with I-O agents. Peregrine’s partners and advisors, including AstraZeneca, Memorial Sloan Kettering Cancer Center, the National Comprehensive Cancer Network (NCCN) and the University of Texas, Southwestern, are leaders in the field of immuno-oncology, and their collective guidance will play an important role in the program. Activities in this area include:

Peregrine and AstraZeneca are currently evaluating the trial designs for the two previously announced clinical trials combining bavituximab with AstraZeneca’s PD-L1 inhibitor, durvalumab. In light of the recent development in the SUNRISE trial, the companies are currently working together to identify the optimal path forward for demonstrating potential mechanistic synergies between bavituximab and durvalumab in different patient populations. The expected timing of initiation of any trial will be determined upon finalization of its trial design.

Peregrine entered into a new research collaboration with the NCCN to expand upon the company’s clinical development program of bavituximab in combination with immuno-oncology agents for the treatment of a range of tumors. NCCN is a not-for-profit alliance of 26 of the world’s leading cancer centers dedicated to improving the quality, effectiveness, and efficiency of cancer care. Peregrine will fund multiple investigator-initiated clinical and correlative studies with bavituximab in multiple cancers at NCCN Member Institutions and their affiliate community hospitals through a $2 million research grant to NCCN’s Oncology Research Program (ORP). NCCN will be responsible for oversight and monitoring of the clinical studies through the research grant.

Supportive Research Highlights
Positive results were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab modulates immune responses in the tumor microenvironment.

Avid Bioservices Highlights

"The Avid business grew 20% in fiscal year 2015 to $26.7 million in revenue, and is expected to top $40 million in revenue for the current fiscal year ending April 30, 2016," stated Paul Lytle, chief financial officer of Peregrine. "Our new state-of-the-art, 40,000 square foot commercial biomanufacturing facility, which was recently formally commissioned, is outfitted with cutting-edge, single-use equipment to accommodate a fully disposable biomanufacturing process for late Phase III clinical and commercial production of biologics. Demand for this new production capacity is high and we already have manufacturing commitments for products to be delivered in fiscal year 2017. With demand expected to grow, we are actively considering options for potentially adding more production capacity to support additional growth of this business."
Avid’s new state-of-the-art commercial biomanufacturing suite has been formally commissioned. The new facility will double the company’s prior manufacturing capacity, supporting up to an additional $40 million in revenue each year.

As of February 1, 2016, Avid Bioservices had a revenue backlog in excess of $58 million under committed contracts from existing clients, covering services to be completed in the fourth quarter of FY 2016 and into FY 2017.

Financial Results

Total revenues for the third quarter of FY 2016 were $6,709,000, compared to $5,677,000 for the same quarter of the prior fiscal year. The increase was attributed to an increase in contract manufacturing revenue generated from Avid Bioservices.

Contract manufacturing revenue from Avid’s clinical and commercial biomanufacturing services provided to its third-party clients for the third quarter FY 2016 were $6,672,000, compared to $5,677,000 for the same quarter of the prior fiscal year. Peregrine expects third-party contract manufacturing revenue for the entire fiscal year to exceed $40 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical manufacturing of bavituximab.

Total costs and expenses in the third quarter of FY 2016 were $23,576,000, compared to $18,699,000 in the third quarter of FY 2015. This increase was primarily attributable to current quarter increases in research and development expenses associated with the increase in manufacturing costs associated with bavituximab, the planned Phase II immuno-oncology combination trial of bavituximab and durvalumab in NSCLC, the Phase II chemotherapy combination trial in breast cancer that was initiated in December 2015 and recently placed on hold, and an increase in the cost of contract manufacturing associated with higher reported revenue. For the third quarter of FY 2016, research and development expenses were $15,156,000, compared to $11,261,000 for the third quarter of FY 2015. For the third quarter of FY 2016, cost of contract manufacturing was $3,896,000, compared to $3,113,000 for the third quarter of FY 2015. Selling, general and administrative expenses were $4,524,000 for the third quarter of FY 2016 compared to the $4,325,000 for the third quarter of FY 2015.

Peregrine’s consolidated net loss attributable to common stockholders was $18,227,000, or $0.08 per share, for the third quarter of FY 2016, compared to a net loss attributable to common stockholders of $14,027,000, or $0.08 per share, for the same prior year quarter.

Peregrine reported $67,470,000 in cash and cash equivalents as of January 31, 2016 compared to $68,001,000 at fiscal year ended April 30, 2015.

More detailed financial information and analysis may be found in Peregrine’s Quarterly Report on Form 10-Q, which will be filed with the Securities and Exchange Commission today.

Epizyme Announces 2015 Financial Results and Financial Guidance

On March 9, 2016 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for patients with cancer, reported certain 2015 and recent accomplishments and reported financial results for the fourth quarter of and full year 2015 (Press release, Epizyme, MAR 9, 2016, View Source [SID:1234509434]). In addition, earlier today, Epizyme announced a multi-year vision for the company’s growth through 2020.

Key 2015 Accomplishments

Regained control of key pipeline assets: In 2015, Epizyme reacquired from Eisai the rights to tazemetostat worldwide outside of Japan and assumed leadership of the tazemetostat development strategy. The company also extended and focused its collaboration agreement with Celgene on three specific targets, regaining worldwide rights to the rest of its preclinical pipeline programs excluding the three programs partnered with GlaxoSmithKline (GSK).

Executed on robust clinical development strategy for tazemetostat: At multiple major medical meetings in 2015, Epizyme presented proof-of-concept data from an ongoing phase 1 trial with tazemetostat that demonstrated clinically meaningful activity and an acceptable safety profile in patients with non-Hodgkin lymphoma (NHL) and in patients with certain genetically defined solid tumors. Based on the findings, Epizyme initiated a global development plan for tazemetostat, which includes a five-arm, phase 2 study in patients with NHL, a three-arm phase 2 study in adult patients with certain genetically defined solid tumors, and a dose-escalation and dose-expansion phase 1 study in pediatric patients with certain genetically defined solid tumors. Epizyme also obtained FDA acceptance of INDs in the U.S. for tazemetostat for the treatment of diffuse-large B-cell lymphoma (DLBCL), the largest subset of NHL, and for certain genetically defined solid tumors.

Expanded pipeline of preclinical assets: Epizyme made substantial progress in its discovery pipeline, identifying and initiating preclinical work against five new targets, against which the company is developing small molecules wholly owned by Epizyme.
Strengthened its scientific leadership: Throughout 2015, Epizyme continued to enhance its platform capabilities. The company’s extensive epigenetics expertise with histone methyltransferases (HMTs) led to the expansion of its efforts to encompass other chromatin modifying proteins (CMPs). Epizyme has identified a prioritized set of HMT and CMP targets from which it plans to build a sustainable pipeline of potential new therapies.

Based on these significant advancements throughout 2015, Epizyme has outlined a vision and strategic plan through 2020, focused on quickly bringing tazemetostat to market, maximizing the potential of tazemetostat in a broad range of cancers and treatment settings, continuing the growth of its pipeline and further establishing the company’s scientific leadership in the field of chromatin modifying proteins. More details on the vision and strategy can be found here.

"In 2015, we made substantial progress across all aspects of the organization, which has provided a solid foundation on which to build our future," said Robert Bazemore, President and Chief Executive officer of Epizyme. "We have a unique lead product candidate, tazemetostat, that is in three registration-supporting clinical trials today, with multiple new clinical trials planned to begin in the near future. In addition, we are driving forward five new wholly owned programs, and we are continuing to expand our pipeline. We believe that Epizyme has the opportunity for tremendous growth and value creation in the short and long-term, and we look forward to executing on the strategic vision that we have laid out for the company."

Full Year 2015 Results and Financial Guidance

Collaboration revenue was $2.6 million for the year ended December 31, 2015, compared to $41.4 million for the prior year. The decrease in collaboration revenue primarily reflects the completion of a significant portion of the Company’s performance obligations under its collaborations during 2014 and achievement of a $3.0 million milestone under its agreement with GSK during 2014. The company expects to recognize an additional $1.9 million of deferred revenue related to the Celgene agreement through December 31, 2016 as the company completes its pinometostat phase 1 clinical trials.

Research and development (R&D) expenses were $111.2 million for the year ended December 31, 2015 compared to $75.6 million for the year ended December 31, 2014. The increase in costs were primarily driven by the expansion of tazemetostat clinical trials and related EZH2 activities and the $40.0 million upfront payment to Eisai in the first quarter of 2015 to reacquire rights to tazemetostat worldwide outside of Japan, partially offset by reductions in external spending on pinometostat and discovery and preclinical programs during 2015 compared to the prior year. After adjusting for the 2015 in-process research and development payment made to Eisai of $40.0 million, Epizyme expects that R&D expenses will increase in 2016, when compared to 2015. The planned increase is primarily driven by the costs of its ongoing and planned clinical trials with tazemetostat, including its registration-supporting trials in patients with non-Hodgkin lymphoma and adult and pediatric patients with certain genetically defined solid tumors, as well as planned combination studies in patients with DLBCL and the planned study in patients with BAP1 loss-of-function mesothelioma. In addition, discovery and preclinical research costs are expected to increase as the company advances its wholly owned small molecule programs against five novel targets, continues the research efforts for its Celgene partnered programs, and expands its target identification and discovery activities. Epizyme plans to offset a portion of the increased cost of its research and development programs through strategic collaborations that it will be evaluating later this year.

General and administrative (G&A) expenses increased to $23.9 million for the year ended December 31, 2015, compared to $20.9 million for the year ended December 31, 2014. The increase in G&A expense was largely due to increased intellectual property-related legal costs and personnel-related expenses associated with scaling up Epizyme’s business operations.

Net loss was $132.4 million for the year ended December 31, 2015, compared to a net loss of $55.0 million for the year ended December 31, 2014. The year-over-year decline was driven by a decrease in collaboration revenue, as well as by the costs associated with reacquiring tazemetostat rights from Eisai.

Cash and cash equivalents as of December 31, 2015 were $208.3 million, compared with $190.1 million as of December 31, 2014. Epizyme’s follow-on public offering in January 2016 raised $130.1 million in net proceeds, after underwriting discounts and commissions, upon the sale of 15.3 million common shares. As this event occurred in fiscal 2016, it is not reflected in the December 31, 2015 cash and cash equivalent balances.

Financial Guidance from Epizyme states that the Company believes its cash and cash equivalents of $208.3 million as of December 31, 2015, together with the net proceeds of $130.1 million from the January 2016 follow-on offering, will be sufficient to fund the Company’s operations through at least the end of 2017, and importantly through many key milestones.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of patients with non-Hodgkin lymphoma and for patients with certain genetically defined solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in dysregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about tazemetostat, including clinical trial information, can be found here.