On November 3, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported financial results for the third quarter ended September 30, 2016. Loss from operations for the three months ended September 30, 2016 was $8.5 million (Press release, Sunesis, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219049 [SID1234516331]). As of September 30, 2016, cash, cash equivalents and marketable securities totaled $24.3 million.

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"Since the beginning of the third quarter we have made significant progress in advancing both our vosaroxin and BTK inhibitor programs. In addition, in October, we secured the financial resources from leading life sciences investors which will help us reach several potential value inflection points," said Daniel Swisher, Chief Executive Officer of Sunesis. "The potential milestones include a marketing authorization decision on vosaroxin in Europe, the potential for a corresponding partnership and product launch in this territory, and the initiation and prosecution of a Phase 1B/2 study of SNS-062, our differentiated, non-covalent BTK-inhibitor, in patients with B-cell malignancies."

"The European regulatory review of vosaroxin has now resumed, following our response to the Day 120 List of Questions, and we look forward to receiving the EMA Day 180 List of Outstanding Issues before year-end. We were also pleased to present Phase 1A Healthy Volunteer Study results demonstrating a favorable safety, pharmacokinetic and pharmacodynamic profile for SNS-062 at the ESH Conference on New Concepts in B-Cell Malignancies in September."

Third Quarter 2016 and Recent Highlights

Submission of Responses to the EMA Day 120 List of Questions for the Marketing Authorization Application for Vosaroxin. In October, Sunesis announced that it submitted its responses to European Medicines Agency (EMA) Day 120 List of Questions issued by the Committee for Medicinal Products for Human Use (CHMP) as part of the centralized review process of the Marketing Authorization Application (MAA) for vosaroxin based on data from the VALOR trial, as a treatment for relapsed/refractory acute myeloid leukemia (AML) in patients aged 60 years and older. Sunesis expects to receive the EMA Day 180 List of Outstanding Issues before year-end.

Presentation of Dose Escalation Results from the Phase 1A Healthy Volunteer Study Evaluating Oral Non-Covalent BTK inhibitor SNS-062. In September, Sunesis announced results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’s (ESH) 2nd International Conference on New Concepts in B-Cell Malignancies at the Estoril Congress Centre in Estoril, Portugal. The presentation, titled "A Phase 1A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects: Preliminary Results" is available on the Sunesis website at www.sunesis.com.

Completion of $25.9 million Financing. In October, Sunesis announced the completion of an equity financing with net proceeds of $25.9 million. The financing attracted participation from leading biotechnology investors.

Announced Publication in "Drugs" Detailing Molecular and Pharmacologic Properties of Vosaroxin. In August, Sunesis announced the publication of an article detailing the molecular and pharmacologic properties of vosaroxin as a new therapeutic for acute myeloid leukemia (AML) in the journal Drugs. Vosaroxin is the first quinolone-based topoisomerase II inhibitor studied in clinical trials in oncology. The article, titled "Molecular and Pharmacologic Properties of the Anticancer Quinolone Derivative Vosaroxin: A New Therapeutic for Acute Myeloid Leukemia," is available online and appeared in the September 2016 print issue of Drugs. The authors describe how the unique chemical and pharmacologic characteristics of vosaroxin may contribute to the efficacy and safety profile observed in Sunesis’ Phase 3 VALOR trial in first relapsed or refractory AML.
Financial Highlights

Cash, cash equivalents and marketable securities totaled $24.3 million as of September 30, 2016, as compared to $46.4 million as of December 31, 2015. The decrease of $22.1 million was primarily due to $28.9 million of net cash used in operating activities, $8.0 million of payments against notes payable, partially offset by $14.8 million in net loan proceeds. An additional $25.9 million in net proceeds was raised in the October 2016 equity financing, resulting in pro-forma September 30, 2016 cash, cash equivalents and marketable securities of $50.2 million. This capital is expected to be sufficient to fund operations into 2018.

Revenue for the three and nine months ended September 30, 2016 was $0.6 million and $1.9 million as compared to $0.7 million and $2.4 million for the same periods in 2015. The decrease between the periods was primarily due to the extension of the amortization period of our deferred revenue.

Research and development expense was $5.3 million and $18.1 million for the three and nine months ended September 30, 2016 as compared to $5.3 million and $16.1 million for the same periods in 2015. The increase of $2.0 million between the comparable nine month periods was primarily due to an increase in professional services, clinical trials and medical affairs expenses.

General and administrative expense was $3.9 million and $12.2 million for the three and nine months ended September 30, 2016 as compared to $4.0 million and $14.3 million for the same periods in 2015. The decrease of $0.1 million between the comparable three month periods was primarily due to a decrease in personnel expenses. The decrease of $2.1 million between the comparable nine month periods was primarily due to decrease in outside service costs.

Interest expense was $0.5 million and $1.2 million for the three and nine months ended September 30, 2016 as compared to $0.2 million and $0.7 million for the same periods in 2015. The increases in the 2016 periods were primarily due to the increase in the notes payable.

Net other income was nil and $0.1 million for the three and nine months ended September 30, 2016 as compared to net other income of $1.8 million and $3.6 million for the same period in 2015. The decrease in net other income is related to the quarterly re-valuation of warrant liabilities.

Cash used in operating activities was $29.0 million for the nine months ended September 30, 2016, as compared to $29.5 million for the same period in 2015. Net cash used in the 2016 period resulted primarily from the net loss of $29.5 million and changes in operating assets and liabilities of $3.6 million, including the payment of a final fee of $1.2 million under the Oxford Loan Agreement, partially offset by net adjustments for non-cash items of $4.1 million. Net cash used in the 2015 period resulted primarily from the net loss of $25.1 million and changes in operating assets and liabilities of $5.6 million, partially offset by net adjustments for non-cash items of $1.2 million.

Sunesis reported loss from operations of $8.5 million and $28.4 million for the three and nine months ended September 30, 2016 as compared to $8.6 million and $28.0 million for the same periods in 2015. Net loss was $9.0 million and $29.5 million for the three and nine months ended September 30, 2016, as compared to $7.0 million and $25.1 million for the same periods in 2015.

On November 3, 2016 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported recent progress of the Company’s clinical-stage programs and reported financial results for the third quarter of 2016 (Press release, Epizyme, NOV 3, 2016, View Source [SID1234516187]).

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"Throughout 2016, we have made substantial progress toward achieving our vision, which includes advancing the clinical development of tazemetostat and expanding its therapeutic benefit into new indications and treatment settings," said Robert Bazemore, President and Chief Executive Officer, Epizyme. "We are executing on a broad clinical program for tazemetostat based on its early clinical activity and safety profile, and guided by strong scientific rationale. We expect 2017 to be an important year for Epizyme, led by data from the Phase 2 studies in non-Hodgkin lymphoma and genetically defined solid tumors in the first half of the year, and determination of our potential registration pathways beginning mid-year."

Execution of Clinical Programs

Enrollment in Phase 2 Programs in NHL and Solid Tumors Progressing: The Company’s Phase 2 studies of tazemetostat in non-Hodgkin lymphoma (NHL) and genetically defined solid tumors are progressing and continue to enroll patients. Epizyme plans to report efficacy, safety and biomarker data from both studies in the first half of 2017. The Company is also preparing for intended regulatory engagement, beginning first with the United States Food and Drug Administration (FDA) in mid-2017 to determine potential registration paths for its genetically defined solid tumor program in adult patients. In addition, Epizyme is preparing for FDA engagement on its NHL program, also in 2017, to determine potential registration paths in various subtypes of NHL.
Immuno-oncology Combination Study Initiated: The Phase 1b study is evaluating tazemetostat in combination with Tecentriq (atezolizumab), in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Tecentriq is the first and only anti-PD-L1 cancer immunotherapy approved by FDA. This study is being conducted by Genentech, a member of the Roche Group, under Epizyme’s collaboration agreement with Roche.
Front-line Combination Study Initiated: The first study of tazemetostat in the front-line treatment setting has been initiated. The Phase 1b/2 study is evaluating tazemetostat in combination with R-CHOP, a chemotherapy regimen, as a first-line treatment for newly diagnosed elderly, high-risk patients with DLBCL. This study is being conducted under the Company’s collaboration with the Lymphoma Study Association.
Mesothelioma Study Initiated: Patient enrollment is underway in Epizyme’s global Phase 2 study evaluating tazemetostat for the treatment of adults with mesothelioma characterized by BAP1 loss-of-function. This study marks the expansion of tazemetostat development as a monotherapy into a new cancer indication.
CRADAs Established with NCI on Tazemetostat and Pinometostat: Epizyme recently entered into separate Cooperative Research and Development Agreements (CRADAs) with the National Cancer Institute (NCI) to evaluate tazemetostat in clinical trials in multiple cancer indications and to evaluate Epizyme’s novel DOT1L inhibitor, pinometostat, in multiple combination regimens. These CRADAs further expand the clinical evaluation of tazemetostat in both adults and children, while also exploring the potential for pinometostat as a combination therapy for certain kinds of acute leukemia.
Collaboration Established with Foundation Medicine: Epizyme entered into a collaboration agreement with Foundation Medicine, Inc. to support patient identification and enrollment for Epizyme’s ongoing Phase 2 clinical trial of tazemetostat in patients with NHL. Foundation Medicine’s SmartTrials Precision Enrollment Program and FoundationOne Heme panel will assist in identifying a population of individuals with NHL who harbor EZH2 mutations, which constitute specific cohorts in the Epizyme trial.
Strengthening of Epizyme Team

The Company made two, recent key hires to prepare for the intended regulatory engagement and determination of potential registration pathways in 2017. Pamela Strode was appointed to the position of Vice President of Regulatory Affairs and Quality Assurance, and Ray Mankoski, M.D., Ph.D. was appointed as Vice President of Medical Affairs.
Third Quarter 2016 Financial Results and Guidance

Cash Position: Cash, cash equivalents and marketable securities were $263.3 million as of September 30, 2016, as compared to $208.3 million as of December 31, 2015.
Revenue: Collaboration revenue was $6.6 million and $7.5 million for the three and nine months ended September 30, 2016, respectively, compared to $0.4 million and $2.0 million for the three and nine months ended September 30, 2015, respectively. The increase was driven predominantly by the recognition of the $6.0 million milestone earned upon GlaxoSmithKline’s (GSK) initiation of patient dosing in a Phase 1 clinical trial of GSK3326595, a PRMT5 inhibitor invented by Epizyme and licensed to GSK. GSK holds worldwide rights to the compound, and Epizyme may receive significant additional payments from GSK if future milestones are met for the program, plus up to double digit royalties on worldwide net sales should this product candidate progress through the clinic to commercialization.
R&D Expenses: Research and development (R&D) expenses were $23.9 million and $63.1 million for the three and nine months ended September 30, 2016, respectively, compared to $16.8 million and $94.4 million for the three and nine months ended September 30, 2015, respectively. The increase in R&D expenses for the three months ended September 30, 2016, is primarily due to the expansion of the tazemetostat clinical development program, increased spending on tazemetostat preclinical activities, and increased discovery and spending on high-priority, earlier-stage programs. The period-over-period decrease from the nine months ended September 30, 2015 was driven by the inclusion of the $40.0 million payment to Eisai for the reacquisition of the tazemetostat worldwide rights, excluding Japan, in R&D expenses in the first quarter of 2015. The Company expects that research and development expenses will continue to increase in the fourth quarter of 2016.
G&A Expenses: General and administrative (G&A) expenses were $7.5 million and $20.8 million for the three and nine months ended September 30, 2016, respectively, as compared to $6.7 million and $17.9 million for the three and nine months ended September 30, 2015, respectively. The increase is primarily due to the staffing of key leadership roles in the first half of 2016. G&A expenses were flat compared to the second quarter of 2016, and we expect G&A expenses to remain relatively constant through the fourth quarter of 2016.
Net Loss: Net loss was $24.3 million and $75.2 million for the three and nine months ended September 30, 2016, respectively, compared to a net loss of $23.1 million and $110.2 million for the three and nine months ended September 30, 2015, respectively.
Financial Guidance: Epizyme reiterates its belief that its cash, cash equivalents and marketable securities of $263.3 million as of September 30, 2016 will be sufficient to fund the Company’s planned operations into at least the second quarter of 2018.

On November 3, 2016 Genocea Biosciences, Inc. (NASDAQ:GNCA), a company developing T cell-directed vaccines and immunotherapies, reported corporate highlights and financial results for the third quarter ended September 30, 2016 (Press release, Genocea Biosciences, NOV 3, 2016, View Source [SID1234516216]). Genocea’s lead clinical candidate, GEN-003, is a T cell-directed immunotherapy for the treatment of genital herpes infections, designed to elicit both a T cell and B cell (antibody) immune response that, if approved, the Company believes would be the first-ever therapeutic vaccine for an infectious disease.

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"We achieved an important GEN-003 milestone in the third quarter with the selection of our Phase 3 dose, demonstrating a significant reduction in viral shedding for the third consecutive clinical trial, this time with an improved, Phase 3-ready formulation," said Chip Clark, president and chief executive officer of Genocea. "We also continue to advance our immuno-oncology program and are now focusing all of our early stage research and pre-clinical resources to these efforts. We believe ATLAS enables better cancer vaccine antigen selection than existing methods and that our demonstrated vaccine development expertise can be a further competitive advantage in this exciting space."

Mr. Clark continued: "We expect to maintain our strong momentum this quarter and throughout 2017. In December, we will be hosting our first R&D day as we set the stage for the expected start of the GEN-003 Phase 3 clinical trials in the second half of 2017, including the important Phase 2b six month placebo-controlled clinical efficacy data expected in January 2017. We will also set out in detail our maturing immuno-oncology strategy and neoantigen cancer vaccine development plans."

Recent Business Highlights

GEN-003 – Immunotherapy for treatment of genital herpes expected to enter Phase 3 development in 2H 2017.

September 2016 – data confirm optimal dose for Phase 3 trials; dose response consistent with T cell therapies and with previous GEN-003 clinical trials
October 2016 – IDWeek presentation: GEN-003 induced durable polyfunctional T cells, IgG and neutralizing antibody titers
In September 2016, Genocea announced positive viral shedding data from its ongoing Phase 2b study. The study achieved its primary endpoint, with GEN-003 demonstrating a statistically significant (versus placebo and baseline) 40 percent reduction in the viral shedding rate immediately after dosing in the 60 µg per protein / 50 µg of adjuvant dose group, using a new Phase 3-ready formulation. This result was consistent with a statistically significant (versus placebo and baseline) viral shedding rate reduction of 41 percent at this same dose and time point in the prior Phase 2 trial. Subsequent data from that prior Phase 2 trial demonstrated virologic and clinical efficacy durable through at least one year after dosing.

The 60 µg per protein / 75 µg of adjuvant dose group in the Phase 2b trial reduced the viral shedding rate by 27 percent, a smaller reduction than that observed in the prior trial, and also showed a less acceptable reactogenicity profile than the prior trial. Research has shown that overstimulation of the T cell immune system, as is suggested by this increase in reactogenicity, leads to a loss in efficacy for T cell therapies. We believe the likely driver of this effect is a more potent adjuvant formulation following customary manufacturing process changes to prepare for Phase 3 trials and commercialization.

In October 2016, the Company presented immunogenicity data from its previous Phase 2 trial at IDWeek 2016, the premier annual meeting for healthcare professionals focusing on infectious diseases. These data show that GEN-003 induced antigen-specific polyfunctional T cell responses in immunized subjects, a hallmark of potent T cell immunity. These data also demonstrated that GEN-003 elicited increases in IgG and neutralizing antibody levels above baseline that persisted for one year after the last dose, consistent with viral shedding and clinical symptom reduction seen at 12 months.

Anticipated Milestones and Events

GEN-003

Phase 2b 6-month placebo-controlled clinical efficacy data expected in January 2017
End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) expected in 1Q 2017
Antiviral combination study now planned as part of GEN-003 Phase 3 program
Immuno-oncology collaborations and cancer vaccine strategy

Data showing ATLAS’s differentiated neoantigen selection capabilities from the ongoing partnership with Memorial Sloan Kettering Cancer Center to be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 31st Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #374, entitled Genome-scale neoantigen screening using ATLAS prioritizes candidates for immunotherapy in a non-small cell lung cancer patient will be presented on Saturday November 12, between 11:45 am and 1:00 pm and 6:45 pm and 8 pm ET
Immuno-oncology strategy and neoantigen cancer vaccine development plan update expected at R&D Day in December
Upcoming Events & Presentations

Neoantigen Summit 2016, Boston, November 15
Stifel 2016 Healthcare Conference, New York City, November 16
Piper Jaffray 28th Annual Health Care Conference, New York City, November 30
Virtual R&D Day, week of December 12
Updated Financial Guidance:

Genocea now expects that its existing cash, cash equivalents and marketable securities are sufficient to support its operating expenses and capital expenditure requirements into the first quarter of 2018, without assuming any receipt of proceeds from potential business development partnerships, equity financings or debt drawdowns. This guidance is made on the basis of Genocea’s current operating plans, which include focusing its research activities on immuno-oncology, conducting the antiviral combination study as part of the GEN-003 Phase 3 program and initiating Phase 3 trials for GEN-003 in the second half of 2017.

Third Quarter 2016 Financial Results

Cash Position: Cash, cash equivalents and investments as of September 30, 2016 were $75.5 million compared to $86.0 million as of June 30, 2016.

Research and Development (R&D) Expenses: R&D expenses for the quarter ended September 30, 2016 increased $2.8 million, to $8.8 million, from the same period in 2015. The increase was driven by increases in headcount and related expenses to support the GEN-003 program and higher clinical costs for the ongoing and anticipated GEN-003 trials. Higher personnel and lab-related costs to advance Genocea’s pre-clinical product candidates and develop the ATLAS platform for immuno-oncology also contributed to the increase. These higher R&D costs were partially offset by lower GEN-004 costs due to the Phase 2a trial which was ongoing in the third quarter of 2015 and has since been completed.

General and Administrative (G&A) Expenses: G&A expenses for the quarter ended September 30, 2016 were unchanged at approximately $3.6 million from the same three-month period in 2015.

Net Loss: Net loss was $12.8 million for the third quarter ended September 30, 2016, compared to a net loss of $9.8 million for the same period in 2015.

On November 3, 2016 Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, reported financial results for the third quarter and nine months ended September 30, 2016 and provided a business update (Press release, Corvus Pharmaceuticals, NOV 3, 2016, View Source;p=RssLanding&cat=news&id=2219512 [SID1234516268]).

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"We continue to make good progress on the development of our lead product candidate, CPI-444," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Enrollment in the dose-selection stage of our Phase 1/1b trial with CPI-444 is complete and we are now enrolling patients in the expansion cohort stage of the trial, which is open in 35 sites in the U.S., Canada and Australia. In addition, we reported data on CPI-444 at two recent scientific meetings."

RECENT BUSINESS PROGRESS
CPI-444 Program

Completed enrollment of 48 patients in four cohorts in the dose-selection part of the Phase 1/1b trial for the Company’s lead oral checkpoint inhibitor, CPI-444, as a single agent and in combination with Genentech’s TECENTRIQ (atezolizumab), an anti-PD-L1 antibody.
Selected an oral dose of 100 mg twice daily for 28 days for both the single agent and combination arms of the disease-specific expansion cohort stage of the trial, which is now enrolling.
Presented preclinical and preliminary biomarker data at the Second CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) in September, which showed that CPI-444 is well tolerated and that single agent treatment is associated with activation of T-cells detected in the blood. Corvus believes this is the first demonstration of immune modulation in cancer patients receiving an adenosine antagonist.
Presented additional biomarker data from the Phase 1/1b study showing continued evidence of treatment-related immune activation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October. CPI-444 continued to be generally well tolerated, with one patient experiencing a possibly drug related serious adverse event.
Other Product Candidates

Demonstrated in preclinical studies that Corvus’ anti-CD73 antibody directly inhibited catalytic activity of CD73 and was differentiated from other competitive CD73 antibodies. Large scale manufacturing of anti-CD73 is in progress and IND enabling studies have been initiated.
Selected a lead compound for Corvus’ interleukin-2 (IL-2)-inducible T-cell kinase (ITK) inhibitor program and initiated IND enabling studies.
UPCOMING MILESTONE

The Company expects to present preliminary efficacy data from the dose-selection part of the Phase 1/1b trial for CPI-444 in the fourth quarter of 2016.
THIRD QUARTER 2016 FINANCIAL RESULTS
At September 30, 2016, Corvus had cash, cash equivalents and marketable securities totaling $145.1 million. This compared to cash, cash equivalents and marketable securities of $94.4 million at December 31, 2015.

Research and development expenses for the three months ended September 30, 2016 totaled $7.7 million, an increase of $5.2 million from $2.5 million in the prior year period, primarily due to an increase of $1.2 million in personnel and related costs associated with higher headcount, an increase of $2.2 million in outside costs for the Phase 1/1b clinical trial for CPI-444, and an increase of $1.4 million in outside costs associated with other clinical development programs.

General and administrative expenses for the three months ended September 30, 2016 totaled $2.8 million, an increase of $2.2 million from $0.6 million in the prior year period, primarily due to an increase of $1.0 million in personnel and associated costs, an increase of $0.7 million in patent and related costs and $0.2 million in costs associated with operating as a public company.

The net loss for the three months ended September 30, 2016 was $10.3 million, compared with a net loss of $3.2 million, for same period in 2015. Total stock compensation expense for the three months ended September 30, 2016 was $1.3 million, compared to $0.1 million in the prior year period.

On November 3, 2016 Mirati Therapeutics, Inc. (NASDAQ: MRTX) ("the Company" or "Mirati") reported financial results for the third quarter ended September 30, 2016 and provided an update on its product development programs (Filing, Q3, Mirati, 2016, NOV 3, 2016, View Source [SID1234516302]).

"We are pleased by the continued progress in all three of our clinical development programs during the third quarter and are encouraged by enrollment rates, particularly in our Phase 2 trial for glesatinib," said Charles M. Baum, M.D., Ph.D., President and CEO of Mirati. "We are focused on establishing the response rate in these patients, and will provide an efficacy update as we collect data on a meaningful number of patients."

Current Programs

Glesatinib (MGCD265)
Patient enrollment continues in the glesatinib Phase 2 clinical trial in non-small cell lung cancer (NSCLC) patients with MET genetic alterations. Enrollment rates in the trial continue to increase, due in part to the Company’s diagnostic partnerships, which have enabled accelerated patient identification and enrollment. Patients in the Phase 2 clinical trial are demonstrating improved tolerability. An interim update will be provided once data is collected on at least 15 patients.

Sitravatinib (MGCD516)
The Phase 1b clinical trial of sitravatinib continues to enroll patients with RET, CHR4q12 and CBL genetic alterations in NSCLC and other solid tumors. Patient enrollment is on track, and updates will be provided on the status of this clinical trial as we receive more data.

We are also initiating a Phase 2 clinical trial to assess the potential for glesatinib or sitravatinib, each in combination with Nivolumab, to enhance the clinical efficacy of Nivolumab in patients with NSCLC.

Mocetinostat (MGCD103)
The Phase 2 clinical trial for mocetinostat in combination with durvalumab, MedImmune’s investigational anti-PD-L1 immune checkpoint inhibitor, is progressing as planned. The clinical trial is exploring the potential of mocetinostat to enhance the effectiveness of checkpoint inhibitors in NSCLC and other solid tumors.

Third Quarter and Nine Month 2016 Financial Results

Cash, cash equivalents, and short-term investments were $73.0 million on September 30, 2016, as compared to $122.3 million on December 31, 2015.

Research and development expenses for the third quarter of 2016 were $16.1 million, compared to $14.6 million for the same period in 2015. Research and development expenses for the nine months ended September 30, 2016 were $52.5 million, compared to $34.0 million for the same period in 2015. The increase in research and development expenses for both the three and nine months ended September 30, 2016 compared to the same periods of 2015 relates to an increase in expenses associated with ongoing clinical trials for both glesatinib and sitravatinib, as well as an increase in other research and development expenses, which reflects higher compensation expense due to an increase in research and development employees during the three and nine

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months ended September 30, 2016. A one-time license fee of $2.5 million related to an early stage discovery project also contributed to the increase in expenses for the nine months ended September 30, 2016 compared to the same period in 2015.

General and administrative expenses for the third quarter of 2016 were $3.5 million, compared to $4.2 million for the same period in 2015. General and administrative expenses for the nine months ended September 30, 2016 were $11.4 million, compared to $12.2 million for the same period in 2015. The decrease in general and administrative expenses for the three and nine months ended September 30, 2016 compared to the same periods of 2015 is largely the result of a decrease in non-cash stock-based compensation expense.
Net loss for the third quarter of 2016 was $19.4 million, or $0.97 per share basic and diluted, compared to net loss of $18.7 million, or $1.11 per share basic and diluted for the same period in 2015. Net loss for the nine months ended September 30, 2016 was $63.4 million, or $3.21 per share basic and diluted, compared to net loss of $46.1 million, or $2.86 per share basic and diluted for the same period in 2015.