On November 2, 2016 NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, reported financial results for the third quarter ended September 30, 2016 (Press release, NanoString Technologies, NOV 2, 2016, View Source [SID1234516304]).

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Third Quarter Financial Highlights

Total revenue of $23.9 million, 53% year-over-year growth
Total product and service revenue of $19.2 million, 38% year-over-year growth
Consumables revenue of $11.5 million, including $1.1 million of Prosigna IVD kits, 27% year-over-year growth
Instrument revenue of $6.9 million, 62% year-over-year growth
Collaboration revenue of $4.8 million
"We continued to execute well during the third quarter, generating strong growth across our business while advancing our product pipeline and partnerships," said president and chief executive officer Brad Gray. "A highlight of the quarter was the robust demand for our nCounter SPRINT Profiler, which helped drive 62% year-on-year growth in instrument revenue and validated that SPRINT’s ability to reach new customers is accelerating instrument placement."

Recent Business Highlights

Grew installed base to approximately 450 nCounter Analysis Systems at September 30, 2016
Launched new nCounter Vantage 3D Solid Tumor Panels for proteins and single nucleotide variations to enable simultaneous analysis of DNA mutations, messenger RNA, fusion genes, and proteins on a single platform
Presented data demonstrating the potential workflow advantages of Hyb & Seq sequencing chemistry, requiring less than 60 minutes of sample processing to enable initiation of a sequencing run
Appointed Kirk Malloy, Ph.D., seasoned life sciences executive, to the company’s board of directors
Third Quarter Financial Results

Revenue for the three months ended September 30, 2016 increased by 53% to $23.9 million, as compared to $15.7 million for the third quarter of 2015. Instrument revenue was $6.9 million, up 62% versus the prior year period, with nCounter SPRINT systems representing approximately half of systems sold. Consumables revenue, excluding Prosigna, was $10.3 million for the third quarter of 2016, 23% higher than in the comparable 2015 quarter. Prosigna IVD kit revenue was $1.1 million for the quarter, an increase of 73% over the third quarter of 2015. Collaboration revenue totaled $4.8 million, compared to $1.8 million for the third quarter of 2015. Gross margin on product and service revenue was 58% for the third quarter of 2016, up from 55% for the prior year period.

Research and development expense increased by 50% to $8.7 million for the third quarter of 2016 versus $5.8 million for the third quarter of 2015, reflecting increased costs associated with biopharma collaborations announced earlier this year and new products and technologies under development for the life science research market. Selling, general and administrative expense increased by 30% to $15.6 million for the third quarter of 2016 compared to $12.0 million for the prior year period.

Net loss for the three months ended September 30, 2016 increased to $10.1 million, or a loss of $0.51 per share, compared with $9.5 million, or a loss of $0.49 per share, for the third quarter of 2015.

Outlook for 2016

The company’s financial outlook for 2016 is unchanged, and includes:

Total revenue in the range of $89 million to $93 million
Gross margin on product and service revenues in the range of 54% to 55%
Operating expenses in the range of $94 million to $99 million
Operating loss in the range of $37 million to $40 million
Net loss per share in the range of $2.15 to $2.30
Cash from collaborations in 2016 in the range of $40 million to $45 million

On November 2, 2016 Bio-Path Holdings, Inc., (NASDAQ: BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported the enrollment and dosing of the first patient in the efficacy portion of its Phase 2 clinical study of BP1001, a liposomal Grb2 antisense for the treatment of acute myeloid leukemia (AML) (Filing, 8-K, Bio-Path Holdings, NOV 2, 2016, View Source [SID1234516251]). The objective of the Phase 2 study is to further assess the efficacy and safety of BP1001, Bio-Path’s lead development candidate.

The Phase 2 clinical trial is a multicenter study of BP1001 in combination with low dose cytarabine (LDAC) in patients with previously untreated AML who are not otherwise eligible for standard or high-intensity chemotherapy regimens or who have elected a low-intensity regimen.

The trial is a single arm, open label, two-stage design to assess the safety profile, pharmacokinetics, pharmacodynamics, and efficacy of 60 mg/m2 of BP1001 in combination with LDAC compared to historical response rates documented for LDAC alone. Evaluable patients will receive an initial dose intravenous (IV) infusion of BP1001 over 60 minutes and every three days thereafter, as eight doses per 28-day cycle of 60 mg/m2 BP1001, and will be administered LDAC as a subcutaneous (SQ) injection, twice daily for 20 consecutive doses per 28-day cycle.

The primary endpoint of the study is the number of patients who achieve Complete Remission (CR), including CR with incomplete hematologic recovery (CRi) and CR with incomplete platelet recovery (CRip). Secondary endpoints assessing the safety and efficacy of BP1001 include overall survival, time to response, duration of response, and adverse events as evaluated by physical examination findings, vital signs and clinical laboratory tests.

The full trial design includes approximately 54 evaluable patients with an interim analysis performed after 19 patients. In the event the interim results exceed the primary endpoint in a number of patients that meets or exceeds statistically determined thresholds, the Company may seek to convert the trial into a registration trial for accelerated approval.

Among the sites registered to conduct the study are Weill Medical College of Cornell University, Baylor Scott & White Health, The University of Kansas and The University of Texas MD Anderson Cancer Center.

"This is an exciting milestone for Bio-Path as it will be the first study to confirm the efficacy of BP1001 as a treatment for AML and to validate our DNAbilizeTM platform," said Peter H. Nielsen, Chief Executive Officer of Bio-Path Holdings. "We are particularly pleased with the Phase 2 trial design, which has a built-in interim analysis that offers a pathway to an accelerated approval should the efficacy results for the first 19 evaluable patients demonstrate the high response rate seen in the safety segment of our Phase 2 trial. We look forward to the completion of this study and expect its results to replicate these very promising early data," added Mr. Nielsen.

Patients in the safety segment of the trial treated with 60 mg/m2 and 90 mg/m2 of BP1001 twice a week over a four-week period, in combination with a standard regimen of frontline low-dose cytarabine (LDAC), showed BP1001 to be safe and well tolerated, with signs of significant anti-leukemia activity. Of the six evaluable patients included in both cohorts of the safety segment, three achieved complete remissions, while two others achieved partial remission. There were no attributable adverse events reported.

As previously reported, BP1001’s pharmacokinetics at a dose of 60 mg/m2 had a 30-hour half-life, significantly better than the half-life with a dose of 90 mg/m2. The final analysis of these data, along with the demonstrated reductions in bone marrow blasts, suggested that 60 mg/m2 is the appropriate dose for use in the Phase 2 trial. Administratively, this required Bio-Path to reformat documents for the Phase 2 trial with the 60 mg/m2 dose and resubmit for approvals with the U.S. Food and Drug Administration (FDA) and site Institutional Review Boards, requiring additional time prior to starting the Phase 2 trial.

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On November 2, 2016 Neurocrine Biosciences, Inc. (NASDAQ:NBIX) reported its financial results for the quarter ended September 30, 2016 (Press release, Neurocrine Biosciences, NOV 2, 2016, View Source;p=RssLanding&cat=news&id=2218719 [SID1234516306]). For the third quarter of 2016, the Company reported a net loss of $36.9 million, or $0.43 loss per share, compared to a net loss of $34.4 million, or $0.40 loss per share, for the same period in 2015. For the nine months ended September 30, 2016, the Company reported a net loss of $96.4 million, or $1.11 loss per share, as compared to net loss of $59.6 million, or $0.71 loss per share, for the first nine months of last year.

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The Company’s balance sheet at September 30, 2016 reflected total assets of $399.2 million, including cash, cash equivalents, investments and receivables of $385.3 million.

"Our NDA for INGREZZATM in tardive dyskinesia was recently accepted by the FDA for Priority Review and we look forward to continuing our work with the FDA to potentially bring this important treatment option to patients and physicians," said Kevin Gorman, President and Chief Executive Officer of Neurocrine Biosciences. "In addition, our partner AbbVie presented Phase III data for elagolix in endometriosis at the 72nd American Society for Reproductive Medicine Scientific Congress & Expo. The results from the Phase III Violet Petal and Solstice clinical trials demonstrate that elagolix has the potential to be an important treatment for women suffering from endometriosis."

Research and development expenses were $20.9 million during the third quarter of 2016 compared to $24.4 million for the same period in 2015. Quarterly external development expense decreased by approximately $2.5 million from 2015 to 2016 primarily due to the completion of certain INGREZZA (valbenazine) manufacturing activities and the conclusion of the Kinect 3 clinical trial in 2016. Additionally, share-based compensation expense for research and development was $3.6 million lower during the third quarter of 2016 compared to the third quarter of 2015. The decrease in share-based compensation expense is primarily due to certain performance-based restricted stock units which met the criteria for expensing during the third quarter of 2015.

For the nine months ended September 30, 2016, research and development expenses were $71.7 million, compared to $59.7 million for the same period last year. This increase was primarily due to expenses related to the Company’s compilation and submission of the New Drug Application (NDA) for INGREZZA in tardive dyskinesia. Additionally, external clinical development expenses related to INGREZZA, which is being evaluated in both tardive dyskinesia and Tourette syndrome, accounted for $4.0 million of the increase in year-to-date expenses.

General and administrative expenses increased from $11.5 million for the third quarter of 2015 to $17.5 million for the third quarter of 2016. For the nine months ended September 30, 2016, general and administrative expenses were $44.4 million, compared to $23.5 million for the first nine months of 2015. The overall increase in general and administrative expense is primarily due to pre-commercialization activities for INGREZZA. General and administrative share-based compensation expense was $4.0 million lower during the third quarter of 2016 compared to the third quarter of 2015. The decrease in quarterly share-based compensation expense is primarily due to certain performance-based restricted stock units which met the criteria for expensing during the third quarter of 2015. Other personnel related costs increased by $3.8 million quarter over quarter, and by $7.6 million for the first nine months of 2015 compared to the first nine months of 2016 primarily due to the expansion of sales and marketing and medical affairs personnel. Additionally, professional costs related to market research and other pre-commercial activities increased by $5.4 million quarter over quarter and by $11.9 million for the first nine months of 2016 compared to the same period in 2015.

Updated 2016 Financial Guidance

The Company expects to end 2016 with approximately $340 million in cash, investments and receivables. The previous financial guidance was to end 2016 with approximately $320 million in cash, investments and receivables. Total expenses for 2016 are expected to be approximately $160 to $170 million. The previous financial guidance for 2016 expenses ranged from $185 to $195 million. The lower than anticipated cost of preclinical and clinical development as well as lower headcount contributed to this reduction in estimated 2016 expenses.

Pipeline Highlights

INGREZZA (valbenazine) Update

The NDA for INGREZZA for the treatment of tardive dyskinesia was submitted to the U.S. Food and Drug Administration (FDA) during the third quarter of 2016. The NDA was accepted for Priority Review by the FDA and received a Prescription Drug User Fee Act (PDUFA) target action date of April 11, 2017.

During the third quarter of 2016, the Company completed the Kinect 3 study, a Phase III trial that included moderate to severe tardive dyskinesia in patients with underlying schizophrenia, schizoaffective disorder, bipolar or major depressive disorder who underwent six weeks of placebo controlled assessment. Subsequent to the initial six weeks of treatment, subjects were eligible to continue in the Kinect 3 study for up to 42 weeks of additional INGREZZA treatment. The Company had previously announced positive efficacy results from the six-week placebo-controlled portion of the Kinect 3 study during the fourth quarter of 2015.

The Company is currently conducting a separate one-year open-label safety study of INGREZZA, Kinect 4. This study is fully enrolled and expected to complete its one year of dosing in early 2017.

The Company is also supporting an INGREZZA roll-over study for those patients who complete the one year of dosing in either the Kinect 3 or Kinect 4 studies. This roll-over study is designed to permit open-label access to INGREZZA for up to an additional 72 weeks of treatment.

INGREZZA is also being investigated in Tourette syndrome through two ongoing placebo-controlled Phase II Tourette syndrome studies in adults and pediatrics, the T-Forward study and T-Force GREEN study, respectively.

The T-Forward study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group study that has completed enrollment of 124 adults with moderate to severe Tourette’s. The adult Tourette patients are receiving once-daily dosing of INGREZZA or placebo during the eight-week treatment period to assess the safety, tolerability and efficacy of INGREZZA. The primary endpoint of this study is a change from baseline of placebo vs. active scores utilizing the Yale Global Tic Severity Scale at the end of Week 8. Top-line data from this study is expected in January 2017.

The T-Force GREEN study is a randomized, double-blind, placebo-controlled, multi-dose, parallel group study of up to 90 children and adolescents. Pediatric Tourette subjects receive once-daily dosing of INGREZZA or placebo during a six-week treatment period to assess the safety, tolerability and efficacy of INGREZZA. The primary endpoint of this study is the change from baseline of the Yale Global Tic Severity Scale between placebo and active treatment groups at the end of Week 6. Top-line data from this study is expected in early 2017.

Additionally, the Company has also launched an open-label, fixed-dose study of INGREZZA in up to 180 subjects with Tourette syndrome. This study is designed to enroll up to 90 children and adolescents and up to 90 adults who have completed either of the two placebo-controlled Tourette clinical trials: T-Force GREEN or T-Forward. This Phase II study will assess the long-term safety and tolerability of INGREZZA in children and adults with Tourette’s.

Elagolix Update

In October, AbbVie presented multiple scientific abstracts at the 72nd American Society for Reproductive Medicine Scientific Congress & Expo in Salt Lake City. The posters and oral presentations highlighted positive primary and secondary efficacy endpoint data from the Phase III studies of elagolix in premenopausal women who suffer from endometriosis as well as research on the economic burden of endometriosis and endometriosis-related surgery in women in the United States:

Elagolix, An Oral Gonadotropin-Releasing Hormone (GnRH) Antagonist, For The Management Of Endometriosis-Associated Pain: Safety And Efficacy Results From Two Double-Blind, Randomized, Placebo-Controlled Studies; Taylor H, et al.
Use Of Elagolix For The Management Of Endometriosis-Associated Pain: Secondary Efficacy Results From Two Randomized, Placebo-Controlled Studies; Surrey, et al.
The Effect of Elagolix On Bone Mineral Density: Safety Results From Two Randomized, Placebo-Controlled Studies In Women With Endometriosis-Associated Pain; Archer et al.
Incremental Costs of Healthcare and Work Loss Attributed to Endometriosis in a Cohort of Commercially Insured Women; Soliman et al.
Incidence of Comorbidities Among Women with Endometriosis: A Retrospective Matched Cohort Study; Soliman et al.
The Effect Of Elagolix On The Endometrium: Safety Results From Two Randomized, Placebo-Controlled Studies In Women With Endometriosis-Associated Pain; Diamond et al.
The Impact of Elagolix on Quality of Life in Women with Endometriosis-Associated Pain: Results From Two Randomized, Placebo-Controlled Studies Using the Endometriosis Health Profile Questionnaire; Taylor H et al.
Direct and Indirect Costs Associated with Endometriosis-Related Surgery Among Employed Women in the US; Soliman et al.
During the first quarter of 2016, AbbVie announced positive top-line results from the second of two Phase III clinical trials, the Solstice Study, a multinational study designed to evaluate the efficacy and safety of elagolix in 815 premenopausal women with endometriosis. The top-line results from this trial were consistent with those of the initial Phase III clinical trial, the Violet Petal Study, where after six months of treatment, both doses of elagolix (150 mg once-daily and 200 mg twice-daily) met the study’s co-primary endpoints of reducing scores of non-menstrual pelvic pain and menstrual pain (or dysmenorrhea) associated with endometriosis at month three, as well as month six, as measured by the Daily Assessment of Endometriosis Pain scale. The observed safety profile of elagolix in the Solstice Study was consistent with observations from prior studies. Among the most common adverse events (AEs) were hot flush, headache and nausea. While most AEs were similar across treatment groups some, such as hot flush and bone mineral density loss, were dose-dependent. AbbVie is targeting a 2017 NDA filing with the FDA for elagolix in endometriosis.

In early 2016, AbbVie announced the initiation of the Phase III uterine fibroids program consisting of two replicate randomized, parallel, double-blind, placebo-controlled clinical trials evaluating elagolix alone or in combination with add-back therapy in women with heavy uterine bleeding associated with uterine fibroids. The studies are expected to enroll approximately 400 subjects each for an initial six-month placebo-controlled dosing period. At the end of the six-months of placebo-controlled evaluation, subjects are eligible to enter an additional six-month safety extension study. The primary efficacy endpoint of the study is an assessment of the change in menstrual blood loss utilizing the alkaline hematin method comparing baseline to month six. Additional secondary efficacy endpoints will be evaluated including assessing the change in fibroid volume and hemoglobin. Bone mineral density will be assessed via DXA scan at baseline, the conclusion of dosing and six months post-dosing. The Company expects the initial top line efficacy data from the uterine fibroid Phase III program in 2017.

Essential Tremor Program (NBI-640756) Update

The Company has successfully completed an initial Phase I single site, randomized, double-blind, placebo-controlled, sequential dose-escalation, pharmacokinetic study assessing the safety and tolerability of a single dose of NBI-640756 in up to 32 healthy volunteers.

Based on the results of this initial study, the Company initiated a second Phase I, single site, randomized, double-blind, placebo-controlled, multiple-dose, sequential dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of NBI-640756 in up to 30 healthy volunteers over a week of continuous dosing. The study is being conducted in multiple sequential cohorts of ten subjects per cohort; data from this second Phase I study is expected later in 2016. The data from this study, in conjunction with the single dose Phase I study and preclinical studies, will be evaluated and utilized in the design of the anticipated Phase II program for NBI-640756 in subjects with essential tremor.

On November 2, 2016 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer, reported financial results for the third quarter ended September 30, 2016 and provided a review of pipeline and corporate highlights (Filing, Q3, Xencor, 2016, NOV 2, 2016, View Source [SID1234516344]).

"During the third quarter, we initiated clinical trials across our internal pipeline of XmAb programs, including Phase 1 studies of subcutaneously administered XmAb5871 and XmAb7195, and a first-in-human Phase 1 study of our lead immuno-oncology bispecific antibody candidate, XmAb14045," said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. "With these milestones complete and a strong cash position, we expect to report data from multiple clinical trials in the year ahead, while also initiating studies of additional bispecific oncology candidates and continuing to explore the breadth of our Fc engineering technology."

Pipeline Highlights:

XmAb5871: XmAb5871 is a first-in-class monoclonal antibody that targets CD19 with its variable domain and that uses Xencor’s XmAb immune inhibitor Fc domain to target FcγRIIb, a receptor that inhibits B-cell function. In March 2016, Xencor initiated Phase 2 clinical studies of XmAb5871 for the treatment of IgG4-Related Disease (IgG4-RD) and systemic lupus erythematosus (SLE), and in July 2016, Xencor initiated a Phase 1 trial of subcutaneously administered XmAb5871.

· Preliminary data from IgG4-RD Phase 2 trial to be presented at the American College of Rheumatology (ACR) 2016 Annual Meeting on November 13, 2016 in Washington, DC; additional data expected in 2017
· Initial data from subcutaneous administration trial expected in 2017
· Initial data from SLE Phase 2 trial expected in 2018

XmAb7195: XmAb7195 is a first-in-class monoclonal antibody that targets IgE with its variable domain and uses Xencor’s XmAb Immune Inhibitor Fc domain to target FcγRIIb, resulting in three distinct mechanisms of action for reducing IgE levels. In September 2016, Xencor initiated a Phase 1b multi-dose trial of subcutaneously administered XmAb7195 for the treatment of allergic disease.

· Initial data from subcutaneous administration Phase 1b trial expected in 1H17

Bispecific Oncology Pipeline: Xencor’s initial bispecific antibody programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T-cell binding domain. These bispecific antibodies activate T cells for highly potent and targeted killing of malignant cells. Their XmAb Fc domains confer long circulating half-lives, stability and ease of manufacture. In September 2016, Xencor initiated a Phase 1 trial of XmAb14045 in acute myeloid leukemia (AML) and other CD123-expressing hematologic malignancies.

· Initial data from XmAb14045 Phase 1 trial expected in 2017
· Initiation of Phase 1 trial for XmAb13676 in B-cell malignancies expected in 1Q17; initial data expected in 2018

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· Investigational New Drug (IND) application filing for XmAb18087 in neuroendocrine tumors expected in 2017
· IND application filing for XmAb20717, a PD-1 x CTLA-4 dual checkpoint inhibitor, in multiple oncology indications expected in 2018

Partnered XmAb Programs: Nine pharmaceutical companies and the National Institutes of Health (NIH) are advancing novel drug candidates either discovered at Xencor or that rely on Xencor’s proprietary XmAb technology. Seven such programs are currently undergoing clinical testing.

· In September, MorphoSys announced that it began dosing in the safety evaluation portion of a Phase 2/3 combination trial of XmAb5574/MOR208 with bendamustine in patients with relapsed or refractory diffuse large B-cell lymphoma (B-MIND trial). Following the Phase 2 safety evaluation, the study is expected to transition into a pivotal Phase 3 part in 2017.

Third Quarter Ended September 30, 2016 Financial Results

Cash, cash equivalents and marketable securities totaled $301.9 million as of September 30, 2016, compared to $193.3 million on December 31, 2015. The increase reflects the $150 million upfront payment received from Novartis in July 2016, net of spending for the nine months ended September 30, 2016.

Revenues for the third quarter ended September 30, 2016 were $7.8 million compared to $3.5 million for the same period of 2015. Revenues for the nine months ended September 30, 2016 were $81.1 million, compared to $6.0 million for the same period in 2015. Revenues in the three and nine-month period ended September 30, 2016 were earned primarily from the Company’s Novartis and Amgen collaborations, compared to revenues for the same period in 2015, which were earned primarily from the Company’s Novo Nordisk, Alexion and CSL collaborations.

Research and development expenditures for the third quarter ended September 30, 2016 were $14.1 million, compared to $10.6 million for the same period in 2015. Total research and development expenses for the nine-month period ended September 30, 2016 were $38.5 million, compared to $23.3 million for the same period in 2015. The increased spending on research and development for the three and nine months ended September 30, 2016 is primarily due to additional spending on Xencor’s XmAb5871 clinical programs and bispecific technologies, including its initial bispecific oncology clinical candidates, XmAb14045 and XmAb13676.

General and administrative expenses in the third quarter ended September 30, 2016 were $3.0 million compared to $3.2 million for the same period in 2015. Total general and administrative expenses for the first nine months of 2016 were $10.0 million, compared to $8.5 million in the first nine months of 2015. Decreased spending on the general and administration areas for the three months ended September 30, 2016 over the same period in 2015 is due to lower stock-based compensation charges in the quarter, while the increased spending for the nine months ended September 30, 2016 over the same period in 2015 reflects additional legal and accounting fees for compliance related activities and additional stock-based compensation charges.

Non-cash, share-based compensation expense for the first nine months of 2016 was $5.9 million compared to $3.4 million for the first nine months of 2015.

Net loss for the third quarter ended September 30, 2016 was $8.1 million, or $(0.20) on a fully diluted per share basis, compared to a net loss of $10.0 million, or $(0.25) on a fully diluted per share basis, for the same period in 2015. For the nine months ended September 30, 2016, net income was $32.7 million or $0.78 on a fully diluted per share basis, compared to net loss of $25.3 million, or $(0.66) on a fully diluted per share basis, for the same period in 2015. The lower loss for the three months ended September 30, 2016 over the loss reported for the same period in 2015 is primarily due to revenue earned from the Company’s Amgen collaboration, while the income earned for the nine months ended September 30, 2016 over the same period in 2015 is primarily due to revenue earned from the Company’s Novartis collaboration.

The total shares outstanding was 41,138,851 as of September 30, 2016, compared to 40,477,003 shares outstanding as of September 30, 2015.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations beyond the end of 2019.

On November 2, 2016 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported financial results for the third quarter ended September 30, 2016. Loxo Oncology will not be conducting a conference call in conjunction with this earnings release (Press release, Loxo Oncology, NOV 2, 2016, View Source [SID1234516197]).

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"Enrollment in the LOXO-101 program and progress in the preclinical pipeline have positioned us well for the remainder of 2016 and 2017," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "In December, we plan to share updated Phase 1 clinical data for LOXO-101 at ESMO (Free ESMO Whitepaper) Asia. At that time, we will also provide a comprehensive program update that integrates trial enrollment progress with written regulatory feedback to provide increased visibility into the commercial timelines for LOXO-101. Additionally, we look forward to starting Phase 1 studies in 2017 for named candidates LOXO-292 and LOXO-195."

Upcoming Milestones

LOXO-101

Updated clinical data from the adult Phase 1 trial of LOXO-101 have been accepted for an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress, taking place December 16-19, 2016 in Singapore. The presentation is titled, "Clinical safety and activity from a phase 1 study of LOXO-101, a selective TRKA/B/C inhibitor, in solid-tumor patients with NTRK gene fusions" and will take place at 4:30PM SGT on Sunday, December 18, 2016.
In conjunction with ESMO (Free ESMO Whitepaper) Asia, Loxo Oncology will be hosting a conference call and webcast on December 19, 2016 at 8:00AM ET. Dial-in instructions and webcast information will be posted to the Loxo Oncology website. During this call, Loxo Oncology will review the updated LOXO-101 Phase 1 data and provide an overview of its clinical development plans across the company’s portfolio of investigational medicines. The LOXO-101 program update is expected to include:
Current enrollment as "percent to goal"
Expected timing of full enrollment relative to goal
Expected timing of NDA/MAA filings and label potential
Preclinical data for LOXO-101 have been accepted for an oral presentation at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place December 3-6, 2016 in San Diego. The presentation is titled, "Genetic Modeling and Therapeutic Targeting of ETV6-NTRK3 with LOXO-101 in Acute Lymphoblastic Leukemia" and will take place at 7:45AM PT on Sunday, December 4, 2016.
Preclinical Programs

Preclinical data for Loxo Oncology’s RET program (LOXO-292) and TRK acquired resistance program (LOXO-195) have been accepted for presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, taking place November 29 – December 2, 2016 in Munich, Germany.
Initiation of a Phase 1 study of LOXO-292, Loxo Oncology’s selective RET inhibitor, is expected in early 2017.
Initiation of a Phase 1 study of next-generation TRK inhibitor LOXO-195, addressing previously treated patients with acquired resistance, is expected in 2017.
Third Quarter 2016 Financial Results

As of September 30, 2016, Loxo Oncology had aggregate cash, cash equivalents and investments of $156.5 million, compared to $153.9 million as of December 31, 2015.

Loxo Oncology continues to expect cash burn of $48 to $52 million in 2016. Based on the current operating plan, the company believes existing capital resources will be sufficient to fund anticipated operations into late 2018.

Research and development expenses were $14.2 million for the third quarter of 2016, compared to $6.3 million for the third quarter of 2015. This increase was primarily due to expanded clinical development activities for LOXO-101, as well as additional expenses related to the preclinical pipeline. Loxo Oncology also recognized research and development-related stock-based compensation expenses of $1.6 million during the third quarter of 2016, compared to $0.5 million for the third quarter of 2015.

Research and development expenses were $34.9 million for the nine months ended September 30, 2016, compared to $15.8 million for the nine months ended September 30, 2015. This increase was primarily due to expanded clinical development activities for LOXO-101, as well as additional expenses related to the preclinical pipeline. Loxo Oncology also recognized research and development-related stock-based compensation expenses of $2.1 million during the nine months ended September 30, 2016, compared to $1.8 million for the nine months ended September 30, 2015.

General and administrative expenses were $3.7 million for the third quarter of 2016, compared to $2.6 million for the third quarter of 2015. This increase was primarily due to employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expense of $1.2 million during the third quarter 2016, compared to $0.7 million for the third quarter 2015.

General and administrative expenses were $10.9 million for the nine months ended September 30, 2016, compared to $7.3 million for the nine months ended September 30, 2015. This increase was primarily due to employment costs and professional fees. Loxo Oncology also recognized general and administrative-related stock-based compensation expenses of $3.3 million during the nine months ended September 30, 2016, compared to $2.0 million for the nine months ended September 30, 2015.

Net loss was $17.7 million and $45.2 million for the three and nine months ended September 30, 2016, respectively, compared to $8.8 million and $23.0 million for the three and nine months ended September 30, 2015, respectively.

About LOXO-101
LOXO-101 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities involving the tropomyosin receptor kinases (TRKs). Growing research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In an ongoing Phase 1 clinical trial, LOXO-101 has demonstrated encouraging preliminary efficacy. LOXO-101 is also being evaluated in the NAVIGATE global Phase 2 multi-center basket trial in patients with solid tumors that harbor TRK gene fusions, and the SCOUT Phase 1 trial in pediatric patients, including patients with advanced cancer, TRK gene fusions and infantile fibrosarcoma. LOXO-101 has been granted Breakthrough Therapy Designation by the U.S. FDA. For additional information about the LOXO-101 clinical trials, please refer to www.clinicaltrials.gov. Interested patients and physicians can contact the Loxo Oncology Physician and Patient Clinical Trial Hotline at 1-855-NTRK-123 or visit www.loxooncologytrials.com.