On November 2, 2016 MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, reported a corporate progress update and reported financial results for the quarter ended September 30, 2016 (Press release, MacroGenics, NOV 2, 2016, View Source [SID1234516198]).

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"MacroGenics continues to make progress across its broad pipeline of clinical compounds, including margetuximab, our Fc-optimized anti-HER2 monoclonal antibody, our two clinical programs targeting B7-H3 as well as several bispecific product candidates based on our DART platform," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "During the third quarter, an IND for MGA012 cleared the FDA and we remain on track to submit two DART molecule INDs in 2017, which would result in a total of eight DART molecules in clinical development. We look forward to providing an update on multiple clinical and preclinical programs at our R&D Day on December 13."

Pipeline Update

Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include:

SOPHIA Study: MacroGenics’ Phase 3 pivotal study in patients with HER2-positive metastatic breast cancer is ongoing, as the Company continues to initiate sites and enroll patients. This study is evaluating the efficacy of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in approximately 530 relapsed/refractory patients. Approximately 90% of the anticipated study sites have been activated as of September 30, 2016.
Phase 1b/2 Gastric Cancer Study: MacroGenics continues to recruit and dose patients in a clinical trial of margetuximab in combination with pembrolizumab, an anti-PD-1 therapy, in patients with advanced HER2-positive gastric cancer. Treatment options for these patients are limited and the combination regimen being explored avoids chemotherapy while exploiting the potential for enhancing the antitumor immune response. This trial is being conducted in collaboration with Merck and is currently recruiting patients in North America. We anticipate the start of this study in Asia by year-end.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action and take advantage of this antigen’s broad expression across multiple solid tumor types. Current ongoing clinical-stage development programs include:

Enoblituzumab: The Company continues to recruit patients in three ongoing studies of enoblituzumab, an Fc-optimized monoclonal antibody that targets B7-H3. These studies include one monotherapy study and two combination studies with each of ipilimumab and pembrolizumab. As previously reported, the monotherapy study was expanded to include additional prostate and bladder cancer cohorts. An additional monotherapy study is planned for children with neuroblastoma and other tumors, and we also anticipate an investigator-sponsored monotherapy study in neo-adjuvant prostate cancer.
MGD009: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 study across multiple solid tumor types.
DART Product Candidates. There are currently six DART molecules in Phase 1 clinical development, including MGD006 (CD123 x CD3, also known as S80880), MGD007 (gpA33 x CD3), MGD009 (B7-H3 x CD3), MGD010 (CD32B x CD79B), MGD011 (CD19 x CD3, also known as JNJ-64052781 or duvortuxizumab) and PF-06671008 (P-cadherin x CD3).

During the third quarter and as previously reported, MacroGenics and Takeda Pharmaceutical Company Limited announced the conclusion of their License and Option Agreement for MGD010, a bispecific molecule targeting CD32B and CD79B. MacroGenics regained the worldwide rights to MGD010, for which the Company plans to continue to advance development based on the encouraging study results reported to date.

An Investigational New Drug (IND) application for MGA012, a monoclonal antibody, recently cleared the FDA and the Company plans to submit INDs for two DART molecules in 2017. These two DART molecules are:

MGD013: MacroGenics is developing MGD013 to simultaneously block two immune checkpoint molecules, PD-1 and LAG-3.
MGD014: MGD014 is a DART molecule that is being developed to eliminate latent HIV infection.
Beyond MGD013 and MGD014, MacroGenics continues to generate and evaluate multiple other candidates that target a range of immune regulatory and other molecules using its proprietary platforms.

Corporate Update

R&D Day: MacroGenics plans to host an R&D Day in New York on Tuesday, December 13, 2016. At this meeting, the Company plans to both provide an update on its clinical pipeline as well as preview its next set of development candidates.
Universal Shelf Registration Statement Filing: MacroGenics has filed a shelf registration statement with the SEC and believes that this filing provides the Company with the flexibility to access the equity or debt capital markets most efficiently should the need arise. However, the Company has no immediate plan to undertake an offering.
Third Quarter 2016 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2016, were $314.1 million, compared to $339.0 million as of December 31, 2015.
Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $3.3 million for the quarter ended September 30, 2016, compared to $14.7 million for the quarter ended September 30, 2015. This decrease was primarily due to recognition of a one-time milestone received from Janssen Biotech, Inc. in 2015.
R&D Expenses: Research and development expenses were $30.3 million for the quarter ended September 30, 2016, compared to $24.1 million for the quarter ended September 30, 2015. This increase was due primarily to increased activity in the Company’s preclinical immune checkpoint programs, including MGD013, MGD014 (funded by NIAID/NIH) and the initiation of two Phase 1 clinical trials combining enoblituzumab with other compounds.
G&A Expenses: General and administrative expenses were $7.2 million for the quarter ended September 30, 2016, compared to $6.0 million for the quarter ended September 30, 2015. This increase was primarily due to increased staff, recruiting costs and stock-based compensation expense.
Net Income/Loss: Net loss was $33.9 million for the quarter ended September 30, 2016, compared to net loss of $15.4 million for the quarter ended September 30, 2015.
Shares Outstanding: Shares outstanding as of September 30, 2016 were 34,813,334.

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.

On November 2, 2016 Foundation Medicine, Inc. (NASDAQ:FMI) reported financial and operating results for its third quarter ended September 30, 2016 (Press release, Foundation Medicine, NOV 2, 2016, View Source [SID1234516193]). Highlights for the quarter included:

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Achieved third quarter revenue of $29.4 million, 16% year-over-year growth;
Reported 11,627 clinical tests in the third quarter, 45% year-over-year growth;
Grew FoundationCORE, the company’s molecular information knowledgebase, to nearly 100,000 patient cases;
Announced acceptance of FoundationOne for Parallel Review by FDA and CMS. If approved, FoundationOne could be the first FDA-approved comprehensive genomic profiling (CGP) assay to incorporate multiple companion diagnostics to support precision medicine in oncology and would be offered as a covered benefit to Medicare beneficiaries nationwide;
Added new immunotherapy clinical markers, Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI), to FoundationOne and FoundationOne Heme to help guide personalized immunotherapy-based treatment plans;
Published an additional 17 manuscripts in high-quality, peer-reviewed journals and delivered six podium and poster presentations at various medical and scientific meetings providing further evidence for the clinical impact of integrating CGP into routine cancer care;
Expanded patient access to CGP through Palmetto, the Medicare Administrative Contractor in North Carolina, who broadened a Local Coverage Determination, covering CGP for all stage IIIB and IV non-small cell lung cancer (NSCLC) patients at diagnosis by removing a patient’s smoking status as a coverage factor.
Foundation Medicine reported total revenue of $29.4 million in the third quarter of 2016, compared to $25.4 million in the third quarter of 2015. Revenue from biopharmaceutical partners grew 77% to $20.7 million in the third quarter of 2016, compared to $11.7 million in the third quarter of 2015. The increase in revenue demonstrates the company’s leading role in molecular information and the value of this information in informing and accelerating drug development for its oncology focused biopharmaceutical customers.

Revenue from clinical testing in the third quarter of 2016 was $8.7 million, compared to $13.7 million in the third quarter of 2015. The decrease was driven by various factors, the most significant of which was the transition in-network with a large national payer for stage IV NSCLC testing, which resulted in the termination of payments for testing in other indications.

The company reported 11,627 clinical tests in the third quarter of 2016, a 45% increase from the same quarter last year. This reported volume number includes 9,398 FoundationOne tests, 1,325 FoundationOne Heme tests and 904 FoundationACT tests.

"Foundation Medicine delivered another solid quarter highlighted by strong biopharma revenue and record clinical testing volume," said Michael Pellini, M.D., chief executive officer of Foundation Medicine. "We believe our progress on building distinct, yet synergistic clinical and biopharma businesses, developing applications that enable patient access to therapies and clinical trials, aggressively working towards reimbursement coverage and payment for our comprehensive genomic profiling assays and pursuing parallel review with FDA and CMS for FoundationOne will drive continued growth and value creation."

The company’s molecular information knowledgebase, FoundationCORE, grew to nearly 100,000 patient cases at the end of the third quarter. FoundationCORE is a unique asset and critical component of the value that Foundation Medicine delivers to its biopharmaceutical and physician customers. The increasing scale and breadth of this high quality, clinically relevant oncology data set derived from the company’s testing platform continues to enhance clinical practice and help enable improved outcomes for patients.

Total operating expenses for the third quarter of 2016 were approximately $44.9 million compared with $35.6 million for the third quarter of 2015. Net loss was approximately $31.3 million in the third quarter of 2016, or a $0.90 loss per share. At September 30, 2016, the company held approximately $167.9 million in cash, cash equivalents and marketable securities.

Recent Enterprise Highlights

Announced a collaboration with Sarah Cannon Research Institute (SCRI) in which SCRI will utilize Foundation Medicine’s full suite of assays to accelerate patient enrollment into clinical trials and facilitate data sharing across its network in the U.S.
Selected as the molecular information provider of choice by The Leukemia & Lymphoma Society for its landmark Beat AML Master Trial, a prospective study aimed at delivering a precision medicine approach to treat newly diagnosed Acute Myeloid Leukemia patients.
Announced the election of life sciences leader, Michael R. Dougherty, to its Board of Directors and the Board’s Audit Committee. Mr. Dougherty joins as an independent director and fills an existing vacancy on the Board.
2016 Outlook

Foundation Medicine’s business and financial outlook for 2016 is the following:

The company continues to expect 2016 revenue will be in the range of $110 to $120 million.
The company is increasing the bottom-end of its clinical volume guidance range and now expects to deliver between 40,000 and 41,000 FoundationOne and FoundationOne Heme clinical tests in 2016.
The company continues to expect operating expenses will be in the range of $175 and $185 million.

On November 2, 2016 Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, reported financial results for the quarter ended September 30, 2016, and provided updates on its clinical development programs of OCR-002 for the treatment of hepatic encephalopathy (HE), a debilitating liver disorder and significant burden on the healthcare system (Press release, Ocera Therapeutics, NOV 2, 2016, View Source [SID1234516192]).

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"We are pleased to report significant progress in our clinical programs. Enrollment in our STOP-HE Phase 2b study for acute hepatic encephalopathy has now surpassed 220 patients and, consistent with previous guidance, we expect to complete full enrollment of approximately 230 patients by year-end and publish top-line results of the study in the first quarter of 2017," said Linda Grais, M.D., Chief Executive Officer of Ocera. "In addition, dosing has commenced with our oral formulation of OCR-002 in a Phase 1 study in patients with cirrhosis as a chronic use option to maintain remission of HE. We remain on track to report results of part one of this study by year-end and initiate part two in the first half of 2017."

Select Third Quarter Financial Results

As of September 30, 2016, Ocera had cash, cash equivalents and investments of $32.5 million.
Net loss for the three and nine months ended September 30, 2016 was $7.1 million and $21.7 million, respectively. Net loss for the three and nine months ended September 30, 2015 was $6.6 million and $19.4 million, respectively. Basic and diluted net loss per share for the three and nine months ended September 30, 2016 was $0.32 and $1.01, respectively. Basic and diluted net loss per share for the three and nine months ended September 30, 2015 was $0.33 and $0.98, respectively.
Research and development (R&D) expense for the three months ended September 30, 2016 was $4.3 million, compared to $4.2 million for the same period in 2015. R&D expense for the nine months ended September 30, 2016 was $12.9 million, compared to $12.0 million for the same period in 2015. The increase in R&D expense for both the three and nine month periods was due primarily to an increase in headcount and related costs.
General and administrative (G&A) expense for the three months ended September 30, 2016 was $2.6 million, compared to $2.4 million for the same period in 2015. G&A expense for the nine months ended September 30, 2016 was $8.1 million, compared to $7.5 million for the same period in 2015. The increase in G&A expense for the three and nine month periods was due primarily to an increase in personnel-related costs, including stock-based compensation expense, as well as costs associated with professional service fees.
Net interest expense of $262,000 and $758,000 for the three and nine months ended September 30, 2016, respectively, was primarily attributable to interest and amortization associated with the debt facility which closed in July 2015.
Net cash proceeds generated from the Company’s "at the market" equity facility totaled approximately $6.0 million for the nine month period ended September 30, 2016.
Financial Guidance

Ocera reiterates its previous guidance and expects net use of cash for 2016 to be in the range of $22 million to $26 million, and updates its expectation that it will have sufficient cash to fund operations into the first quarter of 2018 based on its current operating plan. The Company previously estimated its cash runway into the fourth quarter of 2017. This improvement in projected cash runway is due primarily to the deferral of certain external development costs for OCR-002, lower than expected internal operating expenses, and cash proceeds generated from the "at the market" equity facility.

On November 2, 2016 CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, reported financial results for the three and nine months ended September 30, 2016, and provided a business update (Press release, CombiMatrix, NOV 2, 2016, View Source [SID1234516186]).

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"Excellent execution on our business initiatives keeps us squarely on the path to profitability," said Mark McDonough, CombiMatrix President and CEO. "Among quarterly financial highlights, we are reporting revenue growth of 29%, our third consecutive quarter of gross margin above 50% and record cash reimbursement of $3.1 million, or 95% of total revenues. Combined with our ability to manage expenses, we reduced both our operating loss and our cash burn by nearly half from one year ago.

"We are pleased with our recent performance and expect continued growth in revenue and test volume, along with consistent cash reimbursement and prudent expense management in the coming year with a focus on creating value for our shareholders," Mr. McDonough added. "Given our outlook, we are increasingly confident we will reach our goal of positive cash flow from operations by the fourth quarter of 2017."

Third Quarter Financial and Operating Highlights (all comparisons are with the third quarter of 2015)

Total revenues of $3.2 million, up 29%
Total test volume of 2,835, up 14%
Reproductive health revenues of $2.3 million, up 39%
Reproductive health test volume of 1,483, up 17%
Gross margin of 54.0%, up from 43.6%
Number of billable customers of 257, up 10%
Cash collections at new record of $3.1 million, or 95% of total revenue, up 29%

Volumes Revenues (in 000’s)
Q3 ’16 Q3 ’15 # Δ % Δ Q3 ’16 Q3 ’15 $ Δ % Δ
Prenatal 294 272 22 8 % $ 408 $ 368 $ 40 11 %
Miscarriage analysis 990 866 124 14 % 1,622 1,145 477 42 %
PGS 199 127 72 57 % 286 149 137 92 %
Subtotal – reproductive health 1,483 1,265 218 17 % 2,316 1,662 654 39 %
Pediatric 505 509 (4 ) (1 %) 589 558 31 6 %
Subtotal 1,988 1,774 214 12 % 2,905 2,220 685 31 %
FISH and karyotyping 847 721 126 17 % 306 261 45 17 %
Total – all tests 2,835 2,495 340 14 % 3,211 2,481 730 29 %
Royalties 37 45 (8 ) (18 %)
Total revenues $ 3,248 $ 2,526 $ 722 29 %


Volumes Revenues (in 000’s)
9 Mo’s. ’16 9 Mo’s. ’15 # Δ % Δ 9 Mo’s. ’16 9 Mo’s. ’15 $ Δ % Δ
Prenatal 860 936 (76 ) (8 %) $ 1,203 $ 1,214 $ (11 ) (1 %)
Miscarriage analysis 2,886 2,664 222 8 % 4,701 3,467 1,234 36 %
PGS 566 157 409 261 % 759 189 570 302 %
Subtotal – reproductive health 4,312 3,757 555 15 % 6,663 4,870 1,793 37 %
Pediatric 1,454 1,557 (103 ) (7 %) 1,646 1,687 (41 ) (2 %)
Subtotal 5,766 5,314 452 9 % 8,309 6,557 1,752 27 %
FISH and karyotyping 2,497 2,125 372 18 % 881 735 146 20 %
Total – all tests 8,263 7,439 824 11 % 9,190 7,292 1,898 26 %
Royalties 137 112 25 22 %
Total revenues $ 9,327 $ 7,404 $ 1,923 26 %

Financial Results

Three Months Ended September 30, 2016 and 2015

Total revenues for the third quarter of 2016 increased 29% to $3.2 million from $2.5 million for the third quarter of 2015. Reproductive health diagnostic test revenue, which includes prenatal microarrays, miscarriage analysis and preimplantation genetic screening (PGS), increased 39% to $2.3 million and testing volume increased 17% to 1,483. The third quarter 2016 revenue increase was driven primarily by higher test volume for reproductive health diagnostics, higher average revenue per test particularly for miscarriage analysis and PGS tests, and from an increase in the number of billable customers, which reached 257 during the third quarter of 2016 compared to 234 in the prior-year period.

Total operating expenses were $4.1 million for the third quarter of 2016 compared with $4.2 for the prior-year period. The decrease was due primarily to lower sales and marketing and research and development expenses, partially offset by higher general and administrative expenses due to higher personnel, investor relations and consulting costs and higher cost of services as a result of higher test volume. Gross margin for the third quarter of 2016 improved to 54.0% from 43.6% for third quarter of 2015.

The net loss attributable to common stockholders for the third quarter of 2016 was $856,000, or $0.38 per share, compared with a net loss attributable to common stockholders for the third quarter of 2015 of $1.7 million, or $2.00 per share, an improvement of $831,000.

Nine Months Ended September 30, 2016 and 2015

Total revenues for the first nine months of 2016 increased 26% to $9.3 million from $7.4 million for the first nine months of 2015. Revenues for the first nine months of 2016 included $9.2 million in diagnostic services revenue and $137,000 in royalty revenues.

Operating expenses for the first nine months of 2016 were $12.9 million compared with $12.4 million for the prior-year period, with the increase mainly due to higher general and administrative expenses and higher cost of services resulting from increased testing volumes, partially offset by lower sales and marketing expenses. Gross margin improved to 52.9% for the first nine months of 2016 from 44.8% for the first nine months of 2015.

The net loss attributable to common stockholders for the first nine months of 2016 was $5.2 million, or $3.48 per share, compared to $6.0 million, or $7.21 per share in 2015. The net loss attributable to common stockholders in 2016 reflected one-time, non-cash charges of $1.9 million related to deemed dividends from the issuance of Series F convertible preferred stock and warrants in the $8.0 million public offering that closed on March 24, 2016. This increase was partially offset by the reversal of the $890,000 Series E deemed dividend recognized in 2015 from the repurchase of those securities upon closing of our Series F public offering, partially reduced by the $656,000 deemed dividend paid to the Series E investors in February of 2016.

The Company reported $4.3 million in cash, cash equivalents and short-term investments as of September 30, 2016, compared with $3.9 million as of December 31, 2015. The Company used $813,000 and $3.4 million in cash to fund operating activities during the quarter and nine months ended September 30, 2016, respectively, compared with $1.5 million and $4.2 million used to fund operating activities during the comparable 2015 periods, respectively. The significant decreases in net cash used to fund operating activities for the 2016 periods resulted primarily from improved cash reimbursement of $3.1 million and $8.5 million for the three and nine months ended September 30, 2016, respectively, compared with $2.4 million and $7.0 million for the three and nine months ended September 30, 2015, respectively.