Illumina Reports Full Financial Results for Third Quarter of Fiscal Year 2016

On November 1, 2016 Illumina, Inc. (NASDAQ:ILMN) reported its full financial results for the third quarter of fiscal year 2016 (Filing, Q3, Illumina, 2016, NOV 1, 2016, View Source [SID1234516299]).

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Third quarter 2016 results:

As previously announced on October 10, 2016, revenue of $607 million, a 10% increase compared to $550 million in the third quarter of 2015

GAAP net income attributable to Illumina stockholders for the quarter of $129 million, or $0.87 per diluted share, compared to $118 million, or $0.79 per diluted share, for the third quarter of 2015

Non-GAAP net income attributable to Illumina stockholders for the quarter of $144 million, or $0.97 per diluted share, compared to $120 million, or $0.80 per diluted share, for the third quarter of 2015 (see the table entitled "Itemized Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)

Cash flow from operations of $150 million and free cash flow of $93 million for the quarter, compared to $181 million and $152 million in the prior year period

Gross margin in the third quarter of 2016 was 70.2% compared to 70.4% in the prior year period. Excluding the effect of non-cash stock compensation expense and amortization of acquired intangible assets, non-GAAP gross margin was 72.5% for the third quarter of 2016 compared to 73.2% in the prior year period.

Research and development (R&D) expenses for the third quarter of 2016 were $125.9 million, or 20.7% of revenue, compared to $99.2 million, or 18.1% of revenue, in the prior year period. R&D expenses included $11.5 million and $9.1 million of non-cash stock compensation expense in the third quarters of 2016 and 2015, respectively. Excluding these charges and contingent compensation, R&D expenses as a percentage of revenue were 18.8%, including 2.4% attributable to GRAIL and Helix. This compares to 16.4% in the prior year period.

Selling, general and administrative (SG&A) expenses for the third quarter of 2016 were $139.1 million, or 22.9% of revenue, compared to $136.6 million, or 24.8% of revenue, in the prior year period. SG&A expenses included $20.0 million and $20.1 million of non-cash stock compensation expense in the third quarters of 2016 and 2015, respectively. Excluding these charges, amortization of acquired intangible assets, and contingent compensation, SG&A expenses as a percentage of revenue were 19.3%, including 1.5% attributable to GRAIL and Helix. This compares to 20.9% in the prior year period, including 0.9% attributable to Helix.

Depreciation and amortization expenses were $35.9 million and capital expenditures for free cash flow purposes were $57.1 million during the third quarter of 2016, which excludes an increase of $83.9 million in property and equipment recorded under build-to-suit lease accounting since such expenses were paid for by the landlord.

At the close of the quarter, the company held $1.54 billion in cash, cash equivalents and short-term investments, compared to $1.39 billion as of January 3, 2016.

"While sequencing sample volume growth remains robust, our lowered revenue outlook reflects our updated expectations for HiSeq 2500, HiSeq 4000 and HiSeq X instrument purchases, as well as HiSeq 2500 reagent sales," stated Francis deSouza, President and CEO. "Over the last few weeks it has become clear that certain academic funding practices were modified in the third quarter, limiting our customers’ ability to make HiSeq X capital commitments. Further, HiSeq 2500 and 4000 demand has been impacted by a migration to NextSeq, for enhanced workflow flexibility and HiSeq X, given its beneficial pricing for whole genome sequencing."

Updates since our last earnings release:

Announced a partnership with FlowJo, LLC to develop and co-market analysis software for single cell next-generation sequencing data

Received orders for an additional 2 million samples of the Infinium Global Screening Array, for a total of more than 5 million samples ordered to date

Appointed Philip W. Schiller to the company’s Board of Directors

Announced that Christian Henry, Executive Vice President and Chief Commercial Officer, will be leaving the company. Appointed Mark van Oene, currently Senior Vice President and General Manager, Americas, as Interim Chief Commercial Officer

Announced that Illumina’s Board of Directors has authorized the company to repurchase up to $250 million of outstanding common shares in the open market or in privately negotiated transactions, subject to market conditions and other factors. The company repurchased $13 million of common stock under this new stock authorization

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

The company continues to project fourth quarter revenue to be flat to slightly up compared to the third quarter. For fiscal 2016, non-GAAP earnings per diluted share attributable to Illumina stockholders is forecasted to be $3.27 to $3.32.

Quarterly conference call information
The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, November 1, 2016. Interested parties may listen to the call by dialing 888.771.4371 (passcode: 43579048), or if outside North America

by dialing +1.847.585.4405 (passcode: 43579048). Individuals may access the live teleconference in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com.

A replay of the conference call will be available from 4:30 pm Pacific Time (7:30 pm Eastern Time) on November 1, 2016 through November 8, 2016 by dialing 888.843.7419 (passcode: 43579048), or if outside North America by dialing +1.630.652.3042 (passcode: 43579048).

Myriad Genetics Reports Fiscal First-Quarter 2017 Financial Results

On November 1, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal first-quarter 2017, provided an update on recent business highlights, maintained its fiscal year 2017 financial guidance and issued fiscal second-quarter 2017 financial guidance (Press release, Myriad Genetics, NOV 1, 2016, View Source [SID1234516145]).

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"We were pleased with the first quarter as our hereditary cancer business returned to more normal volume trends, and we secured important endorsements from physician networks representing 70 percent of community oncologists in the United States," said Mark C. Capone, president and CEO of Myriad. "In addition, our newest tests, Genesight, EndoPredict, and Prolaris all exceeded 50 percent growth rates, and we successfully completed PARP inhibitor studies with the first prospective validation of myChoice HRD and an additional validation for BRACAnalysis CDx. We remain committed to transforming Myriad into a larger and more diversified personalized medicine company and delivering upon our five-year strategic goals."

Financial Highlights

Below are tables summarizing the financial results and revenue by product class for our fiscal first-quarter 2017:
Revenue
Fiscal First-Quarter

($ in millions) 2017 2016 % Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 139.3 $ 156.7 (11 %)

GeneSight testing revenue 7.2* 0.0 NM

Vectra DA testing revenue 11.6 11.4 2 %

Prolaris testing revenue 2.9 0.7 314 %

EndoPredict testing revenue 1.7 0.8 113 %

Other testing revenue 2.4 2.3 4 %

Total molecular diagnostic testing revenue 165.1 171.9 (4 %)

Pharmaceutical and clinical service revenue 12.4 11.6 7 %

Total Revenue $ 177.5 $ 183.5 (3 %)

Income Statement
Fiscal First-Quarter

($ in millions) 2017 2016 % Change
Total Revenue $ 177.5 $ 183.5 (3 %)

Gross Profit 137.5 147.0 (7 %)
Gross Margin 77.5 % 80.1 %

Operating Expenses 131.3 103.7 27 %

Operating Income 6.2 43.3 (86 %)
Operating Margin 3.5 % 23.6 %

Adjusted Operating Income 21.6 46.5 (54 %)
Adjusted Operating Margin 12.2 % 25.3 %

Net Income (1.2 ) 30.3 NM

Diluted EPS (0.02 ) 0.42 NM

Adjusted EPS $ 0.23 $ 0.41 (44 %)
* represents revenue for the month of September only

Business Highlights

myRisk Hereditary Cancer
Signed preferred provider agreements with major physician networks in oncology representing approximately 70 percent of community oncologists in the country, or approximately 4,000 physicians.
Launched a customizable myRisk panel for genetics experts who are interested in tailoring their gene selections.
Ended the quarter with 65 percent of revenue under long-term contract and 95 percent of insurance plans in network.

GeneSight
Volumes were up 70 percent year-over-year to approximately 51,000 tests performed in the full fiscal first-quarter 2017.
Reached 90 percent enrollment in a landmark 1,200 patient clinical utility study evaluating GeneSight in patients with depression or anxiety treated by preventive care physicians or psychiatrists.

Vectra DA
Volumes were up four percent year-over-year in the fiscal first-quarter with approximately 39,000 tests performed.
Announced the presentation of four abstracts at the American College of Rheumatology conference in November, showing the ability of Vectra DA to predict which patients will experience flare or sustained remission, and the ability of the Vectra DA score to provide added predictive value to traditional measures of disease activity.

Prolaris
Volumes increased 56 percent year-over-year with approximately 4,400 tests ordered.

Companion Diagnostics
Announced data from the first prospective validation of myChoice HRD from the NOVA study, evaluating the PARP inhibitor, niraparib. In the study, which evaluated platinum-sensitive ovarian cancer patients, myChoice HRD positive patients demonstrated a 9.1 month median progression free survival benefit versus a 3.1 progression free survival benefit in myChoice HRD negative patients. Myriad has submitted the first module of its premarket approval application for myChoice HRD to the FDA.
Announced data from the AstraZeneca SOLO2 study, which compared maintenance olaparib against placebo in patients with platinum-sensitive relapsed ovarian cancer met its primary endpoint. These results further validate that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
Myriad signed an agreement with AstraZeneca to use its newest companion diagnostic, myChoice HRD Plus, to help prospectively identify patients for enrollment in an upcoming exploratory study involving olaparib. myChoice HRD Plus combines Myriad’s proprietary myChoice HRD assay with 102 additional genes involved in DNA repair.

International
Revenues were up 43 percent year-over-year in the first quarter and accounted for approximately five percent of total product revenue.
EndoPredict revenues grew 113 percent year-over-year to $1.7 million in the first quarter of fiscal year 2017.
Completed enrollment in an EndoPredict study evaluating the ability of the test to predict response to neoadjuvant chemotherapy. Results of the study are expected to be presented in calendar year 2017.
In August, the German public reimbursement system (GBA) issued new ambulatory specialty care (ASV) reimbursement covering gene expression testing for breast cancer when conducted in authorized major centers throughout Germany.

Share Repurchase
During the quarter, the Company repurchased approximately 1.0 million shares, or $21 million, of common stock under our share repurchase program and ended the quarter with approximately $171 million remaining on our current share repurchase authorization.
Fiscal Year 2017 and Fiscal Second-Quarter 2017 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2017 and fiscal second-quarter 2017 financial guidance:

Revenue Adjusted Earnings Per Share GAAP Diluted Earnings Per Share
Fiscal Year 2017 $740-$760 million $1.00-$1.10 $0.34-$0.44

Fiscal Second-Quarter 2017 $188-$190 million $0.23-$0.25 $0.06-$0.08

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during its conference call today to discuss the fiscal first-quarter financial results and fiscal year 2017 and fiscal second-quarter 2017 financial guidance.

Phase 1 Study of CB-839, a Small Molecule Inhibitor of Glutaminase, In Combination with Everolimus in Patients with Clear Cell and Papillary Renal Cell Carcinoma

On November 1, 2016 Calithera Biosciences presented the corporate presentation (Presentation, Calithera Biosciences, NOV 1, 2016, View Source [SID1234535277]).

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QLT Announces Third Quarter 2016 Results

On November 1, 2016 QLT Inc. (NASDAQ:QLTI) (TSX:QLT) ("QLT" or the "Company") reported financial results for the third quarter ended September 30, 2016. Unless otherwise specified, all amounts are reported in U.S. dollars and in accordance with U.S. GAAP (Press release, QLT, NOV 1, 2016, View Source;p=RssLanding&cat=news&id=2217788 [SID1234516148]).

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2016 THIRD QUARTER FINANCIAL RESULTS

Operating Expenses/Income

During the third quarter of 2016, research and development ("R&D") expenditures were $2.9 million compared to $2.1 million for the same period in 2015. The $0.8 million (38%) increase was primarily due to higher costs related to preparatory activities for our upcoming Phase III pivotal trial for QLT091001.

During the third quarter of 2016, we incurred $1.9 million of consulting and advisory fees on activities to support our pending merger transaction with Aegerion Pharmaceuticals, Inc. ("Aegerion"), which is described below. In comparison, we incurred $2.2 million of similar costs in 2015 related to: (i) the pursuit of our merger transaction with InSite Vision Incorporated ("InSite"), which was terminated by InSite on September 15, 2015, and (ii) activities to support our investment in Aralez Pharmaceuticals, Inc. ("Aralez"), which was subsequently distributed to our shareholders on April 5, 2016 (the "Aralez Distribution").

Excluding the strategic consulting and advisory fees described above, selling, general and administrative ("SG&A") expenditures for the third quarter of 2016 were relatively consistent with SG&A expenditures incurred during the same period in 2015.

Operating Loss and Net Loss per Share

The operating loss for the third quarter of 2016 was $6.0 million, compared to $2.8 million for the same period in 2015. The net $3.2 million change in our operating loss was primarily due to a $2.7 million non-recurring termination fee received from InSite in September 2015, in connection with InSite’s termination of the merger agreement, as well as higher R&D costs in the third quarter of 2016 associated with preparatory activities for our upcoming Phase III pivotal trial for QLT091001.

Net loss per common share was $0.11 in the third quarter of 2016, compared to $0.05 for the same quarter in 2015. The change in our net loss per common share was primarily due to the same factors described above.

Cash and Cash Equivalents

As at September 30, 2016, the Company’s consolidated cash and cash equivalents were $73.1 million compared to $141.8 million at December 31, 2015. The $68.7 million decrease was primarily due to: (i) the $45.0 million investment in Aralez and subsequent Aralez Distribution (as described above), (ii) $9.2 million of strategic consulting and advisory fees related to the proposed merger with Aegerion, the Aralez Distribution, and the exploration of other strategic alternatives, (iii) $3.0 million advanced to Aegerion pursuant to the terms of the interim loan agreement with Aegerion, and (iv) cash used in operating activities during the period.

AEGERION MERGER TRANSACTION UPDATE

As previously announced, on June 14, 2016, Aegerion and QLT agreed to a merger (the "Merger") under the terms of an Agreement and Plan of Merger by and among Aegerion, QLT and Isotope Acquisition Corp., an indirect wholly-owned subsidiary of QLT. While the proposed Merger has been approved by the boards of directors of both companies, the closing of the Merger is subject to various conditions, including but not limited to (i) receipt of the required approvals of the shareholders at the special meetings of each QLT and Aegerion on November 7, 2016, and (ii) completion of the $21.8 million QLT private placement contemplated by the unit subscription agreement entered into with certain investors in connection with the Merger. The Merger is expected to close in the fourth quarter of 2016.

SYNTHETIC RETINOID UPDATE

The Company continues its Phase III pivotal trial start-up activities to test the safety and efficacy of its Fast Track and Orphan Drug Designated investigational drug product, QLT091001 in subjects with Inherited Retinal Disease phenotypically diagnosed as LCA or RP caused by RPE65 or LRAT gene mutations, with a goal of initiating the pivotal trial in the fourth quarter of 2016.

In addition to the Fast Track and Orphan Drug Designations previously granted to us by the FDA for QLT091001, the Company is currently exploring the potential of submitting to the FDA a request for a Rare Pediatric Disease Designation of QLT091001. Under the Federal Food, Drug, and Cosmetic Act, a sponsor who receives an approval of a New Drug Application (NDA) for a Rare Pediatric Disease and meets certain additional criteria, may be eligible to be awarded a Rare Pediatric Disease Priority Review Voucher (PRV). A PRV can be redeemed to receive a priority review for any subsequent marketing application for a different product. A PRV, if obtained by a sponsor, may be sold or transferred to another sponsor. The FDA’s authority to award Rare Pediatric Disease PRVs is currently set to expire December 31, 2016. The authority has been extended multiple times previously, and while it is possible that it may be further extended or made permanent in the future, there is no guarantee of any such extension.

In addition, U.S. Patent No. 9,403,765 relating to various methods of use of various synthetic retinal esters, including QLT091001, for the treatment of diseases associated with an endogenous 11-cis-retinal deficiency, including LCA and RP, was granted by the USPTO on August 2, 2016. This patent is currently projected to expire on June 20, 2025. This newly issued patent further enhances the Company’s key patent portfolio around methods of using QLT091001 in the treatment of IRD.

Passive Foreign Investment Company

The Company believes that it was classified as a Passive Foreign Investment Company ("PFIC") for 2008 through 2015, and that it may be classified as a PFIC in 2016, which could have adverse tax consequences for U.S. shareholders. Please refer to our 2015 Annual Report on Form 10-K (as amended by the Form 10-K/A filed on April 29, 2016) for additional information.

QLT Inc. – Financial Highlights
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(In thousands of U.S. dollars except share and per share information)
Three months ended Nine months ended
September 30, September 30,
2016 2015 2016 2015

Expenses
Research and development $ 2,855 $ 2,142 $ 8,774 $ 7,754
Selling, general and administrative 3,138 3,166 13,487 13,939
Depreciation 24 141 85 508
Termination fee – (2,667 ) – (2,667 )
6,017 2,782 22,346 19,534
Operating loss (6,017 ) (2,782 ) (22,346 ) (19,534 )
Other (expense) income
Net foreign exchange losses (105 ) (43 ) (214 ) (5 )
Interest income 110 152 240 235
Fair value loss on investment – - (10,704 ) -
Other (39 ) (6 ) (30 ) (8 )
(34 ) 103 (10,708 ) 222
Loss before income taxes (6,051 ) (2,679 ) (33,054 ) (19,312 )
Recovery of (Provision for) income taxes 115 (3 ) 104 (17 )
Net loss and comprehensive loss $ (5,936 ) $ (2,682 ) $ (32,950 ) $ (19,329 )

Basic and diluted net loss per common share
Net loss per common share $ (0.11 ) $ (0.05 ) $ (0.62 ) $ (0.37 )

Weighted average number of common shares outstanding (thousands)
Basic and diluted 52,829 52,829 52,829 51,949

CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands of U.S. dollars) September 30, 2016 December 31, 2015
ASSETS
Current assets
Cash and cash equivalents $ 73,056 $ 141,824
Accounts receivable, net of allowances for doubtful accounts 186 287
Loan receivable 3,073 -
Income taxes receivable 14 14
Prepaid and other assets 450 611
Total current assets 76,779 142,736
Accounts receivable 2,000 2,000
Property, plant and equipment 270 430
Total assets $ 79,049 $ 145,166
LIABILITIES
Current liabilities
Accounts payable $ 3,308 $ 1,656
Accrued liabilities 1,058 1,827
Total current liabilities 4,366 3,483
Uncertain tax position liabilities - 342
Total liabilities 4,366 3,825
SHAREHOLDERS’ EQUITY
Share capital
Authorized
500,000,000 common shares without par value
5,000,000 first preference shares without par value, issuable in series
Issued and outstanding common shares $ 475,333 $ 475,333
September 30, 2016 – 52,829,398 shares
December 31, 2015 – 52,829,398 shares
Additional paid-in capital 63,669 97,377
Accumulated deficit (567,288 ) (534,338 )
Accumulated other comprehensive income 102,969 102,969
Total shareholders’ equity 74,683 141,341
Total shareholders’ equity and liabilities $ 79,049 $ 145,166

OncoMed Pharmaceuticals Reports Third Quarter 2016 Financial Results

On November 1, 2016 OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, reported third quarter financial results. As of September 30, 2016, cash, cash equivalents and short-term investments totaled $207.6 million (Press release, OncoMed, NOV 1, 2016, View Source [SID1234516150]).

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"OncoMed remains focused on execution across our pipeline, completing enrollment in two randomized Phase 2 trials for demcizumab and tarextumab and driving toward randomized Phase 2 results and potential partner opt-ins in the first half of 2017," said Paul J. Hastings, Chairman and Chief Executive Officer. "Additionally, we will continue to generate new data on multiple compounds in the clinic, and we expect to file INDs for two immuno-oncology programs in late 2016 though the first half of 2017."

Q3 Highlights

Completed enrollment of 207 patients a month ahead of schedule in the Phase 2 YOSEMITE trial of demcizumab (anti-DLL4, OMP-21M18) in combination with Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine in first-line metastatic pancreatic cancer. Topline results are expected in the first half of 2017, enabling a potential opt-in by Celgene Corporation (Celgene).

Completed enrollment of 145 previously untreated patients with extensive-stage small cell lung cancer (SCLC) three months ahead of schedule in the Phase 2 PINNACLE clinical trial of tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide and platinum-based chemotherapy. Topline are results expected in the first half of 2017, enabling a potential opt in by GlaxoSmithKline (GSK).

Presented interim data from the Phase 1b clinical trials of vantictumab (anti-Fzd, OMP-18R5) and ipafricept (FZD8-Fc, OMP-54F28) in pancreatic cancer at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Congress. OncoMed expects to submit data packages for both vantictumab and ipafricept to Bayer Pharma AG (Bayer) for opt-in consideration during the first half of 2017.
Development updates

OncoMed’s Phase 2 DENALI clinical trial of demcizumab in combination with carboplatin/pemetrexed in first-line non-small cell lung cancer (NSCLC) has enrolled 81 patients as of October 31, 2016. Based on the evolving treatment landscape for front-line NSCLC, OncoMed has stopped further enrollment of patients in this Phase 2 randomized clinical trial and plans to continue to treat currently enrolled patients and analyze the data from those patients in time to support the YOSEMITE data and the potential opt-in package in the first half of 2017. Additionally, OncoMed will supplement the opt-in package with interim safety, biomarker, and early efficacy data from its ongoing Phase 1b trial of demcizumab combined with pembrolizumab. OncoMed anticipates having response rate, progression-free survival, interim overall survival and safety data for DENALI in parallel with the results of YOSEMITE. DENALI data combined with the Phase 1b combination data with demcizumab and pembrolizumab will inform future development of demcizumab in NSCLC.

GSK has notified OncoMed of its decision to focus its current collaboration with OncoMed on tarextumab in SCLC based on the PINNACLE study and to terminate its option on the brontictuzumab (anti-Notch1, OMP-52M51) program. As a result of the termination, OncoMed will retain the worldwide rights to develop brontictuzumab.

OncoMed will continue its ongoing efforts with investigators to plan the conduct of a Phase 1b clinical trial of brontictuzumab in combination with trifluridine and tipiracil tablets (Lonsurf) in third-line colorectal cancer. The trial includes enrollment of biomarker-positive patients whose tumors express the activated form of Notch1. OncoMed has previously presented Phase 1 data that suggest brontictuzumab has single-agent activity in patients with tumors that are positive for the Notch1 biomarker. The prevalence of activated Notch1 in colorectal cancer is expected to be about 50 percent. Enrollment in the Phase 1b study is expected to commence in late 2016 or early 2017.

2016 Upcoming Milestones

Present first-in-human data for anti-DLL4/VEGF (OMP-305B83) and anti-RSPO3 (OMP-131R10) from ongoing Phase 1 trials at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium being held in Munich, Germany November 29-December 2, 2016.

File an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) before year-end for one of two immuno-oncology therapeutic candidates: IO#2, partnered with Celgene, or GITRL-Fc, a wholly owned OncoMed asset. A second IND application is expected to follow in the first half of 2017.
Third Quarter 2016 Financial Results

Cash, cash equivalents and short-term investments totaled $207.6 million as of September 30, 2016, compared to $171.5 million as of June 30, 2016. The company’s cash balance includes net proceeds of $59.2 million from a follow-on offering completed August 23, 2016.

Revenues for the three months ended September 30, 2016 were $5.9 million, an increase of $1.2 million, compared to total revenue of $4.7 million for the three months ended September 30, 2015. This increase was primarily due to amortization of the $70.0 million safety milestone achieved in the fourth quarter of 2015.

Research and development (R&D) expenses were $27.4 million for the third quarter of 2016 compared with $24.7 million for the same period in 2015. Higher R&D expenditures during the third quarter 2016 were attributable to increased manufacturing costs for the IO#2 and GITRL-Fc programs, increased clinical costs for the anti-RSPO3 and vantictumab programs and increased personnel costs. These increases were partially offset by a decrease in 2016 spending for the tarextumab program.

General and administrative (G&A) expenses were $4.5 million for the quarters ended September 30, 2016 and September 30, 2015. G&A costs during the third quarter 2016 increased due to personnel costs, offset by financing costs in the third quarter of 2015 related to the filing of the Form S-3 registration statement in June 2015.

Net loss for the third quarter 2016 was $25.9 million ($0.77 per share), compared to $24.5 million ($0.81 per share) for the same period of 2015. The change in net loss from the same quarter in 2015 was primarily attributable to an increase in research and development expenses.