On November 7, 2017 CytomX Therapeutics, Inc. (NASDAQ: CTMX), a biopharmaceutical company developing investigational Probody therapeutics for the treatment of cancer, reported third quarter 2017 financial results (Press release, CytomX Therapeutics, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2315188 [SID1234521674]).

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As of September 30, 2017, CytomX had cash, cash equivalents and short-term investments of $331.3 million. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations into 2020.

"We have continued to enjoy a highly productive year with excellent progress in advancing our deep pipeline of potentially transformative Probody therapeutics and the addition of another major partner in Amgen," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "I am delighted with the team’s strong execution across all areas of the organization, and we continue to be well positioned for initial data read outs in 2018 from our lead, wholly owned programs, CX-072 and CX-2009. We also expect that Probody therapeutics targeting CTLA-4, PD-1, and CD71 will enter the clinic next year, demonstrating the considerable momentum behind our pipeline."

Q3’17 BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS

PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical Program

Patient enrollment continued in the monotherapy dose escalation arm (Part A1) of the study evaluating CX-072 in patients with advanced unresectable solid tumors or lymphomas. Enrollment is expected to be complete by year-end.
Patient enrollment has now been initiated in all other dose escalation arms of the study:
Monotherapy expansion in patients with PD-L1-positive tumors at multiple dose levels (Part A2);
Concomitant schedule for CX-072 plus ipilimumab in patients with advanced unresectable solid tumors or lymphomas (Part B1);
Phased schedule for CX-072 plus ipilimumab in patients with advanced unresectable solid tumors or lymphomas (Part B2); and
Combination of CX-072 plus vemurafinib in patients with V600E BRAF-positive melanoma (Part C)
During the first half of 2018, an expansion cohort of the study at the recommended Phase 2 dose is expected to begin enrolling patients to evaluate CX-072 as monotherapy in a tumor type with known sensitivity to PD-L1 and/or PD-1 inhibitors (Part D).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical Program

CX-2009 is a first-in-class Probody drug conjugate (PDC) that targets CD166, an antigen that is broadly and highly expressed in many types of cancers, but has been considered undruggable given that it is also expressed in normal tissue.
Patient enrollment continues in the PROCLAIM-CX-2009 study, a Phase 1/2 clinical trial evaluating CX-2009 as monotherapy in a subset of CD166-positive cancers.
The study was initiated at a dose of 0.25 mg/kg, has advanced through several patient cohorts and is currently enrolling at a dose of 2 mg/kg.
Expansion cohorts at the recommended Phase 2 dose in one or more CD166 positive tumor types are expected to initiate in 2018.
CX-2029 (CD71 Probody Drug Conjugate) Preclinical Program

CytomX, in collaboration with AbbVie, is advancing CX-2029, a CD71-directed PDC, through Investigational New Drug (IND) application-enabling studies and expects to file an IND application in the first half of 2018.
A $15 million milestone payment ($14 million net of associated license fees) was received from AbbVie in conjunction with meeting certain criteria allowing the initiation of GLP toxicology studies by CytomX.
CX-188 (PD-1 Probody Therapeutic) Preclinical Program

CytomX is advancing CX-188, a PD-1-directed Probody therapeutic, through IND application-enabling studies and expects to file an IND application in the second half of 2018.
Amgen Partnership

During the quarter, Amgen and CytomX entered into a strategic collaboration in immuno-oncology in the field of Probody T-cell engaging bispecific antibodies including the co-development of a CytomX Probody T-cell engaging bispecific against the Epidermal Growth Factor Receptor (EGFR), a highly validated oncology target expressed on multiple human cancer types.
Under the terms of the agreement, Amgen and CytomX will co-develop a Probody T-cell engaging bispecific against EGFR-CD3 with CytomX leading early development. Amgen will lead later development and commercialization with global late-stage development costs shared between the two companies.
Amgen made an upfront payment of $40 million and purchased $20 million of CytomX common stock.
CytomX is eligible to receive up to $455 million in development, regulatory and commercial milestones for the EGFR program.
Amgen will lead global commercial activities with CytomX able to opt into a profit share in the U.S. and receive tiered, double-digit royalties on net product sales outside of the U.S.
Amgen also received exclusive worldwide rights to develop and commercialize up to three undisclosed targets. Should Amgen ultimately pursue all of these targets, CytomX will be eligible to receive up to $950 million in additional upfront and milestone payments and high single-digit to mid-double digit royalty payments on any resulting products.
CytomX also received the rights from Amgen to an undisclosed preclinical T-cell engaging bispecific program; Amgen is eligible to receive milestones and royalty payments on any resulting products from this CytomX program.
Bristol-Myers Squibb (BMS) Partnership

BMS continues to advance its CTLA-4-directed Probody therapeutic, which is expected to enter the clinic in early 2018.
In addition, CytomX and Bristol-Myers Squibb are evaluating a Probody version of Bristol-Myers Squibb’s CTLA-4 nonfucosylated (CLTA-4-NF) version of ipilimumab as part of the current collaboration.
Third Quarter Financial Results
Cash, cash equivalents and investments totaled $331.3 million as of September 30, 2017, compared to $181.9 million as of December 31, 2016. The increase reflects a $200 million upfront payment received from BMS in connection with the expansion of the existing collaboration.

Revenue was $24.1 million for the three months ended September 30, 2017, compared to $3.5 million for the three months ended September 30, 2016. The increase was primarily attributable to the recognition of $14.0 million, net of the associated license fees, from the milestone payment received from AbbVie as a result of the Company achieving certain milestones required to be met to begin GLP toxicology studies under the CD71 Agreement and an increase of $6.3 million related to the recognition of the an upfront payment received from BMS in connection with the expansion of our collaboration pursuant to an amendment of our Collaboration and License Agreement entered into in March 2017.

Research and development expenses were $28.9 million for the three months ended September 30, 2017, compared to $13.3 million for the corresponding period in 2016. The increase was primarily attributable to $10.7 million of in-process research and development expense recognized and a $1.2 million sublicense fee payable to UCSB as a result of the Amgen agreement, an increase of $1.7 million in pharmacology studies and clinical trial expenses resulting from the advancement of CX-072, CX- 2009 and CX-2029 in 2017, an increase of $0.9 million in allocations resulting from increases in facilities-related expenses, an increase of $0.4 million in consulting and contracted services and an increase of $0.4 million in personnel-related expense resulting from an increase in headcount.

General and administrative expenses were $6.2 million for the three months ended September 30, 2017, compared to $5 million for the corresponding period in 2016. The increase was primarily attributable to an increase of $0.3 million in personnel-related expenses due to an increase in headcount, an increase of $0.3 million in legal expenses and an increase of $0.4 million in consulting and public relations expenses.

On November 7, 2017 Ignyta, Inc. (Nasdaq: RXDX), a biotechnology company focused on precision medicine in oncology, reported company highlights and financial results for the third quarter ended September 30, 2017 (Press release, Ignyta, NOV 7, 2017, View Source [SID1234521678]). The company is issuing this press release in lieu of conducting a conference call.

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"In addition, during the quarter we continued to advance our pipeline of precision medicines targeted at the molecular and immunological drivers of cancer, and we strengthened our balance sheet through an equity offering that provides us with additional resources to continue developing meaningful new cancer therapies for patients."
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"We are pleased with the continued development and regulatory progress of our lead product candidate, entrectinib—an investigational, CNS-active, potent, and selective tyrosine kinase inhibitor being developed for tumors that harbor TRK or ROS1 fusions—as we approach the expected submission of two NDAs and a PMA in 2018," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "In addition, during the quarter we continued to advance our pipeline of precision medicines targeted at the molecular and immunological drivers of cancer, and we strengthened our balance sheet through an equity offering that provides us with additional resources to continue developing meaningful new cancer therapies for patients."

Company Highlights

Entrectinib

Regulatory Updates: Orphan Drug Designation and PRIME

In July 2017, we announced that FDA granted orphan drug designation to entrectinib for "treatment of NTRK fusion-positive solid tumors."

In October 2017, we announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation for entrectinib in the treatment of NTRK fusion-positive, locally advanced or metastatic solid tumors in adult and pediatric patients who have either progressed following prior therapies or who have no acceptable standard therapy. Entrectinib is the only TRK inhibitor to have been granted PRIME designation, which is analogous to the Breakthrough Therapy Designation from the U.S. FDA that entrectinib received earlier in 2017.

Development and Clinical Data Updates Towards Dual TRK and ROS1 NDA Submissions

In September 2017, we announced completion of enrollment of the efficacy data sets for both the TRK tissue-agnostic (i.e., fusion-positive solid tumor) cohort and the ROS1 NSCLC cohort to support dual NDA submissions in 2018.

In October 2017, at the WCLC, we announced updated interim results from our clinical trials, including the STARTRK-2 trial, of entrectinib. In this interim analysis (based upon an enrollment cut-off of December 31, 2016 and data cut-off of September 13, 2017):

Entrectinib demonstrated a 78% confirmed objective response rate (ORR; by Investigator; 95% CI: 60.0, 90.7) and a 69% confirmed ORR (by Blinded Independent Central Review, or BICR; 95% CI: 50.0, 83.9) in 32 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that harbored ROS1 fusions;
Entrectinib demonstrated compelling durability in these patients, with a median duration of response (mDOR) of 28.6 months (by BICR; 95% CI: 6.8, 34.8; median follow-up of 12.9 months) and a median progression-free survival (mPFS) of 29.6 months (by BICR; 95% CI: 7.7, 36.6; median follow-up of 8.5 months); and
Of the patients evaluated, 11 had CNS metastases at baseline as assessed by investigator, and 83% (5 out of 6; by BICR) of the patients with BICR-confirmed measurable CNS metastases at presentation had confirmed intracranial RECIST responses to treatment with entrectinib.
Entrectinib remained well tolerated, with more than 200 patients treated at the recommended Phase 2 dose, with mostly Grade 1-2 reversible treatment-related adverse events. The program is tracking towards dual NDA submissions in TRK and ROS1 in 2018, if supported by clinical data, with an anticipated U.S. commercial launch in both indications in 2019.

RXDX-105

In September 2017, at the ESMO (Free ESMO Whitepaper) conference, we announced new Phase 1b clinical data on RXDX-105—an investigational, VEGFR-sparing, potent RET inhibitor—in which a preliminary ORR of 75 percent was observed in patients with non-KIF5B-RET fusions, with six of eight patients achieving a confirmed partial response. In contrast, those with KIF5B-RET fusions (14 patients) did not demonstrate RECIST responses. RXDX-105 continued to be well tolerated, with the most common treatment-related adverse events being Grade 1 or 2 and reversible with dose modifications. The most common Grade 3 treatment-related adverse events (> 5%) were rash (10%), hypophosphatemia (7%) and elevated ALT (7%).

RXDX-106

In October 2017, at the AACR (Free AACR Whitepaper) Tumor Immunology and Immunotherapy meeting, we presented new data highlighting the immuno-oncological efficacy of RXDX-106—a novel immunomodulatory agent with potent anti-tumor activity, alone and in combination with checkpoint inhibitors, that in preclinical models has demonstrated immunomodulatory effects in the tumor microenvironment (TME) through TYRO3, AXL, and MER (TAM) receptor tyrosine kinase (RTK) inhibition. The data presented demonstrated immune-mediated, single-agent anti-tumor activity of RXDX-106 in multiple tumor models. The anti-tumor effect was further enhanced by combination therapy with immune checkpoint inhibitors, potentially by reversing immunosuppression of innate immunity in the TME. The data also suggested that RXDX-106 has a novel mechanism of enhancing overall immune function by activating both innate and adaptive immunity, as observed by treatment-mediated changes in relevant cytokine levels and immune cell biomarkers, and regulating cross-talk between immune and cancer cells. These promising early findings support further development of RXDX-106 to potentially treat a wide variety of cancers.

Financing Transaction

In October 2017, the company raised aggregate gross proceeds of $160.0 million after issuing 10.0 million shares of its common stock in an underwritten public offering at a price to the public of $16.00 per share.

Third Quarter 2017 Financial Results

For the third quarter of 2017, net loss was $28.6 million, or $0.51 per share, compared with $23.3 million, or $0.56 per share, for the third quarter of 2016.

Ignyta did not record any revenue for the third quarter of 2017 or for the third quarter of 2016.

Research and development expenses for the third quarter of 2017 were $21.7 million, compared with $16.6 million for the third quarter of 2016. This increase was due to an increase in external clinical development costs and the chemistry, manufacturing and control costs associated with entrectinib and our other product candidates, and increased facilities costs of $1.1 million due to the expansion of our leased facilities space.

General and administrative expenses for the third quarter of 2017 were $6.5 million, compared with $6.1 million for the third quarter of 2016. This increase was due to an increase in our facilities costs, as described above, and an increase in outside services expenses, due to an increase in pre-launch commercial activities, which was partially offset by a reduction in depreciation expense.

At September 30, 2017, we had cash, cash equivalents and available-for-sale securities totaling $144.8 million—which does not include the $150 million of net proceeds from the October financing—and current and long-term debt of $32.0 million. At December 31, 2016, we had cash, cash equivalents and available-for-sale securities totaling $133.0 million and current and long-term debt of $32.0 million.

On November 7, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal first-quarter 2018, provided an update on recent business highlights, maintained its fiscal year 2018 financial guidance, and issued fiscal second-quarter 2018 financial guidance (Press release, Myriad Genetics, NOV 7, 2017, View Source [SID1234521682]).

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"The first quarter exceeded our expectations and represented an excellent start to the fiscal year as a result of strong hereditary cancer and GeneSight test demand," said Mark C. Capone, president and CEO, Myriad Genetics. "Perhaps more importantly we had a number of significant reimbursement catalysts that strengthen our ability to deliver on our long-term financial goals."

Financial Highlights
The following table summarizes the financial results for the fiscal first-quarter 2018:

Revenue
Fiscal First-Quarter
($ in millions) 2018
2017
%
Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 126.7 $ 139.3 (9 %)

GeneSight testing revenue 28.8 7.2 300 %

Vectra DA testing revenue 16.0 11.6 38 %

Prolaris testing revenue 2.9 2.9 0 %

EndoPredict testing revenue 1.9 1.7 12 %

Other testing revenue 2.5 2.4 4 %

Total molecular diagnostic testing revenue 178.8 165.1 8 %

Pharmaceutical and clinical service revenue 11.4 12.4 (8 %)

Total Revenue $ 190.2 $ 177.5 7 %

Income Statement
Fiscal First-Quarter
($ in millions) 2018
2017
%
Change
Total Revenue $ 190.2 $ 177.5 7 %

Gross Profit 147.2 137.5 7 %
Gross Margin 77.4 % 77.5 %

Operating Expenses 59.8 131.8 (55 %)

Operating Income 87.4 5.7 1433 %
Operating Margin 46.0 % 3.2 %

Adjusted Operating Income 24.7 21.6 14 %
Adjusted Operating Margin 13.0 % 12.2 %

Net Income 81.1 (1.2 ) NM

Diluted EPS 1.15 (0.02 ) NM

Adjusted EPS $ 0.26 $ 0.23 13 %

Business Highlights

• Hereditary Cancer

Exceeded three percent hereditary cancer volume target in the first quarter, and achieved the third straight quarter of volume growth with pricing in-line with expectations.
Launched riskScore, a new clinically validated personalized medicine tool to enhance the myRisk Hereditary Cancer test. riskScore quantifies a woman’s risk of developing breast cancer by combining genetic markers throughout the genome with her family and clinical history and represents a major new epoch in hereditary cancer testing.
Presented data at the National Society of Genetic Counselors demonstrating that in a cohort of 17,205 women, the riskScore single nucleotide polymorphism (SNP) panel was highly predictive of breast cancer risk with a p- value of less than 10-50.
The National Comprehensive Cancer Network (NCCN) updated their professional guidelines to include a recommendation that all metastatic prostate cancer patients receive hereditary cancer testing. There are approximately 26,000 men in the United States every year who develop metastatic prostate cancer.
• GeneSight

Achieved statistically significant improvement in the gold-standard outcomes of response and remission in 1,200 patient prospective randomized controlled trial.
Presented data from the IMPACT study at the World Congress of Psychiatric Genetics demonstrating that GeneSight statistically significantly improved anxiety symptom severity in 210 patients with generalized anxiety disorder. Anxiety symptoms based on the GAD-7 scale, improved 45 percent in patients receiving congruent therapy versus 26 percent for patients receiving non-congruent therapy. The result was statistically significant with a p-value of 0.03.
Presented MEDCO health economic data showing patients with generalized anxiety disorder who used GeneSight saved on average $6,747 in prescription costs with congruent versus non-congruent therapy selection.
• Vectra DA

Presented data at the American College of Rheumatology (ACR) meeting demonstrating that Vectra DA was four times better at predicting radiographic progression compared to DAS28 and other conventional measures of disease activity.
Presented new clinical utility data from 60,596 patients demonstrating that physicians use Vectra DA scores to change treatment decisions appropriately. The study found that in patients who were naive to biologics, rheumatologists were 118 percent more likely to recommend a biologic for patients with a high Vectra DA score when compared to patients with a low Vectra DA score. For patients already on a biologic, rheumatologists were 158 percent more likely to change therapy on patients with high Vectra DA scores compared to those with low Vectra DA scores.
Signed coverage with evidence development agreement with CareFirst BlueCross BlueShield, the 18th largest commercial payer in the United States.
• EndoPredict

Presented new data at the World Congress on Controversies in Breast Cancer. In a study of 387 women determined to be at intermediate risk by the Nottingham Prognostic Index, EndoPredict markedly outperformed the first generation test with two times the prognostic power. Additionally, in this patient cohort EndoPredict was the only test that was statistically significant for predicting late stage recurrence (5-10 years).
• Companion Diagnostics

Submitted a supplemental PMA for BRACAnalysis CDx in conjunction with AstraZeneca’s Lynparza submission for HER2- metastatic breast cancer with approval expected in the fiscal third quarter.
UnitedHealthcare recently updated its hereditary breast and ovarian cancer coverage policy to include coverage for all metastatic breast cancer patients based upon the need to evaluate these patients for PARP inhibitor therapy.
• International

Signed the company’s first payer demonstration study with GeneSight in Canada with Sun Life Financial, the largest private health insurer in Canada. The study will evaluate the ability of GeneSight to improve both clinical and health economic outcomes in patients with anxiety and depression.
Submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients.
Fiscal Year 2018 and Fiscal Second-Quarter 2018 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2018 and fiscal second-quarter 2018 financial guidance:

Revenue GAAP Diluted
Earnings Per
Share Adjusted
Earnings Per
Share
Fiscal Year 2018 $750-$770
million $1.41-$1.46 $1.00-$1.05

Fiscal Second-Quarter 2018 $187-$189
million $0.08-$0.10 $0.22-$0.24

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 the conference call today to discuss the fiscal first-quarter financial results, fiscal year 2018 financial guidance, and fiscal second-quarter 2018 financial guidance.

Conference Call and Webcast
A conference call will be held today, Tuesday, November 7, 2017, at 4:30 p.m. EST to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-701-6414. International callers may dial 1-303-223-4376. All callers will be asked to reference reservation number 21859999. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

On November 7, 2017 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter of 2017 (Press release, Navidea Biopharmaceuticals, NOV 7, 2017, View Source [SID1234521683]). Navidea reported total revenues for the quarter of $224,000. Net loss attributable to common stockholders was $1.5 million. Net revenues do not include the guaranteed payments from Cardinal Health 414, LLC ("Cardinal Health 414") because those are represented on the balance sheet in accounts receivable and were already included in the gain on sale of the line of business sold to Cardinal Health 414 for the nine months ended September 30, 2017.

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"We’ve made significant advancements in our pipeline, both on the diagnostic and therapeutics side so far this year. Efforts undertaken since the closing of the Cardinal Health 414 transaction to implement the new strategy have enabled the more rapid development of our proprietary technology. We have demonstrated significant market expansion potential with our imaging agent. We are actively pursuing an approval to utilize our activated macrophage technology as a biomarker. We have formally contacted the U.S. Food and Drug Administration ("FDA") and have scheduled our first meeting with them. In parallel, we are also pursuing an additional approval for our agent so we can administer it intravenously ("IV"). The FDA and many major pharmaceutical companies have indicated their significant interest in developing biomarkers that can assist in developing new therapeutics and in enabling objective monitoring of performance of existing therapies. With our best-in-class activated macrophage targeting system, we have been able to generate significant human imaging data and promising animal data with our therapeutic agents, reinforcing our optimism that this platform holds potential for the diagnosis and treatment of diseases in which macrophages play an important role," said Michael Goldberg, M.D., Navidea’s President and Chief Executive Officer.

Dr. Goldberg continued, "On the diagnostic side, we have generated data with both IV and subcutaneous formulations of Tc99m tilmanocept in rheumatoid arthritis ("RA"). We have completed all but a few of the control dosings in the Phase 1/2 dose escalation registrational study and expect to finalize the report on this study in the fourth quarter of this year. In nonalcoholic steatohepatitis ("NASH") and cardiovascular ("CV") disease, we will also be initiating dosing of an IV formulation shortly. For CV, we are working with the same team at Massachusetts General Hospital in Boston, who designed, managed and published the subcutaneous CV study that has attracted so much interest. In the IV study, we will also explore the ability to image central nervous system inflammation. With Kettering Medical Center in Ohio, we will shortly be dosing in NASH patients. On the therapeutic side, we have synthesized and tested delivery backbones that are one-tenth the size of the existing agents. As we explore formulation opportunities with our therapeutics, smaller agents provide better opportunities for creating therapeutics than can be delivered orally and topically. The newer agents retain the same very high binding we have achieved with our larger constructs. Finally, we have dosed in cancer models our MT1000 class of therapeutics, much more frequently (twice per day as opposed to twice per week) with the same total dose and as expected this resulted in much improved activity. "

Third Quarter 2017 Highlights and Subsequent Events

Executed a letter of intent for a sublicensing contract for worldwide research and development results with Cerveau Technologies, Inc. ("Cerveau") for using NAV4694, a beta-amyloid imaging agent being evaluated as an aid in the differential diagnosis of early-onset Alzheimer’s disease
Executed a letter of intent for an exclusive license with Cerveau for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore
Presented a late-breaking poster presented at the American College of Rheumatology Annual Meeting detailing the results of an IV-administered study in RA patients
Initiated series of regular investor-focused Q&A conference calls to improve Investor Relations strategy
IV-administration RA trial to complete enrollment in fourth quarter 2017
Launched NASH imaging study launch this quarter at Kettering Medical Center in Ohio
Initiate dosing in Phase 1/2 clinical imaging study in Kaposi’s Sarcoma
Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

We recorded a $86.7 million net gain on the line of business sold to Cardinal Health 414 for the nine months ended September 30, 2017, including $16.5 million in guaranteed consideration, which was discounted to the present value of future cash flows. The proceeds were offset by $3.3 million in estimated fair value of warrants issued to Cardinal Health 414, $2.0 million in legal and other fees related to the sale, $800,000 in net balance sheet dispositions and write-offs, and $6.5 million in estimated taxes.
Total revenues for the third quarter of 2017 were $224,000, compared to $1.8 million in the third quarter of 2016. These revenues are grant-related and do not include the $1.7 million of payments received from Cardinal Health 414.
Research and development expenses for the third quarter of 2017 were $875,000, compared to $919,000 in the third quarter of 2016. The net decrease was primarily a result of decreases in net compensation costs coupled with decreased NAV4694 and NAV5001 development costs, offset by increases in Manocept development costs.
Selling, general and administrative expenses for the third quarter of 2017 were $1.7 million, compared to $1.8 million in the third quarter of 2016. The net decrease was primarily due to decreases in general support costs such as rent and depreciation, coupled with decreased net compensation costs, offset by net increased legal and professional services.
Navidea’s net loss attributable to common stockholders for the quarter ended September 30, 2017 was $1.5 million, or a $0.01 loss per share (basic), compared to a net loss of $59,000, or a $0.00 loss per share, for the same period in 2016.
Navidea ended the quarter with $6.6 million in cash and investments, not including the quarterly guaranteed earnout payment of $1.7 million from Cardinal Health 414 which was received after the quarter ended.
Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event: Q3 2017 Earnings and Business Update Conference Call
Date: Wednesday, November 8, 2017
Time: 8:30 am (Eastern Time)
U.S. & Canada Dial-in: 1-866-548-4713 (toll free)
Conference ID: 6714834
Webcast
http://www.audio-webcast.com/cgi-bin/visitors.ssp?fn=visitor&id=5121
A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 7, 2017 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the third quarter ended September 30, 2017 (Press release, Nektar Therapeutics, NOV 7, 2017, View Source [SID1234521684]).

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Cash and investments in marketable securities at September 30, 2017 were $412.2 million as compared to $389.1 million at December 31, 2016. The cash balance includes the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

"Nektar’s immuno-oncology portfolio continues to expand as we add novel drug candidates to our growing pipeline," said Howard W. Robin, President and CEO of Nektar. "NKTR-214 is the first I-O agent to both increase tumor-infiltrating lymphocytes (TILs) and increase PD-1 expression on human immune cells, which uniquely complements checkpoint inhibition and other anti-cancer mechanisms. As the majority of cancer patients have tumors that do not express PD-L1 and these patients receive limited benefit from treatment with checkpoint inhibitors, the potential of NKTR-214 to help patients is significant. Finally, based on recent positive conversations with the agency regarding our regulatory plans for NKTR-181, we are now planning to submit an NDA for NKTR-181 by April 2018 with our data package of over 2,100 patients and healthy volunteers."

Revenue in the third quarter of 2017 was $152.9 million as compared to $36.3 million in the third quarter of 2016. Year-to-date revenue for 2017 was $212.2 million as compared to $128.0 million in the first nine months of 2016. Revenue in 2017 included recognition of $127.6 million of the $150.0 million upfront payment from Nektar’s collaboration with Eli Lilly & Company for the development and commercialization of NKTR-358.

Total operating costs and expenses in the third quarter of 2017 were $83.4 million as compared to $69.2 million in the third quarter of 2016. Year-to-date total operating costs and expenses in 2017 were $247.9 million as compared to $208.7 million for the same period in 2016. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

Research and development expense in the third quarter of 2017 was $65.7 million as compared to $52.0 million in the third quarter of 2016. Year-to-date R&D expense for 2017 was $187.0 million as compared to $153.6 million for the same period in 2016. R&D expense was higher in the third quarter and first nine months of 2017 as compared to the same periods in 2016 primarily because of expenses for our pipeline programs, including Phase 3 clinical studies for NKTR-181, Phase 1/2 clinical studies of NKTR-214 and NKTR-358 and IND-enabling activities for NKTR-262 and NKTR-255.

General and administrative expense was $12.1 million in the third quarter of 2017 as compared to $10.3 million in the third quarter of 2016. G&A expense in the first nine months of 2017 was $40.0 million as compared to $31.5 million for the same period in 2016. G&A expense in the first nine months of 2017 includes a $3.3 million charge for a litigation settlement related to a cross-license agreement.

Net income in the third quarter of 2017 was $60.9 million or $0.39 basic income per share as compared to net loss of $43.2 million or $0.32 basic loss per share in the third quarter of 2016. Net loss in the first nine months of 2017 was $62.9 million or $0.41 basic loss per share as compared to $111.3 million or $0.82 basic loss per share in the first nine months of 2016.

The company also announced upcoming presentations at the following scientific congresses during the fourth quarter of 2017:

Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 32nd Annual Meeting, National Harbor, MD:

Oral Presentation: "PIVOT-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors"
Presenter: Dr. Adi Diab, Assistant Professor, Department of Melanoma Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Session: Clinical Trials: Novel Combinations
Date: Saturday, November 11, 2017, 5:00 p.m. Eastern Time

Poster #P77: "The Novel IL-2 Cytokine Immune Agonist NKTR-214 Harnesses the Adaptive and Innate Immune System for the Treatment of Solid Cancers"
Presenter: Salah Eddine Bentebibel, University of Texas MD Anderson Cancer Center
Session: Biomarkers and Immune Monitoring
Date: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P140: "NKTR-214 enhances anti-tumor T-cell immune responses induced by checkpoint blockade or vaccination"
Presenter: Meenu Sharma, University of Texas MD Anderson Cancer Center
Session: Cancer Vaccines
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P274: "Combination of NKTR-214 and radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T-Cells"
Presenter: Joshua Walker, Oregon Health & Science University
Session: Combination Therapy
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P275: "Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumors"
Presenter: Saul Kivimae, Nektar Therapeutics
Session: Combination Therapy
Date: Friday, November 10, 2017, 12:30-2:00 p.m. Eastern Time

Poster #P332: "Pre-clinical efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15 for immuno-oncology"
Presenter: Peiwen Kuo, Nektar Therapeutics
Session: Combination Therapy
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

Poster #434: "Great Apes Adenoviral vaccine encoding neoantigens synergizes with immunomodulators to cure established tumors in mice"
Presenter: Anna Morena D’Alise, Nouscom srl
Session: Personalized Vaccines and Technologies/Personalized Medicines
Date: Saturday, November 11, 2017, 12:30-2:00 p.m. Eastern Time

American College of Neuropsychopharmacology 56th Annual Meeting, Palm Springs, CA:

Poster #T166: "Abuse potential of NKTR-181 in recreational opioid users: results from a randomized, double-blind crossover oral study"
Presenter: Snow Ge, Nektar Therapeutics
Session: Poster Session II
Date: Tuesday, December 5, 2017, 5:30-7:30 p.m. Pacific Time

Conference Call to Discuss Third Quarter 2017 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, Tuesday, November 7, 2017.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, December 11, 2017.

To access the conference call, follow these instructions:
Dial: (877) 881.2183 (U.S.); (970) 315.0453 (international)
Passcode: 4677348 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investor Relations page at the Nektar website as soon as practical after the conclusion of the conference call.