On March 8, 2018 OncoCyte Corporation (NYSE American:OCX), a developer of novel, non-invasive liquid biopsy tests for the early detection of cancer, reported on the development and commercial launch timeline of DetermaVu, its liquid biopsy lung cancer diagnostic test (Press release, BioTime, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337172 [SID1234524610]).

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As reported in November 2017, during the process of running initial samples for the Clinical Validation Study inconsistent analytic results were observed by OncoCyte’s technical team. OncoCyte determined that this was caused by a variance in the lots of consumables used in the sample-processing system that analyzes blood samples for markers that may indicate whether lung nodules found in patients are benign or suspicious. OncoCyte has been actively engaged with NanoString to more completely understand the issues that have delayed the DetermaVu validation study. The work with NanoString is ongoing. The work to date continues to support OncoCyte’s conclusion that the previous studies of DetermaVu were not impacted by this consumables issue and the positive results reported previously have not changed.

In addition to assessing the NanoString platform’s commercial applicability, OncoCyte is actively evaluating alternative assay platforms for use with its molecular biology diagnostic testing. OncoCyte is announcing the encouraging initial results of its initial clinical sample feasibility study on the Illumina Sequencing platform. The Illumina platform is a market-leading platform for molecular biology testing in the clinical Laboratory Developed Test (LDT) space. While further testing is needed, OncoCyte’s initial results indicate that the Illumina platform could provide consistent and robust support for the further clinical development studies that are necessary for the commercialization of DetermaVu.

Lyndal Hesterberg, OncoCyte’s Senior Vice President of Research and Development, stated, "The initial feasibility results on an established clinical platform may provide OncoCyte with an alternative path to clinical validation and commercial launch of the DetermaVu product in 2018. We will be pursuing the next steps to further assess the Illumina platform, along with other commercially established clinical molecular testing platforms, and we are encouraged by the results of this initial feasibility study."

OncoCyte has also identified ways that potentially may enhance the lung cancer signal identified by DetermaVu and has incorporated this approach into a revised algorithm. This revised algorithm was tested on about 60 clinical samples and resulted in accuracy (as measured by Area Under the Curve (AUC) data) equivalent or superior to previously reported results, although the error bar or potential range of results from this small sample set is wide and the results must be confirmed in a larger sample set.

Because of these developments, OncoCyte is extending its evaluation of the commercial molecular diagnostic platforms by doing a follow-on study utilizing a larger set of clinical samples. The Company expects to complete the process during the second quarter of 2018. After concluding this process, data will be available to determine which platform delivers the most accurate, consistent and robust test results while maintaining a reasonable cost of goods. The Company then intends to complete product development on the selected platform by carrying out an R&D Validation Study followed by an Analytical Validation Study. If these studies are successfully completed, OncoCyte intends to conduct a Clinical Validation Study. Clinical validation is the final step prior to commercial launch, which is still anticipated during 2018. OncoCyte has collected all the samples necessary for carrying out all these studies.

"The results from our recent evaluation of commercially available molecular testing platforms support our continued confidence in DetermaVu as a confirmatory test for the diagnosis of early stage lung cancer," commented William Annett, President and Chief Executive Officer.

About DetermaVu

DetermaVu is OncoCyte’s confirmatory, non-invasive, liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant.

DetermaVu is a trademark of OncoCyte Corporation.

Mirati has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Mirati, 2018, MAR 8, 2018, View Source [SID1234524588]).

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On March 8, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that fourth quarter and year-end 2017 financial and operating results after the close of the U.S. financial markets on Monday, March 12, 2018. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET (Press release, Iovance Biotherapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337036 [SID1234524541]).

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In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 1497629. The live webcast can be accessed under "News & Events" in the "Investors" section of the Company’s website at View Source or you may use the link: View Source

A replay of the call will be available from March 12, 2018 at 7:30 p.m. ET to April 18, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 1497629. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source.

On March 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter of 2017 (Press release, Navidea Biopharmaceuticals, MAR 8, 2018, View Source [SID1234524565]). Navidea reported total revenues for the quarter of $395,000. Net loss attributable to common stockholders for the quarter was $4.1 million. Total revenues for 2017 were $1.8 million, and net income attributable to common stockholders was $74.9 million.

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"It’s been quite a transition year for Navidea going from a commercial operation, with its own dedicated sales force, to a development-focused company leveraging its best-in-class activated macrophage targeting system," said Michael Goldberg, M.D., Navidea’s President and Chief Executive Officer.

Dr. Goldberg continued, "I am more excited today than I have ever been as we push forward on the three key pillars of our business; CD206 biomarker identification, diagnostic imaging and therapeutics. I expect that the coming year will be characterized by the release of data that confirms our strategy that focusing on the targeting of activated macrophages with our proprietary imaging agents in humans and our proprietary therapeutics in animals has the potential to generate significant commercial opportunities for Navidea in the short term."

Fourth Quarter 2017 Highlights and Subsequent Events

Selected as 1 of 25 from 1100 applicants to present a late-breaking poster at the American College of Rheumatology Annual Meeting detailing the results of an intravenous ("IV")-administered study in rheumatoid arthritis ("RA") patients;
Completed the Phase 2 IV RA study;
Commenced dosing and imaging in the 12-subject nonalcoholic steatohepatitis ("NASH") diagnostic study at Kettering Medical Center in Ohio;
Commenced dosing and imaging in the 24-subject visceral Kaposi’s Sarcoma ("KS") diagnostic study at the University of California, San Francisco;
Commenced dosing and imaging in the 24-subject HIV+ Cardiovascular trial at Massachusetts General Hospital-Harvard University under the direction of Dr. Steven Grinspoon;
Commenced dosing and imaging in the 12-subject colorectal cancer trial with synchronous liver metastases at the University of Alabama at Birmingham;
Submitted an extensive grant to support broad expansion of both Navidea’s and the Massachusetts General Hospital’s work in Cardiovascular imaging;
The National Cancer Institute awarded Navidea a Fast Track Small Business Innovation Research ("SBIR") grant that will provide up to $1.8 million to fund preclinical and subsequent clinical studies examining the safety and efficacy of IV Tc 99m tilmanocept to identify and quantify both skin- and organ-associated KS lesions;
Completed regulatory strategies for imaging and inflammation for Phase 3 trials (pending meeting with the U.S. Food & Drug Administration); and
Appointed Claudine Bruck, Ph.D. as a member of the board of directors of the Company effective March 5, 2018.
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, LLC ("Cardinal Health 414") on March 3, 2017 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 $89.2 million net gain on the line of business sold to Cardinal Health 414 for the year ended December 31, 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 $4.1 million in estimated taxes.
Total revenues for the fourth quarter of 2017 were $395,000, compared to $1.0 million in the fourth quarter of 2016. Revenues for the full year of 2017 were $1.8 million, compared to $5.0 million in 2016. Revenues were primarily related to grants and licenses, and do not include the guaranteed earnout payments received from Cardinal Health 414 during 2017.
Research and development ("R&D") expenses for the fourth quarter of 2017 were $1.7 million, compared to $2.1 million in the fourth quarter of 2016. R&D expenses for the full year of 2017 were $4.5 million, compared to $7.1 million in 2016. The net decrease was primarily a result of decreases in Tc99m tilmanocept, NAV4694 and NAV5001 development costs coupled with decreased net compensation costs, offset by increases in Manocept platform development costs.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2017 were $2.2 million, compared to $2.1 million in the fourth quarter of 2016. SG&A expenses for the full year of 2017 were $11.2 million, compared to $7.9 million in 2016. The net increase was primarily due to several non-recurring charges, including a $2.0 increase in legal expenses due to CRG and other concluded legal matters, $949,000 of other items including the FTI settlement, the Cardinal deal completion bonuses, severance payouts and asset disposal costs.
Navidea’s net loss attributable to common stockholders for the quarter ended December 31, 2017 was $4.1 million, or $0.03 per share (basic), compared to a net loss of $3.9 million, or $0.02 per share (basic), for the same period in 2016. Navidea’s net income attributable to common stockholders for the year ended December 31, 2017 was $74.9 million, or $0.47 per share (basic), compared to a net loss of $14.3 million, or $0.09 per share (basic), for the same period in 2016.
Navidea ended the quarter with $4.6 million in cash and investments.
Full Year 2017 Highlights and Subsequent Events

On March 3, 2017, Navidea completed the sale of the North American rights to Lymphoseek to Cardinal Health 414, receiving approximately $82 million at closing;
Presented two papers at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting detailing initial results from the SC-administered study in RA;
Initiated Biomarker Qualification with FDA biomarker division;
Selected by NIH/NIAMS as one of 24 from 1200 awardees to present business development and RA clinical results at the International Biotechnology Innovation Organization 2017 meeting in June, 2017;
Initiated series of regular investor-focused Q&A conference calls to strengthen investor relations;
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;
Transferred three clinical trials in sentinel node biopsy to Cardinal Health 414, including cervical, anal/rectal and pediatric trials;
Completed filings or disclosures on multiple new intellectual property constructs and usages; and
Completed preclinical testing of therapeutic constructs in Zika, Dengue, leishmaniosis, KS, tumor models and NASH model systems.
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: Q4 and Full Year 2017 Earnings and Business Update Conference Call
Date: Thursday, March 8, 2018
Time: 4:30 p.m. (Eastern Time)
U.S. & Canada Dial-in: 646-828-8143 (toll free)
Conference ID: 1826783
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.

Progenics Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Progenics Pharmaceuticals, 2018, MAR 8, 2018, View Source [SID1234524589]).

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