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MarketScreener Homepage  >  Equities  >  Nyse MKT  >  Navidea Biopharmaceuticals Inc    NAVB

NAVIDEA BIOPHARMACEUTICALS INC (NAVB)
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NAVIDEA BIOPHARMACEUTICALS : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

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11/09/2018 | 08:50pm CET

Forward-Looking Statements

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends affecting the financial condition of our business. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including, among other things:



  ? our history of operating losses and uncertainty of future profitability;




  ? our ability to successfully complete research and further development of our
    drug candidates;




  ? the timing, cost and uncertainty of obtaining regulatory approvals of our drug
    candidates;




  ? our ability to successfully commercialize our drug candidates;




  ? our expectations and estimates concerning future financial performance,
    financing plans and the impact of competition;




  ? our ability to raise capital sufficient to fund our development programs;




  ? our dependence on royalties and grant revenue;




  ? our limited product line and distribution channels;




  ? advances in technologies and development of new competitive products;




  ? our ability to maintain effective control over financial reporting;




  ? our ability to comply with NYSE American continued listing standards; and




  ? other risk factors set forth in this report and detailed in our most recent
    Annual Report on Form 10-K and other SEC filings.



In addition, in this report, we use words such as "anticipate," "believe," "plan," "expect," "future," "intend," "estimate," "project," and similar expressions to identify forward-looking statements.

We undertake no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise after the date of this report. In light of these risks and uncertainties, the forward-looking events and circumstances discussed in this report may not occur and actual results could differ materially from those anticipated or implied in the forward-looking statements.



The Company


Navidea Biopharmaceuticals, Inc., a Delaware corporation (NYSE American: NAVB), is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. Navidea is developing multiple precision-targeted products based on our Manocept™ platform to enhance patient care by identifying the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making and targeted treatment.

Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on activated macrophages. The Manocept platform serves as the molecular backbone of Tc99m tilmanocept, the first product developed and commercialized by Navidea based on the platform.

On March 3, 2017, pursuant to an Asset Purchase Agreement dated November 23, 2016, the Company completed its previously announced sale to Cardinal Health 414 of its assets used, held for use, or intended to be used in operating its business of developing, manufacturing and commercializing a product used for lymphatic mapping, lymph node biopsy, and the diagnosis of metastatic spread to lymph nodes for staging of cancer, including the Company's radioactive diagnostic agent marketed under the Lymphoseek® trademark for current approved indications by the FDA and similar indications approved by the FDA in the future, in Canada, Mexico and the United States (giving effect to the License-Back described below and excluding certain assets specifically retained by the Company). Such assets sold in the Asset Sale consist primarily of, without limitation, (i) intellectual property used in or reasonably necessary for the conduct of the Business, (ii) inventory of, and customer, distribution, and product manufacturing agreements related to, the Business, (iii) all product registrations related to the Product, including the new drug application approved by the FDA for the Product and all regulatory submissions in the United States that have been made with respect to the Product and all Health Canada regulatory submissions and, in each case, all files and records related thereto, (iv) all related clinical trials and clinical trial authorizations and all files and records related thereto, and (v) all rights, title and interest in and to the Product, as specified in the Purchase Agreement.




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In connection with the closing of the Asset Sale, the Company entered into a License-Back Agreement (the "License-Back") with Cardinal Health 414. Pursuant to the License-Back, Cardinal Health 414 granted to the Company a sublicensable (subject to conditions) and royalty-free license to use certain intellectual property rights included in the Acquired Assets and owned by Cardinal Health 414 as of the closing of the Asset Sale to the extent necessary for the Company to (i) on an exclusive basis, subject to certain conditions, develop, manufacture, market, sell and distribute new pharmaceutical and other products that are not Competing Products (as defined in the License-Back), and (ii) on a non-exclusive basis, develop, manufacture, market, sell and distribute the Product throughout the world other than in the Territory. Subject to the Company's compliance with certain restrictions in the License-Back, the License-Back also restricts Cardinal Health 414 from using the intellectual property rights included in the Acquired Assets to develop, manufacture, market, sell, or distribute any product other than the Product or another product that (a) accumulates in lymphatic tissue or tumor-draining lymph nodes for the purpose of (1) lymphatic mapping or (2) identifying the existence, location or staging of cancer in a body, or (b) provides for or facilitates any test or procedure that is reasonably substitutable for any test or procedure provided for or facilitated by the Product. Pursuant to the License-Back and subject to rights under existing agreements, Cardinal Health 414 was given a right of first offer to market, sell and/or market any new products developed from the intellectual property rights licensed by Cardinal Health 414 to the Company by the License-Back.

As part of the Asset Sale, the Company and Cardinal Health 414 also entered into ancillary agreements providing for transitional services and other arrangements. The Company amended and restated its license agreement with UCSD pursuant to which UCSD granted a license to the Company to exploit certain intellectual property rights owned by UCSD and, separately, Cardinal Health 414 entered into a license agreement with UCSD pursuant to which UCSD granted a license to Cardinal Health 414 to exploit certain intellectual property rights owned by UCSD for Cardinal Health 414 to sell the Product in the Territory.

Upon closing of the Asset Sale, the Supply and Distribution Agreement dated November 15, 2007, as amended, between Cardinal Health 414 and the Company was terminated and, as a result, the provisions thereof are of no further force or effect (other than any indemnification, payment, notification or data sharing obligations which survive the termination).

Other than Tc99m tilmanocept, which the Company has a license to distribute outside of Canada, Mexico and the United States, none of the Company's drug product candidates have been approved for sale in any market.

We manage our business based on two primary types of drug products: (i) diagnostic substances, including Tc99m tilmanocept and other diagnostic applications of our Manocept platform and NAV4694, and (ii) therapeutic development programs, including therapeutic applications of our Manocept platform and all development programs undertaken by MT. See Note 15 to the consolidated financial statements for more information about our business segments.




Product Line Overview



Our primary development efforts over the last several years were focused on diagnostic products, including Lymphoseek which was sold to Cardinal Health 414 in March 2017. Our more recent initiatives have been focused exclusively on diagnostic and therapeutic line extensions based on our Manocept platform.

Manocept Platform - Diagnostics and Therapeutics Background

Navidea's Manocept platform is predicated on the ability to specifically target the CD206 mannose receptor expressed primarily on activated macrophages. This flexible and versatile platform serves as a molecular engine for purpose-built targeted imaging molecules that may significantly impact patient care by providing enhanced diagnostic accuracy, clinical decision-making, and target-specific treatment. This CD206-targeted drug platform is applicable to a range of diagnostic modalities, including single photon emission computed tomography ("SPECT"), positron emission tomography ("PET"), gamma-scanning (both imaging and topical) and intra-operative and/or optical-fluorescence detection, as well as delivery of therapeutic compounds that target macrophages, and their role in a variety of immune- and inflammation-involved diseases. The FDA-approved sentinel node/lymphatic mapping agent, Tc99m tilmanocept, is representative of the ability to successfully exploit this mechanism to develop powerful new products and to expand this technology into additional diagnostic and therapeutic applications.

Activated macrophages play important roles in many disease states and are an emerging target in many diseases where diagnostic uncertainty exists. Impairment of the macrophage-driven disease mechanisms is an area of increasing and proven focus in medicine. The number of people affected by all the inflammatory diseases combined is estimated at more than 40 million in the United States and perhaps 700 million worldwide, making macrophage-mediated diseases an area of remarkable clinical importance. There are many recognized disorders having macrophage involvement, including rheumatoid arthritis ("RA"), atherosclerosis/vulnerable plaque, nonalcoholic steatohepatitis ("NASH"), inflammatory bowel disease, systemic lupus erythematosus, Kaposi's sarcoma ("KS"), leishmaniosis, and others that span general clinical areas in oncology, autoimmunity, infectious diseases, cardiology, CNS diseases, and inflammation. For the near term, we have selected target diseases that may, if successfully developed, benefit from this remarkable technology, most deriving improved clinical diagnosis and therapy.




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Manocept Platform - Immuno-Diagnostics Clinical Data



Rheumatoid Arthritis


Two Tc99m tilmanocept dose escalation studies in RA have been completed. The first study was completed and included 18 subjects (nine with active disease and nine healthy subjects) dosed subcutaneously with 50 and 200 µg/2mCi Tc99m tilmanocept (ClinicalTrials.gov NCT02683421). The results of this study were presented at five international meetings, including Biotechnology Innovation Organization ("BIO"), Society of Nuclear Medicine and Molecular Imaging ("SNMMI"), and The American College of Rheumatology ("ACR"). In addition, based on completion of extensive preclinical dosing studies pursuant to our dialog with the FDA, we have completed a study involving intravenous ("IV") dosing of 39 subjects with IV-administered Tc99m tilmanocept (ClinicalTrials.gov NCT02865434). In conjunction with this study, we have completed pharmacokinetic, pharmacodynamics and radiation dosimetry phases in human subjects as well. The majority of the costs of these studies have been supported through a Small Business Innovation Research ("SBIR") grant (NIH/NIAMSD Grant 1 R44 AR067583-01A1). Results were presented at the June 2018 SNMMI meeting. These studies have been combined and submitted for peer review publication and full published results will follow.

Cardiovascular Disease ("CV")

In collaboration with researchers at Massachusetts General Hospital, Navidea has completed one and initiated a second clinical study evaluating Tc99m tilmanocept's ability to enable imaging of atherosclerotic plaques. Results of these studies provide strong preliminary evidence of the potential of Tc99m tilmanocept to accumulate specifically in and enable imaging of non-calcified atherosclerotic plaques. Non-calcified atherosclerotic plaques include plaques with morphologies indicating a high risk of rupture. Rupture of such plaques causes myocardial infarctions (heart attacks) and a significant portion of ischemic strokes. The studies compared aortic Tc99m tilmanocept uptake imaged by SPECT/CT in clinically asymptomatic subjects with intermediate Framingham Risk Scores ("FRS") who were infected with Human Immunodeficiency Virus ("HIV") as compared to healthy, uninfected, FRS and age-matched subjects. Tc99m tilmanocept SPECT/CT images were compared to aortic images of the same subjects obtained by contrast enhanced coronary computed tomography angiography and/or [18F]NaF PET/CT.

A nine-subject study to evaluate diagnostic imaging of emerging atherosclerosis plaque with the Tc99m tilmanocept product dosed subcutaneously is complete (ClinicalTrials.gov NCT02542371). The results of this study were presented at two major international meetings (Conference on Retroviruses and Opportunistic Infections ("CROI") and SNMMI, 2017) and published in early release in the Journal of Infectious Diseases in January 2017 (published in the circulated version, Journal of Infectious Diseases (2017) 215 (8): 1264-1269), confirming that the Tc99m tilmanocept product can both quantitatively and qualitatively target non-calcified plaque in the aortic arch of Acquired Immunodeficiency Syndrome ("AIDS") patients (supported by NIH/NHLBI Grant 1 R43 HL127846-01).

We have also begun a second Phase1/2 study in cooperation with Massachusetts General Hospital in subjects with HIV that expands the original study in both the scope of the drug administration as well as the diagnostic assessment of the subjects. This study will enroll up to 24 AIDS subjects and healthy controls in imaging non-calcified plaque using IV-administered Tc99m tilmanocept and will expand the initial investigation to the assessment of aortic plaque as well as carotid and coronary arteries. Initial images from this study are currently being evaluated.




Kaposi's Sarcoma



KS is a serious and potentially life-threatening illness, which in the US occurs disproportionately in persons infected with HIV and in organ transplant patients. The prognosis for patients with treatment resistant KS is poor with high probabilities for mortality and greatly diminished quality of life. We initiated and completed a study of KS in 2015 (ClinicalTrials.gov NCT022201420), and received additional funding from the National Institutes of Health ("NIH") in 2016 to continue diagnostic studies in this disease. The new support not only continues the imaging of the cutaneous form of this disease but expands this to imaging of visceral disease via IV administration of Tc99m tilmanocept (NIH/NCI 1 R44 CA192859-01A1; ClinicalTrials.gov NCT03157167). This now-escalated study includes a pathology/biopsy component as well as an imaging component to determine pathology concordance with image assessment. We received Institutional Review Board approval of the clinical protocol, and we initiated a Phase 1/2 clinical study in KS in 2017.

Colorectal Cancer ("CRC") and Synchronous Liver Metastases

During the first quarter of 2017, we initiated an imaging study in subjects with CRC and liver metastases via IV administration of Tc99m tilmanocept. This study is supported through a SBIR grant (NIH/NCI 1 R44 CA1962783-01A1; ClinicalTrials.gov NCT03029988) and continues to enroll subjects (up to 12 subjects with dose modification; this study may also be expanded depending on NIH/NCI funding). An initial presentation took place at SNMMI in June of 2018. An additional report has been submitted to the National Cancer Institute ("NCI") on the early results of this study.



Nonalcoholic Steatohepatitis


We have initiated a clinical study (ClinicalTrials.gov NCT03332940) that is designed to enroll 12 subjects with IV administration of Tc99m tilmanocept and an imaging comparator to identify and quantify the extent of NASH lesions in human patients. This study is ongoing and includes dose escalation modification for Tc99m tilmanocept. Initial results were presented at the NASH Summit in Boston in April 2018, and the results are available on Navidea's website. This study continues to enroll patients.




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Biomarker Application and Qualification

In November 2017, the Company commenced the qualification of the biomarker CD206 with the FDA Biomarker Section of The Center for Drug Evaluation and Research ("CDER"). As per FDA protocol, Navidea submitted a draft letter of intent ("LOI") to CDER prior to the November meeting. According to the CDER directive, "the Biomarker Qualification Program was established to support the CDER's work with external stakeholders to develop biomarkers that aid in the drug development process. Through the FDA's Biomarker Qualification Program, an entity may request regulatory qualification of a biomarker for a particular context of use ("COU") in drug development." Post-meeting with the FDA and because of Navidea's data sets and the general external publication database, Navidea, in conjunction with FDA, is now reviewing the LOI with the FDA's recommended consultants. Navidea has revised the LOI draft strategy in order to expedite the application process. In March 2018, Navidea had a follow-up meeting with the FDA's assigned strategist and further narrowing of the LOI elements were reviewed. Navidea is continuing the process of finalizing the COU LOI and providing the background data sets for qualification review with the FDA/CDER. Additional meetings have taken place and the pursuit of this qualification is progressing well.

Macrophage Therapeutics Background

In December 2014, the Company formed a new business unit to further explore therapeutic applications for the Manocept platform. In January 2015, Navidea incorporated the business unit as MT, a majority-owned subsidiary of Navidea. Navidea also granted MT an exclusive license for certain therapeutic applications of the Manocept technology. In August 2018, the Company entered into an Agreement with Dr. Michael Goldberg related to his resignation from Navidea. The Agreement provides that MT will redeem all of Dr. Goldberg's MT preferred stock and issue to Dr. Goldberg MT super voting common stock equal to 5% of the outstanding shares of MT. As of the date of filing this Quarterly Report on Form 10-Q, the Definitive Agreements have not yet been signed and the MT preferred shares have not yet been exchanged for MT super voting common stock. See Note 11 to the accompanying consolidated financial statements.

MT has developed processes for producing the first two therapeutic Manocept immuno-constructs, MT-1002, designed to specifically target and kill activated CD206+ macrophages by delivering doxorubicin, and MT-2002, designed to inhibit the inflammatory activity of activated CD206+ macrophages by delivering a potent anti-inflammatory agent. MT has contracted with independent facilities to produce sufficient quantities of the MT-1002 and MT-2002 agents along with the concomitant analytical standards, to provide material for planned preclinical animal studies and future clinical trials.

Manocept Platform - In-Vitro and Pre-Clinical Immunotherapeutics Data

MT has been set up to pursue the therapeutic drug delivery model. This model enables the Company to leverage its technology over many potential disease applications and with multiple partners simultaneously without significant capital outlays. To date, the Company has developed two lead families of therapeutic products. The MT-1000 class is designed to deplete activated macrophages via apoptosis. The MT-2000 class is designed to modulate activated macrophages from a classically activated phenotype to the alternatively activated phenotype. Both families have been tested in a number of disease models in rodents.

We have already reported on the peripheral infectious disease aspects of KS, including HIV and HHV8 (CROI, Boston 2016, and KS HHV8 Summit Miami 2015). As noted, we continue this work funded by the NIH/NIAID and NCI. The Company has completed preclinical studies employing both MT 1000-class and 2000-class therapeutic conjugates of Manocept. The positive results from these studies are indicative of Manocept's specific targeting supported by its strong binding affinity to CD206 receptors. This high degree of specificity is a foundation of the potential for this technology to be useful in treating diseases linked to the over-activation of macrophages. This includes various cancers as well as autoimmune, infectious, CV, and central nervous system ("CNS") diseases.



Kaposi's Sarcoma


The novel MT-1002 construct is designed to specifically deliver doxorubicin, a chemotoxin, which can kill KS tumor cells and their tumor-associated macrophages potentially altering the course of cancer. We have received additional funding to continue therapeutic studies in this disease with the goal of completing an IND submission for a Manocept construct (MT-1000 class of compounds) consisting of tilmanocept linked to doxorubicin for the treatment of KS. The first part of the grant, now complete, supported analyses including in vitro and cell culture studies, to be followed by Parts 2 and 3 FDA-required preclinical animal testing studies. The information from these studies will be combined with other information in an IND application that will be submitted to the FDA requesting permission to begin testing the compound in selected KS subjects (supported by NIH/NCI 1 R44 CA206788-01).

Nonalcoholic Fatty Liver Disease ("NAFLD")

NAFLD is a spectrum of liver disorders and is defined by the presence of steatosis in more than 5% of hepatocytes with little or no alcohol consumption. NASH is the most extreme form of NAFLD. A major characteristic of NASH involves cells undergoing lipotoxicity, releasing endogenous signals prompting the accumulation of various macrophages to assess the damage. Studies have shown that levels of endogenous molecular inflammatory signals positively correlate with inflammation, hepatocyte ballooning, and other NAFLD symptoms. We have developed a molecular delivery technology capable of targeting only the disease-causing macrophages by selectively binding to the CD206 receptor. Selective binding and efficient delivery of this agent mitigates the potential of interfering more broadly with the normal function of the immune system.

We have completed five in vivo studies employing our MT-1002 and MT-2002 Manocept conjugates in a mouse model of NAFLD/NASH and liver fibrosis. The NALFD scores, which correlate to the agents' effectiveness, were significantly reduced, with all the activity related to inflammation and "ballooning" scores. Fibrosis decreased significantly when compared to the control in the later dosing arm of the study. Liver weights did not differ during any phase of the study between control and agent-treated groups, nor was there any evidence of damage to the roughly 30% of the liver made up of un-activated macrophages called Kupffer cells. MT-1002 and MT-2002 both significantly reduced key disease assessment parameters in the in vivo STAMTM NASH model. We believe these agents present themselves as potential clinically effective candidates for further evaluation. We continue to use this model to further assess the activity of our agents.




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Other Immunotherapeutic Applications

We have completed an expanded series of predictive in vitro screening tests of the MT-1002 and MT-2002 therapeutic conjugates against the Zika and Dengue viruses, which included infectivity and viral replication inhibition effectiveness as well as dose finding studies and mechanisms of action, the latter based on conjugate structures. We have also completed a series of predictive in vivo screening tests of the MT-1002 and MT-2002 therapeutic conjugates against Leishmaniosis, which included host cell targeting and killing effectiveness as well as dose finding studies and mechanisms of action. A portion of the results from the in vivo Leishmaniosis study, completed in conjunction with the National Institute of Allergy and Infectious Diseases/NIH, was recently published in the Journal of Experimental Medicine (published in the circulated version Journal of Experimental Medicine 2018 Jan 2;215(1):357-375). The results from all evaluations were positive and have provided a basis for moving forward with additional in vivo testing of the selected conjugates. We have selected collaborators for these in vivo studies, which we expect will take place over the next four to six months. We will provide updates as information becomes available on future testing.

The Company continues to evaluate emerging data in other disease states to define areas of focus, development pathways and partnering options to capitalize on the Manocept platform, including ongoing studies in KS, RA and infectious diseases. The immuno-inflammatory process is remarkably complex and tightly regulated with indicators that initiate, maintain and shut down the process. Macrophages are immune cells that play a critical role in the initiation, maintenance, and resolution of inflammation. They are activated and deactivated in the inflammatory process. Because macrophages may promote dysregulation that accelerates or enhances disease progression, diagnostic and therapeutic interventions that target macrophages may open new avenues for controlling inflammatory diseases. There can be no assurance that further evaluation or development will be successful, that any Manocept platform product candidate will ultimately achieve regulatory approval, or if approved, the extent to which it will achieve market acceptance.



NAV4694 (Sublicensed)


NAV4694 is a fluorine-18 ("F-18") labeled PET imaging agent being developed as an aid in the imaging and evaluation of patients with signs or symptoms of Alzheimer's disease ("AD") and mild cognitive impairment ("MCI"). NAV4694 binds to beta-amyloid deposits in the brain that can then be imaged in PET scans. Amyloid plaque pathology is a required feature of AD and the presence of amyloid pathology is a supportive feature for diagnosis of probable AD. Patients who are negative for amyloid pathology do not have AD. NAV4694 has been studied in rigorous pre-clinical studies and clinical trials in humans. Clinical studies through Phase 3 have included subjects with MCI, suspected AD patients, and healthy volunteers. Results suggest that NAV4694 has the potential ability to image patients quickly and safely with high sensitivity and specificity.

In May 2014, the Board of Directors made the decision to refocus the Company's resources to better align the funding of our pipeline programs with the expected growth in Tc99m tilmanocept revenue. This realignment primarily involved reducing our near-term support for our neurological product candidates, including NAV4694, as we sought a development partner or partners for these programs. Discussions related to the potential partnering or divestiture of NAV4694 were delayed due in large part to litigation brought by Sinotau, one of the potential partners. In August 2015, Sinotau filed a suit for damages, specific performance, and injunctive relief against the Company in the U.S. District Court for the District of Massachusetts alleging breach of a letter of intent for licensing to Sinotau of the Company's NAV4694 product candidate and technology. In September 2016, the Court denied the Company's motion to dismiss. The Company filed its answer to the complaint and the parties have filed multiple joint motions to stay the case pending settlement discussion, which to date have been granted.

In October 2017, the Company executed a letter of intent with Sinotau and Cerveau, outlining a plan to sublicense to Cerveau the worldwide rights to conduct research using NAV4694, as well as grant to Cerveau an exclusive license for the development, marketing and commercialization of NAV4694 in Australia, Canada, China and Singapore. The letter of intent included a provision stating that Sinotau will release all claims in the Sinotau Litigation upon the parties' execution of a definitive agreement; the commercial rights agreement contemplated by the letter of intent would also include a release of such claims and a covenant not to sue on such claims. In April 2018, the Company executed an agreement to provide Meilleur, a wholly-owned subsidiary of Cerveau, worldwide rights to conduct research using NAV4694, as well as an exclusive license for the development and commercialization of NAV4694 in Australia, Canada, China, and Singapore. Meilleur also has an option to commercialize worldwide. As a result of the agreement, the litigation initiated by Sinotau was dismissed in September 2018. See Note 11 to the accompanying consolidated financial statements.




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Outlook


Our operating expenses in recent years have been focused primarily on support of our Manocept platform, Tc99m tilmanocept, and NAV4694 product development. We incurred approximately $3.4 million and $2.8 million in total on research and development activities during the nine-month periods ended September 30, 2018 and 2017, respectively. Of the total amounts we spent on research and development during those periods, excluding costs related to our internal research and development headcount and our general and administrative staff which we do not currently allocate among the various development programs that we have underway, we incurred out-of-pocket charges by program as follows:






                                   Nine Months Ended
                                     September 30,
Development Program (a)          2018            2017
Manocept Platform (b)         $   906,178$ 1,034,380
Macrophage Therapeutics (b)     1,063,992         610,921
Tc99m Tilmanocept (c)             143,928         187,829
NAV4694 (d)                        19,105        (399,146 )




  (a) Certain development program expenditures were offset by grant reimbursement
      revenues totaling $763,000 and $1.3 million during the nine-month periods
      ended September 30, 2018 and 2017, respectively.


  (b) Certain 2017 amounts have been reclassified from Manocept Platform to
      Macrophage Therapeutics to conform to 2018 presentation.


  (c) Amounts in 2017 reflect projects included in discontinued operations in the
      consolidated statements of operations.


  (d) Changes in cost estimates resulted in the reversal of certain previously
      accrued expenses related to the NAV4694 development program during the
      nine-month period ended September 30, 2017.



We expect to continue the advancement of our efforts with our Manocept platform during the remainder of 2018 and into 2019. We expect our total research and development expenses, including both out-of-pocket charges as well as internal headcount and support costs, to be higher in 2018 than in 2017. The suspension of active patient accrual in our NAV4694 trials have decreased our development costs related to that program over the past year, however, we may continue to incur minimal costs while we complete our divestiture activities with Meilleur.

Tc99m tilmanocept is approved by the European Medicines Agency for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity in the EU. Following the January 2017 transfer of the Tc99m tilmanocept Marketing Authorization to SpePharm, we transferred responsibility for manufacturing the reduced-mass vial for the EU market to SpePharm. During the second quarter of 2017, SpePharm launched Tc99m tilmanocept in select EU markets, providing a number of early adopters with sample doses to provide exposure to the product. EU sales commenced during the third quarter of 2017. We anticipate that we will incur costs related to supporting our product, regulatory, manufacturing and commercial activities related to the potential marketing registration and sale of Tc99m tilmanocept in markets other than the EU. There can be no assurance that Tc99m tilmanocept will achieve regulatory approval in any market other than the EU, or if approved in those markets, that it will achieve market acceptance in the EU or any other market.

We continue to evaluate existing and emerging data on the potential use of Manocept-related agents in the diagnosis, disease-staging and treatment of disorders in which macrophages are involved, such as KS, RA, NASH and other disease states, to define areas of focus, development pathways and partnering options to capitalize on the Manocept platform. We will also be evaluating potential funding and other resources required for continued development, regulatory approval and commercialization of any Manocept platform product candidates that we identify for further development, and potential options for advancing development. There can be no assurance of obtaining funding or other resources on terms acceptable to us, if at all, that further evaluation or development will be successful, that any Manocept platform product candidate will ultimately achieve regulatory approval, or if approved, the extent to which it will achieve market acceptance.



Discontinued Operations


In March 2017, Navidea completed the Asset Sale to Cardinal Health 414, as discussed previously under "The Company." In exchange for the Acquired Assets, Cardinal Health 414 (i) made a cash payment to the Company at closing of approximately $80.6 million after adjustments based on inventory being transferred and an advance of $3 million of guaranteed earnout payments as part of the CRG settlement, (ii) assumed certain liabilities of the Company associated with the Product as specified in the Purchase Agreement, and (iii) agreed to make periodic earnout payments (to consist of contingent payments and milestone payments which, if paid, will be treated as additional purchase price) to the Company based on net sales derived from the purchased Product subject, in each case, to Cardinal Health 414's right to off-set. In no event will the sum of all earnout payments, as further described in the Purchase Agreement, exceed $230 million over a period of ten years, of which $20.1 million are guaranteed payments for the three years immediately after closing of the Asset Sale. At the closing of the Asset Sale, $3 million of such earnout payments were advanced by Cardinal Health 414 to the Company, and paid to CRG.




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In April 2018, the Company entered into an Amendment to the Asset Purchase Agreement. Pursuant to the Amendment, Cardinal Health 414 paid the Company approximately $6.0 million and agreed to pay the Company an amount equal to the unused portion of the letter of credit (not to exceed approximately $7.1 million) promptly after the earlier of (i) the expiration of the letter of credit and (ii) the receipt by Cardinal Health 414 of evidence of the return and cancellation of the letter of credit. In exchange, the obligation of Cardinal Health 414 to make any further contingent payments has been eliminated. Cardinal Health 414 is still obligated to make the milestone payments in accordance with the terms of the earnout provisions of the Purchase Agreement. CRG has drawn the entire $7.1 million available under the letter of credit.

We recorded a net gain on the sale of the Business of $86.9 million 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 $6.4 million in estimated taxes. We recorded an additional gain related to the Amendment to the Asset Purchase Agreement of $43,000 for the nine months ended September 30, 2018, including $54,000 of additional consideration, offset by $11,000 in estimated taxes.

Our consolidated balance sheets and statements of operations have been reclassified, as required, for all periods presented to reflect the Business as a discontinued operation. Cash flows associated with the operation of the Business have been combined with operating, investing and financing cash flows, as appropriate, in our consolidated statements of cash flows.



Results of Operations


This discussion of our Results of Operations focuses on describing results of our operations as if we had not operated the Business as a discontinued operation as discussed above during the periods being disclosed. In addition, since our remaining pharmaceutical product candidates are not yet generating commercial revenue, the discussion of our revenue focuses on the grant and other revenue and our operating variances focus on our remaining product development programs and the supporting general and administrative expenses.

Three Months Ended September 30, 2018 and 2017

Royalty Revenue. During the third quarter of 2018, we recognized royalty revenue of $2,000 related to our license agreement with SpePharm in Europe. No royalty revenue was recognized during the third quarter of 2017.

License Revenue. During the third quarter of 2018, we recognized license revenue of $20,000, primarily for activities related to the sublicense of NAV4694 to Meilleur and the sublicense of Tc99m tilmanocept to Sinotau. No license revenue was recognized during the third quarter of 2017.

Grant and Other Revenue. During the third quarter of 2018, we recognized $209,000 of grant and other revenue as compared to $224,000 in the third quarter of 2017. Grant revenue during the third quarters of 2018 and 2017 was primarily related to SBIR grants from the NIH supporting Manocept development.

Research and Development Expenses. Research and development expenses increased $351,000, or 40%, to $1.2 million during the third quarter of 2018 from $875,000 during the same period in 2017. The increase was primarily due to net increases in drug project expenses related to (i) increased therapeutics development costs of $331,000 including increased research consulting costs and manufacturing-related activities; offset by (ii) decreased NAV4694 development costs of $70,000 including decreased clinical trial costs offset by increased manufacturing-related activities; (iii) decreased Manocept development costs of $20,000, primarily decreased clinical trial costs; and (iv) decreased Tc99m tilmanocept development costs of $13,000, primarily decreased manufacturing-related activities. The net increase in research and development expenses also included increased compensation including incentive-based awards of $63,000 and increased general office and travel expenses totaling $37,000.

Selling, General and Administrative Expenses. Selling, general and administrative expenses increased $954,000, or 55%, to $2.7 million during the third quarter of 2018 from $1.7 million during the same period in 2017. The net increase was primarily due to increased compensation including incentive-based awards of $1.2 million, including termination costs associated with the resignation of our former CEO, Michael Goldberg, of $1.1 million, coupled with an increase in investor relations costs, primarily related to the annual stockholders meeting, of $24,000. These increases were offset by decreased legal and professional services of $181,000 and decreased general office, depreciation, and rent expenses totaling $107,000.

Other Income (Expense). Other expense, net, was $25,000 during the third quarter of 2018 as compared to other income, net of $69,000 during the same period in 2017. During the third quarters of 2018 and 2017, $44,000 and $29,000, respectively, of interest expense was compounded and added to the balance of our note payable to Platinum. During the third quarters of 2018 and 2017, we recorded interest income of $17,000 and $102,000, respectively. Of the interest income recorded during the third quarter of 2017, $88,000 was related to the guaranteed consideration due from Cardinal Health 414, which was discounted to present value at the closing date of the Asset Sale.




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Nine Months Ended September 30, 2018 and 2017

Royalty Revenue. During the first nine months of 2018, we recognized royalty revenue of $10,000 related to our license agreement with SpePharm in Europe. No royalty revenue was recognized during the first nine months of 2017.

License Revenue. During the first nine months of 2018, we recognized license revenue of $278,000, primarily for a non-refundable upfront payment related to the sublicense of NAV4694 to Meilleur and the sublicense of Tc99m tilmanocept to Sinotau. During the first nine months of 2017, we recognized license revenue of $100,000 for a non-refundable upfront payment related to the Tc99m tilmanocept license and distribution agreement with Sayre Therapeutics in India.

Grant and Other Revenue. During the first nine months of 2018, we recognized $763,000 of grant and other revenue as compared to $1.3 million in the same period in 2017. Grant revenue during the first nine months of 2018 was primarily related to SBIR grants from the NIH supporting Manocept development. Grant revenue during the first nine months of 2017 was primarily related to SBIR grants from the NIH supporting Manocept and Tc99m tilmanocept development. Other revenue for the first nine months of 2018 and 2017 included $82,000 and $34,000, respectively, of revenue from our marketing partners in Europe and China related to development work performed at their request.

Research and Development Expenses. Research and development expenses increased $602,000, or 22%, to $3.4 million during the first nine months of 2018 from $2.8 million during the same period in 2017. The increase was primarily due to net increases in drug project expenses related to (i) increased therapeutics development costs of $453,000 including increased research consulting, regulatory consulting, and preclinical testing, offset by decreased manufacturing-related activities; and (ii) increased NAV4694 development costs of $418,000 due to reversal of certain previously accrued expenses during the first nine months of 2017, offset by increased clinical testing; offset by (iii) decreased Manocept development costs of $128,000, primarily decreased clinical trial costs; and (iv) decreased Tc99m tilmanocept development costs of $44,000 including decreased manufacturing-related activities, clinical testing, and license fees, offset by increased regulatory costs. The net increase in research and development expenses also included decreased compensation including incentive-based awards of $197,000 related to net decreased headcount offset by increased general office and travel expenses totaling $71,000.

Selling, General and Administrative Expenses. Selling, general and administrative expenses decreased $2.7 million, or 31%, to $6.3 million during the first nine months of 2018 from $9.0 million during the same period in 2017. The net decrease was primarily due to decreased legal and professional services of $2.0 million, a loss on disposal of assets related to our previous office space of $717,000, termination costs related to the arbitration award to Mr. Gonzalez of $478,000 and loss on termination of our previous office lease of $472,000, both during the first nine months of 2017, and decreased general office, insurance, depreciation, rent, and travel expenses totaling $384,000. The net decrease in selling, general and administrative expenses also included termination costs related to the resignation of Dr. Goldberg of $1.1 million.

Other Income (Expense). Other expense, net, was $4.3 million during the first nine months of 2018 as compared to other expense, net of $1.1 million during the same period in 2017. We recorded losses on extinguishment of the CRG debt of $4.3 million and $1.3 million during the first nine months of 2018 and 2017, respectively. Also during the first nine months of 2018 and 2017, we recognized interest income of $113,000 and $236,000, respectively, primarily related to the guaranteed consideration due from Cardinal Health 414, which was discounted to present value at the closing date of the Asset Sale in 2017. During the first nine months of 2018 and 2017, $129,000 and $68,000, respectively, of interest expense was compounded and added to the balance of our note payable to Platinum. For the first nine months of 2017, we recorded non-cash income of $153,000 related to changes in the estimated fair value of financial instruments.

Gain on Discontinued Operations. We recorded a net gain related to the Amendment to the sale of the Business to Cardinal Health 414 of $43,000 for the nine months ended September 30, 2018, including $54,000 of payments by Cardinal Health 414 to Navidea in excess of receivables recognized, offset by $11,000 in estimated taxes. We recorded a net gain on the sale of the Business to Cardinal Health 414 of $86.9 million 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 $6.4 million in estimated taxes. Operating losses from discontinued operations related to the sale of the Business to Cardinal Health 414 were $2,000 and $333,000 for the first nine months of 2018 and 2017, respectively.

Liquidity and Capital Resources

Cash balances increased to $5.7 million at September 30, 2018 from $2.8 million at December 31, 2017. The net increase was primarily due to accelerated receipt of the guaranteed earnout receivable from Cardinal Health 414 of $5.7 million, net of CRG's draw on the letter of credit, proceeds from a private equity placement of $3.0 million, and maturities and sales of available-for-sale securities of $1.2 million, offset by cash used to fund our operations of $6.5 million.




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Operating Activities. Cash provided by operations was $6.4 million during the first nine months of 2018 compared to $61.0 million during the same period in 2017.

Accounts and other receivables decreased to $87,000 at September 30, 2018 from $8.1 million at December 31, 2017, primarily related to Cardinal Health 414's payment of the entire balance of the guaranteed earnout pursuant to the Amendment executed on April 2, 2018.

Prepaid expenses and other current assets decreased to $547,000 at September 30, 2018 from $1.1 million at December 31, 2017. The decrease was primarily due to normal amortization of prepaid insurance and decreased interest receivable related to the guaranteed earnout due from Cardinal Health 414.

Accounts payable decreased to $616,000 at September 30, 2018 from $855,000 at December 31, 2017, primarily driven by net decreased payables due to NAV4694, therapeutics, and operations vendors, offset by increased payables due to Manocept development vendors. Accrued liabilities and other current liabilities increased to $3.0 million at September 30, 2018 from $1.9 million at December 31, 2017. Increased accruals for termination of Dr. Goldberg and incentive-based compensation were offset by decreases in accruals for legal and professional services. Our payable and accrual balances will continue to fluctuate but will likely decrease overall as we work to resolve our legal disputes, offset by planned increases in development activity related to the Manocept platform.

Investing Activities. Investing activities provided $981,000 during the first nine months of 2018 compared to $2.0 million used during the same period in 2017. Investing activities during the first nine months of 2018 included maturities and sales of available-for-sale securities of $1.2 million and capital expenditures of $19,000, primarily for research and computer equipment. Investing activities during the first nine months of 2017 included purchases of available-for-sale securities of $2.2 million and capital expenditures of $31,000, primarily for computer equipment and leasehold improvements.

Financing Activities. Financing activities used $4.5 million during the first nine months of 2018 compared to $60.9 million during the same period in 2017. The $4.5 million used by financing activities in the first nine months of 2018 consisted primarily of CRG's draw on the letter of credit of $7.1 million and principal payments on financed insurance premiums of $318,000, offset by proceeds from a private equity placement of $3.0 million. The $60.9 million used by financing activities in the first nine months of 2017 consisted primarily of principal payments on the CRG, Platinum and IPFS notes payable of $59.7 million and payment of CRG debt-related costs to CRG of $1.3 million, offset by proceeds from issuance of common stock of $54,000.



Private Placement


On September 13, 2018, the Company entered into a Stock Purchase Agreement with an investor, pursuant to which the Company issued 18,320,610 shares of the Company's common stock in exchange for $3.0 million in cash. The Company plans to use the proceeds from the Private Placement for general working capital purposes, including, without limitation, research and development, and other operating expenses.

Cardinal Health 414 Asset Sale

On April 2, 2018, the Company entered into an Amendment to the Asset Purchase Agreement. Pursuant to the Amendment, Cardinal Health 414 paid the Company approximately $6.0 million and agreed to pay the Company an amount equal to the unused portion of the letter of credit (not to exceed approximately $7.1 million) promptly after the earlier of (i) the expiration of the letter of credit and (ii) the receipt by Cardinal Health 414 of evidence of the return and cancellation of the letter of credit. In exchange, the obligation of Cardinal Health 414 to make any further contingent payments has been eliminated. Cardinal Health 414 is still obligated to make the milestone payments in accordance with the terms of the earnout provisions of the Purchase Agreement. On April 9, 2018, CRG drew approximately $7.1 million on the letter of credit.



Platinum Credit Facility


See Notes 9 and 11 to the accompanying consolidated financial statements.



Capital Royalty Group Debt


See Notes 9 and 11 to the accompanying consolidated financial statements.



Summary


Our future liquidity and capital requirements will depend on a number of factors, including the ability of our distribution partners to achieve market acceptance of our products, our ability to complete the development and commercialization of new products, our ability to monetize our investment in non-core technologies, our ability to obtain milestone or development funds from potential development and distribution partners, regulatory actions by the FDA and international regulatory bodies, the ability to procure required financial resources, and intellectual property protection.




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We plan to focus our resources for the remainder of 2018 and into 2019 primarily on development of products based on the Manocept platform. Although management believes that it will be able to achieve these objectives, they are subject to a number of variables beyond our control, including the nature and timing of any partnering opportunities, the ability to modify contractual commitments made in connection with these programs, and the timing and expense associated with suspension or alteration of clinical trials, and consequently there can be no assurance that we will be able to achieve our objective of bringing our expenses in line with our revenues, and we may need to seek additional financing if we cannot achieve that objective in a timely manner.

We will continue to evaluate our time lines, strategic needs, and balance sheet requirements. If we attempt to raise additional capital through debt, royalty, equity or otherwise, we may not be successful in doing so on terms acceptable to the Company, if at all. Further, we may not be able to gain access and/or be able to secure new sources of funding, identify new development opportunities, successfully obtain regulatory approval for and commercialize new products, achieve significant product revenues from our products, or achieve or sustain profitability in the future.

The Company has experienced recent unfavorable court rulings and is currently still engaged in lawsuits with CRG. In addition, the Company has experienced recurring net losses and has used significant cash to fund its operations. Our projected cash burn factors in certain cost cutting initiatives that have been approved by the Board of Directors and implemented, including reductions in the workforce and a reduction in facilities expenses. Additionally, we have considerable discretion over the extent of development project expenditures and have the ability to curtail the related cash flows as needed. The Company also has funds remaining under outstanding grant awards, and continues working to establish new sources of funding, including collaborations, potential equity investments, and additional grant funding that can augment the balance sheet. However, based on our current working capital and our projected cash burn, and without definitive agreements in place for additional funding, management believes that there is substantial doubt about the Company's ability to continue as a going concern for at least twelve months following the issuance of this Quarterly Report on Form 10-Q. See Note 2 to the accompanying consolidated financial statements.

Off-Balance Sheet Arrangements

As of September 30, 2018, we had no off-balance sheet arrangements.

Recent Accounting Standards

See Notes 1(c) and 1(d) to the accompanying consolidated financial statements.



Critical Accounting Policies


We base our management's discussion and analysis of financial condition and results of operations, as well as disclosures included elsewhere in this Quarterly Report on Form 10-Q, upon our consolidated financial statements, which we have prepared in accordance with U.S. generally accepted accounting principles. We describe our significant accounting policies in the notes to the audited consolidated financial statements contained in our Annual Report on Form 10-K. We include within these policies our "critical accounting policies." Critical accounting policies are those policies that are most important to the preparation of our consolidated financial statements and require management's most subjective and complex judgment due to the need to make estimates about matters that are inherently uncertain. Changes in estimates and assumptions based upon actual results may have a material impact on our results of operations and/or financial condition.

Revenue Recognition. We currently generate revenue primarily from grants to support various product development initiatives. We generally recognize grant revenue when expenses reimbursable under the grants have been paid and payments under the grants become contractually due.

We also earn revenues related to our licensing and distribution agreements. The consideration we are eligible to receive under our licensing and distribution agreements typically includes upfront payments, reimbursement for research and development costs, milestone payments, and royalties. Each licensing and distribution agreement is unique and requires separate assessment in accordance with current accounting standards.

Research and Development. R&D expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits, and stock-based compensation, as well as travel, supplies, and other costs to support our R&D staff. External contracted services include clinical trial activities, chemistry, manufacturing and control-related activities, and regulatory costs. R&D expenses are charged to operations as incurred. We review and accrue R&D expenses based on services performed and rely upon estimates of those costs applicable to the stage of completion of each project.




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Use of Estimates. The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We base these estimates and assumptions upon historical experience and existing, known circumstances. Actual results could differ from those estimates. Specifically, management may make significant estimates in the following areas:



  ? Stock-Based Compensation. Stock-based payments to employees and directors,
    including grants of stock options and restricted stock, are recognized in the
    statements of operations based on their estimated fair values on the date of
    grant, subject to an estimated forfeiture rate. The fair value of each option
    award with time-based vesting provisions is estimated on the date of grant
    using the Black-Scholes option pricing model to value such stock-based
    payments and the portion that is ultimately expected to vest is recognized as
    compensation expense over either (1) the requisite service period or (2) the
    estimated performance period. The determination of fair value using the
    Black-Scholes option pricing model is affected by our stock price as well as
    assumptions regarding a number of complex and subjective variables, including
    expected stock price volatility, risk-free interest rate, expected dividends
    and projected employee stock option behaviors. The fair value of each option
    award with market-based vesting provisions is estimated on the date of grant
    using a Monte Carlo simulation to value such stock-based payments and the
    portion that is ultimately expected to vest is recognized as compensation
    expense over either (1) the requisite service period or (2) the estimated
    performance period. The determination of fair value using a Monte Carlo
    simulation is affected by our stock price as well as assumptions regarding a
    number of complex and subjective variables, including expected stock price
    volatility, risk-free interest rate, expected dividends and projected employee
    stock option behaviors.



We estimate the expected term based on the contractual term of the awards and employees' exercise and expected post-vesting termination behavior. Restricted stock awards are valued based on the closing stock price on the date of grant and amortized ratably over the estimated life of the award.

Since stock-based compensation is recognized only for those awards that are ultimately expected to vest, we have applied an estimated forfeiture rate to unvested awards for the purpose of calculating compensation cost. These estimates will be revised, if necessary, in future periods if actual forfeitures differ from estimates. Changes in forfeiture estimates impact compensation cost in the period in which the change in estimate occurs.



  ? Fair Value of Financial Instruments.  Certain of our notes payable included an
    embedded conversion option which was required to be recorded at fair value.
    The estimated fair value of the embedded conversion option was calculated
    using a probability-weighted Monte Carlo simulation.  This valuation method
    includes Level 3 inputs such as the estimated current market interest rate for
    similar instruments with similar creditworthiness.  Unrealized gains and
    losses on the fair value of the embedded conversion option are classified in
    other expenses as a change in the fair value of financial instruments in the
    consolidated statements of operations.




  ? Fair Value of Warrants. We estimate the fair value of warrants using the
    Black-Scholes model, which is affected by our stock price and warrant exercise
    price, as well as assumptions regarding a number of complex and subjective
    variables, including expected stock price volatility and risk-free interest
    rate.

© Edgar Online, source Glimpses

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