Earnings Transcript for NAVB - Q3 Fiscal Year 2021

Operator: Greetings. Welcome to the Navidea Q3 2021 Earnings Conference Call. [Operator Instructions] Please note, this conference is being recorded. I will now turn the conference over to your host, Mike Rosol, CMO. You may begin.

Mike Rosol: Thank you all for joining us today. This call is being webcast live on our website, ir.navidea.com, and a replay will be made available. Following prepared remarks, we will be conducting a question-and-answer segment where we will read submitted questions and provide our responses. Navidea's Vice President of Finance and Administration, Erika Eves, will be joining me on the call today. During the course of this conference call, we will be making forward-looking statements regarding future events and the future performance of the company. These events relate to our business plans to develop Navidea's molecular diagnostics and immunotherapeutics, which include clinical and regulatory developments, and timing of clinical data readouts along with capital resources and strategic matters as well as the impact of the COVID-19 pandemic on Navidea's business operations. All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions, risks and uncertainties, and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements whether as a result of new information, future events or otherwise. Investors should read carefully the risks and uncertainties described within the safe harbor section of our website as well as the risk factors included in the company's most recent quarterly and annual filings with the SEC. Before I begin the third quarter update, I'd like to provide a brief comment on recent events. [Jed Latkin], our former CEO and resigned from his executive positions and as a member of the Board on October 24. On November 8, 2021, the company's Board of Directors transitioned from the office of the CEO and established an executive leadership committee to lead the company on an interim basis while its next CEO is identified. The Executive Leadership committee includes myself, Mike Rosol, the company's Senior VP and Chief Medical Officer; Erika Eves, the company's Vice President of Finance and Administration; and Jeffrey Smith, the Vice President of Operations. The Executive Leadership Committee will work with a newly established Board Oversight Committee consisting of Independent Directors, Alexandre Capello, Thomas Barb and John K. Jr. During this transition, we remain focused on the rheumatoid arthritis pipeline while also working aggressively to advance our therapeutics program into the clinic. In the third quarter, on September 1, we had our end of Phase II Type B meeting to discuss the results of our completed Phase IIb trial in rheumatoid arthritis and advancement into Phase III in RA. We had a constructive meeting with the FDA, have received the formal minutes of that meeting and have submitted our NAV3-33 Phase III protocol and analysis plan with agreed upon modifications based on that discussion. We are actively preparing for initiation of the trial. I'll have some more comments on the RA program in a moment in the clinical update portion of the call. In this past quarter, we also brought in Dr. Michel Mikhail as our Chief Regulatory Officer. As you might have read in our press release, Dr. Michel has over 30 years of experience in the pharmaceutical industry, and has served in 4 regulatory roles at BioNTech AG; SmithKline Beecham, now GSK; and Pharmacia [Upjohn], now Pfizer, to name a few. Dr. Michel has moved here to Ohio in Germany so that we can interact with him readily and on a daily basis. We're excited to have him here. And he is working closely with the clinical team as we advance the RA program, and manage the distribution of Lymphoseek in Europe. This quarter also saw the appointments of several Board members. Alexander Cabello, John Scott Jr., Thomas Farbanca Winkler. Mr. Capello brings over 30 years of banking and public board experience for the company. And Mr. Scott is the company's largest shareholder. Mr. Farm has over 3 decades of experience as an investor in and senior executive of numerous life science and information technology companies, both in the U.S. and internationally. And Ms. Winkler has extensive professional and Board experience with start-up, mid-cap and Fortune 500 companies. Now I would like to cover the clinical update. So I'll begin with the progress on our RA program and an update on our interactions with the FDA. As we have discussed previously, in July, we submitted our end of Phase II Type B meeting package to the agency for their continuing evaluation of the completed Phase IIb trial as well as a review of the proposed Phase III protocol and analysis plan. The Phase IIb trial, NAV3-31, and the data from it were critical to moving us forward in RA. As a reminder, this was a 3-arm trial. In arms 1 and 2, we evaluated the repeatability, reproducibility and stability of our tilmanocept imaging readout in both healthy subjects and in patients with active RA. And in the third arm, we mirrored the upcoming Phase III study to obtain data to help with sample sizing for the Phase III and to have a first look at the ability of tilmanocept imaging to serve as an early predictor of treatment efficacy. As we discussed previously, the data from the completed trial demonstrated that tilmanocept can provide robust quantitative imaging in healthy controls and in patients with active RA that this imaging is reproducible and can define joints with and without RA-involved inflammation, and that tilmanocept imaging can provide an early prediction of treatment efficacy of anti-TNF alpha therapy. In short, the analysis from the complete set of arm 3 patients demonstrated high accuracy at early prediction of treatment effect with a strong predictive value, in particular for nonresponders to anti-TNF alpha therapies even from the baseline scan alone in the defined subset of patients. In these patients, those exhibiting a low level of tilmanocept uptake in the joints on their initial baseline scan, who likely represents the so-called fibroid subtype of RA. There was almost 90% nonresponse rate to anti-TNF alpha therapy using a clinical gold standard assessment. This results on its own, the ability to use a single time point scan to predict that an anti-TNF alpha therapy it's timely unlikely to work in a particular group of patients would be a powerful tool for rheumatologists to be able to rule out an entire class of therapies from the get go, avoiding the high cost, possible side effects and possible worsening of disease that could otherwise be the case. In combination with the predictive capacity we saw on the rest of the arm 3 subjects, the data continue to support our hypothesis. The results from the full data set from this trial will be submitted for presentation at an upcoming international meeting. And of course, we plan to write these up for publication and medical journal. Following submission of the briefing package containing these results as well as the NAV3-33 Phase III study protocol and analysis plan, the FDA granted our end of Phase II meeting request and set the date for September 1. Several days prior to the meeting, the agency sent us their preliminary comments, providing us with the opportunity to send back initial replies to their comments in preparation for an efficient September 1 meeting. The meeting itself was constructive and included 2 key opinion leaders in rheumatology, Dr. Jonathan Bras of UCSF and Dr. Costin Tino Petalas of [indiscernible] in the U.K. both of whom have been site investigators in our Phase II program as well as instrumental advisers in our RA program development and trial design. Since this constructed meeting on September 1 with the FDA, and after receipt of the formal meeting minutes to make sure we remain in alignment, we finalized the agreed-upon modifications to the Phase III protocol design and analysis plan, and it sent these back to the FDA for comment. In the interim, we are preparing to initiate the Phase III this quarter. As I've mentioned before, we have several key sites that we expect to be able to open up quickly. These are sites that were involved in the Phase IIb study and are well acquainted with the trial design and operations. I want to also mention that we continue to make very good progress on automating the imaging quantification as well, which will have significant benefit to the commercial product. We have nearly completed the healthy control study, NAV3-35, to establish what is called normative database for tilmanocept in RA, an integral part of our ability to discriminate RA-inflamed joints from those that do not have inflammation is the knowledge of what healthy joints look like quantitatively. We use the healthy control data from Arm 1 of the completed Phase IIb to start to set the parameters, and we will use this study to add to the size of the current limited database. This should enable us to discriminate RA-involved joints from non-RA inflamed joints with improved accuracy and should have a positive impact on our ability to predict treatment response. This norm in a database establishing the parameters of what a normal joint looks like with tilmanocept, will play an essential part in both the Phase III data analysis as well as commercial product. As of today, we've enrolled all but 4 of the projected total, and are on track to complete enrollments. Our comparison study of [indiscernible] to joint biopsy, NAV3-32, is in active recruitment. In this Phase IIb study, we are comparing tilmanocept imaging dephasology from the joints of patients with active RA. We aim to recruit patients with each of the 3 known subtypes of RA to obtain comparative imaging and theology results in order to establish the correlation between our imaging signal and the number and density of macrophages that RA patient joints. We have opened up Northwestern University, [indiscernible] Health of London, and a third site a research rheumatology group called [indiscernible] in Los Angeles. [indiscernible] this study has really picked up. And as of this call, we have 9 subjects enrolled and additional candidates in pre-enrollment screening. The trial is designed for that we enroll a minimum of 4 subjects in each of the 3 subtypes of RA. So overall trial size is expected to range between 12 and 24. Remember, this trial is not required for FDA approval in the initial indications in RA that we are going for, but we believe it is critical in order to achieve qualification of CD206 as a biomarker for RA as well as to engage with pharma for us in trials of new therapeutics. We will also provide rheumatologists with gold standard information related to our imaging readout and the fundamental biology of a patient's RA. For example, results from this study could directly demonstrate that tilmanocept imaging can be used to determine a patient subtype of RA, and this would have implications for work class of therapy might or might not work on that particular patient. This could, therefore, have immediate impact on the management of RA patients. On the cardiovascular disease front, work has completed on the investigator-initiated atherosclerotic plaque imaging study at MGH in Boston. The group there is submitted an abstract to an international conference for possible presentation in February. The data we have seen have been promising in terms of localization of tilmanocept to sites of atherosclerotic plaque. And they've been in line with what was reported in the pilot study we copublished with them previously. Preclinical studies of Gallium 68 tilmanocept imaging for our NIH-funded project with the University of Alabama Birmingham are also ongoing. This project evaluated tilmanocept in various new imaging agents similar to tilmanocept in a mouse model of atherosclerosis. All planned imaging has been completed. Preliminary analyses have shown significant uptake of the Gallium 68 tilmanocept like imaging agent in atherosclerotic plaque in this mouse model. On the therapeutic front, we continue to make strides forward. For indications in oncology, we have performed preclinical studies that demonstrate macrophage phenotype change from an immunosuppressive to a pro-inflammatory state as well as a synergistic effect on tumor growth reduction in animal models using our doxorubicin-containing construct with an approved checkpoint inhibitor therapy. Put more simply, the tumors grow at a significantly reduced rate with our molecule combined with an approved drug compared to the approved drug alone. Furthermore, evaluations of the cells within these tumors show that our doxorubicin-containing construct altered the inflammatory state of tumor macrophages much as was expected. These are important mechanism of action and proof-of-concept studies that need to be done in order to move forward, and we are excited by the results thus far. We presented these results at the New York Academy of Sciences Frontiers and cancer immunotherapy symposium back in May, and are completing more than the first of several related manuscripts. Further preclinical studies, including a dose-schedule study, looking at different starting points for therapy were also carry out this quarter. In the third quarter, another important set of preclinical editing studies were completed with our collaborators at UAB. These studies evaluated 2 new imaging technologies in a mouse model of cancer. The first technology is designed to increase imaging agent localization to target tissues, while the second technology was designed to block off-target imaging agent localization to deliver a major site of localization when tilmanocept is administered by intravenous injection. These studies were highly successful, showing that we can dramatically increase localization of a new tilmanocept-like imaging agent to tumors while simultaneously significantly blocking off-target localization to the liver. With help from our colleagues at UAB, a manuscript describing these results is being prepared for publication. The success of these imaging studies greatly expands Navidea's imaging know-how and potentially illuminate the path to a next-generation imaging agent. Perhaps as importantly, the success of these imaging studies also points to a pathway leading to synthesis of more effective therapeutic drug delivery constructs. Building on this new information, new drug delivery constructs have been synthesized that carry payloads of either dexamethasone or doxorubicin. In addition, other new constructs have been synthesized that carry new drug payloads that may be more effective than doxorubicin for beneficially altering the immune status of tumor macrophages. All of these new constructs are currently being evaluated in a human macrophage assay system with the first new construct carrying a [indiscernible] payload having progressed to an ongoing evaluation in a mild tumor model. The dexamethasone car and construct will also be evaluated, but in a mouse model of inflammation rather than cancer. This construct would have broad-reaching applications in autoimmunity, inflammation and in diseases of metabolism. As these preclinical studies are completed, we will update you and announce when and where results will be presented. And so our therapeutic pipeline is robust and moving forward. On the intellectual property front. Our provisional patent application titled synthesis of uniformly defined molecular at monopolated dextrans and derivatives thereof, which converted to an A1 application on July 9. This application protects a portion of the new imaging know-how I discussed previously. On August 20, we filed a provisional patent application entitled Compositions and Methods For The Treatment of Rheumatoid Arthritis, which relates to a multivariant algorithmic methods that may improve the predictive accuracy of our rheumatoid arthritis imaging product. Finally, we've received notice of allowance claims in foreign jurisdictions for an application broadly involved in diagnosis and treatment of diseases involving CD206-expressing cells. We have an active IP protection strategy that we believe will provide needed protection and rights to both our current diagnostic and therapeutic agents as well as to our next-generation molecules under these indications. These are just some of the highlights in the last quarter that we wanted to touch on for this update. We remain largely focused on the RA pipeline, specifically preparation for the Phase II as well as enrollment into the currently open biopsy in normative database study, while we continue to support and push for progress on our other diagnostic and therapeutic indications. As always, I want to thank the team here for their tireless efforts to keep things moving and our network of clinical trial sites and academic research collaborators for all of their hard work. Thank you. And now I'll turn this call over to Erika for the financial updates.

Erika Eves: Thank you, Mike. Total net revenues for the third quarter of 2021 were $96,000 compared to $268,000 for the same period in 2020. Total net revenues for the first 9 months of 2021 were $481,000 compared to $695,000 for the same period in 2020. The decrease was primarily due to decreased grant revenue related to small business innovation research grants from the National Institutes of Health, supporting tilmanocept development. Those were offset -- those decreases were offset by received a reimbursement from Cardinal Health of certain R&D costs, and the partial recovery of debt previously written off in 2015. R&D expenses for the third quarter of 2021 were $1 million compared to $1.4 million in the same period in 2020. And R&D expenses for the first 9 months of 2021 were $3.8 million compared to $3.7 million in the same period in 2020. The net increase during year-to-date was primarily due to net increases in drug project expenses, including increased Manocept therapeutic and [indiscernible] tilmanocept development costs, offset by decreased manocept diagnostic development costs. The net increase in research and development expenses also included increased regulatory consulting and general office expenses, offset by decreased employee compensation, including incentive-based awards. Selling, general and administrative expenses for the third quarter of 2021 were $1.5 million compared to $1.8 million in the same period in 2020. SG&A expenses for the first 9 months of 2021 were $5.1 million compared to $4.9 million in the same period of the previous year. And that increase during the year-to-date was primarily due to increased consulting services related to preparing for European distribution of TC99 [indiscernible], increased employee compensation, including incentive-based awards, increased insurance costs, increased director fees related to additional board members, increased travel costs, increased European license fees general office expenses and a loss on the third quarter 2021 abandonment of certain intellectual property. These increases were offset by decreased legal and professional services, decreased investor relations costs, facilities costs and franchise taxes. Navidea's net loss attributable to common stockholders for the third quarter of was $2.4 million or $0.08 per share compared to $3.3 million or $0.13 per share for the same period in 2020. The net loss attributable to common stockholders for the first 9 months of 2021 was $8.1 million or $0.28 per share compared to $8.4 million or $0.37 per share for the same period of the prior year. And finally, Navidea ended the third quarter of 2021 was $7.2 million in cash and cash equivalents. I will now turn the call back over to Mike.

Mike Rosol: Thank you, Erika. We will now read through the submitted shareholder questions and provide our responses. We have collected and collated the questions received and in some cases, have consolidated overlapping or similar questions into ones that capture the overall intent.

Operator: [Operator Instructions] All right.

Erika Eves: First question, it's been a while since Navidea has had this meeting with the FDA. Can you provide any color at this time? And if not, when do you expect to share where things stand regarding Phase III?

Mike Rosol: As mentioned in my earlier remarks, since the constructive meeting on September 1 with the FDA and after receipt of the formal meeting minutes to make sure we remained in alignment. We finalized the agreed upon modifications to the Phase III protocol design and analysis plan, and it then goes back to the FDA for comment. In the interim, we are prepared to initiate the Phase III.

Erika Eves: Is the video purposely slow rolling with the FDA since 2 months seems like a long time since the September 1 meeting, when the investing public was told all along, they were in lockstep with the FDA.

Mike Rosol: No. Our interactions with the FDA are proceeding according to guidelines, and we have been moving rapidly at each step to provide briefing materials and responses as we have progressed in the RA program. There are processes and guidances in place that determine time lines of interactions. As a company, we very quickly provided the initial briefing package back in February and then the end of Phase II Type B meeting package in July. This small team put together these large document packages on an extremely tight time line. The agency's guidances allow sufficient time for their reviewers to thoroughly examine and provide comments. I should add that the agency has been great to work with and extremely helpful in advancing from 1 step to the net rapidly.

Erika Eves: How many sites have now been contacted? And how many sites have agreed to run the 3-33 RA Phase III trial?

Mike Rosol: We've been in touch at 1 level or another with over 50 U.S. sites that have expressed interest in participating in the NAV3-33 trial. The actual number of sites opened here in the U.S. and possibly abroad might differ from that. But there is no shortage of interest in participation.

Erika Eves: The investor presentation graph shows around 15 months left in for 3-33 RA Phase III trial. Does that include testing, assessment and NDA filing time?

Mike Rosol: Time line from the start of trial to [indiscernible] always depends on rate of enrollment. And this is impacted at both the individual site level as well as by total number of sites. Our plan remains to open up sites that have already participated in our earlier phase RA trial and we have demonstrated a good recruitment pace, and we'll work with new sites as well to ensure a rapid recruitment rate as possible. Following the trial, we will work aggressively to finalize assessments for the full submission package. We've demonstrated rapid turnaround of study reported breathing packages in the past, and I expect that to continue for the full filing. We will begin to prepare for the filing as the Phase III program continues.

Erika Eves: Conductor [indiscernible] will elaborate on how a two buckets or dual-track RA diagnostic 3-33 Phase III trial, mentioned that the squire virtual event would work if and when the FDA approves Phase III. And how major it is if approved?

Mike Rosol: Sure. The NAV3-33 trial will take all comers in terms of R patient subgroups in that we will not exclude patients based on factors such as time from first diagnosis of RA treatment history, age, et cetera. We have built into the trial design plans to look at and other subgroups of RA patients and specific anti-TNF alpha drugs in order to have a feeling whether any of these impact the ability of tilmanocept to serve as an early predictor of treatment response to the anti-TNF therapy as hypothesized. These demonstrate an impact on the efficacy of femanocept to act as -- not on the rate of these demonstrated impact on the efficacy of tilmanocept act as an early predictor. And this will support the use of it across the spectrum of patients who are at the point where their doctor determines they need to switch to a new therapy.

Erika Eves: When can we expect to receive preliminary data on the 3-32 trial?

Mike Rosol: Given the small sample size of the NAV3-32 trial with its adaptive design and an expected enrollment of 12 to 24 subjects, and the recent increase in recruitment rate, it's possible that a preliminary readout can occur in Q1 or Q2 of next year. But as always, this is something of an educated guessing game. As I said, though, enrollment has been going very well of late. And if the current pace continues, we should be on the shorter end of that time line.

Erika Eves: How many subjects are investing and have completed testing in the RNA 3-32 Phase Ib novel biopsy trial? And have they all been in the U.S. or in the U.K., also?

Mike Rosol: To date, we have 9 patients enrolled, and it's about an equal distribution between the U.S. and the U.K. and who are at various stages of the trial with an additional 2 in different stages of the screening process.

Erika Eves: What is your estimated completion date for 3-35?

Mike Rosol: Enrollment in imaging events serene shortly in this study as there are only a handful of subjects best to enroll. If all goes as planned, we expect complete enrollment by the end of this month.

Erika Eves: What is the progress on the oncology TAMS and inflammatory preclinical trials? And is there anything you can share on results and/or next steps?

Mike Rosol: Sure. Our preclinical oncology efficacy study is ongoing with our NAND tox construct. We are making excellent progress on several new therapeutic payload constructs for oncology. These are in the pipeline for in vitro efficacy evaluation, and then will be tested in preclinical models as we develop lead candidates. We anticipate presenting some of these preclinical results at upcoming international meetings as well as writing them up for publication. And these advanced in the pipeline safety tox studies are the next step to moving towards an IND and first-in-human trial as well as validating chemical synthesis for reliability of production. On the anti-inflammatory front, we have a well-characterized and functional dexamethasone construct that we plan to bring in the animal model studies soon. We are currently planning for these studies along with our collaborators so that we can move forward expeditiously. Several other areas of new imaging agents and therapeutics contract research are ongoing with our collaborators at UAB as well, and as I discussed earlier in this call.

Erika Eves: Can you speak to Navidea's cash position, a length of runway and level of confidence additional funding will be available if needed? Is there still sufficient cash on the balance sheet to fund the startup of the RA Phase III trial, and from the company into early 2022? And one of the potential sources of funds for the company that are currently lined up.

Mike Rosol: Current cash reserves should take us to at least end of Q1 with initiation of the NAV3-33 trial included. The Board of Directors is currently considering available options for future financing, including both non-dilutive and dilutive needs.

Erika Eves: Is the regulatory approval of Lymphoseek now completed in India? And is there an interim payment due? And if so, how much?

Mike Rosol: Things are progressing, and we are working with our Indian partner to obtain approval as soon as possible. We're in the last stage of the approval process and issuance of a marketing authorization in India. Later this month, there will be a Zoom call with the Drug Controller General of India, the Joint Drug Controller and other senior reviewers to address questions related to stability data and the statistical approach used to obtain those data. This is expected to be the last step to obtain [indiscernible]. We will keep you informed of the fog.

Erika Eves: What have you done to prepare for the probability of that Lymphoseek will be approved in the near future in India?

Mike Rosol: We are in the latter stages of validating API manufacturer that can be used to supply this in other territory.

Erika Eves: As the license to sell in Europe have been approved as previously indicated. If so what are the plans, if any, to market lymphosy that may differ from…

Mike Rosol: The European Medicines Agency previously approved the transfer of Lymphoseek marketing authorization from Norgine back to Navidea, and we obtained the wholesaler dealer authorization to sell Lymphoseek in the EU at the end of September. While we aggressively pursue a new long-term partner for growing the asset in this region, we have a third-party logistics service established to fulfill orders until such partner is identified. The learnings from Norgine's marketing strategy will be incorporated into a new strategy with our future partner.

Erika Eves: Is the Jubilant borrowing marketing ventures still being actively in earnestly negotiated? Have there been any discussions with tubulin over the past week regarding the MOU and the relationship in general, i.e., have they reached out to you or due to them to discuss any concerns either party may have? And can you share the general tone of the talks?

Mike Rosol: Yes. We've had discussions with them in the last couple of weeks, and they remain interested in the RA product. As we have mentioned in prior calls, they like we are anticipating the results of the NAV3-32 study. We'll keep you updated on the progress of that trial.

Erika Eves: Have you been maintaining contact with other possible business partners in case the Jubilee plans do not work out?

Mike Rosol: So our MOU or memo of understanding with Jubilant, grants exclusivity to Jubilant for the RA application of tilmanocept in the U.S., Canada, Mexico and Latin America. And we are certainly abiding by that agreement. We remain active in multiple areas of BP development in ways allowed by these and other binding agreements.

Erika Eves: In the absence of a CEO who is negotiating with Jubilant in the FDA and setting policy?

Mike Rosol: Ongoing negotiations are being handled by senior [indiscernible] and in consult with the Board Oversight Committee. As always, the FDA interactions are handled by the senior leadership of the clinical and regulatory departments.

Erika Eves: Your non-competing agreement with Cardinal Health for lipase experience in November. What impact does that have on your marketing plans for Lymphoseek North America?

Mike Rosol: The initiation of the noncompete clause was at the time of the official closing date, which was March 3, 2017, and extends 5 years beyond that date, meaning it extends to March of 2022. We currently have no plans to develop a new product that accumulates in lymphatic tissue or tumor draining lymph nodes for the purpose of lymphatic mapping or identifying the existence of cancer in the business territory of North America.

Erika Eves: Can you provide an update on the status of potential income from NAV4-694 as well as any plans for a Phase III trial for NAV4-694?

Mike Rosol: The subline for NAV4-694 is held by Malur Technology, who on the basis of that sublicense have specific options related to the pursuit of regional commercialization of NAV4-694. As a beta amyloid imaging agent used as a research tool in Alzheimer's disease, there is particular interest and potential in this now with Biogen's Alzheimer's drug approval. At the current time, the word providing NAV4-694 for use in clinical trials. We will update you with material changes as appropriate.

Erika Eves: How long does the Chairman and the search committee estimate until a new CEO is hired?

Mike Rosol: There's an active process led by members of the Board of Directors. It's difficult to comment on time line, but this is a high priority.

Erika Eves: Will the Chairman relocate to Dublin, Ohio?

Mike Rosol: The Board is based in the senior management of Navidea as well as in the team as a whole. The officers and senior leadership within the company are in very close contact with the Board and are working together with them to ensure progress continues.

Erika Eves: As the company a policy or independent investigators using NAV product allows for that information to be released once the every website in the public -- once in the public domain with the IP owner’s permission, if necessary.

Mike Rosol: We encourage any investigator or a group of investigators to present and publish their findings with any of our products. And a good portion of these do end up on publicly available sites like PubMed. So there they would be available to us to link -- from there, they'd be available to us to late on our site. There are a growing number of such pubs and presentations, which is great news because it demonstrates the value we're bringing to doctors and patients. This is a good idea, and we will think about adding a location on the website to relevant publications or publications of high interest.

Erika Eves: Was there any impropriety expense reimbursements, employee arrestment, not keeping Board informed, et cetera, leveled at debt?

Mike Rosol: I direct your attention to the press release from October 25 for the statement on this matter.

Erika Eves: What is management's plan going forward? Why is the share price still low? Why should investors stay committed to Navidea?

Mike Rosol: The Board of Directors as well as the company management are committed to advancing the pipeline and bringing medicines to patients and value to shareholders. Not only are we focused on advancing the RA product to regulatory submission as well as moving therapeutics and other diagnostics ahead, but the Board and management are actively looking into business development on a number as well as strategies to extend intellectual property protections for existing and new products. The search for a CEO is a priority, and is actively ongoing. From my personal vantage point within the company, I can say that the company has truly committed Board members and a dedicated staff who are working tirelessly to advance the science and deliver our approved and pipeline products to the people who need them. The engagement level of the Board and interaction with the management has never been higher in my time at the company. Overall, you'd have a difficult time finding a harder working group of individuals from the Board to the people here on the ground in Ohio and beyond, and we're working together as a team to grow the company and focus its efforts in the right direction. For what it's worth and again, from my perspective, the feeling here internally is positive and energized. And the right types of strategic thinking are happening in order to position the company for future success.

Mike Rosol: And with that, I'd like to thank those of you who submitted questions for today and all of you who took the time to listen to this call. We will continue to work diligently to progress the science and the company, and we look forward to future updates. Thank you.