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spk01: Greetings. Welcome to the NVIDIA Q3 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A prepared question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Mike Rozal, CMO. You may begin.
spk02: Thank you all for joining us today. This call is being webcast live on our website, ir.navidia.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. NVIDIA's Vice President of Finance and Administration, Erica 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 NVIDIA'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 NVIDIA'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 filing with the SEC. Before I begin the third quarter update, I'd like to provide a brief comment on recent events. Jed Laskin, our former CEO, resigned from his executive positions and as a member of the board on October 24th. On November 8th, 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 Rozal, the company's senior VP and chief medical officer, Erica 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 the newly established Board Oversight Committee consisting of independent directors Alexander Capello, Thomas Farb, and John K. Scott, 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 2 Type B meeting to discuss the results of our completed Phase 2B trial in rheumatoid arthritis and advancement into Phase 3 in RA. We had a constructive meeting with the FDA, have received the formal minutes of that meeting, and have submitted our NAV 333 Phase 3 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. Michelle McHale as our chief regulatory officer. As you might have read in our press release, Dr. McHale has over 30 years of experience in the pharmaceutical industry and has served in senior regulatory roles at BioNTech AG, SmithKline Beecham, now GSK, and Pharmacia Upjohn, now Pfizer, to name a few. Dr. McHale has moved here to Ohio from 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 Lymphaseq in Europe. This quarter also saw the appointments of several board members, Alexander Capello, John Scott, Jr., Thomas Farb, and Agnieszka Winkler. Mr. Capello brings over 30 years of banking and public board experience to the company, And Mr. Scott is the company's largest shareholder. Mr. Farb has over three 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 startup, mid-cap, and Fortune 500 companies. Now I would like to cover the clinical updates. 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 review of the proposed Phase III protocol and analysis plan. The Phase IIb trial, NAV331, and the data from it were critical to moving us forward in RA. As a reminder, this was a three-arm trial. In arms one and two, we evaluated the repeatability, reproducibility, and stability of our Telmanisept imaging readout in both healthy subjects and in patients with active RA. And in the third arm, we mirrored the upcoming phase three study to obtain data to help with sample sizing for the phase three and to have a first look at the ability of Telmanisept imaging to serve as an early predictor of treatment efficacy. As we discussed previously, the data from the completed trial demonstrated that Telmanisept can provide robust quantitative imaging and healthy controls and in patients with active RA that this imaging is reproducible and can divine joints with and without RA-involved inflammation, and that telmanicept imaging can provide an early prediction of treatment efficacy of anti-TNF-alpha therapy. In short, the analysis from the complete set of ARM3 patients demonstrated high accuracy at early prediction of treatment effect with a strong predictive value in particular for non-responders to anti-TNF-alpha therapies, even from the baseline scan alone in a defined subset of patients. In these patients, those exhibiting a low level of temanosept uptake in their joints on their initial baseline scan, who likely represent the so-called fibroid subtype of RA, there was an almost 90% non-response 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 is highly 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 in the rest of the RM3 subjects, the data continue to support our hypotheses. 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 in a medical journal. Following submission of the briefing package containing these results, as well as the NAV333 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 two key opinion leaders in rheumatology, Dr. Jonathan Graff of UCSF and Dr. Constantino Pizzalis of QMAL in the UK, both of whom have been site investigators in our Phase II program, as well as instrumental advisors in our RA program development and trial design. Since this constructive 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 have sent these back to the FDA for comment. In the interim, we are preparing to initiate the Phase III this quarter. As I 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 in automating the imaging quantification as well, which will have significant benefit to the commercial product. We have nearly completed the Healthy Control Study, NAV 335, to establish what is called a normative database for telmaniseptin 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 used the healthy control data from Arm 1 of the completed Phase 2b to start to set these parameters, and we will use this study to add to the size of the current normative 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 normative database, establishing the parameters of what a normal joint looks like with tomanicept, 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 four of the projected total and are on track to complete enrollment in weeks. Our comparison study of telmaniceft imaging to joint biopsy, NAV332, is in active recruitment. In this Phase IIb study, we are comparing telmaniceft imaging to histology from the joints of patients with active RA. We aim to recruit patients with each of the three known subtypes of RA to obtain comparative imaging and pathology results in order to establish the correlation between our imaging signal and the number and density of macrophages in RA patient joints. We have opened up Northwestern University, Barts Health of London, and a third site, a research rheumatology group called Attune Health out in Los Angeles. Recruitment into this study has really picked up, and as of this call, we have nine subjects enrolled and additional candidates in pre-enrollment screening. The trial is designed so that we enroll a minimum of four subjects in each of the three 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 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 its use in trials of new therapeutics. It 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 telmanosept imaging can be used to determine a patient's subtype of RA, and this would have implications for what class of therapies 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 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 tomanacept to sites of atherosclerotic plaque, and have been in line with what was reported in the pilot study we co-published with them previously. Preclinical studies of Gallium-68 telmanisept imaging for our NIH-funded project with the University of Alabama Birmingham are also ongoing. This project evaluated telmanisept and various new imaging agents similar to telmanisept in a mouse model of atherosclerosis. All planned imaging has been completed. Preliminary analyses have shown significant uptake of a gallium-68-telmanisept-like imaging agent in atherosclerotic plaques 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 in Cancer Immunotherapy Symposium back in May and are completing work on the first of several related manuscripts. Further preclinical studies including a dose schedule study looking at different starting points for therapy were also carried out this quarter. In this third quarter, another important set of preclinical imaging studies were completed with our collaborators at UAB. These studies evaluated two 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 the liver, a major site of localization when telmanicept is administered by intravenous injection. These studies were highly successful, showing that we can dramatically increase localization of a new telmanicep-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 NVIDIA's imaging know-how and potentially illuminates a path to a next-generation imaging agent. Perhaps as importantly, 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 doxorubicin payload having progressed to an ongoing evaluation in a mouse tumor model. The dexamethasone carrying construct will also be evaluated, but in a mouse model of inflammation rather than cancer. This construct could 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 Weight and Oscillated Dextrans and Derivatives Thereof was converted to an A1 application on July 9th. This application protects a portion of the new imaging know-how I discussed previously. On August 20th, we filed a provisional patent application entitled Compositions and Methods for the Treatment of Rheumatoid Arthritis, which relates to a multivariate algorithmic method that may improve the predicted accuracy of a rheumatoid arthritis imaging product. Finally, we've received notice of allowance of claims in foreign jurisdictions for an application broadly involving diagnosis and treatment of diseases involving CD206-expressing cells. We have an active IP protection strategy that we believe will provide needed protections and rights to both our current diagnostic and therapeutic agents, as well as to our next generation molecules and disease 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 three, as well as enrollment into the currently open biopsy and normative database studies, 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 Erica for the financial updates.
spk03: 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 nine 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 MANICEP development. Those decreases were offset by receipt of reimbursement from Cardinal Health of certain R&D costs and the partial recovery of debts 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 nine months of 2021 were $3.8 million, compared to $3.7 million in the same period in 2020. The net increase during the year to date was primarily due to net increases in drug project expenses, including increased manuscript, therapeutic, and TC99M to manuscript development costs, offset by decreased manuscript 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 nine 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 TC99M tolmanisept, 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. NVIDIA's net loss attributable to common stockholders for the third quarter of 2021 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 nine 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 the prior year. And finally, NVIDIA ended the third quarter of 2021 with $7.2 million in cash and cash equivalents. I will now turn the call back over to Mike.
spk02: Thank you, Erica. 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.
spk03: All right, first question. It's been a while since NVIDIA had its 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 3?
spk02: 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 3 protocol design and analysis plan and have sent those back to the FDA for comment. In the interim, we are preparing to initiate the phase three.
spk03: Is NVIDIA purposely slow rolling with the FDA since two months seems like a long time since the September 1st meeting when the investing public was told all along they were in lockstep with the FDA?
spk02: 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 timelines of interactions. As a company, we very quickly provided the initial briefing package back in February and then the end of Phase 2 Type B meeting package in July. This small team put together these large document packages on an extremely tight timeline. 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 one step to the next rapidly.
spk03: How many sites have now been contacted, and how many sites have agreed to run the 333RA Phase III trial?
spk02: We've been in touch at one level or another with over 50 U.S. sites that have expressed interest in participating in the NAV333 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 and participation.
spk03: The investor presentation graph shows around 15 months elapsed time for a 333RA Phase III trial. Does that include testing, assessment, and NDA filing time?
spk02: Timeline from the start of trial to finish, as 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 trials and who have demonstrated a good recruitment pace, and we'll work with new sites as well to ensure as rapid a 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 reports and briefing packages in the past, and I expect that to continue for the full filings. We will begin to prepare for the filing as the Phase III program continues.
spk03: Can Dr. Rosell elaborate on how a two-bucket or dual-track RA diagnostic 333 Phase III trial mentioned at the Squire virtual event would work if and when the FDA approves Phase III and how major it is if approved?
spk02: Sure. The NAV333 trial will take all comers in terms of RA 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 these 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 telanosep to serve as an early predictor of treatment response to anti-TNF-alpha therapy. If, as hypothesized, these demonstrate an impact on the efficacy of Tilmanisept to act as an, none of these, sorry, none of these demonstrate an impact on the efficacy of Tilmanisept to act as an early predictor, then 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.
spk03: When can we expect to receive preliminary data on the 332 trial?
spk02: Given the small sample size of the NAV332 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 timeline.
spk03: How many subjects are in testing and have completed testing in the RA-332 Phase IIb synovial biopsy trial, and have they all been in the U.S. or in the U.K. also?
spk02: Today, we have nine 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 two in different stages of the screening process.
spk03: What is your estimated completion date for 335?
spk02: Enrollment and imaging events should end shortly in this study, as there are only a handful of subjects left to enroll. If all goes as planned, we expect complete enrollment by the end of this month.
spk03: 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?
spk02: Sure. Our preclinical oncology efficacy study is ongoing with our Mandox constructs. We're 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. As these advance in the pipeline, safety tox studies are the next step to moving towards an IND and first in human trials. 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 into 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 agent and therapeutics construct research are ongoing with our collaborators at UAB as well, and as I discussed earlier in this call.
spk03: Can you speak to NVIDIA's cash position, 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 fund the company into early 2022? And what are the potential sources of funds for the company that are currently lined up?
spk02: Current cash reserves should take us to at least end of Q1 with initiation of the NAV 333 trial included. The Board of Directors is currently considering available options for future financing including both non-dilutive and dilutive means.
spk03: Is the regulatory approval of LIMFO-AIM now completed in India and is there an interim payment due and if so, how much?
spk02: Things are progressing and we are working with our Indian partner to obtain approval as soon as possible. We are 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 approval. We will keep you informed of the progress.
spk03: What have you done to prepare for the probability that LymphoAIM will be approved in the near future in India?
spk02: We are in the latter stages of validating API manufacture that can be used to supply this and other territory.
spk03: Has the license to sell in Europe been approved as previously indicated? If so, what are the plans, if any, to market Lymphaseq that may differ from Norgene?
spk02: The European Medicines Agency previously approved the transfer of Lymphaseq's marketing authorization from Norgene back to NVIDIA. and we obtained a wholesaler-dealer authorization to sell Lymphaseq 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 Norgene's marketing strategy will be incorporated into a new strategy with our future partners.
spk03: Is the Jubilant RA marketing venture still being actively and earnestly negotiated? Have there been any discussions with Jubilant over the past week regarding the MOU and the relationship in general, i.e., have they reached out to you or you to them to discuss any concerns either party may have, and can you share the general tone of the talks?
spk02: 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 NAV332 study. We'll keep you updated on the progress of that trial.
spk03: Have you been maintaining contact with other possible business partners in case the Jubilant plans do not work out?
spk02: Our MOU, or Memo of Understanding with Jubilant, grants exclusivity to Jubilant for the RA application of Tomanasept in the US, Canada, Mexico, and Latin America. 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.
spk03: In the absence of a CEO, who is negotiating with Jubilant and the FDA and setting policy?
spk02: Ongoing negotiations are being handled by senior management as appropriate 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.
spk03: Your non-compete agreement with Cardinal Health for lymphocyc expires in November. What impact does that have on your marketing plans for lymphocyc in North America?
spk02: The initiation of the non-compete clause was at the time of the official closing date, which was March 3, 2017, and extends five 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 and or identifying the existence of cancer in the business territory of North America.
spk03: Can you provide an update on the status of potential income from NAV 4694, as well as any plans for a Phase III trial for NAV 4694?
spk02: The sublicense for NAV 4694 is held by Malheur Technologies, who on the basis of that sublicense have specific options related to the pursuit of regional commercialization of NAV 4694. 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, Malura is providing NAF4694 for use in clinical trials. We will update you with material changes as appropriate.
spk03: How long does the chairman and the search committee estimate until a new .
spk02: There's an active process led by members of the board of directors. It's difficult to comment on timeline, but this is a high priority.
spk03: Will a chairman relocate to Dublin, Ohio?
spk02: The board has faith in the senior management of NVIDIA 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.
spk03: Has the company a policy where independent investigators using NVIDIA NAVBE product allows for that information to be released once the NAVBE website in the public, once in the public domain with the IP owner's permission if necessary.
spk02: We encourage any investigator or 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. From there they would be available to us to link 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.
spk03: Was there any impropriety, expense reimbursements, employee harassment, not keeping board informed, et cetera, leveled at JET?
spk02: I direct your attention to the press release from October 26 for the statement on this matter.
spk03: What is management's plan going forward? Why is the share price so low? Why should investors stay committed to NVIDIA?
spk02: 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 of fronts, 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. 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.
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