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Executives

Julie Rathbun

Julie M. Eastland - Chief Financial Officer, Principal Accounting Officer, Secretary and Member of New Employee Option Committee

Robert L. Kirkman - Chief Executive Officer, President, Director and Member of New Employee Option Committee

Analysts

Simos Simeonidis - Cowen and Company, LLC, Research Division

Charles C. Duncan - JMP Securities LLC, Research Division

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

Oncothyreon Inc (ONTY) Q2 2012 Earnings Call August 9, 2012 4:30 PM ET

Operator

Good day, ladies and gentlemen, and welcome to your Oncothyreon Second Quarter 2012 Financial Results Conference Call. [Operator Instructions] As a reminder, this program is being recorded. I would now like to introduce your host for today's program, Ms. Julie Rathbun, Investor Relations. Please go ahead, ma'am.

Julie Rathbun

Good afternoon, and welcome to Oncothyreon's financial results conference call for the second quarter of 2012.

With us this afternoon are Dr. Robert Kirkman, Oncothyreon's President and CEO; and Julie Eastland, Oncothyreon's Chief Financial Officer and Vice President, Corporate Development.

In the first part of the call, Ms. Eastland will review Oncothyreon's financial results for the second quarter of 2012. She will also discuss planned amendments to the company's previously filed annual report on Form 10-K for the year ended December 31, 2011, and quarterly report for the period ended March 31, 2012 to correct clarifications of fully diluted earnings per share for certain periods. After that, Dr. Kirkman will provide a brief update and pipeline review and discuss upcoming milestones. We will then open the call to questions.

Before I turn the call over to Ms. Eastland, let me first remind you that during this call, we will be making a number of forward-looking statements. These forward-looking statements include Oncothyreon's expectations regarding the use and adequacy of cash resources, future expenses, the clinical development of Stimuvax, the commercial outlook for Stimuvax, and clinical development activities for PX-866, ONT-10 and ONT-701. Forward-looking statements involve risks and uncertainties related to Oncothyreon's business and the general economic environment, many beyond the company's control. These risks, uncertainties and other factors could cause Oncothyreon's actual results to differ materially from those projected in forward-looking statements.

For a detailed description of these risks and uncertainties, you are encouraged to review our annual report on Form 10-K filed with the SEC and other official corporate documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR.

I would now like to introduce Julie Eastland, Oncothyreon's Chief Financial Officer and Vice President, Corporate Development. Julie?

Julie M. Eastland

Thank you, Julie, and good afternoon. As reported in our press release today, our loss from operations increased to $8.1 million in the second quarter of 2012 compared with $5.8 million in the second quarter of 2011, and to $13.8 million for the 6 months ended June 30, 2012 compared to $11.7 million for the comparable period in 2011. This increase in loss from operations for the 3 and 6 months ended June 30, 2012, compared to prior-year periods was primarily the result of increased research and development expenses due to increased development activity for Oncothyreon's product candidates, particularly PX-866 and ONT-10. The net loss for the 3 months ended June 30, 2012, was $8.7 million or a $0.15 loss per basic and diluted share compared with a net loss of $34 million or a $0.91 loss per basic and diluted share for the comparable period in 2011.

Oncothyreon reported a net income of $1 million or $0.02 per basic, and a $0.28 loss per diluted share for the 6 months ended June 30, 2012, compared with a net loss of $41.4 million or $1.22 loss per basic and diluted share for the comparable period in 2011. The decrease in net loss for the 3 months ended June 30, 2012, compared to the prior-year period, was primarily attributable to the noncash expense as a result of the change in the fair value of warrant liability in the prior year, and offset by increases in research and development and general and administrative expenses. The increase in net income for the 6 months ended June 30, 2012 compared to the prior-year period net loss was primarily attributable to noncash income of $15.3 million as a result of the change in the fair value of the warrant liability, and again, partially offset by increases in research and development expenses and decreases in general and administrative expenses.

As we have discussed in our previous calls, our net income or loss is subject to significant variability as a result of these changes in warrant liability. This arises because some of our outstanding warrants have provisions that, under certain circumstances, could potentially require us to settle the warrants with cash. These settlement provisions require us to carry these warrants as a liability on our balance sheet. Changes in the value of this liability arising primarily from changes in the price of our common stock flow through the income statement, causing these fluctuations. Because this change is all noncash, we think it makes more sense for our investors to focus on our operating results, which I discussed at the start of my talk.

I should also call your attention to the calculation for basic and diluted earnings per share for the 6-month period. You will note that we reported a $0.02 income per basic share, while a loss of $0.28 per diluted share. This is the result of accounting guidance that requires us to subtract the gain from the change in warrant liability from the numerator of the diluted earnings per share calculation. The company was not aware of this guidance until preparing our financial statements for this quarter. Since becoming aware of this guidance, Oncothyreon has discussed this application with both our auditors and the SEC accounting staff. As a result of these discussions, we also announced today in a filing on Form 8-K that we will restate our 2011 10-K and our first quarter 2012 10-Q to correct errors in the calculation of fully diluted earnings per share for certain periods.

In light of the errors, the audit committee of the company's Board of Directors on August 6, 2012, following consultation with and upon the recommendation of management, has determined that the affected financial statements should no longer be relied upon. We expect to file the amended reports shortly, and in the meantime, you can find the details in today's 8-K.

I want to stress that other than the disclosures related to the calculation of the fully diluted earnings per share, no other changes are required to our financial statements. Every other line in our financial statements remain the same, including, most importantly, our expenses, our use of cash and our cash position. These changes in diluted earnings per share relate entirely on noncash items and have no impact on our actual operation.

Turning to our current cash position, as of June 30, 2012, Oncothyreon's cash, cash equivalents and investments were $97.9 million compared to $66.4 million at December 31, 2011. The $31.5 million increase was attributable to the closing of an April underwritten public offering of 13,512,500 shares of Oncothyreon common stock, which generated net proceeds of approximately $50.3 million. This increase was offset in part by $13.2 million cash used in operations, $4.1 million cash used in repayment in full of our term loan with General Electric Capital Corporation, and $0.9 million cash used for principal payments on notes payable, and $700,000 -- million cash used in capital expenditures during the 6 months ending June 30, 2012.

Before I turn the call over to Bob, I'd like to provide financial guidance for 2012, which remains unchanged from what we provided in both our 2011 year-end and our Q1 2012 conference calls. Please note that we believe this guidance to be correct as of today, but that circumstances may change and we assume no obligation to update the guidance.

Expenses in 2012 are expected to be higher when compared to 2011, primarily as a result of the more advanced clinical development of PX-866 and the ongoing Phase I clinical trial of ONT-10. Oncothyreon currently expects cash used in operation in 2012 to be between approximately $30 million and $33 million. This guidance excludes the $4.1 million cash used to repay in full the General Electric Capital Corp term loan, which was repaid on June 30, 2012. As a result, Oncothyreon estimates that its existing cash, cash equivalents and investments will be sufficient to fund the operations for at least the next 12 months.

Let me now turn the presentation over to Oncothyreon's President and CEO, Bob Kirkman, to provide an update on Oncothyreon's pipeline. Bob?

Robert L. Kirkman

Thanks a lot, Julie. I appreciate this opportunity to provide you with the corporate update, and I want to start my remarks by focusing on upcoming data events for our pipeline of products in development, which we believe are at the center of the investment opportunity at Oncothyreon.

Over the course of the next 6 to 9 months, we expect to have both Phase III data for Stimuvax and Phase II data from PX-866. It's very exciting for us to be in this position after all the hard work which has gone into these development programs, and we look forward to sharing these events with you.

We know that many of you are focused on the final outcome for the Stimuvax START trial. As a reminder, Stimuvax is our investigational therapeutic cancer vaccine targeting MUC1 that is being evaluated in 2 Phase III trials in patients with non-small cell lung cancer. These trials are being conducted by our partner, Merck Serono. The most advanced, the START trial, is a randomized placebo-controlled trial that has enrolled just over 1,500 patients. At this point, we are waiting for the data in the START trial to mature. Merck Serono has stated that they expect the event, which will trigger the final analysis, to occur later this year with the primary efficacy analysis available in the first quarter of next year. Since the final analysis is event-driven, the exact timing cannot be predicted with absolute certainty, but Merck Serono has been consistent in this guidance.

As we await results from the START trial, we remain focused on the advancement of our wholly-owned product candidates. Of these, I want to focus your attention today on PX-866, our small molecule PI-3 kinase inhibitor, for which much happened in the second quarter that we expect to lead to data events late this year or early next.

During the second quarter of this year, we reported updated results from 2 trials of PX-866 at the American Society of Clinical Oncology meeting, and we also initiated our fifth Phase II clinical trial. We've also made good progress enrolling our other ongoing Phase II trials, so here's the update.

Results presented at ASCO included data from the Phase I portion of the ongoing Phase I/II trial of PX-866 in combination with docetaxel. This trial enrolled 43 patients with advanced cancer for whom docetaxel is considered the standard of care. Patients were treated at 3 different dose levels of PX-866 administered daily in combination with standard dose docetaxel administered once every 3 weeks. No dose-limiting toxicities were identified and the recommended Phase II daily dose of PX-866 in combination with docetaxel is the same as, as a single agent, 8 milligrams a day.

The combination of PX-866 and docetaxel was generally well-tolerated, with most adverse events being mild to moderate in severity. 33 patients were evaluable for response, and among these patients, the disease control rate was 85% after 2 cycles of therapy and 58% after 4 cycles. 10 patients were on study for more than 200 days, 5 of whom remained on therapy at the time of the ASCO report. 9 patients with stable disease or better discontinued the docetaxel after 4 more cycles and continued on single-agent PX-866, including all 5 remaining on therapy.

This trial advanced to the Phase II portion, which is an open-label randomized evaluation of the antitumor activity and safety of PX-866 in combination with docetaxel versus docetaxel alone in 2 groups of patients. Group 1 is enrolling patients with non-small cell lung cancer receiving second or third-line treatment, and Group 2 is enrolling patients with locally advanced recurrent or metastatic squamous cell carcinoma in the head and neck after failure of prior therapy. And these groups will be randomized and evaluated separately.

Enrollment of a planned 88 patients in the non-small cell lung cancer group has now been completed and we're waiting for the data to mature. The primary endpoint in this trial is progression-free survival. So we can't predict with certainty when the trial will end, but we would expect sometime in the first quarter of next year. With respect to the head and neck arm of the trial, additional centers are being added with a goal to complete enrollment of 82 patients in the first half of next year.

Also reported at ASCO were interim data from an open-label, single-arm Phase II trial of PX-866 in patients with glioblastoma multiforme, a type of brain cancer. This Phase II trial is being conducted by the National Cancer Institute of Canada Clinical Trials Group in Kingston, Canada in patients whose brain tumor is in first relapse during or following primary therapy. This trial has a 2-stage design, with enrollment in the second stage of the trial dependent upon a prespecified endpoint of response or lack of early progression in the first stage.

The results we presented at ASCO were in 17 patients who were enrolled in the first stage of the trial. PX-866 was well-tolerated with the most common adverse events being diarrhea and reversible liver enzyme elevation. All patients were evaluable for response, with one patient having a partial response and 6 patients with stable disease, 3 of whom remained on therapy at the time of the report. These efficacy data met the prespecified endpoint, and the trial has now completed the planned enrollment of patients in the second stage.

In addition to the trial in patients with glioblastoma, the NCIC Clinical Trials Group is also conducting a Phase II trial in up to 40 patients with metastatic or recurrent castration-resistant prostate cancer who have not received primary chemotherapy. The primary endpoint of this single-arm screened trial is the proportion of patients with lack of disease progression at 12 weeks from the initiation of therapy with PX-866.

This trial has a similar 2-stage design to the glioblastoma trial, with progression to the second stage dependent upon achieving a prespecified endpoint of lack of early progression. This trial has also met its prespecified endpoint at the interim analysis, and enrollment in the second stage of that trial is now approximately 50% complete.

We've also advanced to the Phase II portion of a Phase I trial of PX-866 in combination with cetuximab. This is an open-label randomized evaluation of the antitumor activity and safety of 866 administered in combination with cetuximab versus cetuximab alone in 2 groups of patients. Group 1 is enrolling patients with metastatic colorectal cancer who have a history of progression or recurrence following prior treatment with irinotecan and oxaliplatin-containing regiments or who are intolerant of irinotecan. Just over 70 of a planned 80 patients are currently enrolled in this arm of the trial, with enrollment currently expected to be completed in the fourth quarter of this year. Group 2 is currently enrolling patients with incurable progressive, recurrent or metastatic squamous cell carcinoma of the head and neck. Again, the 2 groups will be randomized and evaluated independently, with the primary endpoint of overall survival.

At the end of May, we announced the initiation of our fifth clinical trial of 866, a Phase I/II trial of PX-866 in combination with vemurafenib. The Phase I portion of this trial will evaluate the safety and tolerability of PX-866 in combination with twice-daily oral administration of vemurafenib in up to 36 patients with any form of BRAF-mutant cancer. When that's complete, the Phase II portion of the trial will look at the antitumor activity and the safety of PX-866 and vemurafenib at the doses we obtained from the first phase versus vemurafenib alone. This randomized Phase II trial is expected to enroll 110 patients with advanced BRAF-mutant melanoma and has a primary endpoint of progression-free survival. This trial is being conducted in collaboration with the Melanoma Research Foundation Breakthrough Consortium.

In short, it's been a great quarter for PX-866. We presented encouraging early data at ASCO, enrollment was completed in the Phase II trials in lung cancer and glioblastoma, the prostate trial met its prespecified interim efficacy endpoint and is proceeding with enrollment in the second phase, the colorectal combination trial with cetuximab is nearing full enrollment and we started an exciting new trial in combination with vemurafenib. We believe all of these achievements position us for exciting near-term data events for PX-866.

Let me conclude the pipeline review with a brief update on ONT-10, our follow-on MUC1 vaccine. ONT-10 is currently being evaluated in a Phase I trial designed to assess the safety and immunogenicity of ONT-10 in patients with cancers that commonly express MUC1, including breast, non-small cell lung, ovarian, colorectal, prostate, pancreas, gastric and other cancers. We are currently actively enrolling patients in the dose escalation portion of this trial, which will eventually include up to 48 patients to determine the maximally tolerated or recommended dose of ONT-10 given either once a week or every other week for a total of 8 weeks. Following completion of this, we will begin the second part of this study to investigate the safety of ONT-10 at the maximally tolerated or recommended dose in up to 15 additional patients at the weekly and/or the biweekly schedule. And the ability of ONT-10 to induce both a humoral and a cellular immunoresponse will also be investigated in both parts of the study.

Let me turn now to financial matters. Early in the second quarter, we completed a successful financing with net proceeds to the company of approximately $50 million. As Julie noted earlier, our cash, cash equivalents and investments approximated $98 million at the end of the second quarter. This puts us in a very solid financial position as we approach the data points for both Stimuvax and PX-866. It also allowed us to pay off our GE loan early, saving us some interest and leaving us with no long-term debt. With the financial guidance that we have given for our expenditures, we currently expect to finish the year with just over $80 million.

Let me also briefly address the accounting issues raised earlier. As Julie noted, and which is discussed in more detail in our 8-K filing today, we will be amending our 2011 10-K and first quarter 2012 10-Q to correct errors in the calculation of fully diluted earnings per share. I want to emphasize that Oncothyreon is committed to getting its accounting correct. The erroneous calculations are related to a fairly arcane piece of accounting guidance related to the noncash gain or loss in the value of our warrant liability and how that is factored into the diluted earnings per share calculation. We, and others we work with in connection with the preparation of our financial statements, got it wrong initially, so we're going to fix it. I do want to emphasize that these restatements will have no impact on our operations or on those things we think really matter to our investors. What matters is progress with our products and how we use our resources to advance those products. And that hasn't changed.

The progress at our company is a reflection of our dedicated staff who are diligently focused on advancing our programs and building value.

During the past quarter, we announced the promotion of Scott Peterson to Chief Scientific Officer. Scott's been instrumental in advancing the scientific and preclinical support for PX-866 and ONT-10, and leading our efforts to expand our pipeline, including the preclinical development of our Bcl-2 inhibitor, ONT-701.

In July, we also announced the appointment of Guy Cipriani as Vice President, Business Development. Guy brings more than 12 years of business development experience in the biotechnology and pharmaceutical sectors to our company, and we are pleased to have him join the Oncothyreon team. Guy will be involved in our efforts to maximize opportunities for our wholly-owned product candidates and also in the building of our product development pipeline.

Thank you for your time today, and I will now be happy to take any questions you may have. Operator, we're open for questions.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from the line of Simos Simeonidis from Cowen and Co.

Simos Simeonidis - Cowen and Company, LLC, Research Division

Can I just briefly ask about the restatement just to make sure I understand this correctly? So this has basically to do with how you and your auditors or the people that help you prepare your financial statements stated or treated the potential liability that would arise from the treatment of these 5 million or 6 million -- or warrants to -- that would become 5 or 6 million of shares, and it's an item that doesn't affect your operational expenses, net income or cash. Is that correct?

Robert L. Kirkman

That's all right, Simos. The -- it's really all related to a noncash item. We have to mark these warrants to market, as we said, and that has to flow through our income statement. We got all that part of it right. What we didn't get right was that if there's a gain, you're supposed to subtract it from the numerator in the calculation of diluted earnings per share. I wish this company were in a point where earnings per share actually mattered. We're looking forward to being at that stage, but as you well know, we don't yet have earnings. We're looking forward to that day. And so, we think this is really a nonevent. It's unfortunate we had to restate that, the 2 documents, but I think in the long run, what matters is that in the next 6 to 9 months, we're going to get data for Stimuvax and we're going to get data for PX-866, and that's what our investors should be focused on.

Simos Simeonidis - Cowen and Company, LLC, Research Division

If you had gotten to the point where you're Celgene or Amgen, that would've been a major issue. But I think people don't really expect you to be making money yet, so let's talk about the -- can you tell us about the -- when we can expect to see data from 866? Do you -- is there any near-term conference in the fall where we may see any of the data?

Robert L. Kirkman

Well, as I indicated, we've now completed enrollment in the lung cancer trial. We've completed enrollment in the glioblastoma trial. We're almost complete in the colorectal trial. I can't -- we don't have presentations scheduled at this point in time. The data has to mature in these trials. But I would think that the first quarter of next year is probably a reasonable time to be expecting it. And I can't tell you exactly where yet, but that's what I would be looking towards.

Simos Simeonidis - Cowen and Company, LLC, Research Division

And you think this may be presentations on meetings versus press releases?

Robert L. Kirkman

I don't know yet.

Simos Simeonidis - Cowen and Company, LLC, Research Division

Okay. And then finally, the -- on Stimuvax, you said you guys are predicting or Merck is predicting that the trial will be complete at the end of this year, with data presented -- announced first quarter or early next year. Any chance that we could see the data at the end of this year or no?

Robert L. Kirkman

Well, again, the trial ends when a certain event occurs, which is a predefined number of, unfortunately, deaths which occur in the trial. And we can't predict with precision when that's going to occur, and we're, of course, totally dependent upon the guidance that we get from our partner as to when that's likely. They've been pretty consistent that they think the event will happen sometime in the latter part of this year, and that the top line results from the trial will be in the first quarter of next year. I cannot really give you any guidance about exactly how they're going to present that because they haven't told me yet either what they're going to do.

Operator

Our next question comes from the line of Charles Duncan from JMP Securities.

Charles C. Duncan - JMP Securities LLC, Research Division

My first question's on 866, and I apologize if this was addressed. I've been hopping back and forth between calls. I'm wondering if you can provide some sense of the venue and/or timing for a data release out of that program?

Robert L. Kirkman

Again, as for the timing, we think that the first quarter of next year is most likely. The lung cancer trial, again, is fully enrolled, the colon trial is almost and the glioblastoma trial is. We just have to see how the data mature. We don't yet have a venue for the presentation of those data. But I do think it's reasonable to expect that sometime in the first quarter of next year, we'll have a pretty good idea what the outcome of these trials is going to be.

Charles C. Duncan - JMP Securities LLC, Research Division

And, Bob, the GBM study, that was in naïve patients or recurrent patients?

Robert L. Kirkman

The GBM study was conducted in patients with first -- with a first progression after their primary therapy. So most of these patients will have had their surgery, radiation then probably temozolomide. And then upon progression at that point, they're entered into this study and they get single-agent 866 at that point in time. And again, what we saw in the data we presented at ASCO was one patient with tumor shrinkage and 6 patients with prolonged stable disease. Several of whom were still on therapy at the time we made the report. And that trial's now fully enrolled. So they went on and added another group of patients to that trial.

Charles C. Duncan - JMP Securities LLC, Research Division

Okay. And with regard to Stimuvax, I know -- I mean, I know you folks aren't really involved in conducting that, but I'm wondering if you can provide any incremental update on INSPIRE? You probably are asked mostly about START, but I was wondering about the INSPIRE?

Robert L. Kirkman

INSPIRE is the trial, as you know, that's being -- it looks like START. It's a little bit smaller, it's being conducted entirely in Asia. That trial is still actively enrolling patients. It's by no means fully enrolled at this point, so it's unlikely we'll have the data from that trial for some time yet. It is Merck's intention, should the data from the START trial prove positive, to file on the basis of the START trial alone. The trial was powered all along with that in mind as being a single trial for filing.

Charles C. Duncan - JMP Securities LLC, Research Division

And then with regard to START, let me ask you if you have periodic updates with them and when were you last -- or is that similar to the kind of timelines that we all hear from Merck KGaA?

Robert L. Kirkman

Well, I mean, they're -- contractually, they provide us with formal reports every quarter, but I have much more frequent informal contact and have no reason to think that what they said publicly is -- I mean, that's what I think is going on. So it's the expectation is that the data -- or the trigger event will be later this year and the data in the first or the top line results in the first quarter of next year.

Charles C. Duncan - JMP Securities LLC, Research Division

And then last question on intellectual property. I know we've talked about this some before, but wondering if you could review the primary IP on Stimuvax versus the primary IP on ONT-10.

Robert L. Kirkman

Well, that -- in terms of -- in both cases, there are composition of matter, manufacturing and method of use patents. In the case of Stimuvax, some of those go to the mid-2020s and some of them to the late 2020s. In the case of ONT-10, some of the patents overlap, but some of the patents that we're working on with respect to ONT-10 would go quite a few years beyond that. So not all of that -- a lot of that is still in prosecution.

Charles C. Duncan - JMP Securities LLC, Research Division

And Merck KGaA currently has no call on ONT-10, correct?

Robert L. Kirkman

They have a right of first negotiation, but that's all.

Operator

Our next question comes from the line of Joel Sendek from Stifel, Nicolaus.

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

So I guess on 866, Bob, you have these 5 studies. And I wonder if you could help us with what you find most compelling so far and/or where you should -- where you want to guide us to really focus. I mean it's a lot of different indications and we've gotten some great signals at ASCO. So what's your gut feel as to which one might be the one that we should spend the most time on, if you can help us with that at all?

Robert L. Kirkman

I guess I would say that I think gut feel is not a good way to develop products. And that's why we, in fact, have such a broad Phase II development program for this product. It's -- people have heard me say before, and I've been saying it for quite a while now, that one of the things that small companies don't sometimes do while it's run Phase II programs for their product, they don't run enough trials to adequately determine things like dose and best indications for late-stage development. And we're trying very hard to do as much as we can to pick that. So we're going to be guided by data when it comes to what will be the next development program for this. I mean, we'll have randomized data in 4 different indications next year sometime and development of those, obviously, going to take a little longer. I also think we've gotten a good signal with the glio trial. But I think I would probably look to one of the randomized indications as the place we will have the strongest evidence to justify the next stage of development. And I can't right now tell you which of the 4 it will be.

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

Okay. And then with regard to the next step, once you get that randomized data, are you going to wait and get all the data in-house and then pick an indication, all else being equal, with Stimuvax? Or will you, if the first data comes out really positive, will you move that expeditiously into a Phase III program?

Robert L. Kirkman

We will go as expeditiously as the data allow us to go. These trials are open-label, so I think we'll have a pretty good idea pretty quickly once the data has been able to mature a little more. Nothing makes a drug worth more than developing it more quickly. The best thing you can do for the net present value of a drug is cut time off its development pathway. So we will be aggressive about moving forward as soon as we have solid reasons to do so. And fortunately, we are financially equipped to do that.

Joel D. Sendek - Stifel, Nicolaus & Co., Inc., Research Division

Okay. And I know there are a couple of questions before on timing. I think a lot of people are focused on that. But I think is it fair to say it's unlikely we'll have any data, either at a medical conference or via press release, on 866 until the first quarter of next year?

Robert L. Kirkman

I think that's likely, yes.

Operator

Thank you. This does conclude the question-and-answer session of today's program. I'd like to turn the program back to Mr. Kirkman for any further remarks.

Robert L. Kirkman

I appreciate everybody's time today. We look forward to a fairly busy conference schedule, investor conference schedule over the course of the next few months, I hope I'll have the chance to talk to many of you again. And we are very excited about the upcoming data points that we have. We've worked long and hard over the last several years to get to this point with both our vaccines and our small molecules, and we're excited to be able to share data with you later this year. Thanks very much.

Operator

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.

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