IMV Inc (IMV) 2020 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the IMV, Inc. announces first quarter 2020 financial results and provides corporate and clinical update conference call. (Operator Instructions) I would like to now hand the conference over to your speaker today, Pierre Labbé, Chief Financial Officer. Thank you. Please go ahead, sir.

Thank you, Joanne. Good morning, ladies and gentlemen. My name is Pierre Labbé, I'm CFO at IMV. I'm pleased to welcome you to our clinical and operational update and first quarter financial results conference call. I'm joined today by Fred Ors, our CEO; by Joanne Schindler, IMV's Chief Medical Officer; and also by Marianne Stanford, our VP, R&D. Fred will begin with an overview of the company's operational highlights; then Joanne will provide the clinical update on our ongoing oncology program; and she will be followed by Marianne, who will provide an update with respect to the development of our DPX-COVID-19 vaccine candidate; and finally, I will present the financial highlights of the quarter.

But before we begin, I would like to remind you that except for historical information, this audio presentation contains forward-looking statement, which reflects IMV's current expectations about future events. These forward-looking statements involve known and unknown risks and uncertainties that could cause IMV's actual results to differ materially from those statements. These risks and uncertainties include, but are not limited to our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approval and other risks detailed from time to time in our ongoing quarterly filings and our annual information form.

The forward-looking statements made on this call are based on several assumptions which may prove incorrect, and they represent views only as of the date of this call and are presented for the purpose of assisting potential investors in understanding IMV's business and may not be appropriate for other purposes. IMV does not undertake to update forward-looking statements, whether written or oral, that may be made from time to time by, or on its behalf, except as required under applicable securities legislation. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV's continuous disclosure documents, including in its current annual information form as well as its audited annual consolidated financial statements, which are available on SEDAR and on EDGAR.

The press release, the MD&A and the financial statements are all posted on our website. If you wish to receive a copy of either of these documents, please do not hesitate to contact us.

Finally, take note that we will take questions only from sell-side analysts at the end. I will now turn the call over to Fred. Fred?

Thank you, Pierre, and good morning, everyone. I hope you and your loved ones are healthy and safe. And I would like to start with a few comments about the COVID-19 situation and its impact on our work.

In response to the pandemic, we have been continuously monitoring the situation and adapting our business operations with one thing in mind: prioritizing the health and well-being of our employees, patients, clinical investigators and personnel and, this, in close collaboration with health authorities. We have successfully transitioned to a remote working arrangement to protect our employees and the broader community while maintaining our business continuity.

The effect of the pandemic are slowing the pace of clinical development across our industry due to the absolutely necessary diversion of health care resources to COVID-19. But at IMV, we remain more committed than ever toward our long-term goal of developing a cell therapy with a focus on patient safety and data integrity. We are proud to continue to deliver this new trial of T cell therapy with a potential to offer a better value proposition for patients with high unmet medical needs. Our clinical development strategy is centered on a simple goal, that is to demonstrate the potential of this T cell therapy to significantly improve the duration of a quality of life. That is why we are very happy this morning to report a significant step toward achieving this goal with patients with recurrent/refractory diffuse large B-cell lymphoma, Joanne will give you some more details later in the presentation.

As a company, we're also fortunate to be developing a platform with multiple applications in cancer and vaccines against infectious diseases. And we feel really privileged and humbled at the same time with the opportunity to contribute our technology and our past clinical successes into the fight against the COVID-19 pandemic. We have been making great and rapid progress with our vaccine candidate for COVID-19. We are on scale to complete preclinical studies very soon and are getting ready to initiate a Phase I clinical study early in the summer.

We are also very happy about our recently completed financing, expanding our cash run rate to the end of 2021. It was not only a great vote of confidence from our existing shareholders FTQ, Ruffer and CTI Life Science, but also an opportunity to bring in new friends supporting our vision and science. I'm a strong believer in the old saying that you never have enough friends. So to Lumira and Altium, I want to say welcome, and thank you for your support.

I will now turn the conference over to Joanne, who will provide a clinical update on our oncology program. Joanne?

Thank you, Fred, and welcome to everyone. I'll first start with a review and update of our Phase II SPiReL study in recurrent/refractory diffuse large B-cell lymphoma, which as a reminder is an investigator-initiated study led by Dr. Neil Berinstein, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto. The clinical trial design provides for an enrollment target of up to 25 evaluable patients who have received more than 1 prior treatment regimen. The primary endpoint of the study is to document a minimal objective response rate of 24% to treatment with DPX-Survivac, an intermittent low-dose cyclophosphamide administered with pembrolizumab in patients with recurrent survivin-expressing DLBCL. As of May 7, enrollment is ongoing with a total of 20 patients accrued at 5 different clinical sites in Canada.

The next slide provides an update to the poster presented at the American Society of Hematology Annual Meeting last December. At that time, we had observed a 56% response rate based on 5 clinical responses in the first 9 evaluable patients. Since December, we now have 11 evaluable patients and 2 additional reports of clinical response. This is a total of 7 clinical responses with an objective response rate of 64%. So we're very happy to report that the study has met its primary endpoint of achieving a minimum of 6 responses in the planned 25 evaluable patients.

As Fred previously mentioned, we believe these results continue to provide sufficient support for accelerating the development of DPX-Survivac in DLBCL. To illustrate this point, we've documented on Slide 5 a few of the other clinical trials evaluating pembrolizumab as a combination in this population.

As you can see on this slide, objective response rates in combination with pembrolizumab has been on around 20% to 25%, although AUTO3, an investigational CAR-T therapy in combination with pembrolizumab shows a similar ORR with responses in 7 of 11 patients.

This being said, generally speaking, as we've mentioned in the past, we consider our approach as not directly comparable to CAR-Ts, given, amongst other factors, the bridging chemotherapy often required before lymphodepletion, the serious potential adverse reactions, the required hospitalization, higher cost and longer manufacturing time.

Moving on to Slide 6. I'll now provide a quick update on our other ongoing studies in oncology, starting with the Phase II DeCidE study in advanced recurrent ovarian cancer. This study evaluates the safety and effectiveness of DPX-Survivac with intermittent low-dose cyclophosphamide.

In late February, IMV provided interim data from this study, reported on disease control, duration of response and tolerability. In 19 evaluable patients, we reported a 79% disease control rate with 7 of 9 patients or 37% achieving clinical benefit with partial response or stable disease lasting longer than 6 months. The treatment was well tolerated with the majority of adverse events being grade 1-2 injection site reaction.

At the time of the data cutoff, 6 or 31% of those patients remained on therapy, and 5 of these patients were still on treatment at greater than 6 months. Since then, an abstract has been selected for a poster presentation at the upcoming ASCO conference. The abstract was posted online on Wednesday evening on the ASCO20 Virtual website. The poster presentation will be made by Dr. Oliver Dorigo, Associate Professor of Obstetrics and Gynecology, Oncology at the Stanford University Medical Center. It will provide translational data and an update on clinical responses for those patients that were still on trial in February. The translational data will include survivin-specific T cell analysis in blood and tumors. This data will be made available with the virtual ASCO meeting taking place May 29 through 31.

Now I'd like to discuss the ongoing Phase II basket trial in advanced metastatic solid tumors. The basket trial is an open-label multi-center Phase II study evaluating the safety and efficacy of DPX-Survivac, intermittent low-dose cyclophosphamide in combination with pembrolizumab across 5 cohorts of patients with bladder, liver, ovarian and nonsmall cell lung cancer as well as tumors shown to be positive for the microsatellite instability high biomarker. As of May 7, a total of 92 out of the planned 184 patients were enrolled across all 5 indications at 19 clinical sites in Canada and the U.S. Unfortunately, due to the COVID-19 pandemic, we've seen an impact on data collection and validation processes. However, based on our current assessment of the situation, we anticipate reporting updated results from this study in the second half of 2020.

I thank you for your attention. I'll now turn the conference over to Marianne Stanford, our VP, Research & Development, who will provide an update with respect to the development of a vaccine candidate against COVID-19. Marianne?

Thank you, Joanne. Good morning, everyone. I'd like to give a brief update on IMV's programs to advance the COVID-19 vaccine based on the DPX platform.

I will start on Slide #7.

In March, we announced our intention to develop a COVID-19 vaccine, leveraging our previous work on a DPX-based vaccine for RSV. In the time since then, our research team has identified and tested our selected peptide epitope candidates, and we are currently on track to complete these studies this month. We have had preliminary discussions on our plans with Health Canada, and based on their feedback, we are finalizing the Phase I study design. We have also submitted grants to all relevant authorities to assist in the funding of this program.

On the next slide, on Slide 8, we overview our approach. We are using B-cell peptide epitopes targeting the spike protein, which the SARS-CoV-2 coronavirus uses to enter cells. The spike has 2 main functional areas, known as S1 and S2. The S1 portion contains the receptor binding domain and is involved in attachment to the host cell, while S2 primarily mediate fusion and entry into cells.

Our epitopes have been designed to target several of these key areas in a nonoverlapping fashion. Antibodies to these targets should efficiently inhibit virus entry into cells, and by targeting several areas at once, we lessen the potential for immune escape, even in the case of a mutation.

On the next slide, on Slide 9, we illustrate our progress to date. We have completed our preliminary selection of epitopes and the animal studies that facilitate the prioritization of peptides is ongoing. The final targets will be selected based on both their ability to generate strong immune responses as well as neutralize the virus when formulated in DPX. This candidate will then be formulated at a GMP quality for entry into a Phase I clinical study this summer.

This concludes my presentation, and I will now turn the conference over to Pierre Labbé, CFO of IMV, to discuss the quarter's financial highlights.

Thank you, Marianne. I will start by reminding you that all the numbers I will be discussing are in Canadian dollars.

On May 7, we completed a non-brokered private placement of $25.1 million. So if we added to our cash balance of $7.4 million at the end of the first quarter on a pro forma basis, it represents $32.5 million of cash. And we also have access to $2.5 million of receivables coming from investment tax credit and trade receivable for a total of approximately $35 million of existing and potential sources of cash on a pro forma basis as at March 31, 2020. And this amount does not include the $1.8 million coming from the use of the ATM since April 1, 2020.

The ATM or at-the-market offering was put in place during the first quarter of 2020. We decided to implement it because an ATM program creates further optionality in satisfying capital raising goals. We can decide to use it at our convenience, and it gives us more flexibility. And the money is always raised at market price. ATMs have become an increasingly popular vehicle in the capital markets in recent years. And in 2019, only 185 health care ATMs were filed. So with the completion of our $25.1 million private placement last week, we extended our cash runway well into 2021 and are well funded with many milestones in front of us.

For the first quarter of 2020, we incurred a net and comprehensive loss of $9.7 million or $0.19 per share for the quarter. It was $3.7 million higher than the net loss of the comparative period in 2019. This is mainly explained by the R&D expenses increase of $2.8 million for the quarter compared to 2019. These increases are mainly due to a spike in enrollment prior to the onset of the pandemic related to the ongoing basket trial and also the opening of new sites and nonrecurring purchases of $1.3 million of GMP-grade raw materials and contract manufacturing for DPX-Survivac. With this purchase, IMV's GMP-grade materials cover all the needs of the corporation for ongoing DPX-Survivac trial until mid-2021. The increase in R&D expenses is also related to, a lesser extent, to preclinical development of DPX-SurMAGE for bladder cancer and personnel costs due to an increase in income in 2019.

G&A expenses increased by $1.1 million for the quarter, and this increase is mainly due to noncash DSU compensation caused by share price fluctuations, foreign exchange loss and investor relation activities, including travel costs incurred prior to the start of the COVID-19 pandemic.

For the quarter, our cash burn rate, that we define as the net loss for the period adjusted for operations not involving cash was $8.6 million. We expect that the cash burn for the remaining of 2020 to return to between $5 million to $6 million per quarter due to the nonrecurring expenditure incurred in Q1 and also because of the impact of COVID-19.

Finally, as of May 14, 2020, the number of issued and outstanding common shares was 60.4 million and a total of 5.1 million stock options, DSUs and warrants were outstanding.

Please take note that our unaudited interim consolidated financial statements for the 3 months ended March 31, 2020, and the related MD&A are available on SEDAR and on EDGAR.

So thank you for your attention, and I will now turn the call back over to Fred for his closing comments before the Q&A session. Fred?

Thanks, Pierre. In these challenging times, we are looking ahead to the remainder of 2020 with optimism. At the upcoming ASCO Virtual Scientific Program, which will be held at the end of May, we expect to report updated clinical response data from the DeCidE1 trial of DPX-Survivac in advanced and recurrent ovarian cancer patients.

Additionally, we look forward to reporting top line Phase II results from DPX-Survivac basket trial and SPiReL study in relapsed/refractory DLBCL before the end of the year. We believe our excellent results in relapsed/refractory DLBCL, taken together with emerging promising data from a DeCidE1 study in ovarian cancer, support our plan to accelerate development in these indications.

More so beyond our lead program, we are preparing to advance our clinical candidate for COVID-19 as quickly as possible and continue to leverage the multiple opportunities of our platform against other targets of interest.

We strive continuing making progress in unlocking the value of our platform for patients afflicted with cancer and other serious diseases, including COVID-19, and are still grateful for the continuous support of our partners, shareholders and employees as we continue as a team to deliver on IMV's great opportunities.

Thank you for your attention. Operator, we are now ready to take questions.

Your first question comes from the line of Tom Shrader from BTIG.

Congratulations on the progress. So I guess the first question I have is since the last data, the stock has struggled, really because of the cyclophosphamide confusion, really the role of that drug. And I understand your arguments, I'm just wondering if you've had discussions with regulators, is it an issue for them? Or is it -- or are your arguments widely accepted? Or have you not had discussions yet? Any update would be great.

Tom, thanks for the question. No, honestly, it's never been an issue for us. It never came as a discussion point. There is no strong clinical evidence of the activity of cyclophosphamide. That's the way we are using it in either DLBCL or ovarian cancer. So for the regulators, there is not a strong base or foundation to question the development. The last time we had meeting with FDA, they didn't ask us to prove anything related to cyclophosphamide. So I think it's more of a market perception. But nonetheless, this is something we are taking very seriously and that we want to address. And in that vein, we are planning to provide some updates when we release the updated clinical data on the DeCidE trial at ASCO.

Great. And then so to switch to the COVID vaccine approach, you have this elegant approach with specific peptides, partially driven by the idea of avoiding this antibody-enhanced disease. When do you know if, in fact, that's a problem with the COVID vaccines and whether you get around it? Is it not known until sort of deep Phase III? Or do you get earlier signs?

Well, if I may correct one thing, Tom, about the targeted approach that we are pursuing, it's very much aligned with the idea that we are developing in oncology of really targeting the immune response on a molecularly defined area that we believe is important for the disease. So with -- in, for example, in cancer, we have been adamant about the importance of survivin for cancer. It's not just a flag on cancer cell, but it's something that cancer needs to survive. That's what you call survivin. And it's really the same concept we're applying to COVID-19. We -- like Marianne was explaining, we are targeting what we believe are the most important functional units of the spike protein, and there's more than one. There's the attachment to the receptor, but you also have fusion and entry. Those are 3 different steps, key steps in the mechanism of action for infection. And we believe that the opportunity that we have with our platform and our technology to target the immune response on those weak spots for the virus has the potential, first, I would say, to increase the efficacy. So the driver for what we do is we want to make the best vaccine impossible for COVID-19 focusing on why it matters on the virus. The potential benefit of that, to answer your question, is also because we are targeted, when we discuss with the regulatory authorities about the issue of, for example, of nonneutralizing antibodies, it's already eliminated from the vaccine design from the get go, because everything we do is based on full characterization of the epitopes that the vaccine is targeting. And we really remove the unknown by doing that, because when you use the full virus or use the full spike protein, you have hundreds of antibodies generated. Some are neutralizing. Some are not neutralizing. We just don't have that in our vaccine. So it makes an easier discussion with the regulatory authorities. The immune-enhanced diseases, there's so many unknown about it. I don't know, Marianne, if you want to talk about it, but we feel it's -- there are so many things that are unknown at this stage that's difficult to figure out how this will unfold with the different vaccine technology. I don't know, Marianne, if you want to give your perspective on it.

Yes. I think that it's really very much an evolving field, and not only is the science evolving, the models in which we could use, other than the clinical studies to assess this, are evolving. So I think we'll learn a lot about the potential for this from the animal models as they evolve. And I don't think we'll have to wait until we're in clinical studies.

Your next question comes from the line of Joe Pantginis from H.C. Wainwright.

And I'm glad you're all well. Congratulations on the SPiReL data. I wanted to start with that one, if you don't mind, a couple of questions. So with this data in mind and this being an IST, and I know my question might be going into the competitive arena here, but I was just curious if you could take some broad strokes as to the potential path forward for IMV as you talk about a potential accelerated path forward.

Joanne, you want to get this one? Take this one?

Sure. Yes, we are very excited about this data. We thought it was tracking this way, and so now we're really glad to be able to report that we have seen that 6 patients and actually 7 out of 11 are evaluable. So we do believe this is very promising. We are now moving along our discussions about what that next step will be in terms of a sponsor-initiated trial. So we are in the process of doing that. We do understand there is the pandemic, and so we're trying to manage that to make sure we can move this quickly forward, but the exact timing will depend upon how all of this plays out in the next several months.

I understand. And then with regard to the basket study, you, obviously, due to the pandemic moved some data timing to the second half. So I'm just curious, you do have a lot of patients enrolled in this study already. So is it more of a function of ensuring that you have, a, I guess a certain amount of patients enrolled in each tumor type to be able to disclose a full -- fuller data set?

Yes. Yes. Yes. Sorry, Joanne. Go ahead.

No. Thanks, Fred. Thanks for the question. Yes, that is true. We had -- before the pandemic, we basically had a bolus of patients come in, and they have been followed and we're still accruing additional patients, but it was also a matter of bringing in the data set and making sure we had enough of the data to be able to report on a significant number of those patients. So there were those pieces that needed to come together. And so we're still doing that. It just takes a little bit of time working through all of this remote monitoring and things like that to come together to make sure that we had the appropriate data set and with the appropriate number of patients as well.

Got it. And my last question, I guess, thank you for the additional detail for the COVID-19 vaccine approach. And when we have the timing for the start of the clinical study, I was just curious around your communication strategy around the preclinical data that you might generate.

Well, we'd like to -- so we believe that the work we are doing is unique in the global scientific efforts to develop a vaccine because, again, going back to my answer earlier, we are really developing a targeted approach that's focused on neutralizing antibodies and basically mapping out where are the best interesting weaknesses, immunological weaknesses of the virus. And so we would like to be able to publish that. We believe that will be -- that's great information for us to select the vaccine for sure, but that's also great information to the scientific community. So we'd like to look at the possibility of doing a publication on this. Obviously, we'll try to make it very quick. But like Marianne said, we'll have completed the important piece of the preclinical studies before the end of May, on schedule. And then we'll be able to move in the clinical study. And in between that, we should be able to put out the publication on the detailed results.

Your next question comes from the line of Ted Tenthoff from Piper Sandler.

And my -- clinical trial for the SPiReL update. It's funny to me that cyclophosphamide, it's a question considering it's used with the CAR-Ts as well. So I don't really get that pushback. And I think that's a clear signal of response. I'm looking for additional updates on that.

With respect to the basket trial, I'm trying to understand sort of how you would proceed from those different cohorts from those different readouts. So if you have activity in 2 or 3, what are the plans for expansion? And how quickly could that occur?

Thanks, Ted. Yes, to your comment on cyclophosphamide, I would just add that in the CAR-T context, it's used at very high dose, much higher dose than what we are using. And it's also used all the time in combination with fludarabine. So they -- not only they're using cyclophosphamide high dose, but they're using fludarabine, which is also a very active drug. So -- but thanks for really reinforcing the difference that we have. And we are definitely convinced, and investigators working on this trial are definitely convinced, that we are showing a very strong sign of activity here.

On the basket trial, we -- I think it was at -- I don't remember, sorry, but we published a poster on the design of the basket trial where we described the design of the trial. And in this poster, you find information on the 2-stage design that we, Merck and IMV, developed together to make decision on where are the best opportunity for the combination out of those 5 indications. And it's really based on Simon's 2-stage design where you define a minimal response rate and you want to eliminate the hypothesis that your response rate is going to be below that. And if it's over that, then you have your decision point to move into stage 2 and eventually move into a bigger Phase II, even potentially registrational trial. So that's really how it's -- the basket trial is designed.

Your next question comes from the line of David Novak from Raymond James.

So starting off with the SPiReL study here, the DLBCL results continue to look quite good. I just wanted to first confirm that the 2 additional clinical responses being reported here are indeed responses per modified chasm criteria?

Yes, they are, David.

Excellent. Great. And I also just wanted to clarify, if the trial is still aiming to hit target enrollment of 25 patients? And if so, could you talk a little bit about enrollment rate? It looks like about 1 patient every 2 months. Is that what we should be expecting here? Or is enrollment being closed early based on the results that you've generated today?

It's a difficult question to answer for 2 reasons. First of all, it's an investigator-sponsored trial. So it's not -- there are some limitation in terms of the number of sites and that it's not under the control of IMV. And the second element is COVID-19. It's -- we all hope, obviously, that the situation is going to improve over time with the confinement happening. But we've learned in the last few months that it's very difficult for us, and I guess for any biotech company to provide guidance on what might be happening at the hospitals and with the suppliers that are involved in collecting the data and all of that. So we just want to be careful in creating expectation where we have very limited visibility on what could be the situation in 3 months from now. I'm sorry, I cannot give you more, but that's really a challenging time for making prediction for sure.

Fair enough. But it does sound like the assumption right now is to continue to enroll regardless.

Yes. Okay.

Okay, great. And then finally, just lastly on the DeCidE trial. So in the ASCO abstract, we're still looking at [ORR] here of about 15.8% now. Obviously, that's as of February. So things can change. However, assuming monotherapy antitumor activity does indeed shake out around that sub-20% level, is the company adamant at driving forward here as a monotherapy? Maybe you're looking to tackle its survival endpoint rather than a response-based endpoint going forward? Or is the company currently evaluating go-forward combination opportunities?

Well, I think we want to really get the opportunity to look at the final results. One of the hallmark of immunotherapy is the long tail of benefits and responses. And since we started the development of DPX-Survivac, this is something we have been seeing across all our indications so far. And this is part of the challenge of immunotherapy as well. As you know, the checkpoint inhibitors, they are not successful because of high response rate. They are so successful because of really long duration of benefit. So we want to get the opportunity to get to the final results and really be able to assess what are the benefits of this drug and how this drug fits in the current standard of care for ovarian cancer and think about where are -- what is the most interesting path to market for this drug in ovarian cancer. But we should reach that point before the end of the year and really be able to provide more information on the way we're going to be choosing to move ahead.

Your next question comes from the line of Endri Leno from National Bank.

Just a couple for me, really. You're saying that all your clinical trials, at least on the basket trials, they're still open. Are they recruiting any patients still? It's my first question. And how do you see -- or if you have any comment on patient recruitment for the rest of the year?

Sure. Joanne, can you give more information on how it's working? And what's the situation?

Yes. So we're monitoring that on a regular basis. We are still having patients recruited. They're being screened and enrolled. It varies by site, but it is definitely still occurring. And we expect that to sort of change over time depending upon where the pandemic may be worse at times and getting better. So as things begin to open, we would also expect things to pick up at different centers at different times. But the accrual is ongoing.

Great. Have you seen any patient drops to date because of the pandemic, that is.

In terms of numbers? Is that --

Yes. Yes.

Overall numbers. I would say that there has been a little bit of a slowing at particular centers. But overall, it's -- there's a little bit of a slow, but not like it's come to a trickle or anything like that, we're still seeing activity at many of our centers. That has not changed.

Okay. Great. And still on the patient side, but on recruitment, but looking at more on the COVID trial. I mean, given that there is a bit of a rush with different companies developing treatments and vaccines, like how do you see recruitment there for subjects come summer?

Joanne?

Is this in question in regards to the COVID-19 program itself?

Yes, yes. The COVID vaccine that you're developing.

So in healthy volunteers, that's where we will be going, as other companies have gone. We anticipate that accrual will go quite smoothly.

And Endri, if you could look at some recent examples of Phase I studies, where there's a lot of volunteers coming in at the site, so a lot of people are interested in being vaccinated for COVID-19.

So we don't anticipate it's going to be a challenge. What's going to be a challenge for every vaccine players in the world is really the -- it's more the efficacy Phase III development that hopefully will happen quickly after Phase I/II. But there is some collaborations, hopefully, happening with the WHO and some other players to provide a framework and an environment where those Phase III trials will be able to run, not necessarily in the country where the vaccine is being developed but anywhere in the world.

(Operator Instructions) Your next question comes from the line of Jim Birchenough from Wells Fargo.

It's Nick on for Jim this morning. Just going back to ovarian cancer, Fred. I thought at the beginning of the year, you'd already decided that you would approach FDA for like an end of Phase II meeting to discuss potential single-arm Phase IIb registration trial. Is -- do I understand now that you've decided to wait for the data to mature until you decide whether or not to go meet with FDA?

Yes, in any case, we -- the pattern of responses that we are seeing, those very long duration SDs that we've highlighted in February, it's something that we have to consider in when we go back to the FDA. And plus the COVID-19 situation also influencing the speed at which we can move things. So altogether, we believe it's a better strategy to -- like I was saying, to really get a full understanding of the final results and figure out what's the best path forward for the development in ovarian cancer before we go in front of the FDA.

Yes, that makes sense. You can sense that some of these patients that are potentially benefiting from the vaccine, but then moving on to other therapies, that, that sort of muddies your ability to dissociate what the impact of the vaccine is versus subsequent therapy?

Well, it's more the fact that, like we said, we have a long tail of clinical benefits that maybe they will all translate into that definition of response rate, that 30%, and whether it's absolutely required or are clinically relevant will have to be discussed. But you've seen the pattern of responses, we are seeing a number of patients that are stable over a significant period of time. And it's those discussion with investigators, people, you were at the KOL meeting, the feedback we are getting is that those patients are experiencing clear clinical benefits with meaningful quality of life and that we should consider that in our plan. So that's what we want to do.

And then just moving on to diffuse large B-cell lymphoma. So 20 patients have been enrolled. At this stage, 9 are ineligible for analysis per the investigator. I know we've discussed about this before that Dr. Berinstein sort of defined his own set of criteria for that. So have some of these patients being recently enrolled such that they're not eligible because they have not reached that particular time point? Or is this it? Now we have 11 patients and now what we're looking at is sort of, again, the durability of those responses.

Joanne, I think we had new patients coming in that have been evaluable. And we -- I think we said, yes, we had 20. So and again, just to repeat what was discussed when we did the update in December, bridging chemotherapy is not allowed in this trial. So that probably is a challenge for the treatment in the time between they enroll and the time they can start the trial. It's -- that's long enough to -- for some of those patients to be in a very dramatic progression -- in a very dramatic progression path that make them come in the trial and go out immediately. And this is something we'll be looking at in the next trial, we're going to do in DLBCL, for sure.

And that was my follow-up question prior to this. Again, you've talked about for the next trial trying to avoid these fast progressor patients. What are your latest thoughts in terms of what a next trial would look like and when could that start?

I'll let Joanne answer that one.

So that is exactly what we're looking at to consider this. We think that this is a population of patients where we do see activity. So I think we would be in the same place. We also believe those even with the newer therapies that may be coming in, we're always going to have patients who relapse. So we'll be looking at that population of patients and looking at the design with our KOLs to take that next step.

And is that something that could happen this year? Or do you think that will be into '21?

I think we will do our best to move it as rapidly forward as we can in the environment of a pandemic. It's really hard right now to understand how quickly things may be able to move right now.

And then just moving to the vaccine. Fred, in terms of obviously, vaccine supply, you've commented in the past that your vaccine is amenable to a rapid scale up. But just in terms of current manufacturing plans and what you can support with current cash, and then if you can expand on your comments on the grants applications and how far you can go without getting some of those grant applications granted and just sort of your level of confidence on what the outcome of those applications will be.

Thanks, Nick. Well, our plan is we don't plan or foresee to develop a vaccine for COVID-19 in the absence of -- grant is one thing, give you the money to do it. But I think to me, what's more important is the collaboration with the government because at the end of the day, they're going to be the decision makers, they're going to be the buyers. And I believe that it doesn't make sense for a company to be involved in this pandemic without working in close collaboration with the government. So in essence, we won't proceed to develop a vaccine in the absence of those grants and the collaboration with the government. We feel very confident that we're going to be able to get those grants for the clinical development of the product.

And governments, obviously, the Canadian government is your #1 priority, but are you looking at getting support from other governments as well?

Yes, we are focusing the early Phase I and scale up the manufacturing in Canada, but the -- one of the big advantage of the technology that we had is that the manufacturing process is actually fully synthetic and pretty simple, meaning that it's portable, any place in the world with capacity for lyophilized vaccines, and there's many of them across the world, with the -- could potentially become a manufacturer in a pretty short period of time. So we are focusing in Canada. We have already partners in the U.S. in terms of manufacturing that could be mobilized for U.S. expansion out of Canada after the Phase I or before the Phase I, we'll see. And then beyond that, we've had, had some preliminary discussions with other potential manufacturers that could expand into a more global effort that the WHO and organization like CEPI, for example, are trying to develop.

There are no further questions at this time. I will turn the call back over to the presenters.

Well, I have nothing to add. Just want to thank you all for your time this morning. Really appreciate it.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating. You may now disconnect.