IMV Inc.
Q1 2020 Earnings Call Transcript

Published: 15 May 2020

[Operator:]

Ladies and gentlemen, thank you for standing by and welcome to the IMV, Inc. Announce its First Quarter 2020 Financial Results and provides Corporate and Clinical Updates Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]I would like now hand the conference over to your speaker today, Pierre Labbé, Chief Financial Officer. Thank you. Please go ahead, sir.

[Pierre Labbé:]

Thank you, Juan. Good morning, ladies and gentlemen. My name is Pierre Labbé. I'm CFO at IMV. I am 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, 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 I 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-10 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 statements, 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, successful and timely completion of clinical trials, the receipt of all regulatory approvals 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 our audited annual consolidated financial statements, which are available on SEDAR and also 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 certified analysts at the end.I will now turn the call over to Fred. Fred?

[Frederic Ors:]

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 employees and the broader community, while maintaining our business continuity. The effects of the pandemic are slowing the pace of clinical development across our industry due to the absolutely necessary diversion of healthcare 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 soft [ph] T cell therapy with the 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 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 the presentation.As a company we are also fortunate to be developing a platform with multiple applications in cancer and vaccines against infectious diseases. And we feel really privilege and humble at the same time with the opportunity to contribute 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 1 clinical study early in the summer.We are also very happy about our recently completed financing, extending our cash run rate through the end of 2021. It was not only a great vote of confidence from our existing shareholders, SFW, [ph] Ruffer and CTI Life Sciences, 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 friends so to Julia and Andrew [ph] 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?

[Joanne Schindler:]

Thank you, Fred and welcome to everyone. I'll first start with the review an update of our Phase 2 trial study in Recurrent/Refractory Diffuse Large B-Cell Lymphoma, which is 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 had received more than one prior treatment regimen. The primary endpoint of the study is to document a minimal objective response rate of 24% to treatment with DPX-Survivac and 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 five different clinical sites in Canada.The next slide provides an update to the poster present at the American Society of Hematology annual meeting last December. At that time we had observed a 56% response rate based on five clinical responses in the first nine evaluable patients. Since December, we now have 11 evaluable patients and two additional reports of clinical response. This is a total of seven clinical responses with an objective response rate of 64%. So we're very happy to report the study has met its primary endpoint of achieving a minimum of six responses in the plan 25 of evaluable patients.As Fred previously mentioned, we believe these results continue to provide sufficient support for accelerating the development of DPX-Survivac and DLBCL. To illustrate this point, we documented on slide 5 the 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 other three 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 is not directly comparable to CAR T's given amongst other factors the bridging chemotherapy often required before lymphodepletion, the serious potential adverse reactions, the required hospitalization, higher costs 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 2 DeCidE1 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 reactions.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 ASCO 20 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 to 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 2 Basket Trial in advanced metastatic solid tumors. The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac, intermittent low dose cyclophosphamide in combination with pembrolizumab across five cohorts of patients with bladder, liver, ovarian and non-small cell lung cancer, as well as tumors shown to be positive with micro satellite instability high biomarkers.As of May 7th, a total of 92 out of the planned 184 patients were enrolled across all five 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?

[Marianne Stanford:]

Thank you, Joanne. Good morning, everyone. I'd like to give a brief update on IMVs programs to advance the COVID-19 vaccine based on the DPX platform. I will start on slide number 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 1 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 is the SARS-CoV-2 coronavirus uses to enter cells. The spike has two main functional areas known as F1 and F2. The F1 portion contains the receptor-binding domain and is involved in attachment to the host cell, while F2 primarily mediate fusion and entry into cells.Our epitopes have been designed to target several of these key areas in a non-overlapping fashion. Antibodies for these target should efficiently inhibit virus entry into cells and by targeting several areas at once we lessen the potential for immunoscape, 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 prioritisation 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 BPS. This candidate will then be formulated at a GMP quality for entry into a Phase 1 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.

[Pierre Labbé:]

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 in private placement of $25.1 million. So if we add it to our cash balance of $7.4 at the end of the first quarter on the pro forma basis it represents $32.5 million of cash. And we also have access to $2.5 million loan receivables coming from investment, tax credit and trades 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 1st 2020.The ATM or add-to-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 give us more flexibility and the money is always raised at market price. ATMs have becoming an increasingly popular vehicle in the capital markets in recent year and in 2019 only 185 healthcare ATMs were at work [ph].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 and 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 comprehensive 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 site and non-recurring purchases of $1.3 million of GMP grade raw materials and contract manufacturing for DPX-Survivac.With this purchase, IMV's GMP grain 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 pre-clinical 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 non-cash DSU compensation caused by share price fluctuation, foreign exchange loss, and investor relations 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 non-recurring expenditures 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 notes that are unaudited interim consolidated financial statements for the three 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?

[Frederic Ors:]

Thanks, Pierre. In these challenging times we are looking at the reminder 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 2 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 relapse refractory DLBCL, taken together with emerging promising data from our DeCidE1 study in ovarian cancer, support our plan to accelerate development in both 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 thrive continuing making progress in unlocking the value of our platform for patients afflicted with cancer and other cell diseases, including COVID-19, and are still grateful for the continuous support of our partners, shareholders and employees. I will continue as a team to deliver on IMVs great opportunities.Thank you for your attention. Operator, we are now ready to take questions.

[Operator:]

[Operator Instructions] Your first question comes from the line of Tom Schrader from BTIG. Your line is now open.

[Tom Schrader:]

Good morning. 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.

[Frederic Ors:]

Hi, Tom. Thanks for the question. No, honestly it's never been an issue for us. It never came as other discussion point. There is no you know, strong clinical evidence of the activity of cyclophosphamide, as the way well using it in either DLBCL ovarian cancer. So for the regulators you know, there is not a strong base or a foundation to question the development - you know the last time we had a meeting with FDA they didn't have you know, us to prove anything related cyclophosphamide.So I think it's more of a market perception, but nonetheless this is something you know we taking very seriously and that you know we want to address and in that vein we are planning to provide some updates when we release the updated clinical data on the DeCidE1 at ASCO.

[Tom Schrader:]

Great. Thank you. And then 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 known until sort of deep Phase 3 or do you get earlier signs?

[Frederic Ors:]

Well, if I may correct one thing Tom, about you know, the of the targeted approach that we are pursuing it you know, it's very much you know align 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.For example in cancer with - we have been adamant you know, about the importance of surviving 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 surviving. And it's really the same concept we’re applying to COVID-19, we – like Marianne was explaining you know, we are targeting what we believe are the most important functional units of the spike protein and there's more than one you know, there's the attachment to the receptor, but you also have fusion and entry. Those are three different steps, key steps in the mechanism of action for infection and we believe that you know, 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 you know, the driver for what we do is, is we want to make the best vaccine possible 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 you know, when we discuss with the regulatory authorities about the issue of for example of non-neutralizing antibodies, it's already eliminated from the vaccine design vaccine designed 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 know, you have hundreds of antibodies generated, some are neutralizing, some are not materializing, 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 a - you know, there's so many things 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.

[Marianne Stanford:]

Yeah, 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 to learn clinical studies.

[Tom Schrader:]

All right, great. Thank you for the detailed answers.

[Frederic Ors:]

Thanks, Tom.

[Operator:]

Your next question comes from line of Joe Pantginis from H.C. Wainwright. Your line is now open.

[Joe Pantginis:]

Hey, everyone. Good morning. Thanks for taking the question. 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 ISP 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.

[Frederic Ors:]

Joanne, you want to get this one – take this one.

[Joanne Schindler:]

Sure. Yes, we are very excited about this data. You know, we thought it was tracking this way, and so now we're really glad to be able to report that we have seen that a 6 patient and actually a 7 to out of eleven 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 exact timing will depend upon how all of this plays out in the next several months.

[Joe Pantginis:]

I understand. Thank you. And then with regard to the Basket study, you obviously, due to the pandemic move 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 dataset.

[Frederic Ors:]

Yes. I'm sorry. Yeah, Joanne, go ahead.

[Joanne Schindler:]

Thanks, Fred. Thanks for the question. Yes, that is true. We had you know, 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 you know, 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 you know, with the appropriate number of patients as well.

[Joe Pantginis:]

Got it. Thank you. And my last question I guess you know, thank you for the additional detail for the COVID-19 vaccine approach. And you know, 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?

[Frederic Ors:]

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

[Joe Pantginis:]

Great. Thanks everyone, stay well.

[Frederic Ors:]

Thank you.

[Operator:]

Your next question comes from the line of Ed Tenthoff from Piper Sandler. Your line is now open.

[Ed Tenthoff:]

Thank you very much. And my congrats on SPiReL update. You know, it's funny to me that cyclophosphamide [ph] it's a question considering achieved with the CAR-Ts as well. So I don't really get that pushed back. 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 read out. So you know, if you have activity in two or three, what are the plans for expansion? And how quickly could that occur? Thanks so much, guys and keep up the great work.

[Frederic Ors:]

Thanks, Ed. Yeah, to your comment on cyclophosphamide, I would just you know, had that in the copy [ph] 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 are using cyclophosphamide high dose [ph] but they are using fludarabine [ph] which is also a very active drug. So – but thanks for really reinforcing…

[Ed Tenthoff:]

Very clear…

[Frederic Ors:]

The track that we have and you know, we are definitely convinced and the investigators you know, working on this trial are definitely convinced, that we are showing a very strong sign of activity here.On the Basket trial, you know, I think it was that - I don't remember sorry, but we published the 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 two stage design that you know, we Merck and IMV developed together to make decision on where are the best opportunity for the combination out of those five indication and its really based on you know, on Simon two stage design where you define a minimal response rate and you want to eliminate the hypothesis that your response is going to be below that and if it's over that then you have your decision point to moving to stage 2 and eventually you know moving to a bigger Phase 2, even potentially registrational trial. So that's really how its - the Basket trial is designed.

[Ed Tenthoff:]

Great. Thanks, guys. Keep up the good work.

[Frederic Ors:]

Thanks, Ed.

[Operator:]

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

[David Novak:]

Good morning and thanks for taking my questions. So starting off with the SPiReL study here, the DLBCL results continue to look quite good. And I just wanted to first confirm that the two additional clinical responses being reported here are indeed responses per modified chasm [ph] criteria?

[Frederic Ors:]

Yes. They are David.

[David Novak:]

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 rates. Looks like about one patient every two months. Is that what we should be expecting here? Or is enrollment being closed early based on the results that you've generated today?

[Frederic Ors:]

I'd say it's a difficult question to answer for two reasons, first of all it's an investigator sponsored trials, so it's not you know, there are some limitation in terms of the number of sites and that you know, it's not under the control of IMV.And the second element is COVID-19. We all hope obviously that distribution is going to improve over time with the confinement happening. But you know, 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 hospital and with the suppliers that are involved in collecting the data on all of that.So we just want to be careful in creating expectation where are we have very limited visibility on what could be the situation in three months from now. I'm sorry, I cannot give you more, but that's really a challenging time for making prediction for sure.

[David Novak:]

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

[Frederic Ors:]

Yes.

[David Novak:]

Okay, great. And then finally just lastly on the DeCidE1 trial and so in the ASCO abstract you know, we're still looking at [indiscernible] about 15.8%. Now obviously that's as of February. So things can change. However assuming monotherapy anti tumor activity does indeed shake out around that sub 20% level. Is the company adamant at driving towards here as a monotherapy, maybe you are looking to tackle a survival endpoint rather than a response based endpoint going forward or is the company currently evaluating go toward combination opportunities?

[Frederic Ors:]

Well, I think you know, 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 you know, this is something we have been seeing across all our indications so far.And you know, this is part of the challenge of immunotherapy, as well as you know, the checkpoint inhibitors you know they are not successful because of high response rate, they are successful because of really long durations of benefits. 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 you know, 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.

[David Novak:]

Excellent. Well, thanks very much Fred and I'll hop back in the queue.

[Frederic Ors:]

Thanks, David.

[Operator:]

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

[Endri Leno:]

Good morning, guys. Thanks for taking my questions. Just a couple of 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. Then how do you see or if you have any comment on patient recruitment from the rest of the year?

[Frederic Ors:]

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

[Joanne Schindler:]

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 approval is ongoing.

[Endri Leno:]

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

[Joanne Schindler:]

In terms of numbers?

[Endri Leno:]

Yeah.

[Joanne Schindler:]

Overall numbers. I would say that there has been a little bit of a slowing at particular centers, but overall its - there's a little bit of a slow, but it's 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.

[Endri Leno:]

Okay. I agree. Thank you. 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 a recruitment there for subjects?

[Joanne Schindler:]

It this in question in regards to the COVID-19 program, it so?

[Endri Leno:]

Yeah. The COVID vaccine that you're developing.

[Joanne Schindler:]

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

[Frederic Ors:]

And Endri. If you could look at some recent examples of Phase 1 studies where you know, there's a lot of volunteers coming in at the site. So you know, a lot of people are interesting in being vaccinated for COVID-19. So we don't anticipate its going to be a challenge. What's going to be a challenge for you know, every vaccine players in the world is really you know, is more the efficacy, you know, Phase 3 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 in an environment where those Phase 2 trial would be able to run you know, not necessarily in the country where the vaccine is being developed, but anywhere in the world.

[Endri Leno:]

Okay. Great, thank you.

[Operator:]

[Operator Instructions] Your next question comes from line of Jim Birchenough from Wells Fargo. Your line is now open.

[Unidentified Analyst:]

Good morning. 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 2 meeting to discuss potential single-arm Phase 2b registration trial. Do I understand now that you've decided to wait for the data to mature until you decide whether or not to go and meet with FDA?

[Frederic Ors:]

Yeah. In any case you know, that the pattern of responses that we are seeing you know, those very long duration is these that we highlighted in February. It's something that we have to consider in when we go back to the FDA and plus you know, the COVID-19 situation also influencing the speed at which we can move things.So all together, 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.

[Unidentified Analyst:]

Yeah, that makes sense. So you concerned 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 associate what the impact of the vaccine is versus you know, subsequent therapy?

[Frederic Ors:]

Well, it's more the fact that you know, 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 clinically relevant, will have to be discussed. But you know, you've seen the path - you've seen the pattern of responses we are seeing a number of patients that are stable over a significant period of time.And you know, it's those discussion with investigators, people, you were at the KOL meeting you know, the feedback we are getting is that those patients are experiencing clear clinical benefit with meaningful quality of life and that we should consider that in our plan. So that's why we want to do it.

[Unidentified Analyst:]

Okay. And then just moving on to diffuse large B-cell lymphoma. So 20 patients have been enrolled, at this stage 9, 9 are in eligible 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 are some of these patients being recently enrolled such that you know, they're not eligible because they've 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?

[Frederic Ors:]

Joanne, I think we had new patients coming in at that…

[Joanne Schindler:]

Correct.

[Frederic Ors:]

Have been evaluable and we - I think we said we – yeah, we had 20. And again you know, just to repeat what was discussed when we did the update in December, bridging chemotherapy is not allowed in this trial. So that poses a challenge for further treatment in the time between they enroll and the time they can start the trial and you know, that's no longer enough to for some of those patients to be in a very dramatic probation, in a very dramatically probation part that make them come into trial and go out immediately. And this is something we will be looking at in the next trial, we're going to do deal this year for sure.

[Unidentified Analyst:]

And that was my follow up question there. Fred is, again, you've talked about for the next trial, trying to avoid these past progressive patients. What are your latest thoughts in terms of what the next trial would look like and when could that start?

[Frederic Ors:]

I’ll let Joanne answer that one.

[Joanne Schindler:]

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 were 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.

[Unidentified Analyst:]

And is that something that can happen this year or do you think that'll be into ’21?

[Joanne Schindler:]

I think we will do our best to move it as rapidly forward as we can in the environment of a pandemic.

[Unidentified Analyst:]

Okay.

[Joanne Schindler:]

Its really hard right now to you know, understand how quickly things may be able to move right now.

[Unidentified Analyst:]

Thank you. And then just moving to the vaccine. Fred, in terms of obviously vaccine supply you've commented in the past that your vaccines are amenable to 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 grant applications and how far you can go without getting some of those grant applications granted and just sort your level of confidence on where - what the outcome of those applications will be?

[Frederic Ors:]

Thanks, Nick. Well, our plan is you know, we don't plan or foresee to develop a vaccine for COVID-19 in the absence of - grants 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 dynamic without working in close collaboration with the government.So in a sense you know, 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 can - we're going to be able to get those grants for the clinical development of the product.

[Unidentified Analyst:]

And government's obviously the Canadian government is your number one priority. But are you looking at getting support from other governments as well?

[Frederic Ors:]

Yeah. We are focusing you know, in the early Phase 1 and scale up the manufacturing in Canada. But one of the big advantage of the technology that we have is that the manufacturing process is actually fully synthetic and pretty simple, meaning that it's potable any place in the world with capacity for lyophilized [ph] 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 you know, we are focusing in Canada. We have already partners in the US in terms of manufacturing that could be mobilized for U.S. Expansion out of Canada, after the Phase 1 or before the Phase 1 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 SAP [ph] for example, are trying to develop.

[Unidentified Analyst:]

All right. Thanks. I’ll jump back in the queue.

[Frederic Ors:]

Thanks, Nick

[Operator:]

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

[Frederic Ors:]

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

[Operator:]

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