Q2 2022 Oncolytics Biotech Inc Earnings Call

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2nd Quarter 2022 Conference Call. All participants are now in listen-only mode. There will be a question-and-answer session at the end of this call. Please be advised that this call is being recorded at the company's request. I would now like to turn the call over to John Patton, Director of Investor Relations and Communications. Please go ahead.

Thank you, operator, and good morning, everyone. Earlier this morning, OnClinics issued a press release providing recent operational highlights and financial results for the second quarter of 2022. A replay of today's call will be available on the events and presentation section of the OnClinics website approximately two hours after its completion. After remarks from company management, we will open the call for Q&A.

As a reminder, various remarks made during this call contain certain forward-looking statements relating to the company's business prospects and the development and commercialization of Pella Re-ReP, including statements regarding the company's focus, strategy, and objectives, the company's belief as to the potential and mode of action of Pella Re-ReP as a cancer therapeutic, the design aims and anticipated benefits of the company's current pending clinical trials, and the anticipated timing of the release of additional data, the company's plans and expectations regarding a potential registrational study.

the company's business development plans and strategies, and other statements related to anticipated developments in the company's business.

These statements are based on management's current expectations and beliefs and are subject to a number of factors, which involve known and unknown risks, delays, uncertainties, and other factors not under the company's current control that may cause actual results, performance, or achievements of the company to be materially different from the results, performance, or expectations implied by these four looking statements.

in any poor-looking statement in which oncologics expresses an expectation or belief as to future results.

Such expectations or beliefs are expressed in good faith, and beliefs have a reasonable basis, but there can be no assurance that these statements or expectations or beliefs will be achieved.

These factors include results of current or pending clinical trials, risks associated with intellectual property protection, financial projections, actions by regulatory agencies, and those factors detailed in this company's filings with CDAR and the SEC.

OnClay, this does not undertake any obligation to update these forward-looking statements except as required by App and Overwalks.

I will now pass the call off to Oncolyx President and Chief Executive Officer, Dr. Matt Coffey. Please go ahead, Matt.

Thanks, John , and good morning to all listening. As usual, joining me on today's earnings call are a few fellow members of the Oncolytics leadership team, including Dr. Thomas Heinemann, our Chief Medical Officer, Andrew DiGuttadaro, our Global Head of Business Development, and Kirk Look, our Chief Financial Officer.

I'd like to begin today's call with a brief recap of our very strong second quarter highlighting two clinical data readouts in our breast and pancreatic cancer programs that we find very encouraging.

Each of these readouts further clarifies Pellere-REPS core value proposition.

which is its ability to solve one of oncology's most prevalent and longstanding problems.

the inability of the immune system to recognize and infiltrate tumors.

This problem extends across many tumor types and is known to severely blunt the impact of many of the most widely used and commercially successful classes.

To date, the problem posed by the inaccessibility of tumors to immune cells has yet to be broadly solved due in a large part due to the multiple biological mechanisms perpetuating it.

With Pella ReaRep, or Pella as I'll call it, we believe we have a safe and versatile immunotherapeutic agent that can simultaneously address many of these various mechanisms and make tumors more amenable to successful treatment with complementary anti-cancer therapies.

By doing this, we believe we could substantially broaden the commercial opportunities of these therapies by expanding their reach in large indications such as HR positive, HER2 negative metastatic breast cancer, and pancreatic cancer, which affect approximately 114,000 and 62,000 patients yearly in the US respectively.

This belief is supported by data from multiple clinical studies such as IND-213, which showed a statistically significant near-doubling of overall survival in HR-positive HER2-negative breast cancer patients when Pella was added on top of chemotherapy.

It is also supported by AWARE-1, which provided a mechanistic explanation for IND-213's results by establishing PELUS immunotherapeutic effects in HR-positive HER2-negative breast cancer patients.

These findings were strengthened with new analysis presented at the Esmol breast cancer meeting in May, which showed Pella remodeling tumor micro-abironments in a way that improved patient prognosis and long-term outlook.

Another key finding from AWARE-1 was the demonstration of synergy between Pella and checkpoint inhibition, as combining Pella with ROSA's atezolizumab led to an enhanced immunotherapeutic effect.

This added to the massive data supporting our breast cancer program and provides a clear scientific rationale for the Phase 1-2 goblet trial.

which showed in June that the synergy observed in breast cancer may extend into pancreatic cancer.

Notably, pancreatic cancer is a highly prevalent and challenging indication where checkpoint inhibitors have thus far not provided substantial clinical benefits.

We were thus highly encouraged when goblet's initial readout showed treatment with the combination of Pella, atezolizumab, and standard of care chemotherapy led to dramatic tumor shrinkage and partial responses per resist criteria in all patients in the pancreatic cancer cohort. We were thus highly encouraged when goblet's initial readout showed treatment with the combination of Pella, atezolizumab, and standard of care chemotherapy led to dramatic tumor

Still early, we believe these data are indicative of PELUS potential as a platform molecule that can be used in a variety of indications to enable immune cell access to tumors.

Pella's ability to do this contributes to its anti-cancer activity as a single agent and positions it as a broadly applicable combination partner that can drastically enhance the efficacy of a range of drug classes.

Looking ahead, we plan to present additional data from GOBLiT's pancreatic cancer cohort at a major medical meeting later this year.

With enrollment nearly completed in Stage 1 of the cohort, we submitted an abstract that includes objective response data at Week 16 on all evaluable patients.

This update includes follow-up on the three patients we've already reported on at Esmo GI this past June .

If the early signal of efficacy observed with the first three patients persists in subsequent readouts, we believe it will open up new pathways towards registration that will de-risk our pipeline and increase our avenues for value creation.

Tom and Andrew will be providing additional context on our pancreatic cancer program a bit later.

I'd now like to turn our attention to an important announcement we made in our press release that was distributed early this morning. This was the completion of enrollment in bracelet one, a randomized phase two trial in HR positive HER2 negative metastatic breast cancer.

With race one enrollment finishing near the end of last quarter, the trial is now less than four months away from a complete data set on its primary endpoint of week 16 overall response rate.

Once we have cleaned and locked the database, we will provide our partners at Pfizer and Merck Serrano with a report that will trigger the start of their 90-day period of exclusivity, during which the data could not be publicly announced.

As we are already monitoring the data from this open-label study in real time,

We're able to review the data as it develops, which allows us to engage investigators, cooperative groups, and regulatory consultants on a confidential basis.

While a brief delay in Bricelet 1 enrollment combined with the 90-day exclusivity period from our contractual obligations to Pfizer and Merck Serrano and scheduling of major medical meetings, we have pushed our anticipated disclosure from the end of 2022 into Q2 2023.

It's important to realize that this does not impede our lead program's momentum. We intend to take advantage of this 90-day quiet period to engage with regulators on a confidential basis during this time to discuss the optimal design of the future registrational study.

This new study will be informed and supported by Bracelet-1's results, as well as by Pella's robust safety database, Phase 1 efficacy data demonstrating its single-agent activity, and the aforementioned results from IND-213, which notably counts as one of the two pivotal trials required for approval by the FDA.

With regards to public disclosure of the data, our collaborators and athletics team believe announcing BraceletOne's full suite of clinical and translational data alongside emerging overall survival results.

at a major medical meeting will ultimately be more impactful.

Instead of just piecemeal top-line data, this announcement will include an expansive set of clinical and translational data, including overall response rates, progression-free survival data, and evolving overall survival data from the trial's randomized cohorts.

We'll also provide important external validation and allow us to receive unbiased input from relevant experts and key opinion leaders.

This feedback will be invaluable as we work to advance towards registration as efficiently as possible.

As we stated repeatedly, we expect BraceletOne's data to substantially de-risk our breast cancer program. Both are our business development prospects and fuel Pella's advancement into registrational study by providing key learnings that will inform the trial's design.

Nonetheless, we are still very excited about the breast cancer data we will have in the fourth quarter of this year at the San Antonio Breast Cancer Symposium in December , where we will be seeing clinical data from our Chinese partners HR-positive, HER2-negative breast cancer bridging trial, and additional WER1 data. With that, I'll introduce Tom to provide some additional context around the recent announcements from WER1 and Goblet. Tom? Tom?

Thanks, Matt. The most recent results from the AWARE-1 study further strengthen the overall dataset that demonstrate Pella's immunologic mechanism of action.

Importantly, in doing so, these results clearly reinforce PELIS potential as a versatile platform therapy that can overcome some of the most prevalent tumor defense mechanisms.

These data, which were presented at the ESMO Breast Cancer Meeting in May,

focused on how Pella, when added to the standard of care therapy, Letrozole, with or without the checkpoint inhibitor, Atizolizumab, modified the tumor microenvironment in HR positive, HER2-negative breast cancer patients.

This is the same breast cancer subtype for which Pella provided a statistically significant and clinically meaningful survival benefit in the IND213 study, as mentioned earlier by Matt, and is the breast cancer type we intend to evaluate in the future registrational trial.

Some of the most interesting data presented at the ESMO breast cancer meeting came from the PAM50 gene panel analyses that correlated changes in the tumor with the likelihood of patients cancer recurring following successful treatment.

These correlations were captured using a risk of recurrence score, with results showing all invaluable patients having a risk of recurrence score classified as low following treatment.

This represented a near doubling from the 55% that had this favorable classification at the start of the study.

These exciting results, together with the previously reported aware1 data, including increases in the prognostic cell TIL score,

clearly support the profound clinical benefits we believe Pella can provide.

They also offer a thorough understanding of exactly how Pella may drive clinical benefit.

In essence, PALLA has a multi-pronged mechanism of action by which it educates the immune system in its fight against cancer, it reverses the suppressive micro-environments that typically exclude immune cells from tumors and lessen their effectiveness, and it conditions a tumor to respond to anti-cancer agents such as checkpoint inhibitors, CAR T therapy, or chemotherapy.

These mechanisms of action were established by multiple experimental observations.

First, Pella stimulates the generation, expansion, and activation of CD8 positive T cells.

This illustrates its ability to teach the immune system to recognize tumors.

solving the first half of the long-standing problem Matt laid out at the top of the call, namely the inability of the immune system to recognize and infiltrate tumors.

Second, Pellet promotes the infiltration of anti-cancer immune cells into the tumor and it upregulates PD-L1 expression in tumors.

This is noteworthy because it demonstrates Pella's ability to remodel tumor microenvironments

to enable immune cell access as well as the potential to enhance the activity of other immune-based therapies including checkpoint inhibitors.

This solves the second half of the problem laid out by Matt, improving the impact of some of the most widely used and commercially successful drug classes.

PELIS potential here is further supported by the observation that the checkpoint inhibitor atezolizumab enhances many of its immunotherapeutic effects, demonstrating synergy between the two agents.

Lastly, changes in T cell populations have been identified as potential predictive biomarkers.

that it could improve the odds of success in future trials by informing patient selection.

Collectively, we believe these data highlight a rare one as a foundational study.

It both explains a substantial survival benefit observed in IND213 and it confirms Pella's potential to solve the problems posed by the inaccessibility of tumors to the immune system.

This position is parallel.

to be a partner therapy for a broad spectrum of anti-cancer agents with which it can act synergistically to improve outcomes across a range of indications that are in need of better treatment options.

One indication for which there is a clear need for better therapies is pancreatic cancer.

which is the subject of the second data readout I'll be discussing today.

These data come from the Phase 1-2 goblet study.

which seeks to leverage the aforementioned synergy between Pella and atesolizumab.

Patients in this study were treated with Pella in combination with atezolizumab and the chemotherapeutic agents, germcitabine, and napaclitaxel.

Goblet's initial readout revealed that all three patients in the pancreatic cancer's initial phase 1B portion achieved confirmed partial responses with an average tumor size reduction of 48% at 16 weeks following the initiation of treatment. With these data showing responses in three out of three patients, we have already met the pre-specified success criteria for efficacy in the trial's first stage.

Goblet's initial readout revealed that all three patients in the pancreatic cancer's initial phase 1B portion achieved confirmed partial responses with an average tumor size reduction of 48% at 16 weeks following the initiation of treatment. With these data showing responses in three out of three patients, we have already met the pre-specified success criteria for efficacy in the trial's first stage, which is designed to enroll a total of 12 patients.

This robust early efficacy signal exceeded our expectations and the expectations of our primary investigator. To put these and future data readouts into perspective, the largest randomized control trial evaluating GEMP, Cytobine, and NAPAC attacks on pancreatic cancer patients had an overall response rate of 23%.

Additionally, other studies have shown that adding a checkpoint inhibitor alone to chemotherapy does not benefit the overwhelming majority of pancreatic cancer patients. In fact, checkpoint inhibitors alone have been demonstrated to benefit only those pancreatic cancer patients with tumors, class

which represents less than 1% of all pancreatic cancer patients.

Our promising early data suggests that the synergy we saw between Pella and Atizolizumab and AWARE-1 in breast cancer may extend to pancreatic cancer.

If goblet's pancreatic cancer efficacy data continue to be favorable as the study progresses,

We will work to engage with health authorities to identify a regulatory path that allows us to advance the program as expeditiously as possible.

We expect our next data update in pancreatic cancer to be at a major medical conference later this year. Should this readout continue to demonstrate a strong positive efficacy signal relative to historical controls?

It would provide proof of concept support for moving forward with late stage development.

Therefore, the forthcoming goblet study update could represent an important milestone with positive strategic implications, which I will now let Andrew discuss. Andrew? No

Thank you, Tom, and good morning to all participants.

I'm especially excited about today's BD Update.

we've been making meaningful progress across our licensing drivers.

starting with our most important opportunity, breast cancer.

but also our exciting emerging opportunity in pancreatic cancer and our CAR-T outlicensing activities.

I'll begin by providing context as to the potential of the pancreatic data from a licensing perspective.

We believe that the initial data in pancreatic cancer is significant from both a clinical and a business development perspective.

as pancreatic cancer is one of the major PD-L1 unrealized opportunities.

Despite repeated attempts,

Checkpoint inhibitors have failed to successfully treat pancreatic patients.

with the exception of the 1% of such patients who are MSI high.

Given that the current standard of care can only extend survival by a few months,

and only the minority of patients who respond.

Pella RE-REP may represent PD-L1 agents' best opportunity to redefine the pancreatic standard of care.

Pancreatic cancer also serves as an excellent example of one of Pella RIA-REP's core value for Pella prosecutingJ

which is its potential to dramatically expand P

beyond those that are already approved.

As demonstrated by AWARE-1 successfully meeting its endpoint in the PELOT-centric combination cohort as well as Goblet's current pancreatic readout.

Pella has the ability to synergize with PD-L1 therapies across multiple tumor types.

Pella synergistic potential, therefore, can help produce meaningful clinical responses in patients in significant need of novel, transformative clinical solutions.

Tell RERA its potential to make previously untreatable tumors amenable to successful treatment with approved PD-L1 agents.

positions this to create significant new opportunities across a wide breadth of indications.

This potential has served as a driver for our collaboration with biopharm industry leaders.

including Pfizer, Merc Serrano, Roche, BMS, Insight, and Adlai Norte.

Looking forward, we believe these relationships, together tell us clinically demonstrated ability to overcome one of oncology's most prevalent problems.

the inability of certain immuno-cology therapies to be effective in a broader range of tumors with significant unmet need

leaves us well positioned as we work towards an eventual partnership and successful registration.

Currently?

Her most direct path towards registration continues to be an HR positive or two negative metastatic breast cancer.

That said, if our pancreatic cancer data continues to mature favorably, we may be able to provide potential partners with two near-term registration opportunities.

Breast and pancreatic cancer are, therefore, the primary focus of our development and partnering efforts.

which would be enabled by a global clinical commercialization partnership.

Pursuing a registration-focused breast and pancreatic cancer trial via partnership will allow us to intelligently leverage our capital to pursue these large target market indications.

with significant unkept clinical needs while minimizing risk.

We envision such a partnership preserving our upside potential in the form of upfront payments, milestones and royalties.

with compelling near-term clinical readouts and many key players already intimately familiar with fellow rear-up, thanks to collaborative studies such as Bracelet One, Aware One, and Goblet.

We believe we are poised to successfully execute on our BD strategy.

As Bracelet One and Goblet progress, we will continue to leverage the emerging data to drive the interest of potential partners.

While the nature of the BD process precludes you from predicting the timing of any potential deal,

I can say that we remain in productive discussions with multiple current and potential business development partners. We've presented the moment in our Republic of America and themirror with the name, click

Rather than rush into a deal that favors the partner over on colitis, however, we intend to take a methodical approach that capitalizes on both the strength of our prior results and just as importantly, leveraging the emerging data from Bracelet-1 and GOBLiT.

Our goal remains to secure a deal that minimizes clinical and commercial risk while maximizing shareholder value.

We are pleased to be in the fortunate position of having drawn interest from several competing industry leaders and look forward to providing additional updates as appropriate.

Next, I'd like to give an update on CAR T cell therapy partnering efforts, which represents a separate compelling business development opportunity.

In April , we announced the publication Science Translational Medicine that highlighted Pelorhear is the potential to fully unlock the value of CAR T therapies.

by synergistically enhancing their efficacy against solid tumors.

This was an exciting finding as it points to PelorheaRAP as a potential solution to a problem that has thus far severely limited the therapeutic and commercial impact of CAR-T therapies.

So CAR T cell therapies generate billions of dollars in annual sales and have produced groundbreaking clinical data showing long-term cures in hematologic cancers.

Efforts to extend their benefits to patients with solid tumors have thus far been unsuccessful.

With U.S. National Cancer Institute estimates indicating solid tumors comprised about 90% of new cases last year, the enormous growth opportunity represented by CAR-T's potential ability to treat solid tumors becomes easily evident.

Data featured in the Science and Translational Medicine paper suggests Pelorhea may allow CAR T therapies to reach their full potential.

as the two agents combine to provide statistically significant survival benefits in murine solid tumor models.

Notably, cure rates of greater than 80% were achieved in two separate solid tumor models treated with PEL-loaded CAR-T cells and a subsequent intravenous PEL-rear-rep boost.

Mechanistic analyses tied these benefits to Pella RE-RAP's ability to overcome each of the three key challenges.

currently hampering CAR T therapy, namely limited cell perseverance, challenging tumor micro environments, and antigen escape.

Bolstered by these findings, we are now seeking partners who could in-license Peloriera to develop it as an enabling technology for CAR T cell therapies.

The strategy of these BD efforts is notably different from those of our breast and pancreatic cancer programs, which have the long-term aim of generating direct revenues by selling large volumes of Pelarera.

In contrast, the science translational medicine data suggests pelicans substantially increase the number of patients benefiting from CAR T therapies.

with only one to two palerioreptosis needed per patient.

With CAR T therapies typically priced in the range of $400,000 to $500,000 per patient.

The financial opportunity comes from expanding the market and collecting royalties on the CAR T revenues made possible solely by fellow rear-end synergistic effects.

With this in mind, our goal with CAR T Therapies is to reach a deal based on a combination of upfront, milestone and royalty payments.

in line with what is typical of preclinical licensing agreements.

Such an agreement would position us to sharing the outside of any future commercial success of Pilar-Urof-CART T-cell combination therapy without assuming the associated development risks and costs ourselves.

We are making positive progress in these efforts as we have multiple ongoing preclinical testing collaborations.

These collaborations seek to demonstrate synergy between Pelorheura and the specific CAR T therapies being developed by our collaborators.

Unlike with PD-L1 agents, a class effect cannot be assumed due to CAR T cell therapies behaving according to their own unique genetic makeup.

The confidentiality required by potential partners leaves our ability to provide a more in-depth update on these collaborations.

contingent on the maturation of the ongoing research.

Nonetheless, I will reiterate that we remain enthusiastic about our VT prospects with CAR T therapies.

and look forward to providing additional information when appropriate and permitted by collaboration agreements.

And with that, we will now move on to Kirk's portion of the call and a discussion of our second quarter financial results. Kirk?

Thanks, Andrew.

OnClinics continues to maintain a strong balance sheet throughout the second quarter ending June 30th, 2022, with $33.7 million in cash and cash equivalents.

This compares to $41.3 million in cash and cash equivalents as of December 31, 2021.

I'm pleased to say that our current cache position leaves us well positioned to execute on key clinical milestones.

Based on our projections, our financial runway extends well into the second half of 2023, which is expected to take us through Bracelet-1's clinical and translational data announcement, as well as the additional efficacy data from our goblet study planned for later this year.

Turning now to our financial results. Operating expenses for the second quarter of 2022 were $2.8 million compared to $3.5 million in the second quarter of 2021.

This change has been mainly due to lower investor relations activities.

as the current global economic and political conditions have impacted the market sentiment in the biotech industry along with the overall capital markets.

Consequently, this year we've been mindful of our resource allocation to IR-related activities.

Research and development expenses for the second quarter of 2022 were $3.2 million, which remained consistent with the same period last year.

Now the net loss for the second quarter of 2022 was $5.1 billion compared to $7.2 million for the second quarter of 2021.

This equates to a net loss of $0.09 per share for the second quarter and $0.13 per share for the second quarter of 2021.

With that, I'll now pass the call back to Matt for some concluding remarks. Matt?

Thanks, Kirk.

Before I get into concluding remarks, I'd like to briefly recognize another important corporate achievement from Q2, which was the addition of James Parson to our Board of Directors.

James financial and strategic acumen will be invaluable assets as we work to achieve our objectives and we're thrilled to have the chance to draw on his 20 years of life science leadership experience.

This includes over 10 years spent as the CFO of the immuno-oncology company Trillium Therapeutics, a role James held through Trillium's acquisition by Pfizer for an aggregate purchase price of approximately $2.1 billion.

It's been a pleasure benefiting from James' guidance in the short time since his appointment, and we look forward to our continued work to advance Pella and bring Oncolytics to its next stage of development.

As we move towards these goals, we are doing so with meaningful foundation that we believe leaves us well positioned to solve the pressing problems posed by the inability of the immune system to recognize and infiltrate tumors.

There are several key components to this foundation, the first being our clinical data. Thanks to the success of WhereOne, IND213, and other studies, we have shown that Pella can train immune cells to recognize and attack tumors.

modify tumor micro environments in a way that enable immune cell infiltration, and derive a robust and statistically significant survival benefit in a well-controlled, randomized study.

These are tasks that are not easily accomplished.

The first two require a multi-prong mechanism of action that can simultaneously modulate many biological pathways.

This helps explain why the inaccessibility of tumors to the immune system remains such a prevalent problem that continues to severely hamper a wide range of therapeutics such as checkpoint inhibitors and CAR T therapies.

With Pella, we have a versatile immunotherapeutic agent that can pair with these therapies to tap into large new markets that are not served well by current treatments.

Given the fundamental role immunosuppression plays in cancer growth and survival, Hell's potential is broad, with its ability to awake anti-tumor immunity positioning as a platform molecule with applicability across many indications and as the backbone of combinations with a variety of drug classes.

Internally, our primary focus is on pursuing the robust signals of efficacy seen in breast and pancreatic cancer, as Andrew mentioned.

Our goal is to advance these programs into the next stage of development so we can generate multiple avenues to clinical success and minimize the risk of binary events in late-stage trials.

We are supported in these efforts by our established relationship with industry leaders. This is another core component of Oncolytics Foundation, designed to allow us to pursue large therapeutic and commercial opportunities in a capital efficient manner.

We are of course also supported in our endeavors by the talented team of employees.

academic collaborators, and clinical trial investigators working with us.

They form an additional key component of our foundation and I am always grateful for their contributions.

These contributions have us moving towards key potential value drivers, including Goblet's next update expected later this year.

Numerous breast cancer updates at the San Antonio Breast Cancer Symposium in December , and bracelet 1's comprehensive data expected in Q2 2023. Each of these has the potential to be a crucial inflection point and major step on the path towards our ultimate goal of improving the lives of cancer patients.

Finally, I'll conclude this portion of today's call by reiterating my gratitude for the support of our shareholders and most importantly, by thanking our clinical trial participants.

With that, we will now take questions. Operator? Is trying to remove those calls because you found too many listening. Um….

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We'll pull now just for a moment to allow

We will take our first question from

Please go so.

Hi, this is Jason on for Patrick and congrats on the progress and it's really exciting to see the bracelet study one progressing. So just a quick question because we were just wondering with the safety results presented already in 4Q21 for the IRENE study, when can we expect additional updates on this IRENE program and what else does Oncologia and InSight need to do to progress further into a Phase III trial for IRENE?

And I have a follow-up question after that. Thank you. Sure. Andrew or Tom, do you want to field that question since it's the relationship with InSight? I think it's actually more Tom's question, really, because there's some rules as to how many responses would be needed in order to move forward with the expansion of the crop.

Yes, I mean, Tom here. The IRENE study continues to enroll. We have two sites open and enrolling in IRENE. And we are, this is an investigator sponsored study, as you are aware, and we are in contact with the investigator regarding the progress of that study. I don't have any updates.

at the immediate time regarding that, but we do hope that that study will, that we will be able to update that study in the not too distant future, although it is as a investigator-sponsored study, based not only on our control.

Okay, yeah, that's helpful. And I guess the other thing, what we were just wondering was around the multiple myeloma studies. So, when can we also expect kind of additional updates on the NCI 9603 study, which you already showed achieved safety results in the second quarter of 2020? And how about the WNCIP 4398 trial? Thank you.

I can grab that one. Dr. Kelly and actually Dr. Hofmeister have actually shared with us manuscripts for both studies. They're in the review process now with quite frankly quite prestigious journals. So we're hoping that both of those get accepted. We're also working with one of the investigators on a follow on study that would be in conjunction with a major immunotherapeutic agent. We haven't announced that yet but I think that will be announced.

I'm hoping by end of year.

hoping by end of year. Okay, great. Thank you.

Once again ladies and gentlemen, if you would like to ask a question, please press star 1.

It appears there are no further question

Speaker, I'd like to turn the conference back to you for any closing remarks.

I'd just like to say thank you all for joining us this morning to hear about our recent progress. We're obviously very excited about it. We're in the midst of an exciting time and look forward to providing additional updates on our clinical advances. We do appreciate everyone's continued interest and we do wish everyone a wonderful day. Thank you very much.

This concludes today's call. Thank you for your participation. You may now disconnect. You may disconnect.