Oncolytics Biotech Inc. (ONCY) CEO Matthew Coffey on Q2 2022 Results - Earnings Call Transcript

Oncolytics Biotech Inc. (NASDAQ:ONCY) Q2 2022 Results Conference Call August 11, 2022 8:30 AM ET

Company Participants

Jon Patton - Director of Investor Relations and Communications

Matthew Coffey - President and Chief Executive Officer

Kirk Look - Chief Financial Officer

Thomas Heineman - Chief Medical Officer

Andrew de Guttadauro - President

Conference Call Participants

Jason Kolber - HC Wainwright

Operator

Good afternoon, and welcome to Oncolytics Biotech’s Second 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 conference call over to Jon Patton, Director of Investor Relations and Communications. Please go ahead.

Jon Patton

Thank you, operator, and good morning everyone. Earlier this morning, Oncolytics 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 Presentations section of the Oncolytics website approximately two-hours after its completion. After remarks from Company management will open the call for Q&A.

As a reminder, various remarks made during this call contain certain Forward-Looking Statements relating to our business prospects and the development and commercialization of pelareorep, including statements regarding the Company’s focus, strategy and objectives, Company’s belief as to the potential and mode of action of pelareorep as a cancer therapeutic, design, aims and anticipated benefits of our current and pending clinical trials and anticipated timing of the release of the additional data. Company’s plans and expectations regarding a potential registrational study, 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 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 Forward-Looking Statements.

In any Forward-Looking Statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief 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 other factors detailed in the Company’s filings with SEDAR and the SEC. Oncolytics does not undertake any obligation to update these Forward-Looking Statements, except as required by applicable laws.

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

Matthew Coffey

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 Heineman. Our Chief Medical Officer; Andrew de Guttadauro, our Global Head of Business Development; and Kirk Look, our Chief Financial Officer.

I would 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 telomere reps core value proposition, which is its ability to solve one of oncology’s most prevalent and long standing 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 large part due to the multiple biological mechanisms perpetuating it. With pelareorep, or pela, as I will call it, we believe we have a safe and versatile immunotherapeutic agents that can simultaneously address many of these various mechanisms and make tumors more amenable to successful treatment with complimentary anti-cancer therapies.

By doing this, we believe we could substantially broaden the commercial opportunities 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 U.S. 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 and HR positive HER2 negative breast cancer patients when pela was added on top of chemotherapy.

That is also supported by AWARE-1 which provided a mechanistic explanation for IND-213 results by establishing pela’s immunotherapeutic effects and HR positive HER2 negative breast cancer patients.

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

Another key finding from AWARE-1 was the demonstration of synergy between pela and checkpoint inhibition. As combining pela with roses 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 pela, 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.

Though early, we believe these datas are indicative of pela’s potential as a platform molecule that can be used in a variety of indications to enable immune cell access to tumors. Pela’s ability to do this contributes to its anti-cancer activity as a single agent and positions it as 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 GOBLET pancreatic cancer cohort at a major medical meeting later this year. With enrollment nearly completed in stage one of the cohort, we submitted an abstract that includes objective response data at week 16 on all valuable patients.

This update includes follow up on the three patients we have 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.

And now, I would 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-1, our randomized Phase 2 trial and HR+/HER2negative metastatic breast cancer. With BRACELET-1enrollment finishing near the end of last quarter, the trial is 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 are 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 BRACELET-1enrollment combined with the 90 day exclusivity period from our contractual obligations to Pfizer and Merck Serrono and the scheduling of major medical meetings, we have pushed our anticipated disclosure from the end of 2022 into Q2 2023.

It is 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 with a future registrational study.

This new study will be informed and supported by BRACELET-1’s results, as well as by pela’s robust safety database, Phase 1 efficacy data demonstrating its single agent activity, and the aforementioned results of 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 Oncolytics team believe announcing BRACELET-1’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 rate, progression-free survival data, and evolving overall survival data from the trial’s randomized cohorts.

We will 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 BRACELET-1 data to substantially de-risk our breast cancer program. Bolster our business development prospects and fuels pela’s advancement into registrational study by providing key learnings that will inform the trial of design.

Nonetheless, we are still very excited about the breast cancer data we will have in the fourth quarter of this year at 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 AWARE-1 data.

With that, I will introduce Tom to provide some additional context around the recent announcements from AWARE-1 in GOBLET. Tom.

Thomas Heineman

Thanks, Matt. The most recent results from the AWARE-1 study further strengthen the overall dataset that demonstrate pela’s immunologic mechanism of action. Importantly, in doing so, these results clearly reinforce pela’s 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 pela when added to the standard of care therapy Letrozole with or without the checkpoint inhibitor atezolizumab modified the tumor micro environment in HR positive, HER2 negative breast cancer patients.

This is the same breast cancer subtype for which pela provided a statistically significant and clinically meaningful survival benefit in the IND-213 study, as mentioned earlier by Matt, and is the breast cancer type, we intend to evaluate in a future registrational trial.

Some of the most interesting data presented at the ESMO Breast Cancer Meeting came from the PAM50 gene panel analysis that correlated changes in the tumor with the likelihood of a patient’s cancer recurring following successful treatment.

These correlations were captured using a risk of recurrence score, with results showing all valuable patients, having a risk of recurrence score classified as low following treatment. This represented a near doubling from the 55% that have this favorable classification at the start of the study.

These exciting results together with the previously reported AWARE-1 data including increases in the prognostic cell till score, clearly support the profound clinical benefits we believe pela can provide. They also offer a thorough understanding of exactly how pela may drive clinical benefit.

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

These mechanisms of action were established by multiple experimental observations. First pela stimulates the generation expansion and activation of CD-8 positive T cells. This illustrates its ability to teach the immune system to recognize tumors, solving the first half of the longstanding problem. Math laid-out at the top of the call, namely the inability of the immune system to recognize and infiltrate tumors.

Second, pela promotes the infiltration of anti-cancer immune cells into the tumor and it up regulates PDL-1 expression in tumors. This is noteworthy because it demonstrates pela’s ability to remodel tumor micro environments 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. Pela’s potential here is further supported by the observation that the checkpoint inhibitor atezolizumab enhances many of it is immunotherapeutic effects, demonstrating synergy between the two agents.

Lastly, changes in T cell populations have been identified as potential predictive biomarkers that could improve the odds of success in future trials by informing patient selection. Collectively, we believe these data highlighted AWARE-1 is a foundational study. It both explains a substantial survival benefit observed in IND-213 and it confirms pelareorep’s potential to solve the problems posed by the inaccessibility of tumors to the immune system.

This positions pela 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 will be discussing today.

These data come from the Phase 1/2 GOBLET study, which seeks to leverage the aforementioned synergy between pela and atezolizumab patients in this study were treated with pela in combination with atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel.

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 and the trials 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 gemcitabine and nab-paclitaxel 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 classified as MSI5, which represents less than 1% of all pancreatic cancer patients.

Our promising early data suggests that the synergy we saw between pelareorep atezolizumab 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.

Andrew de Guttadauro

Thank you, Tom, and good morning to all participants. I’m especially excited about today’s BD update, as we have been making meaningful progress across our licensing drivers, starting with our most important opportunity breast cancer, but also our exciting emerging opportunity pancreatic cancer and our CAR T out licensing activities.

I will begin by providing context as to the potential to pancreatic data from a licensing perspective. We believe - initial data in pancreatic cancer 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 few months and only the minority of patients who respond pelareorep 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 pelareorep’s core value drivers, which is its potential to dramatically expand [P801’s] (Ph) addressable patient population beyond those that are already approved. as demonstrated by AWARE-1 successfully meeting its endpoint in the pela test centric combination cohort as well as GOBLET’s current pancreatic readout.

Pela has the ability to synergize with PD-L1 therapies across multiple tumor types. Pela’s synergistic potential therefore can help produce meaningful clinical responses in patients and significant need of novel transformative Clinical Solutions.

Pelareorep is essential to make previously untreatable tumors amenable to successful treatment with approved PD-L1 agents positions it to create significant new opportunities across a wide breadth of indications. This potential has served as a driver for our collaborations with biopharma industry leaders, including Pfizer, Merck Serrano, Roche, BMS, Incyte and Adlai Nortye.

Looking forward, we believe these relationships together with pela’s clinically demonstrated ability to overcome one of oncology’s most prevalent problems. The inability of certain immuno-oncology 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, our most direct path towards registration continues to be an HR positive or HER2 negative metastatic breast cancer.

That said if our pancreatic cancer data continues to mature favorably, we may be able to provide potential partners with to near-term registration opportunities. For us in pancreatic cancer are therefore the primary focus of our development and partnering efforts, which would be enabled by 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 unmet 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 pelareorep.

Thanks to collaborative studies such as BRACELET-1 AWARE-1 and GOBLET, we believe we are poised to successfully execute on our BD strategy. As BRACELET-1 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 me 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, rather than rushing to a deal that favors the partner over Oncolytics, however.

We intend to take a methodical approach to capitalize on both the strength of our prior results and just as importantly, leveraging the emerging data from BRACELET-1 and GOBLET. Our goal remains to secure a deal that minimizes clinical 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 would 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 pelareorep’s potential to fully unlock the value of CAR T therapies by synergistically enhancing their efficacy against all the tumors.

This was an exciting finding as it points to pelareorep’s 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 produce groundbreaking clinical data shown long-term cures and hematologic cancers, efforts to extend their benefits to patients to 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 pelareorep’s may allow CAR T therapies to reach their full potential. As the two agents combined to provide statistically significant survival benefits and mirroring solid tumor models. Notably cure rates of greater 80% were achieved in two separate solid tumor models treated with pela loaded CAR T-cells and a subsequent intravenous pelareorep boost.

Mechanistic analyses tied these benefits to pelareorep’s ability to overcome each of the three key challenges currently hampering CAR T therapy, namely limited self-perseverance, challenging tumor micro environments and antigen escape.

Also by these findings, we are now seeking partners who could in license pelareorep 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 breasts and pancreatic cancer programs, which have the long-term aim of generating direct revenues by selling large volumes of pelareorep.

In contrast, the Science Translational Medicine Data suggests Pelican substantially increased the number of patients benefiting from CAR T therapies with only one to two pelareorep doses 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 meet possible solely by pelareorep’s synergistic effects.

With this in mind, our goal with CAR T therapies is to reach a deal based on combination of upfront, milestone and royalty payments in-line with what is typical of preclinical licensing agreements.

Such an agreement would position us to share the upside of any future commercial success of pelareorep CAR 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 to demonstrate synergy between pelareorep 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.

Kirk Look

Thanks, Andrew. Oncolytics continues to maintain a strong balance sheet throughout the second quarter ending June 30, 2022 with 33.7 million in cash and cash equivalence. This compares to 41.3 million in cash and cash equivalent as of December 31, 2021.

I’m pleased to say that our current cash 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 have 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 remain consistent with the same period last year. Now the net loss for the second quarter of 2022 was $5.1 million 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 will now pass the call back to Matt for some concluding remarks. Matt.

Matthew Coffey

Thanks, Eric. Before I get into concluding remarks, I would like to briefly recognize another important corporate achievement in 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 are 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 Trillion Therapeutics, a role James held through Trillion’s acquisition by Pfizer for an aggregate purchase praise of approximately 2.1 billion.

It has been a pleasure benefiting from James’s guidance in the short time, since his appointments. And we look forward to our continued work to advance pela 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 be in our clinical data, thanks to the success of AWARE-1, IND-213 and other studies. We have shown that pela 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 benefits in a well controlled randomized study.

These are tasks that are not easily accomplished. The first two requiring a multi-pronged 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 pela, we have a versatile immunotherapeutic agent that compare 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 pela’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 supporting these efforts by 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’m always grateful for the contributions.

These contributions habits moving towards key potential value drivers including GOBLET’s next update expect 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 will 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.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] We will take our first question from Patrick Trucchio from HC Wainwright. Please go sir.

Jason Kolber

Hi. This is Jason on for Patrick, and congrats on the progress and it is really exciting to see the BRACELET-1 study progressing. So just a quick question, because we were just wondering with the safety results presented already in 4Q 2021 for IRENE study, when can we expect additional updates on this IRENE program and what else was Oncolytics or an insight need to do to progress further into a Phase 3 trial for IRENE? And I have a follow-up question after that. Thank you.

Matthew Coffey

Sure. Andy or Tom, do you want to fill that question since it is the relationship of insight?

Andrew de Guttadauro

I think it is actually more Tom’s question really, because there is some rules as to how many responses would be needed in order to move forward with the expansion of the trial.

Thomas Heineman

Yes. Tom here. The IRENE study continues to enroll. We have two sites open and enrolling in IRENE. And this is an investigator sponsored study as you are aware, 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 - that we will be able to update that study in the not too distant future. Although it is as investigator sponsored study. It is not fully in our control.

Jason Kolber

Okay, yes that is helpful. And I guess the other thing we will 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 2020? And how about the WINSHIP 4398 trial? Thank you.

Matthew Coffey

I can grab that one. Dr. Kelley actually and actually Dr. Hoffman have actually shared with us manuscripts for both studies. They are in the review process now with quite frankly quite prestigious journals. So we are hoping that both of those get accepted.

We are 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 the end of the year.

Jason Kolber

Okay. Great. Thank you.

Operator

[Operator Instructions] It appears there are no further question at this time. Speaker, I would like to turn the conference back to you for any closing remark.

Matthew Coffey

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

Operator

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