Earnings Transcript for ADXS - Q2 Fiscal Year 2018

Executives: Miriam Miller - LHA Investor Relations Ken Berlin - President and Chief Executive Officer Andres Gutierrez - Executive Vice President and Chief Medical Officer Robert Petit - Executive Vice President and Chief Scientific Officer

Analysts: Swayampakula Ramakanth - H.C. Wainwright

Operator: Welcome to the Advaxis Conference Call. At this time, all participants are in a listen-only mode. Following management’s prepared remarks, we’ll hold a Q&A session [Operator Instructions]. As a reminder, this conference is being recorded, June 07, 2018. I would now like to turn the conference over to Miriam Miller. Please go ahead.

Miriam Miller: Good morning. This is Miriam Weber Miller with LHA, the Investor Relations Agency for Advaxis. Thank you all for participating in today’s call. Joining me from Advaxis are Ken Berlin, President and Chief Executive Officer; Dr. Andres Gutierrez, Executive Vice President and Chief Medical Officer; and Dr. Robert Petit, Executive Vice President and Chief Scientific Officer. Before market opened this morning, Advaxis filed its quarterly report on Form 10-Q with the SEC and issued a press release, providing a business update and disclosing its financial results for the second quarter ended April 30, 2018. If you have not received this news release or if you would like to be added to the Company’s e-mail list, please call LHA in New York at 212-838-3777, and speak with Caroline Kjos. Before we begin, I would like to remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Advaxis. I encourage you to review the Company’s SEC filings, including without limitation, the Company’s Form 10-K for the fiscal year ended October 31, 2017 and other period reports filed with the SEC, including Form 10-Q and 8-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements and other risk factors related to its business operations. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast June 7, 2018. Except as required by law, Advaxis undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With all that said, I will turn the call over to Ken Berlin. Ken.

Ken Berlin: Thanks Miriam. Good morning and thank you for joining us. I'm pleased to have this opportunity to talk with everyone today in my first quarterly call as President and CEO of Advaxis. It's an exciting time to be joining Advaxis, and I believe my experience and expertise will help to advance the Company's mission and goal. I bring a wide range of experience from both large and small development stage and commercial companies, having spent much of my career working in oncology in both therapeutics and diagnostics. I’d helped to develop and launch a number of products, I've scaled up organizations to achieve revenue growth, and I've raised capital along the way to fund it. Over the past couple of decades, I've also led successful efforts in licensing, mergers, acquisitions, divestitures and commercial transactions. I look forward to continuing to leverage my experience and expertise at Advaxis. Since I joined the Company about six weeks ago, we have been working diligently to refine our strategic direction through a prioritization of multiple opportunities afforded by our Lm platform technology. As part of this process, we have also identified concrete steps we can take to make Advaxis more capital efficient. The need for this portfolio prioritization has been triggered in large part by the fact that our earlier states programs, mainly HOT and NEO, have continued to advance toward the clinic. We believe these programs hold great potential in the exciting and fast developing field of neoantigens. So it is important that we allocate capital to invest in these programs in order to realize their potential. But this also requires us to reduce investments in other programs. We believe the best way to create shareholder value is to focus our investments in commercially attractive applications of our LM platform that also have the following two key attributes; first, it must be an indication where we believe we can meaningfully impact cancer care due to the unique attributes of our LM platform; second, it must be an indication where there is potential to rapidly and cost-effectively demonstrate proof of concept, we use these criteria, commercial attractiveness, fit for LM platform and time to validation to evaluate each of the assets in our portfolio in order to determine whether Advaxis can create more value by developing the program internally or externally. I'll walk you through the pipeline of programs shortly and describe how we have prioritized our investments in them. Dr. Gutierrez and Dr. Pettit will also share their thoughts on the programs, and the evolution of the science and our platform that supports our go forward strategy. Before I share more about our strategic direction, I'd like to make a couple of comments about our executive team. We are very excited about the current team, which includes the addition of our Executive Vice President and Chief Medical Officer, Dr. Andres Gutierrez. We are also extremely pleased to have announced just yesterday the appointment of Molly Henderson as Executive Vice President and Chief Financial Officer. We welcome Molly to Advaxis and look forward to leveraging her financial and business acumen as we work as a team to take Advaxis to the next level. I feel confident we have the right leadership team in place to execute our strategy. Now, let's turn to our product pipeline and the strategic framework that guided our decision-making during the recently completed evaluation process. As I stated earlier, our go-forward strategy is to invest in those assets we believe present the highest potential and the best ROI. This means we will increase internal investments in some assets and decrease investments in others by exploring partnering opportunities. Both approaches, internal development and partnering, allow us the opportunity to monetize our assets. I want to emphasize that our refined strategy is based on a simple reality. We believe we have a robust pipeline, which is good but we also believe that we cannot continue to effectively pursue all of our programs with our current level of resources. Given all of this, our pipeline decisions breakdown as follows; our lead program, AXAL and HPV associated cancers, has shown meaningful clinical activity with a manageable safety profile, which we believe demonstrates proof of principle for our Lm platform. However, based on the portfolio assessment criteria I outlined, we have decided that some of the HPV related indication should be partnered, while others merit further internal investment. The net effect of this decision will be a significant reduction in our spend on the HPV program. Specifically, we will look to partner our cervical cancer program and minimize our internal investment in it. Our plan is to expand our search for a U.S. and/or European partner for our cervical program. If no partner emerges, we will wind down the ongoing AIM2CERV trial in high-risk locally advanced cervical cancer, and we will not conduct the ADVANCE PD-1 combination trial in metastatic cervical cancer, which you may recall is not yet been initiated. We have given ourselves a limited period of time to secure a partner. We intend to provide an update on this program during our 3Q call. Importantly, based on the clinical activity we have seen, we continue to believe in HPV as a target. Therefore, we are evaluating cost-effective ways to invest in AXAL and head and neck cancer, a cancer that is growing in incidence and of which nearly 70% of patients are HPV-positive. In short, the HPV program is important to us, but we must be realistic about what we can and cannot develop on our own. Regarding our ongoing trial in metastatic prostate cancer with Advaxis-PSA in combination with KEYTRUDA, early clinical data have proven worthy of continued evaluation. And Andres will provide more color on the results we have seen to-date in the combination trial. So where is Advaxis investing? Today, I'm here to talk with you about an important shift in our strategy, a pivot if you like, which is driven both by the emergence of new antigen-based treatments with a potential to transform cancer care along with the progression into the clinic of our own neoantigen based programs, HOT and NEO. We believe these programs provide an excellent opportunity for us to compete for a leadership position in the neoantigen field, one that is attracting a great deal of attention from physicians, investors and biopharmaceutical companies. We believe the best way to compete with this leadership role and to create shareholder value is to dedicate more resources to the NEO and HOT programs. Not surprisingly, the assets that are part of these programs score very high when we evaluate their commercial attractiveness, fit for our Lm platform and perhaps most importantly, their ability to demonstrate proof-of-principle in a rapid and cost-effective manner. Now, let me tell you why we believe we can and should compete for leadership. First, the neoantigen field is rapidly evolving and has the potential to transform the treatment of cancer, much like checkpoint inhibitors and CAR-Ts have done. Several companies, such as Moderna, Neon, Gritstone and BioNTech along with Advaxis, are investing in this highly innovative space. We think that the unique attributes of our Lm platform allow us to stand out from this crowd. Second, we believe we are uniquely positioned to succeed in the neoantigen space based on our experience, expertise and technology platform. To-date, over 530 patients have been treated with our LM product candidate in multiple clinical trials, and we have assembled a body of data that shows a manageable safety profile, induction of immune responses and clinical activity. Third, our NEO and HOT programs have potential applications across multiple tumor types, which provides us with opportunities to succeed in a number of high-value immunooncology market segments. It is worth noting that Amgen saw value in our NEO program when we struck a deal with them back in 2016, well in advance of being in the clinic with this program. We think this is important validation of our Lm platform in neoantigen space. Our HOT and NEO programs are progressing well, and we now have multiple opportunities in high-value tumor types that we can bring into the clinic in the near term. As we have disclosed publicly, our first product -- our first HOT product candidate entering the clinic is for non-small cell lung cancer. The next product candidates for hot will be selected from among the following six tumor types; prostate, breast, colorectal, bladder, ovarian and head and neck cancers. These are all high-value tumor types, and we believe our HOT product candidate have the potential to meaningfully impact cancer care in these indications. We also believe there are paths forward to demonstrate this potential in a reasonably cost-effective and timely manner. Both Andres and Robert will talk about the potential of these programs, their excitement about the emerging role of neoantigens in the fight against cancer, and the plans for our Neo and hot programs, overall. We are entering a new phase for Advaxis as we implement changes we believe will optimize our assets in a capital efficient way. Some of these changes, while necessary, are very difficult to make. We announced this morning that we will be implementing a reduction in force to align our staffing with our go forward plans. I would like to take this opportunity to thank all our departing employees for their hard work, and I wish them well in their future endeavors. The reduction in force will occur today and involve the elimination of approximately 24% of our workforce. We will be taking a one-time charge related to this restructuring in our fiscal third quarter of approximately $905,000. The elimination of these positions in conjunction with the reduction in clinical expenditures will significantly lower our operating expenses and align our operations to focus on our priority programs. In terms of fiscal Q2 financial highlights, given our new strategic focus, our historical financial results are not indicative of our future plans. So we're not providing a detailed review here today. However, as disclosed in greater detail in our 10-Q, we believe the actions we are taking today and in the future provide us with a cash runway of at least one year from today. If you would like to review our Q2 performance, please refer to our press release and 10-Q filings from earlier this morning. You can find both of these on our Web site. Now I'd like to turn the call over to Dr. Gutierrez, who will introduce himself, share his excitement for our new direction and provide a clinical update. Andres?

Andres Gutierrez: Thank you, Ken. I'm delighted to be speaking with you today as Chief Medical Officer of Advaxis, a position I assumed six weeks ago. I have worked in oncology drug development for more than 25 years with both small molecules and biology. I have seen a lot of approaches to treating cancer, including my own work in gene therapy, and more recently leading the study and all checkpoint inhibitor programs at Bristol-Myers Squibb. I have also served as Chief Medical Officer for several biotech companies, leading the development strategy for peptide vaccine and oncolytic viruses in solid and hematologic malignancies. Before I address the Advaxis clinical programs, I want to share with you why I am so enthusiastic about joining the Company. Quite simply, I believe that Lm based vaccines are among the most efficient antigen delivery systems to elicit the specific antitumor and T-cell responses that then can lead to clinical responses across multiple cancer types. The Lm technology represents an evolution of this field. We’re going from the recently established paradigm checkpoint inhibitors, which induce non-specific detail activation and are now moving to a more nuance approach with our Lm platform, which selectively instructs T-cells to attack new antigens from cancer cells to control tumor growth. Any generation drug candidates, including AXAL, Advaxis-PSA and Advaxis HER2 have shown that these constructs are antigen delivery systems capable of eliciting new responses against a specific tumor target, while exhibiting a manageable safety profile and clinical activity. These early efforts help to instruct T-cells with a single target. In our latest generation vaccines, we now seek to customize the T-cell response to attack multiple targets, using a single Lm vaccine. In my role as CMO, I will apply my expertise to all our development projects. This expertise includes a proven track record in defining focused clinical strategies using biologics, the ability to set and meet clinical and regulatory timelines and goals, applying innovative trial designs that generate meaningful data in a rapid and efficient manner and building and managing teams to maximize efficiency. Now, I would like to disclose the status of the clinical programs, specifically an updates on the clinical hold on the study evaluating the combination of durvalumab and AXAL, the status of our AXAL and Advaxis-PSA program and actionable items related to the increased focus on the NEO and HOT programs. The clinical hold on the combination trial with AXAL and durvalumab pertains to a submission of a safety report we made to the FDA on February 27, 2018, regarding the date of our trial subject that involved pulmonary toxicity, occurring after nine months of therapy. As announced at the time we’ve begun working closely with the site investigator, our partner AstraZeneca and the FDA, to review this event in detail and to resolve this clinical hold. Several external experts from prominent institutions were also consulted in the process. We now plan to submit our response to the FDA shortly, and expect to hear back from them within 30 days from submission. As a reminder, the clinical hold applies only to this respect. Regarding HPV, as Ken articulated, we are searching for a partner for cervical cancer, and are working to establish a cost effective protocol for axle AXEL in head and neck cancer based on the pre-clinical and clinical activity we've already seen. Regarding our working metastatic castration resistant prostate cancer early clinical data are encouraging. We presented or posted at ASCO last Saturday, highlighting results of our chemo KEYNOTE-046 with Merck, which generated a lot of interest. At a high level, we found out that Advaxis-PSA was safe and well tolerated at multiple dosing levels. We also saw an early clinical signal in extending survival among patients treated with Advaxis-PSA plus pembrolizumab, as well as reduction in PSA levels and as previously reported antigen spread. In conjunction with Merck, we concluded that we would like to follow the survival data for another six to nine months to see if the data are sufficiently compelling to warrant further clinical development. Now, let's turn to Advaxis NEO and Advaxis HOT. Our focus will be on the therapeutic development of both personalized vaccines, Advaxis-NEO and cancer type of specific vaccines Advaxis-HOT. These programs will leverage the preclinical and clinical experience we have with the Lm platform. Robert is going to talk about the evolution of our work here, both on the platform and the rapidly emerging opportunities we're seeing. I will focus on providing updates and important clinical readouts and time lines. As you know, Advaxis-NEO is partnered with Amgen, dosing for the first patient is imminent and we are working to enroll additional patients on this study with four sites and growing as of today. Keep in mind that the total time from obtaining the biopsy, sequencing the patient DNA, and producing the personalized vaccine, takes approx a week which is quicker than many of the other personalized approaches in this space. I would like to acknowledge the great effort our Advaxis tech ops and quality team have put into producing these high quality personalized Lm vaccines in house, in such an efficient manner. Turning now to Advaxis-HOT, this is a cancer specific approach for presenting neoantigens and other tumor-associated antigens. We believe HOT has the potential to significantly impair counter proliferation in multiple tumor types. This will be in the form of off the shelf Lm vaccines designed specifically for each tumor type, of which we currently have more than 10 designs at various stages of pre-clinical development. The clinical plan for HOT includes the filing of four INDs by the end of 2019, resulting in pilot studies evaluating safety in new responses and preliminary clinical activity of four different constructs addressing four different tumor types. As Ken stated, the first HOT product named Advaxis-503 will be evaluated in non small cell lung cancer. The next three HOT products will be selected from among prostate, breast, colorectal, bladder, ovarian and head and neck cancer. The scope and design of these trials and the selection of other indications is now on the discussion internally and externally with immunooncology experts. We expect to file the IND for Advaxis-503 within the several weeks, and to have the first patient dose in the non-small cell lung cancers trial by the end of this calendar year. Regarding timeline for both the HOT and NEO programs, we anticipate having safety and immune data in 2019 and readouts of clinical activity across different indications and Lm constructs in 2020. As you can see, we have an increased focus on our NEO and HOT programs along with select trials of AXAL in head and neck and Advaxis-PSA in prostate cancer. We’re excited about this refined approach to develop next generation cancer therapies, and to quickly generate a relevant data. I’ll turn the call to Robert now.

Robert Petit: Thank you. Andres mentioned the building excitement in oncology around the potential of neoantigens in cancer therapy. I’d like to take a few minutes to get into the science behind our neoantigen programs, and explain why we believe these programs will allow us to compete effectively in the space. Our NEO and HOT programs are built on several critical innovations, developed by the Advaxis science team. Preclinical data we have presented at scientific meetings on NEO and on HOT have been generating increasing enthusiasm. Both NEO and HOT incorporate neoantigens as tumor targets, while HOT also incorporates additional tumor-associated antigens. Advaxis-NEO is patient specific and incorporates personal neoantigens, identified by sequencing the patient's own tumor and constructing that into a tailor made immunotherapy targeting their own personal or private mutations. It’s exciting to note that the first patients have now been enrolled in our clinical trial for NEO, and we will be treating the first patient this month. In contrast, the Advaxis-HOT takes a cancer type specific approach rather than a patient specific approach. We’re developing Advaxis-HOT product candidates for each different tumor type. For example, there will be one product for non-small cell lung cancer, a different product for prostate cancer, et cetera. But each Advaxis-HOT product incorporates the most common shared or public hotspot neoantigens that are observed in that particular tumor type, along with multiple other proprietary tumor-associated antigens, which are known to play a role in oncogenesis. All of these elements are rolled up into one off-the-shelf product with the potential for broad application across a given tumor type. Therapeutic cancer vaccines have been under investigation for over 30 years. Unfortunately, the results to-date have been disappointing. Historically, most cancer vaccines have been based on expressing normal or self tumor associated and antigen targets. The problem with that is that the immune system is designed to ignore or be ambivalent towards normal or self sequences primarily to help prevent autoimmunity. As a result, these targets and cancer vaccines only tend to generate weaker T-cells that may not be strong enough to kill the cancer effectively. The hotspot mutation neoantigens used in Advaxis-HOT are non-cell, because they result from acquired mutation. In addition to these hotspot mutation neoantigens, our HOT product candidates also contain multiple tumor-associated antigens that are derived from embryonic cancer tested or oncofetal genes, which we’ve modified to improve their immunogenicity. Another issue with cancer vaccine is that they typically present one target. We know that presenting multiple targets often result in better tumor control. Therefore, to overcome these challenges, Advaxis-HOT constructs are packed full of more than 30 targets that are all capable of generating strong T-cells. Many vaccine approaches have been unable to generate effective T cell responses, particularly against targets that are poorly immunogenic. However, as demonstrated in recently presented data the Advaxis LM vaccines can generate effective CDA dominant T-cell responses that kill tumors even against poorly immunogenic targets. Therefore, we believe that the HOT and NEO product candidates will effectively prime and arm patients with a significant population of cancer fighting T-cells. The immune system needs immunologic soldiers, the T-cells that can identify, hunt down and kill the cancer enemy from within. Advaxis Lm immunotherapies like NEO and HOT have the potential to actively recruit troops from the patient's own immune system, train them to clearly recognize cancer cells, put weapons in their hands, empowering them to kill those cancer cells when they find them and to reduce the ability of the tumors to resist them once the battle begin. Based on these attributes, we believe that our patient specific NEO and cancer type specific HOT product candidate has the potential to become a cornerstone of immunotherapy. And now, I'd like to turn the call back over to Ken for concluding remarks.

Ken Berlin: Thank you, Robert and Andres. I am sure you can tell from Andres and Robert that not only do we believe Advaxis is well positioned to succeed in the neoantigens field, but we have preclinical and clinical data to support this belief. Moreover, we're beginning clinical studies in NEO and HOT this year that we expect will generate data beginning in 2019 to demonstrate that with our differentiated Lm platform, we can be an important player in this exciting field. We believe these efforts in HOT and NEO combined with our efforts in AXAL in head and neck cancer and Advaxis-PSA in metastatic prostate cancer, provide us with an exciting portfolio of product candidates, consisting of multiple shots on goal with a diversified risk profile. We realize there's a lot to digest from the call today. However, we believe this focused approach to development, combined with a partnering strategy for certain assets, will help us move forward as rapidly and as cost efficiently as possible. The team is committed to our mission, a mission that ultimately boils down to helping patients with cancer, while also creating value for our shareholders. On behalf of the Advaxis management team and Board of Directors, I thank you for your support as we continue to build Advaxis into a leading immuno oncology company. With that overview, operator, we're ready to take questions.

Operator: [Operator Instructions] Your first question is from Swayampakula Ramakanth with H.C. Wainwright. Please go ahead.

Swayampakula Ramakanth: This is RK from H.C. Wainwright. Good morning Ken, congratulations on coming over to Advasix and putting together strategy to take this Company forward. A couple of quick questions, so initially starting off with the cervical cancer and the AXAL program, especially focusing on AIM2CERV, since this program has been initiated and has been up for some time. What are the steps being taken for those who are currently on the trial and also for those centers that have actually committed resources to the program to avoid any loss of goodwill at these cancer centers?

Ken Berlin: Good morning, RK. And thank you for your question and thank you for your kind words. We are excited to be here to take Advaxis down a new path. Specifically as it relates to your question concerning the AIM2CERV study, right now, its status quo, we haven't changed anything. What we’ve said is we continue with the study. We’re looking to find a partner. We’re giving ourselves a limited period of time to find a partner. And if we’re unable to do so then we can start talking about what's going to happen to those studies right, what the wind down might look like. And it's too premature to talk about that. But clearly, we are definitely patient focused, so the likelihood is, our intent is to allow patients to complete the study we’re currently on study. Does that answer your question?

Swayampakula Ramakanth: So the second part is the European filing. So where is that in terms of progress and what are the resources being spent on it? And in case, we have an approval, say in the first quarter of ’19 or so. Would you commercialize it or you're still going to be looking for a partner for that? And on the flipside, if the program requires additional resources, so what would you be doing in that instance?

Ken Berlin: RK let me reiterate what our plan is for cervical generally, and how it might relate to the filing in Europe. So again, our goal here is to allocate resources in the most capital efficient and value creating way. And we apply the criteria that were outlined in the opening statements to do that. And as part of that process, it was determined that cervical cancer was not an indication that we were going to take forward on our own. So we are actively searching for a partner in the U.S. and/or Europe to take on the cervical cancer indication. And absent finding that partner, we will be winding down the study and not moving forward. Exactly how the MAA filing will be treated is to be determined, and will really depend on the outcome of our partnering process.

Swayampakula Ramakanth: And then regarding the HOT program. What additional work needs to be done? And we understand that you're going to put in the non-small cell lung cancer in a asset into the clinic pretty soon here. With regards to any data so that we understand how effective this program is, would we see any additional data from here, the next six to 12 months in the pre-clinic side?

Ken Berlin: I'm going to turn this over to Robert and Andres to answer.

Robert Petit: So from the preclinical side, most of the legwork has been done to prepare the necessary documentation for the filing of the regulatory documents with several of our earlier and top priority constructs. And so we feel like there will not be any additional data that will be publicly disclosed beyond what we have, because we're focusing now on moving it into the clinic as expeditiously as time, circumstances and capital will allow. And then Andres can talk about the clinical plan with those and the design of the trial.

Andres Gutierrez: So first of all, as we were mentioning in the -- during the call, we are planning to file the first IND in non small cell lung cancer in the following few weeks. And again, we're going to identify additional indications for three additional INDs in the following 18 months. We are now sketching the final development plan in some of these indications with the help some external experts in immune oncology.

Ken Berlin: And let me just add, as I mentioned, one of the key factors that we're using to evaluate and prioritize the different constructs or product candidate opportunities in HOT is time to validation. So one of the things that's helpful in talking to the immune oncology experts out in the field is to understand where the windows of opportunity may exist for our product to fit in into a study that would generate data in a meaningful timeframe, and in a cost-efficient way. In fact, we've got a lot of feedback at ASCO on that that we're now digesting and helping us figure out the path forward on certain things. As you know, RK, this is a very competitive field, just generally, in the I/O field from a study published in September there are 1,200, at that time, clinical and preclinical candidates in the I/O space with eight hundred different companies. And what we're competing for is by enlarge patients, and you need to attract investigators to want to use our products on these patients for experimental therapies. And the good news is we do have the attention of lot of these experts out there, they're helping us think through the best path forward that’s going to help determine next steps in prioritization.

Swayampakula Ramakanth: Actually, I was thinking about the neoantigen program as well. It’s been about two years, within a month it’ll be two full years, since Amgen came on board. And we’re just getting ready to dose the first patient. I'm just trying to compare in contrast. So we have a huge company behind us, called Amgen, and what are the lessons we learned through that collaboration so that the HOT program moves much faster compared to the NEO program?

Ken Berlin: Well, I think there’ve been a number of changes at the Company. So first and foremost, bringing Dr. Gutierrez on board to help us think through our clinical programs is probably the most important thing that will impact time, because as Andres explained from his background, he has a lot of experience designing programs that will allow us to get into the clinic pretty quickly and generate some early data. So I think one of the things we’ve learned as a company, not necessary from Amgen relationship but just generally, was we really need to bring that expertise in house. And we've done that in the person of Dr. Gutierrez. And I think that's probably the single most important thing that’s going to help us not have an extra lap around the track, and take two years to get in the clinic. As we laid out for you, as Dr. Gutierrez laid out for you, we’re going to file the IND for the first HOT product candidate in lung this month within the next several weeks, and then get in the clinic by the end of the year, if all goes well. And then we will be following the long high construct with the next one from among those six large tumor types that were mentioned earlier and hopefully, we’ll be getting in the clinic early next year with that product candidate, if all goes well. So I think we’ve really got more focus, we have the clinical expertise, which is critical in order for us to move swiftly into the clinic and generate data in a quick and cost-efficient way.

Operator: [Operator Instructions] Your next question comes from [Frank Michaels], Private Investor. Please go ahead.

Unidentified Analyst: Good question with respect to non-small cell lung cancer. Specifically, why did you choose that? And I think the space is quite crowded with the Merck and their results with KEYTRUDA. And what you foresee the challenges in enrollment? Thank you.

Ken Berlin: So I'll take that first question, Frank, thank you for the question. It’s a very good question. And I/O generally and cancer even more generally is a very crowded and competitive space. And so as I mentioned, what we looked at when we were prioritizing our programs even within the hot program itself was competitive intensity like you described, which is very high in non-small cell lung cancer. But we believe that with the size of the opportunity and certain specific attributes of our Lm platform, we think there's a place for us in non small cell lung cancer. We'll be talking about the design of the trial later. We're not ready to disclose what that looks like, but we think there's a place for us to really have an impact. And obviously, we're taking input from experts in the field to make sure that we're thinking about things appropriately. Now, I will turn it over to our experts for this to give you a more clinical response.

Andres Gutierrez: We believe that although lung cancer is a very crowded indication that you were mentioning, there's plenty of opportunity still. For example, just talking about studies with checkpoint inhibitors in different stages, mainly in the first line, we're still missing something because patients are progressing within one year of therapy, that's 60% of the patients they progress within one year of therapy. So clearly, there is a need for adding on additional agents on top of checkpoint inhibitors in that space, for example. But what we have in that we have seen opportunities across different indications in the lung cancer indication. And as you are aware, the treatment now has been segmented in different depending on the different genomic landscape of these patients, so there is opportunity. The answer to treatment of lung cancer is not depending on checkpoint inhibitor with or without chemotherapy and other agents. And of course, we have been consulting these with different experts in the states as well as in Europe.

Operator: There are no further questions at this time. Mr. Ken Berlin, please proceed with your presentation or closing remarks.

Ken Berlin: Again, I'd like to thank you all for participating on today's call and for your questions. I trust my colleagues and I conveyed clearly our change in strategy and the rationale for this change, as well as our optimism for the Company's future as we go down this new path. We look forward to making continued progress, executing the business strategy we laid out today and to providing updates on our achievements. We appreciate your continued interest in Advaxis, and look forward to reporting our progress in our fiscal third quarter business update conference call in September. Thanks again.

Operator: Ladies and gentlemen, that concludes your conference call for today. We thank you for your participation, and ask that you please disconnect your lines.