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Edited Transcript of ADXS earnings conference call or presentation 21-Dec-17 3:00pm GMT

Thomson Reuters StreetEvents

Q4 2017 Advaxis Inc Earnings Call

NORTH BRUNSWICK Dec 25, 2017 (Thomson StreetEvents) -- Edited Transcript of Advaxis Inc earnings conference call or presentation Thursday, December 21, 2017 at 3:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Anthony A. Lombardo

Advaxis, Inc. - Interim CEO

* Noelle Heber

Advaxis, Inc. - Senior Director of Corporate Communications & Government Affairs

* Robert G. Petit

Advaxis, Inc. - Executive VP & Chief Scientific Officer

* Sara M. Bonstein

Advaxis, Inc. - Executive VP, CFO & Corporate Secretary

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Conference Call Participants

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* Charles Anthony Butler

Guggenheim Securities, LLC, Research Division - MD & Senior Equity Analyst

* Mara Goldstein

Cantor Fitzgerald & Co., Research Division - Director of Research, Head of U.S. Healthcare Research & Senior Analyst

* Swayampakula Ramakanth

H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst

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Presentation

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Operator [1]

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Welcome to the Advaxis Year-end Financials Results and Business Update Conference Call. (Operator Instructions) As a reminder, this conference is being recorded today, December 21, 2017.

I would now like to turn the conference over to Noelle Heber. Please go ahead, madam.

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Noelle Heber, Advaxis, Inc. - Senior Director of Corporate Communications & Government Affairs [2]

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Good morning, this is Noel Hebert, Senior Director Corporate Communications at Advaxis. Thank you all for participating in today's call. Joining me from Advaxis are Tony Lombardo, Interim Chief Executive Officer; Sara Bonstein, Chief Financial Officer; and Robert Petit, Chief Scientific Officer. Yesterday, Advaxis filed its annual report on Form 10-K with the SEC, disclosing its financial results for the fourth quarter and fiscal year-end October 31, 2017. Before we begin, I'd 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 filings with the Securities and Exchange Commission including, without limitation, the company's Forms 10-K, 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. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, December 21, 2017. 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 that said, I will turn the call over to Tony Lombardo. Tony?

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [3]

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Thanks, Noelle. Good morning, everyone, and thank you for joining us. 2017 was a year of change for Advaxis, as we evolved into a more focused and disciplined enterprise. In September, the company announced a reprioritization of our clinical programs and is now focused on 4 areas, which we have -- which had been identified as offering the potential to touch the greatest number of patients in both the near- and long term.

HPV-related cancers, personalized neoantigen therapy, disease-focused hotspot and cancer antigen therapies and prostate cancer. From a management perspective, we have made progress in our search for a Chief Medical Officer and interviewed several highly qualified candidates. The Board of Directors is also conducting a search for a permanent CEO, and this is ongoing. I've been honored to lead this company through this change and will continue as Advaxis' Interim CEO, as we move into 2018.

So let's talk about 2017, a year in which the company continued to make significant progress. We moved our HPV-related cancer franchise forward with important milestones including the initiation of patient dosing in our Phase III study AIM2CERV; recipients of the European Medicines Agency's advanced therapy medicinal product certificate for quality and nonclinical data for AXAL; and presentation of the ground-breaking GOG-0265 data at the Society of Gynecological Oncology Annual Meeting. In our personalized neoantigen franchise, the FDA accepted our IND for Advaxis NEO In our prostate cancer program, we presented initial immunological and clinical data from the monotherapy arm for our ongoing Phase I/II study at multiple medical meetings.

Partnerships are also a key element of our business strategy, and in 2017, we signed new collaboration agreements with Bristol-Myers Squibb and SELLAS Life Sciences. We want to congratulate our partner, Aratana Therapeutics, on receiving USDA conditional licensure this week for AT-014, the novel immunotherapy they developed, using our Lm Technology platform for the treatment of dogs diagnosed with osteosarcoma. Kindly refer to Aratana Therapeutics' press release for further details.

As we move into 2018, our focus will be on driving many of the planned catalysts for Advaxis. These include milestones in our HPV-related cancer franchise, such as the anticipated EU submission for a conditional approval of AXAL in metastatic cervical cancer; initiation of the advanced metastatic cervical cancer combination trial with Bristol-Myers' Opdivo; and the announcement of an investigator-sponsored trial on I -- or IST for HPV-associated head and neck cancer. We will initiate the NEO Phase I study with Amgen. We are planning multiple IND submissions for our disease-focused hotspot cancer antigen therapies franchise. And finally, in our prostate cancer franchise, we anticipate a preliminary data readout of both Part B monotherapy and checkpoint combination data for Advaxis PSA.

The immunotherapy landscape continues to evolve, with promising technology advancements, such as checkpoint inhibitors and most recently CAR T therapy. However, there are still significant unmet needs, which we feel that the Lm Technology can address. Specifically, Lm Technology has the potential to enhance other treatments in combination, as it has a generally well tolerated safety profile and does not generate neutralizing antibodies.

It is important to remember the unique attributes of our core technology. Listeria is an effective vector to deliver antigens and activate the immune system against cancer, and our studies continue to build on an understanding of its clinical benefits. Our Lm Technology, for which we hold an exclusive license from the University of Pennsylvania, has important proprietary advantages. These advantages include the use of a tLLO fusion protein, which contributes to effects we see in the tumor microenvironment and the insertion of multiple copies of DNA plasmas, which have the potential to increase the immune response. Most importantly, our Lm Technology platform has generated clinical data that has allowed progression into a Phase III development and a planned filing for approval in the EU.

I will discuss our pipeline, programs and clinical plans in further detail, but first, let me turn the call over to Sara Bonstein, our CFO, for a review of our fiscal 2017 year-end financial results. Sara?

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Sara M. Bonstein, Advaxis, Inc. - Executive VP, CFO & Corporate Secretary [4]

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Thanks, Tony, and good morning, everyone. We are pleased to be reporting our financial results and clinical progress for the fiscal year ending October 31, 2017.

As Tony noted, it has been a year of change. We have made strategic investments to enhance -- to advance our promising Lm Technology across multiple platform franchises, which included the investments to support the marketing authorization application, while winding down or exploring alternative funding approaches for clinical programs that do not fit with our strategic goals to maximize shareholder value. We look forward to building upon our '17 achievements, as we move into fiscal '18, which will be very -- which will be a very important year for the company with multiple catalysts.

I will begin with our balance sheet and cash flow. Our cash equivalents and investments totaled $70.9 million as of October 31, 2017. During fiscal '17, we used approximately $76.9 million to fund operating activities, which was mainly attributed to funding our development programs and related personnel as well as infrastructure to support the company's progress. Last month, we announced our participation in the New Jersey NOL program and anticipate, we'll be able to transfer this credit and receive $4.5 million in cash by the end of our fiscal Q1, 2018. We believe our current cash position will be sufficient to fund our business plan into fiscal '19, as we continue to invest in our core clinical franchises and remain opportunistic regarding investigator-sponsored trials and licensing opportunities.

I want to reiterate Tony's congratulations to Aratana for their conditional licensure of AT-014. As Aratana shared in their press release yesterday, this is a conditional licensure, and the drug will be available for purchase at approximately 2 dozen vet oncology practice groups across the U.S. We will begin to recognize royalty upon the first commercial sale, and approval-related milestone payments are based upon full approval.

As a late-stage biotechnology company with no commercial products, we are cognizant of the need for ongoing funding of our business. We have undertaken a 2-pronged approach for responsible financial management of the business. First, we have done an in-depth review of all of our spending and have eliminated any programs that are not aligned with the strategic goals of the company. Due to this increased discipline, we have returned to our historical quarterly burn rate of approximately $20 million in fiscal Q4 2017, excluding partnership reimbursements and other cash receivables.

As we move into '18, we continue to be very disciplined regarding the utilization of our capital and anticipate our cash burn to decrease from our 2017 level. This decrease is due to several onetime costs in 2017 related to the preparation for the regulatory filing of AXAL in Europe, as well as related infrastructure costs which are not anticipated to reoccur. Second, we are evaluating multiple ways to fund the company beyond our current cash position and remain sensitive to the current market conditions.

Now let me move on to the results of operation. The net loss for fiscal year-end '17 was $93.4 million or $2.31 per share, based on 40.5 million shares outstanding. This compares with a net loss for fiscal '16 of $73.6 million or $2.08 per share, based on 35.4 million shares outstanding. Research and development expenses for the fiscal year 2017 were $71.9 million as compared with $48.8 million for fiscal '16. The $23.1 million increase was primarily a result of our continued investment in R&D to support both our preclinical and clinical development programs.

We had higher third-party cost, specifically related to the HPVs franchise, primarily supporting our AIM2CERV program, MAA filing process and start-up activities related to our DUAL program as well as the support related to our Advaxis PSA Phase I/II trial. The increase also reflects higher headcount to support the company's research and development initiatives.

General and administrative expenses for fiscal year 2017 were $38.7 million compared with $31.7 million for fiscal '16. The increase was largely attributed to a noncash stock-based compensation expense which increased by $6.7 million year-over-year. We anticipate G&A expenses in the near term to remain comparable to current levels, exclusive of the impact of noncash stock awards and onetime expenses. Some of these expenses are offset by revenue, primarily due to the recognition of upfront fees received from Amgen in conjunction with the license agreement signed in 2016.

Headcount increased from 38 to 108 from the beginning of fiscal '16 to fiscal year-end 2017. Over this 2-year period, personnel increases were made primarily in research, development and technical operation departments. We expect headcount to remain flat through fiscal 2018.

With that financial overview, let me turn the call back to Tony for a discussion of our clinical programs.

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [5]

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Thank you, Sara. As I mentioned earlier, we are excited to be moving forward with our clinical development plan and believe that the diversification strategy of the 4 key franchisees, with multiple indications, gives us the potential to create shareholder value. Let me begin the portfolio review with an update on our HPV-related cancer franchise which includes both AXAL and DUAL. HPV-related cancers remain a global healthcare problem with uneven distribution of screening and limited utilization of the preventative HPV vaccines globally.

We do not believe that the HPV preventative vaccines such as Gardasil will have a significant impact on the commercial opportunity of our HPV franchise during a life of its IP protection.

Let's begin by talking about cervical cancer, the leading indication of our HPV franchise. There are limited treatment options for persistent or recurrent metastatic cervical cancer and about 5,000 women in the U.S. succumb to this disease each year. In Europe, the picture is even darker, with over 24,000 women dying each year, with Eastern Europe being a major contributor. We feel our product candidates will be able to help address this global need. Our confidence in our cervical cancer franchise is supported by the promising results from our phase II GOG-0265 trial which evaluated AXAL as a treatment for persistent or recurrent metastatic cervical cancer. This study assessed the safety and efficacy of AXAL, with the primary efficacy end point of 12-month overall survival rate. These data in 50 patients were reported at the Society of Gynecological Oncology's Annual Meeting on women's cancer last spring and show a 38% 12-month overall survival rate in late-stage persistent or recurrent metastatic cervical cancer. This represented a 52% improvement over the GOG model predicted 12-month survival rate of 24.5%, based on the characteristics of the patients in the 265 study.

This also represents the highest rate achieved in any GOG persistent or recurrent metastatic cervical cancer trial in near experience of over 17 trials and more than 525 patients.

Based on the strength of these data, in early 2018, we will submit a marketing authorization application with the European Medicines Agency for conditional approval. This is a 13 month review process. In parallel, we continue to discuss potential partnership opportunities with several comps for the commercialization of the HPV franchise.

Our second generation HPV-related cancer product, DUAL, incorporates additional peptides to increase potency against Alpha 7 strains of HPV. DUAL may give patients the best chance of benefit in the persistent or recurring metastatic cervical cancer setting, especially, if combined with a checkpoint inhibitor.

Under a clinical collaboration agreement with Bristol-Myers Squibb, we'll evaluate their PD-1 inhibitor, Opdivo, in combination with DUAL in the advanced trial. We plan to file an IND application in early 2018 for this global, randomized registrational-quality trial to evaluate this combination in women with persistent or recurrent metastatic cervical cancer, who have failed at least 1 prior line of systemic chemotherapy. We expect to initiate the study in the first half of 2018.

Finally, we continue to progress through our collaboration with AstraZeneca on the Phase I/II open-label, multicenter, 2-part study that is evaluating the safety and efficacy of AXAL in combination with their investigational Anti-PD-L1 inhibitor Imfinzi. In cervical and head and neck cancers, part 1 of the study is complete, and enrollment in the expansion phases have commenced with an interim readout of the Part B expansion expected in 2019.

At this time, we have made the strategic decision, not to fund any new programs in the head and neck or anal cancers in order to focus our resources on other clinical priorities. We will continue to evaluate alternative funding sources and collaborations to further develop these programs, and plan to announce an IST with a prestigious academic institution in head and neck cancer in 2018.

Let's move on to our new antigen franchise, which is in collaboration with Amgen. NEO is a highly targeted, patient-specific treatment approach designed to activate a patient's immune system to respond against the unique mutations, or Neo-Epitopes, identified from each individual patient's tumor. The initial tumor types for the planned Phase I trial are non-small cell lung cancer, microsatellite stable colorectal cancer and head and neck cancer. The FDA has cleared the initial IND application of NEO, and we will file an IND amendment in the early 2018. This amendment is largely driven by enhancements to the manufacturing and antigen selection processes. We do not expect this to impact our project timeline, and we have a pathway to maintain our Phase I study initiation in the first half of 2018. We look forward to updating you on our progress.

Turning now to our disease-focused hotspot cancer antigen therapies franchise known as HOT. This is a program, we are very excited about and which we believe, could be a significant value creator. Expanding the Lm platform into some of the most prevalent cancers. Advaxis has developed a new group of immunotherapy construct for major cancers that combines our optimized Lm Technology vector with promising targets to generate potent anticancer immunity.

The new HOT franchise is a portfolio of disease-specific products which represents the evolution of everything we have learned over the past 10 years. Each of these therapies has been designed to target multiple hotspot mutations. cancer/testis antigens and oncofetal antigens specific to the disease target, which we believe, may be capable of generating potent tumor-specific and high-strength killer T-cells.

HOT franchise products will be off-the-shelf treatments, ready to administer for multiple patients within an expected low cost of goods. The HOT technology has a strong IP position, with protection into 2037 and IP filing strategy providing for broad coverage opportunities across multiple disease platforms in combination therapies.

The company is currently prioritizing product development in the most prevalent cancers with non-small cell lung cancer as the first planned indication. Advaxis anticipates filing multiple HOT INDs with a goal of commencing at least 1 first in-human study in 2018.

Finally, let me update you on our prostate cancer franchise. We continue to make steady progress with the Advaxis PSA clinical development program in prostate cancer with our ongoing Phase I/II study evaluating Advaxis PSA as a monotherapy and in combination with Merck's KEYTRUDA. This program is focused on metastatic castration-resistant prostate cancer, which is associated with deterioration in patient quality of life and has an average survival of only 9 to 13 months. There are currently few therapeutic options available to patients with this stage of prostate cancer. Preliminary data on the monotherapy arm of the trial were presented at this fall's third International Cancer Immunotherapy Conference. These data show that 31% of patients, 4 out of 13 evaluated, achieved stable disease and advancement in this patient population which warrants further study. Additionally, we observed the distinct immunological and gene expression pattern that correlated in patients with stable disease.

Building on these data, last month we presented additional preliminary data from the monotherapy arm at the Society for Immunotherapy of Cancer Annual Meeting. These data showed that after administration of 3 doses of Advaxis PSA, 7 of 9 patients evaluated had increasing numbers and strength of T-cells targeting PSA.

In fact, this increase was threefold in 5 out of the 9 patients. In addition, all 9 patients exhibited increases above baseline in the frequency of T-cells reactive to one or more other well-known prostate cancer antigens. This is evidence of antigen spreading, which may increase the likelihood of the targeted tumor being attacked in multiple ways.

Collectively, these preliminary data show an encouraging signal that Advaxis PSA can generate sustained, strengthened T-cell response against prostate cancer, while modulating the tumor microenvironment and allowing T-cells' access to the tumor. Initial preliminary data from the combination cohort will be available in 2018. As you can see, through 2017, we continued to advance our science and programs. In 2018, our strategy will be to continue to execute, and we expect to achieve a number of value-creating milestones that will advance our portfolio throughout 2018 and beyond.

To summarize, these planned milestones include: filing the MAA with the EMA for conditional approval of AXAL in the first quarter of 2018; filing of the IND for the Phase III advanced trial in early 2018 with initiation of that study in the first half of 2018; filing an amendment to the IND for NEO and subsequent Phase I initiation in the first half of 2018; also in 2018, the filing of multiple INDs for multiple products in the HOT franchise, including non-small cell lung cancer and initiating the first in-human phase I study for 1 tumor type.

The announcement of an IST with a prestigious medical center in head and neck cancer will be accomplished in the first half of 2018, and a preliminary data readout of the combination data in prostate cancer in 2018.

We will continue dialogue with potential EU partners, while continuing to pursue other business development opportunities to support our business.

So in closing, fiscal '17 was a year of much change and realignment, but the cornerstone of the company remains the same. The Lm platform offers patients across a wide array of cancer types with many potential benefits. We are focused on the inflection points that will occur in 2018. It is an exciting time for the company, and we are confident in the future of Advaxis.

I would like to take this opportunity to thank you for your continued support. With that, operator, we are ready to take some questions in the time we have left.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Your first question comes from Biren Amin of Jefferies.

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Unidentified Analyst, [2]

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This is David [Huang] on for Biren. Thanks for taking the question. I was wondering if you could give a little more color around the efficacy endpoints, the data we might see from the KEYTRUDA plus ADXS-PSA readout upcoming in 2018. Will there be biochemical endpoints such as PSA? Will there be clinical response data?

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [3]

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Sure, thanks. Thanks for the call, David. Robert, you want to...

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Robert G. Petit, Advaxis, Inc. - Executive VP & Chief Scientific Officer [4]

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Sure, so that study is using -- it has a primary efficacy end point of -- based on recess criteria, but of course, we'll also be following PSA as well as Pap and other prostate-associated markers, and we've recently had some publications where we -- in our presentations and abstracts and posters and meetings, where we displayed some of the correlative science data associated with the monotherapy part of that trial, and you should expect that similar data will also be generated for the combination arm in that phase, so there will be both clinical-based endpoints as well as correlative study endpoints communicated with that data.

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Operator [5]

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And your next question comes from Tony Butler of Guggenheim Partners.

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Charles Anthony Butler, Guggenheim Securities, LLC, Research Division - MD & Senior Equity Analyst [6]

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Three questions. Sorry, to have 3. But number one is, Sara, I just wanted to go over the notion of, just call it, $71 million, any idea of $80 million which would be burned for the calendar year? And how one might think of reconciling that? And I recognize that you mentioned something around a partnership -- potential partnership for HPV, so I would be hopeful that you could expand upon that a little bit more and something around the timing. And moreover, would it include DUAL as well as the AstraZeneca program, if, in fact, that your collaboration or partnership were to be commenced? So that's question one.

Number two is, in the antigen NEO program, Robert, I'm just curious why it was chosen, not saying it's right or wrong, I'm interested in why it was chosen on CRC plus head, neck and also non-small cell lungs cancer? Why those three tumors? One's clearly a cold tumor, which is really interesting, the other two are, let's just call it warm and hot. And I'm curious if there is a rationale around that, that may be deeper than what we're thinking? And then, I guess, the third area is, and correct me if I'm wrong and it would be helpful to get a better idea, but the data around the prostate cancer expansion cohort in combination would strike me to be very, very important, so you may not be able to speak to this directly, but it would be really helpful to think through what kind of clinical meeting, what kind of clinical setting you'd like to present that data? Because I would think that a clinical meeting would be the best place to actually amplify the store.

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [7]

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Tony, so I think there were 4 pieces. Sara, do you want to, kind of, address the first one?

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Sara M. Bonstein, Advaxis, Inc. - Executive VP, CFO & Corporate Secretary [8]

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Absolutely. Thanks, Tony, and good morning, thanks for calling in, appreciate it. So as you mentioned, our current cash balance, as of October 31, is $70.9 million. We used a little over $79 million in fiscal '17 from an operating perspective. It also noted that we returned back to our normal run rate of around $20 million in cash burn for fiscal Q4. It's important to note that, that $20 million of cash burn, excluded any of our partnership reimbursement funds as well as other receivables. As you can see in our financials, we received $3 million from Stendhal in fiscal '17 as well as we received $9 million from Amgen in fiscal '17 for offsetting costs for both the NEO program and the AIM2CERV program. There was also several onetime costs in fiscal '17 related to primarily the MAA filing, which was a significant cash burn for us in 2017.

We -- like I said, we returned to the normal run rate in Q4, but we plan on continuing to decrease our burn as we move into 2018 and will not see the significant cash outlay related to MAA and related to some other infrastructure costs.

We obviously had a full year of start-up as well as a full-trial initiation for AIM2CERV, and as that trial starts to normalize, we will see potential, some offsets on the cash burn there which will help to offset some of the burn that won't be needed in some of the other programs as you mentioned DUAL and others.

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [9]

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I think there was a sub-point to that. Tony, you asked about partnering, and whether or not AXAL or DUAL, are included in those discussions that will remain open to dialogue?

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Charles Anthony Butler, Guggenheim Securities, LLC, Research Division - MD & Senior Equity Analyst [10]

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Yes, that's right.

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [11]

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The partners, if they include both AXAL and DUAL, obviously, we are receptive to that, so we've made it a broader, sort of, discussion. I think you had 2 more components, and one was on the NEO program, sort of the logic behind the selection criteria for the cancers as you noted. And the second, I think you had this follow-on question, which was the appropriate, sort of, environment for the prostate data in terms of a clinical meeting that we would target to have that data released at. So Robert, you want to talk a little bit about the selection criteria?

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [12]

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Yes, absolutely, I'll address those second 2 questions. So Tony, you sort of hit the nail on the head when you mentioned these 3 tumor types that are selected for the initial clinical evaluation of the NEO program. Conceptually, NEO could be used for literally any type of cancer, because cancer is the disease that's caused by mutations, and this focuses on an individual specific mutations that are acquired in their tumor. So the idea was, we want to first optimize our chance for success by picking immunologically "sensitive" tumor, like non-small cell lung cancer, which is a situation where the checkpoints have good activity and are approved and active. Stepping down the spectrum, we wanted to see, sort of, how the Advaxis platform presenting these NEO antigen works in a warm tumor like head and neck, which has some -- has a higher, sort of, mutational load but has not been quite as responsive to a checkpoint treatment as maybe non-small lung cancer has been. And in microsatellite stable colorectal cancer is as you said, a very interesting to us as well, because it is recognized as a cold tumor. Yes, there is tantalizing anecdotal data that if you can get T-cells into those tumors, they can be responsive to immunotherapy. It's also a situation which facilitates better than some other diseases, post-treatment biopsies, so we can evaluate tumor microenvironment changes. And we have preclinical data that suggests that the Advaxis platform and its effects on the tumor microenvironment may fundamentally change that microenvironment and perhaps, taking that cold tumor microenvironment and warming it up a little bit and making it sensitive to immunotherapy. So these 3 diseases are selected to give us a spectrum across the cancer scenario and really help us inform us about next targets and further expansion of the NEO program. And you're right, the prostate cancer data is interesting and exciting for us. And we feel, as you mentioned, that the proper place to communicate this data would be in a clinical-associated meeting. As this -- we've completed enrollment in this trial. The last few patients are still ongoing with treatment. So as these data become available toward the end of this year in first 3 years, sort of at that point in time, we'll get together with our partners and look at the data as they exist now and as also to what data may develop going forward and look to communicate that data in a scientific meeting, preferably, clinically focused, probably sometime around midyear. I can't guarantee when or where, because we have a partner to discuss this with, but we are hopeful that the timing will work out. We might be able to say something at ASCO in midyear.

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Operator [13]

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Your next question comes from Mara Goldstein of Cantor Fitzgerald.

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Mara Goldstein, Cantor Fitzgerald & Co., Research Division - Director of Research, Head of U.S. Healthcare Research & Senior Analyst [14]

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On the EU conditional approval filing. Can you just speak to, sort of, the nature of the additional information that was requested by the regulatory authorities there and just the thought process behind timing?

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [15]

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Well, Mara, it is nice to hear from you. So we used the opportunity, as you know, originally, we had looked to file that towards actually in December. The EU authority actually eliminated the filing period in December. So it's now currently targeted into the Q1. And it was just more expansion in terms of the statistical analysis surrounding the data. So there's nothing really that was of a critical nature that in terms it was lacking. It just gave us an opportunity to expand that, plus the database itself, in the GOG database is actually an NCI-controlled database and the approval for the release of the database for the European authority had to come from the NCI, and that was provided at the late stage, several weeks ago, which afforded us the opportunity then to enhance the data packet itself for the Europeans, as they would like to say. But again, it's a very unique database, because all of the GOG studies are NCI funded. And in fact, they control the entire database piece, so we had to receive NCI approval with the GOG to actually release the database. And the database itself actually goes directly to the authorities, does not come to us directly. We have a third party to actually helps calculate the data. In essence, it also maintains the integrity of the data, so that other folks, sort of, aren't putting their footprints across it.

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Mara Goldstein, Cantor Fitzgerald & Co., Research Division - Director of Research, Head of U.S. Healthcare Research & Senior Analyst [16]

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Okay. And if I could just ask, I apologize if I missed this early on, but just the sort of thoughts on timing regarding CMO, which you guys had said, you would be engaging in that search this year?

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [17]

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Yes. So Mara, that process ramped up in the last several weeks. And you know we're following a good process in terms of some of some of the board has now begun to interview the candidates. So we hope to have something certainly in Q1, in that timeframe for the CMO.

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Operator [18]

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(Operator Instructions) Your next question comes from Swayampakula Ramakanth of H.C. Wainwright.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD & Senior Healthcare Analyst [19]

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This is RK from H.C.W. Most of my questions have been answered, but in general, for the next 6 to 12 months, what are some of the data that can be published? And what should we be ready for in terms of presentations, a little picture, I guess?

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Robert G. Petit, Advaxis, Inc. - Executive VP & Chief Scientific Officer [20]

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Well I think, I'll take that one RK, this is Robert. So we've already addressed the PSA clinical data that we're all looking forward to taking a peek at that data and communicating that. And in addition, you can expect, as usual, some communication of basic research and preclinical activities, as we continue to work on looking for excellent combinations, looking at more mechanistic issues and trying to further delineate our platform. And there may be also some preliminary discussion of some of the data coming out of the AstraZeneca collaboration with durvalumab with our -- with AXAL, so that's really what you can look for data-wise in the next year. And so we are looking forward to clinical data from the PSA program and an update of the ongoing durvalumab combination, again, partners willing, because we have partners to consider in those. And then preclinically, you'll see the continued output from what has developed to be, what I consider a world-class science team that's behind this platform and this technology.

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Operator [21]

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There are no further questions at this time. Mr. Lombardo, please proceed with any closing remarks.

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Anthony A. Lombardo, Advaxis, Inc. - Interim CEO [22]

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Again, I'd like to thank you all for participating on today's call. We look forward to making continued progress executing our business strategy and to providing timely updates on our achievements. We appreciate your continued interest in Advaxis. And on behalf of the entire team, I wish you a happy holiday season. Have a good day, and thank you.

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Operator [23]

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