Lisata Therapeutics, Inc.

Welcome to the La Sada Therapeutics fourth quarter and full year 2022 financial results and business update conference call. Currently, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star 11 on your telephone. You will then hear an automated message advising you that your hand is raised. As a reminder, this call is being recorded today, Thursday, March 30th, 2023. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at La Sada. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Welcome to OSADA's fourth quarter and full year 2022 conference call to discuss our financial results and provide a business update. Joining me today from our management team are Dr. David Mazzo, Chief Executive Officer, Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer, and James Nisko, Vice President of Finance and Treasuries. Shortly before this call, we issued a press release announcing our fourth quarter and full year 2022 financial results, which is available under the Investors and News section of the company website, along with the webcast replay of this call. If you have not received this news release or you would like to be added to the company's email distribution list, please email me at jmendito at lazada.com. Before we begin, I will 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 LASADA. I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation its forms 10Q, 8K, and 10K, which identify specific risk 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 live broadcast, March, sorry, Thursday, March 30th, 2023. Nezada Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I will now turn the call over to Dr. Mazza. Dave?

Thank you, John, and good afternoon, everyone. Thank you for once again joining us as we provide an overview of recent business highlights and discuss our fourth quarter and full year 2022 financial results. 2022 was a year of exciting transformation for the company, leading to the emergence of Lasada Therapeutics, a financially stable clinical stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases. Our portfolio of product candidates contains treatments in development that are designed to be regenerative and or to bring significant therapeutic improvement. ListaOne, our lead investigational product candidate from the Sendar platform, is the subject of multiple planned and ongoing clinical trials being conducted globally in a variety of solid tumor types and in combination with several anti-cancer agents. Based on substantial preclinical and importantly early human clinical data, we believe that ListaOne has the potential to become an integral part of a revised standard of care therapy for many difficult to treat cancers. Our chief medical officer, Dr. Kristen Buck, will provide more specifics on our clinical programs shortly following our review of the financial results. However, before we get into that and our financial review, I do want to emphasize some of the characteristics of our company that the general market has overlooked. Those who follow the biotech biopharma space will undoubtedly know that there are between 200 and 250 companies at any given time today with a market capitalization below their cash balance. We are, in fact, one of those companies. However, unlike most of those companies that are without sufficient cash to execute their development plans through key milestones and are facing extremely difficult and costly financings this year, if they can finance at all, we are well financed through critical milestones on our key programs. In fact, we are able to project available cash lesting well into the middle of 2025. That's more than two years of operational funding covering almost one dozen clinical programs, the vast majority of which are designed as blinded, controlled, randomized studies. This is the type of study that yields the most definitive data regarding a development candidate's safety and efficacy. It is our firm belief that as more and more companies succumb to financial pressures, and pair their programs, resort to smaller and less definitive study designs, and or fold completely, the market will recognize the strength of our financial position and the robustness of our development strategy. To use an often used analogy, we have many shots on goal, any one of which could provide significant value creation over the next two years. With that in mind, our internal focus is on rapid, efficient, and cost-effective execution and continued rigorous capital management. all leading to what we anticipate will be positive study data and benefits for patients, physicians, and our shareholders. And with that, I now will turn the call over to James Nisko, our Vice President of Finance and Treasury, to review and provide commentary on our fourth quarter and full year 2022 financial results. James?

Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our fourth quarter and full year 2022 financial results, starting with operating expenses. Research and development expenses for the fourth quarter of 2022 were $3.2 million, a 22% decrease compared with $4.1 million for the fourth quarter of 2021, and $13.1 million for the year ended December 31st, 2022, compared to $17.6 million for the year ended December 31st, 2021, representing a decrease of approximately 26%. These decreases were primarily due to reduction expenses associated with our Exona Phase 2b study, the Freedom Trial, as a result of the suspension and enrollment, which commenced in the second quarter of 2022, and study closeout activities in the third quarter of 2022. Also, a decrease in expenses associated with Honedra in Japan related to study closeout costs, along with one-off recruiting expenses and interim chief medical officer consulting expenses in the prior year, partially offset by the addition of chemistry, manufacturing, and control activities, commonly referred to as CMC, related to the production of Lista-1 and enrollment activities for the Phase IIb ASCEND study for Lista 1. Spend related to the research and development in both periods was a result of expenses associated with our Exona Phase 2b study, the Freedom Trial, expenses associated with our registration-eligible study for Honedra and critical limit ischemia in Japan, as well as the corresponding regulatory discussions and support expenses. expenses associated with the addition of manufacturing activities for LISTA-1, enrollment activities for the LISTA-1 Phase IIb ASCEND study, and preparatory activities associated with the design of a planned LISTA-1 proof-of-concept basket trial in various solid tumors in combination with the corresponding standards of care. General and administrative expenses, which focus on general corporate-related activities, were $3.3 million for the three months ended December 31, 2022, representing an increase of 22% compared to $2.7 million for the three months ended December 31, 2021, and $14.1 million for the year ended December 31, 2022, representing an increase of 23% compared to $11.5 million for the year ended December 31st, 2021. These increases were primarily due to one-time fee expenses associated with the review of potential strategic transactions and costs related to our merger with SEND Therapeutics. An increase in equity expense as a result of performance stock unit vesting, merger option assumption expense, and departing board member-restricted stock unit vesting, in addition to an increase in expenses associated with our annual stockholder meeting. Our general and administrative expenses are comprised of general corporate-related activities. Overall, net losses were $54.2 million, includes non-routine merger-related in-process research and development expense of $30.4 million, and $27.5 million for the years ended December 31, 2022, and 2021, respectively. Turning now to our balance sheet and cash flow. As of December 31, 2022, the company had cash, cash equivalents, and marketable securities of approximately $69.2 million. Current projections predict operating cash through the first half of 2025, encompassing anticipated data milestones from many and especially our key ongoing and or planned clinical studies. While we are on the subject of our balance sheet, I also wanted to clarify that none of our treasury investments or cash management services were with or have an exposure to Silicon Valley Bank, Signature, or any of the other institutions that recently became insolvent or unstable. I know there have been ripples throughout the sector because of SBB's link to the industry and wanted to emphasize that we have no financial ties to any of these institutions. That completes the financial overview. I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck, for the review of our clinical development pipeline. Kristen?

Thank you, James, and good afternoon, everyone. I will be providing a high-level summary of what we are doing at La Sada and why we believe our development programs hold so much promise. Before I do that, though, I'd like to reiterate the basis of belief. La Sada's pipeline is built on a portfolio of proprietary and patented technology that is grounded in strong scientific rationale and a body of published, preclinical and early clinical data. Our technologies are designed to address major impediments to successful treatment of cancers and other serious diseases in the context of increasing pharmacoeconomic pressures on the healthcare system. We appreciate the critical importance of generating meaningful clinical data to advance our platform technologies and development candidates, and I can assure you that our entire R&D team has this goal top of mind in everything we do. With that, I will now provide a summary and status update for each of Lissata's active clinical development programs, kicking off with our lead product candidate, LSTA1, which we call Lista1, for the treatment of advanced solid tumors in combination with other anti-cancer agents. Despite advances in cancer therapy today, many solid tumors remain difficult to effectively treat. Cancers such as pancreatic cancer, gastric cancer, and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor. Many tumors also exhibit a hostile tumor microenvironment, or TME, which suppresses a patient's immune system and makes it less effective in fighting the cancer. The combination of a dense stroma and a hostile TME negatively impacts the ability of many cytotoxic agents and immunotherapies to effectively treat these cancers. This coupled with the fact that most anti-cancer therapies are not efficient in targeting only the cancer tissue defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors. To address this double problem of lack of drug targeting and the tumor stroma's role as the primary impediment to effective treatment, Lasada's approach is to activate the C-END rule or SEND-R system, a naturally occurring active transport system to selectively deliver anti-cancer drugs through the stroma and into the tumor. Lysada's lead product candidate, Lista-1, is an investigational drug that actuates the Sendar active transport mechanism while also having the potential to modify the tumor microenvironment, making it less immunosuppressive. Lista-1 targets tumor vascular endothelial cells as well as tumor cells based on its affinity for alpha-V, beta-3, and beta-5 integrins that are upregulated on these cells, but not on healthy tissue. Lista-1 is a 9-amino acid cyclic internalizing RGD peptide that, once bound to these integrins, is cleaved by proteases expressed in the tumor microenvironment to release a peptide fragment called a Sendar fragment. This linear Sendar fragment then has high affinity and binds to an adjacent receptor called Neuropilin 1, which is also upregulated on tumor vascular, endothelial, and tumor cells to activate the C and rule active transport pathway that furries anti-cancer drugs more efficiently into solid tumors. Additionally, ListaOne has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells and adding to the efficacy of anti-cancer drugs used against solid tumors. These results come from Lissata and from collaborators and research groups around the world and have been the subject of over 200 scientific publications. Along with our collaborators, we have also amassed significant non-clinical data demonstrating enhanced delivery of a range of emerging anticancer therapies, including immunotherapies and RNA-based therapeutics. Clinically, LISTA-1 has demonstrated a favorable safety, tolerability, and activity profile to enhance the delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer. Our development programs are designed to exploit the potential of ListaOne to enable a variety of anti-cancer treatment modalities in a range of solid tumors. Currently, ListaOne is the subject of about a dozen planned and active clinical trials globally for the treatment of various solid tumors, including metastatic pancreatic ductal adenocarcinoma, colorectal and appendiceal cancers, glioblastoma multiforme, and peritoneal carcinomatosis in combination with a variety of anti-cancer regimens. Additionally, LISTA-1 will be evaluated in a Phase II placebo-controlled basket trial named the BOLSTER trial in advanced solid tumors including head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, and cholangiocarcinoma with plans to initiate by the end of the second quarter of this year. Now, this is an appropriate time to provide an update on our collaboration with Roche to study Lista-1 in combination with atezolizumab, also known as Ticentric. Roche's PD-L1 inhibitor is a checkpoint inhibitor. Along with standard of care chemotherapy in patients with metastatic pancreatic ductal carcinoma, as part of their Morpheus trial platform. This study has been planned to initiate in the second quarter of 2023, and Roche remains steadfast in their interest in proceeding. However, we were recently informed that they have decided to postpone study initiation until further notice while they refine their overall development strategy for atezolizumab and await additional dosing information from us. likely from the ongoing ASCEND phase 2b trial. Fortunately, we are in negotiation with another organization, actually a foundation in Australia, to support at least one trial and possibly multiple trials testing Lista-1 in combination with immunotherapeutics in the same class as atezolizumab. If we are successful in finalizing these arrangements, we will be able to get clinical information to what we expected to get from the Morpheus trial faster and much less expensively. We look forward to providing updates on this plan in the coming months. Turning now to LSTA-12, Lista-12, or Honedra in Japan, our product candidate for the treatment of critical limb ischemia, or CLI, and Berger's disease. Honedra was awarded a Sakagaki designation from the Japanese regulatory authorities for the treatment of CLI and Berger's disease, which is an orphan-sized subset of CLI. The Sakagaki designation is akin to a Regenerative Medicine Advanced Therapy designation or an RMAT designation in the United States. Sakagaki designation affords the recipient prioritized regulatory consultation, a dedicated review system to the support to support the development and review process, including the option of a rolling registration submission, as well as a reduced review time of approximately six months for the registration application once filed. Additionally, under Japan's regenerative medicine legislation, products such as Henedra are eligible for early conditional approval and possibly full approval in Japan based on the assessment of the data from the trial or trials designed in direct collaboration with the Japanese Pharmaceuticals and Medical Devices Agency, known as the PMDA. Note that conditional approval of a regenerative medicine product only requires the demonstration of a trend toward therapeutic effect together with acceptable safety. Further, the Sakagaki designation is a highly sought regulatory classification in Japan, and we hope that this coupled with positively trending data from our trial will make Henadra an attractive product for partnering to a Japanese pharmaceutical company. Data from the follow-up of all patients treated in the company's registration-eligible study of Henadra in Japan for the treatment of CLI and Berger's disease are consistent with our expectations of therapeutic effect and safety based on previously published clinical trial data generated in Japan and the United States. These data have been compiled and are the subject of discussions with the PMDA as part of the Japanese regulatory pre-consultation process and in preparation for the formal consultation meetings, which precede a Japanese new drug application. To date, we would categorize our pre-consultation discussions as very productive and, if successful, we would expect a formal clinical consultation to occur later this year. Concomitantly, the company continues its efforts to secure a Japanese partner to complete the remaining steps to produce registration in Japan. It is clear at this time that a successful partnering exercise will depend heavily on the PMDA's decision regarding our ability to proceed to JNDA. Moving on to Exona or LSTA16 for the treatment of coronary microvascular dysfunction or CMD. Coronary microvascular dysfunction is a disease that continues to be underdiagnosed and potentially afflicts millions annually, a vast majority of whom are female with no current treatment options. In May of 2020, The former company, Caladrius, announced the full data results from the Phase IIa ESCAPE-CMD trial, showing a highly statistically significant improvement in coronary flow reserve, correlating with symptom relief for patients with CMD after a single intracoronary injection of Exona. Subsequently, the company initiated a rigorous Phase II clinical trial known as the FREEDOM trial, which to our knowledge was the first controlled regenerative medicine trial in CMD in the United States. The FREEDOM trial was a double-blind, randomized, placebo-controlled trial designed to corroborate the results of the ESCAPE CMD trial while assessing the efficacy and safety of delivering autologous CD34 cells. Our zone of product to subjects with CMD with or without obstructive coronary artery disease. Unfortunately, as previously reported, the COVID-19 pandemic in the United States had both a direct and indirect impact on freedom, which made enrollment much slower than originally predicted and challenging to accelerate. As a result, the company suspended trial enrollment and conducted an interim analysis of the data. Following this analysis, and along with key opinion leaders' input, The company determined that execution of a redesigned freedom-like trial would be the next appropriate step, but the cost of such a trial would be prohibitively expensive to undergo without a strategic partner. Thus, Exona development will only be continued if a strategic partner that can contribute the necessary capital for future development is identified and secured. And lastly, LSTA-201 for the treatment of diabetic kidney disease, or DKD. The company initiated a Phase 1B open-label proof-of-concept trial evaluating LISTA-201, a CD34-positive regenerative cell therapy investigational product for intrarenal artery administration in patients with diabetic kidney disease. This development program focused on patients that exhibit rapidly progressing stage 3B4 disease. The scientific rationale for the program was based on association of progressive kidney disease with attrition of the microcirculation of the kidney. Preclinical studies in kidney disease and injury models have demonstrated that production or replenishment, excuse me, protection or replenishment of the microcirculation resulted in improvement in kidney function. Our proof-of-concept protocol provided for a staggered, sequentially-dosed cohort of six patients overseen by an independent data safety monitoring board with the objective of determining the tolerance of intrarenal artery cell therapy injection in diabetic kidney disease patients, as well as the ability of LISTA-201 to regenerate kidney function. The first patient was treated in April of 2022, and all six subjects were treated in the third quarter of 2022. As reported on on 6 February 2023, the top line results showed that LISTA-201 was safe and well tolerated by patients with no serious adverse events related to therapy. However, the study did not demonstrate a consistent improvement in kidney function among patients. That said, We still believe, based on the encouragement received from the study's principal investigator and other key opinion leaders, that there still may be potential for use of CD34 cell therapy for the treatment of diabetic kidney disease. Further development of Lista 201 will certainly require significantly larger studies and a capital investment, and thus, development by Lissata would only be continued if a strategic partner that can contribute the necessary capital for future development is identified. With that, I will now turn the call back to Dave.

Thank you, Kristin.

Having some difficulty with the technology here. As you've heard, our creative team is working hard to maximize the value potential of our development pipeline and to drive our programs to clinical success. We've designed our studies to provide clear results as fast and inexpensively as reasonably practicable. Nevertheless, we understand and certainly share your impatience in getting to quality data as soon as possible, and we are focused on doing everything within our control to achieve this goal. We are excited by the promise of our platform technologies and pipeline of product and partnering opportunities and look forward to providing updates on our progress in the coming months. And with that overview, operator, we're now ready to take questions.

Operator, are there any questions on the line?

Our first question comes from the line of Joseph Pantonese of HC Wainwright. Your line is open.

Hi, good afternoon. This is Sarah on for Joe. We were just wondering if you could provide perhaps some color on how activities are currently going in Australia and what your expectations are moving forward. Thank you.

Certainly. Hi, Sarah. Thanks for the question and thanks for joining us today. We typically don't give weekly or monthly updates on the specifics of enrollment. But I can generalize by telling you that our activities in Australia are going extremely well. So you can look on our website and see a copy of the corporate presentation, which gives a listing of all the various trials, including the locations in which they're being conducted. And the largest trial, The ASCEND trial that is ongoing at the moment being conducted in Australia is actually ahead of schedule on their projections for completing enrollment and is well along in enrollment. So I think that we'll be able to provide perhaps a little bit more specific update in the coming month or so, but really has moved along very nicely. And a number of the other trials that are planned to start in Australia are also imminent in their initiation. So we're very pleased with the progress being made by our Australian clinical investigator colleagues.

Thank you. One moment. Our next question comes from the line of Pete Enderline of MASS Partners. Your line is open.

Thanks. Hi, everybody. Just following up on that last question, question. Dave, can you give us an idea how many people you are shooting to enroll in that program and what the cost may be? I think there's some nice cost sharing with Australia as well, but can you give more details on that?

Sure. So the actual details of the clinical trials can be found on clinicaltrials.gov, so none of this is secret. The ASCEND trial is targeted to enrolled between 125 and ultimately, I think our goal would be closer to 155 patients. And the costs there are probably about half of what they would be, or even less than half of what they would be if conducted in the United States. And then on top of that, we get about half of that back as a direct cash reimbursement for R&D work being done in Australia and through the Australian government.

Okay, thanks. And just as sort of a general process question, or I mean like a technology question, regarding stroma, you know, which is the main basis for a lot of these trials and opportunities, are there varying degrees of permeability of the stroma in different kinds of cancers? And is that one of the things that determines You know, what makes a particular cancer very potentially susceptible to this kind of treatment?

I'm going to ask Kristen, our chief medical officer, to jump in and answer that question. Kristen?

Yeah, thank you. There is a differential basis of stroma for different tumor types, and that was sort of the basis of why we have chosen such advanced cancers such as metastatic pancreatic ductal as well as cholangiocarcinoma. They do have advanced stromas. But seeing as we have a selective targeting asset that attracts, excuse me, selectively binds to integrins as well as norepinephrine, which are upregulated on the stroma, including cancer-associated fibroblasts, which are abundant in the stroma, we believe where other tumor, where other chemotherapies and immunotherapies have failed, we are going after the more difficult to treat because we believe we can access the tumor itself more effectively through the stroma. So that is the basis of our development program.

Okay, thank you. And another core technology question. Broadly, is there an industry trend toward more combination therapies? I think there is, but I don't really have any sense of how, you know, widespread that is becoming at this point. And most of yours, of course, would be combinations.

All will be combinations, to be clear. And I don't know if there's an increasing trend, but it's been pretty much the standard practice for at least 5 to 10 years, if not longer, in oncology to use cocktails of therapies to maximize the response rates for patients. And so I think that you'll see... that many of the newly emerging technologies like immunotherapies are being studied as monotherapies and then also in combination with existing chemotherapies and other modalities. So I think cocktail approach is something that's going to remain popular until such time as a single agent can do the job better.

Okay. Dave, can you give us any kind of sense of the milestones that you're looking to get from KILU, you know, in terms of the $225 million total, but how many different milestones are in that and are there any specific that you can qualify or describe sort of generally as to what they, you know, what they represent as a, you know, approval or phase two, three, whatever.

So, Pete, I'm going to ask our Chief Business Officer, David Slack, to jump on and address that. And while he's getting off mute and getting ready to speak, I'll just mention that we can't disclose all the specifics of that contract because of the confidentiality arrangement, but David can tell you what's in the public domain. Okay.

Yeah, that's correct. There are development and regulatory-based milestones, as well as some commercial-based milestones. The development milestones hinged by advancement into more late-stage clinical trials, as well as regulatory milestones such as filing and approval. But as Dave mentioned, I think the exact magnitude of those has not been publicly disclosed, so we'll refrain from going deeper.

Can you say at all how many different milestones are involved in that $225 million?

Six.

Okay. Does the fact that the company's main focus at this point versus where you were a year ago is really completely different, and even though you just spent a lot of time talking about CD34, the real potential for the company is, going forward seems to lie much more in the SEND technology. So does that in any sense, do you think, cast a question on the credibility of the previous efforts of the company?

Not at all, I don't think. This is drug development, Pete. Things work, things don't work. things work but then aren't recognized by uh or not being willing to be paid for there are all sorts of factors that come into play and it's a dynamic environment i think that we actually you know did a very uh good job of conducting efficient and um and effective development programs for autologous cell therapies but the market never recognized the the potential and never rewarded the company for that potential. And it was in an area of cardiovascular disease where further development was becoming increasingly expensive because of the size and the duration of the studies required. So I think, you know, actually the company's credibility should be enhanced by the smart business decisions taken to, you know, move to something where we can generate data in a reasonable period of time at a reasonable cost and where the market should recognize it eventually.

Thank you. Our next question comes from the line of Steve Brozek of WBB. Your line is open.

Hello. Hi, Steve. Hey, thank you for taking the questions. Getting back to what you were just describing as far as the model and Lusada's corporate model, earlier on you had mentioned between 200 and 250 companies that were trading at below cash. But I want to understand this better. The new biotech model, obviously, is something that we haven't seen before, where a company uses all of its assets to maximize the return and to go out there and to be able to do things that normally you couldn't do by leveraging external partners. Can you tell us what the difference is and what you're seeing as far as potential partnering arrangements and potential collaborations going forward? And I've got one more question after that, please.

Sure. Thank you, Steve. Yeah, I think there are a number of external factors that have influenced significantly our internal strategy and some new developments that have actually then reinforced our decisions. I mean, I think most people on the phone are familiar with the Inflation Reduction Act, which I'm not going to give a treatise on it, but which generally is designed to allow the government to negotiate or even mandate prices on drugs a certain number of years after their launch to reduce costs of the overall healthcare system, but in so doing, reduce returns to the folks who invested in those drugs. And so the anticipation is that as a result of the financial gaps that losing products sooner than might have been originally anticipated when they were launched several years ago in big pharma especially that big pharma is going to become more acquisitive and they're going to be looking to pick up additional products and then on top of that I think there's a general consensus that the specialty pharma model where you know companies accumulate small to mid-size in terms of sales revenue products to generate a lucrative business. I think we're going to see a resurgence of that, which also leads to product acquisition. And I think that that plays right into what we're doing with ListaOne, where we're looking to exploit the full breadth of its applicability in terms of indications and in terms of combinations with other companies, making many, many companies, I think, potential partners. And we've seen that over the last three to six months where we are talking to not only the big players, but regional players and players who may not historically have been major factors in the oncology world. We're thinking about now getting into oncology as a place where the impact of the IRA and some of the banking missteps would be minimized. So I think this plays exactly to our strategy. And I expect over time that we're going to see increased interest. And of course, as I mentioned in my prepared remarks, we're doing exactly the kind of studies and in generating exactly the kind of information that these organizations would seek in order to take positive partnering decisions.

And following up on that with looking at the CD34 platform and the breadth of experience, not just here in the United States, but globally, How would you assess the potential interest, the partnering possibilities, and everything along those lines, given the fact that you've got as much broad-based experience and we're starting to see changes in terms of regulatory and obviously the clinical and pharmaceutical industry needs? What would you say there?

Well, I wouldn't give up hope on the ability for us to partner CD34. The partnering may come from surprising places, though. I think we're seeing more interest in markets that would traditionally have been thought to be immune to such an innovative or potentially expensive therapy. But we've had a number of conversations in that regard. And as Kristin pointed out, our regulatory process in Japan, while it moves at, if I may say, this Japan speed, which is generally slower than US speed, it's moving forward. And as we get closer and closer to a positive decision from the PMDA about our ability and our eligibility to file a Japanese new drug application, I think we'll see the folks who have been focused on that particular decision then make positive overtures toward us to acquire that product in Japan.

Great. I will jump back in the queue. Thanks very much for taking the questions. Appreciate it, Steve. Thank you.

Thank you. Again, if you'd like to ask a question, please press star one, one on your telephone. One moment for our next question. Our next question comes from the line of Kemp Dolliver of Brookline Capital Markets. Your line is open.

Hi, I'm Shubhendu for Kemp. I was wondering when can we expect more updates for the Decentral with Roche?

Thank you. Okay, well, as we just, as Kristin said in her prepared remarks, I mean, the simple answer is we don't know. You know, we were informed recently that they, Roche, are reviewing their internal strategy relative to development and investment in Dicentric. And as a result, they've asked us to, you know, they told us that they're postponing the initiation of the one arm of Morpheus until some later date. And they've also asked us for some additional dosing information. some of which we've already provided from available information, but some of which may come from the ASCEND trial. So I'm sorry, but at this point, it's probably a question better asked of Roche, but we just really don't know. The good news, however, is that we have at least one program and likely two that we can substitute for that, which will not cost us anything, whereas the Roche costs costs were going to be several million dollars a year, and will provide us identical information in terms of the ability of Lister 1 to positively influence the immunotherapies and to do so in a faster timeframe. So we'll keep you posted on those developments because we will have some control over that.

Thank you. Thank you.

One moment, please. Our next question comes from the line of Pete Enderline of Mass Partners. Your line is open.

It cut off when she said my name, so I didn't know if she said it or not. But anyway, getting back to the partnering idea on CD34, do you have any active engagements, i.e., discussions going on right now regarding LSTA 16?

16, no. No? Well, no. The purely semantic correct answer is no.

Okay. Well, fair enough. I mean, I'm glad you're being candid about that. And second, you know, the SEND technology to me is very complicated because I'm basically not very well educated in that area, but What key intellectual property do you have and how much of it is patent protected as opposed to being in the general domain? Because you've had like 200 studies or articles that were published, so some of that must be public knowledge at this point. How does that shake out?

Well, all of the publications are either supportive of the patent applications or are after the patents, you know, have been announced or applied for. So we have strong intellectual property without going into, you know, a long treaties on, on IP, which, and by the way, there's information on the website in that regard, the, you know, we have composition of matter and mode of operation patents that cover the send technology and the platform technology well into the next decade.

Okay, and is there any sort of handy reference on the total number of those patents domestically and internationally?

Again, I'll refer you to the website so I don't misquote the number, but there's a bunch.

Okay, and then just one last little point. Is it possible that the company will, after the dust has settled from the merger, speed up the quarterly and yearly reporting cycles?

Well, quarterly and yearly are not under our control. So quarterly only comes every three months and yearly only comes every 12 months. So I don't know how we can speed that up.

But what I mean is, you know, here it is the last day of the quarter and you're reporting for 2022. That's pretty late, really.

Actually, it's not. Look at the reporting of almost all other public companies to complete a full year audit. We're at the mercy of our external auditors and everybody who's working on a calendar year as their fiscal year. is trying to do this at the same time, often with all the same external auditors. So, you know, we try to go as fast as we can, but we're at the mercy of the external sources.

Yeah, I'm sure that's true. Okay, well, thank you very much.

Okay, thanks, Pete.

Thank you. Again, ladies and gentlemen, if you'd like to ask a question, please press star 11 on your telephone. One moment, please. I'm showing no further questions at this time. This does conclude the question and answer session. I will now turn the call over to Dr. Mazzo for closing remarks.

Again, thank you all for participating on today's call. I appreciate all the questions that were asked, and I hope the responses were clarifying. We look forward to speaking with you again during our next quarterly conference call and to continue to provide updates on our achievements and progress. We remain grateful for your continued interest and support, and we wish you a good evening. Stay well and goodbye.

Thank you. Ladies and gentlemen, this does conclude today's conference. Thank you all for participating. You may now disconnect. Have a great day.