Q1 2024 Lisata Therapeutics Inc Earnings Call

Operator: Welcome to the Lisata Therapeutics First Quarter 2024 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you need to press star one one on your telephone. You will then hear an automated message advising your hand is raised.

Welcome to the Lacerta Therapeutics first quarter 2024 financial results and business update conference call. At this time all participants are in listen only mode. After the speaker's presentation, there will be a question and answer session.

Operator: Yeah.

Operator: To ask a question. During this session you will need to press star one one on your telephone you would be in here an automated message advising your hand he's raised.

Operator: To withdraw your question. Please press star one one again.

Operator: Please be advised that today's conference is being recorded.

Operator: To withdraw your question, please press star 1 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to our first speaker today, John Menditto, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Speaker Change: I would now like to hand the conference.

John D. Menditto: Over to our first speaker today, John mean veto.

John D. Menditto: Vice President of Investor Relations and corporate Communications. Please go ahead.

John D. Menditto: Thank you, operator, and good afternoon, everyone. Welcome to Lisata's first quarter 2024 conference call to discuss our financial results and to provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer, and Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer, and James Nisco, Chief Accounting Officer. Shortly before this call, we actually had.

John D. Menditto: Thank you operator, and good afternoon, everyone welcome to the <unk> first quarter 2024 conference call to discuss our financial results and to provide a business update.

John D. Menditto: Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer.

Speaker Change: Dr. Christian <unk> Executive Vice President of research and development and Chief Medical Officer, and James in ESCO.

John D. Menditto: Chief Accounting officer shortly.

John D. Menditto: Shortly before this call.

John D. Menditto: Announcing our first quarter 2024 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 would like to be added to the company's email distribution list, please email me at jmenditto at lisata.com. Before we begin, I 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 Lisata.

John D. Menditto: Lease.

John D. Menditto: Announcing our first quarter 2024 financial results, which is available under the investors and news section of the company website, along with the webcast replay of this call.

John D. Menditto: You have not received this news release or if you'd like to be added to the company's email distribution list. Please email me at Jay <unk> at <unk> Dot com.

John D. Menditto: I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, its Forms 10-Q, 8-K, and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statement. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Thursday, May 9, 2024. Lisata Therapeutics 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 now turn the call over to Dr. Mazzo. Dave?

John D. Menditto: Before we begin I 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 Lasalle.

David J. Mazzo: I encourage you to review the company's filings with the Securities and Exchange Commission, including without limitation. Its forms 10-Q, 8-K, and 10-K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward looking statements.

John D. Menditto: Are there more of the content of this conference call contains time sensitive information that is accurate only as of the date of this live broadcast Thursday may nine 2024, Lacerta therapeutics undertakes no obligations to revise or update any statements to reflect events or circumstances. After the date of this conference call.

David J. Mazzo: That I will now turn the call over to Dr. Mazzo Dave.

David J. Mazzo: Thank you, John, and good afternoon, everyone. I'm delighted to be with you today to provide an overview of recent business highlights, discuss our first quarter 2024 financial results, and give an update on the progress of our various developments. Building on the momentum of 2023, Lisata is off to a very strong start in 2024.

David J. Mazzo: Thank you John and good afternoon, everyone I'm delighted to be with you today to provide an overview of recent business highlights discuss our first quarter 2024 financial results give an update on the progress of our various development programs.

David J. Mazzo: Building on the momentum of 2023, besides off to a very strong start in 2024 weeks.

David J. Mazzo: We continue to make notable progress developing our lead product candidate, Sirtepatide, formerly known as Lista-1, in combination with a variety of anti-cancer agents of differing modalities as a treatment for multiple solid tumor cancers. As we have previously reported, encouraging preclinical data as well as early clinical data in humans continue to support our belief that cetepetide has the potential to become an integral part of a revised standard of care treatment approach for many challenging solid tumors.

David J. Mazzo: We continue to make notable progress developing our lead product candidate search appetite, formerly known as Lister one in combination with a variety of anti cancer agents of different modalities as a treatment for multiple solid tumor cancers.

David J. Mazzo: As we have previously reported encouraging preclinical data as well as early clinical data in humans continue to support our belief that took appetite has the potential to become an integral part of our revised standard of care treatment approach for many challenging solid tumors, Dr. Christian <unk>, our executive Vice President of research and development and Chief.

David J. Mazzo: Dr. Kristen Buck, our Executive Vice President of Research and Development and Chief Medical Officer, will provide a detailed update of our ongoing and planned clinical programs following the financial results review. But before getting to the numbers, I want to mention the achievement of another important milestone for Lisata.

David J. Mazzo: Medical Officer will provide a detailed update of our ongoing and planned clinical programs. Following the financial results review.

David J. Mazzo: But before getting to the numbers I want to mention the achievement of another important milestone for <unk>.

David J. Mazzo: Certepetide, spelled C-E-R-T-E-P-E-C-I-D-E, is the official international non-proprietary name, or INN, United States adopted name, or USAN, and Australian approved name, or ANN, now formally assigned to Lista 1. INN, USAN, and AAN names are also referred to as generic substance names for pharmaceutical products. Obtaining one of these names is part of the commercial development of a drug and represents an important step along the path to commercialization. Going forward, we will systematically use the name Certipiti when referring to our product, rather than the internal code of LISTA-1 to emphasize the progress being made toward product registration. With that, I now will turn the call over to James Nisco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James?

David J. Mazzo: So turpentine spelled C E. R. T E P E T I D.

James Nisco: The official international non proprietary name or I and in United States adopted name USA and Australia approved name.

James Nisco: Now, formerly assigned to listen to what I.

James Nisco: I am in Houston, and AA and names are also referred to as generic substance names respond with surgical products.

James Nisco: <unk> one of these names as part of the commercial development of the drug and represents an important step along the path to commercialization going forward, we will systematically use the names to tepid tide, when referring to our product rather than the internal code of Lister one to emphasize the progress being made toward product registration with that.

James Nisco: Now I will turn the call over to James the scope, our senior Vice President of Finance, and Treasurer, and Chief Accounting Officer James.

James Nisco: Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our first quarter 2024 financial results, starting with operating expenses. For the three months ended March 31, 2024, operating expenses totaled $6.6 million, compared to $6.8 million for the three months ended March 31, 2023, representing a decrease of 0.2 million or 3.6 percent. Research and development expenses were approximately $3.2 million for the three months ended March 31, 2024, compared to $3.2 million for the three months ended March 31, 2023, representing an essentially unchanged span.

James Nisco: Thanks, Dave Good afternoon, all I am pleased to join you today to present, a summary of our first quarter 2024 financial results.

James Nisco: Starting with operating expenses for the three.

James Nisco: The minor increase of 62,000, or 2%, was primarily due to an increase in expenses associated with our enrollment activities in the current year for our Certepitide Phase 2a proof of concept bolster trial, although partially offset by a reduction in expenses associated with the Phase 2b ASCEND trial, which completed enrollment in the prior year. General and administrative expenses were approximately $3.4 million for the three months ended March 31, 2024, compared to $3.7 million for the three months ended March 31, 2023, representing a decrease of 0.3 million or 8.3 percent.

James Nisco: Three months ended March 31, 2024 operating expenses totaled $6 6 million.

James Nisco: Compared to $6 8 million for the three months ended March 31 2023, representing.

James Nisco: Representing a decrease of <unk> 2 million or three 6%.

James Nisco: Research and development expenses were approximately $3 2 million for the three months ended March 31, 2024, compared to $3 2 million for the three months ended March 31 2023.

James Nisco: Representing an essentially unchanged spend.

James Nisco: The minor increase of 62000 or 2% was primarily due to an increase in expenses associated with our enrollment activities in the current year for our <unk> phase Iia proof of concept bolster trial partially.

James Nisco: Offset by a reduction in expenses associated with the phase <unk> trial, which completed enrollment in the prior year.

James Nisco: General and administrative expenses were approximately $3 4 million for the three months ended March 31, 2024, compared to $3 7 million for the three months ended March 31 2023.

James Nisco: This was primarily due to a decrease in staffing costs associated with the elimination of the chief business officer position on May 1st, 2023. A Reduction in Option Assumption Equity Expense in Connection with the SEND Merger, a decrease in directors and officers insurance premiums, and a reduction in spend on consulting and legal fees partially offset by one-off settlement related costs.

James Nisco: Representing a decrease of <unk> 3 million or eight 3%.

James Nisco: This was primarily due to a decrease in staffing costs associated with the elimination of the Chief business officer position on May one 2023.

James Nisco: A reduction in option assumption equity expense.

James Nisco: Connection with the sand merger.

James Nisco: A decrease in directors and officers insurance premiums.

James Nisco: The reduction in spend on consulting and legal fees, partially offset by one off settlement related costs.

James Nisco: Overall, net losses were $5.4 million for the three months ended March 31, 2024, compared to $6.2 million for the three months ended March 31, 2023. Turning now to our balance sheet and cash flow. As of March 31st, 2024, Lisata had cash equivalents and marketable securities of approximately $43.3 million. Based on its current business and development plans, the company believes that its available capital will fund operations into early 2026, encompassing anticipated data milestones from all its ongoing and currently planned clinical trials. This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Kristen Buck, for a review of our clinical development pipeline. Thanks.

James Nisco: Overall net losses were $5 4 million for the three months ended March 31, 2024, compared to $6 2 million for the three months ended March 31 2023.

Speaker Change: Turning now to our balance sheet and cash flow.

Speaker Change: As of March 31, 2024, Masada had cash cash equivalents and marketable securities of approximately $43 3 million.

Speaker Change: Based on our current business and development plans. The company believes that its available capital will fund operations into early 2026, encompassing and anticipated data milestones for more ongoing and currently planned clinical trials.

Speaker Change: This completes my financial overview, and I will now turn the call over to our Chief Medical Officer, Dr. Christopher Buck for the review of our clinical development pipeline Kristen.

Kristen K. Buck: Thanks, James. And good afternoon, everyone. Lisata's development programs are based on sound scientific rationale from a vast body of published preclinical and early clinical work. These works include those which led to Dr. Urki Rishlodi being awarded the Lasker Prize for the fundamental discoveries that spawned our SendR platform technology. A product of the Sendar platform, Sirtepatide, is designed to address major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing cancer prevalence and growing pharmacoeconomic pressures.

Speaker Change: Thanks, James and good afternoon, everyone Lasalle as development programs are based on sound scientific rationale from a vast body of published preclinical and early clinical works. These works include dose, which led to Doctor Erkki wish slutty being awarded the Lasker Prize for the fundamental discoveries that spawned or send our platform.

Kristen K. Buck: Technology.

Kristen K. Buck: A product of the Sundar platform suite hepatitis is designed to address major impediments to the successful treatment of advanced solid tumors.

Kristen K. Buck: This is especially relevant in an environment of increasing cancer prevalence and growing for Pharmacopeia economic pressures.

Kristen K. Buck: Our clinical studies have been rigorously designed with the end in mind, that is, product registration, and they're optimized to generate clinically meaningful, unambiguous data. As such, unlike many similarly phased studies, our studies are placebo-controlled, appropriately sized, and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials. Further, our trials evaluate certipetide in combination with current standards of care to allow for clear discernment of treatment effects and to fit with current treatment practices at clinical sites. However, these strategic design choices are not always the least expensive approach.

Kristen K. Buck: Our clinical studies had been rigorously designed with the end in mind that as product registration.

Kristen K. Buck: And there are optimized to generate clinically meaningful unambiguous data.

Kristen K. Buck: As such unlike many similarly phase studies, our studies are placebo controlled appropriately sized unemployed primary endpoints that are preferred by regulatory authorities in support of pivotal trials.

Kristen K. Buck: Further our trials evaluate certain peptide in combination with current standards of care to allow for clear discernment of treatment effect.

Kristen K. Buck: And to fit with current treatment practices at clinical sites.

Kristen K. Buck: These strategic design choices are not always the least expensive approach, but they do afford us the most scientifically rigorous methodology by which to generate clinically meaningful data as efficiently and rapidly as possible.

Kristen K. Buck: But they do afford us the most scientifically rigorous methodology by which to generate clinically meaningful data as efficiently and rapidly as possible. This is in keeping with our development mantra, do the last experiment first, to avoid the time and capital consumption on work that could become unnecessary. We have also devised and implemented a regulatory strategy that optimizes ceteptized regulatory review and future commercialization. This strategy includes obtaining special regulatory designations, priority reviews, and accelerated approval. I will speak more about the company's strategy in a moment.

Kristen K. Buck: This is in keeping with our development mantra do the last experiment first.

Kristen K. Buck: To avoid the time and capital consumption on work that could become unnecessary.

Kristen K. Buck: We have also devised and implemented a regulatory strategy that optimizes their tech tight regulatory view and future commercialization.

Kristen K. Buck: This strategy includes obtaining special regulatory designations priority reviews and accelerated approvals.

Speaker Change: I'll speak more to the company's strategy in a moment, but as you can imagine the aforementioned opportunities underpin why we are so excited about the initial top line results that we'll report at the end of the year from our large phase two b ascend trial.

Kristen K. Buck: But if you can imagine, the aforementioned opportunities underpin why we are so excited about the initial top-line results that will be reported at the end of the year from our large phase to be central. However, before I get to the specifics of each of the clinical studies, allow me to provide some important background, especially for those who are listening to me for the first time. Despite advances in cancer therapy, including CAR-T cell therapy and immunotherapies, many solid tumors are still associated with poor outcomes for patients.

Kristen K. Buck: However, before I get to the specific of each of the clinical studies allow me to provide some important background, especially for those who are listening to me for the first time.

Kristen K. Buck: Cancers such as pancreatic cancer, gastric cancers, glioblastoma multiforme, or brain cancer, and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which actually limits access of most pharmacotherapies to the tumor. In addition, many solid tumors also present a hostile tumor microenvironment, or TME, which suppresses a patient's immune system and makes it less effective in fighting cancer.

Kristen K. Buck: Okay.

Kristen K. Buck: Despite advances in cancer therapy, including car T cell therapy, and Immunotherapies. Many solid tumors are still associated with poor outcomes for patients.

Kristen K. Buck: The combination of the dense stroma and the hostile TME prevents many chemotherapies and immunotherapies from being optimally effective in treating these cancers. This, coupled with the fact that most anti-cancer therapies are not efficient in targeting only cancer tissue, defines the major challenge of maximizing effectiveness and safety in the treatment of solid tumors. However, to combat this, Lisata's approach is to exploit the CN rule to activate the SEND-R active transport system.

Kristen K. Buck: Cancers, such as pancreatic cancer gastric cancers, glioblastoma multi form of brain cancer and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which actually limits access of most pharmacotherapy to the tumor.

Kristen K. Buck: In addition, many solid tumors also present with a hostile tumor microenvironment, where T M E.

Kristen K. Buck: Which suppresses a patient's immune system and makes it less effective in fighting cancer.

Kristen K. Buck: The combination of the dense stroma and a hostile tammy prevents many chemotherapies and immunotherapies from optimally being effective in treating these cancers.

Kristen K. Buck: This coupled with the fact that most anti cancer therapies are not efficient in targeting only cancer tissue.

Kristen K. Buck: The major challenge of maximizing effectiveness and safety in the treatment of solid tumors.

Kristen K. Buck: However to combat. This Lucerne is approach is to exploit the C N rule to activate the send our active transport system.

Kristen K. Buck: It's a naturally occurring active transport system to selectively deliver anti-cancer drugs through the stroma and into the tumor. Sirtepatide is a 9-amino acid cyclic peptide with high binding affinity and specificity for alpha-V, beta-3, and beta-5 integrin receptors, which are significantly upregulated on tumor vascular endothelial cells and tumor cells, but not healthy tissue. Once bound to these integrins, certepatite is cleaved by proteases naturally occurring in the tumor microenvironment. The proteases convert sirtepatide from a cyclic peptide into two linear peptides, one of which is a 5-amino acid SEND-R linear peptide fragment.

Kristen K. Buck: It's a naturally occurring active transfer system to selectively deliver.

Kristen K. Buck: <unk> cancer drugs through the stroma and into the tumor.

Kristen K. Buck: So tepid tide is it nine amino acid cyclic peptides with high binding affinity and specificity for Alpha beta three and beta five integrin receptors.

Kristen K. Buck: Which are significantly up rate regulated on tumor vascular endothelial cells and tumor cells, but not healthy tissue.

Kristen K. Buck: Once bounded these integrant certain hepatitis cleaved by protease is naturally occurring in the tumor microenvironment.

Kristen K. Buck: The protease is convert certain hepatitis from a cyclic peptide into two linear peptides.

Kristen K. Buck: One of which is a five amino acid send our linear peptide fragment.

Kristen K. Buck: Upon dissociation of the Sendar fragment from the integrin receptor, it binds to another receptor called norepilin-1 on the same or nearby cell. Once Neuropillin-1 is activated, it actuates the SendR active transport mechanism, which is manifested by the formation of microvesicles at the surface of the cells.

Kristen K. Buck: Upon the association of the Sundar fragment from the integrin receptor. It binds to another receptor called neuro pill and one on the same or nearby cell.

Kristen K. Buck: Once neuro appealing one is activated it actuate the send our active transport mechanism, which is manifested by the formation of micro vessels at the surface of the cells.

Kristen K. Buck: These microvesicles encapsulate moieties in the circulatory system, including any co-administered anti-cancer drugs, unbound certepatide, and Sendar fragments, and essentially ferry them through the stroma and vasculature into the tumor. Sirtepatide's mechanism of action is agnostic to the modality of the companion anti-cancer drug with which it is administered. And it can be combined with a wide range of existing or emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapies. Additionally, as previously reported, cetepatite has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells, reducing tumor resistance to anti-cancer medications, and actually impeding and or preventing the metastatic cascade.

Kristen K. Buck: These micro vehicles encapsulate more <unk> in the circulation circulatory system, including any co administered anti cancer drugs.

Kristen K. Buck: Bouncer turpentine and Sundar fragments.

Kristen K. Buck: And essentially ferries them through the stroma and vasculature into the tumor.

Kristen K. Buck: <unk> mechanism of action is agnostic to the modality of the companion anti cancer drug with which it is administered and it can be combined with a wide range of existing or emerging anti cancer therapies, including chemotherapies immune.

Kristen K. Buck: Immunotherapies in RNA based therapies.

Kristen K. Buck: Additionally, as previously reported certain hepatitis has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells.

Kristen K. Buck: Reducing tumor resistance to anti cancer medications, and actually impeding <unk>, preventing the metastatic cascade.

Kristen K. Buck: These results come from Lisata-sponsored studies and from collaborators and research groups around the world and have been the subject of more than 350 scientific publications relevant to Certepatide's mechanism of action. Along with our collaborators, we've also amassed significant non-clinical data demonstrating enhanced delivery of a range of anti-cancer therapy modalities, including chemotherapies, immunotherapies, RNA-based therapeutics, and And to date, Sirtepidide has demonstrated favorable clinical safety, tolerability, and activity to enhance the delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer. As mentioned earlier, Lisata has worked diligently to optimize our regulatory strategy.

Kristen K. Buck: These results come from sort of sponsored studies and from collaborators and research groups around the world and has been the subject of more than 350 scientific publications relevant to certain hepatitis mechanism of action.

Kristen K. Buck: Along with our collaborators we have also amassed significant non clinical data demonstrating enhanced delivery of a range of anti cancer therapy modalities, including chemotherapy immunotherapies.

Kristen K. Buck: RNA based therapeutics and even cell therapies.

Kristen K. Buck: And to date, so turbidite has demonstrated favorable clinical safety tolerability and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer.

Kristen K. Buck: As mentioned earlier Lasalle has worked diligently to optimize our regulatory strategy.

Kristen K. Buck: The fruits of our labor can be seen in the number of special regulatory designations awarded to our products. For example, Sirtepatide is the recipient of a fast-track designation by the FDA, which affords us more frequent interactions with the FDA and the ability to submit NDA components early for a rolling review. Certepatide will also be eligible for an accelerated approval and priority review if the relevant criteria are met. Furthermore, shotepatitis received multiple orphan designations, including one for pancreatic cancer in both the U.S. and Europe, as well as one for malignant glioma in the United States. Orphan Designation affords Lisata exemption from user fees and provides extended market exclusivity, and until the start of 2024.

Kristen K. Buck: The fruits of our labor can be seen in the number of special regulatory designation awarded to our product.

Kristen K. Buck: For example, certain hepatitis the recipient of a fast track designation by the FDA, which affords us more frequent interactions with the FDA and the ability to submit NDA components early for a rolling review.

Kristen K. Buck: <unk> will also be eligible for an accelerated approval and priority review if the relevant criteria are met.

Kristen K. Buck: Further should hepatitis received multiple orphan designations, including one for pancreatic cancer in both the U S and Europe.

Kristen K. Buck: As well as one for malignant glioma in the United States.

Kristen K. Buck: Orphan designation affords Lasalle exemption from user fees and provides extended market exclusivity.

Kristen K. Buck: And since the start of 2024.

Kristen K. Buck: Certepatide has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States. Just for background, the FDA defines rare pediatric diseases as diseases with fewer than 200,000 cases in the United States that are serious or life-threatening and primarily affect individuals under 18 years of age. A substantial benefit of a rare pediatric disease designation is receipt of a priority review voucher, often referred to as the golden ticket, once the FDA approves a new drug application, or NDA, for the product and indication having received the designation.

Kristen K. Buck: <unk> has also received orphan designation and a rare pediatric disease designation for osteosarcoma in the United States.

Kristen K. Buck: Just for background, the FDA defined rare pediatric diseases.

Kristen K. Buck: Diseases with fewer than 200000 cases in the United States that are serious or life, threatening and primarily affect individuals' under 18 years of age.

Kristen K. Buck: A substantial benefit of a rare pediatric disease designation is receipt of our priority review voucher, often referred to as the Golden ticket once the FDA approves the new drug application or NDA for the product and indication having received the designation.

Kristen K. Buck: Vouchers are especially valuable as they can be used to compel a priority review of an additional NDA or biologic license application for another product or indication, reducing the standard review time of approximately 10 months to 6 months. The voucher may be used by a sponsor or sold to another sponsor for their use. Priority review vouchers have sold for as much as 350 million U.S. dollars historically, and more recently, they have sold for between 75 and 100 million dollars.

Kristen K. Buck: Vouchers are especially valuable as they can be used to compel a priority review of an additional NDA or biologic license application for another product or indication, reducing the standard review time of approximately 10 months to six months.

Kristen K. Buck: The voucher may be used by a sponsor or sold to another sponsor for their use.

Kristen K. Buck: Review vouchers have sold for as much as 350 million U S dollars historically and more recently have sold for between 75 and $100 million.

Kristen K. Buck: Overall, our development strategy includes the pursuit of a rapid certepetide registration for the treatment of metastatic pancreatic ductal adenocarcinoma, alongside studies which further exploit certepetide's ability to enhance a variety of anti-cancer treatments in a range of solid tumors. To this end, certepithyte is currently the subject of nearly a dozen planned or active clinical trials globally for the treatment of various solid tumors. For example,

Kristen K. Buck: Overall, our development strategy includes the pursuit of a rapid sort of tepid hybrid registration for the treatment of metastatic pancreatic ductal adenocarcinoma.

Kristen K. Buck: Alongside studies, which further exploit your type of ties ability to enhance a variety of anti cancer treatments in a range of solid tumors.

Kristen K. Buck: To this end sort of <unk> is currently the subject of nearly a dozen planned four active clinical trials globally for the treatment of various solid tumors.

Kristen K. Buck: For example.

Kristen K. Buck: The ASCEND trial. It's a 158 patient, double blind, placebo-controlled, randomized clinical trial evaluating certepetide in combination with standard of care gemcitabine and nabpaclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, often known as MPDAC. The trial is being conducted at 25 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Cancer Trials Group, or AGITG, in collaboration with the NHMRC Clinical Trial Center at the University of Sydney. The study consists of two cohorts.

Kristen K. Buck: The ascend trial, it's a 158 patient double blind placebo controlled randomized clinical trial evaluating.

Kristen K. Buck: Evaluating <unk> in combination with standard of care, Gemcitabine and Nab paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, often known as M. P deck.

Kristen K. Buck: The trial is being conducted at 25 sites in Australia, and New Zealand led by the Australia Asia, gastrointestinal cancer trials group or AG ITG and.

Kristen K. Buck: In collaboration with the NH MRC clinical trial center at the University of Sydney.

Kristen K. Buck: Cohort A receives a single dose of 3.2 milligrams per kilogram of certeposide, essentially simultaneously with standard of care, while Cohort B is identical to Cohort A, but with a second dose of 3.2 mg per kg of certipetide given four hours after the first.

Kristen K. Buck: The study consists of two cohorts cohort a.

Kristen K. Buck: Received a single dose of $3 two milligram per kilogram <unk> essentially simultaneously with standard of care.

Kristen K. Buck: <unk> B is identical to cover a day, but with the second dose of $3 two milligram per kilogram certain hepatitis given four hours after the first.

Kristen K. Buck: As previously reported, a positive outcome from the Planned Interim Futility Analysis in 2023 was announced by the study's Independent Data Safety Monitoring Committee, which recommended continuation of the study without modification. With trial enrollment completed in the fourth quarter of 2023, we expect top-line data from 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of this year, and the complete data set of all 158 patients from the study to be available by mid-25. The prospect of positive data is encouraging, and we have begun planning the subsequent development steps.

Kristen K. Buck: As previously reported a positive outcome from the planned interim futility analysis in 2023 was announced by the study's independent data safety monitoring Committee, which recommended continuation of the study without modification.

Kristen K. Buck: With trial enrollment completed in the fourth quarter of 2023, we expect top line data from 95 patients assigned to cohort of the study to be reported in the fourth quarter of this year.

Kristen K. Buck: And the complete dataset of all 158 patients from the study to be available by mid 'twenty five.

Kristen K. Buck: The prospect of positive data is encouraging and we have begun planning the subsequent development steps.

Kristen K. Buck: For example, we've already received an opinion from the Therapeutic Goods Administration, or TGA, which is the medicine and therapeutic goods regulatory agency of the Australian government, that they believe positive data from Cohort A of ASCEND warrants submission of an application for provisional determination, the Australian version of a conditional approval. We expect similar discussions with FDA and EMA once the data are in hand. We have already anticipated and designed the required phase 3 study that will be necessary to maintain a conditional approval and support a full registration once completed. The ASCEND data anticipated this year will further inform and optimize our proposed Phase III clinical program in MPDAC. Next, the Bolster Trial.

Kristen K. Buck: For example, we've already received an opinion from the therapeutic goods administration or T. G E, which is the medicine and therapeutic goods regulatory agency of the Australian government.

Kristen K. Buck: That they believe positive data from cohort day of ascend warrants submission of an application for provisional determination.

Kristen K. Buck: The Australian version of a conditional approval.

Kristen K. Buck: We expect similar discussions with FDA and DMA once the data are in hand.

Kristen K. Buck: We have already anticipated and designed the required phase III study that will be necessary to maintain the conditional approval.

Kristen K. Buck: In support of full registration once completed.

Kristen K. Buck: The ascend data anticipated this year will further inform and optimize our proposed phase III clinical program in M. P deck.

Kristen K. Buck: The BOLSTER trial is our Phase 2a double-blind, placebo-controlled, multicenter, randomized trial in the United States, evaluating certepetide in combination with standard of care in first-line cholangiocarcinoma. The BOLSTER trial was originally designed as a phase 2, 3 arm basket trial, evaluating certepetide in combination with standards of care for second-line head and neck squamous cell carcinoma, During months of study planning and initiation activities for the head and neck and esophageal cohorts, however, we deemed that these two arms were not feasible to recruit given challenges with country-specific access to consistent standards of care drugs and delays in adding these standards of care drugs to national formularies.

Kristen K. Buck: Next the bolster trial.

Kristen K. Buck: The bolster trial is our phase two a double blind placebo controlled multicenter randomized trial in the United States evaluating certain appetite in combination with standard of care in first line Cholangiocarcinoma.

Kristen K. Buck: The bolster trial was originally designed as a phase two three arm basket trial evaluating certain hepatitis in combination with standards of care for second line head and neck squamous cell carcinoma second.

Kristen K. Buck: Second line is soft <unk> squamous cell carcinoma, and first line Cholangiocarcinoma.

Kristen K. Buck: During months of study planning and initiation activities for the head and neck and half NGL cohorts. However, we deemed it. These two arms were not feasible to recruit given challenges with country specific access to consistent standard of care drugs and delays in adding the standard of care drugs to national Formularies.

Kristen K. Buck: Given these obstacles, the two arms were going to take much longer to complete and be significantly more costly than originally projected. As a result... We took the fiscally responsible but nevertheless difficult decision to terminate these arms.

Kristen K. Buck: Given these obstacles.

Kristen K. Buck: The two arms were going to take much longer to complete and be significantly more costly than originally projected.

Kristen K. Buck: As a result.

Kristen K. Buck: We took the fiscally responsible but nevertheless difficult decision to terminate these arms.

Kristen K. Buck: Following that action, we strategically refocused the trial on the first-line cholangiocarcinoma arm. As it relates to this, I'm actually delighted to report that Lisata's internal team has made significant enrollment progress to date that has far exceeded expectations. We expect to easily complete enrollment in first-line cholangia carcinoma by the end of the year, if not substantially sooner. Also, the effectiveness of the sites involved in the first-line cholangiocarcinoma arm, along with the enthusiasm and efficiency of the corresponding investigators, has prompted us to consider initiating a bolster study amendment for patients requiring second-line treatment for their cholangiocarcinoma.

Kristen K. Buck: Following that action, we strategically refocus the trial on the first line Cholangiocarcinoma arm.

Kristen K. Buck: As it relates to this I'm actually delighted to report that Lasalle is internal team has made significant enrollment progress to date that has far exceeded expectations.

Kristen K. Buck: We expect to easily complete enrollment in first line cholangiocarcinoma by the end of year, if not substantially sooner.

Kristen K. Buck: Also the effectiveness effectiveness of the sites involved in the first line Cholangiocarcinoma arm, along with the enthusiasm and efficiency of the corresponding investigators has prompted us to consider initiating and bolster study amendment for patients requiring second line treatment for their cholangiocarcinoma.

Kristen K. Buck: To achieve this, we are in active discussions with the FDA and our investigator network, and we'll provide more news on this in the coming weeks and months. Next is the Send-a-Fox study. It's a phase 1b, 2a study.

Kristen K. Buck: To achieve this we are in active discussions with the FDA and our investigator network and will provide more news on this in the coming weeks and months.

Kristen K. Buck: Next is the Sunday Fox study.

Kristen K. Buck: It's a phase one b to a <unk>.

Kristen K. Buck: An open-label trial in the United States of certepetide in combination with neoadjuvant fulfirinox-based therapies in pancreatic, colon, and appendiceal cancers. And it continues to make steady progress with enrollment completion for all three arms expected by the end of this year, 2024. This trial will provide us with pre- and post-treatment biopsy immunoprofiling data, as well as long-term heart outcome data. Qilu Pharmaceutical, the licensee of Certipetide in the Greater China Territory, is also currently evaluating Certipetide in combination with gemcitabine and nabpaclitaxel as a treatment for MP-.

Kristen K. Buck: Open label trial in the United States of certain hepatitis in combination with Neo adjuvant for fear of Nox based therapies in pancreatic colon and Appendiceal cancers, and it continues to make steady progress with enrollment completion for all three arms expected by the end of this year 2024.

Kristen K. Buck: This trial will provide us with pre and post treatment biopsy immuno profiling data as well as long term heart outcome data.

Kristen K. Buck: <unk> pharmaceutical the license of certain appetite in the greater China territory is also currently evaluating certain appetite in combination with Gemcitabine and Nab paclitaxel as a treatment for M. P deck.

Kristen K. Buck: During the 2023 ASCO annual meeting, Chilu Pharmaceutical presented an abstract sharing preliminary data from the trial, which corroborated previously reported findings from the phase 1b2a trial of certepetide plus gemcitabine and nabpaclitaxel conducted in Australia in patients with metastatic pancreatic cancer. As recently announced, Chilo has begun treating patients in their Phase 2 placebo-controlled trial in MPDAC. The studies plan to take approximately 18 months to complete enrollment, and accrual, and another 13 months for patient follow-up and data analysis and reporting.

Kristen K. Buck: During the 2023 <unk> annual meeting Qi Lu pharmaceutical presented an abstract sharing preliminary data from the trial, which corroborated previously reported findings from the phase <unk> trial of <unk>, plus Gemcitabine and Nab Paclitaxel conducted in Australia in patients with metastatic pancreatic cancer.

Kristen K. Buck: Answer.

Kristen K. Buck: As recently announced Sheila has begun treating patients in their phase III placebo controlled trial in M. <unk>.

Kristen K. Buck: Studies.

Kristen K. Buck: To take approximately 18 months to complete enrollment of krill and another 13 months for patient follow up and data analysis and reporting.

Kristen K. Buck: In collaboration with our funding partner, WARP9, the i-LISTA trial is a Phase 1b, 2a, randomized placebo controlled, single blind, single center, safety, early efficacy and pharmacodynamic trial in Australia. This three cohort study is evaluating certepetide in combination with the checkpoint inhibitor durvalamib plus standard of care gemcitabine and nabpaclitaxel chemotherapy versus certepetide in combination with standard of care alone versus standard of care alone in patients with locally advanced non-resectable PDAC. Enrollment completion is expected in the second half of 2024, iGolista, a Phase 1b, 2a proof of concept safety and efficacy study evaluating sirtepatide in combination with nivolumab and fulfirinox as a first line treatment in locally advanced non-resectable gastro esophageal adenocarcinoma is pending initiation as a function of availability of funding by our partner Warp9.

Kristen K. Buck: Okay.

Kristen K. Buck: In collaboration with our funding partner Warp nine the I list. The trial is a phase one b to a randomized placebo controlled single Blind single Center safety early efficacy and Pharmacodynamic trial in Australia.

Kristen K. Buck: Three cohort study is evaluating <unk> in combination with the checkpoint inhibitor development plus standard of care Gemcitabine and Nab Paclitaxel chemotherapy <unk>.

Kristen K. Buck: <unk> in combination with standard of care alone.

Kristen K. Buck: Versus standard of care alone in patients with locally advanced non Resectable P deck.

Kristen K. Buck: Enrollment completion is expected in the second half of 2024.

Kristen K. Buck: I go Lister a phase one b to a proof of concept safety and efficacy study <unk>.

Kristen K. Buck: <unk> in combination with knee Vala, Mab and fulfill <unk> as a first line treatment in locally advanced non Resectable gastro esophageal adenocarcinoma is pending initiation as a function of availability of funding by our partner <unk>.

Kristen K. Buck: The inspiration for this study comes from the findings recently published in Oncology and Cancer Case Reports Journal, which details a patient with metastatic gastroesophageal adenocarcinoma who achieved a complete response when given certepetide in combination with standard of care fulferinox plus pembrolizumab. The subject initially underwent months of standard-of-care treatments and only achieved a partial response.

Kristen K. Buck: The inspiration for this study comes from the findings recently published in oncology and cancer case reports journal, which details a patient with metastatic gastroesophageal adenocarcinoma, who achieved a complete response when given certain appetite in combination with standard of care Fullfare Arnox plus Pembroke.

Kristen K. Buck: As a man.

Kristen K. Buck: The subject initially under one months of standard of care treatments and only achieved a partial response.

Kristen K. Buck: Upon the subsequent addition of certepetide to the existing standard-of-care therapeutic regimen, the subject achieved a complete response, confirmed both radiographically and surgically. Remarkably, and thankfully, the subject remains healthy since achieving the complete response in February of 2023. We hope to provide an update on timing related to the execution of the IGOLISTA study in the coming quarters. A study of Sirtepatide in combination with Temozolomide in Glioblastoma Multiforme, or GBM, has been initiated, with several patients already enrolled and treated.

Kristen K. Buck: Upon the subsequent addition of certain peptide to the existing standard of care therapeutic regimen. The subject achieved a complete response confirmed both radiographically and surgically.

Kristen K. Buck: Remarkably and thankfully the subject remains healthy since achieving the complete response in February of 2023.

Kristen K. Buck: We hope to provide an update on timing related to the execution of the <unk> study in the coming quarters.

Kristen K. Buck: A study of certain hepatitis in combination with T. Mazola wide in Glioblastoma multi form or GBM has been initiated with several patients already enrolled and treated.

Kristen K. Buck: This study is designed as a phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating certepetide when added to standard-of-care temozolomide versus temozolomide alone and matching cetrepetide placebo in patients with newly diagnosed glioblastoma multiforme. This actively enrolling study is being conducted across multiple sites in Estonia and Latvia and is targeted to enroll On top of the previously described studies, we're exploring additional trials supporting our general development strategy.

Kristen K. Buck: This study is designed as a phase two a double blind placebo controlled randomized proof of concept study evaluating <unk> <unk> when added to standard of care team is all online versus team is all might alone and matching certain hepatitis placebo in patients with newly diagnosed glioblastoma multiform.

Kristen K. Buck: This actively enrolling study is being conducted across multiple sites in Estonia, and Latvia and is targeted to enroll 30 patients with a randomization of two to one <unk> plus standard of care versus placebo plus standard of care.

Kristen K. Buck: On top of the previously described studies, we're exploring additional trials supporting our general development strategy.

Kristen K. Buck: However, we remain steadfast in only starting trials that can be funded through to data and trials that can be executed within a reasonable period of time. Finally, I would be remiss if I didn't remind you that several of the studies I mentioned are investigator-initiated trials. And although we have great confidence in our investigators running these studies, Lisata has limited control, and thus, timelines and expectations may be subject to change. That said, we are extremely grateful to the investigators and especially to the patients participating in cetepidctide clinical trials around the world.

Kristen K. Buck: However, we remain steadfast in only starting trials that can be funded through to data and trials that can be executed within a reasonable period of time.

Kristen K. Buck: Finally, I'd be remiss, if I didn't remind you that several of the studies I mentioned are investigator initiated trials.

Kristen K. Buck: And although we have great confidence in our investigators running these studies Masada has limited control and thus timelines and expectations may be subject to change.

Kristen K. Buck: That said, we are extremely grateful to the investigators and especially to the patients participating in <unk> clinical trials around the world.

Kristen K. Buck: For those who are more interested, a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website. Additionally, in the body of the presentation, there are two slides that depict the anticipated timing and execution of key milestones and data readouts from our trials. As you will see, there are numerous execution and data milestones projected from our portfolio of clinical trials over the next year and beyond. With that, I will now turn the call back to Dave.

Kristen K. Buck: For those who are more interested a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website.

Kristen K. Buck: Additionally, in the body of the presentation. There are two slides that depict the anticipated timing and execution of key milestones and data readouts from our trials.

Kristen K. Buck: As you will see there are numerous execution and data milestones projected from our portfolio of clinical trials over the next year and beyond.

Kristen K. Buck: With that I will now turn the call back to Dave.

Kristen K. Buck: Dave.

Kristen K. Buck: Okay.

David J. Mazzo: Hello, can you hear me? Yes. Okay. I was having some technical difficulties.

Dave: Hello can you hear me, yes, Okay I was having some technical difficulties I apologize. Thank you Kristen we appreciate that comprehensive overview.

David J. Mazzo: I apologize. Thank you, Kristen. We appreciate that comprehensive overview. Even with multiple data readouts over the next 18 months, as outlined by Kristen, we see the ASCEND initial top line data as being seminal to the CertepiTi development program and to our company. These results will be instrumental in allowing us to consummate business transactions associated with the product and in defining our future capital needs. That said, we remain committed to advancing all of our CertepiTi development programs across a variety of solid tumor indications in order to fully exploit both the medical and commercial promise of CertepiTi.

Dave: Even with multiple data readouts over the next 18 months as outlined by Kristen we see the ascend initial top line data has been seminal to the <unk> development program into our company.

David J. Mazzo: These results will be instrumental in allowing us to consummate business transaction associated with the product and in defining our future capital needs that said, we remain committed to advancing all of our certificate type development programs across a variety of solid tumor indications in order to fully exploit both the medical and commercial promise a certain appetite.

David J. Mazzo: Now that we have entered the six-month window for data, our excitement and the attention we are receiving from prospective partners, licensors, and investors are increasing daily, and we look forward to sharing further details on our progress throughout the year. And with that overview out of the way, we are ready to take questions. Thank you.

David J. Mazzo: Now that we have entered the six month window to data our excitement and the attention. We are receiving from prospective partners licensor and investors are increasing daily and we look forward to sharing further details on our progress throughout the year and with that overview operator, we are ready to take questions.

Operator: Thank you. As a reminder, to ask a question, please press star one one on your telephone. You will then hear an automated message advising your hand is raised. Each listener will be permitted to ask one question at a time, and we'll return to the queue for any additional questions. Please stand by while I compile the Q&A roster. Our first question comes from Joseph. Pangeanus, from H.C. Wainwright. Please go ahead.

David J. Mazzo: Thank you.

Operator: As a reminder.

Joseph Pangeanus: I ask a question. Please press star one one on your telephone you would deem here an automated message advising Durham is raised it.

Operator: Each listener would be permitted to ask one question at a time and we'll return to the queue for any additional questions. Please standby, while we compile the Q&A roster.

Joseph Pangeanus: Our first question comes from Joseph <unk> from H C. Wainwright. Please go ahead.

Sara Nik: Hi, good afternoon. This is Sara on behalf of Joe. I just wanted to ask, I guess more might be a bit early, but for SIRKs Epitide and GBM, I was wondering when we could, or when you're gauging to reach that target enrollment completion, and if you're planning to kind of give a first look at any initial data cuts along the way, or are you waiting to reach that 30-patient enrollment to give a first look at data? Thank you.

Operator: Hi, Good afternoon. This is Sarah on for Joe just wanted to ask.

Sara Nik:

Sara Nik: Let's say early but for <unk> and GBM.

Sara Nik: I was wondering when we could when you're gauging to reach that target enrollment completion, and if youre planning to kind of get first look at any initial data cuts along the way or are you waiting to reach that 30 patient enrollment.

Sara Nik: Give a first look at data thank you.

David J. Mazzo: Thanks, Sara. I appreciate the question. I'm going to ask Kristen to jump in here in a minute on timing.

Speaker Change: Thanks I appreciate the question I am going to ask Christian to jump in here in a minute on timing, but as it relates to taking a first look at data on this trial like many of our other trials is blinded and does not have a provision for an early breaking of the blind for an early look so we'll have to wait.

David J. Mazzo: But as it relates to taking a first look at data, this trial, like many of our other trials, is blinded and does not have in it a provision for an early breaking of the blind for an early look. So we'll have to wait until all 40 patients are actually enrolled and reach their endpoints. In terms of enrollment, Kristen can give you a better idea of what we're seeing right now, especially given that the trial had a safety period, a safety observation period built in, which we're just coming to the end of and which will allow us now to actually enroll patients at a much higher rate. Okay, so this is for the GBM trial in Estonia and Latvia. Kristen, are you there?

Kristen: Until all 40 patients are actually enrolled and reach their endpoints in terms of enrollment Christian can give you a better idea of what we're seeing right now, especially given that the trial had a safety period. The safety observation period built in which we're just coming to an end up and which will allow us now.

Kristen: For us to actually enroll patients at a much higher pace. So this is this is for the GBM trial.

Kristen: And Ah study Lafayette.

David J. Mazzo: Kristen, are you there? Yes, thanks. Thanks, Sara, for the question.

Kristen: Christopher Yes. Thanks, Thanks, Sara for the question.

Kristen K. Buck: We currently have three subjects enrolled out of 30, and the last subject. I would say the first three subjects require a 30-day observation for safety. Our last subject of the three is two weeks into their 30-day safety run-in. To date, we've not seen any safety concerns, and therefore, within two or three weeks, we anticipate the rest of the enrollment to pick up.

Kristen: We have currently three subjects enrolled out of 30 and the last subject I would say the first three subjects require a 30 day observation for safety are less subject. The of the three is two weeks into their 30 day safety running to date, we've not seen any safety concerns and then.

Kristen K. Buck: Therefore within two or three weeks, we anticipate the rest of the enrollment to pick up.

Kristen K. Buck: Okay.

Kristen K. Buck: Okay, great. Thank you. That's helpful. Thank you. One moment.

Kristen K. Buck: Yes.

Speaker Change: Okay, great. Thank you that's helpful.

Operator: Thank you. One moment for our next question. Our next question comes from Will Hiddle, from Brookline Capital Markets. Please go ahead.

Speaker Change: Thank you one moment for our next question.

Will Hiddle: Our next question comes from will hero.

Will Hiddle: From Brookline capital markets. Please go ahead.

Will Hiddle: Hi, thank you for taking the question. I had a quick question regarding the trial with SHIWU. Why would they need ATMOS?

Will Hiddle: Alright, Thank you for taking the questions.

Will Hiddle: Had a quick question regarding the trial, it's Hugh why would they need routine months.

Will Hiddle: Okay.

Operator: We can hear you. Go ahead, Will. Can you hear me now?

Will Hiddle: We can hear you go ahead, well can you hear me now.

Will Hiddle: Yes, sorry.

Will Hiddle: Yes. Okay. All right. Hi. Thank you for taking the questions.

Speaker Change: Alright, Thank you for taking questions well, if you could mute yourself.

Operator: Well, if you could unmute yourself,

Will Hiddle: Yes, we can hear him operator.

Operator: No, we can hear him, operator.

Operator: Okay.

Operator: Okay, um... So regarding the trial with Shilu, why would you need 18 months to enroll the trial, given your experience with ASCEND and, I guess, the tendency for Chinese oncology trials to enroll quickly?

Operator: So regarding the trial with Sheila.

Operator: Why would you need 18 months to enroll the trial given your experience with ascend.

Operator: The tendency for the Chinese oncology trials to enroll quickly.

David J. Mazzo: Well, thanks. Well, I appreciate the question. To be clear, the Chilu trials are run exclusively by Chilu. All the operations and execution are completely within their purview. We do speak.

David J. Mazzo: Well, thanks, Will. I appreciate the question.

Speaker Change: Well. Thanks I appreciate the question to be clear that the.

David J. Mazzo: The Chile trials are run exclusively by Chill, who all the operations and execution are completely within their purview, we do speak to them about strategy as part of the joint steering committee, but execution is completely up to them within within China.

David J. Mazzo: To be clear, the CHILU trials are run exclusively by CHILU. All the operations and execution are completely within their purview. We do speak to them about strategy as part of the Joint Steering Committee, but execution is completely up to them within China. I'm not sure that they will need 18 months, but that's what they have communicated publicly, that that's their projection at the moment, and hopefully they'll go fast. Okay, thank

David J. Mazzo: I'm not sure that they were.

David J. Mazzo: We'll meet 18 months, but that's what they have communicated publicly that thats there.

David J. Mazzo: <unk> at the moment and hopefully they'll go faster.

Speaker Change: Okay. Thank you.

David J. Mazzo: Okay.

David J. Mazzo: Okay.

David J. Mazzo: Okay.

David J. Mazzo: Okay.

Operator: It appears we're having technical difficulties with our operator to take the next question.

David J. Mazzo: It appears we're having technical difficulties with our operator to take the next question.

Operator: Okay.

Operator: If someone has another question, can you just speak up? John, are you there? Can you see if we can get Antoine to figure out what's going on technically?

Operator: If someone has another question can you just speak up.

Operator: John are you there can you see if we can get an sponsored figure out what's going on technically.

Operator: This is Pete Enderlin. Can you hear me?

Operator: This is Pete and Ron can you hear me go.

Peter J. Enderlin: Go ahead, Pete. Yes. Thanks. Okay.

Peter J. Enderlin: Okay, good. Well, the first question is this, technical financial questions. You filed for a $150 million shelf. I assume that's just to replace one that recently expired, but do you have anything further to say about the use of that other than obviously providing financial flexibility?

Peter J. Enderlin: Go ahead, Pete yes, okay. Good.

Pete: Well the first question is this.

Peter J. Enderlin: Technical financial question, you filed a $150 million shelf.

Peter J. Enderlin: I assume that's just to replace one that recently expired, but do you have anything further to say about the use of that other than obviously, providing.

David J. Mazzo: You answered your own question, Pete. That's really a housekeeping matter. Our previous shelf was expiring, and we always need to keep, you know, a shelf on file in order to be able to take advantage of financing and other opportunities as they might arise. So right now, it's just financing, housekeeping, if you will.

Peter J. Enderlin: Financial flexibility.

Speaker Change: You answered your own question.

David J. Mazzo: Yeah, that's really a housekeeping matter our previous shelf was expiring and we always need to keep a shelf on file in order to be able to take advantage financing and other opportunities as they might arise. So right now its just financing housekeeping if you will.

Peter J. Enderlin: Okay, and then more substantive questions. You know, for example, the bolster trial is in the US, Europe, Canada, Australia, and you have several trials that are in different venues around the world. So the question is, do those all operate, let's say the one for the Bolzer trial, under US FDA protocol or different standards in every country that you do them in? And if that's true, why do you bother having all these different things to work under, which would make it more expensive and more complicated?

Speaker Change: Okay, and then more substantive question.

Peter J. Enderlin: For example, a bolster trials.

Peter J. Enderlin: As in the U S Europe, Canada, Australia.

Peter J. Enderlin: And here you have several trials that are in different venues around the world.

Peter J. Enderlin: So.

Peter J. Enderlin: The question is do those all operate let's say the one for the Bolsa trial under.

Peter J. Enderlin: U S FDA protocol or different standards in every country that you do them and if that's true.

Peter J. Enderlin: Why do you bother, having all these different things.

Peter J. Enderlin: To work under which would make it more expensive and more complicated.

David J. Mazzo: All right, so thanks, Pete, I appreciate the question. First of all, whenever we do, and Frankly, I think this is true across the entire pharmaceutical industry, whenever anyone does a trial with international sites, they all work under the same protocol. Otherwise, it would be different trials. So everybody's working under the same protocol, no matter where they're enrolling.

Speaker Change: Alright, so thanks, Pete I appreciate the question. So first of all whenever we do and frankly I think this is true across the entire pharmaceutical industry whenever anyone does a trial with international sites. They all work under the same protocol otherwise it would be different trials. So everybody is working under the same protocol no matter where.

David J. Mazzo: And the reason that we recruit internationally for certain studies is to be able to acquire patients more readily and to get a broader demographic population, which is typically something that's required in later stage studies. In the case of our Bolster trial, actually, Bolster is running in the United States alone right now. We've enrolled cholangiocarcinoma solely in the United States, and we plan to do the second line study solely in the United States.

David J. Mazzo: They are enrolling and the reason that we enroll internationally for certain studies is to be able to acquire patients more rapidly and to get a broader demographic population, which is <unk>.

David J. Mazzo: Typically something that's required in later stage studies in case of our bolster trial actually bolsters running in the United States alone right now.

David J. Mazzo: Enrol cholangiocarcinoma solely in the United States and we plan to do the second line study solely in the United States ascend is running in.

David J. Mazzo: Ascend is running in Australia and New Zealand, and the GBM trial is running in Estonia and Latvia. And, you know, some of our other trials are looking at sites around the world as well. But it's mostly, again, to take advantage of patient prevalence and sometimes to actually get lower costs rather than higher costs, as you suggested.

David J. Mazzo: Australia New Zealand.

David J. Mazzo: The GBM trial is running in Estonia.

David J. Mazzo: And some of our other trials are looking at sites around the world as well, but it's mostly again to take advantage of.

David J. Mazzo: Patient prevalence and sometimes to actually get lower costs, rather than higher costs as you suggested.

Peter J. Enderlin: For example, with that trial in Estonia and Latvia, then you'd basically be talking to our FDA about that, even though it's being done over there.

Peter J. Enderlin: For example, with the trial in Estonia, Latvia, then that would be the.

Peter J. Enderlin: Basically be talking to the FDA about that even though it's being done over there.

David J. Mazzo: Yeah, and the European Union, you know, the EMA as well.

Peter J. Enderlin: Yes, and the European Union.

David J. Mazzo: As well.

Peter J. Enderlin: Okay, but I'm not clear on who's actually setting the rules on what you have to do to run the trial. Is it the U.S. or Europe?

David J. Mazzo: Okay.

Peter J. Enderlin: Not clear on who is actually setting the rules.

Peter J. Enderlin: What you have to do to run the trial.

David J. Mazzo: Well, the protocol is set by us. But the rules governing good clinical practice are actually set by the International Conference on Harmonization to which the FDA, the EMA, the Japanese regulatory authorities, and a myriad other regulatory authorities are signatory. So basically, there's a consistent international set of rules for conducting clinical trials, and that's what we will follow.

Peter J. Enderlin: U S or Europe.

Peter J. Enderlin: Well the protocol is set by US the rules governing good clinical practice are actually set by the international conference on harmonization to which the FDA the EMA the Japanese regulatory authorities.

David J. Mazzo: Myriad other regulatory authorities.

David J. Mazzo: Our signatory so basically theres a consistent international set of rules for conducting clinical trials and that's what we will fall.

Operator: Okay, thanks for clarifying. Sure. One moment for our next question.

Speaker Change: Okay. Thanks for clarifying that.

Operator: Sure.

Operator: One moment for our next question.

Operator: Okay.

Stephen Gilbertpaul Brozak: Our next question comes from Steve Brozak from WBB Securities. Please go ahead.

Operator: Our next question comes from Steve Brozak from <unk> Securities. Please go ahead.

Stephen Gilbertpaul Brozak: Hey, good afternoon, Dave. And thanks for taking all these questions. I'm going to go back to the finance side. You've obviously focused on making sure that you have funding for as long as possible through 2026. And you just mentioned, I think Kristen just mentioned, the potential for getting a voucher after a successful completion of the trial. But there's one question I've got for you, because you've got all these patients you're treating, and they are very, very ill patients.

Stephen Gilbertpaul Brozak: Hey, good afternoon, Dave and thanks for taking all these questions.

Stephen Gilbertpaul Brozak: To go back on the finance side.

Stephen Gilbertpaul Brozak: Robert.

Stephen Gilbertpaul Brozak: <unk> focused on making sure that you.

Stephen Gilbertpaul Brozak: Have funding.

Stephen Gilbertpaul Brozak: For as long as possible through 2026.

Stephen Gilbertpaul Brozak: You just mentioned.

Stephen Gilbertpaul Brozak: I think Christian just mentioned the potential for getting a voucher. After a successful completion of the Trialing, but there's one question I've got for you because you've got all these patients who are treating and they are very very ill patients.

Stephen Gilbertpaul Brozak: At the end of the day, you're going to be dealing with patients who have undergone quite a bit of therapeutic, you know, treatment at a very, very high cost. Excuse me, can you give us any sense? I'm not asking you to go out there and tell us what Certitude is going to cost or be charged, but what are these patients, and what is the system currently doing? Paying for, and it can be an order of magnitude, paying for these patients who are currently being treated as standard of care in a ballpark, please, and just in the United States because, you know, obviously, different countries have different cost parameters. What are your thoughts there? And I've got one follow-up appointment afterwards, please.

Stephen Gilbertpaul Brozak: At the end of the day, you're going to be dealing with patients who have.

Stephen Gilbertpaul Brozak: <unk> undergone quite a bit of therapeutic.

Stephen Gilbertpaul Brozak: No treatment at.

Stephen Gilbertpaul Brozak: I had a very very high cost.

Stephen Gilbertpaul Brozak: Excuse me can you give us any sense I'm not asking you to go out there and tell you what <unk> going to.

Stephen Gilbertpaul Brozak: Costs are b charge, but what are the patients what are the what is the system currently.

Stephen Gilbertpaul Brozak: <unk> four and it can be an order of magnitude paying for these patients who are currently being treated standard of care in a ballpark. Please.

Stephen Gilbertpaul Brozak: Just in the United States.

Stephen Gilbertpaul Brozak: Obviously different countries have different cost parameters what are your thoughts there and Ive got one follow up afterwards. Please thank you.

David J. Mazzo: All right, so for that, well, thanks for the question, Steve, I appreciate it being on. In the United States, and in fact, in many other countries around the world, the current standard of care for pancreatic cancer is chemotherapy. And it falls pretty evenly distributed between two regimens. One is a combination of gemcitabine and napaclitaxel, which is also known as napraxenine, and the other is fulfirinox.

Speaker Change: Alright, alright.

Speaker Change: So for.

Speaker Change: Well thanks for the question, Steve I appreciate you being on.

David J. Mazzo: In the United States.

David J. Mazzo: And in fact in many other countries around the world. The current standard of care for <unk>.

David J. Mazzo: And these are products, these chemotherapeutics are, you know, they're actually generic right now, and they're covered by insurance generally for all these people. So I don't know the exact cost off the top of my head. But, you know, but the fact is that the introduction of new therapies, like immunotherapies, which are much more costly, is being readily absorbed by these patients because they have such dire circumstances, and they're seriously, you know, looking for other things. Just to give you a ballpark idea, a typical regimen of gemcitabine and napalpitaxel is around $60,000.

David J. Mazzo: Pancreatic cancer is chemotherapy and it falls pretty evenly distributed between two regimens. One is a combination of Gemcitabine and Nab Paclitaxel Paclitaxel is also known as <unk> and the other is fulfill remarks.

David J. Mazzo: And these these are products. These chemotherapeutic are there.

David J. Mazzo: Theyre actually generic right now and they're covered by my insurance generally for all these people. So I don't know the exact cost of off the top of my head but.

David J. Mazzo: The fact is that the introduction of new therapies like Immunotherapies, which are much more costly is being readily absorbed by these patients because they have such dire circumstances and this seriously.

David J. Mazzo: Looking for other things.

David J. Mazzo: A typical just to give you a.

David J. Mazzo: Uh huh.

David J. Mazzo: Ballpark a typical regimen.

David J. Mazzo: Gemcitabine and Nab Paclitaxel is around $60000.

David J. Mazzo: So that gives you some sense. And our product is, as Kristen, I think, so eloquently described, is simply a small cyclic peptide. It's not as inexpensive to make as a small chemical entity, but it's made by solid state chemistry that's pretty well standardized these days.

David J. Mazzo: So that gives you some sense and our product is as Christian I think so eloquently described is simply a small cyclic peptides.

David J. Mazzo: It's not as inexpensive to make.

David J. Mazzo: Yes.

David J. Mazzo: A small chemical entity, but it's made by solid state chemistry, that's pretty well standardize these days and so it's expected to have a cost that will be.

David J. Mazzo: And so it's expected to have a cost that will be very reasonable, especially in comparison to the cost of immunotherapies and some of the CAR-T cellular therapies, which can cost hundreds of thousands of dollars or even millions of dollars. I hope that gives you a better idea. No, no, no, that's exactly what I was looking for.

David J. Mazzo: Reasonable, especially in comparison to the cost of Immunotherapies and some of the car T cellular therapies, which can cost hundreds of thousands or even millions of dollars.

Speaker Change: I hope that gives you a better idea.

David J. Mazzo: Exactly yeah exactly I was looking for you you touched on the on the critical matter of all these.

Stephen Gilbertpaul Brozak: You touched on the critical matter of all these immunotherapies that are out there and that are quite expensive and that are, frankly, not seeing the results that you're looking for. So if you're looking at that, and because, unfortunately, you're seeing these patients who are so late in stage, especially in pancreatic cancer, I would imagine that this would be something we're looking at for positive results, but this would be looked at as something that is providing for a change of standard of care going forward.

Stephen Gilbertpaul Brozak: No therapies that are out there that are that are quite expensive.

Stephen Gilbertpaul Brozak: Frankly, not seeing the results that you're looking for so if youre looking at that and because unfortunately youre seeing these patients who are so late stage, especially in pancreatic cancer.

Stephen Gilbertpaul Brozak: I would imagine that this would be something.

Stephen Gilbertpaul Brozak: We're looking at for positive results, but this would be looked at as something that is providing for a.

Stephen Gilbertpaul Brozak: Change of standard of care going forward, so going back to not just the benefit of a voucher youre looking at a situation where you would actually be.

Stephen Gilbertpaul Brozak: So going back to not just the benefit of a voucher, you're looking at a situation where you would actually be, you know, you would actually be providing quality care that is not seen today. Is that an accurate statement? Please fill in anything else and I'll hop back in the queue. Thank you. No, Steve, I think that's actually, you know, that's it.

Speaker Change: You would actually be providing a quality care that is not.

Speaker Change: <unk> seen today is that an accurate statement and please fill in anything else and I'll hop back in the queue. Thank you.

Speaker Change: Steve I think that that's actually that's it in fact.

David J. Mazzo: In fact, you know, what I think we say in some of our remarks and certainly in our press release, we expect that this is that the addition of certepetide or its final approval will actually change the paradigm for standard of care. You know, adding cetrepetide to current standards of care, which can evolve, should improve them regardless of what they are based on the mechanism of action that Kristen described. And so we really do see this as a paradigm changer for the treatment of solid tumor cancers and expect that it will have very broad applicability as a result.

David J. Mazzo: I think we would say in some of our remarks and certainly in our press release, we expect that this that the addition of so tepid tied where its final approval will actually changed the paradigm for standard of care, adding so tepid tied to current standards of care, which can evolve should it.

David J. Mazzo: Approval.

David J. Mazzo: Regardless of what they are based on the mechanism of action that Christa described and so we really do see this as a paradigm change it for the treatment of solid tumor cancers and expect that it will have very broad applicability as a result.

Operator: Great, let me hop back into the queue, and thanks again for taking the question. Thank you. One moment for our next question.

Speaker Change: Alright, let me hop back in the queue and thanks again for taking the question.

Speaker Change: Thank you while mommy foreigners question.

Robert Sassoon: Our next question comes from Robert Sassoon from Water Tower Research. Please go ahead. Hi, thank you.

Operator: Our next question comes from Robert Sassoon from Water Tower Tower Research. Please go ahead.

Robert Sassoon: Hi, thank you. I was just wondering whether in the early studies that you've done, you've got a number of trials going on, and the studies don't, whether you've seen any variation in performance? [inaudible] with respect to the various conditions that you're targeting.

Robert Sassoon: Hi, yes. Thank you.

Robert Sassoon: I was just wondering whether in the early studies that you've done a good number of trials going on in the study as to whether you've seen any variation in performance.

Robert Sassoon: Petrified.

Robert Sassoon:

Robert Sassoon: With respect to the various conditions.

Robert Sassoon: Conditions that euro.

Robert Sassoon: You are targeting.

Robert Sassoon: Yes.

Kristen K. Buck: Kristen, do you want to comment on that? Sure. Sure.

Robert Sassoon: Christine do you want to comment on that please sure we haven't.

Kristen K. Buck: Sure. You know, we haven't, as Dave and I have previously stated, safety has not been a problem. The drug typically reflects the combination with which it's given, the anti-cancer agent. Anecdotally, I mean, our trials are blinded, so I can't really speak to what is truly happening, but I have received several calls from our investigators off-hours saying they are so encouraged by our drug when given to cholangiocarcinoma patients. Just as an anecdote, one told me this patient had two weeks to live, and three months later, they were out skiing. So I can't answer whether that's on our drug or not, but that's probably where we've heard the most anecdotal data that they're very enthusiastic.

Kristen K. Buck: Dave and I have previously stated safety has not been a problem. The drug typically reflects the combination with which it's given the anti cancer agent anecdotally I mean, our trials are blinded. So I can't really speak to what is truly happening, but I have received several calls from our investigators off hours, saying they are.

Kristen K. Buck: I'm encouraged by our drug when given to Cholangiocarcinoma patients.

Kristen K. Buck: Just as an anecdote one told me this patient had two weeks to live and.

Kristen K. Buck: And three months later, they're out skiing.

Kristen K. Buck: So an answer whether that's on our drug or not but that's probably where we've heard the most anecdotal data that theyre very enthusiastic alright.

Robert Sassoon: And just one more question, do you, I mean, is there any anticipation of getting some milestone payments down the road? Do you have a sort of potential timeline for that?

Speaker Change: And just one more question do you I mean is there any anticipation of getting some milestone payments down the road.

Speaker Change: Sort of.

Robert Sassoon: Such a timeline for that.

David J. Mazzo: Well, we have an activity line, and the timeline is dependent on CHILU's execution, but we do have, you know, milestone payments that will be paid for completion of activities such as technology transfer for manufacturing and for, you know, initiating phase three, and ultimately for registration. Now, they've just started phase two, as we announced a couple weeks ago, and we imagine it'll take a while for them to get through phase two and get to phase three.

Speaker Change: Well, we have a an activity line and the timeline is dependent on chico's execution, but we do have milestone payments that will be paid for completion of activities such as the <unk>.

David J. Mazzo: Technology transfer for manufacturing and for initiating phase III and ultimately for our registration now they've just started phase two as we announced a couple of weeks ago, and we imagine it will take a while for them to get through phase II, when you get to phase III, but.

David J. Mazzo: There is always the possibility that the results in China will be so good that they could convince the Chinese regulatory authorities that this phase two trial could become the basis of a provisional application. And I think, under those circumstances, that would qualify as a pivotal trial, and we could get a milestone along those lines as well. So I can't really speak to timing, but certainly over the course of the next several years, we would expect to see some milestones from China. Take care.

David J. Mazzo: There is always the possibility that the results in China will be.

David J. Mazzo: So good that they could convince the Chinese regulatory authorities that this phase II trial could become the basis of a provisional application and I think under those circumstances that would qualify for.

David J. Mazzo: The pivotal trial, and we could get a milestone along those lines as well so.

David J. Mazzo: It really speak to timing, but certainly over the course of the next several years, we would expect to collect some milestones from GBM.

Robert Sassoon: Okay, thanks. Thanks very much. I'll jump back in the queue. Thank you.

Speaker Change: Okay. Thanks, Thanks, very much I'll jump back in the queue.

Operator: Thank you. As a reminder, to ask a question, please press star 1-1 on your telephone. One moment for our next question. Our next question comes from Robert Boyer from Noble Capital Markets. Please go ahead.

Speaker Change: Thank you.

Robert Boyer: Thank you.

Robert Boyer: As a reminder to ask a question. Please press star one on your telephone.

Robert Boyer: One moment for our next question.

Robert Boyer: Our next question comes from Robert <unk> from Noble capital markets. Please go ahead.

Robert Boyer: I have, well, first, congratulations on all the progress, and in Dr. Buck's summary, I heard that it was a very good comprehensive summary, but one of the things that I didn't catch was whether the BOLSTER trial will be announcing data in 2025 or if there are any timelines for BOLSTER or Sendefox. I caught the expected completion by the end of the year, but didn't hear anything about the expected data

Robert Boyer: I have who will firstly congratulations on all the progress.

Robert Boyer: In Dr. <unk> summary.

Robert Boyer: I heard.

Robert Boyer: Very good comprehensive summary, but one of the things that I didn't catch was whether the bolster trial, we will be announcing data in 25, or if there were any timelines for bolster or send the fox.

Robert Boyer: What the expected completion by the end of the year, but didn't hear anything about the expected data release.

David J. Mazzo: Thanks Robert, I appreciate the question. Thanks for being on the call as well.

Speaker Change: Thanks, Rob I appreciate the question thanks for being on the call as well.

David J. Mazzo: All of our trials, as Kristen pointed out, are designed to reach data before our current cash out date. So we're currently funded through early 26, and everything is designed at this point in order to reach data before that. So I would expect that, you know, with the current BOLSTER trial target of approximately the end of the year for completion of enrollment, we should certainly be announcing data before the end of the year next year. And as Kristen pointed out, we could be completing enrollments in BOLSTER a lot sooner than that, which would just bring forward the data announcements in 2021. Okay, great. Thank you.

Speaker Change: All of our trials as Christian pointed out are designed to.

David J. Mazzo: To reach data.

David J. Mazzo: Before our current cash out date. So we are currently funded through early 2006 and everything is designed at this point in order to reach data before that so I would expect that with a.

David J. Mazzo: Bolster trial current target of approximately end of year for completion of enrollment we should certainly be announcing data before the end of the year next year and as Christian pointed out we could be completing enrollment and bolster a lot sooner than that which would just bring forward the data announcements in 2012.

David J. Mazzo: Hi.

Robert Boyer: Okay, great. Thank you very much.

Speaker Change: Okay, great. Thank you very much.

Robert Boyer: Yeah.

Speaker Change: Thank you.

Operator: I'm showing no further questions. This concludes the question and answer session. I will now turn it back over to Dr. Mazzo for closing remarks.

David J. Mazzo: Thank you, operator. And again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress. We remain grateful for your continued interest and support. Stay well, and have a good evening.

Speaker Change: I am showing no further questions. This concludes the question and answer session I will now turn it back over to Dr. Mazo.

David J. Mazzo: For closing remarks.

David J. Mazzo: Yes.

David J. Mazzo: Thank you operator and again, thank you all for participating in today's call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on our achievements and progress we remain grateful for your continued interest and support stay well and have a good evening.

Operator: Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.

Speaker Change: Thank you for your participation in today's conference. This does conclude the program you may now disconnect.

Operator: Okay.

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Operator: Okay.

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Operator: Yes.

Operator: Okay.

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