Q2 2024 Lisata Therapeutics Inc Earnings Call & Business Update

August 12, 2024

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Operator: Welcome to the Lisata Therapeutics Second Quarter 2024 Financial Results and Business Update Conference. Currently, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star 1 1 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, Monday, August 12th, 2024. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

Operator: Welcome to the Lisata Therapeutics second quarter 2024 financial results and business update. Currently, all participants are in a listen-only mode.

Operator: Welcome to the Lisata Therapeutic second quarter, 2024 financial results and business update conference call. Currently, all participants aren't in a listen-only mode. Following management's prepared remarks, we will hold a question-and-answer session. To ask a question at that time, please press star 1-1 on your telephone. You would then hear an automated message advising you that your hand is raised. As a reminder, this call is being recorded today.

Operator: Following management's prepared remarks, we will hold a question and answer 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.

Speaker Change: Welcome to the Lasalle Therapeutics second quarter 'twenty to 'twenty, four financial results and business update conference call.

Speaker Change: Currently all participants are in a listen only mode.

Speaker Change: Following managements prepared remarks, we will hold a question and answer session.

Speaker Change: To ask a question at that time, Please press star one one on your telephone.

Speaker Change: You will then hear an automated message advisor you bet your hand as rates.

Operator: As a reminder, this call is being recorded today, Monday, August 12th, 2024. I will now turn the call over to John Menditto, Vice President of Investor Relations and Corporate Communications at Lisata. Please go ahead, sir.

Speaker Change: As a reminder, this call is being recorded today Monday August 12 2024.

Operator: Monday, August 12, 2024.

John Menditto: I will now turn the call over to John Menditto, Vice-President of Investor Relations and Corporate Communications at LaSanna. Please go ahead, sir.

Speaker Change: I will now turn the call over to John Bandido, Vice President Investor Relations and corporate Communications at Lasalle. Please go ahead Sir.

John Menditto: Thank you, operator, and good afternoon, everyone. Welcome to Lisata's second quarter 2024 conference call to discuss our financial results and provide a business update. Joining me from our management team are Dr. David Mazzo, President and Chief Executive Officer; Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer; and James Nisco, Senior Vice President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our second quarter 2024 financial results, which is available under the Investors & News section of the company website, along with a webcast replay of this call.

John Menditto: Thank you, Operator, and good afternoon, everyone. Welcome to LaSata's second quarter, 2024 conference call to discuss our financial results and to provide a business update. Joining you from our management team are Dr. David Mazzo, President and Chief Executive Officer. Dr. Kristen Buck, Executive Vice-President of Research and Development and Chief Medical Officer, and James Nisco, Senior Vice-President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our second quarter 2024 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call.

John Bandido: Thank you operator, and good afternoon, everyone. Welcome to the start of second quarter 2020 for a conference call to discuss our financial results and to provide a business update.

Joining me from our management team are Dr. David Mazzo, President and Chief Executive Officer, Dr. Christian <unk> Executive Vice President of research and development and Chief Medical Officer, and James <unk>, Senior Vice President of Finance, and Treasurer, and Chief Accounting Officer.

Speaker Change: Shortly before this call we issued a press release announcing our second 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 Menditto: If you have not received this news release or if you'd like to be added to the company's email distribution list, please subscribe to email alerts on the company website or email me at jmenditto at lisata.com to be added. 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 Lisata. 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.

Jason <unk>: If you have not received this news release or if you'd like to be added to the company's email distribution list. Please subscribe to email alerts on the company website or email me at Jason <unk> at <unk> Dot com to be added.

John Menditto: 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 LaSata. 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. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Monday, August 12, 2024.

Speaker Change: 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 the startup I.

Speaker Change: 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 Menditto: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Monday, August 12, 2021. Lisata Therapeut undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference. With that, I will now turn the call over to Dr. Mazzo. Dave?

John Menditto: Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, Monday, August 12, 2021. Lisata Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference. Dave, do you mind?

Lasalle: Furthermore, the content of this conference call contains time sensitive information that is accurate only as of the data of this live broadcast Monday August 12, 2020 for Lasalle.

John Menditto: LaSata Therapuse undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

Lasalle: Beside of Therapeutics undertakes no obligation to revise or update any statements to reflect events or circumstances. After the date of this conference call.

John Menditto: With that, I will now turn the call over to Dr. Mazzo.

Speaker Change: I will now turn the call over to Dr. Mazzo Dave.

David Mazzo: Dave?

David 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 second quarter 2024 financial results, and give an update on the progress of our clinical development program. During the second quarter of this year, Lisata maintained strong momentum in the advancement of our development pipeline, centered around our novel investigational product, Cepteprotide, in combination with a variety of anti-cancer agents of differing modalities for the treatment of advanced solid tumors.

David Mazzo: Thank you, John.

John Menditto: 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 second quarter 2024 financial results, and give an update on the progress of our clinical development program. During the second quarter of this year, Lisata maintained strong momentum in the advancement of our development pipeline centered around our novel investigational product, Cerpeptetide, in combination with a variety of anti-cancer agents of differing modalities for the treatment of advanced solid tumors.

David Mazzo: Good afternoon, everyone. I'm delighted to be with you today, provide an overview of recent business highlights discussed our second quarter, 2024 financial results, and give an update on the progress of our clinical development programs. During the second quarter of this year, LaSata maintained strongo metham in the advancement of our development pipeline centered around our novel investigational product, Certepartite, in combination with a variety of anti-cancer agents of differing modalities for the treatment of advanced solid tumors. As we have previously reported, consistently encouraging pre-clinical data, as well as early clinical data in humans, continue to support our belief that Certepartite has the potential to become an integral part of a revised standard of care treatment for many challenging solid tumors.

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

Speaker Change: The second quarter of this year with Saddam maintained strong momentum in the advancement of our development pipeline centered around our novel investigational product <unk> in combination with a variety of anti cancer agents with different modalities for the treatment of advanced solid tumors.

John Menditto: As we have previously reported, consistently encouraging preclinical data as well as early clinical data in humans continue to support our belief that cetepatide has the potential to become an integral part of a revised standard of care treatment for many challenging solid tumors. 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. With that, I will now turn the call over to James Nisco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. James.

Speaker Change: As we have previously reported consistently encouraging preclinical data as well as early clinical data in humans continue to support our belief that <unk> has the potential to become an integral part of the revised standard of care treatment for many challenging solid tumors Dr.

David Mazzo: As we have previously reported, consistently encouraging preclinical data as well as early clinical data in humans continue to support our belief that certepiditis has the potential to become an integral part of a revised standard of care treatment for many challenging solid tumors.

Kristen Buck: 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.

David 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. With that, I will now turn the call over to James Nisco, our Senior Vice President of Finance and Treasury and Chief Accounting Officer.

Speaker Change: Dr. Christian <unk>, 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 with that I will now turn the call over to James <unk>, Our senior Vice President of Finance, and Treasurer, and Chief Accounting Officer J.

James Nisco: With that, I will now turn the call over to James Niskel, our Senior Vice President of Finance and Treasury and Chief Accounting Officer. Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our second quarter 2024 financial results, starting with operating expenses. For the three months ended June 30th, 2024, operating expenses totaled 5.5 million compared to 6.9 million for the three months ended June 30th, 2023, representing a decrease of 1.4 million or 19.7%. Research and development expenses were approximately 2.6 million for the three months ended June 30th, 2024, compared to 3.2 million for the three months ended June 30th, 2023, representing a decrease of 0.6 million or 17.7%.

James Nisco: Thanks, Dave. Good afternoon, all.

James Nisco: Thanks, Dave. Good afternoon, all. I'm pleased to join you today to present a summary of our second quarter 2024 financial results, starting with operating expenses. For the three months ended June 30, 2024, operating expenses totaled $5.5 million, compared to $6.9 million for the three months ended June 30, 2023, representing a decrease of 1.4 million, or 19.7 percent. Research and development expenses were approximately $2.6 million for the three months ended June 30, 2024, compared to $3.2 million for the three months ended June 30, 2023, representing a decrease of 0.6 million, or 17.7 percent.

Speaker Change: Yes.

James: Thanks, Dave Good afternoon, I'm pleased to join you today to present, a summary of our second quarter 2024 financial results.

Starting with operating expenses.

James Nisco: I'm pleased to join you today to present a summary of our second quarter 2024 financial results, starting with operating expenses. For the three months ended June 30, 2024, operating expenses totaled $5.5 million, compared to $6.9 million for the three months ended June 30, 2023, representing a decrease of 1.4 million, or 19.7%. Research and development expenses were approximately $2.6 million for the three months ended June 30, 2024, compared to $3.2 million for the three months ended June 30, 2023, representing a decrease of 0.6 million, or 17.7 percent.

James Nisco: This was primarily due to a reduction in expenses associated with the Phase 2B ASCEND trial, which completed enrollment in the prior year. Lower spend on Chemistry, Manufacturing, and Control, or CMC, related expenses, and lower equity expense, partially offset by an increase in expenses associated with enrollment activities in the current year for a bolstered school. General and administrative expenses were approximately $2.9 million for the three months ended June 30, 2024, compared to $3.7 million for the three months ended June 30, 2023, representing a decrease of 0.8 million, or 21.3%.

J. Yes: The three months ended June 32024, operating expenses totaled $5 5 million compared to $6 9 million for the three months ended June 32023.

J. Yes: Representing a decrease of $1 4 million or 19, 7%.

J. Yes: Research and development expenses were approximately $2 6 million for the three months ended June 32024, compared to $3 2 million for the three months ended June 32023.

J. Yes: Representing a decrease of 0.6 million or 17, 7%.

James Nisco: This was primarily due to a reduction in expenses associated with the phase 2B Ascentrile, which completed enrollment in the prior year. Lower spend on chemistry, manufacturing and control, or CMC, related expenses, and lower equity expense partially offset by an increase in expenses associated with enrollment activities in the current year for a bolster trial. General and administrative expenses were approximately 2.9 million for the three months ended June 30th, 2024, compared to 3.7 million for the three months ended June 30th, 2023, representing a decrease of 0.8 million or 21.3%. This was primarily due to one-off related severance costs in the prior year associated with the elimination of the Chief Business Officer on May 1st, 2023, a reduction in equity expense, and a decrease in directors and officers insurance premiums in the current year.

James Nisco: This was primarily due to a reduction in expenses associated with the Phase 2B ASCEND trial, which completed enrollment in the prior year. Lower spend on Chemistry, Manufacturing, and Control, or CMC, related expenses, and lower equity expense, partially offset by an increase in expenses associated with enrollment activities in the current year for a bolster. General and administrative expenses were approximately $2.9 million for the three months ended June 30, 2024, compared to $3.7 million for the three months ended June 30, 2023, representing a decrease of 0.8 million or 21.3 percent.

J. Yes: This was primarily due to a reduction in expenses associated with the phase two b ascend trial, which completed enrollment in the prior year.

J. Yes: Lower spend on chemistry manufacturing and control or CMC related expenses and lower equity expense, partially offset by an increase in expenses associated with enrollment activities in the current year for our bolster trial.

James Nisco: This was primarily due to one-off related severance costs in the prior year associated with the elimination of the chief business officer position on May 1st, 2023, a reduction in equity expense, and a decrease in directors' and officers' insurance premiums in the current year. Benefit from income taxes was zero for the three months ended June 30, 2024, compared to $2.3 million for the three months ended June 30, 2023. In April 2023, we received net proceeds of $2.2 million from the sale of tax benefits to a qualified and approved buyer pursuant to the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Program. Overall, net losses were $5 million for the three months ended June 30, 2024, compared to $4 million for the three months ended June 30, 2023.

J. Yes: General and administrative expenses were approximately $2 9 million for the three months ended June 32024, compared to $3 7 million for the three months ended June 32023.

J. Yes: Representing a decrease of zero point $8 million or 21, 3%.

J. Yes: This was primarily due to one off related severance costs in the prior year associated with the elimination of the Chief business officer position on May one 2023.

J. Yes: A reduction in equity expense and a decrease in directors and officers insurance premiums in the current year.

James Nisco: Benefit from income taxes was 0 for the three months ended June 30th, 2024, compared to 2.3 million for the three months ended June 30th, 2023. In April 2023, we received net proceeds of 2.2 million from the sale of tax benefits to a qualified and approved buyer pursuant to the New Jersey Economic Development Authority's Technology Business Tax Certificate Transfer Program. Overall, net losses were 5 million for the three months ended June 30th, 2024, compared to 4 million for the three months ended June 30th, 2023.

J. Yes: Benefit from income taxes was zero for the three months ended June 32024, compared to $2 3 million for the three months ended June 32023.

J. Yes: In April 2023, we received net proceeds of $2 2 million from the sale of tax benefits to a qualified and approved buyer.

J. Yes: I went to the New Jersey economic development authorities.

J. Yes: Technology business tax certificate transfer program.

James Nisco: Overall, net losses were $5 million for the three months ended June 30, 2024, compared to $4 million for the three months ended June 30, 2023. It is noteworthy that we continue to make progress according to our plans for our research and development and business activities while still continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow. As of June 30, 2024, Lisata had cash equivalents and marketable securities of approximately $38.3 million.

J. Yes: Overall net losses were $5 million for the three months ended June 32024, compared to $4 million for the three months ended June 32023.

James Nisco: It is noteworthy that we continue to make progress according to our plans for our research and development and business activities while still continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow as of June 30th, 2024, Lassada had cash, cash equivalents, and marketable securities of approximately 38.3 million. Based on its current expected capital needs, the company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials.

J. Yes: It is noteworthy that we continue to make progress according to our plans for our research and development and business activities, while still continuing our legacy of prudent capital management and expense Minimisation.

J. Yes: Turning now to our balance sheet and cash flow.

J. Yes: As of June 32024, Masada had cash cash equivalents and marketable securities of approximately $38 3 million.

James Nisco: Based on its current expected capital needs, the company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials. With that, I now turn the call over to Dr. Kristen Buck to provide an overview of the company's development programs.

Speaker Change: Based on its current expected capital needs. The company believes that its projected capital or fund its current proposed operations into early 2026.

Speaker Change: Encompassing anticipated data milestones from all its ongoing and planned clinical trials.

Speaker Change: With that I'll now turn the call over to Dr. Christopher Buck to provide an overview of the company's development programs Kristen.

Kristen Buck: Thank you, James, and good afternoon, everyone. As I've mentioned many times in the past, Lisata's development programs are built upon a strong foundation of published preclinical and early clinical research. Notably, our SendR platform technology is rooted in pioneering discoveries recognized by the Lasker Prize awarded to Dr. Irki Rusladi. A product of the Sendar platform, Sirtepatide, is designed to address the major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing prevalence of these cancers and growing pharmacoeconomic pressure.

Kristen Buck: Thank you, James, and good afternoon, everyone. As I've mentioned many times in the past, Lisata's development programs are built upon a strong foundation of published preclinical and early clinical research. Notably, our SendR platform technology is rooted in pioneering discoveries recognized by the Lasker Prize awarded to Dr. Irki Rushladi. A product of the Sendar platform, Sirtepatide, is designed to address the major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing prevalence of these cancers and growing pharmacoeconomic pressure.

Speaker Change: Thank you James and good afternoon, everyone as I've mentioned many times in the past Lasalle. This development programs are built upon a strong foundation of published preclinical and early clinical research.

Kristen Buck: Notably, our SENDR platform technology is rooted in pioneering discoveries recognized by the last-year prize awarded to Dr. Erky Rushladi. A product of the SENDR platform, Sir Tepatide, is designed to address the major impediments to the successful treatment of advanced solid tumors. This is especially relevant in an environment of increasing prevalence of these cancers and growing pharmacoeconomic pressures. Our clinical studies have been rigorously designed with the end in mind, that is, eventual product registration, and are optimized to generate clinically meaningful, unambiguous data. As such, unlike many studies at a similar stage of development, our studies are placebo-controlled, appropriately sized, and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials.

Speaker Change: Notably our send our platform technology is rooted in pioneering discoveries recognized by the Alaska Prize awarded to Doctor Erkki <unk>.

Speaker Change: A product of a send our platform <unk> is designed to address the major impediments to the successful treatment of advanced solid tumors.

Speaker Change: This is especially relevant in an environment of increasing prevalence of these cancers and growing pharmacodynamic pressures or.

Kristen Buck: Our clinical studies have been rigorously designed with the end in mind, that is, eventual product registration, and are optimized to generate clinically meaningful, unambiguous data. As such, unlike many studies at a similar stage of development, our studies are placebo-controlled, appropriately sized, and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials. Further, our trial evaluates your tepidite in combination with current standard-of-care therapies to allow for clear discernment of treatment effect and to fit with current treatment practices at clinical sites.

Speaker Change: Our clinical studies had been rigorously designed with the end in mind that is eventual product registration and are optimized to generate clinically meaningful unambiguous data.

Speaker Change: As such unlike many studies at a similar stage of development. Our studies are placebo controlled appropriately sized and employee primary endpoints that are preferred by regulatory authorities in support of pivotal trials.

Speaker Change: Further our trials evaluate certain appetite in combination with current standard of care therapies to allow for clear discernment of treatment effect and to fit with current treatment practices at clinical sites.

Kristen Buck: These strategic design choices are not always the least expensive, 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 of doing the last experiment first to avoid time and capital consumption on work that could become unnecessary.

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

Kristen Buck: This is in keeping with our development mantra of, Do the last experiment first, to avoid time and capital consumption on work that could become unnecessary. We have also devised and implemented a regulatory strategy that optimizes Sir Tepatide's regulatory review and future commercialization. This strategy includes obtaining special regulatory designations that afford us priority reviews and the possibility of accelerated approvals.

Speaker Change: This is in keeping with our development mantra of do the last experiment first to avoid time and capital consumption on work that could become unnecessary.

Kristen Buck: We have also devised and implemented a regulatory strategy that optimizes Certepitide's regulatory review and future commercialization. This strategy includes obtaining special regulatory designations that afford us priority reviews and the possibility of accelerated approval. However, before I get to the specifics of each of the clinical studies in our development portfolio, please allow me to summarize some important background information, especially for those who are listening 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 Buck: We have also devised and implemented a regulatory strategy that optimizes Certepetide's regulatory review and future commercialization. This strategy includes obtaining special regulatory designations that afford us priority reviews and the possibility of accelerated approval. However, before I get to the specifics of each of the clinical studies in our development portfolio, please allow me to summarize some important background information, especially for those who are listening 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.

Speaker Change: We have also devised and implemented a regulatory strategy that optimizes certain hepatitis regulatory deal and future commercialization.

Speaker Change: This strategy includes obtaining special regulatory designations that afford us priority reviews, and the possibility of accelerated approvals.

Kristen Buck: However, before I get to the specifics of each of the clinical studies in our development portfolio, please allow me to summarize some important background information, especially for those who are listening 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. Cancer, such as pancreatic cancer, gastric cancers, glioblastoma multiforme, and other solid tumors, are surrounded by a dense, fibrotic tissue known as the stroma, which 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.

Speaker Change: However, before I get to the specifics of each of the clinical studies in our development portfolio. Please allow me to summarize some important background information, especially for those who are listening for the first time.

Kristen Buck: Cancers such as pancreatic cancer, gastric cancers, glioblastoma multiforme, and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which 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.

Speaker Change: Despite advances in cancer therapy, including car T cell therapy in Immunotherapies, many solid tumors are still associated with poor outcomes for patients.

Kristen Buck: The combination of a dense stroma and a hostile tumor microenvironment 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. To combat this, our investigational product, Certepatide, leverages the naturally-occurring SendR active transport system to provide an innovative approach to the selective delivery of anti-cancer drugs through the tumor stroma and directly into the tumor.

Speaker Change: Cancers, such as pancreatic cancer gastric cancers, Glioblastoma multiform and other solid tumors are surrounded by a dense fibrotic tissue known as the stroma, which limits access of most pharmacotherapy to the tumor.

Speaker Change: In addition, many solid tumors also present, a hostile tumor microenvironment or T E.

Speaker Change: Which suppresses the patient's immune system. It makes it less effective in fighting cancer.

Kristen Buck: The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapy 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. To combat this, our investigational products are tepatide, leverages the naturally occurring send our active transport system to provide an innovative approach to the selective delivery of anti-cancer drugs through the tumor stroma and directly into the tumor. Simultaneously, sertepotype has been shown to modify the tumor micro-environment, making it less immunosuppressive, and therefore increasing the tumor's susceptibility to immunotherapy while also inhibiting the metastatic cascade.

Speaker Change: The combination of a dense stroma and a hostile tumor microenvironment permits many chemotherapy and immunotherapy from being optimally effective in treating these cancers.

Speaker Change: This coupled with the fact that most anti cancer therapies are not efficient and targeting only cancer tissue.

Speaker Change: <unk> is the major challenge of maximizing effectiveness and safety in the treatment of solid tumors.

Speaker Change: To combat this our investigational products or peptide leverages, the naturally occurring send our active transport system to provide an innovative approach to the selective delivery of anti cancer drugs through the tumor stroma and directly into the tumor.

Kristen Buck: Simultaneously, certepatide has been shown to modify the tumor microenvironment, making it less immunosuppressive, and therefore increasing the tumor's susceptibility to immunotherapy while also inhibiting the metastatic cascade. Sirtepatide is a 9-aminoacid cyclic peptide with high binding affinity and specificity for alpha-V, beta-3, and beta-5-inigin receptors, Once bound to these integrins, certepatide is subjected to proteolytic cleavage by enzymes naturally occurring in the tumor microenvironment to produce two linear fragments, one of which is a 5-amino acid SendR peptide fragment.

Kristen Buck: Simultaneously, sirtepatide has been shown to modify the tumor microenvironment, making it less immunosuppressive, and therefore increasing the tumor's susceptibility to immunotherapy while also inhibiting the metastatic cascade. Sirtepatide is a 9-aminoacid cyclic peptide with high binding affinity and specificity for alpha-V, beta-3, and beta-5-inigin receptor Once bound to these integrins, certepatide is subjected to proteolytic cleavage by enzymes naturally occurring in the tumor microenvironment to produce two linear fragments, one of which is a 5-amino acid SendR peptide fragment.

Speaker Change: Simultaneously certain hepatitis has been shown to modify the tumor microenvironment, making it less immunosuppressive and therefore, increasing the tumor susceptibility to immunotherapy.

Speaker Change: Ill also inhibiting the metastatic caskey.

Kristen Buck: Sertepotype is a nine 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 themselves, but not on healthy tissue. Once bound to these integrins, sertepotype is subjected to proteolytic cleavage by enzymes naturally occurring in the tumor micro-environment to produce two linear fragments, one of which is a five amino acid send our peptide fragment. Upon dissociation of the send our fragment from the integrin receptor, it binds to another receptor called Noropilin-1 on the same or a nearby cell. Once Noropilin-1 is activated, it actuates the send our active transport mechanism, which is manifested by the formation of micro vesicles at the surface of the cells.

Speaker Change: So tepid titles in nine amino acid cyclic peptides with high binding affinity and specificity for alpha the beta three in beta five integrin receptors.

Speaker Change: Which are significantly up regulated on tumor vascular endothelial cells and tumor cells themselves, but not on healthy tissue.

Speaker Change: Once bounded these immigrants so tepid tide is subjected to proteolix cleavage by enzymes naturally occurring in the tumor microenvironment to produce two linear fragrance.

Speaker Change: One of which is a five amino acid send our peptide fragment.

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

Speaker Change: Upon the association of defend our fragrant from the integrin receptor. It binds to another receptor called neuro pill and one on the same or in nearby cell.

Speaker Change: Once nor our pillar one is activated at actual rates to send our active transport mechanism, which is manifested by the formation of micro vehicles at the surface of the cells.

Kristen Buck: These micro vesicles encapsulate any co-administered anti-cancer drugs, unbound sertepotype, and send our fragments in the circulatory system, and ferry them through the stroma and vasculature into the tumor. Sertepotype's mechanism of action is agnostic to the modality of the companion anti-cancer drugs with which it is administered and can be combined with a wide range of existing or even emerging anti-cancer therapies, including chemotherapies, immunotherapies, and RNA-based therapies. Additionally, as I previously mentioned, sertepotype 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 impeding and preventing the metastatic cascade.

Kristen Buck: These microvesicles encapsulate any co-administered anti-cancer drugs, unbalanced or tepatide, and send our fragments into the circulatory system, where they ferry them through the stroma and vasculature into the tumor. Certipetide's mechanism of action is agnostic to the modality of the companion anti-cancer drugs with which it is administered, and it can be combined with a wide range of existing or even emerging anti-cancer treatments, including chemotherapies, immunotherapies, and RNA-based therapy. Additionally, as I previously mentioned, certepetide 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 impeding and or preventing the metastatic cascade. 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 certepiditis mechanism of action.

Kristen Buck: These microvesicles encapsulate any co-administered anti-cancer drugs, unbalanced or tepatide, and send our fragments into the circulatory system, where they ferry them through the stroma and vasculature into the tumor. Certepatide's mechanism of action is agnostic to the modality of the companion anti-cancer drugs with which it is administered, and it can be combined with a wide range of existing or even emerging anti-cancer treatments, including chemotherapies, immunotherapies, and RNA-based therapy. Additionally, as I previously mentioned, Sirtepatide 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 impeding and or preventing the metastatic cascade. 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 the certificates mechanism of action.

Speaker Change: These micro vessels encapsulate any co administered anti cancer drugs.

Speaker Change: On balance or peptide and sundar fragments in the circulatory system and furry them through the stroma and vasculature into the tumor.

Speaker Change: <unk> mechanism of action is agnostic to the modality of the companion anticancer drugs with which it is administered.

Speaker Change: And can be combined with a wide range of existing or even emerging anti cancer therapies, including chemotherapy immuno.

Speaker Change: Immunotherapy and RNA based therapies.

Speaker Change: Additionally, as I previously mentioned.

Speaker Change: Hepatitis has been shown in a range of preclinical models to modify the tumor microenvironment, making it less hostile to immune cells.

Speaker Change: Reducing tumor resistance to anti cancer medications and.

Speaker Change: And impeding and were preventing the metastatic cascade.

Kristen Buck: These results come from Lasada-sponsored studies and from collaborators and research groups around the world, and have been the subject of more than 350 scientific publications relevant to serotype's mechanism of action. Along with our collaborators, we also have a massed significant non-clinical data demonstrating enhanced delivery and augmented efficacy of a range of anti-cancer therapy modalities, including chemotherapies, immunotherapies, RNA-based therapeutics, and even cell therapies. To date, sertepotype is also demonstrated favorable clinical safety, tolerability, and activity to enhance delivery of standard of chemotherapy for patients with metastatic pancreatic cancer. In addition, our strategic focus on regulatory optimization has yielded significant results, as evidenced by multiple special designations awarded to sub-tepatide.

Lossada: These results come from Lossada sponsored studies and from collaborators and research groups around the world and have been the subject of more than 350 scientific publications relevant to certain hepatitis mechanisms of action.

Kristen Buck: Along with our collaborators, we also have amassed significant non-clinical data demonstrating enhanced delivery and augmented efficacy of a range of anti-cancer therapy modalities, including chemotherapies, immunotherapies, RNA-based therapeutics, and even cell therapies. To date, Sirtepatide has also demonstrated favorable clinical safety, tolerability, and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pan In addition, our strategic focus on regulatory optimization has yielded significant results, as evidenced by the multiple special designations awarded to Ceptepatide.

Lossada: Along with our collaborators we also have amassed significant non.

Lossada: Clinical data demonstrating enhanced delivery and augmented efficacy of a range of anti cancer therapy modalities, including chemotherapy immuno.

Lossada: Immunotherapies RNA based therapeutics and even cell therapies.

Speaker Change: To date <unk> has also demonstrated favorable clinical safety tolerability and activity to enhance delivery of standard of care chemotherapy for patients with metastatic pancreatic cancer.

Speaker Change: In addition, our strategic focus on regulatory optimization has yielded significant results as evidenced by multiple special designation awarded to suit peptide.

Kristen Buck: To date, sub-tepatide 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. Sir Tepatide will also be eligible for accelerated approval and priority review if relevant criteria are met. Further, Sir Tepatide has received multiple Orven drug designations, including one for pancreatic cancer in both the United States and Europe, as well as for malignant glioma in the US Orphan Drug designation. Orven drug designation affords Lisata exemption from FDA user fees and provides extended market exclusivity, as well as other potential sponsored benefits.

Kristen Buck: To date, 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. Sirtepatide will also be eligible for accelerated approval and priority review if relevant criteria are met.

Kristen Buck: To date, 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. Sirtepatide will also be eligible for accelerated approval and priority review if relevant criteria are met.

Speaker Change: To date certain hepatitis the recent 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.

Speaker Change: Early for a rolling review.

Speaker Change: <unk> will also be eligible for accelerated approval and priority review if relevant criteria are met.

Kristen Buck: Further, Sirtepatide has received multiple organ drug designations, including one for pancreatic cancer in both the United States and Europe, as well as for malignant glioma in the U.S. Orphan Drug Designation. Orphan Drug Designation affords Lisata exemption from FDA user fees and provides extended market exclusivity, as well as other potential sponsor benefits, in just the first half of 2024. Certepatitis has not only been granted a pediatric investigation plan waiver by the EMA for the treatment of pancreatic cancer but has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States.

Speaker Change: Further certain hepatitis received multiple orphan drug designations, including one for pancreatic cancer in both the United States and Europe.

Speaker Change: As well as for malignant glioma in the U S orphan drug designation.

Speaker Change: Orphan drug designation affords lossada exemption from FDA user fees and provides extended market exclusivity as well as other potential sponsored benefits.

Kristen Buck: In just the first half of 2024, Sir Tepatide has not only been granted a pediatric investigation plan waiver by the EMA for the treatment of pancreatic cancer, but has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States. 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.

Speaker Change: And just the first half of 2024.

Speaker Change: Tepid tightest not only been granted a pediatric investigation plan waiver by the EMA for the treatment of pancreatic cancer, but has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States.

Kristen Buck: 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. This program is set to expire on September 30th, 2024.

Speaker Change: For background, the FDA defined rare pediatric diseases as diseases with fewer than 200000 cases in the United States that are serious or life, threatening and primarily affect individual's under 18 years of age.

Kristen Buck: However, our expectation and that of many in the industry is that the program will be reauthorized. We will, of course, be monitoring those developments closely. A substantial benefit under the current Rare Pediatric Disease Designation Program is receipt of a Priority Review Voucher, often referred to as a Golden Ticket, once the FDA approves the new drug application, or NDA, for the product and indication having received the designation. 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 The voucher may be used by the sponsor or sold to another sponsor for their use.

Kristen Buck: This program is set to expire on September 30th, 2024; however, our expectation and the expectation of many in the industry is that the program will be reauthorized. We will of course be monitoring those developments closely. A substantial benefit under the current Rare Pediatric Disease designation program is receipt of a priority review voucher, often referred to as a golden ticket once the FDA approves the new drug application or NDA for the product and indication having received the designation. 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.

This program is set to expire on September 32024, However, our expectation and the expectation of many in the industry is that the program will be reauthorized, we will of course be monitoring those developments closely.

Kristen Buck: However, our expectation and that of many in the industry is that the program will be reauthorized. We will, of course, be monitoring those developments closely. A substantial benefit under the current Rare Pediatric Disease Designation Program is receipt of a Priority Review Voucher, often referred to as a golden ticket, once the FDA approves the new drug application, or NDA, for the product and indication having received the designation. 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 The voucher may be used by the sponsor or sold to another sponsor for their use.

Speaker Change: A substantial benefit under the current rare pediatric disease designation program is receipt of a 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.

Speaker Change: 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 Buck: The voucher may be used by the sponsor or sold to another sponsor for their use. Priority review vouchers have sold for as much as $350 million US dollars historically, and more recently have sold for $75 to $100 million.

Speaker Change: The voucher may be used by the sponsor or sold to another sponsor for their use.

Kristen Buck: Priority review vouchers have sold for as much as 350 million U.S. dollars historically and more recently have sold for 75 to 100 million dollars. Overall, our development strategy includes the pursuit of a rapid certepetide registration for the treatment of pancreatic cancer, alongside studies which further exploit certepetide's ability to enhance a variety of anti-cancer treatments in a range of advanced solid tumors. To this end, sirtepatitis is currently the subject of nearly a dozen planned or active clinical trials globally for the treatment of various solid tumors.

Kristen Buck: Priority review vouchers have sold for as much as 350 million U.S. dollars historically and more recently have sold for 75 to 100 million dollars. Overall, our development strategy includes the pursuit of a rapid certepetide registration for the treatment of pancreatic cancer, alongside studies which further exploit certepetide's ability to enhance a variety of anti-cancer treatments in a range of advanced solid tumors. To this end, sirtipatitis is currently the subject of nearly a dozen planned or active clinical trials globally for the treatment of various solid tumors.

Speaker Change: Priority review vouchers have sold for as much as $350 million historically and more recently have sold for $75 million to $100 million.

Kristen Buck: Overall, our development strategy includes the pursuit of a rapid surtepatide registration for the treatment of pancreatic cancer. Alongside studies which further exploit surtepatide's ability to enhance a variety of anti-cancer treatments in a range of advanced solid tumors. To this end, surtepatide is currently the subject of nearly a dozen planned or active clinical trials globally for the treatment of various solid tumors. For example, the Ascend trial is a 158 patient double-blind, randomized placebo-controlled clinical trial, evaluating surtepatide, in combination with standard care gym cytobene and NAB-packletaxal chemotherapy, in patients with metastatic pancreatic ductal adenocarcinoma or MPDAC. The trial was being conducted at 25 sites in Australia and New Zealand led by the Australian Gastrointestinal Cancer's Trial Group, or AGITG, in collaboration with the NHMRC Clinical Trial Center at the University of Sydney.

Over our overall our development strategy includes the pursuit of a rapid <unk> registration for the treatment of pancreatic cancer.

Speaker Change: Alongside studies, which further exploit certain hepatitis ability to enhance a variety of anti cancer treatments any range of advanced solid tumors.

To this end certain hepatitis is currently the subject of nearly a dozen planned or active clinical trials globally for the treatment of various solid tumors.

Speaker Change: For example.

Kristen Buck: The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled clinical trial evaluating certepatide in combination with standard-of-care gemcitabine and nabpaclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, or MPDAC. The trial is being conducted at 25 sites in Australia and New Zealand led by the Australasian Gastrointestin The study consists of two cohorts. Cohort A of the study receives a single dose of 3.2 milligrams per kilogram sirtepatide, essentially simultaneously with standard of care, while cohort B is identical to cohort A, but with a second dose of 3.2 milligrams per kilogram sirtepatide given four hours after the first.

Kristen Buck: The ASCEND trial is a 158-patient, double-blind, randomized, placebo-controlled clinical trial evaluating certepetide in combination with standard-of-care gemcitabine and nabpaclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma, or MPDAC. The trial is being conducted at 25 sites in Australia and New Zealand, led by the Australasian Gastro The study consists of two cohorts. Cohort A of the study receives a single dose of 3.2 milligram per kilogram certepetide, essentially simultaneously with standard of care, while cohort B is identical to cohort A, but with a second dose of 3.2 milligram per kilogram certepetide given four hours after the first.

Speaker Change: The ascend trial is a 158 patient double blind randomized placebo controlled clinical trial evaluating <unk> in combination with standard of care Gemcitabine and Nab paclitaxel chemotherapy in patients with metastatic pancreatic ductal adenocarcinoma or M. P deck.

Kristen 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 the 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of 2024, and the complete data set of all 158 patients from the study to be available by mid-2025.

Speaker Change: The trial is being conducted at 25 sites in Australia, and New Zealand led by the Australian gastrointestinal cancers trial group or AG ITG.

Speaker Change: In collaboration with the NIH MRC clinical trial center at the University of Sydney.

Kristen Buck: The study consists of two cohorts. Cohort A of this study receives a single dose of 3.2 milligram per kilogram sir tapatide, essentially simultaneously with standard of care. While Cohort B is identical to Cohort A, but with a second dose of 3.2 milligram per kilogram sir tapatide, given four hours after the first. 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 the 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of 2024, and the complete data set of all 158 patients from the study to be available by mid 2025.

Speaker Change: The study consists of two cohorts cohort a of the study received a single dose of three two milligram per kilogram certain hepatitis essentially simultaneously with standard of care.

Speaker Change: While cohort B is identical to cohort, but with a second dose of $3 two milligram per kilogram startup tight given four hours after the first.

Speaker Change: 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.

Speaker Change: With trial enrollment completed in the fourth quarter of 2023, we expect topline data from the 95 patients assigned to cohort a of the study to be reported in the fourth quarter of 2024, and the complete data set of all 158 patients from the study to be a value available by mid 2025.

Kristen Buck: The prospect of positive data is encouraging, and we have begun planning the subsequent development steps. For example, we have 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 the ASCEND Cohort A in conjunction with our Phase 1B2A data could warrant submission of an application for provisional determination, the Australian version of a conditional approval. We expect similar discussions with the FDA and the MA 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.

Speaker Change: The prospect of positive data is encouraging and we have begun planning the subsequent development steps for example.

Kristen Buck: For example, we have 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 ASCEND Cohort A, in conjunction with our Phase 1b2a data, could warrant submission of an application for provisional determination, the Australian version of a conditional approval. We expect similar discussions with the FDA and EMA once the data are in hand. We have already anticipated and designed the Requirements Phase 3 study that will be necessary to maintain a conditional approval and support a full registration once completed.

Speaker Change: We have already received an opinion from the therapeutic goods administration or T. G I.

Speaker Change: Which is the medicine and therapeutic goods regulatory agency of the Australian government.

Speaker Change: That they believe positive data from the ascend cohort a.

Speaker Change: In conjunction in conjunction with our phase one b to a data could warrant submission of an application for provisional determination. The Australian version of a conditional approval.

Kristen Buck: We expect similar discussions with the FDA and EMA once the data are in hand. We have already anticipated and designed the Require 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 three clinical program in metastatic pancreatic cancer. The Bolster Trial is our phase 2A, double-blind, placebo-controlled, multi-center, randomized trial in the United States evaluating certepetide in combination with standard of care in first-line cholangiocarcinoma. As we have reported recently, Lisata achieved complete enrollment in this study nearly six months ahead of plan, accelerating top-line data readout to mid-2025.

Speaker Change: We expect similar discussions with the FDA and EMA once the data are in hand.

Speaker Change: We have already anticipated and designed to require a phase three study that will be necessary to maintain a conditional approval and support our full registration once completed.

Kristen Buck: The ascend data anticipated this year will further inform and optimize our proposed Phase 3 clinical program in metastatic pancreatic cancer.

Kristen Buck: The ASCEND data anticipated this year will further inform and optimize our proposed phase 3 clinical program in metastatic pancreatic cancer. The Bolster Trial is our phase 2a, double-blind, placebo-controlled, multi-center, randomized trial in the United States evaluating certepetide in combination with standard of care in first-line cholangiocarcinoma. As we have reported recently, Lisata achieved complete enrollment in this study nearly six months ahead of plan, accelerating top-line data readout to mid-2025.

The ascend data anticipated this year will further inform and optimize our proposed phase III clinical program in metastatic pancreatic cancer.

Kristen Buck: The Bolster trial is our Phase 2A double-blind placebo-controlled multi-center randomized trial in the United States, evaluating sertepotide, in combination with standard of care in first-line cholangiocarcinoma. As we have reported recently, Lassada achieved complete enrollment in this study nearly six months ahead of plan, accelerating top-line data readout to mid 2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line treatment, a second cohort of patients has been added to the Bolster trial, evaluating subjects in second-line colangio carcinoma, and we expect to enroll the first patient by the fourth quarter of 2024.

Speaker Change: The bolster trial.

Speaker Change: As our phase two a double blind placebo controlled multicenter randomized trial in United States valuing certain appetite in combination with standard of carrying first line Cholangiocarcinoma.

Speaker Change: As we have reported recently Lossada achieved complete enrollment in this study nearly six months ahead of plan.

Speaker Change: Accelerating topline data readout to mid 2025.

Kristen Buck: Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line treatment, a second cohort of patients has been added to the Bolster trial, evaluating subjects in second line cholangiocarcinoma, and we expect to enroll the first patient by the fourth quarter of 2024. CENDEFOX is a Phase 1b, 2a, open-label trial in the United States evaluating cetrepetide in combination with neoadjuvant fulfirinox-based therapy in pancreatic, colon, and appendiceal cancer.

Kristen Buck: Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line treatment, a second cohort of patients has been added to the Bolster trial, evaluating subjects in second line cholangiocarcinoma, and we expect to enroll the first patient by the fourth quarter of 2024. CENDEFOX is a Phase 1b, 2a open-label trial in the United States evaluating certepetide in combination with neoadjuvant fulfirinox-based therapy in pancreatic, colon, and appendiceal cancer.

Speaker Change: Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first line treatment.

Speaker Change: Second cohort of patients has been added to the bolster trial.

Speaker Change: Are you waiting subjects in second line Cholangiocarcinoma and.

Speaker Change: And we expect to enroll the first patient by the fourth quarter of 2024.

Kristen Buck: Sendafox is a Phase 1B/2A open-label trial in the United States, evaluating sertepotide, in combination with neo-adjuvant ful phyronox-based therapies in pancreatic, colon, and appendiceal cancers. The trial is completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of 2024.

Speaker Change: Send to Fox is a phase <unk> open label trial in the United States evaluating <unk> in combination with Neo adjuvant <unk> based therapies in pancreatic.

Speaker Change: And Appendiceal cancers.

Kristen Buck: The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of 2024. 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 metastatic pancreatic cancer.

Kristen Buck: The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of 2024. Qilu Pharmaceutical, the licensee of Sirtepatide in the Greater China Territory, is also currently evaluating Sirtepatide in combination with gemcitabine and nabpaclitaxel as a treatment for metastatic pancreatic cancer.

The trial has completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of 2024.

Kristen Buck: Chilu Pharmaceutical, the licensee of Certetetide in the Greater China Territory, is also currently evaluating Certetetide in combination with Jim Cytobene and Nab Pakletaxle as a treatment for metastatic pancreatic cancer. During the 2023 ASCO annual meeting, Chilu Pharmaceutical presented the abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase I B2A trial of Certetetetide plus Jim Cytobene and Nab Pakletaxle conducted in Australia in patients with pancreatic cancer. Additionally, Chilu has begun treating patients in their Phase II placebo-controlled trial and metastatic pancreatic cancer. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting.

Speaker Change: Qi Lu pharmaceutical the licensee of certain peptide in the greater China territory is also currently evaluating certain hepatitis in combination with Gemcitabine and Nab paclitaxel as a treatment for metastatic pancreatic cancer.

Kristen Buck: During the 2023 ASCO annual meeting, Chilu Pharmaceutical presented an abstract sharing preliminary data from the study, which corroborated previously reported findings from the Phase 1B2A trial of certepetide plus gemcitabine and nabpaclodexil conducted in Australia in patients with pancreatic cancer. Additionally, Chilo has begun treating patients in their Phase 2 placebo-controlled trial in metastatic pancreatic cancer. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting.

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

Speaker Change: During the 2023 <unk> annual meeting Chinas pharmaceutical presented in the abstract sharing preliminary data from the study, which corroborated previously reported findings from the phase <unk> trial of certain peptide plus gemcitabine and Nab Paclitaxel conducted in Australia in patients with pancreatic cancer.

Speaker Change: Additionally, kilo has begun treating patients in their phase two placebo controlled trial in metastatic pancreatic cancer.

Speaker Change: The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow up and data analysis and reporting.

Kristen Buck: In collaboration with our funding partner, Warp9, the I-Lista trial is a Phase I B2A randomized placebo-controlled single-blind, single-center, safety, early efficacy, and pharmacodynamic trial in Australia. This three cohort study is evaluating Certetetetide in combination with the checkpoint inhibitor Dervalamab plus standard of care Jim Cytobene and Nab Pakletaxle chemotherapy versus Certetetetide in combination with standard of care alone versus standard of care alone in patients with locally advanced non-resectable pancreatic cancer. And enrollment completion is expected in the second half of 2024.

Kristen 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 durvalumab 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 pancreatic cancer. Enrollment completion is expected in the second half of 2024.

Kristen 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 dervalumab 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 pancreatic cancer. Enrollment completion is expected in the second half of 2024.

Speaker Change: In collaboration with our funding partner Warp nine the eye Lister trial is a phase one b to a randomized placebo controlled single Blind single Center safety early efficacy and Pharmacodynamic trial in Australia.

Speaker Change: This three cohort study is evaluating certain appetite in combination with the checkpoint inhibitor drove allomap plus standard of care Gemcitabine and Nab Paclitaxel chemotherapy.

Speaker Change: Versus certain hepatitis in combination with standard of care alone versus standard of care alone in patients with locally advanced non resectable pancreatic cancer.

Speaker Change: Enrollment completion is expected in the second half of 2024.

Kristen Buck: I go Lista, a Phase I B2A proof of concept safety and early efficacy study evaluating Certetetetide in combination with Nabalamab and Philphyrinox as a first-line treatment in locally advanced non-resectable gastroesophageal adenocarcinoma, is pending initiation as a function of availability of funding by our partner, Warp9. The inspiration for this study actually comes from the findings recently published in the Oncology and Cancer Case Reports journal, which details a patient with metastatic gastroesophageal adenocarcinoma to achieve a complete response when given Certetetetide in combination with standard of care, Philphyrinox, and Pemberlizimab. The subject initially underwent months of standard-of-care treatments and only achieved a partial response.

Kristen Buck: Igolista, a phase 1b, 2a proof of concept safety and early efficacy study evaluating certepetide in combination with nivolumab and fulfirinox as a first line treatment for locally advanced non-resectable gastroesophageal adenocarcinoma, is pending initiation as a function of the availability of funding by our partner Warp9. The inspiration for this study actually comes from the findings recently published in the Oncology and Cancer Case Reports Journal, which details a patient with metastatic gastroesophageal adenocarcinoma who achieved a complete response when given Certepatide in combination with Standard of Care, Fulfironox, and Pembrolizumab. The subject initially underwent months of standard of care treatment and only achieved a partial response.

Kristen Buck: Igolista, a Phase 1b, 2a proof of concept safety and early efficacy study evaluating certepetide in combination with nivolumab and fulfirinox as a first-line treatment for locally advanced, non-resectable gastroesophageal adenocarcinoma is pending initiation as a function of the availability of funding by our partner, Warp 9. The inspiration for this study actually comes from the findings recently published in the Oncology and Cancer Case Reports Journal, which details a patient with metastatic gastroesophageal adenocarcinoma who achieved a complete response when given Certepatide in combination with Standard of Care, Fulfironox, and Pembrolizumab.

Speaker Change: I go Lister a phase one b to a proof of concept safety and early efficacy study evaluating <unk> in combination with Nevada, Mab and fulfill arnox 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 and work nine.

Speaker Change: The inspiration for this study actually comes from the findings recently published in the oncology and cancer case reports journal.

Speaker Change: Which details a patient with metastatic gastroesophageal adenocarcinoma, who achieved a complete response when given certain hepatitis in combination with standard of care for fear of Nox and <unk>.

Kristen Buck: The subject initially underwent months of standard of care treatment and only achieved a partial response. Upon the subsequent addition of cetepetide 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 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.

Speaker Change: The subject initially underwent months of standard of care treatments and only achieved a partial response.

Kristen Buck: Upon the subsequent addition of Certetetide 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 complete response in February of 2023.

Kristen 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 a 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.

Speaker Change: Upon the subsequent additional <unk> to the existing standard of care therapeutic regimen. The subject achieved a complete response confirmed both radio graphically and surgically.

Speaker Change: Remarkably and thankfully the subject remains healthy since achieving complete response in February of 2023.

Kristen Buck: We hope to provide an update on timing related to the execution of the IgoLista study in common quarters.

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

Kristen Buck: A study of Certetetetide in combination with team azolamide in glioblastoma multi-form or GBM has been initiated with several patients already enrolled and treated. This study is designed as a phase 2A double-blind placebo-controlled randomized proof-of-concept study evaluating Certetetetide when added to standard of care team azolamide versus team azolamide alone and matching Certetetetide placebo in subjects with newly diagnosed GBM. 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 2-to-1 Certeppa-type plus standard of care versus placebo plus standard of care. In combination with standard of care and patients with second-line metastatic pancreatic cancer, who have progressed on first-line Philphyranox.

Speaker Change: A study of certain peptide income is a combination with <unk> in glioblastoma multi form or GBM has been initiated with several patients already enrolled and treated.

Kristen 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 subjects with newly diagnosed GBM. 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 Fortified is a phase 1b, 2a, double-blind, placebo-controlled, three-arm, randomized study in the United States evaluating the safety, tolerability, and efficacy of a four-hour continuous infusion of certepetide in combination with standard of care in patients with second-line metastatic pancreatic cancer who have progressed on first-line fulfironox.

Kristen Buck: This study is designed as a Phase IIa 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 subjects with newly diagnosed GBM. 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 Fortified is a phase 1b, 2a, double-blind, placebo-controlled, three-arm, randomized study in the United States evaluating the safety, tolerability, and efficacy of a four-hour continuous infusion of certepetide in combination with standard of care in patients with second-line metastatic pancreatic cancer who have progressed on first-line fulfironox.

Speaker Change: This study is designed as a phase two a double blind placebo controlled randomized proof of concept study evaluating certain appetite when added to standard of care team is ola mined versus team is <unk> alone and matching certain hepatitis placebo in subjects with newly diagnosed GBM.

Speaker Change: 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.

Speaker Change: Four to five is a phase one b to a double blind placebo controlled three arm randomized study in the United States evaluating the safety Tolerability and efficacy of a four hour continuous infusion of <unk> in combination with standard of care in patients with second line.

Static pancreatic cancer, who have progressed on first line fulfill remarks.

Kristen Buck: As part of this study, we have engaged Haystack Oncology to use their MRD technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of cetepatides.

Speaker Change: As part of this study we have engaged haystack oncology to use their <unk> technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study is an exploratory endpoint for analyzing the early therapeutic effect of certain hepatitis.

Kristen Buck: We expect to enroll the first patient in this study by the first half of 2025. On top of the previously described studies, we are exploring additional trials supporting our general development strategy. However, we remain steadfast in only starting trials that can be funded through data and trials that can be executed within a reasonable period of time.

Kristen Buck: We expect to enroll the first patient in this study by the first half of 2025. Additionally, on top of the previously described studies, we are exploring additional trials supporting our general development strategy. However, we remain steadfast in only starting trials that can be funded through 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.

Speaker Change: We expect to enroll the first patient in this study by the first half of 2025.

Speaker Change: On top of the previously described studies, we are exploring additional trials supporting our general development strategy.

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

Kristen Buck: 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 the 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 Certeppa-type clinical trials around the world.

Kristen Buck: 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 the 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 certipetide clinical trials around the world. For those of you who are interested, a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website.

Speaker Change: Finally, I would be remiss, if I didn't remind you that several of the studies I mentioned are investigator initiated trials.

Kristen Buck: And although we have great confidence in the 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 certipetide clinical trials around the world. For those of you who are interested, a more comprehensive description of each trial is available in the appendix section of the corporate presentation on our website.

Speaker Change: And although we have great confidence in the investigators running these studies Lossada has limited control and thus timelines and expectations may be subject to change that.

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

Kristen Buck: For those of you who are 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.

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

Operator: Welcome to the Lisata Therapeutic Second Quarter, 2024 Financial Results and Business Update Conference Call. Currently, all participants aren't a listen only mode. Following management's prepared remarks, we will hold a question and answer session. To ask a question at that time, please press star 1-1 on your telephone. You would then hear an automated message advising you that your hand is raised. As a reminder, this call is being recorded today.

Kristen 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. 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.

Speaker Change: Additionally, in the body of the presentation. There are two slide depict the anticipated timing.

Speaker Change: Execution of key milestones and data readouts from our trials.

Speaker Change: As you will see their abnormal numerous execution and data milestones projected from our portfolio of clinical trials over the next year and beyond.

David Mazzo: With that, I will now turn the call back to Dave. Thanks, Kristen. Overall, we remain optimistic about the potential of Certeppa-type to transform the lives of patients with cancer.

Speaker Change: With that I will now turn the call back to Dave.

David Mazzo: Overall, we remain optimistic about the potential of Sirtepatide to transform the lives of patients with cancer. The upcoming ASCEND data readout will be a seminal moment for Lisata as it will provide critical insights into the efficacy and safety profile of Sirtepatide in combination with standard of care chemotherapy for patients suffering from MPDAC. As we look ahead, we remain committed to advancing the Certepatide program across multiple tumor types and exploring strategic partnerships to maximize its value.

David Mazzo: Overall, we remain optimistic about the potential of certepetide to transform the lives of patients with cancer. The upcoming ASCEND data readout will be a seminal moment for Lisata as it will provide critical insights into the efficacy and safety profile of certepetide in combination with standard of care chemotherapy for patients suffering from MPDAC. As we look ahead, we remain committed to advancing the Certepatide program across multiple tumor types and exploring strategic partnerships to maximize its value. We look forward to sharing further updates on our progress throughout the year. And with that, Operator, we're ready to take questions. As a reminder, to ask.

Operator: Monday, August 12, 2024.

Dave: Thanks, Kristen overall, we remain optimistic about the potential exit hepatitis to transform the lives of patients with cancer. The upcoming ascent data readout will be a seminal moment for the <unk> as it will provide critical insights into the efficacy and safety profile of appetite in combination with standard of care.

John Menditto: I will now turn the call over to John Menditto, Vice-President of Investor Relations and Corporate Communications at LaSanna. Please go ahead, sir. Thank you, Operator, and good afternoon, everyone.

David Mazzo: The upcoming Ascend Data Readout will be a seminal moment for the SODA as it will provide critical insights into the efficacy and safety profile of Certeppa-type in combination with standard of care, chemotherapy for patients suffering from MPDAC. As we look ahead, we remain committed to advancing the Certeppa-type program across multiple tumor types and exploring strategic partnerships to maximize its value. We look forward to sharing further updates on our progress throughout the year, and with that operator, we're ready to take questions.

John Menditto: Welcome to LaSata's Second Quarter, 2024 Conference Call to discuss our financial results and to provide a business update.

Dave: Chemotherapy for patients suffering from MP that.

David Mazzo: Joining you from our management team are Dr. David Mazzo, President and Chief Executive Officer.

Speaker Change: As we look ahead, we remain committed to advancing the <unk> program across multiple tumor types and exploring strategic partnerships to maximize its value. We look forward to sharing further updates on our progress throughout the year and with that operator, we're ready to take questions.

David Mazzo: We look forward to sharing further updates on our progress throughout the year. And with that, Operator, we're ready to take questions. As a reminder, to ask a question, please press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised.

John Menditto: Dr. Kristen Buck, Executive Vice-President of Research and Development and Chief Medical Officer, and James Nisco, Senior Vice-President of Finance and Treasury and Chief Accounting Officer. Shortly before this call, we issued a press release announcing our second quarter, 2024 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or if you'd like to be added to the company's email distribution list, please subscribe to email alerts on the company website or email me at jmangidoatlasada.com to be added.

Operator: As a reminder, to ask a question, please press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions. Our first question comes from the line of Steve Brozak of WBB Securities.

Operator: As a reminder to ask a question, please press star 11 on your telephone. You would then hear an automated message advising that your hand is raised.

Speaker Change: As a reminder to ask a question. Please press star one one on your telephone you will then hear an automated message advising that 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.

Operator: Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions.

Steve Brozak: Our first question. from the line of Steve Brozak, of WBB Securities. Hey, good afternoon, and thanks for taking the questions. I have one specifically around, you know, congrats obviously on the unfortunate but quick enrollment. What kind of feedback did you get from the clinicians in terms of how quick it was? And obviously you opened up a second front as far as enrolling for additional patients. What kind of feedback have you gotten from the clinicians on, not just the demand, but the need in what patients, what patients we're, you know, looking for as far as this and I've got one follow up after that.

Operator: Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions. Our first question comes from the line of Steve Brozak of WBB Security. Hey, good afternoon, and thanks for taking the questions. I have one specifically around, you know, congratulations, obviously, on the unfortunate but quick enrollment.

Speaker Change: Our first question.

John Menditto: 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 LaSata. 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 risks 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 this live broadcast Monday, August 12, 2024.

Speaker Change: Comes from the line of Steve Brozak of <unk> Securities.

David Mazzo: What kind of feedback did you get from the clinicians in terms of how quick it was? And, obviously, you opened up a second front as far as enrollment is concerned for additional patients. What kind of feedback have you gotten from the clinicians on not just the demand but the need and what patients were looking for as far as this, and I've got one follow-up after that. Thanks, Steve. I appreciate you being on the call, and thank you for the question.

Stephen Brozak: Hey, good afternoon, and thanks for taking the questions. I have one specifically around, you know; congratulations, obviously, on the unfortunate but quick enrollment. What kind of feedback did you get from the clinicians in terms of how quick it was? And, obviously, you opened up a second front as far as enrolling additional patients. What kind of feedback have you gotten from the clinicians on not just the demand but the need and what patients were looking for as far as this is concerned? And I've got one follow-up after that. Thank you. Thanks, Steve.

Speaker Change: Hey, good afternoon, and thanks for taking the questions I had one specifically around.

Steve Brozak: Congrats obviously on the unfortunate but quick enrollment.

Speaker Change: What kind of feedback did you get.

Speaker Change: From the clinicians in terms of how quick it wasn't obviously you opened up a second front as far as enrolling.

Speaker Change: For additional patients what kind of feedback have you gotten from the clinicians on not just the demand, but the need and what patients what patients were looking for as far as this and I've got one follow up after that thank you.

John Menditto: LaSata Therapuse undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.

Steve Brozak: Thank you. Thanks, Steve. Appreciate you being on the call, and thank you for the question.

David Mazzo: Thanks Steve, appreciate you being on the call and thank you for the question. The feedback that we've received, and I should say that Kristen actually received directly throughout the enrollment of the first line cholangiocarcinoma trial, was that there was a tremendous level of enthusiasm about the potential for the product and even, I would say, an assumption or speculation that the product was doing something positive. Now Kristen reminded the investigators that the study was blinded. Nobody, including them, knew who was receiving treatment and who wasn't.

Speaker Change: Thanks, I appreciate you being on the call and thank you for the question.

David Mazzo: You know, the feedback that we received, and I should say that Kristen actually received directly throughout the enrollment of the first line, Colandrio Carson on the trial, was that there was a tremendous level of enthusiasm about the potential for the product. And even a, I would say, an assumption or a speculation that the product was doing something positive. Now, Kristen, you know, reminded the investigators that the study was blinded; nobody knew, including them, who was receiving treatments and who wasn't. But their, their, their typical response was, "Yes, we, we understand." But we're seeing some of our patients do things respond in a way that's atypical of patients with Colandrio Carson on receiving, you know, chemotherapy.

David Mazzo: You know, the feedback that we've received, and I should say that Kristen actually received directly throughout the enrollment of the first-line cholangiocarcinoma trial, was that there was a tremendous level of enthusiasm about the potential for the product and even, I would say, an assumption or speculation that the product was doing something positive. Now, Kristen, you know, reminded the investigators that the study was blinded. Nobody, including them, knew who was receiving treatment and who wasn't.

David Mazzo: But their typical response was, yes, we understand, but we're seeing some of our patients do things, respond in a way that's atypical of patients with cholangiocarcinoma receiving chemotherapy. And so we really think that it must be due to the addition of certepatide, and we're very excited about that. Oh, and by the way, because we think something is happening in the first line, there's an even greater need in the second line. Would you please consider opening up a second arm or bolster in second-line cholangiocarcinoma because we believe that we can enroll that very rapidly as well because of the large need? And so based upon that type of feedback, we indeed did open the second line cholangiocarcinoma study, and we hope that that will enroll as quickly as they have projected.

Speaker Change: The feedback that we've received and I should say that Kristen actually receive directly throughout the enrollment of the first line Cholangiocarcinoma trial was that there was a tremendous level of enthusiasm about the potential for the product and an even.

David Mazzo: With that, I will now turn the call over to Dr. Mazzo. Dave? Thank you, John. Good afternoon, everyone. I'm delighted to be with you today, provide an overview of recent business highlights discussed our second quarter, 2024 financial results, and give an update on the progress of our clinical development programs. During the second quarter of this year, LaSata maintained strongo metham in the advancement of our development pipeline centered around our novel investigational product, Certepartite, in combination with a variety of anti-cancer agents of differing modalities for the treatment of advanced solid tumors.

Speaker Change: I would say an assumption our speculation that the product was doing something positive now Christopher.

Christopher Buck: Reminded the investigators the study was blinded nobody including them, who is receiving treatments and who wasn't but they're the typical response was yes, we understand but we're seeing some of our patients do.

David Mazzo: But their typical response was, yes, we understand, but we're seeing some of our patients do things that are atypical of patients with cholangiocarcinoma receiving, you know, chemotherapy. And so we really think that it must be due to the addition of certepatide, and we're very excited about that. Oh, and by the way, because we think something is happening on the first line, there's an even greater need on the second line.

David Mazzo: As we have previously reported, consistently encouraging pre-clinical data, as well as early clinical data in humans, continue to support our belief that Certepartite has the potential to become an integral part of a revised standard of care treatment for many challenging solid tumors.

Speaker Change: Do things respond in a way that's atypical ah patients with Cholangiocarcinoma receiving.

David Mazzo: And so we really think that it must be due to the addition of certifitide, and we're very excited about that. No, and by the way, because we think something is happening in first line, there's an even greater need in second line. Would you please consider opening up a second arm repulsed or in second line Colandrio Carson on because we believe that we can enroll that very rapidly as well because of the, the large need. And so, based upon that type of feedback, we indeed did open the second line, Colandrio Carson, on the study. And we hope that that will enroll as quickly as they have projected.

Speaker Change: Chemotherapy and so we really think that it must be due to the addition of certain appetite and we're very excited about that now and by the way because we think something is happening in first line, there's an even greater need in second line would you. Please consider opening up a second Don repulse during second line Cholangiocarcinoma because we.

Kristen Buck: 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.

David Mazzo: Would you please consider opening up a second arm or bolster in second-line cholangiocarcinoma because we believe that we can enroll that very rapidly as well because of the large need. And so, based upon that type of feedback, we indeed did open the second-line cholangiocarcinoma study, and we hope that that will enroll as quickly as they have projected.

Speaker Change: Believe that we can enroll that very rapidly as well because of the large need and so based upon that type of feedback. We indeed did open the second line Cholangiocarcinoma study and we hope that that will enroll as quickly as they have projected.

Steve Brozak: Got it. Okay. And on the follow-up, when you look at this kind of a response, and we obviously look at, you know, just as a reminder, what would basically standard of care be right now if unfortunately you didn't have this trial running? What would the standard care be to contrast that? And I'll jump back off the queue, please. Inspector, the queue. Sure, and I'll actually call on Kristen to jump in here. You know, you have to talk a little bit about standard of care for the Colandrio Carson on the indication. Thanks, Steve. It's Kristen here.

David Mazzo: Okay. And on the follow-up, when you look at this kind of response, And we obviously look at, you know, just as a reminder, what would basically the standard of care be right now if, unfortunately, you didn't have this trial running.

David Mazzo: Got it. Okay. And on the follow-up, when you look at this kind of response, And we obviously look at, you know, just as a reminder, what would the standard of care be right now if, unfortunately... You didn't have this trial running. What would the standard of care be to contrast that, and I'll jump back off the queue Please inspect the queue

Speaker Change: Yes.

Speaker Change: Got it okay and on.

Speaker Change: On the follow up when you look at this kind of a response and we obviously look at.

Speaker Change: Just as a reminder, what would basically standard of care be right now if unfortunately.

David Mazzo: What would the standard of care be to contrast that? And I'll jump back off the queue, please, Inspector. Sure, and I'll actually call on Kristen to jump in here, you know, to talk a little bit about the standard of care for the cholangiocarcinoma indication. Thanks, Steve. It's Kristen here.

Speaker Change: You didn't have this trial running what would the standard of care be to contrast that and I'll jump back off for Q. Please inspectors with you.

James Nisco: Research and development expenses were approximately 2.6 million for the three months ended June 30th, 2024, compared to 3.2 million for the three months ended June 30th, 2023, representing a decrease of 0.6 million or 17.7%. This was primarily due to a reduction in expenses associated with the phase 2B ascentrile, which completed enrollment in the prior year. Lower spend on chemistry, manufacturing and control, or CMC, related expenses, and lower equity expense partially offset by an increase in expenses associated with enrollment activities in the current year for a bolster trial.

David Mazzo: Sure, and I'll actually call on Kristen to jump in here, you know, to talk a little bit about the standard of care for the cholangiocarcinoma indication. Thanks, Steve. It's Chris.

Sure and I'll actually call on Kristin to jump in here to talk a little bit about the standard of care for the Cholangiocarcinoma indication.

Kristen Buck: Thanks, Steve. It's Kristen here.

Kristin: Thanks, Steve It's Christian here, Yeah, the first line treatment for <unk>.

Kristen Buck: Yeah, the first line treatment for Colandrio carcinoma or bile duct tumor is actually gym cytobine, cisplatinin, and dermalamand. And the reason, you know, we designed the trial as such, we wanted to include that standard of care currently as one of the treatment arms with placebo, and add certified to that baseline standard of care regimen. You know, for patients, this is a pretty devastating disease. These patients, you know, in the first line, perhaps live 11 months overall survival median. And in the second line, unfortunately, they meet their demise between four and six months.

Kristen Buck: Yeah, the first-line treatment for Cholangia Carcinoma or Bile Duct Tumor is actually Gemcitabine, Cisplatin, and Dervalumab. And the reason we designed the trial as such is that we wanted to include that standard of care currently as one of the treatment arms with placebo and add cetepatide to that baseline standard of care regimen. You know, for patients, this is a pretty devastating disease. These patients, you know, in the first line, perhaps live for 11 months; overall survival median. And on the second line, unfortunately, they meet their demise between four and six months. So we're hoping to make a meaningful impact.

Kristen Buck: Yeah, the first line treatment for Cholangia Carcinoma or Bile Duct Tumor is actually Gemcitabine, Cisplatin, and Dervalumab. And the reason we designed the trial as such is that we wanted to include that standard of care currently as one of the treatment arms with placebo and add cetepetide to that baseline standard of care regimen. You know, for patients, this is a pretty devastating disease. These patients, you know, in the first line, perhaps live for 11 months; overall survival median. And in the second line, unfortunately, they meet their demise between four and six months.

Kristin: Cholangiocarcinoma or bile duct tumor is actually gemcitabine.

Speaker Change: Flattening and development.

Speaker Change: And the reason we designed the trial as such we wanted to include that standard of care currently as one of the treatment arms with placebo and add certain hepatitis that baseline care regimen.

Speaker Change: For patients. This is a pretty devastating disease. These patients in the first line, perhaps live 11 months overall survival median and in the second line. Unfortunately, there that meet their demise between four and six months. So we're hoping to make a meaningful impact.

Operator: So we're hoping to make a meaningful impact. Thank you. Our next question comes from the line of Joseph Penn-Guinness of H.C. Wainwright & Company.

Steve Brozak: So we're hoping to make a meaningful impact. Thank you.

James Nisco: General and administrative expenses were approximately 2.9 million for the three months ended June 30th, 2024, compared to 3.7 million for the three months ended June 30th, 2023, representing a decrease of 0.8 million or 21.3%. This was primarily due to one off-related severance costs in the prior year associated with the elimination of the Chief Business Officer on May 1st, 2023, a reduction in equity expense and a decrease in directors and officers insurance premiums in the current year.

Speaker Change: Yeah.

Sara Nik: Our next question comes from the line of Joseph Penn Guinness of H.C. Wainwright & Company.

Speaker Change: Thank you.

Speaker Change: Next question.

Joseph Penn Guinness: Thank you. Our next question comes from the line of Joseph Penn Guinness of H.C. Wainwright & Company.

Speaker Change: It comes from the line of.

Speaker Change: Joseph Papp Genis of HC Wainwright and company.

Sara Nik: Hi, good afternoon. This is Sara on Spur Joe. I had a question actually on the two pharmaceuticals trial and for this case to an MPDAC, kind of wondering how much insight you actually get into the progress of the trial. So, if you can provide, if you have any insight into how enrollment is progressing, I know it's about 18 months to complete a cruel, but do you have any insights into how many patients have been treated to date or any other updates you get along the way.

Sara Nik: Hi, good afternoon. This is Sara on behalf of Joe.

Operator: Hi, good afternoon. This is Sara on behalf of Joe. I had a question actually on the two pharmaceutical trials and, for this case, too, and MPDAC. Kind of wondering how much insight you actually get into the progress of the trial, if you can provide any, if you have any insight into how enrollment is progressing. I know it's about 18 months to complete accrual, but do you have any insights into how many patients have been treated to date or any other updates you get along the way? Thank you. Hi Sara

Speaker Change: Hi, Good afternoon. This is Sarah on for Joe.

Speaker Change: Question actually on that huge pharmaceutical trial.

Sara Nik: I actually had a question on the two pharmaceutical trials and, for this case, too, and MPDAC. I was kind of wondering how much insight you actually get into the progress of the trial. If you can provide any insight into how enrollment is progressing. I know it's about 18 months to complete accrual, but do you have any insights into how many patients have been treated to date or any other updates you can provide along the way? Thank you. Hi Sara, thanks for calling.

Speaker Change: <unk>.

Speaker Change: For the phase two and emptied out kind of wondering.

Speaker Change: Wondering how much insight you actually get into the progress of the trial.

Speaker Change: We'll provide thank you.

Speaker Change: Any insight into how enrollment is progressing I know about 18 months to complete accrual, but do you have any insights into how many patients have been treated to date or any other updates you get along the way. Thank you.

James Nisco: Benefit from income taxes was 0 for the three months ended June 30th, 2024, compared to 2.3 million for the three months ended June 30th, 2023. In April 2023, we received net proceeds of 2.2 million from the sale of tax benefits to a qualified and approved buyer pursuant to the New Jersey Economic Development Authorities Technology Business Tax Certificate Transfer Program. Overall, net losses were 5 million for the three months ended June 30th, 2024, compared to 4 million for the three months ended June 30th, 2023.

Sara Nik: Thank you.

David Mazzo: Hi Sara, thanks for calling in and thanks for your question. So, as Kristen's narrative indicated, Chilu is an independent company; it's a private company in China, so they are not subject to the same rules of disclosure that public companies are. And as a result, they typically do not make any announcements about the progress of their clinical trials. They don't even announce first patient in, last patient out or anything. They just wait until the trials are over, and they make general announcements through the medium of a scientific presentation at a big meeting like ASCO GI or ASCO.

David Mazzo: Hi, Sara. Thanks for calling in, and thanks for your question. So, I think, as Kristen's narrative indicated, Chilu is an independent company. It's a private company in China. So, they do not subject to the same rules of disclosure that public companies are. And as a result, they typically do not make any announcements about the progress of their clinical trials. They don't even announce first patient in last patient doubt or anything. They just wait until the trials are over, and they make, you know, generally an announcement through the medium of a scientific presentation at a big meeting like ASCO GI or ASCO.

David Mazzo: Thanks for calling in and thanks for your question. So, as Kristen's narrative indicated, Chilu is an independent company. It's a private company in China, so they are not subject to the same rules of disclosure that public companies are.

Speaker Change: Hi, Sir thanks for calling in and thanks for your question. So I think as Christians narrative indicated <unk> as an independent company with a private company in China.

Speaker Change: Im not subject to the same rules of disclosure that public companies are and as a result, they typically do not make any announcements about the progress of their clinical trials that they don't even announce first patient in last patient out or anything they just wait until the trials for over and they make.

David Mazzo: And as a result, they typically do not make any announcements about the progress of their clinical trials. They don't even announce first patient in, last patient out or anything. They just wait until the trials are over.

David Mazzo: And they generally make announcements through the medium of a scientific presentation at a big meeting like ASCO GI or ASCO. So as it relates to the Phase 2 product, all we know is that it initiated in the second quarter because they told us. We have our joint steering committee meetings at least quarterly, and during that meeting, they told us they'd initiated the Phase 2 trial. And that's when they projected the roughly 18 months for complete enrollment. We are waiting for our third quarter.

Speaker Change: Generally a announcements through the medium of scientific presentation at a big meeting like ESCO Gi or Oscar so as it relates to the phase II product. All we know is that initiated.

James Nisco: It is noteworthy that we continue to make progress according to our plans for our research and development and business activities while still continuing our legacy of prudent capital management and expense minimization. Turning now to our balance sheet and cash flow as of June 30th, 2024, Lassada had cash, cash equivalents and marketable securities of approximately 38.3 million. Based on its current expected capital needs, the company believes that its projected capital will fund its current proposed operations into early 2026, encompassing anticipated data milestones from all its ongoing and planned clinical trials.

David Mazzo: So as it relates to the Phase 2 product, all we know is that it initiated in the second quarter because they told us we have our joint steering committee meetings at least quarterly. And during that meeting, they told us they'd initiated the Phase 2 trial, and that's when they projected roughly 18 months for complete enrollment. We are waiting for our third quarter JSC meeting to occur. And they may or may not give us a hint as to what the trial enrollment is, but they would typically say things like, "We're on track, you know, all right."

David Mazzo: So, as it relates to phase two product, all we know is that it initiated in the second quarter because they told us we have our joint steering committee meetings at least quarterly. And during that meeting, they told us they've initiated the phase two trial, and that's when they projected the roughly 18 months for completed enrollment. We are waiting for our third quarter, JSC meeting to occur, and they may or may not give us a hint as to what the trial enrollment is. But they would typically say things like, "we're on track, you know, all right."

Speaker Change: In the second quarter, because they told US we have a joint steering committee meetings at least quarterly and during that meeting they told us they are initiated.

Phase two trial and that's when they projected to roughly 18 months for complete enrollment.

Speaker Change: We are waiting for our third quarter.

David Mazzo: JSC meeting to occur, and they may or may not give us a hint as to what the trial enrollment is, but they would typically say things like, we're on track, you know, all right. And at this early stage, I would imagine that they wouldn't say anything other than they're on track to meet their projected 18-month enrollment period. So, you know, we're a little bit blind to what's going on there, but if things go, you know, dramatically different from their projections, they would obviously let us know.

Speaker Change: JSC meeting to occur and they may or may not give us a hint as to what the trial enrollment is but they would typically say things like we are on track.

David Mazzo: And at this early stage, I would imagine that they wouldn't say anything other than they're on track to meet their projected 18-month enrollment period. So, you know, we're a little bit blind to what's going on there, but if things go, you know, dramatically different from the projections, they would obviously let us know.

David Mazzo: And at this early stage, I would imagine that they wouldn't say anything other than they're on track to meet their projected 18-month enrollment period. So, you know, we're a little bit blind to what's going on there, but the things go dramatically different from the projections that they would obviously let us know.

Speaker Change: Alright, and at this early stage I would imagine that they wouldn't say anything other than they are on track to meet their projected 18 months enrollment period. So.

Kristen Buck: With that, I now turn the call over to Dr. Kristen Buck to provide an overview of the company's development programs. Kristen? Thank you, James, and good afternoon, everyone. As I've mentioned many times in the past, Lisata's development programs are built upon a strong foundation of published, pre-clinical, and early clinical research. Notably, our SENDR platform technology is rooted in pioneering discoveries recognized by the last-year prize awarded to Dr. Erky Rushladi. A product of the SENDR platform Sir Tepatide is designed to address the major impediments to the successful treatment of advanced solid tumors.

Speaker Change: We're a little bit blind to what's going on there but.

Speaker Change: If things go dramatically different from our projections.

Speaker Change: Obviously, there was snow.

Sara Nik: Okay, that's helpful.

David Mazzo: Okay, that's helpful. Thank you. Thank you.

David Mazzo: Okay, that's helpful. Thank you. Thank you, Sara.

Sara Nik: Thank you.

Speaker Change: Sure.

Sara Nik: Thank you, Sarah.

Speaker Change: Okay. That's helpful. Thank you.

Speaker Change: Thank you Sir.

Operator: Thank you.

Will Hidell: Our next question comes from a line of, well, Adele, a Brookline Capital Markets. Hey, thank you for taking the questions. I have a quick clarification question I might have missed. But the trial, the Stratovatoid and GBM, as of last quarter, I believe enrollment was, I think you had three patients enrolled, and I might have missed this, but are there any updates on enrollment? Yeah, no, actually, thanks. Well, if we're calling in on the question, we don't really have any updates. You know, as you know, that trial is running in Estonia. Typically, this time of year in that part of Europe is a very, I would say, common vacation time.

Speaker Change: Thank you.

Operator: Thank you. Our next question comes from the line of Will Hidell of Brookline Capital Markets. Hey, thank you for taking the questions. I have a quick clarification question I might have missed, but the trial, the certificate, and GBM, as of last quarter, I believe enrollment was, I think you had three patients enrolled, and I might have missed this, but are there any updates on enrollment? Yeah, no, actually, thanks, Will, for calling in and asking the question. We don't really have any updates. As you know, that trial is running in Estonia. Typically, this time of year in that part of Europe, it's a very, I would say, common vacation time.

Will Hidell: Our next question comes from the line of Will Hidell of Brookline Capital Markets.

Speaker Change: Our next question comes from the line of well hurdle of Brookline capital markets.

Will Hidell: Hey, thank you for taking the questions. I have a quick clarification question I might have missed, but the trial, the certificate, and GBM, as of last quarter, I believe enrollment was, I think you had three patients enrolled, and I might have missed this, but are there any updates on enrollment? Yeah, no, actually. Thanks, Will, for calling in and asking the question.

Speaker Change: Okay.

well hurdle: Hi, Thank you for taking my questions I have a quick Claire for quake casing question I might've missed but.

Trial, the streets I retired in GBM.

Kristen Buck: This is especially relevant in an environment of increasing prevalence of these cancers and growing pharmacoeconomic pressures. Our clinical studies have been rigorously designed with the end in mind, that is eventual product registration, and are optimized to generate clinically meaningful, unambiguous data. As such, unlike many studies at a similar stage of development, our studies are placebo-controlled, appropriately sized, and employ primary endpoints that are preferred by regulatory authorities in support of pivotal trials.

Speaker Change: As of last quarter I believe enrollment was I think you had three patients enrolled and I might've missed this but are there any updates on enrollment.

David Mazzo: Yeah, no, actually, thanks, Will, for calling in and asking the question. We don't really have any updates. As you know, that trial is running in Estonia. Typically, this time of year in that part of Europe is, I would say, common vacation time. And so our investigator, the lead investigator, has been away for the last 10 days, and we probably won't have a chance to touch base with her for another week or so.

Speaker Change: Yeah, no actually thanks for calling in and the question, we don't really have any updates.

Speaker Change: As you know that trials running in dystonia.

Speaker Change: Typically this time of year in that part of Europe is very.

Speaker Change: I would say common vacation time, and so our investigator lead investigator that's been away for the last 10 days.

Will Hidell: And so, our investigator, lead investigator, has been away for the last 10 days. And we probably won't have a chance to touch base with them for another week or so. And hopefully, during our next call, we'll have an update on enrollment from Estonia and Latvia. But, you know, we do know that the site in Latvia is open. And we do hope that we'll see. and the improvement to our rather an increase in enrollment over the originally announced three of the next time we have a chance to chat. Okay, thank you. Thank you.

David Mazzo: And so our investigator, the lead investigator, has been away for the last ten days, and we probably won't have a chance to touch base with her for another week or so. And hopefully, during our next call, we'll have an update on enrollment from Estonia and Latvia. But, you know, we do know that the sites in Latvia are open, and we do hope that we'll see an improvement, or rather an increase in enrollment over the originally announced three the next time we have a chance to chat.

Kristen Buck: Further, our trial devaluates Sir Tepatide in combination with current standard of care therapies to allow for clear discernment of treatment effect and to fit with current treatment practices at clinical sites. These strategic design choices are not always the least expensive, 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 of, do the last experiment first, to avoid time and capital consumption on work that could become unnecessary. We have also devised and implemented a regulatory strategy that optimizes Sir Tepatide's regulatory review and future commercialization. This strategy includes obtaining special regulatory designations that afford us priority reviews and the possibility of accelerated approvals.

Speaker Change: We probably will have a chance to touch base with us for another week or so and hopefully during our next call. We'll have an update on enrollments from from from Estonia, Latvia, but we do know that sites.

David Mazzo: And hopefully, during our next call, we'll have an update on enrollment from Estonia and Latvia. But we do know that the sites in Latvia are open, and we do hope that we'll see what... and Gwyneth Paltrow.

Speaker Change: Last year, our open and we do hope that we'll see.

Speaker Change: An improvement to our or rather an increase in enrollment over the originally.

Speaker Change: <unk> III. The next time, we have a chance to chat.

Speaker Change: Okay. Thank you.

Speaker Change: Okay.

Speaker Change: Thank you.

Pete Enderlin: Our next question comes from the line of Pete Enderlin of Mass Partners. Thank you. Hi, everybody. The congratulations on the strong progress in the enrollment, especially in conjunction with controlling expenses, already effectively. My first question is a quick one, so I'll maybe count it as a half a question. And that is, do you have any estimate of the size of the pediatric population, patient population, and pancreatic cancer? I mean, we know orphan is less than 200,000, but I would think it's a lot less than that in the United States and in your boat. So do we have any numbers?

Pete Enderlin: Our next question comes from the line of Pete Enderlin of Massachusetts.

Operator: Okay, thank you. Thank you. Our next question comes from the line of Pete Enderlin of Mass Partners. Thank you. Hi, everybody. Congratulations on the strong progress in enrollment, especially in conjunction with controlling expenses very effectively. My first question is a quick one, so I'll maybe count it as a half. And that is, do you have any estimate of the size of the pediatric population?

Speaker Change: Our next question comes from the line of Pete Enderlin of mass partners.

Pete Enderlin: Thank you. Hi everybody.

Pete Enderlin: Thank you hi, everybody.

Pete Enderlin: Congratulations on the strong progress in enrollment, especially in conjunction with controlling expenses, very effective. My first question is a quick one, so I'll maybe count it as a half-question, and that is, do you have any estimate of the size of the pediatric... Patient Population and Pancreatic Cancer. I mean, we know the orphan number is less than 200,000, but I would think it's a lot less than that in the United States and in Europe both. So do we have specific numbers? Yeah, the answer is it's not significantly different from zero. Yeah, it's not it's not a disease that's actually found in, you know, in children, basically, right?

Pete Enderlin: Congratulations on the strong progress in the enrollment, especially in conjunction with controlling expenses very effectively. My first question is a quick one may be counted as a half a question and that is do you have any.

Kristen Buck: However, before I get to the specifics of each of the clinical studies in our development portfolio, please allow me to summarize some important background information, especially for those who are listening 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. Cancer, such as pancreatic cancer, gastric cancers, glioblastoma multi-form, and other solid tumors are surrounded by a dense, fibrotic tissue known as the stroma, which limits access of most pharmacotherapies to the tumor.

Speaker Change: Some of the size of the.

David Mazzo: Patient Population and Pancreatic Cancer. I mean, we know the orphan number is less than 200,000, but I would think it's a lot less than that in the United States and in Europe both. So do we have those numbers? Yeah, the answer is, it's the... Not significantly different from zero. Yeah. It's not a disease that's actually found in, you know, in children, basically.

Pete Enderlin: Pediatric.

Speaker Change: Population patient population in pancreatic cancer orphan.

Speaker Change: Orphan is less than 200000, but.

Speaker Change: I would think it's a lot less than that in the United States and in Europe both.

Speaker Change: So.

David Mazzo: Yeah, the answer is it's not significantly different from zero. Yeah. It's not a disease that's actually found in children, basically. Right.

Speaker Change: Yes, the answer is.

Speaker Change: Not significantly different from zero.

Speaker Change: Yes.

Speaker Change: It's not a disease that's actually found in.

Speaker Change: Children's basically right.

David Mazzo: Okay, then more substantively, you know, looking ahead, which, you know, the investment community always tries to do, and sometimes it's difficult. But the question is, are there other companies' drugs in clinical trials, not existing standard of care, but ones where there are ongoing clinical trials, where tying it in with throtepetide conceptually, or potentially, could make the difference between approval of that drug and that series of clinical trials, or not. And do you have any ongoing conversations with other drug companies about that kind of situation? I'm not looking for, you know, we know that it helps in conjunction with that with Paxle and, you know, there's other centers of care, but this is for new drugs.

Pete Enderlin: Okay, then, more substantively, you know, looking ahead, which, you know, the investment community always tries to do, and sometimes, it's difficult to put into words. The question is, are there other companies' drugs in clinical trials, not existing standards of care, but ones where there are ongoing clinical trials, we're tying it in with certipetide, that conceptually or potentially could make the difference between approval of that drug in that series And do you have any ongoing conversations with other drug companies about that kind of situation? I'm not looking for, you know, but we know that it helps, in conjunction with Naplopaxil and those other centers of care. But this is for new. What's the outlook for that?

David Mazzo: Right. Okay, then, more substantively, you know, looking ahead, which, you know, the investment community always tries to do, and sometimes, it's difficult to put it that way. The question is, are there other companies' drugs in clinical trials, not existing standards of care, but ones where there are ongoing clinical trials, we're tying them in with certipetide, that conceptually or potentially could make the difference between approval of that drug in that series of clinical trials or not? And do you have any ongoing conversations with other drug companies about that kind of situation? I'm not looking for, you know, we know that it helps, in conjunction with NAPLAPAXL and those other centers of care. But this is for new.

Speaker Change: Okay then.

Kristen Buck: 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. The combination of a dense stroma and a hostile tumor microenvironment prevents many chemotherapy and immunotherapies from being optimally effective in treating these cancer. 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.

Speaker Change: More substantively.

Speaker Change: Looking head, which.

Speaker Change: The investment Securities always tries to do and sometimes it's difficult but.

Speaker Change: The question is are there other company's drugs in clinical trials not.

Speaker Change: Listing standard of care, but ones, where they're ongoing clinical trials.

Speaker Change: Tying it in with sort of tepid tied.

Speaker Change: Conceptually or potentially.

Speaker Change: Could make the difference between approval of that drug in that series of clinical trials or or not and do you have any.

Kristen Buck: To combat this, our investigational products are tepatide, leverages the naturally occurring send our active transport system to provide an innovative approach to the selective delivery of anti-cancer drugs through the tumor stroma and directly into the tumor. Simultaneously, sertepotype has been shown to modify the tumor micro-environment, making it less immunosuppressive, and therefore increasing the tumor's susceptibility to immunotherapy while also inhibiting the metastatic cascade. Sertepotype is a nine 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 themselves, but not on healthy tissue.

Speaker Change: Go in conversations with other drug companies about that kind of situation.

Speaker Change: I'm not looking for it.

Speaker Change: We noted that it helps.

Speaker Change: And.

In conjunction with that.

Speaker Change: Excellent.

Speaker Change: Other centers of care, but this is for new drugs.

David Mazzo: What's the outlook for that? So, the simple answer to your two questions is yes and yes. You know, as I said, or as Kristen actually said, the mechanism of action of certepetide is agnostic to the modality of the companion anti-cancer agent. That's, you know, fairly fancy talk for saying that it doesn't matter what type of anti-cancer drug you use. If you mix it with cetepetide, you should expect an improvement.

David Mazzo: What's the outlook for that?

Speaker Change: What's the outlook for that.

David Mazzo: So the simple answer to you two questions is yes and yes. As I said, or as Kristen actually said, the mechanism of action of throtepetide is agnostic to the modality of the companion anti-cancer agent. That's fairly fancy speak for saying that it doesn't matter what type of anti-cancer drug you use if you mix it with throtepetide; you should expect an improvement. And so we actually would expect that it could help for products that are currently approved as well as products that are under investigation, and we have in fact spoken to a number of companies who are studying their products for pediatric cancer and other solid tumors, and you know, have an ongoing dialogue to see if we can find a way to collaborate that gives both products, throtepetide and theirs, another shot on gold, but still fall within our strategic remit here of making sure that we can afford whatever we do.

David Mazzo: So the simple answer to your two questions is yes and yes. You know, as I said, or as Kristen actually said, the mechanism of action of certepetide is agnostic to the modality of the companion anti-cancer agent. That's, you know, fairly fancy talk for saying that it doesn't matter what type of anti-cancer drug you use. If you mix it with cetepetide, you should expect an improvement. And so we would actually expect that it could help for products that are currently approved as well as products that are under investigation.

Speaker Change: So the simple answer to your two questions are yes, and yes.

Speaker Change: As I said, whereas Kristen actually said the.

Kristen: Mechanism of action of <unk> appetite.

Speaker Change: It's agnostic to the modality of the companion anticancer agents.

Kristen Buck: Once bound to these integrins, sertepotype is subjected to proteolytic cleavage by enzymes naturally occurring in the tumor micro-environment to produce two linear fragments, one of which is a five amino acid send our peptide fragment. Upon dissociation of the send our fragment from the integrin receptor, it binds to another receptor called Noropilin-1 on the same or a nearby cell. Once Noropilin-1 is activated, it actuates the send our active transport mechanism, which is manifested by the formation of micro vesicles at the surface of the cells.

Speaker Change: Fairly fancy speak for saying that it doesn't matter what type of anti cancer drugs you use if you mix. It with <unk> you should expect an improvement and so we actually would expect that it could help for products that are currently approved as well as products that are under investigation and we have in fact spoken to a number of companies who are.

David Mazzo: And so we actually would expect that it could help for products that are currently approved as well as products that are under investigation. And we have, in fact, spoken to a number of companies who are studying their products for. Pancreatic Cancer and Other Solid Tumors and have an ongoing dialogue to see if we can find a way to collaborate that gives both products, Sirtepatide and theirs, another shot at goal but still falls within our strategic remit here of making sure that we can afford whatever it takes.

David Mazzo: And we have, in fact, spoken to a number of companies who are studying their products for pancreatic cancer and other solid tumors and, you know, have an ongoing dialogue to see if we can find a way to collaborate that gives both products, Certepatide and NARES, another shot at goal but still falls within our strategic remit here of making sure that we can afford whatever we do.

Speaker Change: Our study their products for.

Speaker Change: Pancreatic cancer and other solid tumors and have a I would say ongoing dialogue to see if we can find a way to collaborate that gives both offer both products are <unk> and there's another shot on goal, but still falls within our our.

Speaker Change: Strategic remit hero, making sure that we can afford with that what we do.

Pete Enderlin: Yeah, and so, Dave, does that mean that some of these companies have actually approached you because you don't necessarily know everything that's going on in these different cancer trials and maybe have a drug that they're not that confident about, but they know that if it gets improved efficacy thanks to your drug, that that would make the difference?

David Mazzo: So Dave, does that mean that some of these companies have actually approached you because you don't necessarily know everything that's going on in these different cancer trials, and maybe have a drug that they're not that confident about, but they know that if it gets improved efficacy thanks to your drug, that that would make the difference. Is there some of that kind of dialogue going on? Yes, that is some of that, and some of it is, of course, we scour the clinical trial roles constantly looking for products that, you know, for one reason or another are not behaving as positively as everyone hopes, but that could benefit from a combination of throtepetide.

David Mazzo: Yeah, and so, Dave, does that mean that some of these companies have actually approached you because you don't necessarily know everything that's going on in these different cancer trials and maybe have a drug that they're not that confident about, but they know that if it gets improved efficacy thanks to your drug, that that would make the difference? Yes, that is some of that.

Dave: Yes, so Dave does that mean that some of these companies is actually approached you because you don't necessarily know everything that's going on.

Speaker Change #100: Cancer trials.

Speaker Change #100: And maybe have a drug that they are not that confident about but they know that if it.

Speaker Change #101: It gets improved efficacy thanks to your drug.

Speaker Change #102: It makes a difference is there is some of that kind of dialogue going on.

David Mazzo: Yes, that is some of that, and some of it is, of course, we scour the clinical trial roles constantly looking for products that, for one reason or another, are not behaving as positively as everyone hoped but that could benefit from a combination with certifetide. So it kind of goes both ways. Okay. Thank you.

Speaker Change #102: Yes that is.

David Mazzo: And some of it is, of course, we scour the clinical trial roles constantly looking for products that, you know, for one reason or another, are not behaving as positively as everyone hoped but that could benefit from a combination with cetepetide. So it kind of goes both ways.

Speaker Change #102: Some of that and some of it is of course we.

Speaker Change #102: Scour the clinical trial rolls constantly looking for products that for one reason or another are not behaving as positively as everyone hopes, but that could benefit from a combination of a certain appetite. So it kind of goes both ways.

David Mazzo: Please. But okay, thank you very much. Sure.

Pete Enderlin: Right. Okay. Thank you very much. Sure. Thanks.

David Mazzo: Right. Okay. Thank you very much.

Speaker Change #104: Okay. Thank you very much.

Speaker Change #102: Sure.

Robert Sassoon: Thank you. Our next question comes from the line of Robert Sassoon of Water Tower Research. Our next question comes from Robert Sassoon of Water Tower, Water Tower Research. Please go ahead. Robert, are you there? You must be having connection difficulties. All right.

Speaker Change #102: Thank you.

Robert Sassoon: Our next question comes from the line of Robert Sassoon of Water Tower Research. Our next question comes from Robert Sassoon of Water Tower Research. Please go ahead.

Operator: Sure. Thank you. Our next question comes from the line of Robert Sassoon of Watertower Research. Our next question comes from Robert Sassoon of Water Tower Research. Please go ahead. Robert, are you there? You must be having connection difficulties.

Speaker Change #102: Our next question comes from the line of Robert Sassoon.

Robert Sassoon: Water Tower research.

Kristen Buck: These results come from lasada-sponsored studies and from collaborators and research groups around the world, and have been the subject of more than 350 scientific publications relevant to sertepotype's mechanism of action. Along with our collaborators, we also have a massed significant non-clinical data demonstrating enhanced delivery and augmented efficacy of a range of anti-cancer therapy modalities, including chemotherapies, immunotherapies, RNA-based therapeutics, and even cell therapies. To date, sertepotype is also demonstrated favorable clinical safety, tolerability, and activity to enhance delivery of standard of chemotherapy for patients with metastatic pancreatic cancer.

Our next question comes from Robert Sassoon of Water Tower Order Tower Research. Please go ahead.

Robert Sassoon: Robert you there.

Operator: You must be having connection difficulties. You can jump to the next question. Oh, there you are.

Speaker Change #106: You must be having connection difficulties.

Operator: You can jump to the next question. Oh, there you are. Okay. Hello. Actually, I'm going to give Robert a chance to receive if you could hit star one one again. Yeah, the line. And again, that star one one. And Robert, your line is open. Hello. Yes, there you are. Hello, Robert. Yeah, sorry. I was on mute, I think.

Speaker Change #107: Alright Conjuncture next question.

Operator: You can jump to the next question. Oh, there you are. Okay. Hello. Actually, I'm going to give Robert a chance to escape if you could hit star 11 again.

Speaker Change #106: Right.

Operator: Actually, I'm going to give Robert a chance to re-cue if you could hit star 11 again. And again, that's star 11. And Robert, your line is open.

Robert Sassoon: Oh, okay.

Robert Sassoon: Actually I'm going to give a Robert a chance to re queue. If you can hit star one again.

Robert Sassoon: The alignment.

Operator: And again, that's star 11, and Robert, your line is open. Hello? Yes, there you are. Hello, Robert. Yeah. Sorry, I was on mute, I think.

Robert Sassoon: And again Thats Star one one.

Robert Sassoon: And Robert Your line is open.

Robert Sassoon: Hello.

Kristen Buck: In addition, our strategic focus on regulatory optimization has yielded significant results as evidence by multiple special designations awarded to sub-tepatide. To date, sub-tepatide 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. Sir Tepatide will also be eligible for accelerated approval and priority review if relevant criteria are met. Further, Sir Tepatide has received multiple Orven drug designations, including one for pancreatic cancer in both the United States and Europe, as well as for malignant glioma in the US orphan drug designation.

Robert Sassoon: Yes.

Robert Sassoon: James, Secretary of State, European Parliament, European Union.

Speaker Change #108: Hello, Robert Sorry, I was on mute I think anyway, I wonder whether you could give us a sort of a rundown the picture of your size of your intellectual property real estate.

David Mazzo: Anyway, I don't wonder whether you could give us a sort of a rundown picture of your state of your intellectual property real estate. Sure. So we have a broad intellectual property portfolio that covers to tie from composition of matter through method of use, through indication and even some formulation type that they protect the product into the 2030s. And we have several applications in that are looking to that are actually currently being prosecuted that, if granted, could extend that to the early 2040s. We also would be subject to patent term extension. Because of the length of time, that's where hepatitis has been in development.

Operator: Anyway, I wonder whether you could give us a sort of a rundown of the state of your intellectual property real estate. Sure, so we have a broad intellectual property portfolio that covers everything from composition of matter through method of use, through indication, and even some formulation type patents. They protect the product into the 2030s, and we have several applications in that are looking to, that are actually currently being prosecuted, that, if granted, could extend that into the early 2040s.

James Nisco: Sure, so we have a broad intellectual property portfolio that covers certificates from composition of matter through method of use, through indication, and even some formulation type patents. They protect the product into the 2030s, and we have several applications in that are actually currently being prosecuted that, if granted, could extend that into the early 2040s. We also would be subject to patent term extension because of the length of time that certipetite has been in development, and that could also increase the patent life by up to five years, as you know, under those laws. And then, finally, under the market exclusivity benefits of orphan designations and those indications, we could get market exclusivity independent of the patent situation that extends, you know, seven to ten years, depending on the job.

Robert Sassoon: Sure. So we have we have.

Speaker Change #109: Our broad intellectual property portfolio that covers such appetite from a composition of matter through method of use through indication.

Speaker Change #110: I mean, you have some formulation patents.

Speaker Change #110: Protect the product into the <unk> and we have several applications in that are looking to that are actually currently being prosecuted that if granted could extend that early 2000 <unk>. We also would be subject to patent term extension because.

Operator: We also would be subject to patent term extension because of the length of time that Cerepity has been in development, and that could also increase the patent life by up to five years, as you know, under those laws. And then, finally, under the market exclusivity benefits of orphan designations and those indications, we could get market exclusivity independent of the patent situation that extends seven to ten years, depending on the job.

Speaker Change #111: The length of time that through hepatitis business development and that could also increase the patent life.

Kristen Buck: Orven drug designation affords Lisata exemption from FDA user fees and provides extended market exclusivity, as well as other potential sponsored benefits. In just the first half of 2024, Sir Tepatide has not only been granted a pediatric investigation plan waiver by the EMA for the treatment of pancreatic cancer, but has also received an orphan designation and a rare pediatric disease designation for osteosarcoma in the United States. 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.

David Mazzo: And that could also increase the patent life by, you know, up to five years, as you know, under those laws. And then finally, under the market exclusivity benefits of orphan designation and those indications, we could get market exclusivity independent of the patent situation. That extends, you know, seven to ten years, depending on the geography. Okay, thank you for your use. Thank you.

Speaker Change #111: After five years as you know under those laws and then finally under the market exclusivity benefits of orphan designations in those indications, we could get market exclusivity independent of the patent situation that extends your 7% to 10 years, depending on the geography.

Speaker Change #112: Okay. Thanks, that's very useful thank you.

Speaker Change #111: Yes.

Operator: This concludes the question-and-answer session.

Speaker Change #111: This concludes the question and answer session I will now turn the call back to Dr. Mazzo for closing remarks.

David Mazzo: This concludes the question and answer session. I will now turn the call back to Dr. Mazzo for closing remarks.

David Mazzo: Thanks. Thank you. This concludes the question and answer session. I will now turn the call back to Dr. Mazzo for closing remarks. Well again, thank you to all who are participating today and for joining us on the call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on the achievements and progress of Lisata Therapeutics. We remain grateful for your continued interest and support. We wish you a very nice evening. This concludes today's conference call. Thank you for participating. You may now disconnect.

David Mazzo: I will now turn the call back to Dr. Mazzo for closing remarks. Thank you for all who are participating today and for joining us on the call. We look forward to speaking to you again during our next quarterly conference call and to continuing to provide updates on the achievements and progress of the Status therapeutics. We remain grateful for your continued interest and support.

David Mazzo: Thank you to all who are participating today and for joining us on the call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on the achievements and progress of Lisata Therapeutics. We remain grateful for your continued interest and support. We wish you a very nice evening.

Dr. Mazzo: Well again, thank you for all who are participating today.

Kristen Buck: This program is set to expire on September 30th, 2024, however our expectation and the expectation of many in the industry is that the program will be reauthorized. We will of course be monitoring those developments closely. A substantial benefit under the current rare pediatric disease designation program is receipt of a priority review voucher, often referred to as a golden ticket once the FDA approves the new drug application or NDA for the product and indication having received the designation.

Dr. Mazzo: Thanks for joining us on the call. We look forward to speaking with you again during our next quarterly conference call and to continuing to provide updates on the achievements and progress with Lacerta Therapeutics, we remain grateful for your continued interest and support we wish you a very nicely.

David Mazzo: We wish you a very nice evening.

Operator: This concludes today's conference call. Thank you for participating.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect.

Speaker Change #114: This concludes today's conference call. Thank you for participating you may now disconnect.

Operator: You may now disconnect. Thank you very much.

Yes.

Speaker Change #114: Sure.

Kristen 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 the sponsor or sold to another sponsor for their use. Priority review vouchers have sold for as much as $350 million US dollars historically and more recently have sold for $75 to $100 million.

Speaker Change #114: Okay.

Speaker Change #114: [music].

Speaker Change #114: Okay.

Speaker Change #114: [music].

Speaker Change #114: Okay.

Speaker Change #114: [music].

Kristen Buck: For example, the Ascend trial is a 158 patient double-blind, randomized placebo-controlled clinical trial, evaluating surtepatide, in combination with standard care gym cytobene and NAB-packletaxal chemotherapy, in patients with metastatic pancreatic ductal adenocarcinoma or MPDAC. The trial was being conducted at 25 sites in Australia and New Zealand led by the Australian Gastrointestinal Cancer's Trial Group, or AGITG, in collaboration with the NHMRC Clinical Trial Center at the University of Sydney.

Kristen Buck: With trial enrollment completed in the fourth quarter of 2023, we expect top-line data from the 95 patients assigned to Cohort A of the study to be reported in the fourth quarter of 2024, and the complete data set of all 158 patients from the study to be available by mid 2025.

Kristen Buck: We expect similar discussions with the FDA and the MA 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 3 clinical program in metastatic pancreatic cancer.

Kristen Buck: The bolster trial is our Phase 2A double-blind placebo-controlled multi-center randomized trial in the United States, evaluating sertepotide, in combination with standard of care in first-line colangio carcinoma. As we have reported recently, Lassada achieved complete enrollment in this study nearly six months ahead of plan, accelerating top-line data readout to mid 2025. Based on this rapid enrollment rate and the pressing need to improve treatment outcomes in patients that have progressed after first-line treatment, a second cohort of patients has been added to the bolster trial, evaluating subjects in second-line colangio carcinoma, and we expect to enroll the first patient by the fourth quarter of 2024.

Kristen Buck: Sendafox is a Phase 1B 2A open-label trial in the United States, evaluating sertepotide, in combination with neo-adjuvantful phyronox-based therapies in pancreatic, colon, and appendiceal cancers. The trial is completed enrollment in the pancreatic cohort and remains on track to complete enrollment in the remaining two cohorts by the end of 2024.

Kristen Buck: Chilu Pharmaceutical, the licensee of Certetetide in the Greater China Territory is also currently evaluating Certetetide in combination with Jim Cytobene and Nab Pakletaxle as a treatment for metastatic pancreatic cancer. During the 2023 ASCO annual meeting, Chilu Pharmaceutical presented the abstract sharing preliminary data from the study which corroborated previously reported findings from the Phase I B2A trial of Certetetetide plus Jim Cytobene and Nab Pakletaxle conducted in Australia in patients with pancreatic cancer.

Kristen Buck: Additionally, Chilu has begun treating patients in their Phase II placebo controlled trial and metastatic pancreatic cancer. The study is planned to take approximately 18 months to complete enrollment accrual and another 13 months for patient follow-up and data analysis and reporting.

Kristen Buck: In collaboration with our funding partner, Warp9, the I-Lista trial is a Phase I B2A randomized placebo controlled single-blind, single-center, safety, early efficacy, and pharmacodynamic trial in Australia. This three cohort study is evaluating Certetetetide in combination with the checkpoint inhibitor Dervalamab plus standard of care Jim Cytobene and Nab Pakletaxle chemotherapy versus Certetetetide in combination with standard of care alone versus standard of care alone in patients with locally advanced non-resectable pancreatic cancer. And enrollment completion is expected in the second half of 2024.

Kristen Buck: I go Lista, a Phase I B2A proof of concept safety and early efficacy study evaluating Certetetetide in combination with Nabalamab and Philphyrinox as a first-line treatment in locally advanced non-resectable gastroesophageal adenocarcinoma is pending initiation as a function of availability of funding by our partner, Warp9. The inspiration for this study actually comes from the findings recently published in the oncology and cancer case reports journal which details a patient with metastatic gastroesophageal adenocarcinoma to achieve a complete response when given Certetetetide in combination with standard of care, Philphyrinox, and Pemberlizimab.

Kristen Buck: The subject initially underwent months of standard of care treatments and only achieved a partial response. Upon the subsequent addition of Certetetide 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 complete response in February of 2023.

Kristen Buck: We hope to provide an update on timing related to the execution of the IgoLista study in common quarters.

Kristen Buck: A study of Certetetetide in combination with team azolamide in glioblastoma multi-form or GBM has been initiated with several patients already enrolled and treated. This study is designed as a phase 2A double-blind placebo controlled randomized proof-of-concept study evaluating Certetetetide when added to standard of care team azolamide versus team azolamide alone and matching Certetetide placebo in subjects with newly diagnosed GBM. 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 2-to-1 Certeppa-type plus standard of care versus placebo plus standard of care.

Kristen Buck: In combination with standard of care and patients with second-line metastatic pancreatic cancer, who have progressed on first-line philphyranox. As part of this study, we have engaged Haystack oncology to use their MRD technology to measure circulating tumor DNA levels at multiple time points in patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of Certeppa-type. We expect to enroll the first patient in this study by the first half of 2025.

Kristen Buck: On top of the previously described studies, we are exploring additional trials supporting our general development strategy. However, we remain steadfast in only starting trials that can be funded through 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 the investigators running these studies, Lisata has limited control and thus timelines and expectations may be subject to change.

Kristen Buck: That said, we are extremely grateful to the investigators and especially to the patients participating in Certeppa-type clinical trials around the world. For those of you who are 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.

David Mazzo: With that, I will now turn the call back to Dave. Thanks, Kristen. Overall, we remain optimistic about the potential of Certeppa-type to transform the lives of patients with cancer.

Operator: We look forward to sharing further updates on our progress throughout the year and with that operator, we're ready to take questions. As a reminder to ask a question, please press star 11 on your telephone. You would then hear an automated message advising that your hand is raised. Each listener will be permitted to ask one question at a time and will return to the queue for any additional questions.

Steve Brozak: Our first question, from the line of Steve Brozak, of WBB Securities. Hey, good afternoon and thanks for taking the questions. I have one specifically around, you know, congrats obviously on the unfortunate but quick enrollment. What kind of feedback did you get from the clinicians in terms of how quick it was? And obviously you opened up a second front as far as enrolling for additional patients. What kind of feedback have you gotten from the clinicians on, not just the demand, but the need in what patients, what patients we're, you know, looking for as far as this and I've got one follow up after that.

Steve Brozak: Thank you. Thanks, Steve. Appreciate you being on the call and thank you for the question. You know, the feedback that we received, and I should say that Kristen actually received directly throughout the enrollment of the first line, Colandrio Carson on the trial, was that there was a tremendous level of enthusiasm about the potential for the product. And even a, I would say, an assumption or a speculation that the product was doing something positive.

Steve Brozak: Now, Kristen, you know, reminded the investigators that the study was blinded, nobody knew, including them, who was receiving treatments and who wasn't. But their, their, their typical response was, yes, we, we understand. But we're seeing some of our patients do things respond in a way that's atypical of patients with Colandrio Carson on receiving, you know, chemotherapy. And so we really think that it must be due to the addition of certifitide and we're very excited about that.

Steve Brozak: No, and by the way, because we think something is happening in first line, there's an even greater need in second line, would you please consider opening up a second arm repulsed or in second line Colandrio Carson on because we believe that we can enroll that very rapidly as well because of the, the large need. And so based upon that type of feedback, we indeed did open the second line Colandrio Carson on the study.

Steve Brozak: And we hope that that will enroll as quickly as they have projected. Got it. Okay. And on the follow up, when, when you look at this kind of a response, and we obviously look at, you know, just as a reminder, what would basically standard of care be right now if unfortunately you didn't have this trial running? What would the standard care be to contrast that? And I'll jump back off the queue, please. Inspector, the queue.

David Mazzo: Sure, and I'll actually call on Kristen to jump in here. You know, you have to talk a little bit about standard of care for the Colandrio Carson on the indication. Thanks, Steve.

Kristen Buck: It's Kristen here. Yeah, the first line treatment for Colandrio carcinoma or bile duct tumor is actually gym cytobine, cisplatinin, and dermalamand. And the reason, you know, we designed the trial as such, we wanted to include that standard of care currently as one of the treatment arms with placebo, and add certified to that baseline standard of care regimen. You know, for patients, this is a pretty devastating disease. These patients, you know, in the first line, perhaps live 11 months overall survival median. And in the second line, unfortunately, they're, they meet their demise between four and six months. So we're hoping to make a meaningful impact. Thank you.

Sara Nik: Our next question comes from the line of Joseph Penn Guinness of H.C. Wainwright & Company. Hi, good afternoon.

Sara Nik: This is Sara on Spur Joe. I had a question actually on the two pharmaceuticals trial and for this case to an MPDAC, kind of wondering how much insight you actually get into the progress of the trial. So, if you can provide, if you have any insight into how enrollment is progressing, I know it's about 18 months to complete a cruel but do you have any insights into how many patients have been treated to date or any other updates you get along the way. Thank you.

David Mazzo: Hi, Sara. Thanks for calling in and thanks for your question. So, I think as Kristen's narrative indicated, Chilu is an independent company. It's a private company in China. So, they do not subject to the same rules of disclosure that public companies are. And as a result, they typically do not make any announcements about the progress of their clinical trials. They don't even announce first patient in last patient doubt or anything. They just wait until the trials are over and they make, you know, generally an announcement through the medium of a scientific presentation at a big meeting like ASCO GI or ASCO.

David Mazzo: So, as it relates to phase two product, all we know is that it initiated in the second quarter because they told us we have our joint steering committee meetings at least quarterly. And during that meeting, they told us they've initiated the phase two trial and that's when they projected the roughly 18 months for completed enrollment. We are waiting for our third quarter, JSC meeting to occur and they may or may not give us a hint as to what the trial enrollment is.

David Mazzo: But they would typically say things like we're on track, you know, all right. And at this early stage, I would imagine that they wouldn't say anything other than they're on track to meet their projected 18 month enrollment period. So, you know, we're a little bit blind to what's going on there, but the things go dramatically different from the projections that they would obviously let us know. Okay, that's helpful. Thank you. Thank you, Sarah.

Sara Nik: Thank you.

Will Hidell: Our next question comes from a line of well, Adele, a Brookline capital markets. Hey, thank you for taking the questions. I have a quick clarification question I might have missed. But the trial, the Stratovatoid and GBM, as of last quarter, I believe enrollment was, I think you had three patients enrolled and I might have missed this, but are there any updates on enrollment? Yeah, no, actually, thanks. Well, if we're calling in on the question, we don't really have any updates.

Will Hidell: You know, as you know, that trial is running in Estonia, typically this time of year in that part of Europe is a very, I would say, common vacation time. And so, our investigator, lead investigator has been away for the last 10 days. And we probably won't have a chance to touch base with them for another week or so. And hopefully, during our next call, we'll have an update on enrollment from Estonia and Latvia.

Will Hidell: But, you know, we do know that the site in Latvia are open. And we do hope that we'll see, and the improvement to our rather an increase in enrollment over the originally announced three of the next time we have a chance to chat. Okay, thank you. Thank you.

Peter Enderlin: Our next question comes from the line of Pete Enderlin of Mass Partners. Thank you. Hi, everybody. The congratulations on the strong progress in the enrollment, especially in conjunction with controlling expenses already effectively. My first question is a quick one, so I'll maybe count it as a half a question. And that is, do you have any estimate of the size of the pediatric population, patient population, and pancreatic cancer? I mean, we know orphan is less than 200,000, but I would think it's a lot less than that in the United States and in your boat. So do we have any numbers? Yeah, the answer is it's not significantly different from zero. Yeah. It's not a disease that's actually found in children, basically. Right.

David Mazzo: I'm not looking for, you know, we know that it helps in conjunction with that with paxle and, you know, there's other centers of care, but this is for new drugs. What's the outlook for that? So the simple answer to you two questions are yes and yes. As I said, or as Kristen actually said, the mechanism of action of throtepetide is agnostic to the modality of the companion anti-cancer agent. That's fairly fancy speak for saying that it doesn't matter what type of anti-cancer drug you use if you mix it with throtepetide, you should expect an improvement.

David Mazzo: And so we actually would expect that it could help for products that are currently approved as well as products that are under investigation, and we have in fact spoken to a number of companies who are studying their products for pediatric cancer and other solid tumors, and you know, have a ongoing dialogue to see if we can find a way to collaborate that gives both products, throtepetide and theirs, another shot on gold, but still fall within our strategic remit here of making sure that we can afford whatever we do. So Dave, does that mean that some of these companies have actually approached you because you don't necessarily know everything that's going on in these different cancer trials, and maybe have a drug that they're not that confident about, but they know that if it gets improved efficacy thanks to your drug that that would make the difference.

David Mazzo: Is there some of that kind of dialogue going on? Yes, that is some of that, and some of it is, of course, we scour the clinical trial roles constantly looking for products that, you know, for one reason or another are not behaving as positively as everyone hope, but that could benefit from a combination of throtepetide. Please. But okay, thank you very much. Sure. Thank you.

Robert Sassoon: Our next question comes from the line of Robert Sassoon of Water Tower Research. Our next question comes from Robert Sassoon of Water Tower, Water Tower Research. Please go ahead. Robert, are you there? You must be having connection difficulties. All right.

Operator: You can jump to the next question. Oh, there you are. Okay. Hello. Actually, I'm going to give Robert a chance to recieve if you could hit star one one again. Yeah, the line. And again, that star one one. And Robert, your line is open. Hello. Yes, there you are. Hello, Robert. Yeah, sorry. I was on mute, I think.

Robert Sassoon: Anyway, I don't wonder whether you could give us a sort of a rundown picture of your state of your intellectual property real estate. Sure. So we have we have a broad intellectual property portfolio that covers to tie from composition of matter through method of use, through indication and even some formulation type that they protect the product into the 2030s. And we have several applications in that are looking to that are actually currently being prosecuted that if granted, could extend that to the early 2040s.

Robert Sassoon: We also would be subject to patent term extension. Because of the length of time, that's where hepatitis been in development. And that could also increase the patent life by, you know, up to five years, as you know, under those laws. And then finally, under the market exclusivity benefits of orphan designation and those indications, we could get market exclusivity independent of the patent situation. That extends, you know, seven to 10 years, depending on the geography.

David Mazzo: Okay, thank you for your use. Thank you.

Operator: This concludes the question and answer session.

David Mazzo: I will now turn the call back to Dr. Mazzo for closing remarks. Thank you for all who are participating today and for joining us on the call. We look forward to speaking to you again during our next quarterly conference call and to continuing to provide updates on the achievements and progress of the status therapeutics. We remain grateful for your continued interest and support. We wish you a very nice evening.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Thank you very much.

Q2 2024 Lisata Therapeutics Inc Earnings Call & Business Update

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