Q2 2024 Lumos Pharma Inc Earnings Call

Speaker Change: Good afternoon and welcome to Lumos Pharma's second quarter 2024 financial results and clinical programs update call.

Operator: and Clinical Programs Update Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded.

Operator: Currently, all participants are in a listen-only mode. Later, we will conduct the question-and-answer session. And instructions will follow at that time. As a reminder, this conference call is being recorded.

Speaker Change: Currently all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time.

Lisa Miller: I want to turn the call over to Lisa Miller by President of Investor Relations.

Speaker Change: As a reminder, this conference call is being recorded. I will now turn the call over to Lisa Miller, Vice President of Investor Relations.

Lisa Miller: Thank you, operator.

Lisa Miller: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. Forward-looking statements made during this call can speak only as of the date hereof, and the company undertakes no obligation to update or revise such forward-looking statements.

Lisa Miller: Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal security laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC. A forward-looking statement made during this call can speak only as of the day hereof, and the company undertakes no obligation to update or provide support for the statements.

Lisa Miller: Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations.

Lisa Miller: Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with the SEC.

Lisa Miller: Forward-looking statements made during this call can speak only as of the date hereof and the company undertakes no obligation to update or revise the forward-looking statements.

Lisa Miller: Information presented on this call is contained in the press release. We issued this afternoon. And in our form, 10-Q and 8-K, which may be accessed from the Investors page of the loose from the website.

Lisa Miller: Information presented on this call is contained in the press release we issued this afternoon and in our Form 10-Q and 8-K, which may be accessed from the Investors Page of the Lumos Pharma website.

Lisa Miller: Speaking on today's call, we'll be Rick Hawkins, CEO and Chairman, John McEw, President and Chief Scientific Officer, and Laurie Lolley, Chief Financial Officer. Dr. Duke Ptuchuanan, our Chief Medical Officer, will also join the call for the question-and-answer section.

Lisa Miller: Taking on today's call will be Rick Hawkins, CEO and Chairman, John McKew, President and Chief Scientific Officer, and Lori Lawley, Chief Financial Officer. Dr. Duke Pitukcheewanont, our Chief Medical Officer, will also join the call for the question and answer session. It is now my pleasure to turn the call over to Rick for our opening remarks.

Speaker Change: Speaking on today's call will be Rick Hawkins, CEO and Chairman, John McKew, President and Chief Scientific Officer, and Lori Lawley, Chief Financial.

Speaker Change: Chief Financial Officer. Dr. Pitukcheewanont, our Chief Medical Officer, will also join the call for the question and answer section. It is now my pleasure to turn the call over to Rick for our opening remarks.

Rick Hawkins: It is now my pleasure to turn the call over to Rick for our opening remarks. Thank you, Lisa, and good afternoon, everyone. I'm pleased to be speaking with you today to provide an update on our progress advancing Room 201 as the first oral therapeutic from moderate pediatric growth on the deficiency or PGHD. During the second quarter, in recent weeks, we've made significant progress in advancing our plans for phase three pivot trial of Room 201 and PGHD. While in a very positive and productive end of phase two meeting with the FDA, we've nearly finalized our proposal for a phase three double-blinded placebo-controlled clinical trial with a 201 randomization and approximately 150 patients.

Richard Hawkins: Thank you, Lisa, and good afternoon, everyone. I'm pleased to be speaking with you today to provide an update on our progress advancing Lume 201 as the first oral therapeutic for moderate pediatric growth hormone deficiency, or PGHD. The FDA's input has been instrumental in shaping our proposed trial design, acknowledging Lin-201's unique mechanism as a growth hormone secretagogue and recognizing that a placebo-controlled clinical trial is an appropriate approach for Phase 3. We expect to finalize the design details in the fourth quarter.

Richard Hawkins: Additional time is required to complete the manufacturing process and create the placebo-matched materials necessary for use in the study, thereby extending our intended timeline to initiate phase three into the second quarter of 2025. And this extension also allows all of us to continue managing our cash resources crudely and extend our cash runway. Additionally, in today's press release, we announced that we have engaged Piper Sandler to explore all strategic opportunities to maximize shareholder value and advance the Loom 201 platform, which are regular, ongoing business development activities that generate significant interest in the global potential for Room 201 in multiple markets. Given this positive feedback, we feel it's the right time to formally engage Piper Sandler to ensure we're thoroughly exploring every potential transaction and opportunity that serves our shareholders' best interests.

Rick Hawkins: Thank you, Lisa, and good afternoon, everyone. I'm pleased to be speaking with you today to provide an update on our progress advancing LUMEN 201 as the first oral therapeutic for moderate pediatric growth hormone deficiency, or PGHD.

Rick Hawkins: During the second quarter and recent weeks, we've made significant progress in advancing our plans for a Phase 3 clinical trial of LUM201 and PGHD.

Rick Hawkins: All in a very positive and productive end of Phase 2 meeting with the FDA, we've nearly finalized our proposal for a Phase 3 double-blinded placebo-controlled clinical trial with a 2 to 1 randomization and approximately 150 patients.

Rick Hawkins: The FDA's input has been instrumental in shaping our proposed trial design, acknowledging to the once-unique mechanism as a growth hormone secretedog, and recognizing that a placebo-controlled clinical trial is an appropriate approach for phase three. We expect to finalize the design details in the fourth quarter. Prior to our meeting with the FDA, we had not developed plans for manufacturing a placebo to match our patented form of Room 201. Now, with the decision to move forward with a placebo-controlled phase three trial, additional time is required to complete the manufacturing process and create the placebo match materials necessary for use in the study.

Rick Hawkins: The FDA's input has been instrumental in shaping our proposed trial design.

Rick Hawkins: acknowledging Lin-201's unique mechanism as a growth hormone secretagogue and recognizing that a placebo-controlled clinical trial is an appropriate approach for Phase 3. We expect to finalize the design details in the fourth quarter.

Rick Hawkins: Prior to our meeting with the FDA, we had not developed plans for manufacturing a placebo to match our patented form of LUM201.

Rick Hawkins: Now, with the decision to move forward with a placebo-controlled phase 3 trial, additional time is required to complete the manufacturing process and create the placebo-matched materials necessary for use in the study.

Rick Hawkins: Consequently, for extending our intended timeline to initiate phase three into the second quarter of 2025, this extension also allows all of us to continue managing our cash resources quickly and extend our cash runway.

Rick Hawkins: Consequently, extending our intended timeline to initiate Phase 3 into the second quarter of 2025, and this extension also allows all of us to continue managing our cash resources crudely and extend our cash runway.

Rick Hawkins: High.

Rick Hawkins: Additionally, in today's press release, we announced that we have engaged Piper Sandler to explore all strategic opportunities to maximize shareholder value and advance the Lum201 platform. Our regular ongoing business development activities have generated significant interest in the global potential for Lum201 in multiple markets. Given this positive feedback, we pose the right time to formally engage Piper Sandler to ensure we're thoroughly exploring every potential transaction and opportunity that serves our shareholders' best interest. We're confident in Lum201's potential as the first world therapeutic in the expanding $5 billion global growth hormone market. We're going to continue to focus our efforts on optimizing value for all of our stakeholders.

Rick Hawkins: Additionally, in today's press release, we announced that we have engaged Piper Sandler to explore all strategic opportunities to maximize shareholder value and advance the Loom 201 platform.

Rick Hawkins: Our regular, ongoing business development activities have generated significant interest in the global potential for Lume 201 in multiple markets.

Rick Hawkins: Given this positive feedback, we feel it's the right time to formally engage Piper Sandler to ensure we're thoroughly exploring every potential transaction and opportunity that serves our shareholders' best interest.

Richard Hawkins: We're confident in Lume 201's potential as the first oral therapeutic in the expanding $5 billion global growth hormone market, and we're going to continue to focus our efforts on optimizing value for all of our stakeholders. In a moment, Don and Lori are going to provide more details on this and other measures we're implementing to ensure we're well prepared to successfully initiate this trial next year. In the second quarter, we're pleased to see new analyses of data from our Orgo 212 tool presented at ENDO 2024.

Speaker Change: We're confident in Lume 201's potential as the first oral therapeutic in the expanding five billion dollar global growth hormone market. We're going to continue to focus our efforts on optimizing value for all of our stakeholders.

Rick Hawkins: In a moment, Don and we're going to provide more details on this and other measures we're implementing to ensure we're well prepared to successfully initiate this trial next year. In the second quarter, we're pleased to see new analyses of data from our ORGO-2122 presented at the end of 2024. The data emphasized the significance of the pulsatility pattern and growth hormone secretion for the growth response from Lum201. They further illustrate Lum201's unique ability to restore natural pulsatile growth hormone secretion, achieving similar to injectable recombinant growth hormone with significantly less exposure to circulating growth hormone. These findings strongly support our plant placebo control phase 3 trial of Lum201 in modern GHD.

Speaker Change: In a moment, Don and Lori are going to provide more details on this and other measures we're implementing to ensure we're well prepared to successfully initiate this trial next year.

Speaker Change: In the second quarter, we're pleased to see new analyses of data from our Orgo 212 trial presented at ENDO 2024.

Richard Hawkins: The data emphasize the significance of the pulsatility pattern in growth hormone secretion for the growth response from LUM201. They further illustrate lympholog-1's unique ability to restore natural pulsatile growth hormone secretion, achieving a growth response similar to injectable recombinant growth hormone with significantly less exposure to circulating growth hormone. These findings strongly support our planned placebo-controlled Phase 3 trial of LUM201 in moderate PGHD. Top-line results from the Orobrook trial were presented at three major endocrinology conferences in May this year.

Speaker Change: The data emphasize the significance of the pulsatility pattern in growth hormone secretion for the growth response from LUM201.

Speaker Change: They further illustrate LIMP2L1's unique ability to restore natural pulsatile growth hormone secretion, achieving similar to injectable recombinant growth hormone with significantly less exposure to circulating growth hormone.

Speaker Change: These findings strongly support our planned placebo-controlled Phase 3 trial of LUM201 in moderate PGHD.

Rick Hawkins: The top line results from the ORGO trial were presented at three major endocrinology conferences and made this year. After Pediatric Endocrine Society meeting in Chicago, after Andrew Dover highlighted data showing that Lum201 had a dose of 1.6 mixed particular day that achieved annual and high velocity comparable to daily injectable growth hormone and GHD for the promising safety profile. Meanwhile, at the Growth Hormone Research Society and the European Congress of Endocrinology, Dr. Peter Clayton presented a detailed analysis of Lum201's effectiveness in restoring growth hormone secretion and increasing annualized high velocity and moderate GHD patients. The evolving data from the ORGO trials continued to attract significant interest from the global endocrinology community.

Speaker Change: Top-line results from the Orobrook trial were presented at three major endocrinology conferences in May this year.

Speaker Change: At the Pediatric Endocrine Society meeting in Chicago, Dr. Andrew Dauber highlighted data showing that LUM201, at a dose of 1.6 mg per kick a day, achieved annualized high velocity comparable to daily injectable growth hormone and PGHD.

Richard Hawkins: At the Growth Hormone Research Society and the European Congress on Endocrinology, Dr. Peter Clayton presented detailed analysis of LUM201's effectiveness in restoring growth hormone secretion and increasing annualized height velocity in moderate-PGSD patients. The evolving data from our Orgo trials continue to attract significant interest from the global endocrinology community, and we're encouraged by the growing enthusiasm from experts eager to participate in our phase three trial as we finalize our plans.

Speaker Change: and the Promising Safety Profile. Meanwhile...

Peter Clayton: At the Growth Hormone Research Society and the European Congress of Endocrinology, Dr. Peter Clayton presented detailed analysis of LUM201's effectiveness in restoring growth hormone secretion and increasing annualized height velocity in moderate PGSD patients.

Speaker Change: The evolving data from our oral growth trials continue to attract significant interest from the global endocrinology community and we're encouraged by the growing enthusiasm from experts eager to participate in our phase 3 trial as we finalize our plans.

Rick Hawkins: We're encouraged by the growing enthusiasm from experts eager to participate in our Phase 3 trial as we finalize our plans.

John McKew: Now I'm going to turn over to John McCube for more details on our engagement with the FDA and our Phase 3 plan, John. Thanks, Rick, and good morning and good afternoon, everyone. As Rick mentioned following our productive end of phase 2 meeting with the FDA, we have been diligently designing a placebo-controlled phase 3 registrational trial. Based on the FDA's recommendations and insights from our regulatory consultants, key opinion leaders, and statisticians, we have crafted a trial design aimed at maximizing the likelihood of success. The trial will involve approximately 150 patients at over 80 global centers, the 2-to-1 randomization ratio of LUM-2-1 to placebo. One group will receive LUM-2-1 for 12 months, while the other group will start with a placebo for six months and then cross over to LUM-2-1 for the remaining six months.

John McKew: Now I'm going to turn it over to John McKew for more details on our engagement with the FDA and our Phase 3 planning. John ?

John McKew: Thanks, Rick, and good morning and good afternoon, everyone. As Rick mentioned, following our productive end of Phase 2 meeting with the FDA, we have been diligently designing a placebo-controlled Phase 3 registrational trial. Based on the FDA's recommendations and insights from our regulatory consultants, key opinion leaders, and statisticians, we have crafted a trial design aimed at maximizing the likelihood of success. This trial will involve approximately 150 patients at over 80 global centers.

John McKew: Thanks Rick and good morning and good afternoon everyone. As Rick mentioned, following our productive end of Phase 2 meeting with the FDA, we have been diligently designing a placebo-controlled Phase 3 registrational trial.

Speaker Change: Based on the FDA's recommendations and insights from our regulatory consultants, key opinion leaders and statisticians, we have crafted a trial design aimed at maximizing the likelihood of success.

Speaker Change: This trial will involve approximately 150 patients at over 80 global centers. The 2 to 1 randomization ratio of LUM201 to placebo. One group will receive LUM201 for 12 months while the other group will start with a placebo for 6 months and then cross over to LUM201 for the remaining 6 months.

John McKew: The two-to-one randomization ratio of LUM201 to placebo. One group will receive LUM201 for 12 months, while the other will start with a placebo for six months and then cross over to LUM201 for the remaining six. All participants must meet our PEM-positive criteria during the screening process before randomization.

John McKew: All participants must need our pen-positive criteria during the screening process before randomization. To say three trial aims to achieve two key strategic objectives, the first is to provide the FDA with a comprehensive data from a blinded, controlled trial to support the evaluation approved with LUM-2-1, and the second is to ensure that all participants receive LUM-2-1 at some point during the study, enhancing its appeal to both patients and physicians for enrollment. The study will have two primary endpoints. The first would be to demonstrate the superiority of LUM-2-1 and annualized high velocity compared to the growth on placebo.

Speaker Change: All participants must meet our PEM-positive criteria during the screening process before randomization.

John McKew: This phase three trial aims to achieve two key strategic objectives. The first is to provide the FDA with comprehensive data from a blinded, controlled trial to support the evaluation and approval of LUM201. And the second is to ensure that all participants receive LUM201 at some point during the study, enhancing its appeal to both patients and physicians for enrollment. The study will have two co-primary endpoints. Our first objective would be to demonstrate the superiority of LUM201 in annualized height velocity compared to growth on placebo.

John McKew: Second, co-primary would be to ensure that the AHC of LUM201 has a lower bound of the 95% confidence interval above 6.7 centimeters per year, which is the minimal clinically meaningful AHV agreed upon with the FDA. Following the 12-month treatment period, all participants will have the option to transition into a long-term safety extension, receiving room-to-home treatment for up to three years.

Speaker Change: This Phase 3 trial aims to achieve two key strategic objectives.

Speaker Change: The first is to provide the FDA with it.

Speaker Change: comprehensive data from a blinded, controlled trial to support the evaluation and approval of LUM201, and the second is to ensure that all participants receive LUM201 at some point during the study, enhancing its appeal to both patients and physicians for enrollment.

Speaker Change: The study will have two co-primary endpoints.

Speaker Change: The first would be to demonstrate the superiority of Lume 201 in annualized height velocity compared to the growth on placebo.

John McKew: The second co-primer would be to ensure that the HD of LUM-2-1 has a lower bound of the 95% confidence interval above 6.7 centimeters per year, which is a clinically meaningful HD agreed upon with the FDA. Following the 12-month treatment period, all participants will have the option to transition into a long-term safety extension, receiving LUM-2-1 treatment for up to three years. We believe this extension will be a compelling feature for enrollment and will help fulfill FDA's requirements for longer-term exposure. We are confident that the trial is sufficiently powered to achieve the two co-primer endpoints. We are currently finalizing the design proposal and expect a secure final agreement with the FDA in the fourth quarter.

Speaker Change: Second co-primary would be to ensure that the AHC of Lume 201 has a lower bound of the 95% confidence interval above 6.7 centimeters per year.

Speaker Change: which is the minimal, clinically meaningful AHV agreed upon with the FDA. Following the 12-month treatment period, all participants will have the option to transition into a long-term safety extension, receiving wound-to-arm treatment for up to three years.

John McKew: We believe this extension will be a compelling feature for enrollment and will help fulfill FDA's requirements for longer-term exposure. We are confident that the trial is sufficiently powered to achieve the two co-primary endpoints. We are currently finalizing the design proposal and expect a secure final agreement with the FDA in the fourth quarter. A key component of the trial was the manufacturing of the placebo material, which we began after our end of Phase 2 meeting with the FDA.

Speaker Change: We believe this extension will be a compelling feature for enrollment and will help fulfill FDA's requirements for longer-term exposure.

Speaker Change: We are confident that the trial is sufficiently powered to achieve the two co-primary endpoints. We are currently finalizing the design proposal and expect a secure final agreement with the FDA in the fourth quarter.

John McKew: A key component of the trial is the manufacturing of the placebo material, which we began after the end of phase two meeting with the FDA. As Rick mentioned, the placebo needs to be a capsule filled with many tablets that exactly match the presentation of active LUM-2-1 capsules. Additionally, we must establish all standard stability data for this newly-created placebo, although we began work on these elements promptly. Producing the initial batches that met these specifications took longer than anticipated. Consequently, we chose to postpone other preparatory steps for trial initiations to manage our cash reserves effectively. I believe this is a burden use of resources and expect to be fully prepared to launch phase three in the second quarter of 2025.

Speaker Change: A key component of the trial is the manufacturing of the placebo material, which we began after end of Phase 2 meeting with the FDA. As Rick mentioned, the placebo needs to be a capsule filled with mini tablets that exactly match the presentation of active Lube 201 capsules.

John McKew: As Rick mentioned, the placebo needs to be a capsule filled with many tablets that exactly match the presentation of the active Lube 201 capsules. Additionally, we must establish all standard stability data for this newly created placebo. Although we began work on these elements promptly, producing the initial batches that met these specifications took longer than anticipated. Consequently, we chose to postpone other preparatory steps for trial initiations to manage our cash reserves effectively. I believe this is a sensible use of resources and expect to be fully prepared to launch Phase 3 in the second quarter of 2025.

Rick Hawkins: Additionally, we must establish all standard stability data for this newly created placebo. Although we began work on these elements promptly, producing the initial batches that met these specifications took longer than anticipated.

Rick Hawkins: Consequently, we chose to postpone other preparatory steps for trial initiations to manage our cash reserves effectively.

Rick Hawkins: I believe this is a pertinent use of resources and expect to be fully prepared to launch Phase 3 in the second quarter of 2025. With the careful attention given to the trial design, we are confident in our ability to enroll patients in this pivotal trial in a timely manner.

John McKew: With the careful attention given to the trial design, we are confident in our ability to enroll patients in this pivotal trial in a timely manner.

John McKew: With the careful attention given to the trial design, we are confident in our ability to enroll patients in this pivotal trial in a timely manner. With that, I'll turn it over to Lori for a review of our financial results for the second quarter.

Lori Lawley: With that, I will turn it over to Laurie for review of our financial results for the second quarter. Thank you, John. We ended the quarter on June 30, 2024, with cash, cash equivalence, and short-term investment totaling $16.8 million, as compared to $36 million on December 31, 2023.

Rick Hawkins: With that, I'll turn it over to Lori for a review of our financial results for the second quarter.

Lori Lawley: We ended the quarter on June 30th, 2024 with cash, cash equivalents, and short-term investments totaling $16.8 million as compared to $36 million on December 31st, 2023. As Rick and John have discussed, we are managing our cash resources conservatively. By extending the initiation date of our phase three trial into the second quarter of 2025, we have also extended our cash runway into the first quarter of next year. We will continue to manage our resources carefully and work with Piper Sandler to explore our opportunities to ensure we are well prepared to launch the trial effectively when the time is right.

Lori Lawley: Thank you, John .

Lori Lawley: We ended the quarter on June 30, 2024 with cash-to-cash equivalents and short-term investments totaling $16.8 million, as compared to $36 million on December 31, 2023.

Lori Lawley: As Rick and John have discussed, we are managing our cash resources conservatively by extending the initiation date of our phase three trial into the second quarter of 2025. We have also extended our cash runway through into the first quarter of next year. We will continue to manage our resources carefully and work with Piper Sandler to explore our opportunities to ensure we are well prepared to launch the trial effectively when the time is right. Research and development expenses for the quarter of 4.6 million, a decrease of 1.4 million for the quarter ended June 30th, 2024, compared to the same period in 2023.

Lori Lawley: As Rick and John have discussed, we are managing our cash resources conservatively. By extending the initiation date of our Phase III trial into the second quarter of 2025, we have also extended our cash runway into the first quarter of next year.

Speaker Change: We will continue to manage our resources carefully and work with Piper Sandler to explore our opportunities to ensure we are well prepared to launch the trial effectively when the time is right.

Lori Lawley: Research and Development expenses for the quarter were $4.6 million, a decrease of $1.4 million for the quarter ended June 30, 2024, compared to the same period in 2023, primarily due to decreases of $1.1 million in contract manufacturing expenses, $0.3 million in personnel-related expenses, and $0.2 million in clinical trial expenses offset by an increase of $0.2 million in consulting expenses. General and administrative expenses for the quarter were $3.7 million, a decrease of $0.5 million compared to the same period in 2023, primarily due to decreases of $0.2 million in personnel-related expenses, $0.1 million in travel, $0.1 million in consulting, and $0.1 million in other expenses.

Speaker Change: Research and development expenses for the quarter were $4.6 million, a decrease of $1.4 million for the quarter ended June 30, 2024, compared to the same period in 2023.

Lori Lawley: Primarily due to decreases of 1.1 million in contract manufacturing expenses, 1.3 million in personnel related expenses, 1.2 million in clinical trial expenses, offset by an increase of 1.2 million in consulting expenses. General and administrative expenses for the quarter were 3.7 million, a decrease of 0.5 million compared to the same period in 2023, primarily due to decreases of 0.2 million in personnel related expenses, 0.1 million in travel, 0.1 million in consulting, and 0.1 million in other expenses. And that loss for the quarter ended June 30th, 2024, was 7.6 million compared to that loss of 8.9 million for the same period in 2023.

Speaker Change: primarily due to decreases of $1.1 million in contract manufacturing expenses, $0.3 million in personnel-related expenses, and $0.2 million in clinical trial expenses offset by an increase of $0.2 million in consulting expenses.

Lori Lawley: General and administrative expenses for the quarter were $3.7 million, a decrease of $0.5 million compared to the same period in 2023, primarily due to decreases of $0.2 million in personnel-related expenses, $0.1 million in travel, $0.1 million in consulting, and $0.1 million in other expenses.

Loomis-Varma: The net loss for the quarter ended June 30, 2024 with $7.6 million, compared to a net loss of $8.9 million for the same period in 2023. Lumos Pharma ended Q2 2024 with $8,123,186 outstanding.

Lori Lawley: Lumos Pharma ended 2-2, 2024 with 8,123,186 years outstanding.

Rick Hawkins: So that I will now turn it over to Rick for his closing remarks. Thank you, Lori and John. And, as we mentioned at the start of the call, it's been an exciting and productive period for Lumos. Again, we're thrilled by the outcome of the end of the phase to the meeting with the FDA. In recognition that Lum 201 is not another growth hormone mnemetic, the FDA guidance supporting a placebo control trial, we believe has significantly de-risked our program. We're progressing to initiate a phase three registration trial and achieving our goal of establishing Lum 201 as the first oral therapeutic capable of transforming the global growth hormone market, which has been dominated by injectable products for nearly 40 years.

Speaker Change: With that, I will now turn it over to Rick for his closing remarks.

Rick Hawkins: Thank You Lori and John and as we mentioned at the start of the call it's been an exciting and productive period for Lumos.

Rick Hawkins: Again, we're thrilled by the outcome of the end of the Phase II meeting with the FDA. In recognition that LUM201 is not another growth hormone mimetic, the FDA's guidance supporting a placebo-controlled trial, we believe has significantly de-risked our program.

Lori Lawley: We're progressing toward initiating a phase three registrational trial and achieving our goal of establishing Mutual One as the first oral therapeutic capable of transforming the global growth hormone market, which has been dominated by injectable products for nearly 40 years.

Rick Hawkins: We're progressing toward initiating a Phase III Registrational Trial and achieving our goal of establishing Mutual One as the first oral therapeutic capable of transforming the global growth hormone market.

Rick Hawkins: which has been dominated by injectable products for nearly 40 years.

Rick Hawkins: We anticipate some very exciting developments throughout this year and look forward to keeping you informed about our progress.

Rick Hawkins: We anticipate some very exciting developments throughout this year and look forward to keeping you informed about our progress. Thank you all very much and operator, we're ready to take questions.

Operator: Thank you all very much, and operator, we're ready to take questions.

Operator: We will now begin the question and answer session. To ask the question, you may press star, then wanting a telephone keypad. If using a speaker phone, please pick up your hands up before pressing the keys.

Operator: To ask a question, you may press star then 1 on your telephone keypad. Our first question will come from Catherine Novack with Jones Trading.

Speaker Change: We will now begin the question and answer session.

Speaker Change: To ask a question, you may press star then 1 on your telephone keypad.

Catherine Novack: To withdraw your question, please press star, then two. At this time, we'll pause momentarily to assemble our roster. Our first question will come from Katherine Novak with Jones Trading. You may not go ahead.

Speaker Change: If you're using a speakerphone, please pick up your handset before pressing the keys.

Speaker Change: To withdraw your question, please press star then 2.

Speaker Change: At this time, we'll pause momentarily to assemble our roster.

Speaker Change: Our first question will come from Catherine Novack with Jones Trading. You may now go ahead.

Catherine Novack: Hey, good afternoon, guys. You know, it's exciting that you're able to get the phase three trial design nailed down with the FDA, but I wanted to ask about your expectations for enrollment dynamics. How long is it going to take for you to enroll 150 patients study? I'm given that this is a 12-month study.

Catherine Novack: Hey, good afternoon, guys. I wanted to ask about, you know, your expectations for enrollment dynamics. How long is it going to take for you to enroll 150 patients? study, you know, and given that this is a 12-month study.

Catherine Novak: Hey, good afternoon, guys.

Catherine Novak: You know, it's exciting that you're able to get the phase 3 trial design nailed down with the FDA, but...

Speaker Change: I wanted to ask about you know your expectations for enrollment dynamics. How long is it going to take for you to enroll 150 patients?

Speaker Change: study, and given that it is a 12-month study,

Catherine Novack: Should we not be expecting data until late 2026, 2027? When are we going to see updates from this?

Speaker Change: Should we not be expecting data until late 2026, 2027? When are we going to see updates from this?

Operator: So, Duke, will you answer that question? And recall Duke is our chief medical officer in pediatric endocrinology. Thank you.

Duke Pitukcheewanont: So, we answer that question and recall Duke is our Chief Medical Officer in the pediatric endocrinologist. Thank you. Thank you, Katherine. That's a good question, right? So, one we have that's right, you know, decide placebo control trial. We have been looking to diligently about, you know, where the site might be. So, as you know, this type of placebo control trial, we want to make sure now to meet the time live 15 to 18 months like what we plan. We do believe, and we can get that pass in that duration complete.

Speaker Change: So Duke, will you answer that question and recall Duke is our chief medical officer and he's a pediatric endocrinologist.

Pisit Pitukcheewanont: That's a good question, right? So, when we have the trial, you know, the placebo-controlled trial, we have been looking diligently at, you know, where the site might be. So, as you know, this type of placebo-controlled trial, we want to make sure now to meet the timeline of 15 to 18 months, like what we planned. We do believe and are confident we can get that task done within that duration. What we plan to do is to try to enroll the patient in different continents, especially Latin America and Asia and Southeastern Europe. In those areas, we have limited access to growth hormone.

Pisit Pitukcheewanont: Thank you. Thank you, Catherine.

Duke: Thank you. Thank you, Catherine. That's a good question, right?

Duke: So when we have the trial, you know, the placebo-controlled trial, we have been looking diligently about, you know, where the site might be. So as you know, this type of placebo-controlled trial, we want to make sure now to meet the timeline 15 to 18 months like what we planned. We do believe and be confident we can get that task in that duration complete. What we plan to do is that we try to enroll the patient in different continents.

Duke Pitukcheewanont: What we plan to do is that we try to enroll the patient in different continents, especially if we go including Latin America and Asia and South Eastern Europe. In those areas, we have limited access to growth hormone. And we do believe that by includes some of those area, we will be able to enroll those patients. Not to mention when we announced the placebo control trial, the last year earning call, we have influx of interest of the physician who interest to be part of our face tree. We have more than sight that we need. So, we expect 150 subject, 80 to 100 patient.

Speaker Change: especially if we go including Latin America and Asia and Southeastern Europe . In those areas, we have limited access to growth hormones.

Pisit Pitukcheewanont: And we do believe that by including some of those areas, we will be able to enroll those patients. Not to mention, when we announced the placebo-controlled trial on the last year's earnings call, we had an influx of interest from physicians who were interested to be part of our phase three. We have more than one site that we need. So, with expected 150 subjects, 80 to 100 patients, and we do believe that with 15 to 18 month enrollment, we can achieve that pretty quickly.

Speaker Change: and we do believe that by including some of those areas.

Speaker Change: we will be able to enroll those patients. Not to mention, when we announced the placebo-controlled trial, the last year earning call, we have influx of interest.

Speaker Change: of the physician who interest to be part of a phase 3. We have more than site that we need, so we expect that 150 subjects, 80 to 100 patients, and we do believe that with 15 to 18 month enrollment, we can achieve that pretty easily.

Duke Pitukcheewanont: And we do believe that with 15 to 18 month enrollment, we can achieve that pretty easily. Absolutely.

Catherine Novack: Got it.

Catherine Novack: What is another question? Sorry. Okay.

Speaker Change: got it is that and what is another

Rick Hawkins: And then sort of a strategic thought, you know, assuming you are able to secure additional financing, are there other opportunities these you could explore in the meantime to compensate for a data catalyst, or data shadow from PGHD? Well, Catherine, we are completely focused on PGHD, obviously. Yes, there are other indications that are out there for us to explore, but we're going to do, you know, a proven use of our capital to focus on where we're going to get across the finish line first.

Catherine Novack: sort of. Strategic thought: assuming you are able to secure additional financing, are there other opportunities you could explore in the meantime to compensate for a data shadow from PGHD?

Speaker Change: Sorry. Okay, and then...

Speaker Change: sort of a

Speaker Change: strategic thought, you know, assuming you are able to secure additional financing, are there other opportunities you could explore in the meantime to compensate for a data catalyst or data shadow from PGHD?

Richard Hawkins: Well, Catherine, we're completely focused on PGHD, obviously. Yes, there are other indications that are out there for us to explore. But we're going to do, you know, a prudent use of our capital to focus on where we're going to get across the finish line first. And I don't know, Lori, if you have any additional things you want to add to that.

Speaker Change: Well, Catherine, we're completely focused on PGHD, obviously. Yes, there are other indications that are out there for us to explore, but we're going to do a prudent use of our capital to focus on where we're going to get across the finish line first.

Lori Lawley: And I don't know, Lori, if you have any additional thing you want to add to that. No, I think you covered it well, Rick. I think, as we suggested, our goal is to manage cash conservatively and ensure that we are extending our runway to support operations and evaluate all opportunities at hand.

Speaker Change: and I don't know Lori if you have any additional thing you want to add to that.

Lori Lawley: I think you covered it well, Rick. As we suggested, our goal is to manage cash conservatively and ensure that we are extending our runway to support operations and evaluate all opportunities at hand.

Lori Lawley: I think you covered it well Rick. I think as we suggested our goal is to manage cash conservatively and ensure that we are extending our runway to support operations and evaluate all opportunities at hand.

Catherine Novack: Got it.

Catherine Novack: Got it. Thanks, guys.

Catherine Novack: Thanks, guys. Thank you, Catherine.

Operator: Thank you, Catherine.

Lori Lawley: Got it. Thanks, guys.

Leland Gertel: Our next question will come from Leland Gertel with Oppenheimer. You may now go ahead. Hey, good afternoon. Thanks for taking our questions. Just just wanted to ask Rick, sounded from your commentary around the the potential goals with the strategic, you know, opportunities that you could be looking at, but maybe XUS deals for them to a one and then initial monies from those deals could help fund your registration file. Is that a reasonable scenario? Thanks.

Leland Gershell: Our next question will come from Leland Gershell on Oppenheimer.

Catherine Novak: Thank you, Catherine.

Speaker Change: Our next question will come from Leland Gershell with Oppenheimer.

Leland Gershel: You may now go ahead. Hey, good afternoon. Thanks for taking our questions. I just wanted to ask, Rick, it sounded from your commentary around the

Speaker Change: the potential goals with the

Rick Hawkins: strategic, you know, opportunities that you could be looking at what may be Ex-U.S.

Leland Gershell: deals for Loom 201, and then the initial monies from those deals could help fund your registration file. Is that a reasonable scenario? Thank you.

Speaker Change: deals for LUM201 and then initial monies from those deals could help fund your registration file. Is that a reasonable scenario?

Rick Hawkins: Yeah, it's reasonable, but you have to remember, Leland, you know, on a regular basis, our business development folks have been generating a significant amount of interest on, you know, a global potential of them to a one in multiple markets. And we've gotten a lot of positive feedback. And as a result, we've felt it's probably the right time to engage an investment banker to make sure that we explore every one of these opportunities and any kind of potential transaction or opportunity that really serves all of our shareholders best. So, as a result, I think it's easy to say we've got a lot of different directions we can go.

Rick Hawkins: It's reasonable, but you have to remember, Leland, you know, on a regular basis, our business development folks have been generating a significant amount of interest on, you know, global potential of Lume 201 in multiple markets.

Richard Hawkins: And we've gotten a lot of positive feedback. And as a result, we felt it was probably the right time to engage an investment banker to make sure that we explore every one of these opportunities and any kind of potential transaction or opportunity that really serves all of our shareholders best. So, as a result, I think it's easy to say we have a lot of different directions we can go.

Rick Hawkins: and we've gotten a lot of positive feedback.

Rick Hawkins: And as a result, we felt it's probably the right time to engage an investment banker to make sure that we explore every one of these opportunities and any kind of potential transaction or opportunity that really serves all of our shareholders best.

Rick Hawkins: So...

Rick Hawkins: As a result, I think it's easy to say, we're...

Rick Hawkins: We're in active discussions with not just investors, but, as you pointed out, the strategics have been interested for quite some time, both for maybe either global and also their regional players. But we're going to really choose the right deal or combination deals that provide just the highest value to our shareholders at the lowest cost of capital that we can. Now, I can tell you, you know, we're as a phase three rate asset in a $5 billion market that we offer some really significant advantage, not just the fact oral delivery, but unique mechanism of action. I think we're feeling pretty good about our position right now.

Richard Hawkins: We're in active discussions with not just investors, but, as you pointed out, strategics have been interested for quite some time, both for maybe, you know, either global or also their regional players. But we're going to really choose the right deal or combination of deals that provide just the highest value to our shareholders at the lowest cost of capital that we can. Now, I can tell you, you know, we're a phase three ready asset in a $5 billion market that we offer some really significant advantages, not just the fact of oral delivery but a unique mechanism of action. I think we're feeling pretty good about our position right now.

Speaker Change: got a lot of different directions we can go. We're in active discussions with not just investors, but as you pointed out, strategics have been interested for quite some time, both for maybe a, you know, either global and also their regional players.

Speaker Change: But we're going to really choose the right deal or combination of deals that provide just the highest value to our shareholders at the lowest cost of capital that we can.

Speaker Change: Now, I can tell you, you know,

Speaker Change: And we're as a phase three ready asset in a $5 billion market that we offer some really significant advantages, not just the fact oral delivery, but a unique method of action. I think we're feeling pretty good about our position right now.

Leland Gertel: Okay, thanks, Patelple.

Richard Hawkins: Okay, that's helpful. And then I just wanted to ask, I believe you have an ongoing study on the academic side of non-alcoholic fatty liver. Just wanted to see if there's any update you can provide there.

Rick Hawkins: And then, just wanted to ask, I believe you have an ongoing study on the academic side in non-alcoholic fatty liver. Just wanted to see if there's any update you can provide there. Thank you. Not much of an update except to say that the study is progressing and not outgoing fatty liver disease with our clinician at MGH. And, you know, as you know, I think we have a potential in the cardiovascular and the combination product. And we have some very interesting data that tells us we should spend more time there. And I think this study will also help us get to the next stage.

Speaker Change: Okay, that's helpful. And then just wanted to ask, I believe you have an ongoing study on the academic side in non-alcoholic fatty liver. Just wanted to see if there's any update you can provide there. Thank you.

Richard Hawkins: Not much of an update except to say that the study is progressing in non-alcoholic fatty liver disease with our clinician at MGH. And, you know, as you know, I think we have potential in the cardiometabolic space as a combination product. And we have some very interesting data that tells us we should spend more time there. And I think this study will also help us get to the next stage. Great. Terrific. Thanks very much.

Speaker Change: Not much of an update except to say that that the study is progressing in non-alcoholic fatty liver disease with our clinician at MGH.

Speaker Change: And as you know, I think we have a potential in the cardiometabolic space as a combination product.

Speaker Change: And we have some very interesting data that tells us we should spend more time there. And I think this study will also help us get to the next stage.

Rick Hawkins: Great.

Leland Gertel: Perfect. Thanks very much for the other color.

Speaker Change: Great. Terrific. Thanks very much for for the edit color.

Charles Duncan: Our next question will come from Charles Duncan with Cancer for Children. You may now go ahead.

Operator: Our next question will come from Charles Duncan with Cancer Fitzgerald. You may now go.

Speaker Change: Our next question will come from Charles Duncan with Cancer Fitzgerald. You may now go ahead.

Charles Duncan: Good afternoon, Rick and team. Thanks for taking our question. And let's see, I guess congratulations on the recent end of Phase Two meeting. I guess we've talked about that a little bit in the past, but I wanted to ask you a couple of more questions about that. Do you plan or are you contemplating in the interim review to look at conditional powers? Is there any natural coupling in which you may take a look at, you know, the patients enrolled and what, you know, kind of rates you're seeing in terms of annual height change, even just on a blinded basis.

Charles Duncan: Good afternoon, Rick and team. Thanks for taking our question. And let's see, congratulations on the recent end of Phase 2 meeting. I guess we've talked about that a little bit in the past, but I wanted to ask you a couple of more questions about that. Do you plan or are you contemplating an interim review to look at conditional power? Is there any natural cut point at which you may take a look at the patients enrolled and what kind of rates you're seeing in terms of annual height change? Even on a blinded basis, is there any news flow during the conduct of the trial that you could point to?

Charles Duncan: Good afternoon, Rick and team. Thanks for taking our question.

Charles Duncan: And let's see, I guess congratulations on the recent end of Phase 2 meeting. I guess we've talked about that a little bit in the past, but I wanted to ask you a couple of questions.

Speaker Change: More questions about that. Do you plan or are you contemplating an interim review to look at conditional power? Is there any natural cut point in which you may take a look at the patients enrolled and what...

Speaker Change: You know, kind of rates you're seeing in terms of annual height change, even just on a blinded basis. Is there any news flow during the conduct of the trial that you could point to?

Charles Duncan: Is there any news flow during the conduct of the trial that you could point to?

John McKew: John, do you want to answer that question? Of course.

John McKew: John, do you want to answer that question?

Speaker Change: John , do you want to answer that question?

John McKew: Hi, Charles. No, we do not plan to take an interim peak. Not a not a great idea because the phase three study, even in a blinded sense, so we will keep the data. Here's we can go forward.

John McKew: Hi Charles. No, we do not plan to take an interim peak. Not a great idea for the phase three study, even in a blinded sense. So we will keep the data as clear as we can going forward.

Speaker Change: [inaudible]

Speaker Change: Hi Charles. No, we do not plan to take an interim peak. Not a great idea for the phase 3 study, even in a blinded sense, so we will keep the data here as we can going forward.

John McKew: Okay, appreciate the rigor. The other question that I had with regard to operationalizing that protocol, I get what you're saying in terms of manufacturing the placebo because that was a new and, you know, in many ways positive twist to the plan. But I'm kind of wondering between now and second quarter, what are some of the rate limiting steps? Is it possible that your second quarter, you know, goal is not June? It's maybe April or help us understand the path to getting this trial underway.

Charles Duncan: Okay, I appreciate the rigor. The other question that I had with regard to operationalizing...

Speaker Change: I appreciate the rigor. The other question that I had with regard to operationalizing

Speaker Change: I get what you're saying in terms of manufacturing the placebo because that was a new and in many ways positive twist.

Speaker Change: to the plan, but I'm kind of wondering between now and second quarter, what are some of the rate limiting steps? Is it possible that your second quarter...

Speaker Change: You know, goal is not June , it's maybe April , or help us understand the path to getting this trial underway.

John McKew: John, I want you to answer that question, too.

Rick Hawkins: John, I want you to answer that question too. So while we are, you know, finalizing the protocol with the FDA, we are doing quite a bit of prework right now. We are looking at sites identifying investigators; you know, identifying the best regions to work at finalizing our placebo work.

Speaker Change: John , I want you to answer that question too.

John McKew: So while we are finalizing the protocol with the FDA, we are doing quite a bit of pre-work right now. We are looking at sites, identifying investigators, identifying the best regions to work in, finalizing our work, right, and as we transition to having an FDA-approved protocol towards the end of the year in Q4. Then we start the regulatory outreach for all the ex-U.S. regulators. We go to the EMA, we go to some of the other regions.

Speaker Change: So while we are, you know, finalizing the

Speaker Change: protocol with the FDA, we are doing quite a bit of pre-work right now. We are looking at sites, identifying investigators, you know, identifying the best regions to work at, finalizing our placebo work, right? And as we transition to having an FDA approved

Rick Hawkins: Right. And as we transition to having an FDA approved. Drought a call towards the end of the year in Q4. Then we start the regulatory outreach out for all the XUS regulators. We go to the EMA; we go to some of the other regions. And then that starts the process of negotiating contracts and budgets with each one of the 80 sites that we intend to have in the Phase 3 trial. So I think there really is quite a bit of work for us to do after the FDA finalizes the design with us that will take us that period of time.

Speaker Change: protocol towards the end of the year in Q4. Then we start the regulatory reach out for all the ex-U.S.

John McKew: And then that starts the process of us negotiating contracts and budgets with each one of the 80 plus sites that we intend to have in the phase 3 trial. So I think there really is quite a bit of work for us to do after the FDA finalizes the design with us that will take us that period of time. You know, Q2 is, you know, three months long, so we'll be in that window. I don't have any more precise estimates for you.

Speaker Change: regulators. We go to the EMA, we go to some of the other regions, and then that starts the process of us negotiating contracts and and budgets with each one of the 80.

Speaker Change: of sites that we intend to have in the phase 3 trial.

Speaker Change: So I think there really is quite a bit of work for us to do after the FDA finalizes the design with us that will take us that period of time.

Rick Hawkins: Q2 is three months long. So we'll be in that window. I don't have any more precise estimates for each person.

Speaker Change: T2 is, you know, three months long, so we'll be in that window. I don't have any more precise estimates for each of those.

Charles Duncan: Okay, and then with regard to the FDA finalizing the protocol, if you will, as you just mentioned, are there any outstanding issues? Do you see this as a Gantt chart thing, or do you believe there are points of, you know, call it debate, that you really want to get their input on? At this point, do you have full alignment?

John McKew: Okay. And then, with regard to the FDA finalizing the protocol, if you will, as you just mentioned, are there any outstanding issues? Do you see this as a Gantt chart thing? Or do you believe there are points of, you know, call it debate that you really want to get their input on? At this point, do you have full alignment?

Speaker Change: Okay, and then with regard to the FDA finalizing the protocol, if you will, as you just mentioned, are there any outstanding issues? Do you see this as a Gantt chart thing or...

Speaker Change: Do you believe there are points of, call it debate, that you really want to get their input on? At this point, do you have full alignment?

John McKew: Please continue, John. Yeah. I think there's points of clarification on the specifics of the design.

John McKew: Eight, please continue, John.

John McKew: Yeah, I do think there's quite a bit of clarification on the specifics of the design, and remember we have to proceed with the FDA's timelines for back-and-forth interactions, right? So that's really where we are right now.

Eight: Eight, please continue, John .

John McKew: And remember, we have to, we have to proceed with the FDA timelines for back-and-forth interactions. So that's really, really our right now. Okay.

John McKew: Yeah, I do think there's points of clarification on the specifics of the design and remember we have to, we have to proceed with the FDA's timelines for back and forth interactions, right? So that's, that's really where we are right now.

Charles Duncan: Okay, my last question is perhaps for Lori. I'm wondering if you've been able to put

Lori Lawley: My last question is, perhaps for Laurie, I'm wondering if you've been able to put a pen to paper. I imagine you have been able to, subsequent to the end of phase two meeting, to kind of plan the budget for this trial. And I'm wondering where you're landing in terms of all in capital or cash needed to at least complete enrollment. Sure. So, you know, if you recall, Charles, and great to talk with you today, we previously had said, and we've continued to say about 85 to 100 million will support operations through 2026. And so that has been the goal in terms of the capital.

Eight: Okay, my last question is perhaps for Lori. I'm wondering if you've been able to put

Lori Lawley: I imagine you have been able to

Lori Lawley: Subsequent to the end of Phase 2 meeting to kind of plan the budget for this trial. And I'm wondering where you're landing in terms of all-in capital or cash needed to at least complete enrollment.

Lori Lawley: Sure. So, you know, if you recall, Charles, and it's great to talk with you today, we previously have said, and we continue to say, about 85 to 100 million.

Lori Lawley: So go ahead, Lori.

Lori Lawley: Sure. So, you know, if you recall, Charles, and great to talk with you today, we previously had said, and we continue to say, about 85 to 100 million will support operations through 2026.

Charles Duncan: We're looking to bring in to finance the phase three and to initiate the phase three trial. As we initiate and finalize the plans with the FDA, we'll issue additional guidance around timelines from an enrollment perspective. And we may update those numbers as we finalize that trial design. Okay. That's great. No, I didn't recall that. So I appreciate you reminding us. So thanks for taking the questions. Thank you.

Speaker Change: And so that has been the goal in terms of the capital we're looking to bring in to finance the Phase 3 and to initiate the Phase 3 trial. As we initiate and finalize the...

Speaker Change: The plans with the FDA will issue additional guidance around timelines from an enrollment perspective, and we may update those numbers as we finalize that trial design.

Charles Duncan: Okay, that's great. No, I didn't recall that, so I appreciate you reminding us. So, thanks for taking the questions.

Speaker Change: Okay, that's great. No, I didn't recall that, so I appreciate you reminding us. So, thanks for taking the questions.

Speaker Change: Thank you, Charles. Thank you.

Yasmeen Rahimi: Our next question will come from Yasmeen Rahimi with Piper Sandler. You may now go ahead. Hey, good afternoon, team.

Operator: Our next question will come from Yasmeen Rahimi with Piper Sandler. You may now go.

Speaker Change: Our next question will come from Yasmeen Rahimi with Piper Sandler. You may now go ahead.

Yasmeen Rahimi: Hey, good afternoon team. This is Jungwoo on behalf of Yas.

Yasmeen Rahimi: This is Jumgu on for Yas. Thanks for taking our questions. First, could you remind us of the rationale for the formulation change from phase two to phase three? Do you need to do any additional bioequivalence studies with the mini tablets? And secondly, could you provide a little bit more color on what types of potential strategic opportunities are considering at this junction? Thank you.

Speaker Change: Hey, good afternoon team. This is Jungwoo Ahn for Yas. Thanks for taking our questions.

Jungwoo: Thanks for taking our questions. First, could you remind us of the rationale for the formulation change from Phase 2 to Phase 3? Do you need to do any additional bioequivalent studies with the mini tablets? And secondly, could you provide a little bit more color on what types of potential strategic opportunities you are considering at this junction?

Jungwoo Ahn: First, could you remind us of the rationale for the formulation change from Phase 2 to Phase 3? Do you need to do any additional bioequivalence studies with the mini tablets? And secondly, could you provide a little bit more color on what types of potential strategic opportunities are considering at this junction? Thank you.

John McKew: I'll let you go first, John, in terms of bioquilness or any other types of studies. Yes, so the rationale for the change in formulation was really threefold. So we wanted to, if you remember, we are dosing by weight across a wide weight range with an oral product. So switching to this mini tab in a capsule allows us to make three different dosage strengths by just varying the number of the same mini tablets inside a capsule that allows us to have a much tighter those variants across that large weight range. And it also gives us the opportunity for several different routes of administration.

John McKew: I'll let you go first, John, in terms of bioequivalence or any other types of studies.

Speaker Change: I'll let you go first, John , in terms of bioequivalence or any other types of studies.

Speaker Change: Yes, so the rationale for the change in formulation was really threefold. So we wanted to, if you remember, we are dosing by weight across a wide weight range with an oral product.

Speaker Change: So switching to this mini-tab.

Speaker Change: in a capsule allows us to make three different

Speaker Change: dosage strengths by just varying the number of the same mini tablets inside a capsule. That allows us to have a much tighter dose variance across that large weight range. And it also gives us the opportunity for several different routes of administration.

John McKew: The larger kids and the older kids who are able to swallow a capsule or able to just take their capsules, the younger children who might have a harder time and open the capsule up and take a mini tablet or even a mini tablet in the soft food like pure banana. That will ease kind of the treatment burden, you know, across that old age range that we're talking about in our trial and commercially.

Speaker Change: The larger kids and the older kids who are able to swallow a capsule are able to just take their capsules. The younger children who might have a harder time can open the capsule up and take a mini-tablet or even a mini-tablet in a soft food like pureed banana.

Speaker Change: That will ease kind of the treatment burden, you know, across that whole age range that we're talking about in our trial and commercially.

Rick Hawkins: And yes, there would be a bridging PK study that we have already completed. So to answer your second part of the question is, yeah, you can imagine. I mean, our BD folks have done a great job and outreach to all the markets, and they really generated considerable interest. And we've had ongoing discussions once again; we can't be specific about those discussions, but let's say that the least that there not only strategic and strategic markets, but even in beyond. So global and regional type of players who are interested. But we're going to be very careful and look at all the possibilities and potential deals that are on the table, and the combination of whether the financing or strategic is really going to be an interesting exercise over the next coming weeks and months.

Speaker Change: And, yes, there would be a bridging PK study that we have already completed.

John McKew: So, to answer the second part of that question is, yeah, you can imagine, I mean, our BD folks have done a great job in outreach to all the markets, and they've really generated considerable interest, and we've had ongoing discussions. Once again, we can't be specific about those discussions, but let's say at least that they're not only strategic and strategic markets but even beyond. So, both global and regional types of players who are interested.

Speaker Change: So to answer the second part of that question is, yeah, you can imagine, I mean our BD folks have done a great job in outreach to all the markets and they've really generated considerable interest and we've had...

Speaker Change: those discussions, but let's say that at least that they're not only strategics and strategic markets but even in beyond. So both global and regional type of players who are interested.

John McKew: We're going to be very careful and look at all the possibilities and potential deals that are on the table, and the combination of whether it be financing or strategics, it's really going to be an interesting exercise over the next weeks and months.

Speaker Change: We're gonna...

Speaker Change: Be very careful and look at all the possibilities and potential deals that are on the table and the combination of whether it be financing or strategics is really going to be an interesting exercise over the next coming weeks and months.

Rick Hawkins: I can leave it back.

Operator: All right. Thank you very much. That was very helpful.

Speaker Change: I think we'll leave it at that.

John McKew: All right. Thank you very much. That was very helpful.

Speaker Change: All right. Thank you very much. That was very helpful.

Operator: This concludes our question and answer session, as well as the conference. Thank you for today's presentation. You may now.

Speaker Change: This concludes our question and answer session as well as the conference. Thank you for attending today's presentation. You may now disconnect.