Q1 2024 Panbela Therapeutics Inc Earnings Call

Operator: Good afternoon everyone, and welcome to the Panbela Therapeutics first quarter 2024 earnings call. At this time, all participants have been placed on a listen-only mode, and we will open for questions following the presentation. If anyone should require operator assistance during this conference, please press star zero on your phone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations. James, it's over to you.

Good afternoon, everyone and welcome to the Potbelly Therapeutics first quarter 'twenty 'twenty four earnings call. At this time, all participants have been placed on a listen only mode and we will open for questions. Following the presentation. If anyone should require operator assistance. During this conference. Please.

Star Zero on your phone keypad. Please note. This conference is being recorded I will now turn the conference over to your host James Carbonara Investor Relations James over to you.

James Carbonara: Thank you, operator. Joining me on today's call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer. Before we begin, please note that statements made during this call that are not historical facts may be considered forward-looking statements. Risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements are detailed in the company's filings with the SEC. Any forward-looking statements made on this call speak only as of today's date, and the company does not undertake any obligation to update or revise any of these statements to With that, I will turn the call over to Dr. Simpson. Jennifer, please go ahead.

James Carbonara: Thank you operator, joining me on today's call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath Chief Financial Officer.

Operator: Before we begin please note that statements made during this call that are not historical facts may be considered forward looking statements.

Operator: Risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward looking statements are detailed in the companys filings with the SEC.

Operator: Any forward looking statements made on this call speak.

Speaker Change: Speak only as of today's date and the company does not undertake any obligation to update or revise any of these statements to reflect future events or circumstances with that I will turn the call over to Dr. Dr. Simpson Jennifer. Please go ahead.

Jennifer K. Simpson: Thank you, James, and thank you all for joining us. I will start by discussing our clinical development program, recent achievements, and upcoming milestones. Then Sue will review our financial results before we open up the call for Q&A. Now, let us begin with our Phase 3 Aspire Global Clinical Trial. Aspire is evaluating ibospemin, or SBP 101, in combination with gemcitabine and napaxitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. We were excited to announce in January that Aspire enrollment had surpassed 50%, proceeding faster than initially anticipated.

Speaker Change: Thank you James and thank you all for joining us.

Speaker Change: I will start by discussing our clinical development programs.

Speaker Change: And achievements and upcoming milestones.

Speaker Change: Sue will review our financial results before we open up the call for Q&A.

Jennifer K. Simpson: With all sites now open and actively enrolling, we expect full enrollment of approximately 600 patients to be completed by the first quarter of 2025. With respect to interim data, the ASPIRE trial requires 33% of the total expected events to occur before the interim analysis can be conducted. However, as of the latest assessment, less than half of the required events for the interim analysis had occurred.

Sue: Let us begin with our phase III aspire global clinical trial.

Sue: Aspire is evaluating either balanced or SPP 101 in combination with Gemcitabine and Nab paclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma.

Sue: We were excited to announce in January that the aspire enrollment has surpassed 50% preceding faster than initially anticipated.

Speaker Change: With all sites now open and actively enrolling we expect full enrollment of approximately 600 patients to be completed by the first quarter of 2025.

Speaker Change: With respect to interim data the aspire trial requires 33% of the total expected events do occur before the interim analysis can be conducted.

As of the latest assessment less than half of the required events for the interim analysis had occurred.

Jennifer K. Simpson: While we initially anticipated the interim analysis to take place in mid-2024, we are encouraged by the lower-than-expected event rate, which suggests that patients in the ASPIRE trial have experienced prolonged survival. We are now projecting the interim analysis to occur as early as the first quarter of 2025. This is a positive development for patients and underscores the potential of idospemin in addressing a significant unmet need in the treatment of metastatic pancreatic ductal adenocarcinoma. We also want to reiterate the significance of the ASPIRE trial in the context of recent advancements in metastatic pancreatic ductal adenocarcinoma treatment, such as the NAPLI 3 trial, which led to the approval of liposomal arena tecan or Onabide, in combination with Florisil, Oxaliplatin, and Leucovord, known as the Naylor-Fox regimen.

Speaker Change: While we initially anticipated the interim analysis to take place in mid 2024, we are encouraged by the lower than expected event rate, which suggests that patients in the inspire trial have experienced prolong survival.

Speaker Change: We are now projecting the interim analysis to occur as early as first quarter 2025.

Speaker Change: This is a positive development for patients and underscores the potential of Idaho spending in addressing a significant unmet need in the treatment of metastatic pancreatic ductal adenocarcinoma.

Speaker Change: We also want to reiterate the significance of the inspire trial in the context of recent advancements in metastatic pancreatic ductal adenocarcinoma treatment.

Speaker Change: As the Napoli trial, which led to the approval of lysosomal arena chicken or antibody in combination with Oracle at Sally Flatten and Luca Award known as the Kneller Fox regimen.

Jennifer K. Simpson: Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nabpaclitaxel, the prognosis for patients with metastatic pancreatic ductal adenocarcinoma remains poor, with median overall survival still less than 12 months. The incremental benefits and median survival have been modest in the past 11 years, with the recent approval of Onavide in the Naloxone regimen demonstrating a 1.9 month survival benefit compared to the approval of Gemcitabine and Nalpaclitaxel, which was based on a median overall survival benefit of 1.8 months over Gemcitabine alone.

Speaker Change: Despite this approval, which was based on the median overall survival benefit of $1 nine months compared to Gemcitabine and Nab paclitaxel the prognosis for patients with metastatic pancreatic ductal adenocarcinoma remains poor with median overall survival is still less than 12 months.

Speaker Change: The incremental benefit of median survival have been modest in the past 11 years with the recent approval of <unk> and the Nellix, what's regimen, demonstrating the one nine months survival benefit compared to the approval of Gemcitabine and Nab Paclitaxel, which was based on the median overall survival benefit of $1 eight months.

Speaker Change: Over genocide of being alone.

Jennifer K. Simpson: We believe that the addition of ibuprofen or SVP-101 to the standard of care regimen of gemcitabine and nabpaclitaxel has the potential to significantly improve outcomes for patients with metastatic pancreatic ductal adenocarcinoma beyond the incremental benefits observed with the recently approved therapy. The early indications from the ASPIRE trial support this belief, and we remain committed to advancing this important study and look forward to sharing the interim results in the first quarter of 2025.

Speaker Change: We believe that the addition of Ivy Zelman or S. P. T 101 to the standard of care regimen of Gen Decitabine, and Nab Paclitaxel has the potential to significantly improve outcomes for patients with metastatic pancreatic ductal adenocarcinoma beyond the incremental benefit observed with the recently approved therapy.

Speaker Change: The early indications from the aspire trial support this belief and we remain committed to advancing this important study and look forward to sharing the interim results in the first quarter of 2025.

Jennifer K. Simpson: Turning to our Familial Abnormal Polyposis, or FAP, program, we remain committed to collaborating with the FDA, EMA, and the FAP community to advance this initiative. Once we obtain consensus on a global registration plan, we intend to move this program forward while exploring ways to maximize its value.

Speaker Change: Turning to our familial adenomatous polyposis or a P. P program.

Speaker Change: We remain committed to collaborating with the F D. A N a and the F. A P community to advance this initiative.

Speaker Change: Once we obtain consensus on a global registration plan, we intend to move this program forward, while exploring ways to maximize value.

Jennifer K. Simpson: In our PACES trial, a phase 3 study of Flampovie for the prevention of high-risk adenomas and second, primary colorectal cancers, enrollment is complete, and we anticipate data by the second half of 2026. This study, funded by the NCI and conducted by the Southwest Oncology Group, known as SWOG, successfully passed a planned futility analysis. Moving on to our Phase 2 study, in September, we entered into an agreement with U.S. World Meds to divest assets from the Aflormazine Pediatric Neuroblastoma Program.

Speaker Change: In our case these trial a phase III study of <unk> for the prevention of high risk Adenomas and second primary colorectal cancers enrollment is complete and we anticipate data by the second half of 2026.

Speaker Change: This study funded by the NCI and conducted by the southwest Oncology group known as Swab successfully passed the planned futility analysis.

Speaker Change: Moving on to our Phase two study in September we entered into an agreement with U S. Roadmaps to divest assets from the Horn Athene pediatric neuroblastoma program.

Jennifer K. Simpson: Panbela has received an upfront payment of $400,000, with an additional $775,000 received in lieu of U.S. sales milestones in the latter years. Panbela stands to receive additional payments as U.S. ROMES achieves key milestones. As a reminder, in December, U.S.

Speaker Change: Pandora has received an upfront payment of $400000 with an additional 775000 received in lieu of U S sales milestones in the latter years.

Pandora: Pandora's stands to receive additional payments as U S romance chiefs key milestone.

Jennifer K. Simpson: Rural Meds received FDA approval of its NDA for flornithine, marking the first FDA approval of a pining-targeted therapy in a cancer indication. This approval not only benefits Panbela financially but also helps to validate the role polyamines can play in sensor therapy as we advance our other programs. We also entered into a clinical trial agreement for a phase two trial of florinidine-encastration-resistant metastatic prostate cancer. This study is actively enrolling patients. The Phase 2 Aflornithine Trial in Type 1 Diabetes is a multi-center, double-blind, placebo-controlled, 2-to-1 random-assigned clinical trial led by Indiana University School of Medicine and supported by JDRF. All six centers are open and enrolling patients with an anticipated interim analysis next year.

Pandora: As a reminder, in December U S. Roadmaps received FDA approval of its NDA for Florida, marking the first FDA approval of opining targeted therapy and a cancer indication.

Pandora: This approval not only benefit Pandora financially, but I'll also helps to validate the role <unk> can play in cancer therapy, as we advance our other programs.

Pandora: We also entered into a clinical trial agreement for a phase two trial of a foreign athene in castration resistant metastatic prostate cancer. This.

Pandora: This study is actively enrolling.

Pandora: The phase two of foreign Athene trial in type one diabetes is a multi center double blind placebo controlled two to one random assigned clinical trial led by Indiana University School of Medicine, and supported by J D. R. F.

Pandora: I'll stick centers are open and enrolling patients with an anticipated interim analysis next year.

Jennifer K. Simpson: We are also planning a phase two study evaluating ibuprofen in platinum-resistant ovarian cancer, which we hope to begin in the second half of this year in collaboration with Johns Hopkins University School of Medicine. In fact, last month at the American Association for Cancer Research's annual meeting, we presented a poster highlighting the efficacy of isospemin as a polyamine metabolism modulator in ovarian cancer. Ivofemin reduces the viability of human ovarian adenocarcinoma cell lines regardless of their platinum sensitivity, and we found that combined treatment with doxorubicin increases median survival, delays tumor onset, and decreases overall tumor burden compared to either clinical or subclinical doxorubicin dosing schemes. These results suggest that SVP101, in combination with doxorubicin, may have In particular, it's difficult to treat platinum-resistant populations where few options exist.

Pandora: We are also planning a phase two study evaluating IV <unk> in the platinum resistant ovarian cancer, which we hope to begin in the second half of this year in collaboration with Johns Hopkins University School of Medicine.

In fact last month at the American Association for cancer research or ACR annual meeting.

Speaker Change: We presented a poster highlighting the efficacy of IV is a tiny metabolism modulator in ovarian cancer.

Speaker Change: I will spend then reduces the viability of human ovarian adenocarcinoma cell lines, regardless of their platinum sensitivity and we found that the combination treatment with doxorubicin increases median survival delays tumor onset and decreases overall tumor burden compared to either clinical or subclinical doxorubicin.

Speaker Change: Doxorubicin dosing scheme.

Speaker Change: The results suggest that S. E. T 101 in combination with doxorubicin may have a role in the clinical management of ovarian cancer in particular, the difficult to treat platinum resistant population where few options exist.

Jennifer K. Simpson: These studies continue to support the basis for moving into a clinical trial program in ovarian cancer with the goal of developing effective, novel therapeutics in combination with standard of care for patients with unmet medical needs. The poster provided additional details on the preclinical studies. Treatment with Doxorubicin significantly increased the in-vitro toxicity of SCP-101 in both cisplatinum-sensitive and cisplatinum-resistant ovarian cancer cell lines. SCP-101 and Gox Rubicin cooperatively increased polyamine catabolism and decreased overall cell survival in vitro.

Speaker Change: These studies studies continue to support the basis for moving into a clinical trial program in ovarian cancer with a goal of just that developing effective novel therapeutics in combination with standard of care for patients with unmet medical needs.

Jennifer K. Simpson: In an immunocompetent mouse model of ovarian cancer, the combination of SBP101 and doxorucin significantly increased median survival time, delayed ascites formation, and decreased overall tumor burden. Interestingly, this survival benefit was not observed in immunodeficient mice, indicating that an intact immune system is required for the efficacy of this therapy. These promising preclinical results provide a strong foundation as we prepare to initiate our ovarian cancer clinical program later this year. Future studies will evaluate IL-7 in combination with other polymine metabolites and modulators, as well as immune modulators.

Speaker Change: The poster provided additional details on the preclinical studies.

SPP 101: Treatment with doxorubicin significantly increase the in vitro toxicity of SPP 101.

SPP 101: This platinum sensitive and platinum resistant ovarian cancer cell lines.

SPP 101: S B Tijuana, one in golf's Rubinsohn cooperatively increased Paul you mean catabolism and decreased overall cell survival in an in vitro.

SPP 101: And in immuno competent mouse model of ovarian cancer, the combination of SB Tijuana, one and Doctor within significantly increased median survival time latest <unk> formation and decreased overall tumor burden.

SPP 101: Interestingly the survival benefit was not insert in the immuno deficient mice, indicating that an intact immune system is required for the efficacy of this therapy.

SPP 101: These promising preclinical results provide a strong foundation as we prepare to initiate our ovarian cancer clinical program later this year.

SPP 101: Future studies will evaluate <unk> in combination with other pardon me metabolism modulators as well as immune modulators.

Jennifer K. Simpson: In Phase 1 development, we have two programs. Our Phase 1-2 collaboration at the Cancer Center is off. Nassau-Selkirk is open and screening.

SPP 101: In phase one development, we have two programs our phase once you collaborate with Moffitt cancer Center.

Speaker Change: Nah bussell or is open and screening.

Jennifer K. Simpson: We anticipate enrolling our first patient in the first half of this year and initiating the Phase II trial in the first half of 2025. Finally, we are looking to initiate the geographic investigator initiative in the second half of this year. In the preclinical setting, we are also engaged in an ongoing research initiative with MD Anderson Cancer Center, focusing on evaluating polyamine metabolic inhibitor therapies with CAR-T cell therapy and bispecific monoclonal antibodies in preclinical models.

Speaker Change: We anticipate enrolling our first patient first half of this year and initiating the phase two trial in the first half of 2025.

Speaker Change: Finally, we are looking to initiate the Razek investigator initiative in the second half of this year.

Speaker Change: In the preclinical setting we are also engaged in ongoing research initiative with MD Anderson cancer center, focusing on evaluating pining metabolic inhibitor therapies with car T cell therapies and by specific monoclonal antibodies in preclinical models.

Jennifer K. Simpson: We recently announced the acceptance of an abstract detailing research on SDP-101 and CPD-19. Honathain, and Melissa Lomaselle-Lyons for online publication at the Asch meeting. On the IP front, we recently announced the issuance of a new patent in the U.S. and Canada. This patent is for claims of a fixed-dose combination of afluridine and sulindac. In summary, our projected first half 2024 milestones include enrolling our first patient in the non-small cell lung cancer phase 1 trial, announcing gastric cancer prevention phase 2 results, In the second half of this year, we anticipate opening the neoadjuvant pancreatic cancer trial, opening the phase 2 ovarian trial, publishing the final phase 1.1b metastatic pancreatic trial data, and obtaining FDA and EMA feedback for a global registration trial in FAP, and in 2025.

Speaker Change: We recently announced the acceptance of an abstract detailing research on SPP 101 and C. P.

Speaker Change: On a T M.

Speaker Change: Hello, Michelle lines for online publication at the Ash meeting.

Speaker Change: On the IP front, we recently announced the issuance of a new patent in the U S and Canada. This patent is for claims of a fixed dose combination of a floor athene in cylinder.

Speaker Change: In summary, our projected first half 2024 milestones include enrolling our first patient in the non small cell lung cancer phase one trial announcing gastric cancer prevention phase two results and.

Speaker Change: In the second half of this year, we anticipate opening the new adjuvant pancreatic cancer trial.

Speaker Change: <unk> the phase two ovarian trial.

Speaker Change: The final phase <unk> metastatic pancreatic trial data.

Speaker Change: And obtaining FDA and EMA feedback for global registration trial in S E T.

Speaker Change: And in 2025.

Jennifer K. Simpson: Early on, we anticipate overall survival interim analysis for our Phase 3 ASPIRE trial in the first quarter and the opening of the non-small cell lung cancer Phase 2 trial in the first half of the year. The first quarter and year to date have marked significant clinical development strides for Panbela. We look forward to continued progress and value creation in 2024. I will now turn the call over to Sue to discuss our financial results. Sue?

Speaker Change: Early on we anticipate overall survival interim analysis for our phase III inspire trial.

Speaker Change: In the first quarter and the opening of the non small cell lung cancer phase II trial in the first half of the year.

Susan Horvath: Thank you, Jennifer. General and Administrative expenses were approximately $1.2 million in Q1 2024 compared to $1.4 million in Q1 2023. This decrease was primarily due to lower professional fees in 2024. Research and development expenses were approximately $5.5 million in the quarter ended March 31, 2024, up from $3.5 million in the same quarter last year, the increase due primarily to increased enrollment in the ASPIRE trial. The net loss for the quarter was $7.1 million, or $2.28 per diluted share, compared to a net loss of $5.1 million, or $392.76 per diluted share, in Q1 2023.

The first quarter and year to date have mark significant clinical developments drives for Penn power.

Susan Horvath: Total cash as of March 31st, 2024 was approximately $260,000, which included net proceeds of approximately $8.1 million from our public offering which closed in January. Total current assets were $1.8 million, and current liabilities were $10.5 million a quarter in. Non-current assets, consisting primarily of cash deposits held by our CRO, were $8.7 million. During the quarter, $1 million of the current portion of our debt plus accrued interest of approximately $260,000 was paid as per the terms of the note.

Speaker Change: We look forward to continued progress and value creation in 2024.

Susan Horvath: Regarding our capitalization, as of March 31, 2024, we had approximately 4.85 million common shares outstanding, including shares reserved for options, and warrants are issued in a fully reserved share count with approximately 13.95 million shares. Cash used in operations for Q1 of 2024 totaled approximately $9.4 million. Cash used in operations included our net loss for the quarter, payments made to vendors for expenses incurred in 2023, and approximately 0.9 million for prepayments made to secure additional supplies of standard of care chemo avages.

Sue: I will now turn the call over to Sue to discuss our financial results.

Sue: Okay.

Speaker Change: Thank you Jennifer Gen.

Sue: General and administrative expenses were approximately $1 2 million in Q1 2024 compared to one 4 million in Q1 2023. This streak curious was primarily due to lower professional fees in 2024.

Sue: Research and development expenses were approximately $5 5 million in the quarter ended March 31, 'twenty 'twenty four.

Sue: Up from $3 5 million in the same quarter last year, the increase due primarily to increased enrollment in the inspire trial.

Sue: Net loss for the quarter was 7.1 billion or $2.28 per diluted share compared to a net loss of $5 1 billion or $392.76 per diluted share in Q1 2023.

Sue: Total cash as of March 31, 2024 was approximately 260000, which includes net proceeds of approximately $8 1 billion from our public offering which closed January.

Susan Horvath: In January, we closed the $9 million public offering with net proceeds of approximately $8.1 million. And on April 28th, 2024, the company signed an amendment to our 2023 agreement with U.S. Roadmen. In exchange for a second non-refundable payment of approximately $0.8 million, the company has agreed to give up two potential future payments associated with future milestones. This non-dilutive payment was received by the company at the signing of the amendment. Per the amended terms, the total potential payments remaining if these milestones are achieved are approximately $7.6 million.

Sue: Total current assets were one 8 million and current liabilities were $10 5 million at quarter end.

Sue: Non current assets, consisting primarily of cash deposits held by our CFO were $8 7 million.

Sue: During the quarter 1 million of the current portion of our debt plus accrued interest of approximately 260000 was paid per the terms of the note.

Sue: Regarding our capitalization.

Sue: As of March 31, 2024, we had approximately 4.85 million common shares outstanding.

Sue: Including shares reserved for options and warrants are issued and fully reserved share count was approximately 13.95 million shares.

Sue: Cash used in operations for Q1 of 'twenty 'twenty four totaled approximately $9 4 million.

Sue: Cash used in operations included our net loss for the quarter.

Sue: Payments made to vendors for expenses incurred in 2023, and approximately <unk> 9 million for prepayments made to secure additional supply standard of care chemo agents.

Sue: In January we closed a $9 million public offering with net proceeds of approximately 8.1.

Speaker Change: And on April 28, 2024, the company signed an amendment to our 2023 agreement with U S roadmap and.

Speaker Change: In exchange for a second Don Refundable payment of approximately 0.8 million. The company has agreed to give up to potential future payments associated with future milestones.

Speaker Change: This non dilutive payment was received by the company at the signing of the Amendment.

Speaker Change: Per the amended terms total potential payments remaining if these milestones that are achieved is approximately $7 6 million.

Susan Horvath: During the quarter, Panbela's common stock was suspended from trading on Nasdaq and is now eligible for quotation on the OTCQB under the symbol PBLA. The company is pursuing a new listing of its common stock on a national securities exchange. Operator, we are now ready to take questions.

Speaker Change: During the quarter that was common stock was suspended from trading on Nasdaq.

Speaker Change: It is now eligible for quotation on the OTC QB under the symbol P. B L. A.

Speaker Change: The company is pursuing a new listing of its common stock at a national Securities Exchange.

Speaker Change: Operator, we are now ready to take questions.

Operator: Thank you very much. We are now conducting our question and answer session. If you would like to ask a question, please press star 1 on your phone keypad now. A confirmation tone will indicate that your line is in the queue. You may press star 2 if you would like to remove your question from the queue. For any participants using speaker equipment, it may be necessary to pick up your handset before you press the keypad. Please wait a moment whilst we poll for questions. Thank you. Your first question is coming from Jonathan Aschoff of Roth MKN. Jonathan, your line is live.

Speaker Change: Thank you very much we are now conducting a question and answer session. If you would like to ask a question. Please press star one on your phone keypad now a confirmation tone will indicate that you'll line isn't Nicky you May press star two if you would like to remove your question from the key for any participants using speaker equipment it may be necessary.

Speaker Change: Sorry to pick up your handset before you press the keys. Please wait a moment, whilst we poll for questions.

Jonathan Matthew Aschoff: Thank you. Good afternoon.

Speaker Change: Thank you. Your first question is coming from Jonathan Aschoff of Ralph M pad, Jonathan Your line is life.

Jonathan Matthew Aschoff: I was wondering, you know, can you tell us the stopping criteria for the hopefully 1Q25 Aspire interim, you know, for both efficacy and futility? Can you just close that?

Jonathan Matthew Aschoff: Thank you good afternoon.

Jonathan Matthew Aschoff: I was wondering can you tell us the stopping criteria for the hopefully <unk> twenty-five aspire interim you know for both for efficacy and for futility.

Jonathan Matthew Aschoff: Can you just close the.

Jennifer K. Simpson: Hi Jonathan. How are you today?

Speaker Change: Hi, Jonathan how are you today.

The interim analysis is based on approximately 33% of the total events on the total events that we're looking for is 512.

Speaker Change: So basically about 170 events.

Speaker Change: It's actually a superiority.

Speaker Change: And so if we are in.

Speaker Change: In terms of stopping.

Speaker Change: Stopping them I think you know it's probably.

Speaker Change: Unlikely that we would be stopping.

Speaker Change: And at that point. The reality is we will have most likely completed enrollment.

Jennifer K. Simpson: The interim analysis is based on approximately 33% of the total events. The total number of events that we're looking for is 512, so basically, about 170 events. It is actually a superiority.

Speaker Change: So we had a very interesting yeah, we had a very interesting thing happening right for enrollment with much faster than we anticipated and the patients are living longer than anticipated and so the two created an interesting dynamic by which they're both going to hit about the same time.

Jennifer K. Simpson: And so it would, in terms of stopping, I think, you know, It's probably unlikely that we would be stopping, and at that point, the reality is we will have most likely completed enrollment. So we had a very interesting thing happening, right? So enrollment was much faster than we anticipated, and patients are living longer than anticipated. And so the two created an interesting dynamic by which they're both going to hit about the same time.

Jonathan Matthew Aschoff: Okay, Mia, maybe can you tell us anything about alpha spend, just some sort of statistical hurdle we can think about?

Speaker Change: Okay.

Speaker Change: Maybe you can tell us about anything about alpha spend just some sort of.

Speaker Change: Source statistic hurdle, we can think about.

Jennifer K. Simpson: Yeah, so, you know, the alpha spend is minimal. It really is de minimis in terms of the spend. We designed it that way. The study is powered at 90% with a hazard ratio of 0.75 overall and an alpha of 0.025 one-sided. So the alpha spend for the interim analysis is actually quite small.

Speaker Change: Yeah, so the alpha spend is minimal.

Speaker Change: It really is it's de Minimis in terms of the spend island, we designed it that.

That way.

Speaker Change: The study is powered at 90%.

Speaker Change: The hazard ratio of <unk> 75 overall.

Speaker Change: And an alpha of point or 251 sided so the alpha spend for the interim analysis.

Speaker Change: It's actually quite small.

Jonathan Matthew Aschoff: Okay, and do you think that the 1Q25 timing is at risk, or are the events that are occurring still strongly tracking to 1Q25?

Speaker Change: Okay.

Speaker Change: Do you think that the once you twenty-five timing is that risk or are the events occurring you know that are occurring still strongly tracking toward 225.

Jennifer K. Simpson: At this time, I'd say we're still tracking to 1Q25. If we do start to see slippage and we think it's going to be even later, we certainly will update the public. But at this point, we are still on track for our first quarter.

Speaker Change: At this time I'd say, we're still tracking to <unk> 25, if we do start to see a slippage and we think it's going to be even later, we certainly will update the public but at this point, we are still on track for a first quarter.

Jonathan Matthew Aschoff: Okay, thank you very much for the update.

Speaker Change: Okay. Thank you very much for the update.

Speaker Change: Certainly.

Operator: Thank you very much. Just as a reminder, if you do have any remaining questions, you can press star 1 on your phone keypad now. Your next question is coming from Joe Panginis of HC Wainwright. Joe, your line is live.

Speaker Change: Thank you very much just as a reminder, if you do have any remaining questions. You can press star one on your phone keep up now.

Joshua Aaron Korsen: Hi, this is Josh on behalf of Joe. I was just wondering if we could get a little bit more insight into the current cash position. I was wondering if there are any steps that you may be taking to help strengthen the cash position?

Speaker Change: Your next question is coming from Joe Pat genus of H C. Wainwright, Joe Your line is life.

Speaker Change: Hi, This is Josh on for Joe I was just wondering if we could get a little bit more insight into the current cash position and I was wondering if there's any steps that you may be taking to help strengthen the cash position.

Susan Horvath: Sure. Well, we did raise a portion of the cash that we needed in the first quarter of January, but certainly not sufficient to keep up with our burn rate. Right now, last year we were burning close to six and a half per quarter if we excluded the Braxine that we were required to purchase. As enrollment increases, that burn rate will probably jump closer to seven per quarter. You might have noticed the filing of an S-1 that was completed in April, and it would be our intention as we look to find a national exchange to uplist on to also raise the capital that's identified in that S-1.

Speaker Change: Sure.

Speaker Change: Well.

Speaker Change: We did raise a portion of the cash that we need it in the first quarter in January but I'm, certainly not sufficient to keep up for four burn rate right. Now last year, we were burning close to six and a half per quarter.

Speaker Change: If we excluded the.

Speaker Change: T. A L brack, saying that we were we were required to purchase that as the.

Speaker Change: Ah the enrollment increases that burn rate will probably jump into closer to seven per quarter.

Speaker Change: You might have noticed the filing of an S. One that was completed in April and it would be our intention.

Speaker Change: As we look to find the national exchange uplift to also raise the capital that's identified and that S. One.

Susan Horvath: Okay, and I just wanted to verify if I heard this correctly, the $262,000 cash that does include the net proceeds from the January raise.

Speaker Change: Okay.

Speaker Change: I just wanted to verify if I heard this correctly the all too.

Speaker Change: 62, 1000 cash that does include the net proceeds from the January rates.

Susan Horvath: It was Yes, that was included in there because those proceeds were received in January, but we burned on top of that, you know, with a loss in the quarter of $7 million. So that leaves us with a balance at the end of the quarter. What it did not include was the incremental upfront payment that we received from U.S. World Med in April, which was basically a bridge to help us take our next step in fundraising.

Speaker Change: It was yes that was included in there because those proceeds you received in January but we we burned on top of that you know with a loss in the quarter of 7 million.

Speaker Change: So that leaves us with a balance at the end of the quarter.

Speaker Change: What it did not include was the incremental upfront payment that we received from U S. Roadmap in April which was basically a bridge to help us.

Speaker Change: Two our next step in fundraising.

Joshua Aaron Korsen: All right, perfect. Thank you so much.

Speaker Change: Alright, perfect. Thank you so much.

Speaker Change:

Operator: Thank you very much. Just a reminder, if there are any remaining questions, you can press star 1 on your phone keypad now. Okay, we don't appear to have any further questions in the queue, and I will now conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.

Speaker Change: Thank you very much just a reminder, if at all any remaining questions. You can press star one on your phone keep up now.

Speaker Change: Okay. We don't appear to have any further questions in the queue and I will now conclude today's conference call. You may disconnect. Your phone lines at this time and have a wonderful day sankey feel participation.