Q2 2024 Panbela Therapeutics Inc Earnings Call
Operator: Dr. Johnson, Jennifer Simpson, Jennifer Simpson, Susan Horvath, James Carbonara, James Carbonara, Good afternoon, everyone, and welcome to the Panbela Therapeutics second quarter 2024 earnings call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara of Investor Relations. Sir, the floor is yours.
Operator: Good afternoon, everyone, and welcome to the Panbela Therapeutics Second Quarter 2024 Earnings Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation.
Speaker Change: Good afternoon everyone and welcome to the Panbella Therapeutics second quarter 2024 earnings call.
Speaker Change: At this time, all participants have been placed on a listen-only mode. We will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara of Investor Relations. Sir, the floor is yours.
James Carbonara: It is now my pleasure to turn the floor over to your host, James Carbonara, of Investor Relations. Sir, the floor is yours.
James Carbonara: Thank you, operator.
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 on 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.
James Carbonara: 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 on 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 reflect future events or circumstances.
James Carbonara: Thank you, operator. Joining me on today's call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer.
Speaker Change: Before we begin, please note that statements made on this call that are not historical facts may be considered forward-looking statements.
Speaker Change: 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.
James Carbonara: 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 reflect future events or circumstances. With that, I will turn the call over to the company's CEO, Jennifer Simpson. Dr. Simpson, please go ahead.
Speaker Change: 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 reflect future events or circumstances.
Jennifer Simpson: With that, I will turn the call over to the company CEO, Jennifer Simpson.
Speaker Change: With that, I will turn the call over to the company's CEO, Jennifer Simpson. Dr. Simpson, please go ahead.
Jennifer Simpson: Dr. Simpson, please go ahead. Thank you, James, and thank you all for joining us. I will start today's call by discussing our clinical development program, our recent achievements, and upcoming milestones.
Jennifer Simpson: Thank you, James, and thank you all for joining us. I will start today's call by discussing our clinical development program, our recent achievements, and upcoming milestones. Then Sue will review our financial results before we open up the call for Q&A, beginning with our Phase 3 Aspire Global Clinical Trial. Aspire is evaluating Iversemin, or SDP-101, in combination with gemcitabine and nabpaclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. We were excited to announce in June that the Independent Data Safety Monitoring Board, or DSMB, recommended study continuation without modification, marking the third consecutive positive safety review. At that time, we shared that the safety database had reached 395 patients compared to 214 patients on November 29th, 2023. As you may recall, in January, Aspire enrollment surpassed 50%, proceeding faster than initially anticipated.
Jennifer Simpson: Thank you, James, and thank you all for joining us. I will start today's call by discussing our clinical development program, our recent achievements, and upcoming milestones. Then Sue will review our financial results before we open up the call for Q&A.
Jennifer Simpson: Then Sue will review our financial results before we open up the call for Q&A. Beginning with our Phase 3, Aspire Global Clinical Trial. Aspire is evaluating Iver Semen, or SDP 101, in combination with Gempside Abbein and NADPAC Botoxyl, for patients with untreated metastatic tankrietic ductal adenocarcinoma. We were excited to announce in June that the independent data safety monitoring board, or DSMB, recommended study continuation without modification, marking the third consecutive positive safety review. At that time, we shared that the safety database had reached 395 patients, compared to 214 patients on November 29, 2023. As you may recall, in January, the Aspire enrollment surpassed 50 percent, preceding faster than initially anticipated.
Jennifer Simpson: With all sites open and actively enrolling, we reiterate our expectation for 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, or deaths, to occur before the interim analysis can be conducted. In April, we announced that less than half of the required events, or deaths, for the interim analysis had occurred.
Speaker Change: Beginning with our Phase 3 Aspire Global Clinical Trial. Aspire is evaluating ivo-7 or SDP-101 in combination with gemcitabine and nabpaclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma.
Speaker Change: We were excited to announce in June that the Independent Data Safety Monitoring Board, or DSMB, recommended study continuation without modification, marking the third consecutive positive safety review.
Speaker Change: At that time, we shared that the safety database had reached 395 patients, compared to 214 patients on November 29, 2023.
Speaker Change: As you may recall, in January, the ASPIRE enrollment surpassed 50%, proceeding faster than initially anticipated.
Jennifer Simpson: With all sites open and actively enrolling, we reiterate our expectation for 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 percent of a total expected event or death to occur before the interim analysis can be conducted. In April, we announced that less than half of the required events or deaths for the interim analysis had occurred. Consequently, the Aspire's trial's interim analysis, initially expected in the middle of 2024, is now projected for early 2025, due primarily to patients' prolonged survival, suggesting the potential benefit of idle specimens in treating metastatic pancreatic structural adenocarcinoma.
Speaker Change: With all sites open and actively enrolling, we reiterate our expectation for 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, or deaths, to occur before the interim analysis can be conducted.
Speaker Change: In April, we announced that less than half of the required events, or deaths, for the interim analysis had occurred.
Jennifer Simpson: Consequently, the ASPIRE trial's interim analysis, initially expected in the middle of 2024, is now projected for early 2025, due primarily to patients' prolonged survival, suggesting the potential benefit of ibospemin in treating metastatic pancreatic ductal adenocarcinoma. This encouraging development follows the FDA's approval of the Naloxone regimen, which demonstrated a relatively modest 1.9 month improvement in median overall survival Despite this regulatory milestone, metastatic pancreatic cancer's prognosis remains grim, with median survival still under 12 months, underscoring the critical need for more effective treatment.
Speaker Change: Consequently, the ASPIRE's trial...
Speaker Change: trial's interim analysis, initially expected in the middle of 2024, is now projected for early 2025 due primarily to patients' prolonged survival, suggesting the potential benefit of ibuprofen in treating metastatic pancreatic ductal adenocarcinoma.
Jennifer Simpson: This encouraging development follows the FDA's approval of the Nail or Fox Regimen, which demonstrated a relatively modest 1.9-month improvement in median overall survival, compared to gem-sighted gene and and Michael. Despite this regulatory milestone, metacetic pancreatic cancer prognosis remains grim, with median survival still under 12 months, underscoring the critical need for more effective treatment. In this context, we believe that I was feminine, or SCP-101, combined with the standard care regimen of jump side-to-been and napapotexal, holds promise, with early aspire trial indications suggesting the potential to outperform the incremental benefits of recently approved therapies. Given the current regulatory landscape in metacetic pancreatic cancer, we anticipate that the potential of adverse feminine efficacy may position it favorably for an FDA approval.
Speaker Change: This encouraging development follows the FDA's approval of the naloxone regimen, which demonstrated a relatively modest 1.9 month improvement in median overall survival compared to gemcitabine and nabpapitaxel.
Speaker Change: Despite this regulatory milestone, metastatic pancreatic cancer prognosis remains grim, with median survival still under 12 months, underscoring the critical need for more effective treatment.
Jennifer Simpson: In this context, we believe that Ibosefemin, or SVP 101, combined with the standard of care regimen of Jumcidabine and nabpaclitaxel holds promise, with early ASPIRE trial indications suggesting the potential to outperform the incremental benefits of recently approved therapy. Given the current regulatory landscape in metastatic pancreatic cancer, we anticipate that the potential for IboSpemin's efficacy may position it favorably for FDA approval.
Speaker Change: In this context, we believe that ibospemin, or SVP-101, combined with the standard of care regimen of gemcitabine and nabpapotexil holds promise, with early ASPIRE trial indications suggesting the potential to outperform the incremental benefits of recently approved therapies.
Speaker Change: Given the current regulatory landscape in metastatic pancreatic cancer, we anticipate that the potential of ibuprofen's efficacy may position it favorably for an FDA approval.
Jennifer Simpson: The company remains steadfast in its commitment to this transformative study and eagerly awaits the interim results in Q-1 2025, which we expect could signal a turning point in the treatment landscape for patients facing this formidable disease.
Jennifer Simpson: The company remains steadfast in its commitment to this transformative study and eagerly awaits the interim results in Q1 2025, which we expect could signal a turning point in the treatment landscape for patients facing this formidable disease. Our commitment to advancing the familial adenomatous polyposis, or FAP, program remains strong as we continue to work closely with the FDA, EMA, and the FAP community. Upon reaching a consensus on a global registration plan, we plan to progress this program while exploring strategies to optimize its value.
Speaker Change: The company remains steadfast in its commitment to this transformative study and eagerly awaits the interim results in Q1 2025, which we expect could signal a turning point in the treatment landscape for patients facing this formidable disease.
Jennifer Simpson: Our commitment to advancing the familial adnomitus polyposis, or FAP, program remains strong as we continue to work closely with the FDA, EMA, and the FAP community. Upon reaching a consensus on a global registration plan, we plan to progress this program while exploring strategies to optimize its value.
Speaker Change: Our commitment to advancing the familial adenomatous polyposis, or FAP, program remains strong as we continue to work closely with the FDA, EMA, and the FAP community.
Speaker Change: Upon reaching a consensus on a global registration plan, we plan to progress this program while exploring strategies to optimize its value.
Jennifer Simpson: Regarding the PACES trial, a Phase 3 study investigating Slimpovy for the prevention of high-risk adenoma and 2nd primary colorectal cancers, we are pleased enrollment has concluded. With the study successfully passing that planned utility analysis, we expect data read out by the second half of 2026. This study, supported by the NCI and conducted by the Southwest and College Group, or SLOG, has the potential to reduce the 3-year event rate of adnomitus and 2nd primary colorectal cancers in patients previously treated for stages 0-3 on a rectal cancer. Just in focus to phase 2 studies, in April, we saw additional monetization from the cell of assets from the Affleurnathy and Pediatric NeuroBlastoma program.
Jennifer Simpson: Regarding the PACE trial, a phase three study investigating Swampovi for the prevention of high-risk adenoma and second primary colorectal cancers, we are pleased enrollment has concluded. With the study successfully passing that planned futility analysis, we expect data readout by the second half of 2026. This study, supported by NCI and conducted by the Southwest Oncology Group, or SWAS, has the potential to reduce the three-year event rate of adenomas in second primary colorectal cancers in patients previously treated for stages 0 through 3 colon or rectal cancer.
Speaker Change: Regarding the PACE's trial, a phase 3 study investigating Swampovi for the prevention of high-risk adenoma and second primary colorectal cancers, we are pleased enrollment has concluded.
Speaker Change: With the study successfully passing that planned futility analysis, we expect data readout by the second half of 2026.
Speaker Change: This study, supported by the NCI and conducted by the Southwest Oncology Group, or SWOG.
Speaker Change: has the potential to reduce the three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for stages 0 through 3 on a rectal cancer.
Jennifer Simpson: It's shifting focus to Phase II studies. In April, we saw additional monetization from the sale of assets from the Aflornithine Pediatric Neuroblastoma Program. We received an additional $775,000 obtained in place of US sales milestones in later years.
Speaker Change: Shifting focus to Phase 2 studies, in April we saw additional monetization from the sale of assets from the Aflornithine Pediatric Neuroblastoma program.
Jennifer Simpson: We received an additional 775,000 obtained in place of U.S. cell milestones in the later years. As U.S. low-meds reaches key milestones; PANBELLA is positioned to receive further payments. It is worth reiterating that in December, U.S. world med secured FCA approval for its NDA for Affleurnathy, representing the first FCA approval of polyming targeted therapy in a cancer indication. This approval not only provides financial benefits to PANBELLA, but also serves to validate the potential role of polyming in cancer therapy as we continue to progress our other programs. We have also entered into a clinical trial agreement for a phase 2 study of Affleurnathy and CASTration-resistant metacetic prostate cancer, which is actively recruiting patients.
Speaker Change: We received an additional 775,000 obtained in place of US sales milestones in the later years.
Jennifer Simpson: As U.S. Low Meds reaches key milestones, Panbela is positioned to receive further payments. It's worth reiterating that in December, US World Med secured FEA approval for its NDA for aflornithine, representing the first FEA approval of a polymine-targeted therapy in a cancer indication. This approval not only provides financial benefits to Panbela but also serves to validate the potential role of polyamines in cancer therapy as we continue to progress our other programs. We have also entered into a clinical trial agreement for a phase two study of fluoridine and castration-resistant metastatic prostate cancer, which is actively recruiting patients. The Phase II of Fluorinibine Study in Type 1 Diabetes is a multi-center, double-blind, placebo-controlled trial with a 2-to-1 randomization ratio conducted under the leadership of Indiana University's School of Medicine and supported by JDRF.
Speaker Change: As U.S. Home Meds reaches key milestones, Panbella is positioned to receive further payments.
Speaker Change: It's worth reiterating that in December, U.S. World Med secured FDA approval for its NDA for aflornithine, representing the first FDA approval of polyamine-targeted therapy in a cancer indication.
Speaker Change: This approval not only provides financial benefits to PAMBELLA but also serves to validate the potential role of polyamines in cancer therapy as we continue to progress our other programs.
Speaker Change: We have also entered into a clinical trial agreement for a phase two study of a flornithine and castration-resistant metastatic prostate cancer, which is actively recruiting patients.
Jennifer Simpson: The phase 2 affleurnathy and type 1 diabetes is a multi-center, double-blind, placebo-controlled trial with a true-to-one randomization ratio, conducted under the leadership of Indiana University's School of Medicine and supported by JDRF. All six participating centers are now open and enrolling patients, with an intro-analysis expected to take place next year.
Speaker Change: The Phase II of Fluorinibine Study in Type 1 Diabetes is a multi-center, double-blind, placebo-controlled trial with a 2-to-1 randomization ratio conducted under the leadership of Indiana University's School of Medicine and supported by JDRF.
Jennifer Simpson: All six participating centers are now open and enrolling patients, with an interim analysis expected to take place next year. Furthermore, we are in the process of planning a Phase II trial to assess ibospemin in platinum-resistant ovarian cancer, which we aim to initiate in collaboration with Johns Hopkins University School of Medicine during the latter half of this year. In fact, in April, at the American Association for Cancer Research, or AACR, annual meeting, we presented a poster showcasing ibosperm's efficacy as a polyimide metabolism modulator in ovarian cancer.
Speaker Change: All six participating centers are now open and enrolling patients with an interim analysis expected to take place next year.
Jennifer Simpson: Furthermore, we are in the process of planning a phase two trial to assess Ivo Semen in platinum-resistant ovarian cancer, which we aim to initiate in collaboration with Johns Hopkins University School of Medicine during the latter half of this year. In fact, in April at the American Association for Cancer Research, or AACR Annual Meeting, we presented a poster showcasing Ivo Semen's efficacy as a polyming metabolism modulator in ovarian cancer. The encouraging data of complete pre-clinical investigations offer a robust basis as we gear up to launch our ovarian cancer clinical program in the latter part of this year.
Speaker Change: Furthermore, we are in the process of planning a phase 2 trial to assess ibospemin in platinum-resistant ovarian cancer, which we aim to initiate in collaboration with Johns Hopkins University School of Medicine during the latter half of this year.
Speaker Change: In fact, in April, at the American Association for Cancer Research, or AACR, annual meeting, we presented a poster showcasing ibospemin's efficacy as a polymine metabolism modulator in ovarian cancer.
Jennifer Simpson: The encouraging data for pre-clinical investigations offer a robust basis as we gear up to launch our ovarian cancer clinical program in the latter part of this year. upcoming trials are designed to assess IL-7 in conjunction with additional polyimine metabolism modulators and immune modulators.
Speaker Change: The encouraging data for pre-clinical investigations offer a robust basis as we gear up to launch our ovarian cancer clinical program in the latter part of this year.
Jennifer Simpson: upcoming trials are designed to assess Ivo Semen in conjunction with additional polyming metabolism modulators and immune modulators. In phase one development, we have two programs. Our phase one-two collaboration with Moffat Cancer Center in stick 11 mutant non-small-cell lung cancer is open and screening for patients. We look forward to enrolling our first patient this year and initiating Phase two trial in 2025.
Speaker Change: Upcoming trials are designed to assess IL-7 in conjunction with additional polyamine metabolism modulators and immune modulators.
Jennifer Simpson: In Phase 1 development, we have two programs. Our Phase 1-2 collaboration with Moffitt Cancer Center in STIK 11, mutant non-small cell lung cancer, is open and screening for patients. We look forward to enrolling our first patient this year and initiating a Phase 2 trial in 2025. Last, on the clinical front, we are looking to initiate a neoadjuvant pancreatic investigator-initiated trial in the second half of this year. In addition to our clinical stage programs, we are also making progress in our preclinical development efforts.
Speaker Change: In Phase 1 development, we have two programs. Our Phase 1-2 collaboration with Moffitt Cancer Center in STIK 11, mutant non-small cell lung cancer, is open and screening for patients.
Speaker Change: We look forward to enrolling our first patient this year and initiating Phase 2 trial in 2025.
Jennifer Simpson: Last on the clinical front, we are looking to initiate the Neo-Agevant pancreatic investigator-initiated trial in the second half of this year.
Speaker Change: Last, on the clinical front, we are looking to initiate the neoadjuvant pancreatic investigator initiated trial in the second half of this year.
Jennifer Simpson: In addition to our clinical stage programs, we are also making progress in our pre-clinical development efforts. Currently, we are collaborating with MD Anderson Cancer Center on an ongoing research project. The primary goal of this initiative is to investigate the potential benefits of combining polyming metabolic inhibitor treatment with car key cell therapy and bi-specific monoclonal antibodies using pre-clinical models. This pre-clinical work complements our clinical programs and demonstrates our commitment to exploring innovative approaches to cancer treatment.
Speaker Change: In addition to our clinical stage programs, we are also making progress in our preclinical development efforts.
Jennifer Simpson: Currently, we are collaborating with MD Anderson Cancer Center on an ongoing research project. The primary goal of this initiative is to investigate the potential benefits of Combining Polyamine Metabolic Inhibitor Treatment with CAR-T cell therapy and bispecific monoclonal antibodies using preclinical models.
Speaker Change: Currently, we are collaborating with MD Anderson Cancer Center on an ongoing research project.
Speaker Change: The primary goal of this initiative is to investigate the potential benefits of combining polyamine metabolic inhibitor treatment with CAR-T cell therapy and bi-specific monoclonal antibodies using preclinical models.
Jennifer Simpson: This preclinical work complements our clinical program and demonstrates our commitment to exploring innovative approaches to cancer treatment. Additionally, in June, we were excited to announce that our collaborators at Vanderbilt University Medical Center presented oral findings at the recent Digestive Disease Recon. The presentation, titled Evaluation of the Safety and Efficacy of Aflornazine in Patients with Gastric Premalignant Conditions in High Incidence Areas of Latin America, highlighted the results of a Phase 2a placebo-controlled randomized clinical trial funded by the National Cancer Institute.
Speaker Change: This preclinical work complements our clinical programs and demonstrates our commitment to exploring innovative approaches to cancer treatment.
Jennifer Simpson: Additionally, in June, we were excited to announce that our collaborators at Vanderbilt University Medical Center presented oral findings at the recent Digestive Disease Week conference. The presentation titled Evaluation of the safety and efficacy of a foreign disease in patients with gastric cream malignant conditions in the high incidence areas of Latin America. Highlighted the results of a phase 2A placebo-controlled randomized clinical trial funded by the National Cancer Institute. The study demonstrated that a foreign disease, a key component of our polyming pathway approach, was safe, well-tolerated, and reduced DNA damage long-term in patients after completing treatment. These findings underscore the potential of targeting the polyming pathway for both prevention and treatment of cancer, particularly in patients with a high risk for developing infection-associated gastric cancer.
Speaker Change: Additionally, in June, we were excited to announce that our collaborators at Vanderbilt University Medical Center presented oral findings at the recent Digestive Disease Week conference.
Speaker Change: The presentation, titled Evaluation of the Safety and Efficacy of Aflornithine in Patients with Gastric Premalignant Conditions in the High Incidence Areas of Latin America
Speaker Change: highlighted the results of a phase 2a placebo-controlled randomized clinical trial funded by the National Cancer Institute.
Jennifer Simpson: The study demonstrated that fluorinibine, a key component of our polymine pathway approach, was safe, well-tolerated, and reduced DNA damage long-term in patients after completing treatment. These findings underscore the potential of targeting the polymine pathway for both prevention and treatment of cancer, particularly in patients with a high risk of developing infection-related gastric cancer.
Speaker Change: The study demonstrated that aflorinazine, a key component of our polymine pathway approach, was safe, well-tolerated, and reduced DNA damage long-term in patients after completing treatment.
Speaker Change: These findings underscore the potential of targeting the polymine pathway for both prevention and treatment of cancer, particularly in patients with a high risk for developing infection-associated gastric cancer.
Jennifer Simpson: We are thrilled that the progress made through this collaboration and look forward to further advancing our research in this area.
Jennifer Simpson: We are thrilled with the progress made through this collaboration and look forward to further advancing our research in this area. In summary, our projected second half of 2024 clinical milestones include enrolling our first patient in the non-small cell lung cancer phase 1 trial, opening the neoadjuvant pancreatic cancer trial, opening the phase two 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.
Speaker Change: We are thrilled with the progress made through this collaboration and look forward to further advancing our research in this area.
Jennifer Simpson: In summary, our projected second half of 2024 clinical milestones include enrolling our first patient in the non-small cell lung cancer phase 1 trial, opening the neo-adjuvant pancreatic cancer trial, opening the phase 2 ovarian trial, publishing the final phase 1-1-B metastatic pancreatic trial data, obtaining the FDA and EMAC back for global registration trial in FAP, and in 2025 we anticipate the overall survival intra-analysis for our phase 3 aspire trial in the first quarter of 2025, as well as the completion of enrollment. The second quarter and year-to-date have marked significant clinical development drives for Panbela. We look forward to continue progress and value creation in 2024.
Speaker Change: In summary, our projected second half of 2024 clinical milestones include
Speaker Change: enrolling our first patient in the non-small cell lung cancer phase one trial.
Speaker Change: opening the neoadjuvant pancreatic cancer trial, opening the phase 2 ovarian trial, publishing the final phase 1 1b metastatic pancreatic trial data, obtaining the FDA and EMA feedback for global registration trial in FAP,
Jennifer Simpson: And in 2025, we anticipate the overall survival interim analysis for our Phase 3 ASPIRE trial in the first quarter of 2025, as well as the completion of enrollment. The second quarter and year to date have marked significant clinical development strides for Panbela.
Speaker Change: And in 2025, we anticipate the overall survival interim analysis for our Phase 3 ASPIRE trial in the first quarter of 2025, as well as the completion of enrollment.
Speaker Change: The second quarter and year to date have marked significant clinical development strides for PAMBELLA. We look forward to continued progress and value creation in 2024.
Susan Horvath: 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 Horvath: I will now turn the call over to Sue to discuss our financial results.
Speaker Change: I will now turn the call over to Sue to discuss our financial results. Sue? Sue?
Sue Horvath: Sue? Thank you, Jennifer. General and administrative expenses were approximately 1.1 million in Q2 of 2024 compared to 1.6 million in Q2 of 2023. The decrease was primarily due to lower legal fees and lower non-cash compensation expenses in 2024. Research and development expenses were approximately 7 million in Q2 of 2024. Up from 4.2 million in the prior year quarter, mainly due to increased enrollment in the aspire trial. Net loss for the quarter was 7.1 million or $1.47 per diluted share compared to a net loss of $5.8 million or $1.59 in 15 cents per diluted share in Q2 of 2023.
Susan Horvath: Thank you, Jennifer. General and administrative expenses were approximately $1.1 million in Q2 of 2024, compared to $1.6 million in Q2 of 2023. The decrease was primarily due to lower legal fees and lower non-cash compensation expenses in 2024. Research and development expenses were approximately $7 million in Q2 of 2024, up from $4.2 million in the prior year quarter, mainly due to increased enrollment in the ASPIRE trial. The net loss for the quarter was $7.1 million or $1.47 per diluted share compared to a net loss of $5.8 million or $159.15 per diluted share in Q2 of 2023.
Sue Horvath: Thank you, Jennifer. General and administrative expenses were approximately $1.1 million in Q2 of 2024, compared to $1.6 million in Q2 of 2023.
Sue Horvath: The decrease was primarily due to lower legal fees and lower non-cash compensation expenses in 2024.
Speaker Change: Research and development expenses were approximately seven million in Q2 of 2024, up from 4.2 million in the prior year quarter, mainly due to increased enrollment in the ASPIRE trial.
Speaker Change: Net loss for the quarter was $7.1 million, or $1.47 per diluted share, compared to a net loss of $5.8 million, or $159.15 per diluted share in Q2 of 2023.
Sue Horvath: On April 28th, 2024, the company signed an amendment to the agreement with U.S. world meds. In exchange for a second non-refundable payment of approximately 0.8 million, the company agreed to give up to potential future payments associated with future milestones. This non-dilutive payment was received by the company at the signing of the amendment and is reflected in other income for the quarter. For the amended terms, total potential payments remaining, if milestones are achieved, is approximately 7.6 million.
Susan Horvath: On April 28, 2024, the company signed an amendment to the agreement with U.S. World Med. In exchange for a second non-refundable payment of approximately $0.8 million, the company 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 and is reflected in other income for the quarter. Under the amended terms, the total potential payments remaining, if milestones are achieved, are approximately $7.6 million.
Speaker Change: On April 28, 2024, the company signed an amendment to the agreement with U.S. World Meds.
Speaker Change: In exchange for a second non-refundable payment of approximately $0.8 million, the company agreed to give up two potential future payments associated with future milestones.
Speaker Change: This non-dilutive payment was received by the company at the signing of the amendment and is reflected in other income for the quarter.
Speaker Change: Per the amended terms, total potential payments remaining, if milestones are achieved, is approximately $7.6 million.
Sue Horvath: Total cash as of June 30th, 2024 was approximately $59,000. Total current assets were 0.8 million and current liabilities were 16.8 million at quarter end. Non-current assets consisting primarily of cash deposits found by our zero were 8.6 million. Regarding our capitalization, as of June 30th, 2024, we had approximately 4.85 million common shares outstanding. After including shares reserved for options and warrants, our issued and fully reserved share count was approximately 13.95 million shares.
Susan Horvath: Total cash as of June 30, 2024 was approximately $59,000. Total current assets were $0.8 million, and current liabilities were $16.8 million at quarter end. Non-current assets, consisting primarily of cash deposits settled by our CRO, were $8.6 million. Regarding our capitalization, as of June 30, 2024, we had approximately 4.85 million common shares outstanding. After including shares reserved for options and warrants, our issued and fully reserved share count was approximately 13.95 million shares.
Speaker Change: Total cash as of June 30, 2024 was approximately $59,000.
Speaker Change: Total current assets were $0.8 million and current liabilities were $16.8 million at quarter end.
Speaker Change: Non-current assets consisting primarily of cash deposits settled by our CRO were $8.6 million.
Speaker Change: Regarding our capitalization, as of June 30, 2024, we had approximately 4.85 million common shares outstanding.
Speaker Change: After including shares reserved for options and warrants, our issued and fully reserved share count was approximately 13.95 million shares.
Sue Horvath: Kass used in operations for the six months and did June 30, 2024, totaled approximately 10.4 million. Kass used in operations included our net loss for the six months, offset primarily by an increase in the company's accounts payable balance.
Susan Horvath: Cash used in operations for the six months ended June 30, 2024 totaled approximately $10.4 million, and gas used in operations included our net loss for the six months, offset primarily by an increase in the company's accounts payable balance on July 24th.
Speaker Change: Cash used in operations for the six months ended June 30, 2024 totaled approximately $10.4 million.
Speaker Change: Cash used in operations included our net loss for the six months offset primarily by an increase in the company's accounts payable balance.
Sue Horvath: On July 24, 2024, the company entered into a loan agreement with US Road Med LLC. Pursuant to a loan agreement, the company and our wholly owned subsidiary, CPP, obtained a term loan from the lender in the original principal amount of 1.5 million. The loan proceeds were used by the company for payment of fees and expenses owed to its contract research organizations for the Aspire trial.
Susan Horvath: In 2024, the company entered into a loan agreement with U.S. Rogue Med, LLC. Pursuant to the loan agreement, the company and our wholly owned subsidiary, CPP, obtained a term loan from the lender in the original principal amount of $1.5 million. The loan proceeds were used by the company for payment of fees and expenses owed to its contract research organization for the ASPIRE trial. Panbela's common stock remains 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.
Speaker Change: On July 24th...
Speaker Change: 2024, the company entered into a loan
Speaker Change: Pursuant to the loan agreement, the company and our wholly owned subsidiary CPP obtained a term loan from the lender in the original principal amount of 1.5 million.
Speaker Change: The loan proceeds were used by the company for payment of fees and expenses owed to its contract research organization for the ASPIRE trial.
Sue Horvath: Panbela's common stock remains eligible for quotation on the OTC QB under the symbol PBLA. The company is pursuing a new listing of its common stock on a national 30s exchange.
Speaker Change: Pembella's common stock remains 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: Operator, we are now ready to take questions. Certainly, everyone at this time be conducting a question and answer session. If you have any questions or comments, please press star one on your phone at this time.
Operator: Operator, we are now ready to take questions. Certainly, everyone will be conducting a question and answer session at this time. If you have any questions or comments, please press star 1 on your phone at this time. We do ask that while you are posing your question, please pick up your handset if you're listening on speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone. Please hold Wallypole for questions. Thank you. Your first question is coming from Joe Pantinginus from H.C. Wainwright.
Speaker Change: Operator, we are now ready to take questions.
Speaker Change: Certainly, everyone at this time will be conducting a question and answer session. If you have any questions or comments, please press star 1 on your phone at this time.
Operator: Good afternoon, everyone, and welcome to the Panbela Therapeutic Second Quarter 2024 Earnings Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation.
Operator: We do ask a while posing your question. Please pick up your handset if you're listening on speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press star one on your phone. Please hold Wallipoll for questions.
Speaker Change: We do ask that while posing your question, please pick up your handset if you're listening on speakerphone to provide optimum sound quality.
Speaker Change: Once again, if you have any questions or comments, please press star 1 on your phone.
James Carbonara: It is now my pleasure to turn the floor over to your host, James Carbonara, of Investor Relations. Sir, the floor is yours. Thank you, operator.
Speaker Change: Please hold Wallypole for questions.
James Carbonara: James Carbonara, Jennifer Simpson, Susan Horvath, James Carbonara
James Carbonara: 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 on 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.
Joshua Korsen: Thank you. Your first question is coming from Joe Pentinginess from H.C. Wainwright, your line is live.
Speaker Change: Thank you. Your first question is coming from Joe Pentanginas from HC Wainwright. Your line is live.
Joshua Korsen: Your line is live. Hello, this is Josh on behalf of Joe. I just had a question about the pediatric neuroblastoma program. I was wondering if there were any updates that you could give us in relation to the current status of the program with U.S. World Meds, ideally about the clinical development status or anything like that. Hi, Josh. Good evening. How are you.
James Carbonara: 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 reflect future events or circumstances.
Jennifer Simpson: Hello, this is Josh on for Joe. So I just had a question about the pediatric neuroblast stormer program. I was wondering if there were any updates that you could give us in relation to the current status of the program with U.S. world meds? I'd be really about like medical development status or anything like that.
Jennifer Simpson: Well, the so they have the XCA approval in the maintenance setting, and there was a trial that was run through Children's Oncology Group in the first-line setting. Enrollment, I believe, is done in that trial now, so now it's just letting the trial run its course. So in terms of anything more than that, that probably would have to be directed to U.S. World Med., but they do have an approval, and they are actively commercializing that indication that was approved in December of last year.
Speaker Change: Hello, this is Josh on for Joe. So I just had a question about the pediatric neuroblastoma program. I was wondering if there were any updates that you could give us in relation to the current status of the program with U.S. World Meds, ideally about like clinical development status or anything like that?
Jennifer Simpson: Hi Josh, good evening. How are you? Well, they have the FDA approval in the maintenance setting. There was a trial that has been run through Children's Oncology Group in the first line setting. Enrollments, I believe, have done in that trial now, so now it's just letting the trial run its course.
Operator: All right, perfect, thank you. Thank you. Once again, everyone, if you have any questions or comments, please press star, then one on your phone. Please hold while we poll for questions. Thank you.
Speaker Change: Hi, Josh. Good evening. How are you? I'm well. So they have the...
Jennifer Simpson: With that, I will turn the call over to the company CEO, Jennifer Simpson. Dr. Simpson, please go ahead.
Speaker Change: The XCA approval in the maintenance setting, there was a trial that has been run through Children's Oncology Group in the first-line setting. Enrollment, I believe, is done in that trial now, so now it's just, you know, letting the trial run its course.
Jennifer Simpson: Thank you, James, and thank you all for joining us. I will start today's call by discussing our clinical development program, our recent achievements, and upcoming milestones. Then Sue will review our financial results before we open up the call for Q&A. Beginning with our phase 3, Aspire Global Clinical Trial. Aspire is evaluating Iver Semen, or SDP 101, in combination with Gempside Abbein and NADPAC Botoxyl, for patients with untreated metastatic tankrietic ductal adenocarcinoma.
Jennifer Simpson: So, in terms of anything more than that, that probably would have to be directed to U.S. world med. But they do have an approval, and they are actively commercializing that indication that was approved in December of last year.
Speaker Change: so in in terms of anything more than that that probably would have to be directed to US World Med but if they do have an approval and they are actively commercializing that indication that was approved in December of last year
Joshua Korsen: Perfect.
Operator: Thank you. Once again, everyone, if you have any questions or comments, please press star a thin one on your phone. Please hold while you pull for questions.
Speaker Change: All right, perfect. Thank you.
Jennifer Simpson: We were excited to announce in June that the independent data safety monitoring board, or DSMB, recommended study continuation without modification, marking the third consecutive positive safety review. At that time, we shared that the safety database had reached 395 patients, compared to 214 patients on November 29, 2023. As you may recall, in January, the Aspire enrollment surpassed 50 percent, preceding faster than initially anticipated. With all sites open and actively enrolling, we reiterate our expectation for full enrollment of approximately 600 patients to be completed by the first quarter of 2025.
Speaker Change: Thank you. Once again, everyone, if you have any questions or comments, please press star, then 1 on your phone. Please hold while we poll for questions.
Operator: Dr. Johnson. Thank you.
Speaker Change: Thank you very much for watching this video, and if you enjoyed this video, please leave a like, share, and subscribe to the channel.
Operator: That completes our Q&A session.
Operator: Everyone that concludes today's event, you may disconnect at this time and have a wonderful day. Thank you for your participation.
Jennifer Simpson: With respect to interim data, the Aspire trial requires 33 percent of a total expected event or death to occur before the interim analysis can be conducted. In April, we announced that less than half of the required events or deaths for the interim analysis had occurred. Consequently, the Aspire's trial's interim analysis, initially expected in the middle of 2024, is now projected for early 2025, due primarily to patients prolonged survival, suggesting the potential benefit of idle specimens, in treating metastatic pancreatic structural adenocarcinoma.
Jennifer Simpson: This encouraging development follows the FDA's approval of the Nail or Fox Regimen, which demonstrated a relatively modest 1.9-month improvement in median overall survival, compared to gem-sighted gene and and Michael. Despite this regulatory milestone, metacetic pancreatic cancer prognosis remains grim, with median survival still under 12 months, underscoring the critical need for more effective treatment. In this context, we believe that I was feminine, or SCP-101, combined with the standard care regimen of jump side-to-been and napapotexal holds promise, with early aspire trial indications suggesting the potential to outperform the incremental benefits of recently approved therapies.
Jennifer Simpson: Given the current regulatory landscape in metacetic pancreatic cancer, we anticipate that the potential of adverse feminine efficacy may position it favorably for an FDA approval. The company remains steadfast in its commitment to this transformative study and eagerly awaits the interim results in Q-1 2025, which we expect could signal a turning point in the treatment landscape for patients facing this formidable disease.
Jennifer Simpson: Our commitment to advancing the familial adnomitus polyposis or FAP program remains strong as we continue to work closely with the FDA, EMA and the FAP community. Upon reaching a consensus on a global registration plan, we plan to progress this program while exploring strategies to optimize its value.
Jennifer Simpson: Regarding the PACES trial, a phase 3 study investigating slimpovy for the prevention of high risk adnoma and 2nd primary colorectal cancers, we are pleased enrollment has concluded. With the study successfully passing that planned utility analysis, we expect data read out by the second half of 2026. This study, supported by the NCI and conducted by the Southwest and College Group, or SLOG, has the potential to reduce the 3-year event rate of adnomitus and 2nd primary colorectal cancers in patients previously treated for stages 0-3 on a rectal cancer.
Jennifer Simpson: Just in focus to phase 2 studies, in April, we saw additional monetization from the cell of assets from the Affleurnathy and Pediatric NeuroBlastoma program. We received an additional 775,000 obtained in place of U.S, cell milestones in the later years. As U.S, low-meds reaches key milestones, PANBELLA is positioned to receive further payments. It is worth reiterating that in December, U.S, world med secured FCA approval for its NDA for Affleurnathy, representing the first FCA approval of polyming targeted therapy in a cancer indication.
Jennifer Simpson: This approval not only provides financial benefits to PANBELLA, but also serves to validate the potential role of polyming in cancer therapy as we continue to progress our other programs. We have also entered into a clinical trial agreement for a phase 2 study of Affleurnathy and CASTration-resistant metacetic prostate cancer, which is actively recruiting patients. The phase 2 affleurnathy and type 1 diabetes is a multi-center, double-blind, placebo-controlled trial with a true-to-one randomization ratio, conducted under the leadership of Indiana University's School of Medicine and supported by JDRF.
Jennifer Simpson: All six participating centers are now open and enrolling patients with an intro-analysis expected to take place next year. Furthermore, we are in the process of planning a phase two trial to assess Ivo Semen, in platinum-resistant ovarian cancer, which we aim to initiate in collaboration with Johns Hopkins University School of Medicine, during the latter half of this year. In fact, in April at the American Association for Cancer Research, or AACR Annual Meeting, we presented a poster showcasing Ivo Semen's efficacy as a polyming metabolism modulator in ovarian cancer.
Jennifer Simpson: The encouraging data of complete pre-clinical investigations offer a robust basis as we gear up to launch our ovarian cancer clinical program in the latter part of this year, upcoming trials are designed to assess Ivo Semen in conjunction with additional polyming metabolism modulators and immune modulators. In phase one development, we have two programs. Our phase one-two collaboration with Moffat Cancer Center in stick 11 mutant non-small-cell lung cancer is open and screening for patients.
Jennifer Simpson: We look forward to enrolling our first patient this year and initiating phase two trial in 2025. Last on the clinical front, we are looking to initiate the Neo-Agevant pancreatic investigator initiated trial in the second half of this year.
Jennifer Simpson: In addition to our clinical stage programs, we are also making progress in our pre-clinical development efforts. Currently, we are collaborating with MD Anderson Cancer Center on an ongoing research project. The primary goal of this initiative is to investigate the potential benefits of combining polyming metabolic inhibitor treatment with car key cell therapy and bi-specific monoclonal antibodies using pre-clinical models. This pre-clinical work compliments our clinical programs and demonstrates our commitment to exploring innovative approaches to cancer treatment.
Jennifer Simpson: Additionally, in June, we were excited to announce that our collaborators at Vanderbilt University Medical Center presented oral findings at the recent Digestant Disease Week conference. The presentation titled evaluation of the safety and efficacy of a foreign disease in patients with gastric cream malignant conditions in the high incidence areas of Latin America. Highlighted the results of a phase 2A placebo controlled randomized clinical trial funded by the National Cancer Institute. The study demonstrated that a foreign disease, a key component of our polyming pathway approach was safe, well-tolerated, and reduced DNA damage long-term in patients after completing treatment.
Jennifer Simpson: These findings underscore the potential of targeting the polyming pathway for both prevention and treatment of cancer, particularly in patients with a high risk for developing infection associated gastric cancer. We are thrilled that the progress made through this collaboration and look forward to further advancing our research in this area.
Jennifer Simpson: In summary, our projected second half of 2024 clinical milestones include, enrolling our first patient in the non-smossile lung cancer phase 1 trial, opening the neo-adjuvant pancreatic cancer trial, opening the phase 2 ovarian trial, publishing the final phase 1-1-B metastatic pancreatic trial data, obtaining the FDA and EMAC back for global registration trial in FAP, and in 2025 we anticipate the overall survival intra-analysis for our phase 3 aspire trial in the first quarter of 2025, as well as the completion of enrollment. The second quarter and year-to-date have marked significant clinical development drives for Panbela. We look forward to continue progress and value creation in 2024.
Susan Horvath: I will now turn the call over to Sue to discuss our financial results. Sue? Thank you, Jennifer. General and administrative expenses were approximately 1.1 million in Q2 of 2024 compared to 1.6 million in Q2 of 2023. The decrease was primarily due to lower legal fees and lower non-cash compensation expenses in 2024. Research and development expenses were approximately 7 million in Q2 of 2024. Up from 4.2 million in the prior year quarter mainly due to increased enrollment in the aspire trial. Net loss for the quarter was 7.1 million or $1.47 per diluted share compared to a net loss of $5.8 million or $159 in 15 cents per diluted share in Q2 of 2023.
Susan Horvath: On April 28th, 2024, the company signed an amendment to the agreement with U.S, world meds. In exchange for a second non-refundable payment of approximately 0.8 million, the company agreed to give up to potential future payments associated with future milestones. This non-dilutive payment was received by the company at the signing of the amendment and is reflected in other income for the quarter. For the amended terms, total potential payments remaining if milestones are achieved is approximately 7.6 million.
Susan Horvath: Total cash as of June 30th, 2024 was approximately 59,000. Total current assets were 0.8 million and current liabilities were 16.8 million at quarter end. Non-current assets consisting primarily of cash deposits found by our zero were 8.6 million.
Susan Horvath: Regarding our capitalization, as of June 30th, 2024, we had approximately 4.85 million common shares outstanding. After including shares reserved for options and warrants, our issued and fully reserved share count was approximately 13.95 million shares.
Susan Horvath: Kass used in operations for the six months and did June 30, 2024, totaled approximately 10.4 million. Kass used in operations included our net loss for the six months, offset primarily by an increase in the company's accounts payable balance.
Susan Horvath: On July 24, 2024, the company entered into a loan agreement with US Road Med LLC. Pursuant of a loan agreement, the company and our wholly owned subsidiary, CPP, obtained a term loan from the lender in the original principal amount of 1.5 million. The loan proceeds were used by the company for payment of fees and expenses owed to its contract research organizations for the Aspire trial.
Susan Horvath: Panbela's common stock remains eligible for quotation on the OTC QB under the symbol PBLA. The company is pursuing a new listing of its common stock on a national 30s exchange.
Operator: Operator, we are now ready to take questions. Certainly, everyone at this time be conducting a question and answer session. If you have any questions or comments, please press star one on your phone at this time.
Operator: We do ask a while posing your question. Please pick up your handset if you're listening on speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press star one on your phone. Please hold Wallipoll for questions.
Operator: Thank you.
Operator: Your first question is coming from Joe Pentinginess from H.C. Wainwright, your line is live. Hello, this is Josh on for Joe.
Joshua Korsen: So I just had a question about the pediatric neuroblast stormer program. I was wondering if there were any updates that you could give us in relation to the current status of the program with U.S, world meds? I'd be really about like medical development status or anything like that.
Jennifer Simpson: Hi Josh, good evening. How are you? Well, they have the the FDA approval in the maintenance setting. There was a trial that has been run through children's oncology group in the first line setting. Enrollments, I believe, have done in that trial now, so now it's just letting the trial run its course. So in terms of anything more than that, that probably would have to be directed to U.S, world med. But they do have an approval and they are actively commercializing that indication that was approved in December of last year.
Joshua Korsen: Perfect.
Operator: Thank you.
Operator: Once again everyone, if you have any questions or comments please press star a thin one on your phone. Please hold while you pull for questions.
Operator: Dr. Johnson. Thank you.
Operator: That completes our Q&A session.
Operator: Everyone that concludes today's event, you may disconnect at this time and have a wonderful day. Thank you for your participation.