5/15/2024

speaker
Operator

Good afternoon, everyone, and welcome to the Panbella 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, over to you.

speaker
James

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 reflect future events or circumstances. With that, I will turn the call over to Dr. Simpson. Jennifer, please go ahead.

speaker
Jennifer

Thank you, James, and thank you all for joining us. I will start by discussing our clinical development programs, recent achievements, and upcoming milestones. Then Sue will review our financial results before we open up the call for Q&A. Let us begin with our phase three ASPIRE global clinical trial. ASPIRE is evaluating ibuprofen or SPP-101 in combination with gemcitabine and nabpaclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. We were excited to announce in January that the ASPIRE enrollment had surpassed 50%, proceeding faster than initially anticipated. 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. As of the latest assessment, less than half of the required events for the interim analysis had occurred. 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 first quarter 2025. This is a positive development for patients and underscores the potential of ibospemin 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 fetal adenocarcinoma treatment, such as the NAPLI-3 trials, which led to the approval of liposomal arenatechin, or Onivide, in combination with Floracil, Oxaliplatin, and Leucovorn, known as the Naller-Fox regimen. 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 endocarcinoma 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 Onivide in the Niller-Flax regimen demonstrating the 1.9-month survival benefit compared to the approval of gemcitabine and nabpaclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. 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. Turning to our familial adenomatous 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. In our PACES trial, a phase three study of plenpovy 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 two studies, In September, we entered into an agreement with U.S. Rural Meds to divest assets from the aflornithine pediatric neuroblastoma program. PAMBELLA 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. PAMBELLA stands to receive additional payments as U.S. Rural Meds achieves key milestones. As a reminder, in December, U.S. World Meds received FDA approval of its NDA for flornithine, marking the first FDA approval of a polyamine-targeted therapy in a cancer indication. This approval not only benefits Pambella financially, but also helps to validate the role polyamines can play in cancer therapy as we advance our other programs. We also entered into a clinical trial agreement for a Phase II trial of a flornithine, in castration-resistant metastatic prostate cancer. This study is actively enrolling. The phase two of thornithine trial in type 1 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 JDRF. All six centers are open and enrolling patients with an anticipated interim analysis next year. We are also planning a phase two study, evaluating ibisbemin 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 AACR's annual meeting, we presented a poster highlighting the efficacy of ibisbemin as a polyamine metabolism modulator in ovarian cancer. Ivosfemin 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 dosing schemes. The results suggest that SVP-101 in combination with doxorubicin, may have a role in the clinical management of ovarian cancer. In particular, it's difficult to treat platinum-resistant populations where few options exist. These studies continue to support the basis for moving into a clinical trial program in ovarian cancer with a 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 SVP101 in both cisplatin sensitive and cisplatin resistant ovarian cancer cell lines. SVP101 and doxorubicin cooperatively increased polyamine catabolism and decreased overall cell survival in vitro. In an immunocompetent mouse model of ovarian cancer, the combination of SPT-101 and doxorucin significantly increased median survival time, delayed ascites formation, and decreased overall tumor burden. Interestingly, this survival benefit was not inserved in the 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 IVO7 in combination with other polyamine metabolism modulators, as well as immune modulators. In Phase I development, we have two programs. Our Phase I-II collaboration with Moffitt Cancer Center is open and screening. 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 Graphic 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 polyamide metabolic inhibitor therapies with CAR-T cell therapies and bispecific monoclonal antibodies in preclinical models. We recently announced the acceptance of an abstract detailing research on SPP101 and and FloraLoma cell lines for online publication at the ASH 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 a FloraLoma and Sulandoc. In summary, our projected first half 2024 milestones include enrolling our first patients 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 II ovarian trial, publishing the final Phase I-Ib metastatic pancreatic trial data, and obtaining FDA and EMA feedback for a global registration trial in FAP. And in 2025, early on, we anticipate overall survival interim analysis for our Phase III Aspire trial in the first quarter, and the opening of the non-small cell lung cancer phase two trial in the first half of the year. The first quarter and year to date have marked significant clinical development strides for PAMBELLA. 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
Sue

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. 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. Total cash as of March 31, 2024, was approximately $260,000, which includes 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 at quarter end. 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 per the terms of the note. Regarding our capitalization, as of March 31st, 2024 we had approximately 4.85 million common shares outstanding including shares reserved for options and warrants are issued in fully reserved share count was 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 supply of standard of care chemo adages. In January, we closed the $9 million public offering with net proceeds of approximately 8.1. On April 28, 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, total potential payments remaining, if these milestones are achieved, is approximately $7.6 million. During the quarter, Panbello's common stock was suspended from trading on NASDAQ. It 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
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 keys. Please wait a moment whilst we poll for questions. Thank you. Your first question is coming from Jonathan Ashoff of Roth MKM. Jonathan, your line is live.

speaker
Jonathan

Thank you. Good afternoon. I was wondering, you know, can you tell us the stopping criteria for the hopefully 1Q25 Aspire interim, you know, for both for efficacy and for futility? Can you just close that?

speaker
Jennifer

Hi, Jonathan. How are you today? The interim analysis is based on approximately 33% of the total events. The total events that we're looking for is 512, so basically about 170 events. It is actually a superiority. In terms of stopping, I think 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 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.

speaker
Jonathan

Okay, Miu, maybe can you tell us about anything about alpha spend, just some sort of statistic hurdle we can think about?

speaker
Jennifer

Yeah, so 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 spends for the interim analysis is actually quite small.

speaker
Jonathan

Okay. You know, and do you think that the 1Q25 timing is at risk or are the events occurring, you know, that are occurring still strongly tracking to 1Q25?

speaker
Jennifer

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
Jonathan

Okay. Thank you very much for the update.

speaker
Jennifer

Certainly.

speaker
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 Pangenis of HC Wainwright. Joe, your line is live.

speaker
Joe Pangenis

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?

speaker
Sue

Sure. Well, We did raise a portion of the cash that we needed in the first quarter in January, but certainly not sufficient to keep up for our burn rate. Right now, last year, we were burning close to six and a half per quarter if we excluded the bracing that we were required to purchase. the enrollment increases that burn rate will probably jump in 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 up list on to also raise the capital that's identified in that S-1.

speaker
Joe Pangenis

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
Sue

Yes, that was included in there because those proceeds were received in January, but we burned on top of that 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 to our next step in fundraising. Perfect.

speaker
Joe Pangenis

Thank you so much.

speaker
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.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-