Panbela Therapeutics, Inc. (NASDAQ:PBLA) Q1 2024 Earnings Call Transcript

Panbela Therapeutics, Inc. (NASDAQ:PBLA) Q1 2024 Earnings Call Transcript May 15, 2024

Panbela Therapeutics, Inc. misses on earnings expectations. Reported EPS is $-2.28 EPS, expectations were $-1.23.

Operator: Good afternoon, everyone, and welcome to the Panbela Therapeutics First Quarter 2024 Earnings Call. [Operator Instructions]. 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 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. With that, I will turn the call over to Dr. Simpson. Jennifer, please go ahead.

Jennifer 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. Let us begin with our Phase III ASPIRE global clinical trial. ASPIRE is evaluating ivospemin, or SBP-101, in combination with gemcitabine and nab-paclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. We were excited to announce in January that the ASPIRE enrollment has surpassed 50%, proceeding faster than initially anticipated. With all sites are 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 ivospemin 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 NAPOLI 3 trial, which led to the approval of liposomal irinotecan, or ONIVYDE, in combination with fluorouracil, oxaliplatin, and leucovorin, known as the NALIRIFOX regimen.

Despite this approval, which was based on the median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with metastatic pancreatic ductal adenocarcinoma remains poor, with median overall survival still less than 12 months. The incremental benefit and median survival have been modest in the past 11 years with the recent approval of ONIVYDE and NALIRIFOX regimen demonstrating the 1.9-month survival benefit compared to the approval of gemcitabine and nab-paclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. We believe that the addition of ivospemin, or SBP-101, to the standard-of-care regimen of gemcitabine 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.

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 III study of Flynpovi for the prevention of high-risk adenoma 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 the planned futility analysis.

Moving on to our Phase II study. In September, we entered into an agreement with US WorldMeds to divest assets from the eflornithine pediatric neuroblastoma program. Panbela has received an upfront payment of $400,000 with an additional $775,000 received in lieu of US sales milestones in the latter years. Panbela stands to receive additional payments as US WorldMeds achieves key milestones. As a reminder, in December, US WorldMeds received FDA approval of its NDA for eflornithine, marking the first FDA approval of polyamine-targeted therapy in a cancer indication. This approval not only benefit Panbela financially, but also help also helped to validate the role that polyamine 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 eflornithine in castration-resistant metastatic prostate cancer.

This study is actively enrolling. The Phase II eflornithine trial in type 1 diabetes is a multi-center, double-blind, placebo-controlled 2:1 random assigned clinical trial led by Indiana University’s 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 II study evaluating ivospemin 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 ivospemin as a polyamine metabolism modulator in ovarian cancer.

Ivospemin 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 scheme. The results suggest that SBP-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. 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 need.

The poster provided additional details on the preclinical studies. Treatment with doxorubicin significantly increased the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increased polyamine metabolism and decreased overall cell survival in vitro. In an immunocompetent mouse model of ovarian cancer, the combination of SBP-101 and doxorubicin significantly increased median survival time, delayed ascites formation, and decreased overall tumor burden. Interestingly, this survival benefit was not [indiscernible] in the immunodeficient mice, indicating an intact immune system is required for the efficacy of the 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 ivospemin 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 [Technical Difficulty] is open and screening. We anticipate enrolling our first patient first half of this year and initiating the Phase II trial in the first half of 2025. Finally, we are looking to initiate investigator initiative in the second half of this year. In the preclinical setting, we are also engaged in ongoing research initiatives with MD Anderson Cancer Center, focusing on evaluating polyamine 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 SBP-101 [Technical Difficulty] cell lines for online publication at the ASH meeting. On the IP front, we recently announced the issuance of a new patent in US and Canada. This patent is for claim for the fixed dose combination of eflornithine and sulindac. In summary, our projected first-half 2024 milestones include enrolling our first patient in the non-small cell lung cancer Phase I trial, announcing gastric cancer prevention Phase II 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 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 II trial in the first half of the year. The first quarter and year to date have marked significant clinical development drive 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?

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 is 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 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 31, 2024, we had approximately 4.85 million common shares outstanding. Including shares reserved for options and warrants, our issued and 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 agents.

In January, we closed a $9 million public offering with net proceeds of approximately $8.1 million. On April 28, 2024, the company signed an amendment to our 2023 agreement with US WorldMeds in exchange for a second non-refundable payment of approximately $0.8 million. The company has agreed to give up to potential future payments associated with future milestones. This non-dilutive payment was received by the company after 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, Panbela’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.

Q&A Session

Operator: [Operator Instructions] Your first question is coming from Jonathan Aschoff of Roth MKM.

Jonathan Aschoff: Thank you. Good afternoon. I was wondering, can you tell us the stopping criteria for the, hopefully, 1Q ’25 ASPIRE interim for both for efficacy and for futility? Can you just quote that?

Jennifer Simpson: 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. And so it would — 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. We had a very interesting thing happening, right? 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 about the same time.

Jonathan Aschoff: Okay. And maybe you can tell us about — anything about , just some specific hurdles we can think about?

Jennifer Simpson: 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 spend for the interim analysis is actually quite small.

Jonathan Aschoff: Okay. And do you think that the 1Q ’25 timing, is there risk of the events occurring — that are occurring still strongly tracking to 1Q ’25?

Jennifer Simpson: At this specific time, I’d say we’re still tracking to 1Q ’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 our first quarter.

Jonathan Aschoff: Okay. Thank you very much for the update.

Jennifer Simpson: Certainly.

Operator: [Operator Instructions]. Your next question is coming from Joe Pantginis of H.C. Wainwright.

Unidentified Analyst: 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. 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 in January, but certainly not sufficient to keep up for our burn rate right now. Last year, we were burning close to per quarter if we excluded the abraxane that we were required to purchase. That is the enrollment increases that burn rate will probably jump in closer to per quarter. You might have noticed the filing of an S-1 that was completed in April. It would be our intention as we look to find a national exchange to uplift that and to also raise the capital that’s identified in that S1.

Unidentified Analyst: 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 rates.

Susan Horvath: It was — yes, that was included in there because those proceeds are received in January. But we burned — on top of that was 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 US WorldMeds in April, which was basically a bridge to help us to our next step in fundraising.

Operator: [Operator Instructions]. 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.