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..

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..

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?.

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..

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

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?.

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..

Okay.

And maybe you can tell us about -- anything about , just some specific hurdles we can think about?.

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..

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?.

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..

Okay. Thank you very much for the update..

Certainly..

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

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..

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..

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..

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 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..