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spk04: Greetings. Welcome to Panbella Therapeutics' fourth quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, James Carbonara, Investor Relations. James, you may begin.
spk00: Thank you, Operator. With me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath, Chief Financial Officer. Before I turn the call, please note that statements made on this call that are not historical facts may be forward-looking statements. Significant risks and uncertainties that could cause actual results to differ from those expressed or implied in the forward-looking statements are detailed in the company's annual report on Form 10-K, and supplemented by subsequently filed reports on Form 10-Q, as well as in other reports that the company has filed with the SEC. Any forward-looking statements made on this call are made only as of today's date, and the company does not undertake any obligation to update or supplement any such statements to reflect subsequent developments. Now, I would like to turn the call over to Jennifer Simpson, CEO of Panvala. Jennifer, please proceed.
spk02: Thank you, James, and thank you, everyone, for joining. I will begin the call with a review of our clinical development program, recent accomplishments, and upcoming milestones. Stu will then follow with a review of the financial results, and then we will open it up for Q&A. So let's start with our phase three initiative, specifically the ASPIRE Global Clinical Trial. ASPIRE is a global, randomized, double-blind, placebo-controlled study designed to assess ibospemin, or SBP101, in conjunction with gemcitabine and Mabpaclitaxel for patients with untreated metastatic pancreatic ductal adenocarcinoma. During Q4, the Independent Data Safety Monitoring Board, or DSMB, completed its second pre-specified review of safety data for treated patients, which included the first 214 patients in the trial. The DSMB has recommended that the study continue without modification. Then, in January, we surpassed 50% enrollment for the ASPIRE trial, moving faster than originally projected. As we have reached the full complement of sites open and enrolling, we have seen a steady cadence of enrollment, expecting full enrollment to be completed by the first quarter of 2025. We are looking forward to the interim data analysis based on overall survival. We originally projected this to occur in mid-2024, However, we have not seen enough deaths at this time. With patients living longer, we are evaluating the data and working to update the expected timing for the interim analysis. There also has been positive movement in the metastatic pancreatic cancer treatment landscape. Based on the NAPLI-3 trial, Onabide was approved in February for use within the Neller Fox regimen for first-line metastatic pancreatic cancer. This approval was based on a 1.9-month median overall survival benefit, 11.1 months in the treatment arm versus 9.2 months for the control arm, which was gemcitabine and abraxane. This approval is significant to Pembella for a number of reasons. It is the first approval in first-line metastatic pancreatic cancer in approximately 11 years. The 1.9-month survival benefit is similar to the approval of gemcitabine and abraxane versus gemcitabine in the MPACT trial. Additionally, for the ASPIRE trial, it helps to validate the assumed median survival of the control arm, which has not changed greatly since its original approval 11 years ago with a median survival of 8.5 months in the MPACT trial. With enrollment of the ASPIRE trial moving faster than anticipated, we look forward to the overall survival interim analysis and the completion of the trial in the hope that our product may be a potential option for patients in the future. Turning to familial adenomatous polyposis, or FAP, PAMBELLA remains committed to collaborating with the FDA, EMA, and the FAP community to move this program forward with the goal of bringing a novel treatment option for FAP patients. Once we obtain consensus on a global registration plan among the FDA and EMA, We plan to advance this initiative while upholding our established cost model. Concurrently, we intend to explore ways to maximize the value of this asset. Moving on to the PACES trial, our phase three double-blind, placebo-controlled study of Sympovy aims to prevent the recurrence of high-risk adenomas and second primary colorectal cancers in patients diagnosed with stage zero to three colorectal cancer. As a reminder, the PACEY trial receives funding from the National Cancer Institute, or NCI, and is being run by the Southwest Oncology Group, also known as SWOG. The study successfully cleared a planned futility analysis, and enrollment is complete. We expect data by the second half of 2026. Shifting gears to Phase II studies, in July, we announced an agreement with U.S. World Meds to divest assets from the Aflornitine Pediatric Neuroblastoma Program for non-dilutive payments of up to $9.5 million. Pembela has already received an initial upfront payment of $400,000 and stands to receive further payments as U.S. World Meds achieves key milestones related to aflornithine's clinical advancement, regulatory approval, and commercial sales. To that end, in December, U.S. World Meds received FDA approval of its new drug application, or NDA, for aflornithine, marking the first FDA approval of an NDA for any polyamine targeted therapy and a cancer indication. As mentioned, PAMBELLA benefits financially from this continued advancement of the program. Additionally, this approval validates the role polyamines can play in cancer therapy as we look forward to data from our ongoing programs that we are discussing today in metastatic pancreatic cancer, colorectal cancer, non-small cell lung cancer, and prostate cancer, as well as the advancement of preclinical programs in ovarian cancer and multiple myeloma. Continuing with phase two trials, in September, we entered into a clinical trial agreement for a phase two trial in castration-resistant metastatic prostate cancer, or CRPC. Leveraging preclinical models that demonstrate a potential role for polyamines in androgen-resistant prostate cancers, this clinical trial will determine if the addition of a fluornithine to the treatment regimen will demonstrate further efficacy in these difficult-to-treat patients. The study is actively enrolling. Staying with phase two investigations, the phase two trial for CPP1X, or aflornadine, is led by Indiana University School of Medicine and financially supported by the Juvenile Diabetes Research Foundation, or JVRF. Results show that DFMO or aflornadine treatment may preserve beta cell function, reflected by C-peptide levels in patients with type 1 diabetes through the modulation of urinary polyamines, in particular putrescine. There is a pressing need for the development of safe and effective treatments addressing the underlying cause of early-stage disease, and we are thrilled to champion this initiative with JDRF and the Indiana University School of Medicine. This trial continues to enroll patients. As a reminder, this study referred to as the TAGPOL study, is a multicenter, double-blind, placebo-controlled, two-to-one random assigned phase two trial for individuals with recent onset type 1 diabetes. The study is enrolling approximately 70 patients, and an interim analysis is anticipated next year. In phase one development, we have three programs that we plan to initiate. We are currently engaged in a clinical trial collaboration with Moffitt Cancer Center for a phase 1-2 program designed specifically for patients with SICK11 mutant non-small cell lung cancer. In the phase 1 trial's initial stages, our objective is to determine the maximum tolerated dose of aflornadine in conjunction with pembrolizumab while simultaneously evaluating its efficacy. Following this phase, our intention is to advance into a phase 2 trial to further assess effectiveness. The study is open and screening patients, and we anticipate enrolling our first patient in the first half of this year with plans to initiate the phase two trial in the latter half of the year. Our second phase one program, scheduled to begin in the first half of this year, will focus on evaluating ibuprofen in the platinum resistant ovarian cancer population. This endeavor underscores the ongoing collaboration between the company and Johns Hopkins University School of Medicine. Third, we are also engaged in an ongoing collaborative research initiative with the University of Texas MD Anderson Cancer Center, focusing on evaluating polyamine metabolic inhibitor therapies along CAR-T cell therapies and bispecific monoclonal antibodies in preclinical models. Recently, we announced the acceptance of an abstract detailing research on SPP-101, or IVOS-7, and CPP-1X, or flornithine, in multiple myeloma cell lines for online publication at the American Society of Hematology Meeting, or ASH meeting, and it was included in the November supplemental issue of the journal Blood. PAMBELLA's new programs place focus on the modulation of the immune system by polyamines. Our initial clinical proof of concept involves polyamine-targeted therapy combined with a checkpoint inhibitor for patients with STIK11 mutant non-muscle lung cancer. We are excited about expanding this research collaboration to explore the potential benefits of polyamines in immune modulation for hematologic malignancies. Finally, we are currently engaged in collaborative efforts with key opinion leaders to start the neoadjuvant pancreatic investigator initiative. We are in the advanced stages of securing the necessary institutional approvals to initiate the trial in the first half of this year. Turning briefly to our intellectual property or IP efforts, We strengthen our portfolio by announcing the issuance of new patents in China, Australia, and Europe. These patents cover claims of a novel process for the production of SBP101, a product developed in collaboration with FinGene International Limited. In closing, our unyielding commitment is to advance our development program for the benefit of patients worldwide. To summarize our projected milestones, We expect in the first half of 2024 to open the neoadjuvant pancreatic cancer trial, enroll our first patient in the non-small cell lung cancer phase one trial, to open the phase one ovarian trial, to announce gastric cancer prevention phase two results, publication of the final phase one 1B metastatic pancreatic trial data, and the overall survival interim analysis of the phase three Aspire trial, which we originally projected for the middle of 2024. However, with not enough events or deaths at present, we are working to evaluate the data so that we may update the projected timing. And in the second half of 2024, we anticipate to obtain feedback from the FDA and EMA for global registration in FAP and to open the non-small cell phase two trial, non-small cell lung cancer phase two trial. In summary, the fourth quarter and year to date have marked significant strides for PAMBELLA. We are enthusiastic about the ongoing creation of value for our shareholders as we progress in 2024. I will now turn it over to Sue.
spk01: Thank you, Jennifer. General and administrative expenses were $0.9 million in the fourth quarter of 2023 compared to $1.7 million in the fourth quarter of 2022. This decreases the results of lower professional fees in 2023 versus 2022. Research and development expenses were $6.1 million in the fourth quarter of 2023 compared to $3.5 million in the fourth quarter of 2022. The increase is primarily due to the increased activity in the ASPIRE trial. All share and per share amounts of our common stock presented here and in our report 10-K have been retroactively adjusted reflect the reverse stock splits completed in January of 2024 as well as those that occurred in 2023. Net loss in the fourth quarter of 2023 was $6.5 million or $65.90 per diluted share compared to a net loss of $4.7 million or $344.61 per diluted share in the fourth quarter of 2022. Total cash was approximately 2.6 million as of December 31st, 2023, which does not include proceeds from the $9 million public offering we closed in January. Total current assets were 3.1 million and current liabilities were 12.3 million as of the end of the quarter on December 31st, 2023. Total non-current assets consisting primarily of cash deposits held by our contract research organization were $8.7 million. As a result of the CPP acquisition in Q2 of 2022, we added debt and accrued interest to our balance sheet. During the quarter ended December 31st, 2023, no debt or interest payments were due or paid. The principal balance remaining on the notes is $5.2 million, and there was approximately $238,000 of accrued and unpaid interest as of that date. The current portion of $1 million plus the accrued interest was paid per the terms of the note earlier this month. Looking to the cap table, first, a reminder, all shares have been retroactively restated for the reverse split. that occurred on January 18th. As of December 31st, 2023, we had approximately 480,000 common shares outstanding. And including shares reserved for options and warrants, we were at a total of approximately 826,000 shares. The shares reserved number includes all outstanding equity awards, including stock options, which were held primarily by insiders and all warrants to purchase common stock. Our cash used in operations for the year ended December 31st, 2023 totaled approximately $25.2 million. Cash used in operations for the year ended December 31st, 2023 included approximately $3.7 million in payments necessary to secure a supply of standard of care chemotherapy agents for the Aspire trial as well as $2 million in the total payments made to increase those deposits held by our CRO for future clinical trial costs. On December 2, 2023 and December 21, 2023, the company induced certain warrant holders to exercise their warrants for cash. Gross proceeds received from this exercise totaled approximately $1.9 million and $2 million, respectively. In January of this year, we closed a $9 million public offering consisting of 4,375,000 shares of its common stock or pre-funded warrants in lieu thereof and two classes of warrants to purchase up to an aggregate of 8,750,000 shares of common stock. at a purchase price of $2.06 per share plus the associated warrants. Those warrants will have an exercise price of $2.06 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The net proceeds on this offering was approximately 8.2 million. Pembela's common stock is listed on the NASDAQ stock market exchange under the symbol PBLA, but it is currently trading on the OTC pink sheets under that same ticker. The company is currently pursuing a new listing of its common stock on a national securities exchange. Operator, can you please open the phone lines now for Q&A and poll for questions?
spk04: Certainly. At this time, we'll be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Once again, that's star 1 if you wish to ask a question at this time. And please hold while we poll for questions. And the first question today is coming from Jonathan Ashoff from Roth MCAN. Jonathan, your line is live.
spk03: Thank you. Hello, Jennifer and Susan. Good afternoon. I have a few questions. What's the FAP trial going to cost, do you think?
spk02: Hi, Jonathan. Good afternoon. I'm sorry, which trial? I didn't hear that one.
spk03: The Phase III FAP trial that you need to get regulatory approval. guidance and clearance on.
spk02: Oh, gotcha, gotcha. So for the FAP trial, that is a program that once we have agreement on the global registration path, most likely we'll be seeking a partner for that program. So for us, we are trying to remain cost neutral on that one while moving that asset forward. Okay, that's definitely clear.
spk03: You know, can I ask you, you know, If Aflornethine approved, so could you elaborate on the financial, the actual direct financial benefit to Pandela for that?
spk02: Yeah, so with the approval, obviously the first approval was in the neuroblastoma program that we divested to U.S. World Med. And so with that program, there was a $400,000 upfront payment, and then there's a total of another $9.1 million in non-dilutive milestones mostly tied to the commercial sales, both U.S. and Europe, as well as there's an ongoing trial in the children's oncology group in the first line setting of neuroblastoma. So just as a quick reminder, the first approval was in the maintenance setting. And so as that current trial moves forward, which went to U.S. World Med as part of our agreement, there are regulatory milestones around that trial as well. So we are anticipating that, you know, probably between the end of the second half of this year and first half of next year, we will start to see some of those milestone payments come in, probably to the tune of, you know, half million to a million to start, and then they ramp up as sales continue.
spk03: Okay, that is very helpful. Thank you. Even the R&D... level fluctuations. Can you help us out with how the R&D looks over 2024?
spk02: In terms of program of financials, I was going to say that will be a two question.
spk03: Yes. Are we going to stay in the sixes and go higher?
spk01: Right now, we're projecting that between six and six and a half per quarter for the total burden for the company. So that would include the modest spending we do on G&A and then the balances R&D. And almost all of that really is the Aspire trial. The other thing that affected us last year was the need to secure... standard of care chemotherapy agents for the trial. That wasn't expected. That will also continue. We just have to determine at what level that will impact the numbers.
spk02: Yeah, I think, Jonathan, if I might add just one more thing, too. I think it's really important. You know, the Aspire trial, as Sue mentioned, the primary driver of our cash needs is the Aspire trial. You know, it is a $600 patient, you know, approximately 600 patient trials, randomized, double-blind, placebo-controlled. The other programs that we went through, it's quite an extensive pipeline. We are very fortunate to have funding for almost all those programs from other sources. So I think that's an important distinction. You know, a lot of times when you have a company with so many programs, you know, the cash needs are split across those programs, and we really have a main driver and are fortunate to to have all these other programs in conjunction with funding from other sources.
spk03: Okay, that was helpful. And lastly, you know, can you tell us about the exchange that you might go to given the delisting? You know, it doesn't have to be the pink sheets. Isn't there a far more favorable option perhaps?
spk01: Sue, do you want to take that or do you want to take it? Yeah, I can take it, yes. Certainly, I mean, the pink sheets are a temporary place for us to be likely even the OTC QB will be not necessarily a long term solution either. We need to be on the national exchange. So we're looking at all of the others. that we might be able to uplist to. That might include the CBOE, the American with the NYSE are a couple of the options that we're looking at.
spk03: Well, what seems to maybe provide the most, you know, the potential for the most liquidity, you think? You think the CBOE is the best of between that and Amex?
spk01: In our research, what we found is that the volume on the CBOE tends to be very close to what's seen on NASDAQ. So if that's the primary driver for our decision, that might be the right place to go.
spk03: Okay. Thank you very much.
spk02: Thank you so much, Jonathan.
spk04: Thank you. And the next question is coming from Joel Pangenis from HC Wainwright. Joel, your line is live.
spk05: Thank you. Hi, this is Josh on for Joe. I just had two quick questions. So for the first one, I believe last quarter it was maybe said that we would potentially see some data in 2024 for the phase one stick 11 trial. Now just wondering now with the first patients being enrolled in the first half of 2024, do we still expect that or would that potentially be pushed back? And then just quickly, I think I missed it about the phase one study in platinum-resistant ovarian cancer. I was just wondering if you could reiterate when that is set to begin.
spk02: Yeah, absolutely. And thanks so much, Josh. So for the SICK11 mutant phase one, since the trial is open and screening for patients now, we would most likely have data towards the end of this year. And that would then feed into the start of the phase two portion. As of right now, that is our current projection. We're going to have to see how the enrollment goes. You know, as a reminder, the STIC-11 mutant population of non-small cell lung cancer, depending on which source you look at, ranges between 10% and 30% of lung cancers. But I will say, you know, Moffitt's been actively screening. And so as enrollment starts, we will keep everyone updated on the progress But our hope right now is data from that by the end of the year. For the ovarian cancer, we have been working very closely with Johns Hopkins University School of Medicine and looking to finalize that protocol and have that phase one program open by the first half of this year. And it's interesting because we're looking at a number of trial designs. It could end up being a phase two instead of a phase one, depending on which path we take. But we have a very engaged team, so we look forward to finalizing that and updating everyone accordingly.
spk05: Perfect. Thank you for answering my questions, and thank you for the update.
spk02: Yeah, thank you so much.
spk04: Thank you. This does conclude the Q&A session and also concludes today's conference. You may disconnect your lines at this time, and thank you for your participation.
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