Q3 2024 Panbela Therapeutics Inc Earnings Call

Speaker Change: Greetings and welcome to the Panbella Therapeutics third quarter 2024 earnings call. At this time all participants are on a listen-only mode and a question and answer session will follow the formal presentation.

Speaker Change: If anyone should require operator assistance during the conference, please press star zero on your telephone keypad.

Please note, this conference is being recorded.

Speaker Change: 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

Speaker Change: 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 are implied by such forward-looking statements are detailed in the company's filings with the SEC.

Speaker Change: Any forward-looking statements made on this call speak only as of today's date.

Speaker Change: and the company does not undertake any obligation to update or revise any of these statements to reflect future events or circumstances.

Speaker Change: With that, I will turn the call over to the company's CEO, Jennifer Simpson. Dr. Simpson, please go ahead.

Jennifer Simpson: Thank you and thank you all for joining us. I will start today's call by highlighting our investment from NantCapital, then discussing our clinical development program, our recent achievements, and upcoming milestones.

Jennifer Simpson: After that, Sue will review our financial results before we open the call-up for Q&A.

Jennifer Simpson: As mentioned, a significant recent development is our $12 million strategic loan commitment from NAP Capital.

The loan consists of two tranches of convertible promissory notes.

Jennifer Simpson: The first tranche was funded in the gross amount of $2.85 million on October 22nd, and the second tranche is expected to fund in a gross amount of $9.15 million by November 15th subject to customary conditions.

Jennifer Simpson: This commitment is more than just a financial investment. It represents the potential of orchestrating the activation of the patient's immune system and the metabolic pathways as an evolutionary approach to address pancreatic cancer, an extremely difficult to treat cancer.

Jennifer Simpson: Our lead assets, ivo-spemin, aflornithine, and flimpovi, target the polymine pathway in ways that could complement ImmunityBio's natural killer cell and killer T cell activation technology.

Jennifer Simpson: The combination of immunotherapy and metabolic pathway platforms could create powerful synergies in enhancing patient outcomes.

Jennifer Simpson: We believe the strategic investment reflects the investors' confidence in the potential of this multi-targeted approach to reset dysregulated biology and potentially enhance anti-tumor activity.

Jennifer Simpson: We're especially encouraged by Dr. Patrick Shumshong's recognition of the synergistic potential between our platforms.

Jennifer Simpson: His perspective as both a surgeon and leader of NetCapital and ImmunityBio validates our approach, particularly regarding our lead assets, Iodospemin, Aflornathine, and Plimpovi.

Jennifer Simpson: We're excited about the potential impact of combining these innovative approaches in our fight against cancer.

Jennifer Simpson: Now, let me provide an update on our lead program, the Phase 3 ASPIRE Global Clinical Trial. This pivotal study evaluates our candidate ibuprofen, or SVP 101, in combination with gemcitabine and nabpaclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma.

Jennifer Simpson: As many of you know, our safety database has continued to expand substantially throughout 2024, and we're pleased with the consistent safety profile observed as announced through the Data Safety Monitoring Board, or DSMB, meetings that have taken place.

Jennifer Simpson: The trial's progression has been remarkable with strong site engagement driving a faster than expected enrollment rate. We anticipate achieving full enrollment of approximately 600 patients by second quarter 2025.

Jennifer Simpson: Regarding the timing of our interim analysis, as we've mentioned before, we continue to observe a notably lower event rate than initially projected, potentially signaling that patients may be experiencing better outcomes than expected.

Jennifer Simpson: This persistent trend of extended survival times has led to our interim analysis timeline of the first quarter, 2025.

Jennifer Simpson: And as we all know, this becomes particularly significant when we consider the current treatment landscape. Even with recent advances like Malar Fox, which showed a modest 1.9 month survival benefit, the urgent need for more effective therapies remains clear.

Jennifer Simpson: Metastatic pancreatic cancer continues to carry a devastating prognosis with median survival still falling short of one year.

Jennifer Simpson: The lower event rate we've observed in the ASPIRE trials so far takes on added significance. If these early signals translate into meaningful survival benefits, Iowa's spending could represent a significant advance over current standards of care.

Jennifer Simpson: The current regulatory environment for pancreatic cancer treatment, combined with our encouraging signals, positions us well for potential future FDA consideration.

Jennifer Simpson: We remain focused on executing this trial with the highest standards, driven by the urgent needs of pancreatic cancer patients.

Jennifer Simpson: The next few months leading to our first quarter 2025 interim analysis will be crucial, and we look forward to sharing those results, which could potentially reshape the treatment paradigm for this challenging disease.

Jennifer Simpson: Turning to our FAP program, we have worked with key opinion leaders to help finalize the protocol, which is in the final stages as we prepare to submit to the regulatory agencies for review.

Jennifer Simpson: We look forward to advancing the protocol for review while evaluating opportunities to maximize the program's potential.

Jennifer Simpson: Regarding the PACE's trial, as many know, this phase three study of Flampovi for preventing high-risk adenoma and second primary colorectal cancers has completed enrollment.

Jennifer Simpson: As we've mentioned before, having successfully passed the planned utility analysis, we anticipate data readout by the second half of 2026.

Jennifer Simpson: This NCI-supported study, conducted by SWOG, has the potential to impact the treatment landscape for patients previously treated for stages 0 through 3 colorectal cancer.

Jennifer Simpson: In our Phase 2 portfolio, we continue to see progress across multiple programs.

Jennifer Simpson: The Aflornithine Pediatric Neuroblastoma Program has provided additional value through monetization with U.S. World Med's FDA approval of Aflornithine, marking a significant milestone as the first FDA-approved polyamine-targeted therapy in cancer.

This validation strengthens our confidence in our polyamine-focused approach.

Our clinical programs continue to expand.

Jennifer Simpson: The Phase II of Flornithine Study in Castration-Resistant Metastatic Prostate Cancer.

Jennifer Simpson: is actively recruiting while our type 1 diabetes trial in collaboration with Indiana University School of Medicine and JDRF has all six centers actively enrolling with an interim analysis expected next year.

Jennifer Simpson: Looking ahead, our planned Phase 2 trial of ibospemin in platinum-resistant ovarian cancer, in collaboration with Johns Hopkins University School of Medicine, is progressing as anticipated.

Jennifer Simpson: The encouraging pre-clinical data presented at AACR provides a strong foundation as we prepare to evaluate ibospemin in combination with polyamine metabolism and immune modulators.

Jennifer Simpson: Moving to our Phase 1 pipeline programs, I'm pleased to report that in late September we enrolled the first patient in the dose escalation study of CPP1X for STIK11 mutant non-small cell lung cancer. This study is being conducted at the prestigious Moffitt Cancer Center.

Jennifer Simpson: The key points of this program are evaluating the fluorinepine sachets in combination with Keytruda.

Jennifer Simpson: The initial Phase I objectives focus on determining maximum tolerated dose and the safety profile. We expect data readout by mid-2025, and the Phase II initiation is targeted for later in 2025.

These program objectives are being executed under excellent clinical leadership.

Jennifer Simpson: on particularly encouraged by Dr. Janelle Gray's leadership as principal investigator.

Jennifer Simpson: Dr. Gray, who chairs Moffitt's Department of Thoracic Oncology, recognizes the critical need for new combination approaches with immunotherapy, especially for SIK-11 mutant tumors, which typically show reduced anti-tumor T-cell levels.

Jennifer Simpson: This trial is especially meaningful following our recent success with CPP1X in neuroblastoma.

Jennifer Simpson: Our preclinical data suggests polyamine modulation could potentially reinvigorate immune response and we're eager to explore this clinically in the STIK11 mutant non-small cell lung cancer patients, a population that historically responds poorly to checkpoint inhibitors.

Jennifer Simpson: Looking ahead, once we establish safety in Phase 1, we'll advance to Phase 2 to evaluate efficacy.

Jennifer Simpson: Beyond this specific trial, we're excited about exploring a flornithine and iospemin's potential role in combination with other immunotherapies including CAR T therapy.

Jennifer Simpson: Turning to our neoadjuvant pancreatic program, we continue to progress toward opening this investigator-initiated trial. Our preclinical development efforts also continue to show promise, particularly through our ongoing collaboration with MD Anderson Cancer Center.

Jennifer Simpson: This research initiative remains focused on evaluating the potential synergies between our polyamine metabolic inhibitor treatment and advanced immunotherapy approaches, including RT cell therapy and bi-specific monoclonal antibodies.

Jennifer Simpson: These preclinical studies continue to complement our broader clinical strategy and reinforce our commitment to innovative cancer treatment approaches.

Jennifer Simpson: Building on earlier presentations, our research collaboration with Vanderbilt University Medical Center continues to generate valuable insights. Their presentation at Digestive Disease Week Conference earlier this year focused on the Florentine's evaluation in gastric premalignant conditions.

Jennifer Simpson: The Phase IIa trial results demonstrated important safety and efficacy findings, particularly showing a flornithine's ability to reduce DNA damage in treated patients.

Jennifer Simpson: These findings continue to validate our polyamine pathway approach, especially for patients at high risk of developing infection-associated gastric cancer.

Jennifer Simpson: The data from this NCI funded study remains particularly relevant as we advance our understanding of polyamine pathway targeting in both cancer prevention and treatment settings.

Jennifer Simpson: In summary, our remaining 2024 clinical milestones include completing the necessary steps to open the neoadjuvant pancreatic cancer trial in early 2025.

Jennifer Simpson: finalizing the phase 2 ovarian trial to open in early 2025 and submitting the FAP global registration protocol to the FDA and EMA for feedback.

Jennifer Simpson: In 2025, we anticipate the overall survival interim analysis for our Phase III ASPIRE trial in the first quarter of 2025, as well as the completion of enrollment anticipated in the second quarter of 2025.

Jennifer Simpson: In closing, the third quarter and subsequent period have been important for PAMBELLA.

marked by significant clinical advancement and a new strategic relationship.

Jennifer Simpson: Most notably, we secured a $12 million strategic loan commitment from NAC Capital in late October, representing not just financial backing, but a powerful clinical alliance that looks to combine our polyamine metabolic inhibitor platform with our natural killer cell and killer T cell activation technology.

Jennifer Simpson: Dr. Patrick Shin Chung's endorsement of the synergistic approach, particularly regarding ibispeminoflorencine and pomovi, validates our strategy and opens new possibilities in our fight against cancer and metabolic conditions.

Jennifer Simpson: As we move through the final quarter of 2024, we remain focused on advancing our robust clinical pipeline while leveraging this new partnership to enhance our therapeutic potential.

Speaker Change: The momentum we've built, coupled with the strategic alliance, positions us strongly for continued progress and value creation. I will now turn the call over to Sue to discuss our financial results. Sue?

Thank you, Jennifer.

Sue Horvath: General and administrative expenses for approximately $1.1 million in Q3 of 2024. This is flat compared to the same quarter last year.

Sue Horvath: Research and development expenses were approximately $6.1 million in Q3 of 2024, compared to $6.7 million in the prior year quarter.

Sue Horvath: Slightly lower spending is due to reduced preclinical costs and lower direct costs from the CRO for the ASPIRE trial.

Sue Horvath: Net loss for the quarter was $7.2 million, or $1.48 per diluted share, compared to a net loss of $7.8 million, or $53.74 per diluted share in Q3 of 2023.

Total cash as of September 30, 2024 was approximately $142,000.

Sue Horvath: This balance does not reflect the $12 million funding agreement we filed on October 22nd.

Sue Horvath: Total current assets were $5.2 million and current liabilities were $20.1 million at the quarter end.

Sue Horvath: Regarding our capitalization, as of September 30th, 2024, we had approximately 4.85 million common shares outstanding.

Sue Horvath: After including shares reserved for options and warrants, our issued and fully reserved share count was approximately 13.95 million shares.

Sue Horvath: Cash used in operations for the nine months ended September 30, 2024 totaled approximately $12.5 million.

Sue Horvath: Cash used in operations included our net loss for the nine months, offset primarily by an increase in the company's accounts payable and accrued liability balances.

Sue Horvath: On July 24th, 2024, the company entered into a loan agreement with U.S. World Med, LLC. Pursuant to that 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.

Sue Horvath: The loan proceeds were used by the company for payment of fees and expenses owed to its contract research organization for the ASPIRE trial.

Speaker Change: As Jennifer highlighted earlier, on October 22nd, we executed a note purchase agreement with Mance Capital.

which includes two convertible notes.

Speaker Change: a $2.85 million tranche A note issued immediately and a $9.15 million tranche B note to be issued by November 15, 2024.

Speaker Change: The notes have 6-month maturity and earn interest at SOFR plus 8%.

Speaker Change: Both notes can be converted to company stock at $0.37 per share with a 33.33% ownership cap until maturity.

Speaker Change: The funds will be used for general corporate purposes and debt repayment.

Speaker Change: The U.S. Road Med note was paid off immediately upon receipt of the Trouch A funds.

Speaker Change: Pambela's common stock remains eligible for quotation on OTCQB under the symbol PBLA.

Speaker Change: The company continues to pursue a new listing of its common stock on a national securities exchange.

Operator, we are now ready to take questions.

and the other one.

Speaker Change: Thank you, Mel. At this time, we will be conducting our question and answer session.

Speaker Change: If you would like to ask a question, please press star 1 on your telephone keypad.

Speaker Change: The confirmation tone will indicate your line is in the question queue, and you may press star 2 if you would like to remove your question from the queue.

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One moment please while we poll for questions.

For more information visit www.FEMA.gov

Thank you.

Speaker Change: We have questions on the line from Jonathan Ashoff with Roth Capital. Your line is live.

Speaker Change: Hello Jennifer and Sue, glad to hear about the $12 million. Can you tell me you know what that does for you in terms of your potential to uplist? You know how does that maybe kick that up to a higher gear or a higher likelihood?

Thank you.

Thank you for joining us. Thank you.

Speaker Change: Did you want to take that or do you want me to? Excuse me. We're still pursuing the EMPLIS round. Because it's a loan, it doesn't immediately assist us in terms of our stockholder equity requirement. And anything other than that would be speculation.

Speaker Change: Okay, so how long do you think that will last and you know what triggers, if anything triggers, the second tranche, the larger tranches, because I didn't hear any mention of that.

There are no requirements for the second tranche.

Thank you.

Speaker Change: So that that should be completed actually by the 15th, which is tomorrow.

Speaker Change: Okay, in the language of $212 million, you know, it's down to a bit less than certain.

Thank you.

and we'll continue to manage.

Speaker Change: We'll continue to manage cash as closely as we can and make that last into the first quarter of next year.

Speaker Change: I mean, because you can hold off the people, you know, you owe and a portion of that debt you can push to a longer maturity, correct? You don't have to pay all that debt off.

fairly soon, right?

Speaker Change: I'm not I'm not sure I understand that the two notes with Nant Capital have a six-month maturity date.

Okay, all right

Speaker Change: I think, I mean, you know, congrats on the progress but I think, you know, this alone was quite critical and, you know, congrats on securing that.

I think that's it for me. Thank you. Thanks, Jonathan.

Thank you ladies and gentlemen.

Speaker Change: As we have no further questions in queue at this time, this will conclude today's conference and you may disconnect your lines at this time and we thank you for your participation.