Q4 2020 Panbela Therapeutics Inc Earnings Call

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Happy birthday, greeting greetings and welcome to Bella Therapeutics fourth quarter 2020 conference 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. As a reminder. This conference is being recorded. I would now like to turn the program over to James Carbonaro with hidden investor relations.

Thank you. And once again, welcome to Pam Bella's fourth quarter 2020 earnings call with me on the call are Jennifer Simpson chief executive officer and two Horvat Chief Financial Officer off or turn the call over to dr. Simpson. 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 quarterly reports on form 10-K 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 will turn the call over to Jennifer Simpson CEO Jennifer, please proceed.

Thank you everyone for joining. I'll begin the call by touching on twenty-twenty significant accomplish accomplishments as a month. I will then move into our 2021 focus on continued execution and expanding our addressable Market opportunity in addition to pancreatic cancer too. Will then follow with a review of the results and then we will we will open it up for questions and answers.

So starting with the 2020 highlights in January of last year. We presented interim SP pea 101 data in a poster presentation.

The data is on the street a street edge of tumor or objective response rate in 62% of the patients versus gemcitabine and abraxane which produce a 23% response from the abraxane registration trial.

Also at eight weeks we had a one hundred percent Disease Control rate conveying an important benefit to this patient population.

The data from the study demonstrates a compatible safety and tolerability profile for SP pea 101. Most notably not aggravating the known bone marrow suppression a purple neuropathy associated with gemcitabine and abraxane.

Additionally prior research has shown that there is a correlation between a decrease in the common tumor marker CA 19-9 and improved survival in the registration trial for them in a bra claim any decrease in the ca 19-9 level resulted in the median survival of 13.2 months compared to eight point three months when it was unchanged or off when the biomarker decrease with greater than or equal to 60% There was an additional month of benefit or 14.2 months of median survival.

In our interim data for SP pea 101 combined gemcitabine and abraxane in approximately 90% of patients. There was some decrease in the 99 level and about 70% of patients had a greater than 75% decrease if our final data remains consistent with the interim data, we expect to see a survival benefit.

Inspired by the announcement of the data Milestone at the Oscar GI conference marking a new level in the company's development in January 2020 initiated a search for a CEO to succeed. Dr. Michael Cohen doctor calling remains executive chairman of our board and works with the team to advance new treatment options for patients with pancreatic cancer and other cancers wage undervaluation shortly after the announcement of the CEO search the global pandemic cause disruption to all Industries including cancer research in a given uncertainties that were associated with the COVID-19 pandemic including the risk to our supply chain and the limitation and redistribution of clinical resources at our investigative sites dead. We elected to pause new patient recruitment.

Welcome, they proved to be relatively brief as I am pleased to highlight that in June enrollment resumes, and it was completed in the fourth quarter.

Also during the pandemic we received Fast Track designation from the FDA for SVP 101 for the treatment of patients with metastatic pancreatic adenocarcinoma wage act as a nation is important for him because it enhances our ability to develop STP 101 as efficiently as possible. There is an urgent need for new therapeutic options for patients with pancreatic cancer, and we look forward to working closely with the FDA as we continue to advance our development program of STP 101 for patients with metastatic pancreatic cancer.

continuing on the moment

EMA resumed enrollment and Fast Track designation during the third quarter about six weeks after I started as CEO. We completed a 10.5 million dollar public offering of equity providing cash. Wait that enables us to execute against multiple milestones and is expected to take us into 2022.

Simultaneously the opposite NASDAQ expanding our access to a broader investment community and finally in December of last year. We changed our corporate name to pain Therapeutics Inc off all the more appropriate and the transformative year.

Turner the 20 21 we are focused on continued advancement of SP pea 101 for the treatment of patients with pancreatic cancer and identifying additional cancer indications to that end of February. We provided an update on our current clinical trial evaluating the safety and tolerability of SP pea 101. When used in combination with standard apps are agents gemcitabine and abraxane for First Choice treatment of patients with metastatic pancreatic. Adenocarcinoma are updates share that pembela continues to be in communication with the trial investigators regarding the recommendation from the dependent data safety monitoring board or dsmb of the ongoing Phase 1 clinical trial to hold the administration of SP pea 101 pending further review of visual disturbance Adverse Events.

As we communicated some patients and trial were noted to have complaints a visual changes. Although visual changes were not seen in the SP pea 101 monotherapy study. We have consulted with the dsmb and STP 101 will not be administered to ongoing patience and the current trial while additional safety information is analyzed patients will continue with the standard drug regimen Dead rated and all other activities in the trial will continue. We have conferred with the FDA regarding the plan to complete the trial but withhold the dosing of STP 101 and I'm going patience wage investigation continues withholding SP pea 101 constitutes an FDA partial clinical hold. There is no impact on enrollment as enrollment of the trial completed in December of $20, and the study is ongoing

In terms of next steps. We are working to finalize a visual screening programs understand the significance of reported visual changes and to inform our future studies. We will also seek to evaluate the cause of visual events and to determine whether regular eye exams during treatment can identify potential toxicity or risk before symptoms develop.

While we evaluate the available data, we remain confident in the potential benefits of SP101 including its potential benefit for patients with pancreatic cancer. We are thankful to the patients who have jobs or are participating in our clinical trials. We are committed to objectively evaluating the data from those clinical studies to confirm both the safety profile and the therapeutic benefits of our Polly metabolic and have faith in metastatic pancreatic cancer patient in addition to pancreatic cancer. We remain committed to expanding or clinical development programs as a reminder with the increased level of poly mean off the relationship with mutations within cancers, the possibilities across tumor types such as lung prostate colon breast or ovarian and others are being explored published research also confirms the relationship between the tumor microenvironment immune cell response and pollen levels.

To further explore that relationship in February. We announced a research agreement with the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

University School of Medicine, the collaboration is intended to focus on the the the Sydney the further development of Campbell has investigated agent s p p one oh one month including activity and so line in addition to pancreatic cancer biomarkers informing Diagnostics with therapeutic implications and the potential combinations with checkpoint inhibitors.

The research is being led by Professor Robert costero in internationally-recognized researcher in Pauline and cancer biology at the Johns Hopkins Kimmel cancer center and a professor of psychology at Johns Hopkins University School of Medicine. Professor costero is a molecular pharmacologist whose research focuses on the role of poly mean in cancer cell proliferation and ways to expect the metabolism function as antiproliferative and chemo preventative targets including Amin metabolism epigenetic regulation and inflammation.

It's another indication that we are moving ahead with s c p one. Oh one for pancreatic cancer and expanded indication this month. We announced the appointment of dr. Gary as vice president of clinical development and medical Affairs Doctor Williams joined $10 from sarek or where he was senior director of clinical development. Dr. Williams has considerable experience in malignant Hematology Oncology and immunotherapeutics with responsibility for numerous clinicaltrials in all stages of development.

We have made considerable progress in the last 12 months and now is an important moment as we begin to plan expand and development of SP101.

Gary substantial background of success in executing clinical programs specifically and oncology will bring tremendous value to Pam Bella with key Milestones expected during this year as well Communications with the FDA that will help shape our lead program and pancreatic cancer. His expertise will be an asset immediately at this point. I would like to finish by reiterating our Milestone. No.

Topline data from the old days when trial is expected in the first half of this year and we plan to initiate the randomized phase 2 trial mid-year the neoadjuvant study and pancreatic cancer and preclinical investigation of additional tumor type represent other potential milestones. In fact, we expect our collaboration with Johns Hopkins and other preclinical work that is ongoing will yield clinical data to inform future development Pathways across tumors in addition to pancreatic cancer in the second half of this year and finally assuming we translate the research literature took a compound a combination of SP pea 101 and a checkpoint inhibitor is an opportunity that we will also pursue vigorously.

In summary, we made tremendous progress in 2020. Now, we are navigating our clinical pathway with our lead indication pancreatic cancer. Furthermore. We are funding research am tired additional Personnel to expand our addressable Market Beyond pancreatic cancer. We look forward to sharing more as we execute on our Milestones ahead and issues press releases in the interim wage were excited to grow shareholder value in 2021, advancing further with our leave indication and pursue new indications. I will stop there and turned over to Sioux to review the financial.

Thank you, Jennifer.

General and administrative expenses were point nine million in the fourth quarter of 2020 compared to point five million in the fourth quarter of 2019. The change is due primarily to incremental headcount incentive compensation in the higher costs associated with being a nasdaq-listed company research and development expenses, four point seven million in the fourth quarter of 2020 compared to point eight million in the fourth quarter of 2019. The change is due to lower cost of manufacturing of the active drug ingredient offset in part by higher clinical trial call a net loss in the fourth quarter of 2020 with 9 million or 9 cents per diluted share compared to a net loss of 1 million or fifteen cents per diluted share in the fourth quarter of 2019.

Total cash was 9 million as of December 31st, 2020 total current assets for 9.8 million and current liabilities were 1.4 million as of the same date wage. Also as of that date, we had no debt on the balance sheet looking to the cap table. We had nine point seven million of common shares outstanding and not a fully-diluted basis. We were at eighteen point four million shares. The fully diluted number includes all outstanding Equity Awards including stock options, which are held primarily by insiders wage as well as all warrants to purchase Comstock we have now for several quarters averaged approximately 1 million in cash used in operations. We do expect that we will pick up to approximately 1.5 million per quarter as we move into the randomized trial. However, we have already received.

Quarter approximately 1 million from cash from the exercise of warrants which will help to offset. This increase in cash used in operations are available cash We Believe will allow us to complete the current clinical trial and initiate a randomized trial in the middle of 2021 and invest preclinical dollars in other clubs or indications and will take us into the second quarter of 2022 concludes. My prepared remarks operator. Can you please open the phone lines and poles or questions?

Yes, thank you at this time will be we will be conducting a question-and-answer session. If you would like to ask you a question, please press star one on your telephone keypad a confirmation tone your line as in the question queue. You may press star to if you would like to remove your question from the Q4 participants using speaker equipment. It may be necessary to pick up your handset before pressing the star Keys. One moment. Please walk ins.

Our first question is from Robin Garner from craig-hallum. Please proceed.

Hi.

Good evening, and thank you for taking my question. I have a few if I may I'd love to be able to hear more about the work that dr. Costero is doing based on his prior research. Can you share what kind of biomarker data you would be looking for and how that might change your future study designs.

Bristol good evening, Robin nice to take your questions. You know, I think at this point it's probably too preliminary to guess, you know, where that will lead us know. I think one of the things you know, we've seen and in some of the published data, you know, I've been scouring, you know, we know that there's elevated pollen levels in urine and you know oftentimes, you know several fold higher in those with malignant diseases versus those with that have, you know, do not have that off. No, I don't think that's actually translated at this point into a biomarker, but I think that you know with his expertise and with this deep dive we are hopeful that we will identify them, you know, hopefully a biomarker that will you know, give us an indication and incorporate into future trials.

Thank you. And then very similarly you mentioned the published data. We've come across a few different articles showing just regulation of poly means and areas like correct, obviously pancreatic and then as well as prostate. Is there any sort of quantitative published research that shows the relative expression of Polly either Polly mean or related genome across the various tumor types.

So it's a good question. Actually, we do know that there's a relationship, you know a pretty strong one with the oncogenic driven cancers, you know specifically queiroz, and you know, and as I mentioned we also know that Pauline levels have been found to be elevated in malignancies versus, you know, normal individuals and these are areas that we look forward to understanding and greater detail to our research collaboration with dr. Costero. You know, I think right now. It's a little spotty and I This research collaboration we are hoping will will prove very fruitful to understand some of these relationships.

Okay, great. Thank you. And then thanks for the guidance regarding sg&a, especially if there are additional studies going on this year and possibly some sort of combination or or tumor type. What should we expect regarding R&D spend for 20 21

This is who you know, we're still designing randomized clinical trials and we'll be assessing what other options we might have in terms of preclinical work depending on the package the results that we get from that work. So I I really reluctant to give any guidance specifically regarding R&D at this point. I am comfortable that we can we can begin of a randomized trial of a very reasonable randomized trial in the middle of the Year. And that that would cash Runway will still extend into the second quarter of 2022.

Okay, great. Thank you. And then lastly is are there any other analyses correlating factors that you can share regarding the partial clinical hold?

Unfortunately rather not at this time, we do look forward though to working with the FDA and upon agreement. That is something that we look forward to sharing because I think it is an important, you know, certainly important for all to understand what we've what we've uncovered and what the plan is moving forward.

Okay, thank you for that and I guess regarding that and perhaps you can't answer but are the symptoms that patients have seen Beyond what's already included in the labeled as being Adverse Events with gemcitabine or abraxane?

Yeah, you know at this time we it's we're still you know, kind of pulling all that information together and you know, as you can imagine the way patients, you know, characterized can be very different and not want to make sure that when we give the information but it's it's complete. So we we do look forward to sharing that as soon as we have everything and it's been reviewed with the FDA.

Okay, fully understood. Thank you so much for taking my questions tonight.

Certainly. Thank you so much.

Thank you. Our next question is from Jason McCarthy with Maxim group. Please proceed everyone it's a Dave on the line for a Jason. Thanks for taking my question. I was just wondering if you could perhaps share, you know, any any progress you you made getting the partial clinical resolved and when perhaps we can expect any any updates on that page and also has the partial clinical hold impacted on any of the near-term milestones at all or twenty-one.

Thank you find good evening to you as well. You know, so here's what I can tell you. You know, we are as a company we are on track for the ranch clinicaltrials mid year. So I think but it's it's fair to say that, you know, we do need to have agreement with the FDA before that can move forward. So that is something that we are working towards from a timing perspective. So, I hope that helps but right now we are on track with our milestones and working to come to an agreement with the FDA so that God does Milestone same place.

Okay, and that's helpful. Thank you. Sure.

Okay, I see no further questions at this time and this concludes today's conference. Thank you very much for your participation. You may disconnect your lines at this time.