This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk03: Good afternoon, ladies and gentlemen, and welcome to the PanBella Therapeutics Third Quarter 2021 Earnings Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonera. Sir, the floor is yours. Thank you.
spk04: And once again, welcome to PanBella's Third Quarter 2021 Earnings Call. With me on the call are Jennifer Simpson, Chief Executive Officer, and Sue Horvath. Chief Financial Officer. Before I 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 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 Dr. Jennifer Simpson, CEO of Penn Ballot. Jennifer, please proceed.
spk02: Thank you, everyone, for joining. I'll begin the call by touching on Q3 and recent significant accomplishments. Sue will then follow with a review of the financial results, and then we will open it up for Q&A. So starting with the third quarter and recent highlights. Beginning with our current clinical trial, which I'll remind everyone, is a Phase 1A-1B study of the safety, tolerability, and pharmacokinetics of SPP-101 when administered in combination with gemcitabine and nabpaclitaxel as first-line treatment of subjects with metastatic pancreatic ductal adenocarcinoma. Since completing enrollment in December 2020, 16 patients are in survival follow-up, with two patients from Cohort 2 now exceeding 26.9 and 28.7 months. Median overall survival for Cohort 4 plus the Phase 1b portion has not yet been reached. Additionally, we remain focused on expanding our clinical development program. With the increased level of polyamines and the relationship with mutation-driven cancers, The possibilities across tumor types such as lung, glioblastoma, colon, breast, gastric, ovarian, and others are being explored with the Johns Hopkins University School of Medicine. Published research also suggests a relationship between the tumor microenvironment, immune cell response, and polyamide metabolism, which is also being explored in our preclinical program with Johns Hopkins. Shifting gears to intellectual property, During the quarter, we announced that we received an issue notification for a patent that focused on methods for producing SPP 101. This patent, developed in collaboration with Syngene International Limited, an integrated research, development, and manufacturing services company, claims a novel process for the production of our lead investigational product, SPP 101. This reduces the number of synthetic steps for its production from 17 to 6 and provides patent coverage to 2039. This patent covering a shorter synthesis of SBP 101 provides many benefits, including the ability to manufacture a product with a reduced lead time, quicker access to drug supply, which facilitates expansion into additional indications, and lastly, enables a potentially scalable, efficient, and cost-effective manufacturing process to be in place as soon as we are ready to commercialize upon approval. Also in Q3, we closed on a $10 million underwritten bought deal offering of our common stock, which provided important resources to keep us on the path of further developing and expanding the application of SDP 101 and drive shareholder value. At this point, I would like to close by recapping our milestones. In pancreatic cancer, we intend to start a randomized trial by year end, as well as a neoadjuvant study in pancreatic cancer. Lastly, the preclinical investigation of additional tumor types may create other potential milestones. We expect our partnership with Johns Hopkins University School of Medicine and other preclinical work will produce the preclinical data to support new development pathways across tumors outside of pancreatic cancer before year end. In conclusion, we've made substantial progress in Q3 and year to date. We have advanced our lead indication in metastatic pancreatic cancer. Also, we are progressing research to further augment our addressable market of pancreatic cancer patients. We anticipate updates as we achieve our milestones ahead and we'll share this news through press releases along the way. We're keen to grow shareholder value by further
spk00: This increase is due to lower non-cash employee compensation in 2021 versus 2020. Research and development expenses were $1.3 million in the third quarter of 2021 compared to $0.8 million in the third quarter of 2020. This increase is due to incremental manufacturing costs as we produce investigational products for our next clinical trial. Net loss in the third quarter of 2021 was 2.1 million or 16 cents per diluted share compared to a net loss of 1.7 million or 21 cents per diluted share in the third quarter of 2020. A foreign currency loss of 0.3 million increased the operating loss in the third quarter of 2021. Total cash and cash equivalents was 14.1 million as of September 30th, 2021. inclusive of approximately $9.1 million of net proceeds from our bought deal offering which closed on July 2nd for 3,333,334 shares of common stock of the company at a price to the public of $3 per share before underwriting discounts and commissions. Total current assets were $14.7 million and current liabilities were 1.3 million, and there was no debt on the balance sheet as of September 30th, 2021. Looking to the cap table, we had 13.4 million of common shares outstanding, and on a fully diluted basis, we were at 21.0 million shares. The fully diluted number includes all outstanding equity awards, including stock options, which are held by insiders, and warrants to purchase common stock held by investors. Our available cash following the offering, we believe, will allow us to wrap up the current clinical trial, initiate a randomized trial by the end of this year, and invest preclinical dollars in other cancer indications. That concludes our prepared remarks. Operator, can you please open the phone lines for Q&A and polls or questions?
spk03: Certainly. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We do ask that while posing your question, please pick up your handset if you're listening on speakerphone to provide optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone. Your first question is coming from Robin Garner from Craig Hallam. Your line is live.
spk01: Good evening. Thank you for the update, and a big congratulations to those two patients in the second cohort. I wanted to ask, what is the nature of the data you expect to release by year end regarding the Johns Hopkins collaboration? Is there any other color that you can add as to what we might see?
spk02: Sure. So, you know, Robin, thank you so much for that question. What we have been looking at is panels across many different tumor types, and What we are looking is to identify at least one tumor to start that shows activity that warrants moving into a development program. So it would be a phase one trial looking at the first part of next year. So that's the start. As you can imagine, it's a pretty lengthy process, and we anticipate that we won't stop at one, but the goal is to have at least one tumor identified that we would move into development. starting in the first half of next year.
spk01: Okay, thank you. And can you comment at all about any sort of immuno-oncology drug candidates and combinations with them? Is that something we might see by year end as well?
spk02: It's possible. That may end up coming out in the early part of next year. We are looking at both preclinical programs, if you will, So it just depends on how the experiments are moving forward and whether or not we'll have data for that by year end. It's very possible it'll be more into the early part of next year for that portion.
spk01: Okay, thank you. And then for my second question, excluding the two patients that are doing very well in cohort two, does cohort two have a median survival that we can look at? I understand the rest of the study started later, but is there anything that we can learn from cohort two at this point?
spk02: Yeah, so if you look at the last ASCO poster presentation, the median survival was at 10.3 months. So that was just roughly about two months better than what we see with geminobraxen at 8.5 months. I think it is important to note there were only seven patients in that cohort. So those are very small numbers. For us, we're really keeping an eye towards cohort four in the expansion, because now you're looking at approximately 30 patients, which certainly will be a little bit more robust. But I do think it's important, you know, cohort two has the same dose that we're using in cohort four in the expansion. And to see that kind of tell, it's pretty impressive. So it's a nice signal to see this early. And we're looking forward to seeing the mature data from cohort four in the expansion. But all of which, I think, importantly, Robin, points to the need to advance this program. So they're looking at the randomized trial that will start by year end.
spk01: Okay, thank you.
spk03: Thank you. Your next question is coming from Tony Butler from Roth Capital. Your line is live.
spk05: Jennifer, In the cohort two patients that are out just for a long time with survival benefit, do they still have any tumor? And if they do, or I assume they're still receiving scans. And then the question is, is that amount of tumor that they may have, has that fluctuated? That's my first question.
spk02: So, Tony, that I'd actually have to dig into, but my guess is, yes, I'm sure they do have some level of tumor. Unfortunately, just the nature of metastatic pancreatic cancer is one that it does tend to come back. But I would have to dig into that a little bit further and could give you more information. You know, I think for us, the most important thing is that it's allowing the patients, the treatment that we gave the patients, it's allowing them to have an extended survival. We certainly know that as tumor fluctuates, there may be other things that they try. But the fact that we're looking at over 27 months, essentially, it's pretty impressive for this patient population.
spk05: Absolutely agree. Second question is around the randomized, I guess, phase two trial, which maybe could blossom into something that at least could be registrational, I guess, but has there been any thought, and this is to some degree related to one of the previous questions, but has there been any thought to actually use a three-arm study so that you can find 101 plus say Pembroke versus 101 alone versus a versus standard of care, in other words, absent 101?
spk02: That's a great question, Tony. I think, you know, one of the things is to make sure that we have given, which we have, a great deal of thought into the structure of this trial. If we would like it to serve possibly to support registration, it's important to keep it pretty clean. So, you know, from a one-to-one standpoint. But I will tell you that given what we're hoping out of the preclinical research, that is something that we will look to do, and most likely in a phase one development program to combine with one of the immuno-oncology drugs. And so we're focused on identifying that potential change in tumor microenvironment, which tumor makes the most sense, and then subsequently, which agents in the immuno-oncology space makes the most sense as well.
spk05: Thank you. And obviously, I assume you may have begun some conversations with Mark or Bristol to have, you know, that collaboration so you can receive drug. Otherwise, as you know, it would be very costly. The last question is around the second tumor type, if you will. And again, the relationship with Hopkins. And again, Will you send out via press release what that phase one trial and what tumor that might be that would begin in 2022? Would you send that out via press release? Because I ask because as you alluded to, the information that Hopkins is generating is very involved. And I guess to the extent that You know, some of the criteria that they went through to actually give you confidence that the tumor X might be the most beneficial next step I think could be very important to all of us. So I guess the question really is around how much information would you give?
spk02: Tony, that's a very good question. And the answer is yes. We will figure out some forum, whether it's a press release or, you know, maybe even a conference call. because I think it is very important to help walk people through, you know, how we got to this point, why it makes the most sense, and why we're excited to begin the next development program in this tumor type. So, absolutely.
spk05: Jennifer, thank you so much.
spk01: Certainly. Thank you, Tony.
spk03: Thank you, ladies and gentlemen. At this time, there are no further questions in the queue, and we would like to thank you for your participation in today's program. You may disconnect your lines at this time.
Disclaimer