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spk02: Good day, and welcome to the PanBella Therapeutics third quarter 2022 earnings call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, James Carbonara.
spk01: James, the floor is yours. Thank you. And once again, welcome to Pan Bella's third quarter 2022 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 are not historical facts, 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-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 Penvella. Jennifer, please proceed.
spk03: Thank you, and thank you, everyone, for joining. I will begin the call with a review of our clinical development program, recent accomplishments, and upcoming milestones. We will then follow with a review of the financial results, and then we will open it up for Q&A. Starting with our Phase III program, in August, we announced the international expansion of our ASPIRE trial, evaluating gemcitabine and nabpaclitaxel with or without isostemin, which is our new generic name for SCP-101, for untreated metastatic pancreatic ductal adenocarcinoma into Australia, as well as the first patient enrolled. We also announced regulatory approval for the opening of trial sites in Spain, France, and Italy. With approximately 95 sites planned throughout the United States, Europe, Australia, and South Korea, we are continuing to focus on site initiation and enrollment in order to ultimately deliver a more effective treatment for pancreatic cancer, a deadly disease with few treatment options. We expect that a significant number of global sites will be open by year end, with the full complement of sites open by early to mid 2023. The trial sample size is 600 patients, and the primary endpoint will be overall survival. We will use overall survival for the interim analysis as well. It is anticipated to take approximately 36 months for complete enrollment, with the interim analysis still available in early 2024. The interim analysis allows us to assess the merits of continuing the study as well as to ensure optimal resource utilization. We are excited to have these recent approvals as we move forward towards the interim analysis expected in a little over one year from now. Turning to familial adenomatous polyposis, or FAP, The registration trial with Compovi is anticipated to begin mid-2023 and is funded by our licensing partner, 1-2 Therapeutics. We are working closely with 1-2 to ensure alignment with the FDA on all key aspects of the trial before the trial commences. As the trial will utilize European clinical sites and we retain the rights outside of the U.S. and Canada, we will seek advice from the European authorities regarding the utilization of the registration trial for approval in Europe. As a reminder, a prior phase three study evaluating aflornadine and sullendeck, or FLMPOVI, versus either agent alone showed a 100% risk reduction in the need for surgery in the lower gastrointestinal, or GI group. As there are currently no approved drug therapies for the treatment of FAP, this data is exciting, and the lower GI group is intended to be the focus of the new registration trial. Lastly, we, in partnership with OneTwo, also have an ongoing phase three double-blind placebo-controlled trial of Sympovi, the combination of a fluorethine insulin doc, prevent recurrence of high-risk adenomas and second primary colorectal cancers in patients with stage zero to three colon or rectal cancer. This trial is known as the PACES trial and is funded by the National Cancer Institute, or NCI, in collaboration with the Southwest Oncology Group, also known as SWOG, and we look forward to a futility analysis in the first half of 2023. Moving to phase two studies. First, there is an ongoing trial in relapsed refractory neuroblastoma utilizing efloranthine sashays. This trial is funded through the Children's Oncology Group, or COG, and the NCI. We will also be starting in early 2023 a phase two trial in early onset type 1 diabetes utilizing efloranthine tablets. This study is supported by Indiana University and the Juvenile Diabetes Research Foundation, or JDRF. In phase one development, we have three programs that we will be starting. First, opening by year end, we will be evaluating a fornifine sachet in combination with Keytruda in the STIC11 mutation population of non-small cell lung cancer. STIC11 mutant non-small cell lung cancer responds poorly to checkpoint inhibitors and bioinformatic analyses suggest that alterations in polyamine metabolic pathways may play a role in the resistance to immunotherapy. In preclinical tumor models, a fluoroazine treatment improves anti-PD-1 efficacy by increasing tumor-specific cytotoxic T cell populations, as well as increased expression of PD-1 on tumor-associated CD8-positive T cells. The Phase I portion is fully funded, and we look forward to this trial starting as it will be the first clinical proof-of-concept trial focused on the relationship between polyamines and the immune system. If this trial is positive, it opens the possibility for combining with a checkpoint inhibitor in other tumors, as well as the possibility of combining with other immunotherapies, such as CAR T therapy, to improve response rates. Our second phase one program, which is scheduled to begin in the first half of 2023, will focus on the evaluation of IVOS-7 in the platinum-resistant ovarian cancer population. As a reminder, we've collaborated with Johns Hopkins University School of Medicine to identify this indication. Additionally, a poster on the treatment of immune-competent mice injected with VDID-8 positive ovarian cancer with IVOS-7 was presented and showed a significantly prolonged survival and decrease in overall tumor burden. The mature data was later published in the International Journal of Molecular Sciences, titled Expanded Potential of the Polyamine Analog, SBP101, as a Modulator of Polyamine Metabolism and Cancer Therapeutics. The publication highlighted that in vitro studies determined that SBP101 reduced cellular viability across a broad range of cancer cell types with an exceptionally strong reduction in ovarian adenocarcinoma viability, resulting in a 42% increase in median survival in the VDID-A positive ovarian cancer mouse model. The data supports efforts to initiate an ovarian cancer clinical program. Lastly, we have completed preclinical work necessary to begin a pancreatic cancer neoadjuvant investigator-initiated trial. We are working with the key opinion leaders to finalize the protocol and obtain the necessary institutional approvals to open this trial by early 2023. Turning to milestones, in addition to continued execution of the various trials in our development program, we anticipate announcing final data from our phase one trials in untreated metastatic pancreatic cancer patients and early onset type 1 onset diabetes by year end or early 2023. There will be final data from a previously completed gastric cancer prevention trial by year end or early 2023, as well as the futility analysis for the PACES trial in the first half of 2023. We also anticipate the phase one data from the Aflornithine-K-TRUDA combination and the STIC11 non-small cell lung cancer trial by mid-2023, and the interim analyses from the ASPIRE trial in early 2024. In summary, we have made tremendous progress in Q3 and year to date. We are excited to enhance stockholder value as we move ahead into Q4 and onward by executing against our milestones. I will stop here and turn it over to Sue to review the financials. Thank you, Jennifer.
spk04: General and administrative expenses were $1.3 million in the third quarter of 2022 compared to $0.9 million in the third quarter of 2021. The change is due primarily to services and personnel costs associated with the acquisition and integration of cancer prevention pharmaceuticals, or CPP. Research and development expenses were $2.3 million in the third quarter of 2022 compared to $1.3 million in the third quarter of 2021. The increase is due to spending on our clinical studies as we ramped up efforts to activate up to 95 clinical sites around the world in the ASPIRE clinical trial. As a reminder, the results for the nine months ended September 30th, 2022 included approximately 17.7 million of in-process research and development. IPR&D represents the primary asset acquired as a result of the acquisition of CPP. and GAAP accounting required writing off this asset to research and development expenses immediately after the acquisition in June. Net loss in the third quarter of 2022 was 4.4 million or 21 cents per diluted share compared to a net loss of 2.1 million or 16 cents per diluted share in the third quarter of 2021. Total cash was approximately $0.9 million as of September 30th, 2022. That does not include gross proceeds of approximately $6 million from our public offering, which priced on September 30th and closed early in October. Total current assets were $1.8 million and current liabilities were $8 million as of the end of the quarter. Also at September 30th, 2022, total non-current assets consisting of cash deposits held by our contract research organization was 3.1 million. As a result of the CPP acquisition, we now have debt and accrued interest on our balance sheet totaling approximately 8 million as of September 30th, 2022. This includes two notes with principal balances of 6.2 million and 650,000 respectively, along with accrued interest. Both notes accrued simple interest at a rate of 5% per annum. Looking to the cap table, as of September 30, 2022, we had 20.8 million of common shares outstanding. And including shares reserved for options and warrants, we were at 30.3 million 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. After the public offering, which closed on October 4, 2022, we had approximately 27.9 million common shares outstanding. And including all shares reserved for options, warrants, including pre-funded warrants, we were at 80.5 million shares. Our cash used in operations for the nine months just ended totaled approximately $10.3 million. During the first nine months, the company paid $2.6 million in cash deposits to our global contract research organization, which will be held to pay clinical expenses at the end of the ASPIRE trial. This cash outlay for CRO deposits is not expected to be repeated. Ramped up activity in the randomized trial and costs associated with our acquisition drove remaining increase in cash used in operations. We project that cash with the early Q4 capital raise will take us into Q1 of 2023. We will continue to focus our cash on those items in our plan which will drive value for our stockholders such as the Aspire trial. That concludes my financial remarks. Operator, can you please open the phone lines for Q&A and poll for questions?
spk02: Certainly. Ladies and gentlemen, the floor is now open for questions. If you would like to join the queue to ask a question at this time, you may press star 1 on your telephone keypad to enter the queue. We do ask if listening on speakerphone this evening that you pick up your handset while asking your question to provide optimal sound quality. Should you wish to remove yourself from queue, you can press star 2. Once again, ladies and gentlemen, that will be star one to enter the queue to ask a question at this time. Please hold a moment while we poll for questions. We have a question from Tony Butler from Roth Capital. Tony, your line is live. Please go ahead.
spk00: Jennifer, thank you very much first. Jennifer, the data that you will release, the full phase one and the pancreatic trial as well as the diabetes, trial, is that going to be, could you or do you know how you might release that information? For example, is it through a press release? Will it be on a call? And or is it possible that it's actually at a clinical meeting? Thanks very much.
spk03: Thank you, Tony. Yes. Actually, we are focused on peer-reviewed journals in the respective areas of focus. And as soon as those journals are available for public viewing, we will also put out a press release highlighting the data in those trials.
spk00: Thank you, Jennifer. Appreciate it.
spk02: Thank you. Once again, ladies and gentlemen, if you would like to enter the queue to ask a question, you may press star 1 on your telephone keypad at this time. And there are no further questions in queue at this time. This will conclude today's conference call and webcast. We do thank you for your participation. You may disconnect your phone lines at this time and have a wonderful day. Thank you again for your participation.
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