Panbela Therapeutics, Inc.

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the PanBella Therapeutics First Quarter 2022 Earnings Call. At this time, all participants are on a listen-only mode. After management's prepared remarks, there will be a question and answer session. I would now like to turn the call over to the host, James Carbonara, Investor Relations at Hayden. Please go ahead.

Thank you. And once again, welcome to PanBella's First 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 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 poor-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 PanBella. Jennifer, please proceed.

Thank you, James, and thank you, everyone, for joining. I will begin the call by touching on Q1 and our 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 Q1 and recent highlights. As we highlighted on our last earnings call, in February, we entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals Incorporated, or CPP for short. A closing is expected to occur in the second quarter of 2022, subject to the satisfaction of customary closing conditions. As we've shared, the combined company will have a much larger pipeline targeting approximately a $5 billion aggregate market opportunity for the areas of initial focus. Acquiring CPP will substantially advance our mission of treating diseases where there is an unmet need through a diversified pipeline, addressing numerous targets and thus expanding the potential of the combined company. Turning to SPP 101. Just last week, we held an R&D day and we were joined by leading experts from the Cindy Kimmel Comprehensive Cancer Center at the Johns Hopkins University School of Medicine for a deep dive on SPP 101 as a polyamine metabolism modulator in ovarian cancer. Presenters included the following doctors. Deborah Armstrong, Director of Breast and Ovarian Surveillance Service and Professor of Oncology. Robert Casero, Associate Director for Shared Resources and Professor of Oncology, Stephanie Gaillard, Director of Gynecologic Cancer Trials and Assistant Professor of Oncology, Cassandra Holbert, Postdoctoral Fellow, and Tracy Marie Stewart, Cancer Biologist and Rare Disease Researcher. The topics covered in the call included a preclinical data presentation, which was led by Dr. Holbert, and a clinical presentation of the ovarian treatment landscape, which was led by Dr. Gaillard. The call is structured to help attendees gain a greater understanding of the potential of, and our clinical strategy for, SCP-101 in ovarian cancer. On a related note, one month earlier, we were pleased to announce a poster presentation highlighting the results for SCP-101 in ovarian cancer at the American Association for Cancer Research, or AACR, which took place April 8th through the 13th of this year. Correspondingly, the work reflects our ongoing collaboration with the Johns Hopkins University School of Medicine. The poster presentation points out that the treatment of immune-competent mice injected with BdA-positive ovarian cancer with SBP101 was observed to significantly prolong survival and decrease overall tumor burden. We remain grateful to our collaborators at the Johns Hopkins University School of Medicine who are on the leading edge of cancer research. The results suggest that SVP101 may have a role in the clinical management of ovarian cancer. This data supports our efforts to initiate an ovarian cancer clinical program this year. We look forward to continuing our work with the Johns Hopkins School of Medicine to identify additional target tumors for future development programs in patients with unmet medical needs. Turning to our work in pancreatic cancer, earlier in the year, we announced the initiation of our global randomized trial. This phase two trial is a randomized, double-blind, placebo-controlled clinical trial for SVP101 in combination with gemcitabine and nabpaclitaxel versus gemcitabine, nabpaclitaxel, and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma and is referred to as the ASPIRE trial. Summit Cancer Centers in Spokane, Washington was the first clinical site activated with Dr. Arun Chowdhury. serving as its principal investigator. Approximately 60 to 70 additional sites are expected to be activated in 2022. We have commenced screening for eligible patients with enrollment expected to complete in approximately 12 months after the first patient is enrolled. Supporting the advancement into the ASPIRE trial was data announced in January of this year at the ASCO GI meeting, which included an objective response rate of 48%, a disease control rate of 76%, and a median overall survival of 12 months, which at the time of the poster presentation was not yet final. All exceeded historical rates reported for gemcitabine and nabpaclitaxel. Since the poster presentation, the median overall survival has been reached at 12.53 months and is now final. This is four months longer than what is typically seen with jacitabine and naphthaxapaxil. Last, we have also had two patients who have demonstrated long-term survival with the two patients from cohort two, one of which achieved 30.3 months, which is now final data, and the other at 33 months and is still alive. There are seven patients, one from cohort two and six from cohort four and the expansion, that are still alive. We are excited to continue development of SPP-101 in our global randomized study in metastatic pancreatic cancer, which I spoke about earlier. Also of note, last year we completed preclinical work necessary to begin a neoadjuvant trial. We are working with the key opinion leaders to finalize the protocol and obtain the necessary institutional approvals to open this investigator-initiated trial in the second half of this year. Regarding milestones, we announced the ASCO GI Coaster presentation in January and the research call to review the ovarian cancer data and ovarian cancer treatment standards. Additionally, in the first half of this year, we anticipate the first patient enrolled in our ASPIRE trial, as well as expansion to sites outside of the United States, the satisfaction of conditions and closing of the CPP acquisition, the final data from our phase one first line metastatic pancreatic cancer study, and the initiation of the ovarian cancer clinical program for SPP 101 around mid-year. In the second half of this year, we expect to announce that the neoadjuvant pancreatic cancer investigator initiative trial will be open for enrollment. With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022 will increase the flow of planned development activity and data. In summary, we have made tremendous progress in Q1 and year to date. We are excited to enhance shareholder value as we move ahead in 2022 by executing against our stated milestones. I will stop here and turn it over to Sue to review the financials. Thank you, Jennifer.