Panbela Therapeutics, Inc.

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.

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.

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