On March 24, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with cancer, reported that financial results for the quarter and full year ended December 31, 2021 (Press release, Processa Pharmaceuticals, MAR 24, 2022, View Source [SID1234610951]). Management is hosting an earnings call today at 4:30 p.m. ET.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The fourth quarter and full year 2021 was marked by meaningful corporate, financial and clinical progress.
2021 and early 2022 Highlights:
Agreed to acquire Cancer Prevention Pharmaceuticals, Inc. (CPP) setting the stage for a combined entity with an expanded pipeline addressing an estimated $5 billion aggregated market opportunity upon closing.
Initiated our ASPIRE trial – a global, randomized, double-blind, placebo controlled Phase II/III clinical trial of SBP-101 in combination with Gemcitabine and Nab-Paclitaxel versus Gemcitabine, Nab-paclitaxel and placebo in patients with untreated metastatic pancreatic ductal adenocarcinoma.
Announced a new development program in Ovarian Cancer expected to start in the first half 2022 as the result of positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines.
Abstracts for SBP-101 were accepted for poster presentations at both the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2022 and the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2021; Median overall survival of 12.53 months for the phase 1 first line metastatic pancreatic trial reached shortly after the January poster presentation.
Announced issuance of key U.S. Patent for claims of a novel, more efficient, manufacturing process for the production of SBP-101.
Closed a $10.0 million bought deal public offering of common stock on July 2, 2021.
Joined the Russell Microcap Index.
Formed a research agreement with the Johns Hopkins University School of Medicine to further development of Panbela’s investigative agent SBP-101, including activity in cell lines outside of pancreatic cancer, biomarkers informing diagnostics and potential combination with checkpoint inhibitors.
"2021 and this year to date has been a transformative period of significant value creation for Panbela. Most recently, we entered into a definitive agreement to acquire CPP. The combined company will have an expanded pipeline addressing an estimated $5 billion aggregate market opportunity," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. A few highlights of the transaction include adding a lead asset with a fully funded registration trial targeting familial adenomatous polyposis (FAP) that is scheduled to begin this year. The acquisition also adds an ongoing Phase III trial, the PACES trial, in colon cancer survivors that is funded by National Cancer Institute in collaboration with the Southwest Oncology Group (SWOG). Additionally, CPP has clinical trials in neuroblastoma, gastric cancer, and early-onset type-1 diabetes underway, each in collaboration with various cooperative groups.
"Organically, Panbela has advanced our pancreatic cancer program into a Phase II/III trial. Due to its rigor, we are optimistic that the ASPIRE trial results, if positive, could support our registration efforts. Additionally, we’ve expanded SBP-101 into ovarian cancer based on positive preclinical results. We also completed pre-clinical work for our neoadjuvant investigator-initiated trial (IIT). Through pending M&A and organic execution, Panbela is well positioned to treat more patients and increase stockholder value," continued Dr. Simpson.
Upcoming Milestones:
For the first half of 2022, we expect to announce:
Satisfaction of conditions and closing the CPP transaction
First patient enrolled in our ASPIRE trial as well as expansion outside the US
We will host a Research call to review the ovarian cancer data and ovarian cancer treatment standards
Availability of Final Data – Phase I first- line metastatic pancreatic cancer
Initiation of SBP-101 development efforts in ovarian cancer
Also, during the second half of 2022, we expect to announce the opening of the Neoadjuvant Pancreatic Cancer IIT. With the expected closing of the CPP transaction, we anticipate that additional milestones for 2022 will reflect the increased flow of planned development activity and data.
Fourth Quarter ended December 31, 2021 Financial Results
General and administrative expenses were $1.3 million in the fourth quarter of 2021, compared to $0.9 million in the fourth quarter of 2020. The change is due to expenses, including legal and financial advisory fees, associated with the acquisition of CPP.
Research and development expenses were $2.0 million in the fourth quarter of 2021, compared to $0.7 million in the fourth quarter of 2020. The change is due primarily to an increase in spending on our clinical studies as we prepared to launch the ASPIRE clinical trial, as well as manufacturing expenses for product and placebo required for this trial.
Net loss in the fourth quarter of 2021 was $3.5 million, or $0.26 per diluted share, compared to a net loss of $0.9 million, or $0.09 per diluted share, in the fourth quarter of 2020.
Total cash was $11.9 million as of December 31, 2021. Total current assets were $12.3 million and current liabilities were $2.7 million as of the same date. The company had no debt as of December 31, 2021.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Webcast replay: Webcast: View Source
About: SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma, ovarian cancer and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 12.53 months which is now final, and an objective response rate (ORR) of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source