Panbela Provides Business Update and Reports Q1 2021 Financial Results
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced significant clinical advancements in its recent earnings call. The FDA lifted a partial clinical hold on its Phase 1 study of SBP-101, which shows promising results with a 62% objective response rate in combination with existing treatments for metastatic pancreatic cancer. Financially, the company reported a net loss of $2.3 million for Q1 2021, an increase from $1.8 million the previous year, with total cash standing at $8.1 million. Future milestones include data releases at the ASCO meeting in June 2021 and the initiation of a Phase 2 study mid-year.
- FDA lifted the partial clinical hold on SBP-101, facilitating further clinical trials.
- SBP-101 demonstrated a 62% objective response rate, over double the historical standard.
- Research agreement with Johns Hopkins University may expand development potential.
- Net loss increased to $2.3 million in Q1 2021 from $1.8 million in Q1 2020.
- General and administrative expenses rose to $1.1 million, up from $0.5 million the previous year.
- Research and development expenses also increased to $1.1 million, indicating higher costs.
MINNEAPOLIS, May 12, 2021 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today provides a business update and reports financial results for the quarter ended March 31, 2021. Management is hosting an earnings call today at 4:30 p.m. ET.
The first quarter 2021 was marked by meaningful clinical progress.
Q1 and Recent Highlights
- Abstract accepted with poster presentation at American Society of Clinical Oncology (ASCO) Annual Meeting June 4-8, 2021.
- Partial clinical hold lifted from the company's Phase 1 first-line study of SBP-101.
- Research agreement entered into with Johns Hopkins University School of Medicine; Preclinical studies underway.
As previously announced, in April the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on the company's Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treatment of patients with metastatic pancreatic ductal adenocarcinoma. The company has agreed to include in the design of future studies the exclusion of patients with a history of retinopathy or at risk of retinal detachment and scheduled periodic ophthalmologic monitoring for all patients, and in future dose-finding studies screening for retinal toxicity will be included.
“Year to date, we have focused on advancing SBP-101 in its first indication and exploring the broader potential of polyamine metabolic inhibition,” said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. “With the hold lifted, we are excited to move the pancreatic cancer program forward. Additionally, the research initiated with Johns Hopkins will help to inform development outside of pancreatic cancer as well as potentially in combination with a checkpoint inhibitor.”
Based on interim data from our Phase I trial, SBP-101 demonstrated a
We believe SBP-101 has the potential to expand into other cancers with known elevated levels of polyamine metabolism.
Upcoming Milestones
- Public release of additional data from phase 1 trial – ASCO Annual Meeting June 4-8, 2021
- Initiation of randomized phase 2 study mid-year
- Public release of preclinical data across tumors outside of pancreatic cancer 2H’21
First Quarter ended March 31, 2021 Financial Results
General and administrative expenses were
Research and development expenses were
Net loss was
Total cash was
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date: May 12, 2021
Time: 4:30 PM Eastern Time
Toll Free: 877-407-9205
International: 201-689-8054
The call will also be available over the Internet and accessible at: https://www.webcaster4.com/Webcast/Page/2556/40994
Conference Call Replay Information
Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 40994
Webcast replay: https://www.webcaster4.com/Webcast/Page/2556/40994
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 and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an 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. Recently observed serious visual adverse events are being 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 https://clinicaltrials.gov/ct2/show/NCT03412799 .
About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. The company’s initial product candidate, SBP-101, is for the treatment of patients with metastatic pancreatic ductal adenoc
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