Panbela Schedules Conference Call on March 25, 2021 to Report 2020 Fourth Quarter Financial Results

Rhea-AI Summary

Panbela Therapeutics (Nasdaq: PBLA) announced a conference call on March 25, 2021, to discuss its fourth-quarter results for 2020. The call will feature insights into the performance of SBP-101, a therapeutic candidate for pancreatic cancer, which has shown promise in clinical studies without exacerbating chemotherapy-related adverse events. However, a partial clinical hold has been placed by the FDA due to serious visual adverse events, pending further evaluation. Investors are advised to stay tuned for updates post-call.

Positive

• SBP-101 has shown potential in clinical studies for tumor growth inhibition in pancreatic cancer patients.
• No significant exacerbation of bone marrow suppression and peripheral neuropathy, common chemotherapy side effects.

Negative

• The FDA has issued a partial clinical hold on SBP-101 due to serious visual adverse events.
• Uncertainty surrounding the timeline for the removal of the partial clinical hold could affect future trials.

MINNEAPOLIS, March 17, 2021 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer today announced that it will host a conference call on March 25, 2021 at 4:30 PM Eastern Time to discuss results for its fourth quarter ended December 31, 2020.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.

Date: March 25, 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/2556/40332

Conference Call Replay Information

Toll Free: 877-481-4010 
International: 919-882-2331 
Replay Passcode: 40332

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 the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold.  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 adenocarcinoma, the most common type of pancreatic cancer. Panbela Therapeutics, Inc. is dedicated to treating patients with pancreatic cancer and exploring SBP-101’s potential for efficacy in combination with other agents and in treating other types of cancer. Further information can be found at www.panbela.com. Panbela Therapeutics, Inc. common stock is listed on The Nasdaq Stock Market LLC under the symbol PBLA.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements,” including within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “believes,” “continue,” “dedicated,” “expect,” “intend,” “may,” “plan,” and “seek.” Examples of forward-looking statements include, among others, statements we make regarding future determinations of the characteristics of SBP-101 and its effectiveness, removal of the partial clinical hold, other trial activities and the timing of the same. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially and adversely from the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: (i) our ability to obtain additional funding to complete a randomized clinical trial; (ii) progress and success of our Phase 1 clinical trial; (iii) the impact of the COVID-19 pandemic on our ability to complete monitoring and reporting in our current clinical trial; (iv) our ability to demonstrate the safety and effectiveness of our SBP-101 product candidate (v) our ability to obtain regulatory approvals for our SBP-101 product candidate in the United States, the European Union or other international markets; (vi) the market acceptance and level of future sales of our SBP-101 product candidate; (vii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our SBP-101 product candidate; (viii) the rate of progress in establishing reimbursement arrangements with third-party payors; (ix) the effect of competing technological and market developments; (x) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xi) such other factors as discussed in Part I, Item 1A under the caption “Risk Factors” in our most recent Annual Report on Form 10-K, any additional risks presented in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Any forward-looking statement made by us in this press release is based on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement or reasons why actual results would differ from those anticipated in any such forward-looking statement, whether written or oral, whether as a result of new information, future developments or otherwise.

Contact Information:

Investors: 
James Carbonara 
Hayden IR 
(646) 755-7412 
james@haydenir.com

Media: 
Tammy Groene 
Panbela Therapeutics, Inc. 
(952) 479-1196 
IR@panbela.com

FAQ

When is the Panbela Therapeutics conference call regarding Q4 results?

The conference call is scheduled for March 25, 2021, at 4:30 PM Eastern Time.

What is the status of SBP-101 in clinical trials?

SBP-101 is currently under evaluation with a partial clinical hold by the FDA due to reported serious adverse events.

What are the potential benefits of SBP-101?

SBP-101 has demonstrated tumor growth inhibition in pancreatic cancer patients without significant worsening of chemotherapy side effects.

What issues has Panbela reported regarding SBP-101?

Panbela has reported serious visual adverse events associated with SBP-101, leading to an FDA partial clinical hold.