On November 10, 2022 Panbela Therapeutics, Inc. (Nasdaq: PBLA) , a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported that financial results for the quarter ended September 30, 2022 (Press release, Panbela Therapeutics, NOV 10, 2022, View Source [SID1234623712]). Management is hosting an earnings conference call today at 4:30 p.m. ET.

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The third quarter was marked by meaningful progress.

Q3 and early Q4 Highlights:

First Patient Enrolled in the company’s Aspire Trial, Panbela’s clinical trial in the first-line treatment of metastatic pancreatic cancer.
Announced Regulatory approval for the opening of Aspire Trial sites in Spain, France and Italy.
Received approval from the Australian Human Research Ethics Committee (HREC) to expand the Aspire Trial to Australia.
Poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022.
Completed registered public offering totaling gross proceeds of $6 Million.
"During Q3 we advanced our pipeline, which is largely funded through partnerships and targets an approximate $5 billion total addressable market," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Milestones achieved included first patient enrolled in our Aspire global trial for metastatic pancreatic cancer, approval to expand the trial into Australia and approval to open sites in Spain, France and Italy. Through our acquisition of Cancer Prevention Pharmaceuticals (CPP) and organic operational advancements, we have programs spanning pre-clinical to registration studies, including a lead asset with a fully funded registration trial scheduled to begin mid- 2023. Additionally, we bolstered our balance sheet with gross proceeds from a public offering of approximately $6.0 million. In 2023, we anticipate a consistent stream of milestones to drive shareholder value."

During Q4 2022, we expect the initiation of a Phase I/II program in STK11 mutant non-small cell lung cancer which will be our first clinical proof of concept study evaluating polyamine modulation to improve anti-PD-1 efficacy.

Looking ahead to early 2023, we expect to announce the final data from our Phase I untreated metastatic pancreatic cancer study as well as the Phase I data from the recent onset type I diabetes program. We will also be opening a neoadjuvant pancreatic cancer investigator-initiated trial with ivospemin (SBP-101) and a Phase II study in recent onset type I diabetes which is supported by Indiana University and the Juvenile Diabetes Research Foundation (JDRF).

Third quarter ended September 30, 2022 Financial Results

General and administrative expenses were $1.3 million in the third quarter of 2022, compared to $0.9 million in the third quarter of 2021. The change is due to slightly higher professional services cost as the Company continues to integrate CPP into its operations.

Research and development expenses were $2.3 million in the third quarter of 2022 compared to $1.3 million in the third quarter of 2021. The increase relates to an increase in spending on our clinical studies.

Net loss in the third quarter of 2022 was $4.4 million, or $0.21per diluted share, compared to a net loss of $2.1 million, or $0.16 per diluted share, in the third quarter of 2021.

Total cash was $0.9 million as of September 30, 2022. Total current assets were $1.8million and current liabilities were $8.0 million as of the same date. Also at September 30, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.1million. Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $7.0 million. The current portion of the notes payable plus accrued interest totaled approximately $1.8 million.

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About our Pipeline

The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of news flow with programs ranging from pre-clinical to registration studies.

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, demonstrating a median overall survival (OS) of 14.6 months which is 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

Flynpovi

Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism of action inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. In our Phase III trial focusing on FAP patients with lower gastrointestinal tract anatomy (patients with an intact colon, retained rectum or surgical pouch) comparing Flynpovi to single agent eflornithine and single agent sulindac, Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI group for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP.

CPP-1X

CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.