On August 15, 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 June 30, 2022 (Press release, Panbela Therapeutics, AUG 15, 2022, View Source [SID1234618352]). Management is hosting an earnings conference call today at 4:30 p.m. ET.

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The second quarter was marked by meaningful progress.

Q2 and Recent Highlights:

First Patient Enrolled in its Aspire Trial.
Received approval from the Australian Human Research Ethics Committee (HREC) to expand the company’s global clinical trial to Australia.
Closed on the acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP).
Hosted a virtual R&D Day on the company’s investigational drug, ivospemin (SBP-101), as a polyamine metabolism modulator in ovarian cancer.
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. The work reflects the company’s ongoing collaboration with Johns Hopkins University School of Medicine.
"Through the second quarter we significantly increased our addressable market at Panbela. First, during the quarter we closed on our definitive agreement to acquire CPP. The combined entity targets an estimated $5 billion aggregated market opportunity. Additionally, we presented ovarian cancer data at AACR (Free AACR Whitepaper), supporting SBP-101’s potential use beyond our first indication, pancreatic cancer," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Via our acquisition of CPP and organic operational advancements, Panbela now has a diversified pipeline, with an ability to hit multiple targets. The development programs now consists of the randomized, double-blind, placebo controlled trial in first line metastatic pancreatic cancer patients, and a Phase III clinical trial funded by the National Cancer Institute (the "NCI") for the study of colon cancer risk reduction and colon adenoma therapy ("CAT"). Additional programs are evaluating a single agent tablet eflornithine (CPP-1X) or high dose powder eflornithine sachet (CPP-1X-S) for several indications including prevention of gastric cancer and treatment of high risk refractory neuroblastoma. As we now have programs ranging from pre-clinical to registration studies, including a lead asset with a fully funded registration trial scheduled to begin in early 2023, we expect a steady flow of achievements."

During the second half of 2022, we expect to announce final data from our Phase I untreated metastatic pancreatic cancer study, and the opening of a neoadjuvant pancreatic cancer investigator-initiated trial with ivospemin (SBP-101). With the closing of the CPP transaction, we also anticipate achieving additional milestones during the remainder of 2022 that will reflect the increased flow of planned development activity and data. These milestones include initiation of a Phase I/II program in non-small cell lung cancer and a Phase II study in Type I onset Diabetes.

Second quarter ended June 30, 2022 Financial Results

General and administrative expenses were $1.3 million in the second quarter of 2022, compared to $1.2 million in the second quarter of 2021. The change is due primarily to legal fees, associated with the acquisition of CPP.

Research and development expenses were $20.0 million in the second quarter of 2022, inclusive of a one-time, non-cash expense of $17.7 million. This expense was the write-off of in process research and development (or IPR&D). The company has accounted for the acquisition of CPP as an asset purchase. IPR&D represents the asset purchased and asset acquisition accounting requires writing off this asset immediately after the acquisition. The remaining R&D expense in the quarter of approximately $2.3 million compares to $1.0 million in the second quarter of 2021. This is related to an increase in spending on our clinical studies.

Net loss in the second quarter of 2022 was $21.1 million, or $1.51 per diluted share, compared to a net loss of $2.2 million, or $0.22 per diluted share, in the second quarter of 2021.

Total cash was $2.5 million as of June 30, 2022. Total current assets were $3.5 million and current liabilities were $6.2 million as of the same date. Also at June 30, 2022, total noncurrent assets, consisting of cash deposits held by our contract research organization, were $3.1 million. New notes payable on the balance sheet, the result of the acquisition of CPP, totaled approximately $6.9 million. Current portion of the notes payable plus accrued interest totaled approximately $1.7 million.

Conference Call Information

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 inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase 3 clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase 3 trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), Flynpovi showed statistically significant benefit compared to both single agents (p≤0.02) in delaying surgical events in the lower GI 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 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment is well tolerated and has potential activity.