Exhibit 99.1
Panbela Provides Business Update and Reports Q3 2022 Financial Results
MINNEAPOLIS -- Panbela Therapeutics, Inc. (Nasdaq: PBLA) , a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today provides a business update and reports financial results for the quarter ended September 30, 2022. Management is hosting an earnings conference call today at 4:30 p.m. ET.
The third quarter was marked by meaningful progress.
Q3 and early Q4 Highlights:
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First Patient Enrolled in the company’s Aspire Trial, Panbela’s clinical trial in the first-line treatment of metastatic pancreatic cancer. |
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Announced Regulatory approval for the opening of Aspire Trial sites in Spain, France and Italy. |
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Received approval from the Australian Human Research Ethics Committee (HREC) to expand the Aspire Trial to Australia. |
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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) in April 2022. |
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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.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date: November 10, 2022
Time: 4:30 PM Eastern Time
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Participant Numbers: |
Toll Free: 877-545-0523 |
Webcast Link: https://www.webcaster4.com/Webcast/Page/2556/46946
Conference Call Replay Information
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Replay Number: |
Toll Free: 877-481-4010 |
Webcast Replay: https://www.webcaster4.com/Webcast/Page/2556/46946
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 https://clinicaltrials.gov/ct2/show/NCT03412799
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.
About Panbela
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. The company’s lead assets are SBP-101 and Flynpovi. Further information can be found at https://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: “believe,” “continue,” “design,” “expect,” “may,” “plan,” “scheduled,” and “will.” Examples of forward-looking statements include statements we make regarding results of collaborations with third parties, future milestones, and future studies and trials. All statements other than statements of historical fact are statements that should be deemed forward-looking statements. 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 execute our business and clinical development plans; (ii) progress and success of our clinical development program; (iii) the impact of the current COVID-19 pandemic on our ability to conduct our clinical trials; (iv) our ability to demonstrate the safety and effectiveness of our product candidates: SBP-101 and eflornithine (v) our reliance on a third party for the execution of the registration trial for our product candidate Flynpovi; (vi) our ability to obtain regulatory approvals for our product candidates, ivospemin (SBP-101) and eflornithine (CPP-1X) in the United States, the European Union or other international markets; (vii) the market acceptance and level of future sales of our product candidates, ivospemin (SBP-101) and eflornithine (CPP-1X); (viii) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, ivospemin (SBP-101) and eflornithine (CPP-1X); (ix) the rate of progress in establishing reimbursement arrangements with third-party payors; (x) the effect of competing technological and market developments; (xi) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xii) such other factors as discussed 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
Panbela Therapeutics, Inc.
Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(In thousands, except share and per share amounts)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||||||||||
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2022 |
2021 |
Percent Change |
2022 |
2021 |
Percent Change |
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Operating expenses: |
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General and administrative |
$ | 1,294 | $ | 924 | 40.0 | % | $ | 4,349 | $ | 3,316 | 31.2 | % | ||||||||||||
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Research and development |
2,329 | 1,286 | 81.1 | % | 24,563 | 3,383 | 626.1 | % | ||||||||||||||||
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Operating loss |
(3,623 | ) | (2,210 | ) | 63.9 | % | (28,912 | ) | (6,699 | ) | 331.6 | % | ||||||||||||
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Other income (expense): |
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Interest income |
6 | 1 | 1.00 | 10 | 1.00 | - | ||||||||||||||||||
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Interest expense |
(87 | ) | (2 | ) | 4250.0 | % | (107 | ) | (9 | ) | 1088.9 | % | ||||||||||||
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Other income (expense) |
(754 | ) | (335 | ) | 125.1 | % | (1,293 | ) | (611 | ) | 111.6 | % | ||||||||||||
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Total other income (expense) |
(835 | ) | (337 | ) | 147.8 | % | (1,390 | ) | (620 | ) | 124.2 | % | ||||||||||||
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Loss before income tax benefit |
(4,458 | ) | (2,547 | ) | 75.0 | % | (30,302 | ) | (7,319 | ) | 314.0 | % | ||||||||||||
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Income tax benefit |
56 | 404 | -86.1 | % | 104 | 721 | -85.6 | % | ||||||||||||||||
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Net loss |
(4,402 | ) | (2,143 | ) | 105.4 | % | (30,198 | ) | (6,598 | ) | 357.7 | % | ||||||||||||
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Foreign currency translation adjustment |
727 | 327 | 122.3 | % | 1,240 | 566 | 119.1 | % | ||||||||||||||||
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Comprehensive Loss |
$ | (3,675 | ) | $ | (1,816 | ) | 102.4 | % | $ | (28,958 | ) | $ | (6,032 | ) | 380.1 | % | ||||||||
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Basic and diluted net loss per share |
$ | (0.21 | ) | $ | (0.16 | ) | 31.3 | % | $ | (1.85 | ) | $ | (0.59 | ) | 213.6 | % | ||||||||
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Weighted average shares outstanding - basic and diluted |
20,780,848 | 13,285,223 | 56.4 | % | 16,313,639 | 11,122,725 | 46.7 | % | ||||||||||||||||
Panbela Therapeutics, Inc.
Consolidated Balance Sheets (unaudited)
(In thousands, except share amounts)
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September 30, 2022 |
December 31, 2021 |
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| (Unaudited) | ||||||||
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ | 941 | $ | 11,867 | ||||
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Prepaid expenses and other current assets |
779 | 91 | ||||||
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Income tax receivable |
46 | 321 | ||||||
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Total current assets |
1,766 | 12,279 | ||||||
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Deposits held for clinical trial costs |
3,101 | 593 | ||||||
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Total assets |
$ | 4,867 | $ | 12,872 | ||||
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LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY |
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Current liabilities: |
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Accounts payable |
$ | 5,394 | $ | 640 | ||||
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Accrued expenses |
758 | 2,020 | ||||||
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Accrued interest payable |
150 | - | ||||||
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Notes payable |
650 | - | ||||||
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Debt, current portion |
1,000 | - | ||||||
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Total current liabilities |
7,952 | 2,660 | ||||||
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Debt, net of current portion |
5,194 | - | ||||||
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Total non current liabilities |
5,194 | - | ||||||
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Total liabilities |
13,146 | 2,660 | ||||||
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Stockholders' (deficit) equity: |
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Preferred stock, $0.001 par value; 10,000,000 authorized; no shares issued or outstanding as of September 30, 2022 and December 31, 2021 |
- | - | ||||||
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Common stock, $0.001 par value; 100,000,000 authorized; 20,789,962 and 13,443,722 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively |
21 | 13 | ||||||
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Additional paid-in capital |
76,686 | 66,227 | ||||||
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Accumulated deficit |
(86,359 | ) | (56,161 | ) | ||||
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Accumulated comprehensive income |
1,373 | 133 | ||||||
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Total stockholders' (deficit) equity |
(8,279 | ) | 10,212 | |||||
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Total liabilities and stockholders' (deficit) equity |
$ | 4,867 | $ | 12,872 | ||||
Panbela Therapeutics, Inc.
Consolidated Statements of Cash Flows (unaudited)
(In thousands)
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Nine Months Ended September 30, |
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2022 |
2021 |
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Cash flows from operating activities: |
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Net loss |
$ | (30,198 | ) | $ | (6,597 | ) | ||
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Write off of in process research and development (IPR&D) |
17,737 | - | ||||||
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Stock-based compensation |
857 | 951 | ||||||
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Non-cash interest expense |
97 | - | ||||||
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Changes in operating assets and liabilities: |
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Income tax receivable |
302 | (201 | ) | |||||
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Prepaid expenses and other current assets |
(451 | ) | 221 | |||||
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Deposits held for clinical trial costs |
(2,561 | ) | - | |||||
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Accounts payable |
5,392 | 873 | ||||||
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Accrued liabilities |
(1,448 | ) | (264 | ) | ||||
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Net cash used in operating activities |
(10,273 | ) | (5,017 | ) | ||||
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Cash flows from investing activities: |
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Investment in IPR&D |
(660 | ) | - | |||||
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Cash acquired in merger |
4 | - | ||||||
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Net cash used in investing activities |
(656 | ) | - | |||||
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Cash flows from financing activities: |
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Proceeds from public offering of common stock net of underwriters discount and offering costs of $946 |
- | 9,053 | ||||||
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Proceeds from exercise of stock purchase warrants |
5 | 1,042 | ||||||
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Net cash provided by financing activities |
5 | 10,095 | ||||||
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Effect of exchange rate changes on cash |
(2 | ) | (28 | ) | ||||
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Net change in cash |
(10,926 | ) | 5,050 | |||||
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Cash and cash equivalents at beginning of period |
11,867 | 9,022 | ||||||
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Cash and cash equivalents at end of period |
$ | 941 | $ | 14,072 | ||||
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Supplemental disclosure of cash flow information: |
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Cash paid during period for interest |
$ | 9 | $ | 9 | ||||
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Supplemental Disclosure of non-cash transactions: |
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Fair value of common stock, stock options and stock warrants issued as consideration for asset acquisition |
$ | 9,605 | $ | - | ||||