Q1 2024 and recent Highlights:
Clinical
- Announced revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests high potential for improved survival outcomes for patients in the trial.
- Poster presentation of Ivospemin (SBP-101) at AACR highlighting the efficacy of SBP-101 in combination with doxorubicin to treat platinum-resistant ovarian cancer
- ASPIRE trial has exceeded 50% enrollment; complete enrollment of approximately 600 patients anticipated by Q1 2025
- Publication of Clinical Data: Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial. Br
J Cancer 130 , 788–797 (2024)
Financial / Business
- Gained eligibility for quotation of common stock on the OTCQB
- Closed
$9.0 million public offering of common stock and warrants - Issuance of a New Patent in the US and
Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac
"We were thrilled to announce that our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma, or mPDAC, is now expected to reach its interim data analysis in the first quarter of 2025, due to a lower-than-anticipated event rate, suggesting improved survival outcomes for patients in the trial. This gives us hope for meaningful advancements in mPDAC treatment beyond the incremental benefits seen with recently approved therapies," said
"In addition to the progress in our ASPIRE trial, which has now exceeded 50% enrollment with complete enrollment of approximately 600 patients anticipated by Q1 2025, we were pleased to present a poster highlighting the efficacy of SBP-101 in combination with doxorubicin for treating platinum-resistant ovarian cancer at AACR. We also welcomed the publication of clinical data from our Phase I study of high-dose DFMO, celecoxib, cyclophosphamide, and topotecan for patients with relapsed neuroblastoma in the
First Quarter ended
General and administrative expenses were approximately
Research and development expenses were approximately
Net loss in the quarter was approximately
Total cash was
Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately
During the first quarter, the Company completed a registered public offering. Net proceeds from the raise, which closed on
Conference Call Information
Toll Free: 877-545-0523
International: 973-528-0016
Participant Access Code: 234396
Webcast Link: https://www.webcaster4.com/Webcast/Page/2556/50531
Conference Call Replay Information
Toll Free: 877-481-4010
International: 919-882-2331
Replay Passcode: 50531
Webcast Replay: https://www.webcaster4.com/Webcast/Page/2556/50531
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, ovarian cancer and diabetes. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.
SBP-101 Ivospemin
Ivospemin 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. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for 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, ivospemin 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 previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. For more information, please visit https://clinicaltrials.gov/study/NCT03412799 .
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 III 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 Eflornithine
CPP-1X (eflornithine) is being developed as a single agent tablet or high dose power sachet for several indications including prevention of gastric cancer and recent onset Type 1 diabetes. Preclinical studies as well as Phase 1 or Phase 2 investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.
About Panbela
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements, “which can be identified by words such as: “anticipate,” “design,” “hope,” “may,” “plan,” and “will.” Examples of forward-looking statements include statements we make regarding timing of trials and results of collaborations with third parties and future studies. 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 capital, on acceptable terms or at all, required to implement our business plan; (ii) our lack of diversification and the corresponding risk of an investment in our Company; (iii) our ability to maintain our listing on a national securities exchange; (iv) progress and success of our randomized Phase II/III clinical trial; (v) our ability to demonstrate the safety and effectiveness of our product candidates: ivospemin ( SBP-101 ), Flynpovi, and eflornithine (CPP-1X) (v) our ability to obtain regulatory approvals for our product candidates, SBP-101, Flynpovi and CPP-1X in
Contact Information:
Investors:
Hayden IR
(646) 755-7412
james@haydenir.com
Media:
(952) 479-1196
Consolidated Statements of Operations and Comprehensive Loss (unaudited)
(In thousands, except share and per share amounts)
Three months ended | |||||||||||
2024 | 2023 | Percent Change | |||||||||
Operating expenses: | |||||||||||
General and administrative | $ | 1,204 | $ | 1,352 | -10.9 | % | |||||
Research and development | 5,522 | 3,508 | 57.4 | % | |||||||
Operating loss | (6,726 | ) | (4,860 | ) | 38.4 | % | |||||
Other income (expense): | |||||||||||
Interest income | 0 | 16 | - | ||||||||
Interest expense | (63 | ) | (102 | ) | -38.2 | % | |||||
Other income (expense) | (469 | ) | (167 | ) | 180.8 | % | |||||
Total other income (expense) | (532 | ) | (253 | ) | 110.3 | % | |||||
Loss before income tax benefit | (7,258 | ) | (5,113 | ) | 42.0 | % | |||||
Income tax benefit | 138 | - | - | ||||||||
Net loss | (7,120 | ) | (5,113 | ) | 39.3 | % | |||||
Foreign currency translation adjustment | 459 | 163 | 181.6 | % | |||||||
Comprehensive Loss | $ | (6,661 | ) | $ | (4,950 | ) | 34.6 | % | |||
Basic and diluted net loss per share | $ | (2.28 | ) | $ | (392.76 | ) | -99.4 | % | |||
Weighted average shares outstanding - basic and diluted | 3,125,835 | 13,018 | 23911.6 | % | |||||||
Consolidated Balance Sheets (unaudited)
(In thousands, except share amounts)
ASSETS | (Unaudited) | ||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 262 | $ | 2,578 | |||
Prepaid expenses and other current assets | 1,210 | 299 | |||||
Income tax receivable | 313 | 183 | |||||
Total current assets | 1,785 | 3,060 | |||||
Other non-current assets | 8,742 | 8,742 | |||||
Total assets | $ | 10,527 | $ | 11,802 | |||
LIABILITIES AND STOCKHOLDERS' DEFICIT | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 8,506 | $ | 9,939 | |||
Accrued expenses | 979 | 1,141 | |||||
Accrued interest payable | 34 | 238 | |||||
Debt, current portion | 1,000 | 1,000 | |||||
Total current liabilities | 10,519 | 12,318 | |||||
Debt, net of current portion | 3,194 | 4,194 | |||||
Total non-current liabilities | 3,194 | 4,194 | |||||
Total liabilities | 13,713 | 16,512 | |||||
Stockholders' deficit: | |||||||
Preferred stock, | - | - | |||||
Common stock, | 5 | - | |||||
Treasury Stock at cost; 70 shares at both of | (1 | ) | (1 | ) | |||
Additional paid-in capital | 128,223 | 120,043 | |||||
Accumulated deficit | (132,617 | ) | (125,497 | ) | |||
Accumulated comprehensive income | 1,204 | 745 | |||||
Total stockholders' deficit | (3,186 | ) | (4,710 | ) | |||
Total liabilities and stockholders' deficit | $ | 10,527 | $ | 11,802 | |||
Consolidated Statements of Cash Flows (unaudited)
(In thousands)
Three Months Ended | |||||||
2024 | 2023 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (7,120 | ) | $ | (5,113 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation | 103 | 180 | |||||
Non-cash interest expense | 34 | 42 | |||||
Changes in operating assets and liabilities: | |||||||
Income tax receivable | (140 | ) | - | ||||
Prepaid expenses and other current assets | (912 | ) | (2,108 | ) | |||
Other non-current assets | - | (5,441 | ) | ||||
Accounts payable | (957 | ) | 4,644 | ||||
Accrued liabilities | (400 | ) | (1,955 | ) | |||
Net cash used in operating activities | (9,392 | ) | (9,751 | ) | |||
Cash flows from financing activities: | |||||||
Proceeds from public offering of common stock and warrants net of underwriters discount and offering costs of | 8,082 | 15,358 | |||||
Cash paid for fractional shares | - | (4 | ) | ||||
Principal payments on notes | (1,000 | ) | (1,650 | ) | |||
Net cash provided by financing activities | 7,082 | 13,704 | |||||
Effect of exchange rate changes on cash | (6 | ) | (3 | ) | |||
Net change in cash | (2,316 | ) | 3,950 | ||||
Cash and cash equivalents at beginning of period | 2,578 | 1,285 | |||||
Cash and cash equivalents at end of period | $ | 262 | $ | 5,235 | |||
Supplemental disclosure of cash flow information: | |||||||
Cash paid during period for interest | $ | 266 | $ | 386 | |||
Supplemental disclosure of non-cash transactions: | |||||||
Cashless exercise of warrants | $ | - | $ | (8 | ) | ||
Source:
2024 GlobeNewswire, Inc., source