Panbela Provides Business Update and Reports Q3 2024 Financial Results
Panbela Therapeutics (PBLA) reported Q3 2024 financial results and secured a $12.0 million financing commitment from Nant Capital. The company enrolled its first patient in a Phase I study of CPP-1X-S for STK11 mutant NSCLC. The Phase III ASPIRE trial continues with interim analysis expected in Q1 2025. Q3 financial results showed general and administrative expenses of $1.1 million, R&D expenses of $6.0 million, and a net loss of $7.2 million ($1.48 per share). Total cash was $142,000 as of September 30, 2024, with current assets at $5.2 million and current liabilities at $20.1 million.
Panbela Therapeutics (PBLA) ha riportato i risultati finanziari del terzo trimestre del 2024 e ha ottenuto un impegno di finanziamento di 12,0 milioni di dollari da Nant Capital. L'azienda ha arruolato il suo primo paziente in uno studio di Fase I di CPP-1X-S per il NSCLC mutante STK11. Il trial di Fase III ASPIRE continua, con un'analisi intermedia attesa per il primo trimestre del 2025. I risultati finanziari del terzo trimestre hanno mostrato spese generali e amministrative di 1,1 milioni di dollari, spese per R&S di 6,0 milioni di dollari e una perdita netta di 7,2 milioni di dollari (1,48 dollari per azione). La liquidità totale era di 142.000 dollari al 30 settembre 2024, con attivi correnti pari a 5,2 milioni di dollari e passività correnti a 20,1 milioni di dollari.
Panbela Therapeutics (PBLA) reportó los resultados financieros del tercer trimestre de 2024 y aseguró un compromiso de financiamiento de 12,0 millones de dólares por parte de Nant Capital. La compañía inscribió a su primer paciente en un estudio de Fase I de CPP-1X-S para NSCLC mutante STK11. El ensayo de Fase III ASPIRE continúa, con un análisis intermedio previsto para el primer trimestre de 2025. Los resultados financieros del tercer trimestre mostraron gastos generales y administrativos de 1,1 millones de dólares, gastos de I+D de 6,0 millones de dólares y una pérdida neta de 7,2 millones de dólares (1,48 dólares por acción). El efectivo total era de 142,000 dólares al 30 de septiembre de 2024, con activos corrientes de 5,2 millones de dólares y pasivos corrientes de 20,1 millones de dólares.
Panbela Therapeutics (PBLA)는 2024년 3분기 재무 결과를 발표하고 Nant Capital로부터 1,200만 달러의 자금 지원 약속을 확보했습니다. 회사는 STK11 변이 NSCLC를 위한 CPP-1X-S의 1상 연구에 첫 환자를 모집했습니다. 3상 ASPIRE 시험은 계속 진행 중이며, 2025년 1분기에 중간 분석이 예정되어 있습니다. 3분기 재무 결과는 일반 및 관리 비용이 110만 달러, 연구 및 개발 비용이 600만 달러, 순손실이 720만 달러(주당 1.48 달러)로 나타났습니다. 2024년 9월 30일 기준 총 현금은 14만 2,000달러였으며, 현재 자산은 520만 달러, 현재 부채는 2,010만 달러입니다.
Panbela Therapeutics (PBLA) a publié les résultats financiers du troisième trimestre 2024 et a obtenu un engagement de financement de 12,0 millions de dollars de Nant Capital. La société a inscrit son premier patient dans une étude de Phase I de CPP-1X-S pour le NSCLC mutant STK11. L'essai de Phase III ASPIRE se poursuit, avec une analyse intermédiaire prévue pour le premier trimestre 2025. Les résultats financiers du troisième trimestre ont montré des dépenses générales et administratives de 1,1 million de dollars, des dépenses R&D de 6,0 millions de dollars et une perte nette de 7,2 millions de dollars (1,48 dollar par action). La trésorerie totale était de 142 000 dollars au 30 septembre 2024, avec des actifs courants de 5,2 millions de dollars et des passifs courants de 20,1 millions de dollars.
Panbela Therapeutics (PBLA) hat die Finanzzahlen für das dritte Quartal 2024 veröffentlicht und eine Finanzierungszusage in Höhe von 12,0 Millionen Dollar von Nant Capital gesichert. Das Unternehmen hat seinen ersten Patienten in einer Phase-I-Studie zu CPP-1X-S für STK11-mutiertes NSCLC eingeschrieben. Die Phase-III-ASPIRE-Studie läuft weiter, mit einer interimistischen Analyse, die im ersten Quartal 2025 erwartet wird. Die Finanzzahlen für das dritte Quartal zeigten allgemeine und administrative Kosten von 1,1 Millionen Dollar, F&E-Ausgaben von 6,0 Millionen Dollar und einen Nettoverlust von 7,2 Millionen Dollar (1,48 Dollar pro Aktie). Zum 30. September 2024 betrugen die Gesamtliquidität 142.000 Dollar, die Umlaufvermögen beliefen sich auf 5,2 Millionen Dollar und die kurzfristigen Verbindlichkeiten auf 20,1 Millionen Dollar.
- Secured $12.0 million financing commitment from strategic investor Nant Capital
- Lower event rate in Phase III ASPIRE trial suggests potential improved survival outcomes
- Reduced net loss per share from $53.74 in Q3 2023 to $1.48 in Q3 2024
- Decreased R&D expenses from $6.7M to $6.0M year-over-year
- Significant cash position concerns with only $142,000 in cash as of September 30, 2024
- Current liabilities ($20.1M) substantially exceed current assets ($5.2M)
- Notes payable plus accrued interest total $6.9M
- Net loss of $7.2M in Q3 2024
MINNEAPOLIS, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (OTCQB: 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, 2024. As previously announced, management is hosting an earnings call today at 4:30 p.m. ET.
Q3 2024 and Recent Highlights:
- Up to
$12.0 million financing commitment secured from strategic investor, Nant Capital. - First patient enrolled in a Phase I dose escalation study to evaluate CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer (NSCLC).
Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela, commented: "The third quarter marked another period of significant advancement for Panbela, and momentum has continued into Q4, highlighted by a transformative
We're particularly encouraged by the expansion of our clinical programs, including the initiation of patient enrollment in our Phase I dose escalation study of CPP-1X-S in STK11 mutant non-small cell lung cancer. This new indication represents an important step in broadening the application of our polyamine metabolic inhibitor technology.
The momentum we've built across our clinical programs, coupled with the strategic investment from Nant Capital, allows us to continue advancing our mission of delivering meaningful therapeutic options to patients. As we approach several key milestones, including our ASPIRE trial interim analysis, we remain focused on efficient execution and creating value for our stockholders."
Patrick Soon-Shiong, M.D., Founder of Nant Capital and Executive Chairman, Founder and Global Chief Scientific and Medical Officer at ImmunityBio commented:
"As a surgeon on a life-long scientific quest to address pancreatic cancer, I recognize the compelling potential of orchestrating the activation of the patient’s immune system and the metabolic pathways as an evolutionary approach to address this difficult to treat cancer. By combining Panbela's polyamine metabolic inhibitor platform with our immunotherapy approaches, we may change the course of how we address many solid tumors. Their lead assets, ivospemin, eflornithine, and Flynpovi, target the polyamine pathway in ways that could complement our natural killer cell and killer T cell activation technology. Given the encouraging delay in survival data for the interim analysis in the Panbela pancreatic cancer trial, I believe the combination of immunotherapy and metabolic pathway platforms could create powerful synergies in enhancing patient outcomes. This strategic investment reflects our confidence in the potential of this multi-targeted approach to reset dysregulated biology and potentially enhance anti-tumor activity. The versatility of Panbela's technology platform, from cancer applications to metabolic conditions, presents exciting opportunities for future clinical development programs that could deliver meaningful benefits to patients."
Third Quarter ended September 30, 2024 Financial Results
General and administrative expenses were approximately
Research and development expenses were approximately
Net loss in the quarter was approximately
Total cash was
Total current assets were
Notes payable, plus accrued interest, totaled approximately
Conference Call Information
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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, 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
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 >
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
Panbela Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing disruptive therapeutics for patients with urgent unmet medical needs. Panbela’s lead assets are Ivospemin (SBP-101) and Flynpovi. Further information can be found at www.panbela.com. Panbela’s common stock is eligible for quotation on the OTCQB under the symbol “PBLA”.
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 and the corresponding risk of potential deterioration of our financial condition and results due to failure to diversify; (iii) our ability to obtain and maintain our listing on a national securities exchange; (iv) results, progress and success of our randomized Phase Ia/Ib and Phase II/III clinical trials; (v) our ability to demonstrate the safety and effectiveness of our product candidates: ivospemin ( SBP-101 ), Flynpovi, and eflornithine (CPP-1X); (vi) potential delays or risks to the success of our randomized Phase II/III clinical trial resulting from a termination in our relationship with our CRO; (vii) our ability to obtain regulatory approvals for our product candidates, SBP-101, Flynpovi and CPP-1X in the United States, the European Union or other international markets; (viii) the market acceptance and level of future sales of our product candidates, SBP-101, Flynpovi and CPP-1X ; (ix) the cost and delays in product development that may result from changes in regulatory oversight applicable to our product candidates, SBP-101, Flynpovi and CPP-1X ; (x) the rate of progress in establishing reimbursement arrangements with third-party payors; (xi) the effect of competing technological and market developments; (xii) the costs involved in filing and prosecuting patent applications and enforcing or defending patent claims; and (xiii) 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
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, | |||||||||||||||||||||
| 2024 | 2023 | Percent Change | 2024 | 2023 | Percent Change | |||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||
| General and administrative | $ | 1,113 | $ | 1,107 | 0.5 | % | $ | 3,422 | $ | 4,102 | -16.6 | % | ||||||||||
| Research and development | 6,052 | 6,739 | -10.2 | % | 18,570 | 14,501 | 28.1 | % | ||||||||||||||
| Operating loss | (7,165 | ) | (7,846 | ) | -8.7 | % | (21,992 | ) | (18,603 | ) | 18.2 | % | ||||||||||
| Other income (expense): | ||||||||||||||||||||||
| Interest income | - | 49 | -100.0 | % | - | 114 | -100.0 | % | ||||||||||||||
| Gain on sale of intellectual property | - | 400 | - | 775 | 400 | - | ||||||||||||||||
| Interest expense | (442 | ) | (71 | ) | 522.5 | % | (564 | ) | (245 | ) | 130.2 | % | ||||||||||
| Other income (expense) | 435 | (382 | ) | -213.9 | % | 203 | (622 | ) | -132.6 | % | ||||||||||||
| Total other income (expense) | (7 | ) | (4 | ) | 75.0 | % | 414 | (353 | ) | -217.3 | % | |||||||||||
| Loss before income tax benefit | (7,172 | ) | (7,850 | ) | -8.6 | % | (21,578 | ) | (18,956 | ) | 13.8 | % | ||||||||||
| Income tax benefit | - | 19 | -100.0 | % | 139 | 167 | -16.8 | % | ||||||||||||||
| Net loss | (7,172 | ) | (7,831 | ) | -8.4 | % | (21,439 | ) | (18,789 | ) | 14.1 | % | ||||||||||
| Foreign currency translation adjustment | (422 | ) | 381 | -210.8 | % | (204 | ) | 612 | -133.3 | % | ||||||||||||
| Comprehensive Loss | $ | (7,594 | ) | $ | (7,450 | ) | 1.9 | % | $ | (21,643 | ) | $ | (18,177 | ) | 19.1 | % | ||||||
| Basic and diluted net loss per share | $ | (1.48 | ) | $ | (53.74 | ) | -97.2 | % | $ | (5.00 | ) | $ | (287.01 | ) | -98.3 | % | ||||||
| Weighted average shares outstanding - basic and diluted | 4,854,861 | 145,711 | 3231.8 | % | 4,289,989 | 65,463 | 6453.3 | % | ||||||||||||||
Panbela Therapeutics, Inc.
Consolidated Balance Sheets (unaudited)
(In thousands, except share amounts)
| September 30, 2024 | December 31, 2023 | |||||||
| ASSETS | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 142 | $ | 2,578 | ||||
| Prepaid expenses | 109 | 299 | ||||||
| CRO deposits | 4,585 | - | ||||||
| Income tax receivable | 332 | 183 | ||||||
| Total current assets | 5,168 | 3,060 | ||||||
| Other non-current assets | - | 8,742 | ||||||
| Total assets | $ | 5,168 | $ | 11,802 | ||||
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 10,950 | $ | 9,939 | ||||
| Accrued expenses | 5,469 | 1,141 | ||||||
| Accrued interest payable | 523 | 238 | ||||||
| Notes payable | 2,200 | - | ||||||
| Debt, current portion | 1,000 | 1,000 | ||||||
| Total current liabilities | 20,142 | 12,318 | ||||||
| Debt, net of current portion | 3,194 | 4,194 | ||||||
| Total non-current liabilities | 3,194 | 4,194 | ||||||
| Total liabilities | 23,336 | 16,512 | ||||||
| Stockholders' deficit: | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 5 | - | ||||||
| Treasury Stock at cost; 70 shares at both of September 30, 2024 and December 31, 2023 | (1 | ) | (1 | ) | ||||
| Additional paid-in capital | 128,223 | 120,043 | ||||||
| Accumulated deficit | (146,936 | ) | (125,497 | ) | ||||
| Accumulated comprehensive income | 541 | 745 | ||||||
| Total stockholders' deficit | (18,168 | ) | (4,710 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 5,168 | $ | 11,802 | ||||
Panbela Therapeutics, Inc.
Consolidated Statements of Cash Flows (unaudited)
(In thousands)
| Nine Months Ended September 30, | |||||||
| 2024 | 2023 | ||||||
| Cash flows from operating activities: | |||||||
| Net loss | $ | (21,439 | ) | $ | (18,789 | ) | |
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
| Stock-based compensation | 103 | 699 | |||||
| Non-cash interest expense | 523 | 172 | |||||
| Gain on sale of intellectual property | (775 | ) | (400 | ) | |||
| Changes in operating assets and liabilities: | |||||||
| Income tax receivable | (140 | ) | (112 | ) | |||
| Prepaid expenses and other current assets | (170 | ) | (381 | ) | |||
| Other non-current assets | 4,516 | (5,541 | ) | ||||
| Accounts payable | 798 | 4,370 | |||||
| Accrued liabilities | 4,091 | (2,187 | ) | ||||
| Net cash used in operating activities | (12,493 | ) | (22,169 | ) | |||
| Cash flows from investing activities: | |||||||
| Proceeds from sale of intellectual property | 775 | 400 | |||||
| Net cash provided by investing activities | 775 | 400 | |||||
| Cash flows from financing activities: | |||||||
| Proceeds from public offering of common stock and warrants, net of fees and offering costs of | 8,082 | 23,052 | |||||
| Cash paid for fractional shares | - | (9 | ) | ||||
| Proceeds from sale of promissory notes | 2,200 | - | |||||
| Principal payments on notes | (1,000 | ) | (1,650 | ) | |||
| Net cash provided by financing activities | 9,282 | 21,393 | |||||
| Effect of exchange rate changes on cash | - | (2 | ) | ||||
| Net change in cash | (2,436 | ) | (378 | ) | |||
| Cash and cash equivalents at beginning of period | 2,578 | 1,285 | |||||
| Cash and cash equivalents at end of period | $ | 142 | $ | 907 | |||
| Supplemental disclosure of cash flow information: | |||||||
| Cash paid during period for interest | $ | 279 | $ | 398 | |||
FAQ
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