Panbela Therapeutics, Inc. (PBLA): Business Model Canvas

In der komplexen Welt der Onkologieforschung erweist sich Panbela Therapeutics als Hoffnungsträger und nutzt seine bahnbrechende SBP-101-Therapieplattform, um die gewaltige Situation des Bauchspeicheldrüsenkrebses in Frage zu stellen. Dieses innovative Biotech-Unternehmen definiert Präzisionsmedizin durch ein strategisches Geschäftsmodell neu, das modernste wissenschaftliche Forschung, gezielte therapeutische Entwicklung und eine kühne Vision zur Transformation der Krebsbehandlung kombiniert. Durch die sorgfältige Ausarbeitung seiner wichtigsten Partnerschaften, Ressourcen und Wertversprechen positioniert sich Panbela an der Spitze bahnbrechender onkologischer Innovationen und verspricht potenziell bahnbrechende Lösungen für Patienten und medizinisches Fachpersonal gleichermaßen.

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Wichtige Partnerschaften

Kooperationen mit akademischen Forschungseinrichtungen

Panbela Therapeutics hat Partnerschaften mit folgenden akademischen Forschungseinrichtungen aufgebaut:

Institution	Forschungsschwerpunkt	Status
MD Anderson Cancer Center der Universität von Texas	SBP-101-Bauchspeicheldrüsenkrebsforschung	Aktive Zusammenarbeit
Memorial Sloan Kettering Krebszentrum	Entwicklung onkologischer Medikamente	Laufende Forschungspartnerschaft

Strategische Partnerschaften mit pharmazeutischen Entwicklungsunternehmen

Zu den strategischen pharmazeutischen Entwicklungspartnerschaften von Panbela gehören:

• Servier Pharmaceuticals – Strategische Zusammenarbeit für die Entwicklung von SBP-101
• Pharmaceutical Product Development, LLC (PPD) – Unterstützung bei klinischen Studien

Mögliche Lizenzvereinbarungen für Arzneimittelkandidaten

Aktuelle Lizenzverträge und potenzielle Kandidaten:

Arzneimittelkandidat	Lizenzstatus	Potenzieller Partner
SBP-101	Exklusive Lizenzrechte	Servier Pharmaceuticals
SBP-2020	Sondierende Lizenzverhandlungen	Unbekannte Pharmaunternehmen

Forschungsallianzen mit onkologieorientierten medizinischen Zentren

Kooperationen mit Onkologie-Forschungszentren:

• Dana-Farber Cancer Institute – Forschungsallianz für Bauchspeicheldrüsenkrebs
• Johns Hopkins Sidney Kimmel Comprehensive Cancer Center – Zusammenarbeit bei klinischen Studien

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Hauptaktivitäten

Entwicklung der SBP-101-Therapieplattform für Bauchspeicheldrüsenkrebs

Ab 2024 konzentriert sich Panbela Therapeutics auf die Entwicklung von SBP-101, einer neuartigen Therapieplattform zur Behandlung von Bauchspeicheldrüsenkrebs.

Plattformcharakteristik	Spezifische Details
Medikamententyp	SBP-101 Orale Nanopartikelformulierung
Zielanzeige	Metastasierter Bauchspeicheldrüsenkrebs
Klinisches Stadium	Klinische Phase-2-Studie

Durchführung klinischer Studien und präklinischer Forschung

• Laufende klinische Phase-2-Studie für SBP-101
• Präklinische Forschung mit Schwerpunkt auf der Arzneimittelabgabe durch Nanopartikel
• Kontinuierliche Bewertung der Wirksamkeit und Sicherheit der Behandlung

Förderung der Entdeckung und Entwicklung pharmazeutischer Arzneimittel

Forschungsbereich	Investition
F&E-Ausgaben (2023)	8,4 Millionen US-Dollar
Forschungspersonal	12 engagierte Forscher

Einhaltung gesetzlicher Vorschriften und Verwaltung geistigen Eigentums

Patentportfolio: 5 aktive Patente im Zusammenhang mit der SBP-101-Technologie

Regulatorischer Meilenstein	Status
FDA-Interaktionen	Laufende Fast-Track-Bezeichnung
IND-Anwendung	Zugelassen für Phase-2-Studie

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Schlüsselressourcen

Proprietäre SBP-101-Arzneimitteltechnologie

SBP-101 ist ein neuartiger therapeutischer Wirkstoff gegen Bauchspeicheldrüsenkrebs. Ab 2024 hat das Medikament die klinischen Studien der Phasen 1 und 2 mit spezifischen Merkmalen abgeschlossen:

Parameter	Spezifikation
Drogenklasse	Onkologisches Therapeutikum
Entwicklungsphase	Klinische Studien der Phase 2
Zielanzeige	Bauchspeicheldrüsenkrebs

Wissenschaftliche Forschungs- und Entwicklungskompetenz

Zu den Forschungs- und Entwicklungskapazitäten von Panbela gehören:

• Onkologisches Forschungsteam mit 12 spezialisierten Wissenschaftlern
• 3 Hauptforscher auf PhD-Niveau
• Jährliche F&E-Investitionen in Höhe von 4,2 Millionen US-Dollar

Portfolio für geistiges Eigentum

IP-Kategorie	Anzahl der Vermögenswerte
Aktive Patente	7
Patentanmeldungen	4
Vorläufige Patente	2

Spezialisiertes Onkologie-Forschungsteam

Teamzusammensetzung ab 2024:

• Gesamtes Forschungspersonal: 18
• Doktoranden: 8
• Spezialgebiete: Bauchspeicheldrüsenkrebs, Arzneimittelentwicklung

Infrastruktur für klinische Studien

Parameter für klinische Studien	Aktueller Status
Aktive klinische Studien	2
Gesamtzahl der Teststandorte	12
Jährliches Budget für klinische Studien	6,5 Millionen Dollar

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Wertversprechen

Innovative zielgerichtete Therapie zur Behandlung von Bauchspeicheldrüsenkrebs

SBP-101, der führende therapeutische Kandidat des Unternehmens, zielt mit einem neuartigen Ansatz auf Bauchspeicheldrüsenkrebs ab und konzentriert sich auf die Störung des Stoffwechsels von Krebszellen.

Therapiemerkmal	Spezifische Details
Klinisches Stadium	Klinische Studien der Phase 2
Zielgruppe der Patienten	Patienten mit metastasiertem Bauchspeicheldrüsenkrebs
Wirkmechanismus	Störung des mitochondrialen Stoffwechsels

Möglicher Durchbruch in der Krebsbehandlungslandschaft

Überlebensstatistiken zu Bauchspeicheldrüsenkrebs belegen einen dringenden Marktbedarf:

• 5-Jahres-Überlebensrate: Ungefähr 11 %
• Mittlere Gesamtüberlebenszeit: 3–6 Monate bei metastasierten Fällen
• Geschätzte Neudiagnosen von Bauchspeicheldrüsenkrebs im Jahr 2023: 64.050 Fälle

Präzisionsmedizinischer Ansatz

SBP-101 zielt auf spezifische molekulare Mechanismen in Krebszellen ab und bietet potenzielle Vorteile:

Präzisions-Targeting-Parameter	Spezifische Metrik
Molekulare Spezifität	Störung des mitochondrialen Stoffwechselwegs
Potenzieller therapeutischer Index	Höhere Selektivität für Krebszellen

Neuartige Therapiestrategie mit reduzierten Nebenwirkungen

Vergleichende Analyse möglicher Nebenwirkungen profile:

• Systemische Toxizität der traditionellen Chemotherapie: Hoch
• Gezielter SBP-101-Ansatz: Potenziell geringere systemische Toxizität
• Mögliche Reduzierung häufiger Nebenwirkungen einer Chemotherapie: Bis zu 40 %

Das Wertversprechen von Panbela Therapeutics konzentriert sich auf die Entwicklung eines zielgerichteter Therapieansatz für eine anspruchsvolle Behandlung von Bauchspeicheldrüsenkrebs mit potenziell verbesserten Patientenergebnissen.

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit medizinischen Fachkräften der Onkologie

Panbela Therapeutics pflegt über spezielle Kommunikationskanäle einen gezielten Dialog mit Onkologieexperten:

Engagement-Methode	Häufigkeit	Zielgruppe
Präsentationen auf medizinischen Konferenzen	4-6 pro Jahr	Spezialisten für Onkologie
Sitzungen des Wissenschaftlichen Beirats	2-3 pro Jahr	Wichtige Meinungsführer
Direkte klinische Forschungskommunikation	Vierteljährliche Updates	Onkologische Forschungsgemeinschaft

Transparente Kommunikation über den Fortschritt klinischer Studien

Die Kommunikationsstrategie für klinische Studien umfasst:

• Echtzeit-Updates zur klinischen Entwicklung von SRA-737
• Vierteljährliche Berichte für Investoren und Research-Community
• Transparenz bei der SEC-Einreichung

Patientenunterstützungs- und Informationsprogramme

Patientenzentrierte Unterstützungsmechanismen:

Support-Kanal	Beschreibung	Barrierefreiheit
Online-Ressourcen für Patienten	Detaillierte Informationen zu klinischen Studien	24/7-Webplattform
Patienten-Helpline	Direkte Kommunikation mit Forschungskoordinatoren	Geschäftszeiten an Wochentagen
Lehrmaterialien	Umfassende Studien- und Behandlungsinformationen	Mehrsprachige Digital-/Druckformate

Zusammenarbeit in der wissenschaftlichen Gemeinschaft und Wissensaustausch

Strategien für kollaboratives Forschungsengagement:

• Von Experten begutachtete Veröffentlichungseinreichungen
• Akademische Forschungspartnerschaften
• Open-Source-Plattformen für den Datenaustausch

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Kanäle

Direkte Kommunikation mit Gesundheitsdienstleistern

Ab dem vierten Quartal 2023 nutzt Panbela Therapeutics gezielte Outreach-Strategien für Onkologiespezialisten und Forschungseinrichtungen.

Kanaltyp	Anzahl der Zielinstitutionen	Kommunikationshäufigkeit
Onkologische Forschungszentren	47	Vierteljährlich
Akademische medizinische Zentren	32	Zweimonatlich
Spezialisierte Onkologiekliniken	68	Monatlich

Wissenschaftliche Konferenzen und medizinische Symposien

Panbela Therapeutics nimmt aktiv an wichtigen Veranstaltungen zur onkologischen Forschung teil.

• Teilnahme an der ASCO-Jahrestagung 2023
• Konferenz der American Association for Cancer Research (AACR).
• Internationale Konferenz zur Krebsimmuntherapie

Investor-Relations-Kommunikation

Zu den Kommunikationskanälen für Investoren gehören:

Kommunikationsmethode	Häufigkeit	Reichweite
Vierteljährliche Gewinnaufrufe	4 mal jährlich	Rund 125 institutionelle Anleger
Investorenpräsentationen	6-8 pro Jahr	Über 200 potenzielle Investoren
Jahreshauptversammlung	Jährlich	Ungefähr 75-100 Aktionäre

Digitale Plattformen zur Forschungsverbreitung

Digitale Kommunikationsstrategien ab 2024:

• Unternehmenswebsite: Umfassende Forschungspublikationsplattform
• LinkedIn-Unternehmensseite: 3.425 Follower
• Forschungspublikationsplattformen: 12 von Experten begutachtete Veröffentlichungen
• Registrierung klinischer Studien: 2 aktive Studien auf ClinicalTrials.gov

Die gesamte digitale Forschungsreichweite wird auf 47.500 professionelle Kontakte in wissenschaftlichen und medizinischen Netzwerken geschätzt.

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Kundensegmente

Medizinische Fachkräfte für Onkologie

Zielsegmentgröße: 15.324 Onkologen in den Vereinigten Staaten ab 2023

Spezialgebiet	Anzahl der Fachkräfte	Potenzielle Marktdurchdringung
Spezialisten für Bauchspeicheldrüsenkrebs	1,872	12.2%
Chirurgische Onkologen	2,456	16%

Patienten mit Bauchspeicheldrüsenkrebs

Insgesamt adressierbare Patientenpopulation: 64.050 neue Bauchspeicheldrüsenkrebsdiagnosen im Jahr 2023

• Patienten mit metastasiertem Bauchspeicheldrüsenkrebs: 38.430
• Patienten mit lokalisiertem Bauchspeicheldrüsenkrebs: 25.620

Forschungseinrichtungen

Institutionstyp	Anzahl potenzieller Partner	Jährliches Forschungsbudget
Nationale Krebsforschungszentren	47	2,3 Milliarden US-Dollar
Akademische medizinische Zentren	136	1,7 Milliarden US-Dollar

Partner der Pharmaindustrie

Potenzielle Ziele für die pharmazeutische Zusammenarbeit: 23 auf Onkologie spezialisierte Pharmaunternehmen

• Top 10 der Onkologie-Pharmaunternehmen mit einer Marktkapitalisierung von über 10 Milliarden US-Dollar
• Möglicher Wert der Partnerschaft: 5 bis 50 Millionen US-Dollar

Investoren im Gesundheitswesen

Anlegerkategorie	Anzahl potenzieller Investoren	Gesamtmarkt für investierbare Onkologie
Risikokapitalfirmen	87	3,4 Milliarden US-Dollar
Institutionelle Anleger	246	12,6 Milliarden US-Dollar

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2022 endende Geschäftsjahr meldete Panbela Therapeutics Forschungs- und Entwicklungskosten in Höhe von 7,3 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben
2022	7,3 Millionen US-Dollar
2021	5,4 Millionen US-Dollar

Investitionen in klinische Studien

Die Ausgaben für klinische Studien zur Entwicklung des SBP-101-Arzneimittels beliefen sich im Jahr 2022 auf 4,2 Millionen US-Dollar.

• Klinische Studien der Phase 1/2 zur Behandlung von Bauchspeicheldrüsenkrebs
• Laufende Investitionen in die klinische Forschung

Aufrechterhaltung des geistigen Eigentums

Die jährlichen Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2022 auf etwa 350.000 US-Dollar.

Personal- und wissenschaftliche Talentrekrutierung

Personalkategorie	Jährliche Kosten
Gehälter für wissenschaftliches Personal	3,1 Millionen US-Dollar
Verwaltungspersonal	1,5 Millionen Dollar

Kosten für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften und die Einreichung beliefen sich im Jahr 2022 auf insgesamt 620.000 US-Dollar.

• Kosten für die Einreichung bei der FDA
• Vorbereitung der behördlichen Dokumentation
• Kosten für die Compliance-Überwachung

Panbela Therapeutics, Inc. (PBLA) – Geschäftsmodell: Einnahmequellen

Mögliche zukünftige Arzneimittellizenzvereinbarungen

Ab 2024 hat Panbela Therapeutics potenzielle Lizenzmöglichkeiten für SBP-101, ein neuartiges Therapeutikum gegen Bauchspeicheldrüsenkrebs.

Mögliche Lizenzkategorie	Geschätzter Wertebereich
Vorauszahlung der Lizenz	5 bis 15 Millionen US-Dollar
Meilensteinzahlungen	50 bis 100 Millionen Dollar
Lizenzgebührenprozentsätze	8 % - 12 % des Nettoumsatzes

Forschungsstipendien und Finanzierung

Panbela Therapeutics sichert sich Forschungsgelder aus verschiedenen Quellen.

• Zuschuss der National Institutes of Health (NIH): 2,1 Millionen US-Dollar
• Zuschuss der Cancer Research Foundation: 750.000 US-Dollar
• Forschungsstipendium des US-Verteidigungsministeriums für Onkologie: 1,5 Millionen US-Dollar

Potenzielle Einnahmen aus pharmazeutischen Partnerschaften

Potenzieller Partner	Geschätzter Partnerschaftswert
Großes Onkologie-Pharmaunternehmen	25 bis 75 Millionen US-Dollar
Spezialisiertes Unternehmen für Krebsbehandlung	10 bis 40 Millionen US-Dollar

Zukünftige Kommerzialisierung therapeutischer Produkte

SBP-101 stellt ein primäres Kommerzialisierungspotenzial dar.

• Geschätzter Spitzenjahresumsatz: 150 bis 250 Millionen US-Dollar
• Voraussichtliche Marktdurchdringung: 15–22 % des Marktes für die Behandlung von Bauchspeicheldrüsenkrebs
• Potenzielle geografische Märkte: Vereinigte Staaten, Europa, Japan

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Value Propositions

You're looking at the core reasons why Panbela Therapeutics, Inc. (PBLA) believes its assets create value for patients and the market. Honestly, for a clinical-stage company, the value proposition is all about the data coming out of the trials and the breadth of the platform.

Potential to significantly improve overall survival for first-line metastatic pancreatic cancer (mPDAC)

The value here centers on Ivospemin (SBP-101) in the Phase III ASPIRE trial, combining it with standard chemotherapy. The trial has shown encouraging signs that suggest patients are living longer than anticipated. The Data Safety Monitoring Board (DSMB) has recommended the study continue without any changes for the third time, based on a safety database now including 395 patients. The interim survival analysis was expected as early as the first quarter of 2025. Enrollment completion was positioned for the first quarter of 2025, which was earlier than initially planned.

To give you context on the drug's prior performance in a similar setting, look at the data from the earlier Phase 1a/1b study combining SBP-101 with gemcitabine and nab-paclitaxel:

Metric (Phase 1a/1b)	Result
Median Overall Survival (OS) Final	14.6 months
Objective Response Rate (ORR)	48%
Best Response (Evaluable Subjects N=29)	CR in 3%, PR in 45%, SD in 34%, PD in 17%

That 48% ORR and 14.6 months OS in the prior study are the baseline against which the ASPIRE data is being measured.

Flynpovi™ for prevention of pre-cancerous lesions in Familial Adenomatous Polyposis (FAP)

Flynpovi, a combination of eflornithine (CPP-1X) and sulindac, targets polyamine metabolism. The value proposition is strong based on prior Phase III data for sporadic polyps and supportive data for FAP patients.

Indication/Study	Key Efficacy Measure	Result
Sporadic Large Bowel Polyps (Phase III vs Placebo)	Prevention of subsequent pre-cancerous sporadic adenomas	Prevented > 90%
FAP Patients (Post-hoc Analysis, up to 48 months)	Risk Reduction for Need for Lower GI Surgery vs Sulindac	HR = 0.00 (HR = 0.00-0.48; p = 0.005)
FAP Patients (Post-hoc Analysis, up to 48 months)	Risk Reduction for Need for Lower GI Surgery vs CPP-1X	HR = 0.00 (HR = 0.00-0.44; p = 0.003)

The data suggests a near-total elimination of the need for lower GI surgery versus single agents over a four-year period in that specific FAP sub-population.

Multi-targeted approach to reset dysregulated biology in high unmet medical need areas

Panbela Therapeutics, Inc. is built around modulating the polyamine pathway, which is critical across several difficult-to-treat conditions. This platform approach is a key component of its long-term value.

• Exploits Polyamine Metabolic Inhibition (PMI) mechanism.
• Targets diseases including pancreatic cancer, FAP, and colorectal cancer prevention.
• The technology is seen as having the potential to complement immunotherapy by modulating polyamine levels.

Pipeline expansion into new indications like STK11 mutant non-small cell lung cancer (NSCLC)

The company is actively broadening the application of its polyamine metabolic inhibitor technology beyond its core focus areas. This expansion into NSCLC is a direct attempt to address a population with historically poor outcomes on current therapies.

• Initiated Phase I dose escalation study of CPP-1X-S (eflornithine sachets) in STK11 mutant NSCLC.
• The Phase I trial goal is to determine the maximum tolerated dose in combination with the immune checkpoint inhibitor, Keytruda.
• Data from the Phase I trial was expected by mid-2025.

To give you a snapshot of the financial footing supporting this pipeline development, here are the latest reported figures as of September 30, 2024:

Financial Metric (As of 9/30/2024)	Amount
Net Loss in Quarter	Approximately $7.2 million
Research and Development Expenses (Q3 2024)	Approximately $6.0 million
Total Cash	$142,000
Total Current Assets	$5.2 million
Current Liabilities	$20.1 million

Finance: draft 13-week cash view by Friday.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Customer Relationships

You're managing relationships in a clinical-stage biotech, so your focus is intensely on the scientific community and the capital providers who believe in your near-term catalysts. The relationships are highly personalized, driven by data milestones, not volume.

High-touch, direct collaboration with clinical investigators and key opinion leaders

Panbela Therapeutics, Inc. maintains direct, high-touch engagement with the principal investigators steering its key clinical programs. This is critical for maintaining trial momentum and ensuring data integrity, especially in complex oncology trials.

The Phase III ASPIRE trial, evaluating ivospemin (SBP-101) for metastatic pancreatic ductal adenocarcinoma (mPDAC), is a prime example of this deep collaboration. The trial's independent Data Safety Monitoring Board (DSMB) recommended continuation without modification for a third time after reviewing 395 patients. This positive oversight directly supports the relationship with the investigators running the trial sites.

The company is also engaging investigators in new indications. For instance, the first patient in the Phase I dose escalation study of CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer was enrolled in late September at the Moffitt Cancer Center. Data readout from this Phase I study is anticipated by mid-2025, with a Phase 2 initiation targeted for later in 2025. Furthermore, Panbela Therapeutics, Inc. has plans for a Phase II trial in platinum-resistant ovarian cancer in collaboration with Johns Hopkins.

Historical data from prior studies on ivospemin provides context for investigators: it showed a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48% when combined with standard chemotherapy.

Key clinical milestones driving these relationships include:

• ASPIRE trial interim survival analysis expected in Q1 2025.
• ASPIRE trial full enrollment completion anticipated by Q1 2025.
• Data readout from the STK11 mutant NSCLC Phase I study expected by mid-2025.

Investor relations focused on communicating clinical milestones

Investor relations communication is tightly coupled with clinical progress, as the market values data readouts above all else. The primary focus for late 2024/early 2025 was the ASPIRE trial interim analysis. The initial expectation for this analysis was mid-2024, but the delay to Q1 2025 was framed as a positive, suggesting patients lived longer than expected due to a lower-than-anticipated event rate.

Financial reporting provides the backdrop for these clinical updates. For the third quarter ended September 30, 2024, Panbela Therapeutics, Inc. reported Research & Development expenses of approximately $6.1 million and a net loss of approximately $7.2 million, or $1.48 per diluted share. Total cash on hand as of September 30, 2024, was only $142,000, making the communication of financing events crucial.

Personalized relationships with strategic investors like Nant Capital

The relationship with Nant Capital, LLC is a cornerstone of the current financial structure, moving beyond a simple transaction to a strategic alliance. This was formalized through a $12 million strategic loan commitment.

The terms of this personalized financing are detailed below:

Financing Component	Amount (Principal Sum)	Funding Date
Tranche A Senior Convertible Promissory Note	$2,850,000	October 22, 2024
Tranche B Senior Convertible Promissory Note	$9,150,000	November 15, 2024

The notes carried an initial interest rate of SOFR plus 8 percent and were convertible at 37 cents per share, subject to a 33.33 percent ownership cap. As of January 22, 2025, no shares had been issued under these note terms. However, Panbela Therapeutics, Inc. notified Nant Capital of a default event as of December 31, 2024, which increased the interest rate to Monthly SOFR plus 12% per annum. Nant Capital, LLC, along with Dr. Patrick Soon-Shiong, may be deemed to beneficially own 32,432,432 shares issuable upon conversion, representing approximately 86.98% of the total Common Stock (outstanding plus issuable) as of November 11, 2024.

Engagement with patient advocacy groups for diseases with urgent unmet needs

Engagement with patient advocacy groups is implicit in the focus on diseases with urgent unmet needs, such as metastatic pancreatic ductal adenocarcinoma (mPDAC). The company's lead product candidate, ivospemin, is being evaluated in mPDAC, a disease where recent approvals only offered a median overall survival benefit of 1.9 months over the prior standard of care. Panbela Therapeutics, Inc. emphasizes that its approach has the potential to significantly improve outcomes beyond these incremental benefits. The pipeline also targets familial adenomatous polyposis (FAP) and ovarian cancer, both areas where advocacy group engagement is standard for driving awareness and trial recruitment.

The company's focus areas requiring advocacy support include:

• Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC).
• Familial Adenomatous Polyposis (FAP).
• STK11 Mutant Non-Small Cell Lung Cancer (NSCLC).

Finance: review covenant compliance related to the Nant Capital notes by end of Q1 2025.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Channels

You're looking at how Panbela Therapeutics, Inc. gets its science and corporate story out to the world, which is critical when you're a clinical-stage company. The channels right now are heavily weighted toward clinical operations and investor communication, which makes sense given the stage of development.

Global network of clinical trial sites for patient enrollment and drug administration

The primary channel for your lead asset, ivospemin (SBP-101), is the network of clinical trial sites running the ASPIRE trial for metastatic pancreatic ductal adenocarcinoma (mPDAC). This is where the drug actually gets administered to patients and where the critical efficacy and safety data are generated. You need these sites to be active and enrolling to hit your milestones. The ASPIRE trial, a Global Randomized Double-Blind Placebo Controlled Trial, was targeting a global network of sites. While earlier plans mentioned a target of 60-80 sites, another filing indicated the trial would be conducted globally at approximately 95 sites across the United States, Europe, and Asia - Pacific. The target enrollment for this Phase III registration program was approximately 600 patients. You should be tracking the site activation rate closely; the company had reported exceeding 50% enrollment as of mid-2024. Hitting the anticipated full enrollment by Q1 2025 was a key operational channel metric.

Here's a snapshot of the clinical trial footprint based on the ASPIRE trial:

Metric	Value/Detail	Context/Phase
ASPIRE Trial Target Sites (Range)	60-80	Phase III Pancreatic Cancer (SBP-101)
ASPIRE Trial Global Sites (Approximate)	95	US, Europe, Asia-Pacific
ASPIRE Trial Target Enrollment	600 Patients	Phase III Registration Program
Enrollment Status (as of mid-2024)	Exceeded 50%	ASPIRE Trial
Anticipated Enrollment Completion	Q1 2025	ASPIRE Trial

Scientific publications and presentations at major medical conferences (e.g., DDW)

For a biopharma company, scientific dissemination is a vital channel to establish credibility with key opinion leaders (KOLs) and potential prescribers. Panbela Therapeutics, Inc. uses peer-reviewed publications and major conference presentations to communicate clinical progress. For instance, an oral presentation at Digestive Disease Week (DDW) was announced in June 2024. Furthermore, a poster presentation was made at the American Association for Cancer Research (AACR) in April 2024. You also saw clinical data from a Phase I study published in the British Journal of Cancer in 2024. These are the primary channels for validating the science behind SBP-101.

Investor relations portals and SEC filings for corporate communication

Keeping the investment community informed is a non-negotiable channel, especially for a publicly traded entity on the OTCQB market. Panbela Therapeutics, Inc. maintains a dedicated Investor Relations section on its corporate website, which serves as the hub for official documents. The fiscal year end is December 31. Key filings in the first half of 2025 included a SCHEDULE 13D/A on April 24, 2025, and an S-8 on January 10, 2025. The most recent Quarterly Report (10-Q) listed was from November 14, 2024. The company also uses earnings calls to communicate updates; the call for the Third Quarter 2024 results was held on November 14, 2024. You can access all these documents directly via the SEC's EDGAR database or through the company's IR portal.

Future channel: Specialized pharmaceutical distribution network post-approval

This channel is currently theoretical but becomes the most important post-potential FDA approval for commercialization. Right now, there are no concrete, publicly stated numbers regarding a fully established, specialized pharmaceutical distribution network for Panbela Therapeutics, Inc. This will involve establishing relationships with wholesalers, specialty pharmacies, and potentially third-party logistics (3PL) providers capable of handling cold chain or specialized oncology drug logistics. The structure of this channel will be heavily influenced by the final approved indication and geographic reach, but it's the necessary bridge between regulatory approval and patient access.

The current focus is on generating the data that makes this future channel relevant.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Customer Segments

You're looking at the specific patient populations Panbela Therapeutics, Inc. is targeting with its pipeline assets as of late 2025. This defines who the company is building its commercial and clinical strategy around.

Patients with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC)

This segment is the focus of the Phase III ASPIRE trial, evaluating Ivospemin (SBP-101) in combination with gemcitabine and nab-paclitaxel for patients previously untreated for mPDAC. The trial's safety database included 395 patients as of June 24, 2024. Panbela Therapeutics is seeking to conduct this trial at a target of 60-80 sites globally. Prior clinical studies of SBP-101 in metastatic pancreatic cancer patients showed a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%.

Patients with Familial Adenomatous Polyposis (FAP) requiring surgical delay

This orphan indication targets FAP patients with intact lower gastrointestinal anatomy, using the combination therapy Flynpovi (CPP-1X and sulindac). Data from the FAP-310 trial indicated a 100% risk reduction in the need for lower gastrointestinal (LGI) surgery over up to 48 months when comparing the combination arm to either monotherapy arm (HR = 0.00 for both comparisons). The global FAP treatment market is projected to reach $800 million by 2025.

Oncology specialists and prescribing physicians in cancer treatment centers

These are the key intermediaries and decision-makers who will prescribe Panbela Therapeutics, Inc.'s products upon approval. They are the target for clinical data dissemination, such as the ASPIRE trial interim analysis expected as soon as Q1 2025. The company's Research & Development expenses were $6.0 million in the third quarter of 2024, reflecting investment in trials targeting these specialists.

Patients with STK11 mutant non-small cell lung cancer (NSCLC) in early trials

This segment is being addressed with CPP-1X-S in combination with Keytruda in a Phase I/II trial. This population historically shows a poor response to standard checkpoint inhibitor therapy. In some analyses, STK11 mutations were identified in 8.6% of patients. Data from the Phase I dose escalation study is expected by mid-2025.

Here's a quick look at the patient populations and key associated metrics:

Indication	Product Candidate	Trial Phase/Status	Key Numerical Data Point
mPDAC (First-line)	Ivospemin (SBP-101)	Phase III (ASPIRE Trial)	Safety database included 395 patients (as of June 2024)
FAP (Surgical Delay)	Flynpovi (CPP-1X + sulindac)	Registration Trial Design	100% risk reduction in LGI surgery need in prior trial arm
STK11 mutant NSCLC	CPP-1X-S + Keytruda	Phase I Dose Escalation	Phase I data expected by mid-2025

The company's financial structure in Q3 2024 showed R&D expenses of $6.0 million and a net loss of $7.2 million for the quarter, which supports the ongoing clinical engagement with these customer segments.

The key groups Panbela Therapeutics, Inc. is focused on are:

• Patients with first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).
• Patients with Familial Adenomatous Polyposis (FAP) targeting surgical delay.
• Oncology specialists and prescribing physicians in cancer treatment centers.
• Patients with STK11 mutant non-small cell lung cancer (NSCLC) in early trials.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Cost Structure

You're looking at the hard costs Panbela Therapeutics, Inc. incurs to keep the lights on and, more importantly, to push its clinical pipeline forward. For a pre-revenue biotech, the cost structure is almost entirely driven by R&D and the associated overhead.

The most recent reported operating expenses give us a clear picture of the burn rate leading into late 2025. Research and Development (R&D) expenses, which were $6.0 million in Q3 2024, represent the largest single cost component, reflecting the ongoing investment in the ASPIRE trial and other pipeline activities. General and Administrative (G&A) expenses were approximately $1.1 million in Q3 2024, which management noted was flat compared to the prior year period.

Here's a quick look at the key cost elements based on the latest available figures:

Cost Category	Latest Reported Amount	Period/Context
Research and Development (R&D) Expenses	$6.0 million	Q3 2024
General and Administrative (G&A) Expenses	$1.1 million	Q3 2024
CEO Annual Salary (Post-Reduction)	$30,200	Effective February 2025
CFO Annual Compensation (Post-Reduction)	$23,150	Effective February 2025
CEO Cash Retention Bonus (Contingent)	$186,000	Approved January 2025
CFO Cash Retention Bonus (Contingent)	$105,000	Approved January 2025

Clinical trial operational costs are a major driver within R&D. You should note the operational shift in the ASPIRE trial. In August 2024, the primary Contract Research Organization (CRO) began terminating its relationship due to payment delays, which forced Panbela Therapeutics to assume direct trial responsibility. This transition required specific capital outlay; for instance, a $1.5 million term loan from USWM was specifically used for payment of fees and expenses owed to the CRO for the ASPIRE trial.

Financing costs are a distinct, non-operating expense that impacts cash flow and the balance sheet. The financing secured post-Q3 2024 introduced new interest obligations. The Senior Convertible Promissory Notes from Nant Capital, totaling $12.0 million ($2.85 million Tranche A funded October 22, 2024, and $9.15 million Tranche B expected by November 15, 2024), carry a specific interest structure. These notes earn interest at SOFR + 8% PIK interest (Payment-In-Kind interest), meaning the interest accrues and is added to the principal balance rather than being paid in cash immediately.

Compensation and retention bonuses reflect efforts to secure key personnel through critical milestones. Beyond the significantly reduced base salaries effective February 2025, the Compensation Committee approved specific retention arrangements in January 2025 for key employees:

• CEO and President Jennifer K. Simpson is eligible for a cash retention bonus of $186,000.
• VP of Finance and CFO Susan Horvath is eligible for a cash retention bonus of $105,000.

These bonuses are contingent upon remaining employed through the earliest of several conditions, including achieving an unrestricted cash balance exceeding $10,000,000 or reaching December 31, 2025.

The cost structure is further detailed by these operational and financial items:

• The US WorldMeds note was paid off immediately upon receipt of the Tranche A Nant Capital funds.
• The Nant Capital Notes mature in six months from issuance.
• The notes are convertible to common stock at $0.37 per share, subject to a 33.33% ownership cap until maturity.

Finance: draft 13-week cash view by Friday.

Panbela Therapeutics, Inc. (PBLA) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Panbela Therapeutics, Inc. (PBLA) as of late 2025. For a clinical-stage biopharmaceutical company, the revenue picture is almost entirely about non-operating cash flow until a drug gets the green light from the FDA.

Currently, Panbela Therapeutics, Inc. has no product revenue because its key assets, Ivospemin (SBP-101) and Flynpovi™, remain in clinical development. The focus is on hitting milestones, not shipping product.

The near-term financial reality is that operating cash flow is negative, driven by significant Research and Development expenses, like those tied to the ASPIRE trial. For example, cash used in operations for the nine months ended September 30, 2024, totaled approximately $12.5 million. You have to look at financing activities to see where the cash to fund operations is coming from.

Future revenue streams are entirely contingent on regulatory success and subsequent commercialization. These are the two primary potential product revenue sources:

• Future revenue from sales of Ivospemin (SBP-101) post-regulatory approval, primarily targeting metastatic pancreatic ductal adenocarcinoma (mPDAC) and other indications.
• Future revenue from sales of Flynpovi™, which is being developed for Familial Adenomatous Polyposis (FAP).

To keep the lights on and fund the clinical path-especially with the ASPIRE trial interim analysis being tracked for Q1 2025-Panbela Therapeutics, Inc. relies on proceeds from equity and debt financing. This is the most concrete financial data we have for the revenue stream block right now.

A significant recent infusion was the strategic financing from Nant Capital, LLC, which was a $12.0 million commitment announced in late 2024. This wasn't all at once, mind you; it was structured to provide staged support.

Here's a quick look at the components of that recent financing, which is critical for understanding the current cash runway:

Financing Event/Source	Date of Agreement/Funding	Principal Amount
Nant Capital Tranche A Note	October 22, 2024	$2,850,000
Nant Capital Tranche B Note (Expected)	On or before November 15, 2024	$9,150,000
Total Nant Capital Commitment	Late October 2024	$12,000,000
Subordinated Promissory Notes (Q3 2024)	During Q3 2024	$700,000
Registered Public Offering (Gross Proceeds)	January 31, 2024	Approximately $9.0 million

What this estimate hides is the burn rate; cash on hand as of September 30, 2024, was only about $142,000 before the Nant Capital funds hit, so these financing proceeds are the lifeblood. Also, remember that the $12.0 million from Nant Capital is structured as convertible promissory notes, meaning it's debt that converts to equity, not pure revenue.

You should also track other potential, non-product inflows, though they are less certain than the financing activities. For instance, in April 2024, Panbela Therapeutics, Inc.'s partner in Pediatric Neuroblastoma, US WorldMeds®, provided a non-dilutive payment of approximately $0.8 million in exchange for a reduction in potential future milestone payments. That's a small, one-time bump, not a sustainable stream.

Finance: draft 13-week cash view by Friday.