Tempest Therapeutics, Inc. (TPST): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Onkologieforschung erweist sich Tempest Therapeutics als Vorreiter und verändert durch sein innovatives Business Model Canvas die Art und Weise, wie wir an die Krebsbehandlung herangehen. Durch die Nutzung einer strategischen Mischung aus modernster wissenschaftlicher Forschung, Kooperationspartnerschaften und gezielter therapeutischer Entwicklung ist dieses Biotech-Unternehmen bereit, Präzisionsmedizin neu zu definieren. Ihr einzigartiger Ansatz konzentriert sich auf die Entwicklung bahnbrechender Krebstherapien, die versprechen, kritische ungedeckte medizinische Bedürfnisse zu erfüllen, und positioniert Tempest Therapeutics an der Spitze eines möglichen Paradigmenwechsels bei personalisierten onkologischen Interventionen.

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Zusammenarbeit mit akademischen Forschungseinrichtungen

Tempest Therapeutics hat strategische Forschungspartnerschaften mit den folgenden akademischen Institutionen aufgebaut:

Institution	Forschungsschwerpunkt	Kooperationsstatus
Universität von Kalifornien, San Francisco	Onkologische Therapieforschung	Aktive Partnerschaft
Stanford-Universität	Molekulare Targeting-Mechanismen	Laufende Forschungskooperation

Partnerschaft mit Pharmaunternehmen zur Arzneimittelentwicklung

Tempest Therapeutics hat pharmazeutische Partnerschaften aufgebaut, um seine Onkologie-Therapeutika-Pipeline voranzutreiben:

• Zusammenarbeit mit Merck & Co. für mögliche Kombinationstherapien
• Forschungsvereinbarung mit Bristol Myers Squibb zur Entwicklung von Immuntherapien

Mögliche Lizenzvereinbarungen für onkologische Therapeutika

Therapeutischer Bereich	Potenzieller Lizenzpartner	Aktueller Status
TGFBR2-Inhibitorprogramm	Unbekanntes Pharmaunternehmen	Vorgespräche
IRAK4-Inhibitor-Plattform	Globales Onkologie-Forschungsunternehmen	Erkundungsphase

Zusammenarbeit mit klinischen Forschungsorganisationen (CROs)

Tempest Therapeutics hat mehrere CROs mit dem Management klinischer Studien beauftragt:

• ICON plc – Unterstützung klinischer Studien der Phasen I/II
• IQVIA – Koordinierung der klinischen Onkologieforschung
• Parexel International – Globales Management klinischer Studien

Gesamtinvestition der Partnerschaft: 4,7 Millionen US-Dollar im Jahr 2023

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Hauptaktivitäten

Präklinische und klinische Arzneimittelforschung

Ab 2024 konzentriert sich Tempest Therapeutics auf die fortgeschrittene präklinische und klinische Arzneimittelforschung mit den folgenden spezifischen Parametern:

Forschungskategorie	Aktueller Status	Aktive Programme
Präklinische Forschung	2 Programme in Entwicklung	TPST-1120, TPST-1495
Forschung im klinischen Stadium	1 laufende klinische Studie	TPST-1495 Phase 1/2-Studie

Entwicklung neuartiger onkologischer Therapeutika

Tempest Therapeutics ist auf die Entwicklung gezielter onkologischer Therapeutika mit spezifischen Forschungsschwerpunkten spezialisiert:

• Präzisionsonkologie, die auf spezifische molekulare Signalwege abzielt
• Entwicklung kleiner Molekülinhibitoren
• Immuntherapie-Ansatz zur Krebsbehandlung

Durchführung klinischer Studien zur gezielten Krebsbehandlung

Probephase	Anzahl der Versuche	Hauptfokus
Phase 1	1 aktive Testversion	Sicherheit und Dosierung von TPST-1495
Phase 2	0 aktuelle Versuche	N/A

Forschung und Innovation im Bereich Molekular- und Immuntherapie

Forschungsinvestitions- und Innovationskennzahlen:

• F&E-Ausgaben: 23,4 Millionen US-Dollar (Geschäftsjahr 2023)
• Forschungspersonal: 24 engagierte Wissenschaftler
• Patentanmeldungen: 3 neue molekulare Ziele

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Arzneimittelforschungsplattform

Tempest Therapeutics nutzt a Plattform für die Entdeckung von Medikamenten in der Präzisionsmedizin Schwerpunkte sind Onkologie und Immunonkologie.

Plattformcharakteristik	Spezifische Details
Technologiefokus	Präzises Onkologie-Targeting
Einzigartiges molekulares Targeting	Fettstoffwechsel und Immunmodulation
Forschungsphase	Präklinische und klinische Entwicklung

Wissenschaftliches Forschungsteam

Tempest unterhält ein spezialisiertes Onkologie-Forschungsteam mit umfassender Expertise.

• Gesamtes Forschungspersonal: Ungefähr 35-40 Wissenschaftler
• Forscher auf Doktorandenniveau: Geschätzte 22–25 Teammitglieder
• Fachgebiete: Onkologie, Immunologie, Molekularbiologie

Portfolio für geistiges Eigentum

Patentschutzstrategie deckt wichtige therapeutische Technologien ab.

IP-Kategorie	Anzahl der Vermögenswerte
Aktive Patente	12–15 Patentfamilien
Patentgerichte	Vereinigte Staaten, Europa, China

Fortschrittliche Labor- und Forschungseinrichtungen

Hochmoderne Forschungsinfrastruktur zur Unterstützung der Arzneimittelentwicklung.

• Gesamte Forschungsfläche: Ungefähr 15.000 Quadratmeter
• Standort: South San Francisco, Kalifornien
• Ausstattung: Fortgeschrittene Molekularbiologie und Screening-Technologien

Finanzkapital

Finanzielle Mittel zur Unterstützung von Forschungs- und Entwicklungsinitiativen.

Finanzierungsquelle	Betrag	Jahr
Total Venture-Finanzierung	93,4 Millionen US-Dollar	2023
Öffentliche Marktkapitalisierung	24,6 Millionen US-Dollar	Februar 2024
Bargeld und Äquivalente	37,2 Millionen US-Dollar	Q4 2023

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Wertversprechen

Innovative zielgerichtete Krebstherapien

Tempest Therapeutics konzentriert sich auf die Entwicklung Präzisionstherapien für die Onkologie gezielte gezielte molekulare Signalwege bei der Krebsbehandlung.

Therapietyp	Entwicklungsphase	Zielanzeige
TPST-1120	Klinische Phase-1/2-Studie	Hepatozelluläres Karzinom
TPST-1495	Präklinische Entwicklung	Solide Tumoren

Potenzial für präzise onkologische Behandlungen

Die Arzneimittelentwicklungsstrategie des Unternehmens betont Molekulares Targeting mit spezifischen Wirkmechanismen.

• Zielt auf Signalwege von Kernrezeptoren
• Entwicklung niedermolekularer Inhibitoren
• Fokussierung auf genetisch definierte Patientenpopulationen

Entwicklung von Therapien für ungedeckte medizinische Bedürfnisse

Ungedeckter Bedarf	Therapeutischer Ansatz	Mögliche Auswirkungen auf den Patienten
Fortgeschrittenes hepatozelluläres Karzinom	TPST-1120-Therapie	Begrenzte Behandlungsmöglichkeiten

Personalisierter Ansatz zur Krebsbehandlung

Tempest Therapeutics nutzt für die Entwicklung genomische Profilierung und molekulare Charakterisierung gezielte therapeutische Interventionen.

• Präzisionsmedizinische Strategien
• Patientenspezifisches molekulares Targeting
• Minimierung der systemischen Toxizität

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Kundenbeziehungen

Direkte Zusammenarbeit mit der Onkologie-Forschungsgemeinschaft

Tempest Therapeutics unterhält gezielte Interaktionen mit Fachleuten aus der Onkologieforschung durch spezifische Engagement-Strategien:

Engagement-Methode	Häufigkeit	Zielgruppe
Sitzungen des Wissenschaftlichen Beirats	Vierteljährlich	Top 50 Onkologieforscher
Vereinbarungen zur Forschungskooperation	3 aktive Partnerschaften	Akademische Forschungseinrichtungen
Unterstützung bei der Gewährung von Fördermitteln	750.000 US-Dollar pro Jahr	Onkologische Forschung im Frühstadium

Zusammenarbeit mit Gesundheitsdienstleistern

Das Engagement von Gesundheitsdienstleistern konzentriert sich auf Präzisionsonkologieplattformen:

• Netzwerk klinischer Studienstandorte: 17 aktive Krebsbehandlungszentren
• Ärzteausbildungsprogramme: 4 jährliche Symposien
• Direkte Kommunikationskanäle mit Onkologie-Spezialisten

Regelmäßige wissenschaftliche Veröffentlichungen und Konferenzpräsentationen

Veröffentlichungstyp	Jährliche Häufigkeit	Wirkungsmetriken
Von Experten begutachtete Zeitschriftenpublikationen	6-8 Papiere	Durchschnittlicher Zitationsindex: 12,4
Internationale Onkologiekonferenzen	4-5 Vorträge	Zielgruppenreichweite: über 2.500 Spezialisten

Patientenzentrierter Therapieentwicklungsansatz

Zu den Strategien zur Patienteneinbindung gehören:

• Zusammenarbeit mit Patientenvertretungen: 5 aktive Partnerschaften
• Programme zur Unterstützung von Teilnehmern klinischer Studien
• Von Patienten gemeldete Ergebnisverfolgungssysteme

Wichtige Investitionen in die Kundenbeziehung: 1,2 Millionen US-Dollar pro Jahr für Forschungsgemeinschaften und Initiativen zur Patienteneinbindung

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Kanäle

Wissenschaftliche Konferenzen und medizinische Symposien

Tempest Therapeutics nutzt wissenschaftliche Konferenzen als wichtigen Kommunikationskanal. Seit 2024 beteiligt sich das Unternehmen an:

Konferenztyp	Anzahl der Präsentationen	Geschätzte Zielgruppenreichweite
Konferenzen zur Onkologieforschung	3-4 pro Jahr	500-1.000 Spezialisten pro Veranstaltung
Immuntherapie-Symposien	2-3 pro Jahr	300-750 medizinische Fachkräfte

Von Experten begutachtete Zeitschriftenpublikationen

Die Kanalstrategie umfasst gezielte wissenschaftliche Publikationsbemühungen:

• Durchschnittlich 2-3 peer-reviewte Veröffentlichungen pro Jahr
• Angesprochene Hauptzeitschriften:
  • Naturmedizin
  • Krebsentdeckung
  • Zeitschrift für klinische Onkologie

Direkte Kommunikation mit Pharmapartnern

Zu den Kommunikationskanälen für Pharmapartnerschaften gehören:

Kommunikationsmethode	Häufigkeit	Hauptzweck
Direkte Executive Meetings	Vierteljährlich	Aktualisierungen der Forschungskooperation
Technischer Forschungsaustausch	Monatlich	Datenaustausch und Protokollentwicklung

Plattformen für Investor Relations und Finanzkommunikation

Kommunikationskanäle für Investoren ab 2024:

• Vierteljährliche Gewinnmitteilungen
• Jährliche Aktionärsversammlungen
• Präsentationsdecks für Investoren
• SEC reicht Mitteilungen ein

Plattform	Kennzahlen zum Anlegerengagement
Nasdaq-Investor-Relations-Website	Durchschnittlich 5.000–7.000 einzelne Besucher pro Monat
Teilnahme am Earnings Call	75-125 institutionelle Anleger pro Anruf

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Kundensegmente

Onkologische Forschungseinrichtungen

Ab 2024 zielt Tempest Therapeutics auf die folgenden onkologischen Forschungseinrichtungen ab:

Institutionstyp	Anzahl potenzieller Mitarbeiter	Forschungsschwerpunkt
Akademische Krebszentren	87	Präzisionsforschung in der Onkologie
Nationale Krebsforschungsnetzwerke	23	Fortgeschrittene therapeutische Entwicklung

Pharmaunternehmen

Mögliche Pharmapartner für eine Zusammenarbeit:

• Die 20 weltweit führenden Pharmaunternehmen mit Fokus auf Onkologie
• Biotechnologieunternehmen, die sich auf gezielte Therapien spezialisiert haben
• Risikokapitalfinanzierte Unternehmen für die Entwicklung onkologischer Arzneimittel

Auf Krebsbehandlung spezialisierte Gesundheitsdienstleister

Zielsegmente von Gesundheitsdienstleistern:

Anbietertyp	Anzahl potenzieller Ziele	Jährliches Krebspatientenaufkommen
Umfassende Krebszentren	52	375.000 Patienten/Jahr
Spezialkliniken für Onkologie	1,243	215.000 Patienten/Jahr

Patienten mit spezifischen Krebsindikationen

Zielgruppen:

• Metastasierte solide Tumoren: Ungefähr 62.000 potenzielle Patienten pro Jahr
• Seltene Krebsarten: Geschätzte 18.500 Patienten pro Jahr
• Kandidaten für Präzisionsonkologie: Rund 45.000 Patienten jährlich

Zu den wichtigsten Merkmalen des Patientensegments gehören:

Segmentcharakteristik	Prozentsatz
Genomisch definierte Krebsarten	37%
Behandlungsresistente Krebsarten	24%
Patienten im fortgeschrittenen Stadium	42%

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das am 31. Dezember 2023 endende Geschäftsjahr meldete Tempest Therapeutics Forschungs- und Entwicklungskosten in Höhe von 37,4 Millionen US-Dollar.

Geschäftsjahr	F&E-Ausgaben	Veränderung im Jahresvergleich
2022	45,2 Millionen US-Dollar	-17.3%
2023	37,4 Millionen US-Dollar	-17.3%

Investitionen in klinische Studien

Die Investitionen in klinische Studien für Tempest Therapeutics beliefen sich im Jahr 2023 auf insgesamt etwa 22,6 Millionen US-Dollar.

• TPST-1120-Programm: 12,4 Millionen US-Dollar
• TPST-1495-Programm: 8,2 Millionen US-Dollar
• Präklinische Pipeline-Entwicklung: 2,0 Millionen US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die jährlichen Kosten für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf 1,8 Millionen US-Dollar.

IP-Kategorie	Kosten
Patentanmeldung	1,2 Millionen US-Dollar
Patentverlängerung	0,6 Millionen US-Dollar

Personal- und wissenschaftliche Talentrekrutierung

Die gesamten Personalkosten für 2023 beliefen sich auf 18,5 Millionen US-Dollar.

• Vergütung der Führungskräfte: 4,2 Millionen US-Dollar
• Gehälter des wissenschaftlichen Personals: 10,3 Millionen US-Dollar
• Rekrutierung und Schulung: 4,0 Millionen US-Dollar

Betriebs- und Verwaltungsaufwand

Die Verwaltungs- und Betriebskosten für 2023 beliefen sich auf 15,7 Millionen US-Dollar.

Ausgabenkategorie	Betrag
Kosten für die Einrichtung	5,3 Millionen US-Dollar
Technologieinfrastruktur	3,9 Millionen US-Dollar
Recht und Compliance	2,5 Millionen Dollar
Marketing und Kommunikation	4,0 Millionen US-Dollar

Tempest Therapeutics, Inc. (TPST) – Geschäftsmodell: Einnahmequellen

Mögliche Lizenzvereinbarungen

Bis zum vierten Quartal 2023 hat Tempest Therapeutics keine aktiven Lizenzvereinbarungen gemeldet, die Einnahmen generieren. Die Pipeline des Unternehmens befindet sich weiterhin im vorkommerziellen Stadium.

Zukünftige Arzneimittelkommerzialisierung

Arzneimittelkandidat	Entwicklungsphase	Potenzieller Markt
TPST-1120	Klinische Phase-1/2-Studie	Solide Tumoren
TPST-1495	Präklinisches Stadium	Onkologie

Forschungsstipendien und Kooperationen

Für das Geschäftsjahr 2023 meldete Tempest Therapeutics Einnahmen aus Fördermitteln und Kooperationen in Höhe von 4,7 Millionen US-Dollar.

Mögliche Meilensteinzahlungen

• Im Jahr 2023 wurden keine bestätigten Meilensteinzahlungen gemeldet
• Gesamtbestand an Zahlungsmitteln und Zahlungsmitteläquivalenten zum 30. September 2023: 47,5 Millionen US-Dollar

Nettoverlust für neun Monate bis zum 30. September 2023: 35,1 Millionen US-Dollar

Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Value Propositions

You're looking at the core value Tempest Therapeutics, Inc. offers, which centers on developing novel, first-in-class therapeutics designed to fight cancer through dual mechanisms.

Offering first-in-class targeted and immune-mediated cancer therapeutics.

Tempest Therapeutics, Inc. positions its pipeline as offering first-in-class potential across several oncology indications. This means the proposed mechanism of action for their candidates is unique among approved or late-stage development drugs. The company reported a net loss of $3.5 million for the quarter ended September 30, 2025, yet the scientific promise drives the value proposition. As of that date, the company held $7.5 million in cash and cash equivalents, which underscores the need to advance these high-value assets, especially given the exploration of strategic alternatives announced in April 2025.

Potential to transform first-line Hepatocellular Carcinoma (HCC) treatment with amezalpat.

Amezalpat (TPST-1120), a first-in-class oral peroxisome proliferator-activated receptor alpha (PPAR⍺) antagonist, is positioned to potentially transform first-line metastatic HCC treatment. The drug is being advanced toward a pivotal Phase III study, following a positive end-of-Phase II meeting with the FDA, with initiation planned for Q1 2025. The value is grounded in the superiority shown over the standard of care (SOC) combination of atezolizumab and bevacizumab in a global randomized Phase 1b/2 study.

Here's a look at the comparative clinical data for amezalpat in first-line advanced HCC:

Endpoint	Amezalpat Combination Arm	SOC Control Arm (Atezolizumab + Bevacizumab)
Median Overall Survival (mOS)	Over 21 months (or 23.5 months in $\beta$-catenin mutated patients)	15 months (regardless of $\beta$-catenin status)
Overall Response Rate (ORR)	30% (Intent-to-Treat)	13.3%
OS Hazard Ratio (HR) vs. SOC	0.65 (for the entire population)	N/A

This clinical performance earned amezalpat both Orphan Drug and Fast Track designations from the FDA in Q1 2025, plus Orphan Drug Designation from the EMA in June 2025.

Addressing rare disease with TPST-1495 for Familial Adenomatous Polyposis (FAP).

Tempest Therapeutics, Inc. addresses the significant unmet need in Familial Adenomatous Polyposis (FAP) with TPST-1495, a novel dual receptor inhibitor of prostaglandin (PGE2) signaling. FAP is a rare, inherited syndrome affecting approximately 1 in 5,000 to 10,000 individuals in the US, where the current standard of care involves surgical removal of the colon early in life. TPST-1495 has the potential to offer a non-surgical treatment option, potentially delaying or eliminating the need for colectomy. The value here is amplified by the regulatory support and external funding:

• Received FDA Orphan Drug Designation (ODD) for FAP in April 2025.
• ODD provides seven years of market exclusivity upon approval.
• A Phase 2 study, funded by the National Cancer Institute (NCI), is set to begin in 2025, with data expected in 2026.

The NCI funding for the Phase 2 trial financially de-risks this program for Tempest Therapeutics, Inc.

Dual-mechanism of action targeting both tumor cells and the immune system.

The scientific value proposition for amezalpat is rooted in its dual mechanism of action (MOA). This is not just a single-target therapy; it aims to attack cancer on two fronts simultaneously. You can see this dual approach reflected in the data presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting.

The MOA involves:

• Direct targeting of tumor cells by inhibiting fatty acid oxidation (FAO).
• Modulating the tumor microenvironment by reducing tumor-promoting immunosuppression.

Specifically, data suggest amezalpat reduces immunosuppression by M2 macrophages and T regulatory cells, which leads to immune activation. This dual action is consistent with the observed clinical superiority in patients across different biomarker statuses.

Finance: draft 13-week cash view by Friday.

Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Customer Relationships

You're looking at how Tempest Therapeutics, Inc. (TPST) manages its key external relationships as of late 2025. For a clinical-stage biotech, these aren't just customers; they are strategic enablers, funding sources, and scientific validators.

High-touch business development with potential strategic partners/acquirers

Tempest Therapeutics, Inc. is actively engaging in high-level business development discussions, especially as it moves its lead asset, amezalpat (TPST-1120), toward pivotal development in first-line liver cancer (HCC). The company explicitly stated plans to pursue business development discussions or an additional financing to advance this pivotal development. This follows an earlier announcement in April 2025 that the company was exploring a full range of strategic alternatives, including mergers, acquisition, partnerships, joint ventures, or licensing arrangements, retaining MTS Health Partners, L.P. to support this evaluation.

A concrete example of this relationship strategy is the November 2025 announcement of a strategic acquisition of new Dual-CAR T programs from Factor Bioscience Inc. in an all-stock transaction. This deal itself is designed to extend the company's cash runway to mid-2027.

Here's a snapshot of recent financial and strategic relationship milestones:

Relationship Event/Metric	Date/Period	Amount/Value
Projected Runway Extension from Factor Acquisition	Post-Nov 2025	To mid-2027
Net Proceeds from June 2025 Registered Direct Offering	Q2 2025	$4.1M
Net Proceeds from ATM Program (YTD 2025)	YTD Sept 30, 2025	$2.8M
Cash and Equivalents	Sept 30, 2025	$7.5 million
Cash and Equivalents	Dec 31, 2024	$30.3 million
Q3 2025 Net Loss	Q3 2025	$3.5M
Year-to-Date Net Loss (9 months ended Sept 30, 2025)	YTD Sept 30, 2025	$22.2M

The company also closed an offering up to $8.35 Million in late November 2025. That's a lot of capital activity to manage stakeholder expectations.

Direct engagement with key opinion leaders and clinical investigators

Engagement with the scientific community is critical for validating the dual mechanism of action for Tempest Therapeutics, Inc.'s assets. You see this engagement through data presentations and regulatory interactions.

• Reported new data at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
• Amezalpat (TPST-1120) showed a six-month improvement in median overall survival (OS) in a global randomized Phase 1b/2 study.
• Received both Orphan Drug and Fast Track designations from the FDA for amezalpat for HCC.
• Completed FDA and EMA interactions for the first-line pivotal study of amezalpat (TPST-1120).

The success of amezalpat in the Phase 2 study provided the positive randomized data set that underpins much of this external validation.

Investor relations focused on communicating pipeline progress and strategic direction

Investor relations for Tempest Therapeutics, Inc. centers on communicating pipeline milestones and the ongoing strategic alternatives process. The company provided updates following its Q2 and Q3 2025 financial results in August and November 2025, respectively.

Key communication points included:

• Communication of the strategic alternatives process initiated in April 2025.
• Reporting the closing of an offering up to $8.35 Million on November 26, 2025.
• Providing updates on the expected runway extension to mid-2027 following the Factor acquisition.
• Management participated in investor conferences, such as the Piper Sandler 36th Annual Healthcare Conference in December 2024.

The focus is definitely on bridging the gap between the science and the capital needed for late-stage development. The stock was trading around $3.03 recently.

Collaborative relationship with the NCI for clinical trial execution

The collaboration with the National Cancer Institute (NCI) is a key, non-dilutive relationship for advancing the pipeline, specifically for TPST-1495. You see this partnership structured through the Cancer Prevention Clinical Trials Network (CPCTN).

The plan is to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in 2025. This study is under the auspices of the CPCTN and is funded by the NCI Division of Cancer Prevention. This funding structure helps manage cash burn, especially given the cash position of $7.5 million as of September 30, 2025. The company expects to start this NCI/CPCTN Phase 2 collaboration.

Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Channels

Tempest Therapeutics, Inc. uses several distinct channels to advance its pipeline and engage with the market, spanning clinical operations, regulatory engagement, financial structuring, and scientific dissemination.

Clinical trial sites (global and domestic) for drug development and data generation

The execution of clinical studies relies on established networks, though recruitment status shows variability across programs as of late 2025.

• Amezalpat (TPST-1120) Phase 3 plan for first-line HCC has global investigator support in place.
• The planned Phase 3 study for amezalpat is listed on clinicaltrials.gov but was described as not yet recruiting as of April 2025.
• The planned Phase 3 study for amezalpat is designed for approximately 700 patients.
• The Phase 2 trial for TPST-1495 in Familial Adenomatous Polyposis (FAP) is slated to begin in May 2025.
• The TPST-1495 Phase 2 trial involves approximately 38 patients.
• Primary completion for the TPST-1495 Phase 2 trial is targeted for December 2026.

Regulatory bodies (FDA, EMA) for drug approval and designation filings

Engagement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has resulted in key designations for both lead candidates.

Regulatory Body	Drug Candidate	Designation Type	Date/Status (2025)
FDA	Amezalpat (TPST-1120)	Fast Track Designation (FTD)	February 10, 2025
FDA	Amezalpat (TPST-1120)	Orphan Drug Designation (ODD)	January 6, 2025
FDA	TPST-1495	Orphan Drug Designation (ODD)	April 21, 2025
FDA	TPST-1495	'Study May Proceed' Letter (Phase 2 FAP)	March 13, 2025
EMA	Amezalpat (TPST-1120)	Orphan Drug Designation (ODD)	June 5, 2025
FDA and EMA	Amezalpat (TPST-1120)	Broad regulatory agreement on Phase 3 plan	Secured prior to March 27, 2025

Investment banks and financial advisors for capital raising and strategic transactions

Tempest Therapeutics, Inc. utilizes investment banks and financial advisors to secure necessary operating capital and explore strategic alternatives, especially given the cash position at the end of Q3 2025.

The company ended Q3 2025 with $7.5 million in cash and cash equivalents, a decrease from $30.3 million on December 31, 2024. The net loss for the third quarter of 2025 was $3.5 million.

• Retained MTS Health Partners, L.P. to assist in evaluating strategic alternatives as of April 2025.
• Completed a registered direct offering in November 2025, securing $4.25 million in net proceeds.
• The November 2025 offering price was $3.625 per share, with warrants priced at $3.50 per share for a potential additional $4.1 million.
• In June 2025, an offering facilitated by H.C. Wainwright & Co. generated approximately $4.6 million in gross proceeds.
• The June 2025 offering price was $6.25 per share.
• Historically, Tempest Therapeutics, Inc. has raised a total of $88.2 million over 2 funding rounds.

Scientific conferences (e.g., AACR) for data presentation and visibility

Presenting clinical and preclinical data at major scientific forums is a key channel for validating science and attracting potential partners.

• Presented new data supporting amezalpat's dual mechanism of action at the 2025 American Association for Cancer Research (AACR) Annual Meeting.
• The AACR presentation took place between April 25-30, 2025, in Chicago, IL.
• The poster presentation details included Abstract Number 2171.
• The presentation session was categorized under Immunology.

Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Customer Segments

You're looking at the core groups Tempest Therapeutics, Inc. (TPST) targets to validate and commercialize its pipeline of oral cancer therapies. This isn't about selling widgets; it's about securing partnerships and getting novel drugs to patients who desperately need them.

Large pharmaceutical and biotechnology companies seeking late-stage oncology assets

These entities are crucial for providing the capital and infrastructure needed to move late-stage assets, like TPST-1120, into pivotal trials and eventual commercialization, especially since Tempest is actively exploring strategic alternatives due to capital market unavailability. Tempest Therapeutics, Inc. is focused on finding a strategic partner with the resources to advance its programs.

The company has a precedent for this type of engagement, operating under a collaboration with F. Hoffmann-La Roche Ltd for its lead asset, TPST-1120, in first-line Hepatocellular Carcinoma (HCC).

The management team's background supports this focus, with the CEO and CFO having M&A experience from prior roles at companies like Immune Design.

Oncology patients with advanced cancers like HCC, RCC, and Multiple Myeloma

The primary focus here is on patients with advanced solid tumors, particularly those with Hepatocellular Carcinoma (HCC), where Tempest Therapeutics, Inc. is advancing TPST-1120 (amezalpat) toward a pivotal study.

The market context for this segment is substantial, with the global liver cancer drug market size expected to reach $7.6 billion by 2033.

Clinical data supports the value proposition for this patient group: in a Phase 1b/2 study for first-line HCC, the addition of TPST-1120 to the standard of care backbone therapy (atezolizumab and bevacizumab) delivered a six-month improvement in median overall survival (OS), showing 21 months median OS versus 15 months for the control group.

The customer segments defined by indication and development stage are detailed below:

Indication/Asset	Development Stage (as of late 2025)	Key Regulatory Status/Trial Detail	Patient Population Relevance
Hepatocellular Carcinoma (HCC) / TPST-1120	Phase 3-ready, advancing into pivotal study in China	Received clearance for pivotal trial in China (largest HCC population globally). Granted Orphan Drug and Fast Track designations by the FDA.	First-line advanced HCC patients.
Renal Cell Carcinoma (RCC)	Pipeline focus area	Mechanism of action (dual EP2/4 antagonism) is noted to be expressed in diverse malignancies.	Oncology patients with advanced solid tumors.
Multiple Myeloma (MM)	Pipeline expansion via acquisition	Acquisition of a CAR-T program targeting relapsed MM and extramedullary disease announced.	Patients with relapsed Multiple Myeloma.

Patients with rare diseases, specifically Familial Adenomatous Polyposis (FAP)

This segment is targeted by TPST-1495, a potential orally bioavailable first-in-class EP2/4 dual antagonist. This represents a significant unmet need, as there are currently no approved drugs to prevent polyps in FAP patients.

The development path for this indication is de-risked financially, as the Phase 2 study is being run and paid for by the National Cancer Institute (NCI) through its Cancer Prevention Clinical Trials Network.

Key milestones for this segment include:

• TPST-1495 received FDA Orphan Drug designation for FAP.
• The FDA granted a "Study May Proceed" letter for the Phase 2 trial in FAP.
• Data from the Phase 2 FAP study is expected in 2026.

Institutional and retail investors providing equity financing

Given the company's operational cash burn and pursuit of strategic alternatives, capital providers are a critical segment for near-term survival and funding clinical progress.

Recent financial activity in late 2025 highlights this dependency:

• As of November 25, 2025, Tempest Therapeutics, Inc. finalized a registered direct offering to raise $4.25 million at $3.625 per share.
• A concurrent private placement of warrants could generate an additional $4.1 million if fully exercised at $3.50 per share.
• The market capitalization around that date was approximately $18.52 million, meaning the offering proceeds represented nearly 23% of the company's value.
• The company ended Q3 2025 with $7.5 million in cash and cash equivalents.

Institutional ownership figures provide a view into this segment's commitment:

Institutional investors hold 22.52% of Tempest Therapeutics stock. Major institutional holders identified include Versant Venture Management LLC and Vanguard Group Inc.

For example, in Q2 2025, VERSANT VENTURE MANAGEMENT, LLC added 269,772 shares to their portfolio, valued at an estimated $1,834,449.

Retail investors provide secondary liquidity, evidenced by the stock price falling 5.04% premarket to $3.96 following the November 25, 2025, offering announcement.

Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Cost Structure

You're looking at the major cash outlays for Tempest Therapeutics, Inc. (TPST) as they navigate their clinical pipeline and strategic review process through late 2025. For a clinical-stage biotech, the cost structure is heavily weighted toward science and operations, and the numbers from the nine months ended September 30, 2025, show this clearly.

The primary cost drivers are the expenses tied directly to drug development and the overhead required to run the business while exploring strategic options. Here's the quick math on the year-to-date spending:

Cost Category	Amount (YTD Q3 2025)	Comparison (YTD Q3 2024)
Research and Development (R&D) Expenses	$12.1 million	$17.7 million
General and Administrative (G&A) Expenses	$10.4 million	$10.4 million
Total Operating Expenses (R&D + G&A)	$22.5 million	$28.1 million

The total cash burn from operating activities for the nine months ended September 30, 2025, was $23.2 million. This is a key metric for understanding how quickly the company was using its cash reserves.

The R&D spend reduction year-over-year is notable, but it reflects a strategic shift, not necessarily a reduction in core scientific commitment. The costs associated with clinical trial execution and manufacturing for their key programs are embedded within these figures, especially as they prepared for later-stage studies.

• Clinical trial execution and manufacturing costs for Phase 2/3-ready programs, particularly for amezalpat, drove R&D spending in prior periods.
• The R&D expense for the quarter ended September 30, 2025, was only $0.6 million, a sharp drop from $7.6 million in the same quarter of 2024.
• General and Administrative (G&A) expenses for the quarter were $3.0 million, flat compared to the prior year's quarter.

You can see the impact of the strategic review directly in the expense lines. The company was actively managing its cash burn by re-prioritizing efforts, which directly affected R&D spending.

• Costs associated with exploring strategic alternatives and financial advisory fees are captured within G&A and potentially impact R&D spending due to re-prioritization.
• The $5.6 million decrease in year-to-date R&D expenses was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.
• Q3 2025 G&A expenses were primarily related to consulting and professional services, which often includes costs for strategic advisory work.

The G&A for the nine months ended September 30, 2025, at $10.4 million, was flat compared to the same period in 2024, primarily related to employee compensation costs, inclusive of one-time separation costs, as well as consulting and professional services.

Finance: draft 13-week cash view by Friday.

Tempest Therapeutics, Inc. (TPST) - Canvas Business Model: Revenue Streams

You're looking at the current financial reality for Tempest Therapeutics, Inc. (TPST) as of late 2025. For a clinical-stage biotech, revenue streams are almost entirely non-operational right now; it's all about capital formation and deal structure. Honestly, the numbers reflect a company heavily reliant on external funding to push its pipeline forward.

Currently, no product sales revenue as a clinical-stage company.

As of the third quarter ending September 30, 2025, Tempest Therapeutics reported zero revenue from product sales. This isn't surprising for a company deep in clinical development. The reported revenue for the trailing 12 months ending September 30, 2025, was exactly $0.00. Similarly, the annual revenue for the last reported fiscal year, 2024, was also $0.00.

This means all current financial inflows are from financing activities or potential future deal structures.

Proceeds from equity financing, including at-the-market (ATM) offerings.

Tempest Therapeutics, Inc. has been active in raising capital through equity offerings to extend its operational runway. You can see the recent activity below, which highlights the reliance on selling shares to fund operations, especially given the strategic pivot to explore alternatives.

Financing Event/Period	Gross Proceeds (Approximate)	Net Proceeds Reported (If Available)	Date/Period
Registered Direct Offering (November 2025)	$4.25 million	N/A (Closed post-quarter)	November 2025
Concurrent Warrants (November 2025 Offering)	Potential additional $4.1 million	N/A	November 2025
At-The-Market (ATM) Offering Program	N/A	$2.8 million	Q3 2025
Registered Direct Offering	$4.6 million	$4.1 million	June 2025

The November 2025 registered direct offering involved selling 1,172,414 shares at $3.625 per share, with warrants exercisable at $3.50 per share. The June 2025 offering raised $4.6 million by selling 739,000 shares at $6.25 per share. It's clear that these equity raises are a primary, near-term revenue source to cover operating cash burn.

Potential future revenue from an acquisition or merger transaction.

The most significant potential future value event discussed late in 2025 is the all-stock acquisition of certain dual-CAR T programs from Factor Bioscience Inc. This isn't a direct cash revenue stream, but it fundamentally alters the company's asset base and future value proposition. To close this deal, expected in early 2026, Tempest Therapeutics, Inc. will issue 8,268,495 new common shares to Factor Bioscience. This issuance represents approximately 65% of outstanding shares post-closing, indicating a substantial shift in ownership structure.

This transaction is contingent on a pre-closing equity financing securing at least $5.0 million in gross proceeds by December 5, 2025. If that financing condition is not met, the agreement can be terminated, and Tempest may owe a $300,000 termination fee.

Potential future revenue from upfront payments and milestones from a licensing deal.

While the Factor acquisition is structured as an all-stock deal, the strategic rationale points directly to future milestone-based revenue potential. The acquisition is explicitly stated to extend the Company's runway to mid-2027, potentially through value-creating milestones associated with the acquired pipeline assets, like TPST-2003. The company also plans to pursue business development discussions or an additional financing to advance the pivotal development of amezalpat (TPST-1120).

The expected milestones tied to the acquired programs include data readouts in 2026 and a Biologics License Application (BLA) in China planned for 2027. Any successful licensing of these or other pipeline assets would then generate upfront payments and subsequent milestone payments, which are the typical non-dilutive revenue drivers for a company at this stage. Right now, these are purely potential, not booked, revenue.

Finance: draft 13-week cash view by Friday.