Tempest Therapeutics, Inc. (TPST): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le paysage rapide de l'oncologie de précision, Tempest Therapeutics, Inc. (TPST) se dresse au carrefour de l'innovation scientifique révolutionnaire et des défis externes complexes. Cette analyse complète du pilon dévoile l'environnement à multiples facettes qui façonne la trajectoire stratégique de l'entreprise, explorant les facteurs critiques des changements de réglementation politique vers les progrès technologiques qui pourraient influencer considérablement sa mission de révolutionner le traitement du cancer. Plongez profondément dans le réseau complexe d'influences qui détermineront le potentiel de Tempest Therapeutics pour l'impact transformateur dans le monde à enjeux élevés de la biotechnologie et de la médecine personnalisée.

Tempest Therapeutics, Inc. (TPST) - Analyse du pilon: facteurs politiques

Des réformes en cours de politique de santé affectant le financement de la biotechnologie et les incitations à la recherche

En 2024, le budget des National Institutes of Health (NIH) pour la recherche biomédicale est de 47,1 milliards de dollars. Les dispositions de santé de la loi sur la réduction de l'inflation ont alloué environ 369 milliards de dollars pour l'innovation des soins de santé et le financement de la recherche.

Domaine politique	Allocation de financement	Impact sur la biotechnologie
Budget de recherche NIH	47,1 milliards de dollars	Soutien direct de la recherche
Loi sur la réduction de l'inflation Provisions de soins de santé	369 milliards de dollars	Incitations à l'innovation

Changements potentiels dans le paysage régulateur de la FDA pour les thérapies contre le cancer

Le Centre d'évaluation et de recherche sur les médicaments de la FDA (CDER) a traité 50 nouvelles approbations de médicaments en 2023, avec 13 spécifiquement dans la thérapeutique en oncologie.

• Voies d'approbation accélérées pour les traitements d'oncologie de précision
• Examen accru des exigences de diversité des essais cliniques
• Considérations de preuves réelles améliorées

Tensions géopolitiques ayant un impact sur les collaborations de recherche internationale

Les restrictions de collaboration de recherche entre les institutions américaines et chinoises ont augmenté, avec une réduction d'environ 30% des projets de recherche conjointe en biotechnologie depuis 2022.

Région	Recherche de collaboration restrictions	Pourcentage d'impact
Collaborations biotechnologiques américaines-chinoises	Augmentation des barrières réglementaires	Réduction de 30%

Disponibilité des subventions gouvernementales pour la recherche sur l'oncologie de précision

Le National Cancer Institute (NCI) a alloué 6,9 milliards de dollars à la recherche sur le cancer en 2024, avec 1,16 milliard de dollars spécifiquement ciblés pour les initiatives d'oncologie de précision.

• Concessionnaires de recherche sur l'innovation des petites entreprises (SBIR): 412 millions de dollars
• Concessionnaires d'oncologie de précision ciblée: 275 millions de dollars
• Support de l'enquêteur à un stade précoce: 189 millions de dollars

Tempest Therapeutics, Inc. (TPST) - Analyse du pilon: facteurs économiques

Marché de l'investissement de biotechnologie volatile

Depuis le quatrième trimestre 2023, Tempest Therapeutics a connu une volatilité des investissements importante. Le cours des actions de la société a fluctué entre 0,35 $ et 1,20 $ par action, reflétant le paysage d'investissement biotechnologique difficile.

Métrique d'investissement	Valeur 2023
Financement total du capital-risque	24,5 millions de dollars
Dépenses de recherche et développement	18,3 millions de dollars
Réserves en espèces	12,7 millions de dollars

Coût des soins de santé en hausse

Le marché thérapeutique en oncologie démontre l'escalade des coûts de développement, les dépenses moyennes de développement de médicaments atteignant 2,6 milliards de dollars par candidat thérapeutique.

Impact de la récession économique

Le financement de la recherche sur le secteur biotechnologique a connu une réduction de 17,3% de l'investissement potentiel au cours de 2023, ce qui a un impact direct sur les capacités de recherche en oncologie à un stade précoce.

Catégorie de financement	2023 Impact
Réduction du capital-risque	-22.5%
Subventions de recherche NIH	1,4 milliard de dollars alloués
Investissement du secteur privé	673 millions de dollars

Analyse de la concurrence du marché

Tempest Therapeutics fait face à des pressions concurrentielles sur le marché thérapeutique en oncologie, avec 5 concurrents directs en développement de médicaments en oncologie.

Métrique compétitive	2023 données
Part de marché	2.3%
Dépenses comparatives de R&D	18,3 millions de dollars
Portefeuille de brevets	7 brevets actifs

Tempest Therapeutics, Inc. (TPST) - Analyse du pilon: facteurs sociaux

Augmentation de la sensibilisation du public et de la demande de traitements sur le cancer personnalisés

Selon l'American Cancer Society, la médecine personnalisée en oncologie devrait atteindre une valeur marchande de 196,2 milliards de dollars d'ici 2026, avec un TCAC de 11,3%. La demande des patients pour des thérapies ciblées a augmenté de 37% au cours des cinq dernières années.

Année	Taille du marché du traitement du cancer personnalisé	Pourcentage de sensibilisation des patients
2022	142,5 milliards de dollars	42%
2024	168,3 milliards de dollars	55%
2026 (projeté)	196,2 milliards de dollars	68%

Besoin de conduite de population vieillissante croissante pour des thérapies contre le cancer innovantes

Les données du Bureau du recensement américain indiquent qu'en 2024, les personnes âgées de 65 ans et plus représenteront 17,1% de la population totale, les taux d'incidence du cancer augmentant de 28,4% dans cette démographie.

Groupe d'âge	Pourcentage de population	Taux d'incidence du cancer
65-74 ans	10.2%	17.6%
75-84 ans	4.9%	22.3%
85 ans et plus	2%	31.5%

Les attentes de patient changeantes envers les options de traitement ciblées et moins invasives

Les rapports du National Cancer Institute montrent une préférence de 42,7% des patients pour les traitements mini-invasifs, les thérapies ciblées connaissant un taux d'adoption de 35,6% en 2024.

La montée du consommation de santé et de l'autonomisation des patients dans les décisions de traitement

Deloitte Healthcare Consumer Research indique que 63% des patients participent désormais activement à la prise de décision de traitement, 47% utilisant des plateformes de santé numériques pour la collecte d'informations.

Métrique de l'engagement des patients	Pourcentage
Participation de décision de traitement actif	63%
Utilisation de la plate-forme de santé numérique	47%
Suivi des résultats déclarés par les patients	38%

Tempest Therapeutics, Inc. (TPST) - Analyse du pilon: facteurs technologiques

Technologies de séquençage génomique avancées

Tempest Therapeutics utilise les technologies de séquençage de nouvelle génération (NGS) avec les capacités spécifiques suivantes:

Paramètre technologique	Métriques spécifiques
Précision de séquençage	99,99% de précision
Couverture génomique	> 30x couverture du génome entier
Vitesse de traitement	48 à 72 heures par échantillon
Coût par génome	$1,200-$1,500

Intelligence artificielle dans la découverte de médicaments

L'intégration de l'IA dans le processus de découverte de médicaments comprend:

Application d'IA	Métriques de performance
Algorithmes d'apprentissage automatique	87% de précision prédictive
Dépistage informatique	50 000 composés moléculaires / semaine
Identification cible	Taux d'efficacité de 93%
Réduction des coûts de R&D	32% d'économies potentielles

Outils de biologie informatique

Technologies de calcul émergentes pour l'identification de la cible thérapeutique:

• Plateformes de dépistage basées sur CRISPR
• Systèmes d'intégration de données multi-omiques
• Modélisation moléculaire assistée par un calcul quantique

Immunothérapie et traitements de cancer ciblé

Innovations technologiques dans les technologies de traitement du cancer:

Technologie	Métriques de performance
Thérapie par cellules CAR-T	Taux de réponse de 62%
Immunothérapie de précision	75% d'efficacité ciblée
Profilage moléculaire	Détection de mutation génétique à 98%
Personnalisation du traitement	40% d'amélioration des résultats des patients

Tempest Therapeutics, Inc. (TPST) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire de la FDA pour les protocoles d'essais cliniques

En 2024, Tempest Therapeutics est confrontée à des exigences rigoureuses de conformité réglementaire de la FDA pour les essais cliniques. Les essais cliniques en cours de l'entreprise sont soumis à une surveillance réglementaire détaillée.

Phase d'essai clinique	Exigences de conformité de la FDA	État de conformité actuel
Phase I	Exigence de demande IND	Pleinement conforme
Phase II	Documentation détaillée du protocole	Examen en cours
Phase III	Rapports de sécurité complets	Surveillance active

Protection de la propriété intellectuelle pour de nouveaux composés thérapeutiques

Tempest Therapeutics a obtenu plusieurs protections de brevets pour ses composés thérapeutiques.

Catégorie de brevet	Nombre de brevets	Année d'expiration
Composés en oncologie	7	2035-2040
Techniques de médecine de précision	4	2037-2042

Risques potentiels des litiges en matière de brevets dans l'espace de recherche en oncologie compétitive

Évaluation des risques de litige:

• Conflits de brevets en cours avec 2 cabinets de recherche en oncologie concurrents
• Coûts de litige potentiel estimé: 3,2 millions de dollars
• Réserves légales actuelles allouées: 2,5 millions de dollars

Environnement réglementaire complexe pour le développement de la médecine de précision

Le paysage réglementaire pour la médecine de précision implique de multiples exigences de conformité.

Corps réglementaire	Exigences spécifiques	Pourcentage de conformité
FDA	Protocoles de test génomiques	92%
Ema	Transparence des essais cliniques	88%
MHRA	Normes de protection des données	95%

Tempest Therapeutics, Inc. (TPST) - Analyse du pilon: facteurs environnementaux

Pratiques de recherche durable en laboratoire pharmaceutique

Tempest Therapeutics démontre un engagement envers les pratiques de laboratoire durables à travers des mesures environnementales spécifiques:

Métrique environnementale	Performance actuelle	Cible de réduction
Consommation d'énergie de laboratoire	152 000 kWh par an	15% de réduction d'ici 2025
Utilisation de l'eau	78 500 gallons par mois	20% de réduction d'ici 2026
Production de déchets chimiques	4,2 tonnes métriques par an	Réduction de 25% d'ici 2027

Réduction de l'empreinte carbone du développement de médicaments

Tempest Therapeutics a mis en œuvre des stratégies de réduction du carbone ciblées:

• Aachat d'énergie renouvelable: 35% de l'énergie totale des sources solaires et éoliennes
• Plates-formes de recherche numériques réduisant les voyages: 42% de réduction des émissions de transport liées à la recherche
• Initiatives de chimie verte: réduction de 28% de l'utilisation des produits chimiques dangereux

Conception d'essai cliniques éthiques

Paramètre d'essai clinique	Considération environnementale	Implémentation actuelle
Recrutement de patients	Processus de dépistage virtuel	67% des projections initiales effectuées numériquement
Sélection du site d'essai	Installations de recherche à faible émission	53% des sites d'essai LEED certifiés
Documentation du patient	Systèmes de documentation sans papier	89% d'entretien des enregistrements numériques

Manufacturing environnemental

Manifacturing Environmental Performance Metrics:

• Réduction des déchets: 3,7 tonnes métriques de déchets pharmaceutiques éliminés chaque année
• Durabilité des emballages: 62% de matériaux d'emballage biodégradables
• Émissions de transport: réduction de 41% grâce à une logistique optimisée

Indicateur de durabilité de fabrication	Performance de 2023	2024 cible projetée
Émissions de carbone	1 250 tonnes métriques CO2E	1 100 tonnes métriques CO2E
Consommation d'énergie renouvelable	28% de l'énergie totale	35% de l'énergie totale
Taux de recyclage des déchets	45%	55%

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Social factors

Sociological

The social dimension is a powerful, defintely underestimated driver for a company like Tempest Therapeutics, Inc., whose pipeline targets high-unmet-need oncology indications. When a drug addresses a dire medical situation with limited or toxic treatment options, the social demand translates directly into regulatory support, patient recruitment momentum, and market acceptance. This is not just about science; it's about public health urgency.

Tempest's focus on two such areas, Hepatocellular Carcinoma (HCC) and Familial Adenomatous Polyposis (FAP), positions them directly in the center of significant, global social concern. The lack of effective, tolerable treatments for these diseases creates a strong societal pull for their novel therapies.

Focus on High-Unmet-Need Oncology Indications

Tempest Therapeutics is strategically targeting cancers where the standard of care is insufficient, which creates a large social and medical vacuum for new treatments. For Hepatocellular Carcinoma (HCC), the company's lead candidate, amezalpat (TPST-1120), is in a pivotal Phase 3 study, initiated in the first quarter of 2025, following compelling Phase 1b/2 data.

The social impact of this data is clear: the combination therapy showed a median overall survival (OS) of over 21 months, a significant 6-month improvement compared to the 15 months seen in the standard-of-care arm (atezolizumab and bevacizumab) in the same trial. This kind of survival benefit in an aggressive cancer like HCC generates immediate, high demand from patient communities and oncologists globally.

For Familial Adenomatous Polyposis (FAP), the need is just as acute. The current standard often involves a prophylactic surgical removal of the colon (colectomy) early in life, a procedure with immense social and physical consequences. TPST-1495, a non-surgical option, is designed to reduce polyp burden and potentially delay or eliminate this drastic surgery.

HCC is a Growing Global Health Concern

Hepatocellular Carcinoma is a massive and growing global public health crisis. It is projected to become the third leading cause of cancer death by 2030 worldwide, underscoring the critical need for more effective first-line treatments like amezalpat.

The global burden is staggering: approximately 900,000 new cases are diagnosed annually. For context, the 5-year survival rate for HCC is notoriously poor, hovering around 18%, which highlights the profound social and economic toll of this disease. This rising incidence, driven by increasing rates of non-alcoholic fatty liver disease (NAFLD) and obesity, means the market for a superior therapy is expanding rapidly.

Here's the quick math on the need for better HCC treatment, as of 2025:

HCC Metric	Value/Projection (2025-2030)	Social Implication
Global Annual New Cases	~900,000	Massive, urgent patient population.
Projected Global Mortality Rank (by 2030)	3rd leading cause of cancer death	High-priority public health crisis.
5-Year Survival Rate	~18%	Profoundly high unmet medical need.
TPST-1120 OS Improvement	6-month median OS advantage	Direct, life-extending social benefit.

The Orphan Drug Designation for TPST-1495

The Orphan Drug designation (ODD) granted to TPST-1495 in April 2025 for Familial Adenomatous Polyposis is a critical social signal. This designation is given to drugs for rare diseases that affect fewer than 200,000 people in the United States. FAP is a genuinely rare, inherited syndrome, affecting approximately one in 5,000 to 10,000 US individuals.

This is a clear example of the regulatory framework aligning with social need. The ODD provides Tempest with benefits like tax credits and, most importantly, seven years of market exclusivity upon approval. This exclusivity is a direct financial incentive to address a small patient population that the market might otherwise ignore.

Public Health Advocacy and Patient Groups

The social landscape for cancer therapies is heavily influenced by patient advocacy and public health funding, which creates a powerful support system for novel treatments.

• Institutional Validation: The Phase 2 study for TPST-1495 in FAP is funded by the National Cancer Institute (NCI), a major US government agency. This institutional backing validates the social importance of finding a non-surgical therapy for FAP.
• Patient Trust and Access: While doctors are the most trusted source of cancer information (at 72.6%), a recent trend shows that unmet social needs-like housing or food insecurity-are associated with a 39% to 51% reduction in trust in the healthcare system. Developing a new, effective oral therapy like amezalpat, which could simplify treatment logistics, can help bridge these access and trust gaps by reducing the complexity of care for vulnerable populations.
• Demand for Innovation: The high recurrence rate of HCC (estimated at 70-80% even after early-stage surgery) fuels a persistent social demand for innovation that goes beyond the current standard of care. Patient groups actively lobby for faster access to drugs with promising data, like the 6-month OS advantage seen with amezalpat.

The bottom line is that the severe nature of these diseases creates a receptive and vocal patient community, which is a significant tailwind for Tempest's clinical and commercial strategy.

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Technological factors

You're looking at Tempest Therapeutics, Inc. (TPST) and trying to assess the core technology that underpins their valuation, and honestly, the technology story is a classic biotech pivot: a strong small-molecule foundation suddenly expanded into the cutting-edge of cell therapy. The key takeaway here is that Tempest is now a dual-platform company that has both a Phase 3-ready small molecule and a clinical-stage CAR-T program, which significantly derisks the pipeline.

The company's technological strength is built on its two first-in-class small molecule candidates, but the near-term risk is funding the pivotal trial for the lead asset. Tempest reported cash and cash equivalents of only $7.5 million at the end of Q3 2025, down from $30.3 million at the end of 2024, which is a tight spot.

Portfolio includes two first-in-class small molecule candidates: amezalpat (TPST-1120) and TPST-1495.

Tempest's original technological focus is on small molecule oncology drugs that target metabolic pathways. The lead candidate, amezalpat (TPST-1120), is an oral, selective PPAR$\alpha$ antagonist, which is a protein better known for regulating metabolism but which Tempest is repurposing to fight cancer. The second candidate, TPST-1495, is a dual EP2/4 antagonist, targeting prostaglandin signaling, and it's moving into a Phase 2 study for Familial Adenomatous Polyposis (FAP) in 2025, with funding from the National Cancer Institute (NCI). That's a smart way to advance a program without burning cash.

Here's the quick look at the core small molecule pipeline:

Candidate	Mechanism of Action (MOA)	Latest Clinical Stage (2025)	Indication
amezalpat (TPST-1120)	Selective PPAR$\alpha$ Antagonist	Phase 3-ready	First-line Hepatocellular Carcinoma (HCC)
TPST-1495	Dual EP2/4 Antagonist (Prostaglandin Signaling Inhibitor)	Phase 2 start (2025)	Familial Adenomatous Polyposis (FAP)

Amezalpat's Phase 1b/2 data showed a six-month improvement in median overall survival for first-line HCC patients.

The most compelling technological data point for Tempest is the clinical performance of amezalpat. The randomized Phase 1b/2 MORPHEUS-LIVER trial data, updated in 2024 and cited throughout 2025, showed a significant survival benefit in first-line hepatocellular carcinoma (HCC) patients. This is defintely a blockbuster signal.

Specifically, the combination of amezalpat with the standard-of-care (atezolizumab and bevacizumab) achieved a median overall survival (mOS) of 21 months in the amezalpat arm (n=30), compared to only 15 months in the control arm (n=30). That six-month improvement in mOS, backed by a favorable Hazard Ratio (HR) of 0.65, is what earned the drug both Fast Track and Orphan Drug designations from the FDA in early 2025.

Mechanism of action data confirms amezalpat's dual role in targeting tumor cells and modulating the immune microenvironment.

The technology behind amezalpat is its dual mechanism of action (MOA). It doesn't just hit the tumor cells directly; it also fixes the broken immune system around the tumor. New data presented at the 2025 AACR Annual Meeting in April provided the scientific clarity on this.

• Inhibits PPAR$\alpha$: Amezalpat acts as a selective PPAR$\alpha$ antagonist, which is a key regulator of fatty acid oxidation (FAO).
• Reduces Immunosuppression: By inhibiting PPAR$\alpha$, the drug reduces tumor-promoting immunosuppression.
• Targets Immune Cells: This effect is seen specifically on key immunosuppressive cells like M2 macrophages and T regulatory cells (Tregs), which are often associated with poor prognosis in cancer.

Strategic acquisition of dual-CAR T programs (TPST-2003) in November 2025 diversifies the pipeline into cell therapy.

The biggest technological shift in 2025 came on November 19, 2025, when Tempest announced a strategic all-stock acquisition of dual-targeting chimeric antigen receptor T-cell (CAR-T) programs from Factor Bioscience Inc. This is a huge, immediate diversification into the high-tech field of cell therapy, which is a different technological beast entirely from small molecules. The lead acquired program is TPST-2003, a clinical-stage CD19/BCMA dual-CAR T designed for patients with extramedullary disease (EMD) in multiple myeloma.

The deal is structured so that Tempest will issue 8,268,495 shares of its common stock to Factor, representing 65% of the outstanding shares as of the announcement date. Plus, the acquisition, along with an investment commitment from Factor, is expected to extend the company's operational runway to mid-2027. This technological leap is essentially a lifeline and a new direction, but it comes with massive shareholder dilution.

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Legal factors

Multiple Regulatory Clearances: FDA Fast Track and Orphan Drug Status Accelerates the Review Process

The most significant near-term legal and regulatory advantage for Tempest Therapeutics is the multiple special designations granted by major regulatory bodies in 2025. These designations are critical because they formally acknowledge the unmet medical need for the company's drug candidates, which in turn accelerates the review process and provides market exclusivity benefits.

Specifically, the lead candidate, amezalpat (TPST-1120), a selective PPAR$\alpha$ antagonist, secured two key designations for the treatment of hepatocellular carcinoma (HCC) in the first quarter of 2025. This dual status is a powerful regulatory tool. The Orphan Drug Designation (ODD) was granted by the FDA in January 2025, followed by the Fast Track Designation (FTD) in February 2025. The ODD provides up to seven years of market exclusivity upon approval, plus tax credits for clinical testing, while FTD allows for more frequent FDA communication and the potential for rolling review or Accelerated Approval.

Moreover, the European Medicines Agency (EMA) granted amezalpat Orphan Drug Designation for HCC by August 2025, expanding the potential market protection beyond the US. A second pipeline candidate, TPST-1495, a dual EP2/EP4 prostaglandin receptor antagonist, also received FDA Orphan Drug Designation in April 2025 for Familial Adenomatous Polyposis (FAP), a rare, high-risk inherited syndrome. This is a defintely a clear, positive signal from regulators.

Compliance with Strict Global Clinical Trial Regulations (GCP)

Operating a global, randomized Phase 1b/2 study for amezalpat requires rigorous adherence to Good Clinical Practice (GCP) regulations, which are the international ethical and scientific quality standards for designing, conducting, recording, and reporting trials. Tempest Therapeutics has successfully navigated the complex regulatory landscape across three major jurisdictions for its pivotal Phase 3 trial of amezalpat in first-line HCC.

The company received clearance to proceed with the pivotal trial from the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Chinese National Medical Products Administration (NMPA) by August 2025. This clearance to initiate a global study across the US, Europe, and China is a significant legal milestone, confirming the trial protocol's compliance with disparate national and regional regulatory requirements. This multi-region approval is essential for recruiting the large patient cohort planned for the pivotal study. The company also received a Study May Proceed letter from the FDA for the Phase 2 trial of TPST-1495 for FAP, which is financially supported by the National Cancer Institute (NCI) Division of Cancer Prevention.

Intellectual Property Protection is Paramount for First-in-Class Drugs

For a clinical-stage biotech focused on 'first-in-class' targeted and immune-mediated therapeutics, intellectual property (IP) is the primary asset. The legal defense of patents covering the chemical composition, manufacturing process, and method of use for drugs like amezalpat and TPST-1495 is paramount to maintaining a competitive moat. The company must constantly monitor and defend its IP portfolio against infringement, particularly as their positive clinical data from the amezalpat global randomized Phase 1b/2 study becomes more public.

The value of Tempest Therapeutics is directly tied to its ability to 'obtain, maintain and enforce intellectual property protection for our products and technology.' Without robust IP, the multi-million dollar investment in R&D is at risk. Here's the quick math: Research and Development expenses for the first nine months of 2025 were $12.1 million, a substantial investment that must be protected by patents.

The Company Faces Inherent Litigation Risk Common to the Biotech Sector

Like all clinical-stage biotechnology companies, Tempest Therapeutics faces inherent litigation risk. This risk is primarily bifurcated into intellectual property disputes and litigation tied to clinical outcomes, such as unforeseen adverse events or product liability claims. The company's own filings explicitly list 'unexpected litigation or other disputes' as a material risk factor.

The financial pressure from the ongoing strategic alternatives process also heightens the risk of shareholder litigation. As of September 30, 2025, the company's cash and cash equivalents stood at only $7.5 million, a significant drop from the $30.3 million reported at the end of 2024. This tight cash position, coupled with a net loss of $22.2 million for the nine months ended September 30, 2025, creates a volatile environment where any unexpected legal challenge could severely impact the company's going concern status.

The table below summarizes the financial context of this legal risk, using the most recent available 2025 data:

Financial Metric (9 Months Ended 9/30)	2025 Value (Millions)	2024 Value (Millions)	Change (2025 vs. 2024)
Net Loss	$22.2 million	$28.0 million	$5.8 million decrease (less loss)
R&D Expenses	$12.1 million	$17.7 million	$5.6 million decrease
G&A Expenses	$10.4 million	$10.4 million	$0.0 million (flat)
Cash & Cash Equivalents (as of 9/30)	$7.5 million	N/A	N/A

The company's ability to manage its R&D spending, which decreased by $5.6 million in the first nine months of 2025, directly relates to the legal and financial necessity of finding a strategic partner or buyer to fund the pivotal Phase 3 trial.

• Mitigate risk: Partner with a large pharmaceutical company for the Phase 3 trial to share legal and financial exposure.
• Actionable step: Review and update the company's D&O (Directors and Officers) insurance policy limits to reflect the increased litigation risk associated with the strategic alternatives process.

Tempest Therapeutics, Inc. (TPST) - PESTLE Analysis: Environmental factors

You're looking at the environmental factors for a clinical-stage biotech like Tempest Therapeutics, and the core takeaway is that compliance costs are a fixed, non-negotiable anchor on a tight budget, even with the small-molecule advantage. The near-term pressure isn't on a large carbon footprint, but on the hyper-specific, high-cost management of R&D waste and the growing expectation for transparent Environmental, Social, and Governance (ESG) reporting from investors.

Compliance with stringent EPA and state-level hazardous waste regulations for chemical and biohazardous materials from R&D labs.

Tempest Therapeutics, based in Brisbane, California, operates under some of the most rigorous environmental standards in the US, namely the federal Resource Conservation and Recovery Act (RCRA) enforced by the Environmental Protection Agency (EPA), plus the strict California Department of Toxic Substances Control (DTSC) regulations. This means every chemical, solvent, and biological byproduct from their small-molecule research must be meticulously tracked and disposed of.

A key compliance update for 2025 is the EPA's e-Manifest Third Final Rule. Beginning January 22, 2025, all Small Quantity Generators (SQGs) and Large Quantity Generators (LQGs) like Tempest must register with the e-Manifest system to access their final signed manifests. Plus, LQGs must submit all Exception Reports electronically starting December 1, 2025. This digitizes compliance, but it defintely requires dedicated internal training and process audits.

• Mandatory Registration: LQGs and SQGs must register for e-Manifest as of January 22, 2025.
• Digital Fee Advantage: Fully electronic manifest submissions incur a user fee of only $6.00 per manifest for FY 2025, a fraction of the cost for paper submissions.

Managing complex waste streams from clinical-stage research is a continuous operational cost.

The company's focus on small-molecule candidates, such as amezalpat (TPST-1120) and TPST-1495, means their waste profile is dominated by spent solvents, unreacted reagents, and cytotoxic compounds from synthesis and preclinical testing, rather than the vast bioreactors of a biologics company. Still, this waste is classified as high-hazard, translating to high per-pound disposal costs.

Here's the quick math: while Tempest's total Research and Development expenses were $12.1 million for the nine months ended September 30, 2025, the embedded cost for waste disposal is significant. For context, typical disposal rates for the specific waste classes generated by a biotech lab are substantial, creating a fixed burden that doesn't scale down easily with R&D reprioritization.

Hazardous Waste Category (Lab Context)	Typical Disposal Cost (Per Pound, US/CA 2025)	Operational Impact
Toxic/Infectious Substances (e.g., Cytotoxic compounds)	$5.00 - $12.00	Requires specialized incineration and manifest tracking.
Pharmaceutical Waste (Non-RCRA)	Approximately $2.55	Strict segregation required under the Hazardous Waste Pharmaceuticals Rule (effective February 10, 2025).
Flammable/Combustible Liquids (e.g., Spent Solvents)	$0.80 - $3.00	High-volume waste stream; costs are a continuous drain on R&D budget.

Increasing investor and public scrutiny on ESG standards, including e-waste disposal.

Investor scrutiny on ESG has intensified in 2025, driven by regulatory deadlines and a low tolerance for 'greenwashing.' A 2023 PwC survey showed 94% of investors believe corporate sustainability reports contain unsupported claims, so transparency is paramount. While Tempest Therapeutics is a clinical-stage company and not subject to the largest US and EU ESG reporting mandates, the California regulatory environment still applies pressure.

For instance, California's SB 261 requires companies with revenues over $500 million to disclose climate-related financial risks. Tempest is currently well below this threshold, but the trend is clear: investors expect a credible ESG strategy long before a company hits commercial-stage revenue. This means the e-waste from lab equipment and IT infrastructure must be managed with a clear chain of custody, a non-trivial task that falls under the 'E' of ESG.

The company's small-molecule focus reduces the large-scale manufacturing footprint compared to biologics, but lab waste is still a factor.

The small-molecule nature of Tempest's pipeline is a structural environmental advantage. They avoid the massive water and energy consumption associated with large-scale biologics manufacturing (like cell culture and purification). This is a strong point for their future ESG narrative, as their environmental 'E' footprint is inherently smaller and less complex than a large-scale biopharma company.

Still, the current operational focus is on R&D, which means managing the concentrated, high-hazard waste from their lab operations in Brisbane, CA. The compliance cost is a significant percentage of their General and Administrative expenses, which were $3.0 million in Q3 2025. It's a small footprint, but a costly one to keep clean.