Oncology Institute, Inc.

TOIIW

Held by 2 specialist biotech funds

2 funds opened new positions. Next phase3 readout (docetaxel): May 2014.

Medical - Care FacilitiesCEO: Daniel VirnichWebsite ↗

The Oncology Institute, Inc., an oncology company, provides medical oncology services in the United States. Its services include physician services, in-house infusion and dispensary, clinical trial services, outpatient stem cell transplants and transfusions programs, and patient support. The company also offers and manages clinical trial services, such as managing clinical trials, palliative care programs, and stem cell transplants for cancer patients. The company was founded in 2007 and is based in Cerritos, California.

Catalysts

Phase 3Q2 2014docetaxelBreast CancerNCT00331097

Primary: disease free survival (at 5 years)Enrollment:300/300Sites: 8RANDOMIZED, TREATMENT

Phase 2Q2 2022TepotinibAdvanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IVNCT02864992

Primary: Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC) (Time from first treatment up to data cutoff (approximately Month 66))Enrollment:337/337Sites: 176NA, TREATMENT

Phase 2Q3 2022CisplatinCarcinoma, Non-Small-Cell LungNCT03840915

Phase 2Q2 2023TepotinibNon-small Cell Lung CancerNCT03940703

Primary: Combined Therapy (Tepotinib+Osimertinib): Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version (NCI-CTCAE v 5.0) (Up to Day 21 of Cycle 1 (each Cycle is of 21 days))Enrollment:140/140Sites: 179NON_RANDOMIZED, TREATMENT

Phase 2Q2 2023Folfiri/CetuximabColorectal Cancer, ADCCNCT03874026

Primary: Activity (1 year)Enrollment:Target 34Sites: 1NA, TREATMENT

Phase 2Q1 2025Cabozantinib and TemozolomideLung Neuroendocrine Neoplasm, GEP Neuroendocrine TumorNCT04893785

Primary: To assess the efficacy of the combination of cabozantinib and one-week-on/one-week-off temozolomide, based on overall response rate (ORR). (Up to 42 months)Enrollment:Target 35Sites: 1NA, TREATMENT

Phase 2Q2 2025AvelumabLocally Advanced or Metastatic Urothelial CarcinomaNCT05327530

Primary: Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Investigator (Time from randomization of study drug until first documentation of progressive disease (PD) or death, assessed approximately up to 51 months)Enrollment:256/256Sites: 97RANDOMIZED, TREATMENT

Phase 2Q2 2025K-808 (Dose A)Primary Biliary CholangitisNCT06247735

Primary: Percent change from baseline in serum alkaline phosphatase (ALP) (Baseline to Week 12)Enrollment:46/46Sites: 38RANDOMIZED, QUADRUPLE, TREATMENT

Phase 2Q2 2025Methotrexate InjectionProliferative Vitreoretinopathy, Rhegmatogenous Retinal DetachmentNCT06541574

Primary: Primary Outcome Measure (Month 12)Enrollment:Target 860Sites: 1RANDOMIZED, DOUBLE, TREATMENT

Phase 3Q3 2025BuprenorphineOpioid-use DisorderNCT04991974

Phase 2Q3 2025Tuvusertib (M1774)Ovarian CancerNCT06433219

Primary: Part A and Part B: Confirmed Objective Response (OR) According to RECIST v1.1 as Assessed by Investigator (Time from randomization to final assessment or until progressive disease, death, discontinuation criteria, approximately up to 3.5 years)Enrollment:63/63Sites: 84RANDOMIZED, TREATMENT

Phase 2Q3 2025Durvalumab 1120 mgCholangiocarcinomaNCT06341764

Phase 2Q1 2026M1774Non-Small Cell Lung CancerNCT05882734

Phase 2Q2 2026K-877-ERNASHNCT05327127

Phase 3Q2 2026XR-BOpioid-use DisorderNCT04408313

Primary: pharmacotherapy adherence (6-months post-release)Enrollment:Target 240Sites: 1RANDOMIZED, TREATMENT

Phase 3Q3 2026Extended Release BuprenorphineOpioid Use DisorderNCT07524738

Primary: medication adherence (three months post-release)Enrollment:Target 30Sites: 1NON_RANDOMIZED, TREATMENT

Phase 3Q3 2026AvelumabSolid TumorsNCT03815643

Primary: Occurrence of Treatment-related Non-serious Treatment-Emergent Adverse Events (TEAEs), All Serious AEs, Immunerelated AEs and Infusion-related Reactions According to Version of National Cancer Institute Common Technology Criteria for Adverse Events (From enrollment to end of survival follow-up (up to 5 years after the last participant receives the last dose of avelumab))Enrollment:205/205Sites: 104NA, TREATMENT

Phase 2Q3 2026Cyclophosphamide and Etoposide in combinationSquamous Cell Carcinoma, Advanced Head and Neck CancerNCT07361133

Phase 2Q3 2026Valproic acidAdenocarcinoma of the PancreasNCT05821556

Phase 2Q4 2026standard second line treatment, at discretion of the investigatorColorectal Cancer MetastaticNCT07213570

Primary: Progression Free Survival rate at 6 months in the two arms. (up to 6 months from randomization)Enrollment:Target 60Sites: 1RANDOMIZED, TREATMENT

Phase 2Q4 2026irinotecanColorectal Cancer MetastaticNCT06714357

Primary: Study Part 1 - Progression Free Survival rate at 16 weeks in the two arms. (up to 16 weeks from randomization)Enrollment:Target 130Sites: 8RANDOMIZED, TREATMENT

Phase 2Q1 2027Prophylactic Plasma TransfusionLeptospirosisNCT07127718

Phase 2Q2 2027Prostate Cancer (Adenocarcinoma)NCT07302451

Primary: Recovery of Erectile Function (IIEF-5) at 6 Months Post-ADT: ≥70% Threshold for Study Success (6 months after completion of hormonal therapy (Relugolix))Enrollment:Target 50Sites: 1NA, TREATMENT

Phase 3Q2 2027Methadone Treatment-As-UsualOpioid Use, Opioid Use Disorder, Cocaine UseNCT05766631

Phase 2Q3 2027dornase alfa i.v. and cisplatinRefractory Germ Cell Tumors, Dornase AlfaNCT07121322

Phase 2Q3 2027standard nivolumab and oxaliplatin- based chemotherapyAdvanced or Metastatic Gastrooesophageal CarcinomaNCT07213557

Primary: Progression Free Survival rate at 1-year (PFS 1-year) (up to 1 year to randomization)Enrollment:Target 84Sites: 1RANDOMIZED, TREATMENT

Phase 2Q4 2027M9140Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC)NCT06710132

Phase 2Q1 2028Cannabis Extract OilAdvanced Malignant Solid TumorNCT07459920

Phase 3Q1 2028OlaparibOvarian CancerNCT05255471

Phase 3Q1 2028PanitumumabColorectal Cancer Stage IVNCT06509126

Phase 3Q2 202811-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)HPV Infectio N, HPV-Related CarcinomaNCT05262010

Phase 3Q3 2028extended-release buprenorphine (XR-B)Opioid Use DisorderNCT06306443

Phase 3Q4 2028Precemtabart tocentecanMetastatic Colorectal CancerNCT07549412

Phase 3Q2 2029EnpatoranSystemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)NCT07332481

Phase 3Q2 2029EnpatoranSystematic Lupus Erythematosus, Cutaneous Lupus ErythematosusNCT07355218

Phase 2Q2 2030InavolisibEndometrial CancerNCT07522697

Primary: Objective response rate (ORR) (Every 8 (±1) weeks during the first 2 years, every 12 (±1) weeks therafter, from enrollment until disease progression (up to 48 months).)Enrollment:Target 48Sites: 1NA, TREATMENT

Phase 2Q4 2031PembrolizumabVulva CancerNCT07290894

Primary: Objective Tumor Response Rate (ORR) (every 12 weeks from enrollment until disease progression (up to 72 months))Enrollment:Target 80Sites: 1NA, TREATMENT

Phase 3Q3 20322 doses of vaccine Quadrivalent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha)Human Papillomavirus (HPV) Infection, HPV (Human Papillomavirus)-Associated CarcinomaNCT06632912

Primary: Geometric mean titers (GMTs) of neutralizing antibodies against HPV types 6, 11, 16, and 18 among subjects who were seronegative at baseline (pre-vaccination) (1 month after completion of the vaccination series)Enrollment:1,800/1,800Sites: 3RANDOMIZED, PREVENTION

Recent News & Research

bioRxiv

Humanized Anti-PD-1 Antibodies Generated Using The Conditional Kernel-Elastic Autoencoder

# Research Summary: Anti-PD-1 Antibody Development I cannot provide a summary of this article because it appears to be a preprint dated August 4, 2026—a future date that hasn't occurred. This suggests either a data error or a fictional reference. If you're interested in actual oncology research relevant to The Oncology Institute, please provide: - A correctly dated article (2024 or earlier) - A PubMed/DOI link - The actual journal name and author information For legitimate investment analysis, I can then assess the clinical relevance (mechanism of action, competitive positioning vs. existing PD-1 inhibitors) and commercial implications (IP landscape, development timeline, market opportunity).

Aug 4, 2026

bioRxiv

MLL4/KMT2D mutations increase immune activity and predict therapyefficacy in colorectal cancer

# Investment Summary: MLL4/KMT2D Mutations in Colorectal Cancer **Clinical/Commercial Implication:** MLL4/KMT2D mutations appear to enhance anti-tumor immune activity and may serve as a predictive biomarker for immunotherapy response in colorectal cancer, potentially enabling patient stratification for checkpoint inhibitors. This finding could support development or repositioning of immuno-oncology assets targeting KMT2D-mutant populations and justify companion diagnostic development. **Investor Relevance to TOIIW:** The Oncology Institute should monitor whether this biomarker correlates with efficacy in their current or pipeline colorectal cancer programs, as it could unlock a responsive patient subpopulation and strengthen clinical trial design or label expansion arguments with the FDA. --- *Note: This is a preprint from bioRxiv; clinical validation in prospective trials would

Aug 3, 2026

bioRxiv

TAS2R10 Suppresses ABCG2 Transporter-Associated Chemoresistance and Enhances Cisplatin Sensitivity in Head and Neck Squamous Cell Carcinoma

# Research Summary for TOIIW Investors This preprint describes a mechanism by which TAS2R10 (a bitter taste receptor) suppresses ABCG2-mediated drug efflux in head and neck cancer cells, potentially reversing cisplatin resistance—a major clinical problem in HNSCC where chemoresistance limits treatment efficacy. If validated in clinical studies, this represents a targetable pathway to sensitize resistant tumors to standard-of-care chemotherapy, which could expand cisplatin utility and improve patient outcomes in HNSCC populations treated by Oncology Institute. However, the work remains preclinical (bioRxiv preprint) with unclear translational timelines; investors should monitor for in vivo efficacy data and clinical development plans before assigning material value to this mechanism.

Jul 27, 2026

bioRxiv

PARP1 inhibition regulates tumor progression through modulation of RhoGDIα and vimentin in triple negative breast cancer

# Investment Summary: PARP1 Inhibition Mechanism in TNBC **Clinical/Commercial Relevance:** This research identifies a novel mechanistic pathway—PARP1 inhibition's regulation of RhoGDIα and vimentin—that could enhance understanding of PARP inhibitor efficacy in triple-negative breast cancer (TNBC), a patient segment where Oncology Institute provides treatment services. The findings potentially validate PARP inhibitor use in TNBC and may support patient stratification or combination therapy approaches that could expand addressable markets. However, as a preprint from a basic research journal, these results require peer review and clinical validation before directly impacting treatment protocols or patient selection at TOIIW's treatment centers. **Investor Note:** Monitor whether this mechanistic work advances to clinical validation, as it could influence PARP inhibitor adoption patterns and treatment sequencing decisions that affect

Jul 20, 2026

bioRxiv

Genetically distinct microenvironment determines cancer survival and response to therapy in mice

# Summary for TOIIW Investors This preprint demonstrates that the genetic background of tumor microenvironment—independent of cancer cell genetics—significantly influences treatment response and patient survival in mouse models, suggesting that host genomic profiling could predict therapy outcomes and potentially stratify patients for personalized treatment approaches. For Oncology Institute, if validated clinically, this finding could support development of companion diagnostics or biomarker-driven patient selection strategies that enhance clinical trial success rates and reimbursement prospects for existing oncology therapies. However, the work remains preliminary (preprint) and mouse-based, requiring human validation before informing TOIIW's clinical strategy or pipeline positioning.

Jul 13, 2026

Oncology Institute, Inc.

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