What TYME does

TYME Technologies, Inc. (NASDAQ: TYME) is a clinical-stage biotechnology company developing Cancer Metabolism-Based Therapies (CMBTs™), a proprietary class of investigational therapeutics that target the metabolic mechanisms underlying cancer cell survival rather than symptoms of disease. Its lead compound, SM-88 (racemetyrosine), is an orally administered modified tyrosine derivative given with low-dose conditioning agents Methoxsalen, Phenytoin, and Sirolimus (MPS); SM-88 has been administered to approximately 180 patients and has produced confirmed tumor responses across 15 different solid and hematologic cancer types. The pipeline also includes SM-88i (an injectable formulation of SM-88 in preclinical development), TYME-18 (a preclinical intra-tumoral therapy combining a proprietary surfactant with a natural sulfonic/bile acid that achieved complete resolution of more than 90 percent of colorectal tumors in preclinical xenograft studies), and TYME-19 (an oral synthetic bile acid being explored preclinically as an antiviral against COVID-19). The platform is protected by approximately 200 granted and pending patent applications worldwide extending through 2032 and beyond, and TYME retains full commercial rights to all pipeline assets.

The company is pre-revenue: SM-88 and pipeline compounds are available only through clinical trials and Compassionate Use, not commercial sale, and no product pricing or licensing income is disclosed. Clinical development is executed through an externalized network of academic medical center partnerships, including Mayo Clinic, NYU Langone Health's Perlmutter Cancer Center, Georgetown University (OASIS breast cancer trial), the Pancreatic Cancer Action Network's Precision Promise platform, and the Frost family's HopES Sarcoma trial. Marketing and stakeholder engagement occur primarily through scientific conferences (ASCO, ESMO, AACR), peer-reviewed publications, the TYMEtrials.com enrollment site, and investor relations communications.

TYME is headquartered in Bedminster, New Jersey, employs 11–50 people, and is led by CEO Richie Cunningham (appointed November 2020) with Chairman Douglas A. Michels (since March 2022) and a board of directors drawn primarily from senior executive ranks at Novartis, Johnson & Johnson, Pfizer, Valeant, GlaxoSmithKline, and Bristol-Myers Squibb. Annual net losses have ranged from approximately $19M to $33M over 2018–2022, funded historically through equity rounds including a $100M raise in February 2021.

Name

TYME

Legal name

TYME Technologies, Inc.

Website

https://tymeinc.com

Company type

Public

Founded year

2011

Operating status

Operating

Headcount range

11–50 employees

Short description

TYME Technologies is a pre-revenue clinical-stage biotech developing oral and injectable Cancer Metabolism-Based Therapies (CMBTs™), led by SM-88 for advanced solid and hematologic cancers, with pipeline assets in sarcoma, breast, and pancreatic cancer trials at academic medical centers.

Ownership category

akta.pro rank

Product category

Oncology Therapeutics

NAICS

Pharmaceutical Preparation Manufacturing (325412), Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834), Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Therapeutic Peptides & Protein/Peptide Biologics (HLAAAAAH)

Keywords

• Cancer metabolism therapy
• Oncology drug development
• Clinical stage biotech
• Investigational cancer drugs
• Targeted cancer therapeutics

Headquarters

HQ city

Bedminster

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. No Commercial Revenue: TYME is a pre-commercial biotechnology company developing investigational cancer therapies. SM-88 is not approved for any indication and is not available for purchase. The company does not currently generate product revenue.

Distribution channels1 record

Marketing channels5 records

Core offering

TYME Inc. is a pre-commercial biotechnology company developing proprietary Cancer Metabolism-Based Therapies (CMBTs™) for advanced and metastatic cancers. Its lead investigational compound is SM-88 (racemetyrosine), an oral modified tyrosine derivative administered with conditioning agents methoxsalen, phenytoin, and sirolimus (MPS). The pipeline additionally includes SM-88i (injectable formulation), TYME-18 (intra-tumoral therapy), and TYME-19 (oral synthetic bile acid for COVID-19), all currently in preclinical or clinical development and not approved for any indication.

Product overview

TYME is an emerging biotechnology company developing Cancer Metabolism-Based Therapies (CMBTs™). The company's product portfolio centers on SM-88 as the lead clinical compound, an oral modified tyrosine derivative for cancer treatment administered with MPS (methoxsalen, phenytoin, sirolimus). The pipeline includes SM-88i (injectable formulation in preclinical development), TYME-18 (intra-tumoral solid tumor treatment in preclinical development), and TYME-19 (antiviral bile acid for COVID-19 in preclinical development). The therapeutic approach targets cancer cell metabolic requirements to cause cancer cell death while maintaining relatively low toxicity profiles.

Differentiator

Problem solved

Functional benefit

Products and services

• SM-88 (racemetyrosine) with MPS

Quantifiable outcome

• Minimal observed drug-related serious adverse events (SAE) in approximately 180 patients treated with SM-88
• +2 more outcomes

Segments2 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• Mayo CliniccoreStrategic or Co-development PartnerPreclinical research collaboration with Mayo Clinic to broaden understanding of SM-88 mechanisms, identify patient/disease biomarkers for clinical trial selection, and explore combination therapies with other anti-cancer mechanisms.
• NYU Langone Health (Perlmutter Cancer Center)coreStrategic or Co-development PartnerResearch collaboration with NYU Langone Health for SM-88 development, including preclinical research and clinical trial participation with investigators like Dr. Paul Oberstein and Dr. Diane Simeone.
• Georgetown UniversitycoreStrategic or Co-development PartnerCollaboration on the OASIS Breast Cancer Trial, a multicenter phase II study of SM-88 used with MPS in metastatic HR+/HER2- breast cancer.
• Pancreatic Cancer Action Network (PanCAN)coreStrategic or Co-development PartnerPartnership on the Precision Promise adaptive Phase II/III trial platform. TYME SM-88 included as experimental arm for monotherapy in patients who failed one prior line of chemotherapy, with planned evaluation in combination with gemcitabine and nab-paclitaxel.
• Jason Frost (Frost Family) - HopES Sarcoma TrialcoreStrategic or Co-development PartnerNamed HopES (Helping Excellence in Sarcoma) trial in honor of Jason Frost, evaluating SM-88 for patients with high-risk sarcomas including Ewing's sarcoma.

Scale indicators3 records

Recent moves6 records

Expansion highlights5 records

Emerging players

• Inhibrx: Clinical-stage biotech developing novel biologic therapeutics for oncology and rare diseases. Comparable as a small-to-mid-cap public biotech with innovative mechanisms in oncology development.
• Cogent Biosciences: Clinical-stage biotech developing precision oncology therapies for genomically defined cancers. Comparable as a small-cap clinical-stage oncology company targeting specific molecular mechanisms.
• Actinium Pharmaceuticals: Clinical-stage biotech developing targeted radiotherapies for hematologic cancers. Comparable as a small-cap public oncology biotech with pipeline-focused approach and similar capitalization profile.
• Cellectar Biosciences: Clinical-stage biotech developing targeted cancer therapeutics using proprietary phospholipid drug conjugate technology. Comparable in size, stage, and public-market capitalization as a small-cap oncology biotech.

Direct peers

• Cardiff Oncology: Small-cap public biotech developing oncology therapeutics with novel mechanisms, including programs in KRAS-mutated cancers. Comparable in size, stage, and public-market profile to TYME as a clinical-stage oncology company.
• Aprea Therapeutics: Clinical-stage biotech developing cancer therapies that target cancer metabolism and DNA damage response pathways. Most comparable to TYME given its focus on novel metabolism-targeting oncology mechanisms in early-stage clinical development.
• Rafael Pharmaceuticals: Developed devimistat (CPI-006), a cancer metabolism-targeting agent evaluated in pancreatic and other cancers. Closely aligned with TYME's CMBT approach to targeting tumor metabolism, though Rafael has faced significant clinical and financial setbacks.

Broad incumbents

• Bristol-Myers Squibb: Major oncology pharmaceutical company with broad portfolio across immuno-oncology, targeted therapy, and cell therapy. Relevant as both a potential partner/acquirer for TYME's pipeline and a benchmark for the broader oncology therapeutics market.
• Roche: Global pharmaceutical leader with one of the largest oncology franchises, spanning targeted therapies, immuno-oncology, and diagnostics. Relevant as both a potential partner for TYME's metabolism-targeted pipeline and as an industry benchmark.
• AstraZeneca: Major oncology-focused pharmaceutical company with deep pipeline across multiple cancer types including pancreatic and breast cancer—two of TYME's target indications. Relevant as both a potential acquirer and competitor in shared indications.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/tyme_inc
• Facebookfacebook.com/TYME2ConquerCancers

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds4 records

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about TYME