Marshall Edwards, Inc.

What Marshall Edwards, Inc. does

Marshall Edwards, Inc. is a clinical-stage oncology company headquartered in San Diego, California, that develops novel anti-cancer therapeutics derived from an isoflavone-based chemistry platform originally licensed from its majority shareholder and Australian parent, Novogen Limited (ASX:NRT). The company was incorporated in Delaware in December 2000, began trading on Nasdaq (ticker: MSHL) in December 2003, and relocated its headquarters from Sydney to San Diego in April 2010 following the appointment of Dr. Daniel Gold as CEO. The lead pipeline is organized around two complementary mechanisms targeting tumor cell metabolism: the NADH oxidase inhibitor program (lead candidate ME-143, with first-generation Phenoxodiol and Triphendiol precursors) and the mitochondrial inhibitor program (lead candidate ME-344, with first-generation NV-128 precursor). The platform has generated more than 400 synthetic chemical structures based on naturally-occurring plant isoflavones, and the company holds exclusive worldwide rights through an IP portfolio of 11 issued U.S. patents, 40+ foreign patents, and 80+ foreign applications acquired from Novogen in May 2011.

The core technology targets cancer cell metabolism through two distinct pathways — ME-143 inhibits the sphingosine kinase-Akt signaling pathway to induce caspase-mediated apoptosis, while ME-344 induces caspase-independent cell death via DNA fragmentation and destructive autophagy by targeting the terminal respiratory chain complex. ME-143 entered a Phase I clinical trial in September 2011 for patients with refractory solid tumors, and ME-344 demonstrated tenfold greater anti-tumor activity than NV-128 in preclinical studies, with an IND application filed in Q1 2012. Marshall Edwards is a pre-revenue, publicly traded development-stage company with 11–50 employees, no commercial products, and no product pricing. Its stated go-to-market is the completion of early-stage clinical trials followed by out-licensing or partnering with pharmaceutical companies for late-stage development and commercialization; its primary customers, when commercial, will be oncology healthcare institutions and patients with chemotherapy-resistant cancers including platinum/taxane-refractory ovarian cancer, KRAS-mutant NSCLC, and prostate cancer. Capital to date has been sourced primarily through a December 2011 $2 million private placement from Novogen Limited, supplemented by periodic equity offerings to fund ongoing R&D and clinical operations.

Name

Marshall Edwards, Inc.

Legal name

Marshall Edwards, Inc.

Website

https://marshalledwardsinc.com

Company type

Public

Founded year

2000

Operating status

Operating

Headcount range

11–50 employees

Short description

Marshall Edwards, Inc. is a San Diego-based clinical-stage oncology company developing isoflavone-based anti-cancer therapeutics, with lead candidates ME-143 (NADH oxidase inhibitor in Phase I) and ME-344 (mitochondrial inhibitor) targeting chemotherapy-resistant solid tumors for eventual out-licensing to pharmaceutical partners.

Ownership category

akta.pro rank

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Private Placement Financing: The company raises capital through private placement offerings. In December 2011, the company sold approximately 1.94 million shares of common stock to its majority shareholder Novogen Limited for gross proceeds of $2 million.
2. Future Product Revenue: Pre-revenue clinical stage company planning to commercialize drug candidates through partnering agreements with pharmaceutical companies upon successful clinical development and regulatory approval.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Marshall Edwards, Inc. is a clinical-stage oncology company developing novel anti-cancer therapeutics based on an isoflavone technology platform derived from naturally occurring plant compounds. The company's lead programs focus on two families of small molecules that target tumor cell metabolism: the NADH oxidase inhibitor program led by ME-143, and the mitochondrial inhibitor program led by ME-344, supported by first-generation compounds Phenoxodiol, NV-128, and Triphendiol.

Product overview

Marshall Edwards is a San Diego-based oncology company developing a pipeline of novel anti-cancer therapeutics derived from an isoflavone technology platform. The company's lead programs focus on two families of small molecules targeting tumor cell metabolism: the NADH oxidase inhibitor program (led by ME-143, with first-gen Phenoxodiol) and the mitochondrial inhibitor program (led by ME-344, with first-gen NV-128). The platform has generated over 400 synthetic compounds based on naturally-occurring plant isoflavones.

Differentiator

Problem solved

Functional benefit

Products and services

• ME-143 Next-generation NADH oxidase inhibitor and primary active metabolite of Triphendiol. Demonstrates superior anti-tumor activity against a broad range of tumor cell lines compared to Phenoxodiol and Triphendiol. FDA IND approved with Phase I clinical trial initiated in September 2011 for patients with refractory solid tumors.
• ME-344 Next-generation mitochondrial inhibitor and active metabolite of NV-128, showing tenfold more anti-tumor activity than NV-128 in pre-clinical studies. Targets the terminal respiratory chain complex in rapidly proliferating cells and induces caspase-independent cell death. IND application submitted in Q1 2012.
• Phenoxodiol First-generation NADH oxidase inhibitor that has been well tolerated in hundreds of patients. Administered via oral or intravenous routes in multiple clinical trials including the Phase III OVATURE trial.
• NV-128 First-generation mitochondrial inhibitor that induces caspase-independent cell death through both DNA fragmentation and destructive autophagy, targeting the terminal respiratory chain complex in rapidly proliferating cells.
• Triphendiol (NV-196) Second-generation isoflavone derivative and precursor to ME-143, developed for pancreaticobiliary cancers. Phase Ia clinical trial completed.

Quantifiable outcome

• ME-143 demonstrated superior anti-tumor activity against a broad range of tumor cell lines compared to Phenoxodiol and Triphendiol in pre-clinical studies
• +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

Feature3 records

Partnerships

One partnership is on record.

• Yale University School of Medicine (Dr. Gil Mor)coreStrategic or Co-development PartnerResearch collaboration with Dr. Gil Mor, gynecological oncologist at Yale School of Medicine, on the mitochondrial inhibitor program. Dr. Mor's research demonstrated NV-128's activity against chemotherapy-resistant ovarian cancer stem cells, leading to identification of next-generation compound ME-344.

Scale indicators3 records

Recent moves8 records

Expansion highlights4 records

Direct peers

• Puma Biotechnology: Clinical-stage US oncology company developing small molecule therapeutics for solid tumors (notably breast cancer) with similar small-cap, single-platform profile. Both companies operated as thinly-traded Nasdaq-listed clinical biotechs advancing late-Phase I/II assets.
• Verastem: Clinical-stage US oncology company that acquired certain isoflavone-technology assets with ties to the Marshall Edwards/Novogen lineage. Focused on small molecule drug development targeting cancer stem cells and solid tumors with comparable small-cap profile.
• MEI Pharma: Clinical-stage US oncology company with similar size, small-cap Nasdaq profile, and pipeline of small molecule hematologic and solid tumor candidates. Directly comparable as a near-pure-play clinical-stage oncology biotech of the same era.
• ArQule: Clinical-stage US oncology company focused on small molecule kinase inhibitor discovery (later acquired by Merck). Directly comparable as a small-cap, Nasdaq-listed clinical-stage oncology biotech of the same era with a similar pipeline-stage profile.
• Geron Corporation: Clinical-stage US oncology biotech of similar size developing small molecule telomerase-targeted therapy (imetelstat) for hematologic malignancies. Comparable as a small-cap, Nasdaq-listed clinical oncology company with a single-platform, mechanism-focused pipeline.
• Infinity Pharmaceuticals: Clinical-stage US oncology company developing small molecule therapeutics for solid tumors and hematologic malignancies (PI3K/mTOR pipeline). Comparable stage, scale, and focus on novel mechanism oncology drug development.
• Molecular Templates: Clinical-stage biotech developing engineered toxin-based oncology candidates and small molecule therapeutics (formerly Threshold Pharmaceuticals before merger). Comparable as a small-cap clinical-stage oncology company with platform-derived candidates targeting solid tumor metabolism.
• Clovis Oncology: Clinical-stage US oncology company developing small molecule targeted therapeutics against solid tumors during a similar time period. Closely matches Marshall Edwards' stage, capitalization profile, and focus on tumor metabolism/DNA-damage pathways.
• Sunesis Pharmaceuticals: Clinical-stage US oncology company developing small molecule kinase inhibitors for hematologic malignancies. Directly comparable as a thinly-traded, small-cap, Nasdaq-listed clinical oncology biotech advancing novel-mechanism candidates in the same era.
• Novogen Limited: Australian oncology biotech and majority shareholder/parent of Marshall Edwards; originally developed the isoflavone platform that ME-143 and ME-344 were derived from. Operates in the same therapeutic area with overlapping mechanistic lineage, making it the most directly comparable peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

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 Marshall Edwards, Inc.