Sermonix Pharmaceuticals
Sermonix Pharmaceuticals is a privately held, clinical-stage biopharmaceutical company developing lasofoxifene, an oral next-generation SERM, for ESR1-mutated ER+/HER2- metastatic breast cancer, with global Phase 3 ELAINE-3 enrollment underway and China rights licensed to Henlius Biotech.
- Company typePrivate
- Founded2014
- HeadquartersColumbus, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Sermonix Pharmaceuticals does
Sermonix Pharmaceuticals is a privately held, clinical-stage biopharmaceutical company founded in late 2014 by David Portman, MD, and headquartered at 250 East Broad Street in Columbus, Ohio. The company develops female-specific oncology products, with its entire pipeline centered on lasofoxifene, a next-generation nonsteroidal selective estrogen receptor modulator (SERM) originally developed by Pfizer and later returned to Ligand Pharmaceuticals before Sermonix acquired global rights and pivoted the asset into ESR1-mutated metastatic breast cancer based on discoveries at Duke University. Lasofoxifene is an oral once-daily therapy that functions as an ESR1 antagonist, demonstrating anti-tumor activity as monotherapy and in combination with CDK4/6 inhibitors, with prior non-oncology data on more than 15,000 postmenopausal women supporting its tissue-selective profile and beneficial effects on vaginal and bone health.
The company's clinical program comprises ELAINE-1 (Phase 2 monotherapy vs fulvestrant), ELAINE-2 (Phase 2 combination with abemaciclib showing approximately 13 months median PFS and 56% ORR), ELAINE-3 (global Phase 3 registrational trial in 400 patients, more than 50% enrolled as of January 2026 with top-line data expected mid-2027), and an I-SPY 2 Endocrine Optimization Platform arm in neoadjuvant early-stage HR+/HER2- breast cancer. Prospective ESR1 mutation screening uses Guardant Health's Guardant360 CDx liquid biopsy, and enrollment leverages Tempus's TIME Trial Network just-in-time model. Sermonix supplements clinical work with the EQUALS patient-reported outcomes program and patient advocacy partnerships with METAvivor, FORCE, and the Chrysalis Initiative.
Sermonix operates without a traditional commercial sales motion today. It is pre-revenue and funds operations through equity financing (approximately $67.55 million disclosed across 2016, 2019, and 2021 rounds led by WILD Family Office and Perceptive Xontogeny Ventures Fund II). Its go-to-market model historically relied on KOL engagement at major oncology conferences (ASCO, ESMO, SABCS) and peer-reviewed publication. In December 2025, Sermonix licensed global development and commercialization rights (excluding Asia and certain Middle Eastern countries) to Athira Pharma, now rebranded as LeonaBio, for approximately $34.9 million in equity, $16.8 million in third-party payments, monthly payments of $75,000, and up to $100 million in milestones, while Henlius Biotech retains exclusive China rights under a separate January 2024 collaboration that produced Chinese IND approval in June 2024.
Sermonix Pharmaceuticals firmographics
Firmographics- Name
- Sermonix Pharmaceuticals
- Legal name
- Sermonix Pharmaceuticals
- Website
- https://sermonixpharma.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Sermonix Pharmaceuticals is a privately held, clinical-stage biopharmaceutical company developing lasofoxifene, an oral next-generation SERM, for ESR1-mutated ER+/HER2- metastatic breast cancer, with global Phase 3 ELAINE-3 enrollment underway and China rights licensed to Henlius Biotech.
- Ownership category
- akta.pro rank
Sermonix Pharmaceuticals industry classification
Industry- Product category
- Oncology Therapeutics
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714)
- SIC
- Medicinal Chemicals & Botanical Products (2833)
- akta.pro primary industry
- Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health) (HLAIAAAJ)
- akta.pro secondary industries
- Clinical Development (Phase I–III Trial Design & Execution) (HLAIALAE), Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH), Breast Oncology (HLAKAFAJ)
Keywords
Where Sermonix Pharmaceuticals is headquartered
LocationHeadquarters
- HQ city
- Columbus
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Sermonix Pharmaceuticals business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales, Others
Revenue model
- Drug Commercialization (Future): Sermonix Pharmaceuticals is a privately held clinical-stage biopharmaceutical company that does not currently generate revenue. The company is focused on developing and commercializing lasofoxifene for the treatment of metastatic breast cancer. Upon successful completion of clinical trials and regulatory approval, the company expects to commercialize its lead product candidate through traditional pharmaceutical sales channels.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels7 records
Sermonix Pharmaceuticals product offering
Product offeringCore offering
Sermonix Pharmaceuticals is developing lasofoxifene, an investigational oral next-generation selective estrogen receptor modulator (SERM), for the treatment of estrogen receptor-positive (ER+)/HER2- metastatic breast cancer in patients with ESR1 mutations who have progressed on aromatase inhibitor and CDK4/6 inhibitor therapy. The drug is being advanced through the ELAINE clinical trial program (ELAINE-1 Phase 2 monotherapy vs fulvestrant, ELAINE-2 Phase 2 combination with abemaciclib, and ELAINE-3 Phase 3 registrational combination study) supported by Guardant360 CDx liquid biopsy companion diagnostics and Tempus TIME Trial Network enrollment.
Product overview
Sermonix Pharmaceuticals is a privately held biotechnology company focused on the development of female-specific oncology products. The company's core product is lasofoxifene, a next-generation selective estrogen receptor modulator (SERM) in Phase 3 clinical development for treating metastatic breast cancer patients with ESR1 mutations. The product portfolio includes the ELAINE clinical trial program (ELAINE-1, ELAINE-2, ELAINE-3) evaluating lasofoxifene as monotherapy and in combination with CDK4/6 inhibitor abemaciclib, supplemented by the EQUALS patient quality-of-life survey program. The company also participates in the I-SPY 2 neoadjuvant study and has strategic collaborations with Henlius Biotech (China) and Regor for global development and target discovery.
Differentiator
Problem solved
Functional benefit
Products and services
- Lasofoxifene Investigational oral next-generation selective estrogen receptor modulator (SERM) being developed for the treatment of estrogen receptor-positive (ER+)/HER2- metastatic breast cancer with ESR1 mutations. Demonstrates robust target engagement as an ESR1 antagonist in the breast, with anti-tumor activity as monotherapy and in combination with CDK4/6 inhibitors (abemaciclib). Has unique tissue selectivity with beneficial effects on vaginal and bone health versus current endocrine therapies.
- ELAINE Clinical Trial Program (ELAINE-1, ELAINE-2, ELAINE-3) Series of open-label, randomized, multicenter clinical trials evaluating lasofoxifene in patients with ESR1-mutated metastatic breast cancer. ELAINE-1 compares lasofoxifene monotherapy vs fulvestrant; ELAINE-2 evaluates lasofoxifene plus abemaciclib combination; ELAINE-3 is the registrational Phase 3 study of lasofoxifene plus abemaciclib vs fulvestrant plus abemaciclib. Trials are conducted across the U.S., Europe, Israel, Canada, and Asia-Pacific with Guardant360 CDx companion diagnostic screening.
Quantifiable outcome
- Median PFS of 6.04 months for lasofoxifene vs. 4.04 months for fulvestrant (P=0.138) in ELAINE-1
- +5 more outcomes
Companies that use Sermonix Pharmaceuticals
Customer profileNamed customers4 records
Segments2 records
Ideal customer profiles3 records
Sermonix Pharmaceuticals technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
Feature3 records
Sermonix Pharmaceuticals partnerships and signals
Strategic signalPartnerships
Eleven partnerships are on record, tiered supporting, key and core.
- RegorsupportingStrategic collaboration to optimize Regor's proprietary rCARD platform for identification of novel targets and therapeutics. The partnership aims to develop efficacious and well-tolerated treatments for advanced metastatic breast cancer by leveraging Regor's innovative discovery platform alongside Sermonix's expertise in female-specific oncology.
- Henlius Biotech (Shanghai Henlius Biotech)keyStrategic collaboration and exclusive license agreements for lasofoxifene. Henlius acquired exclusive rights to develop and commercialize lasofoxifene in China, expanding Sermonix's global development footprint. The partnership allows Henlius to expand its portfolio with license of exclusive China rights for this novel endocrine therapy. Henlius subsequently received Chinese IND approval for lasofoxifene.
- TempuskeyCollaboration using Tempus TIME Trial Network for patient enrollment in ELAINE-2 and ELAINE-3 studies. Sermonix enrolled 45% of ELAINE-2 patients through this just-in-time enrollment model, which rapidly opens trial sites closer to patient homes after eligibility identification. TIME Trial sites reduced contract execution time from 200.5 days to 7.6 days on average.
- Guardant HealthkeyCompanion diagnostic partnership for ESR1 mutation detection using Guardant360 CDx liquid biopsy in ELAINE-3 trial. Guardant360 CDx is the first FDA-approved blood test for comprehensive genomic profiling for all solid tumors. This partnership enables prospective screening of subjects for ESR1 mutations using NGS-based liquid biopsy technology.
- Quantum Leap Healthcare CollaborativekeyCollaboration for I-SPY 2 Endocrine Optimization Pilot Protocol (EOP) evaluating lasofoxifene as neoadjuvant endocrine therapy in HR+/HER2- breast cancer. Quantum Leap serves as trial sponsor and manages all study operations. Sermonix supplies lasofoxifene and provides financial support. The I-SPY program includes 41 major U.S. cancer research centers.
- Ligand PharmaceuticalscoreGlobal license agreement for lasofoxifene development and commercialization. Ligand originally developed lasofoxifene; Pfizer had developed it and returned rights to Ligand after 2009 FDA complete response letter. Sermonix subsequently in-licensed the asset and pivoted it to oncology.
- Duke UniversitycoreExclusive rights to develop and commercialize lasofoxifene for ESR1 mutations. Duke University researchers discovered lasofoxifene's novel activity in ESR1 mutations, which forms the basis of Sermonix's precision medicine approach targeting this specific patient population.
- Eli Lilly and CompanykeyClinical trial collaboration and drug supply agreement. Eli Lilly provides abemaciclib (Verzenio) for the ELAINE-3 Phase 3 study. Sermonix uses 150 mg abemaciclib twice daily in combination with lasofoxifene in the registrational trial.
- METAvivor Research and SupportsupportingPatient advocacy partnership supporting the EQUALS survey program. METAvivor helped ensure diverse patient participation in surveys examining quality of life and genomic knowledge among metastatic breast cancer patients.
- The Chrysalis InitiativesupportingPatient advocacy partnership supporting diversity in clinical research and patient education. Partnered with Sermonix for the EQUALS survey program to reach ethnically diverse patient populations.
- FORCE (Facing Our Risk of Cancer)supportingPatient advocacy partnership supporting metastatic breast cancer awareness and education. Partnered with Sermonix for EQUALS survey program examining patient knowledge of genomic testing and quality of life concerns.
Scale indicators10 records
Recent moves6 records
Expansion highlights5 records
Sermonix Pharmaceuticals competitors and assessment
Company assessmentDirect peers
- Radius Health (Menarini Group): Radius developed and Menarini commercializes elacestrant (Orserdu), the first FDA-approved oral SERD for ER+/HER2- metastatic breast cancer with ESR1 mutations — the most direct competitor to Sermonix's lasofoxifene in the same ESR1-mutated patient population.
- Olema Oncology: Clinical-stage oncology company developing palazestrant, an oral SERD for ER+/HER2- metastatic breast cancer, including in ESR1-mutated settings. Directly competes with lasofoxifene on mechanism (oral endocrine therapy in post-CDK4/6i patients) and indication.
- Arvinas: Developing vepdegestrant, an oral PROTAC estrogen receptor degrader in partnership with Pfizer for ER+/HER2- metastatic breast cancer. Competes with lasofoxifene in next-generation oral endocrine therapy for ESR1-mutated and broader ER+ populations.
Broad incumbents
- AstraZeneca: Markets fulvestrant (Faslodex) — the comparator in Sermonix's ELAINE-1 and ELAINE-3 trials — and is developing camizestrant, a next-generation oral SERD. Broad incumbent in breast cancer endocrine therapy with full-scale commercialization.
- Roche / Genentech: Develops giredestrant, an oral SERD in Phase III for ER+ metastatic breast cancer. As a broad oncology incumbent with established breast cancer franchise, competes directly with lasofoxifene's positioning in ESR1-mutated and broader ER+ populations.
- Eli Lilly: Markets Verzenio (abemaciclib), the CDK4/6 inhibitor used in Sermonix's ELAINE-2 and ELAINE-3 combination regimens. Strategic drug-supply partner and a broader breast cancer endocrine therapy competitor.
- Pfizer: Originally developed lasofoxifene (returned to Ligand after 2009 CRL) and markets Ibrance (palbociclib), a leading CDK4/6 inhibitor used in ER+ metastatic breast cancer. Both a legacy developer of Sermonix's core asset and a broad competitive incumbent.
Others
- Ligand Pharmaceuticals: Original licensor of lasofoxifene to Sermonix and previously to Pfizer. Comparable as a small-molecule licensing platform with specialty pharmaceutical exposure, including in women's health (e.g., bazedoxifene via Duavee).
- Guardant Health: Sermonix's companion diagnostic partner, providing Guardant360 CDx — the first FDA-approved liquid biopsy for comprehensive tumor profiling — for ESR1 mutation screening in ELAINE-3. Comparable as an enabler of precision patient identification in Sermonix's clinical and (future) commercial workflow.
Emerging players
- LeonaBio (formerly Athira Pharma): Recently rebranded from Athira Pharma (formerly CNS-focused) to focus on oncology after licensing global ex-Asia lasofoxifene rights from Sermonix in December 2025. Comparable as a clinical-stage oncology company now anchored by the same asset Sermonix developed.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Sermonix Pharmaceuticals social profiles
Digital presenceSermonix Pharmaceuticals financial estimates
Financial estimateRevenue estimate
Valuation estimate
Sermonix Pharmaceuticals leadership team
Management profileNumber of profiles
Profiles8 records
Sermonix Pharmaceuticals funding detail
Funding detailFunding overview
Funding rounds3 records
Investors2 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Sermonix Pharmaceuticals M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Sermonix Pharmaceuticals
What does Sermonix Pharmaceuticals do?
Sermonix Pharmaceuticals is developing lasofoxifene, an investigational oral next-generation selective estrogen receptor modulator (SERM), for the treatment of estrogen receptor-positive (ER+)/HER2- metastatic breast cancer in patients with ESR1 mutations who have progressed on aromatase inhibitor and CDK4/6 inhibitor therapy. The drug is being advanced through the ELAINE clinical trial program (ELAINE-1 Phase 2 monotherapy vs fulvestrant, ELAINE-2 Phase 2 combination with abemaciclib, and ELAINE-3 Phase 3 registrational combination study) supported by Guardant360 CDx liquid biopsy companion diagnostics and Tempus TIME Trial Network enrollment.
Is Sermonix Pharmaceuticals a public or private company?
Sermonix Pharmaceuticals is a private company. It is classified as venture growth investor backed and is currently operating.
When was Sermonix Pharmaceuticals founded?
Sermonix Pharmaceuticals was founded in 2014. It employs 1 to 10 people.
Where is Sermonix Pharmaceuticals based?
Sermonix Pharmaceuticals is headquartered in Columbus, United States, in the North America region.
How does Sermonix Pharmaceuticals make money?
One revenue line is on record: drug Commercialization (Future).
Who are Sermonix Pharmaceuticals's main competitors?
Direct peers on record are Radius Health (Menarini Group), Olema Oncology and Arvinas. Broad incumbents are AstraZeneca, Roche / Genentech, Eli Lilly and Pfizer. Others are Ligand Pharmaceuticals and Guardant Health. LeonaBio (formerly Athira Pharma) is listed as an emerging player.
Does Sermonix Pharmaceuticals have an API?
No public API is recorded for Sermonix Pharmaceuticals.
What industry is Sermonix Pharmaceuticals in?
Sermonix Pharmaceuticals's product category is Oncology Therapeutics. Its primary akta.pro industry code is HLAIAAAJ, Endocrinology & Reproductive Health Pharmaceuticals (incl. Women’s Health), with a secondary code of HLAIALAE, Clinical Development (Phase I–III Trial Design & Execution). Its NAICS code is 541714 and its SIC code is 2833.