Foresight Diagnostics Provides 2025 Outlook and 2024 Year in Review

– Achieved 100% revenue growth versus prior year –

– Received Investigational Device Exemption approval from the FDA for the use of Foresight CLARITY™ for patient enrollment in the ALPHA3 clinical trial –

– Goals in 2025 include expanding biopharma partnerships and regulated use of Foresight CLARITY™, preparing for the commercialization of Foresight CLARITY™ in lymphoma, and establishing an LDT with real-time testing for solid tumors –

BOULDER, Colo., Jan. 08, 2025 (GLOBE NEWSWIRE) — Foresight Diagnostics (Foresight), a leader in ultra-sensitive minimal residual disease (MRD) detection technology, today provided its strategic outlook for 2025 and a review of corporate highlights from the past year.

“Foresight has achieved or exceeded 100% revenue growth every year since our founding, and in 2024 we reached significant clinical and regulatory milestones that further our mission of delivering innovative diagnostics for cancer patients,” said Jake Chabon, Ph.D., CEO and co-founder of Foresight Diagnostics. “In 2025 we will prepare for the commercial launch of Foresight CLARITY™ in lymphoma, expand our biopharma partnerships, and advance our position in the solid tumor MRD market. I am grateful for the contributions of the entire Foresight team and their relentless dedication to empowering therapeutic decisions that improve patient outcomes.”

2025 Goals

• Grow revenue through both new and expanded biopharma and academic partnerships, with an emphasis on regulated use of Foresight CLARITY™, including companion diagnostic development and MRD-based endpoints in global clinical trials.

• Prepare Foresight CLARITY™ for commercial launch by securing reimbursement in lymphoma and solidifying our launch strategy.

• Advance Foresight CLARITY™ for solid tumors through new strategic partnerships and offer real-time testing as a laboratory-developed test (LDT).

2024 Highlights:

• Doubled revenue in 2024 and delivered consistent growth at >100% CAGR since 2021, representing over 60 contracts with 20+ pharmaceutical partners and 10+ academic partners.

• Entered into a strategic partnership with Allogene Therapeutics to use Foresight CLARITY™ as an investigational-use only (IUO) in-vitro diagnostic to determine patient eligibility for ALPHA3, the first pivotal trial for first line (1L) consolidation treatment of large B-cell lymphoma (LBCL) based on MRD status. Foresight CLARITY™ IUO received FDA Investigational Device Exemption (IDE) approval in June 2024 and patient enrollment is underway.

• Expanded to a new corporate headquarters and CLIA-certified lab in Boulder, CO, delivering automated testing with an average turnaround time of 7 days and scalable capacity allowing for processing of thousands of samples per week.

• Closed $33 million in new Series B capital with participation from existing investors: Foresite Capital, Civilization Ventures, Bluebird Ventures, Pear Ventures, Agent Capital, Stanford University, and the University of Colorado Healthcare Innovation Fund. The additional funds enabled accelerated development of Foresight CLARITY™ in solid tumors. To date, Foresight has raised $86 million in venture funding.

• Improved the performance of Foresight CLARITY™ in solid tumors, delivering an industry-leading analytical sensitivity (LOD95) of 3 parts per ten million (3×10^-7)^1,2,3, and generated clinical evidence in early-stage lung and breast cancers in partnership with Memorial Sloan Kettering Cancer Center:
  • Lung cancer study presented at American Society of Oncology (ASCO) showcased the clinical performance of MRD detection by Foresight CLARITY™ in early-stage non-small cell lung cancer (NSCLC) within the post-operative adjuvant setting.¹
  • Breast cancer study initially presented at the European Society for Medical Oncology (ESMO) Congress followed by an expanded cohort presentation at the San Antonio Breast Cancer Symposium (SABCS) demonstrated that MRD clearance following various perioperative treatments – including surgery, neoadjuvant chemotherapy, and adjuvant chemotherapy – is strongly associated with favorable survival outcomes^2,3.

• Launch of SHORTEN-ctDNA, an MRD-driven clinical trial with Columbia University which aims to evaluate real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL) based on mid-therapy ctDNA status.

Foresight will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 7:30 a.m. Pacific Time. Additionally, Foresight Diagnostics will be hosting meetings at the LifeSci Corporate Access Event from January 13-15, 2025, and will also be available for additional meetings on January 16. To schedule a meeting with the Company, please contact InvestorRelations@foresight-dx.com.

References:

1 Isbell, et al. ASCO 2024
2 Cabel, et al. ESMO 2024
3 Cabel, et al. SABC 2024

About Foresight Diagnostics

Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-certified laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

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InvestorRelations@foresight-dx.com