Cleveland Diagnostics Completes $75M Financing to Advance its Early-detection Oncology Testing Platform

Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers announced the closing of over $75M in growth capital financing. The financing was led by Novo Holdings, a leading global life sciences investor, responsible for managing the assets of the Novo Nordisk Foundation, along with participation from existing investors as well as a credit facility from Symbiotic Capital. The financing will accelerate Cleveland Diagnostics' commercial and corporate development goals.

"We are pleased to have secured this growth capital and support from a mix of new and existing investors, exhibiting their confidence in our company's growth potential and our ability to execute financial discipline as we anticipate increased test utilization and achievements of key clinical and regulatory milestones in 2024," said Arnon Chait, Ph.D., Cleveland Diagnostics CEO & co-founder. "These funds provide Cleveland Diagnostics the capital and flexibility to advance our portfolio of non-invasive tests as demonstrated by the rapidly increasing demand for our IsoPSA^® prostate cancer test."

IsoPSA is a blood test used to further stratify the risk of prostate cancer and aid in biopsy decisions for men identified at higher risk based on results from screening methods, such as PSA testing. Differentiating cancer from benign conditions, this protein-based test is critical for many patients to identify cancer at its earliest stage to minimize the cost of overdiagnosis and overtreatment ? a vital test as 1 in every 8 men are expected to be diagnosed with prostate cancer in their lifetime. In 2023 alone, there were an estimated 288,000 new prostate cancer diagnoses and over 34,000 deaths in the United States, according to the American Cancer Society. IsoPSA can provide more specific insights to better inform healthcare providers and support actionable evidence when evaluating the ongoing unmet medical need for patients affected by prostate cancer.

Cleveland Diagnostics' portfolio of oncology related tests will be expanding beyond prostate cancer into additional indications in 2024. Proceeds will accelerate the commercial strategy of IsoPSA, fund expanded infrastructure and R&D pipeline development, and broaden the geographic scope of its novel IsoPSA prostate cancer test.

"It's all about the patients," said Noel Jee, Partner on the Growth Investments team at Novo Holdings US. "We believe that IsoPSA has the potential to improve treatment, reduce costs, and increase quality-of-life for patients who may have prostate cancer. The company's differentiated blood-based approach presents an opportunity to further improve diagnostics for other cancers and diseases."

In connection with the financing, Jee will join the Cleveland Diagnostics Board of Directors.

"We are delighted to be a part of ClevelandDx's growth trajectory and support the team as they tackle the diagnostic uncertainty that remains in urology and other therapeutic areas," added Jee.

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics, Inc. is a cancer biotechnology company that has unlocked the diagnostics power of protein structural change. Its scientists are developing highly efficacious, lab-friendly, affordable diagnostics tests that use proprietary technology to detect cancer earlier. Cleveland Diagnostics' revolutionary Solvent Interaction Analysistm (SIA) technology investigates protein biomarkers at the structure level (as opposed to mere biomarker concentration) in blood, providing better and more clinically relevant insights regarding the protein origin on the cellular level. Cleveland Diagnostics' portfolio of non-invasive cancer diagnostics will soon expand beyond its novel IsoPSA prostate cancer test to breast cancer, lung cancer, and other diseases. Learn more at ClevelandDx.com and IsoPSA.com.

About Novo Holdings

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people's health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novozymes A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. www.novoholdings.dk