Celsius Therapeutics Highlights Recent Accomplishments and Key Initiatives for 2022

First Clinical Candidate, Anti-TREM1 Antibody for IBD, Identified Through Novel SCOPE Platform; Phase 1 Study Anticipated in Early 2023

$83 Million in Additional Financing

CAMBRIDGE, Mass. – March 24, 2022

Celsius Therapeutics, a biotechnology company leveraging its human tissue-based platform to develop precision medicines for patients with cancer and autoimmune disease, today provided a summary of recent corporate highlights, including the nomination of its first clinical candidate for inflammatory bowel disease (IBD), an additional $83 million in financing and key initiatives for 2022.

“2021 was a pivotal year of growth and advancement for Celsius,” said Tariq Kassum, M.D., president and CEO of Celsius. “We have successfully scaled our SCOPE (Single Cell Observations for Precision Effect) platform to allow us to discover therapeutic targets of high interest in IBD and solid tumors. In addition, our approach allows us to identify patient stratification hypotheses based on cell types and cell signatures, expanding the reach of precision medicine into new territory. We have now performed single cell RNA sequencing of over 1,000 clinical tissue samples using this platform technology and our dataset continues to grow rapidly. We are excited to be fulfilling the vision of Celsius as we advance a potential first-in-class TREM1 antibody program for IBD and look to design smarter clinical studies based on biologic insights from our proprietary platform.”

Announcement of lead clinical candidate for IBD

Celsius today announced its first clinical candidate, CEL383, an anti-TREM1 antibody, for the treatment of IBD. TREM1, a myeloid target with a central role in IBD, was identified through single cell analysis of hundreds of clinical samples using machine learning algorithms via the company’s SCOPE platform. Through this approach, Celsius was able to identify and deeply characterize subsets of a pathogenic cell type that drive resistance to anti-TNF therapies and has defined a series of targets modulating behavior of these cell subtypes. TREM1, an amplifier of inflammation that resides at the intersection of the microbiome and the immune system, is the first of these targets.

The company anticipates filing an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) within the next year, with a Phase 1 study expected to commence in early 2023. Celsius also plans to enable a precision medicine approach for CEL383 in IBD and has developed multiple biomarker hypotheses for evaluation in early clinical studies.

Progress in oncology pipeline

Beyond CEL383, Celsius has two ongoing drug discovery programs in oncology, both directed towards targets identified through analysis of hundreds of clinical solid tumor samples using the company’s SCOPE platform. The company plans to release more information on these programs in 2022. Additionally, the first candidate target in the company’s colorectal cancer collaboration with Servier, a global independent pharmaceutical group, has recently been selected, triggering a milestone payment to Celsius.

Additional $83 million in financing secured

Celsius also announced that it has raised $83 million in additional financing, comprised of a Series A extension and a Series B financing. The Series B financing was led by Casdin Capital, with participation from original investors Alexandria Venture Investments, GV, Heritage Provider Network and Third Rock Ventures and new investors Amgen Ventures, Amplitude Ventures, Catalio Capital, Co-Win Ventures, Fast Track Initiative, Section 32, as well as other undisclosed institutional investors. In connection with the completion of the Series B, Suzanne Jung Angell from Casdin Capital joined Celsius’ board of directors.

Key initiatives for 2022

Celsius expects 2022 to be an important year as the company continues to advance its mission to create new precision medicines for complex diseases such as autoimmunity and cancer. In 2022, the company plans to pursue the following key initiatives:

  • Continue to build the company’s clinically annotated, proprietary collection of human tissue data in IBD and cancer, and mine this dataset for new targets and patient stratification approaches
  • Prepare an IND for CEL383, the company’s lead antibody program for IBD
  • Advance the company’s oncology programs towards development candidate nomination
  • Nominate additional novel targets, derived from the company’s SCOPE platform, as drug discovery programs
  • Further progress the identification and validation of targets for colorectal cancer under the company’s ongoing drug discovery collaboration with Servier

About Celsius Therapeutics

Celsius Therapeutics is charting a new course of target and drug discovery by combining a deeply curated collection of clinically annotated human tissue samples, single cell RNA sequencing, and complex algorithms to discover precision therapies with a transformative impact on the lives of patients with autoimmune diseases and cancer. Celsius is based in Cambridge, Mass. For more information, please visit www.celsiustx.com, or follow us on LinkedIn or Twitter.

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