Celex Oncology plans up to GBP 30m raise to fund late-stage trial
Celex Oncology plans up to GBP 30m raise to fund late-stage trial - CEO
by Deborah Balshem
Celex Oncology Innovations plans to raise capital in 3Q26 to support its lead drug candidate through to potential US Food and Drug Administration (FDA) approval, said co-founder and CEO Carsten Faltum.
The UK-based biotechnology company will seek GBP 20m-GPB 30m (USD 26.4m-USD 39.7m) primarily from institutional investors in the US, as well as Europe, Faltum said. Proceeds will support CL-S03 through a Phase 2/3 clinical trial set to begin in early 2027, he added.
Faltum said Celex has raised GBP 6m in capital and is about to close a USD 4m round. Its capitalisation table consists primarily of family offices.
Celex is focused on treatments that slow or halt progression of cancer and metastasis by targeting sodium overload in tumour cells, a crucial cell component and key regulator of tumour cell behavior, according to Faltum. The company is initially targeting pancreatic cancer, with CL-S03 intended to complement standard treatments like chemotherapy and immunotherapy and potentially improve their effectiveness, he said.
Moreover, CL-S03 targets only malfunctioning cells, resulting in fewer side effects, the CEO added.
The Phase 2/3 trial is expected to take three years, after which the company will file for a new drug application (NDA), if successful, according to Faltum. FDA approval could come as soon as 2030-31, he said.
Celex may start attracting serious partner or buyer interest halfway through the trial, or around mid-2028, the CEO added.
Pancreatic cancer treatment is currently available at only a limited number of centres, which Celex could reach independently, Faltum said. However, to fully capture the “significant market opportunity” — given rising cases and high mortality — the ideal path would be a partnership or sale to a larger strategic player, he added.
The company would consider licensing agreements for certain indications or geographies, or a full acquisition, Faltum said. He noted larger pharmaceutical companies with KRAS inhibitor programmes, such as Merck, Roche, and Novartis, as logical strategic partners or acquirers. KRAS inhibitor programmes target cancers driven by mutations in the KRAS gene, which controls signals that tell cells when to grow and divide.
Every year in the US, there are around 66,000 new cases of pancreatic cancer, with approximately 87% of people diagnosed dying within five years, according to the National Cancer Institute. Pancreatic cancer may become the second leading cause of cancer‑related deaths (behind lung cancer) by 2030 because of demographic shifts and limited progress in early detection and treatment, reports the Pancreatic Cancer Action Network.
Once CL-S03 is approved in the US, Celex will seek approval in other regions such as Europe and China, Faltum said. Potential indications to follow include triple-negative breast cancer, according to Faltum, who said the company has identified more than 25 tumour types.
“We have used ranolazine, which targets our channel, but is marketed for Angina pectoris, as a model drug,” Faltum said. In 165 patients that had angina and developed cancer, Ranolazine treatment resulted in a significant 60% reduction in cancer-related mortality over 10 years in patients with breast, colon, and prostate cancer, he noted.
According to Faltum, “no one is addressing sodium in oncology”. He pointed to Dutch biotech firm Merus, which is developing antibody therapies for cancer, as an adjacent player that is in the process of being acquired by Genmab in an all‑cash deal valued at approximately USD 8bn.
Celex was spun-out of Imperial College London in 2017. Faltum, 56, a former medical device and product executive at companies including Coloplast, Biolin Scientific, and Medela, joined as founding COO and was promoted to CEO in 2024.
The company has 10 corporate employees and 10 patent families. It works with law firm Child & Child and accounting firm Harris & Trotter.