Scancell Secures FDA Green Light for Phase 3 Melanoma Trial as Pipeline and Cash Runway Advance

Scancell Holdings ( (GB:SCLP) ) has shared an announcement.

Scancell reported interim results showing strong clinical and regulatory momentum for its oncology pipeline, led by iSCIB1+, the company’s DNA ImmunoBody cancer immunotherapy, which has demonstrated potentially best-in-class progression-free survival in advanced melanoma when combined with checkpoint inhibitors. The FDA has cleared an Investigational New Drug application for a global registrational Phase 3 trial in advanced melanoma, targeted to start in 2026 with potential commercialisation in 2029, while Scancell explores financing and partnering options to fund Phase 3 development and maximise shareholder value. The company is also progressing its Moditope-based vaccine Modi-1 in a Phase 2 study for head and neck and renal cancers with key data expected in the first half of 2026, and has consolidated its antibody assets in wholly owned subsidiary GlyMab Therapeutics, where lead candidate SC134 for small cell lung cancer and partnered Genmab programmes are advancing towards potential 2026 milestones. Financially, Scancell reported a reduced operating loss of £8.9 million for the half year, cash of £8.6 million supplemented post-period by £3.0 million in R&D tax credits, and visibility on funding into the second half of 2026, which should carry the group through several important clinical, regulatory and business development inflection points.

The most recent analyst rating on (GB:SCLP) stock is a Hold with a £14.00 price target. To see the full list of analyst forecasts on Scancell Holdings stock, see the GB:SCLP Stock Forecast page.

Spark’s Take on GB:SCLP Stock

According to Spark, TipRanks’ AI Analyst, GB:SCLP is a Neutral.

The score is held back primarily by weak financial performance (ongoing losses, negative equity, and cash burn), only partly offset by improved burn in 2025. Technicals show an uptrend but are extremely overextended, adding pullback risk. The latest earnings call was comparatively supportive due to strengthened liquidity/runway and pipeline/regulatory progress, while valuation remains difficult to justify using traditional metrics because the company is loss-making.

To see Spark’s full report on GB:SCLP stock, click here.

More about Scancell Holdings

Scancell Holdings is a clinical-stage biotechnology company focused on developing off-the-shelf active immunotherapies to generate durable, tumour-specific immune responses against cancer. Its lead platforms, DNA ImmunoBody and Moditope, are being advanced through Phase 2 and planned Phase 3 trials in melanoma and other solid tumours, while subsidiary GlyMab Therapeutics develops a pipeline of high-affinity antibodies targeting tumour-specific glycans, including assets licensed to Genmab.

Average Trading Volume: 1,369,235

Technical Sentiment Signal: Buy

Current Market Cap: £138.8M

For an in-depth examination of SCLP stock, go to TipRanks’ Overview page.