Scancell Holdings Charts Risky but Promising Phase III Path

Scancell Holdings ((GB:SCLP)) has held its Q2 earnings call. Read on for the main highlights of the call.

Scancell Holdings Signals Clinical Momentum but Faces Funding Clock in Latest Earnings Call

Scancell Holdings’ latest earnings call struck an overall optimistic tone, underpinned by strong clinical data, a key U.S. regulatory clearance, and a clearer path to potential commercialization for its lead melanoma vaccine iSCIB1+. Management highlighted compelling progression-free survival (PFS) data, FDA approval to proceed directly into a registrational Phase III trial and multiple pipeline and partnership upsides. However, the call also underscored ongoing losses, a lack of current revenue, a finite cash runway into the second half of 2026, and a long, blinded Phase III timeline out to a potential commercial launch in 2029—factors that keep financing and dilution risks firmly in view.

iSCIB1+ Shows Strong Progression-Free Survival Signal

A central focus of the call was the efficacy signal from iSCIB1+ in advanced melanoma. Phase II translational data showed a 74% progression-free survival rate at 16 months, implying a roughly 24 percentage-point improvement versus historic and real-world benchmarks for the ipilimumab plus nivolumab (ipi/nivo) combination, which typically shows a median PFS around 11.5 months. Management also referenced earlier SCIB1 data showing about a 16% overall survival benefit versus its comparator in their dataset, and noted that the magnitude of benefit they are seeing is broadly similar to published five‑year follow-up data from Moderna’s mRNA melanoma vaccine program. While these cross-study comparisons are not definitive, they reinforce confidence that iSCIB1+ may meaningfully enhance the standard of care.

FDA IND Clearance Sets Up Registrational Phase III Path

Investors received a major regulatory de-risking milestone as Scancell reported that the U.S. Food and Drug Administration has cleared the Investigational New Drug (IND) application for its Phase III trial of iSCIB1+. Crucially, the FDA has accepted the proposed dose and delivery method, the overall study design, the statistical analysis plan, choice of endpoints, and the underlying manufacturing and nonclinical package. Moreover, regulators agreed to the use of a surrogate primary endpoint, opening the door to a potential accelerated approval pathway if the results are positive. This comprehensive sign-off positions the upcoming trial squarely as a registrational study with a clearly defined route to market.

Phase III Design, Global Reach and Long Timeline

The Phase III study will be a randomized, double-blind, two-arm trial enrolling around 460 patients—approximately 230 per arm—comparing standard ipi/nivo plus placebo against ipi/nivo plus iSCIB1+. Enrollment will be global, spanning the UK, Europe, the U.S., Australia and other regions, broadening both the clinical and commercial relevance of the data. The trial will use an adaptive design, which can help optimize the study as it progresses, but because it is double-blind, investors should not expect interim efficacy updates, only operational updates such as recruitment progress. Management currently targets a registrational readout and potential commercialization in the second half of 2029, underscoring the long duration of this pivotal program.

Biomarker Strategy Aims to De-Risk Development

To improve the probability of Phase III success, Scancell has identified a biomarker from the Phase II program that appears to enrich for responders to iSCIB1+. This biomarker-based enrichment strategy is intended to increase the observed treatment effect in the pivotal setting and reduce development risk. The adaptive trial design is paired with a conservative statistical delta—the minimal difference the trial is powered to detect—while patient characteristics are being carefully matched to those seen in landmark trials like CheckMate 067 and recent real-world datasets. This focus on comparability is designed to ensure that any observed benefit can be meaningfully interpreted by regulators, clinicians and investors.

Manufacturing, Delivery and Global Regulatory Alignment

Management emphasized that the manufacturing backbone for iSCIB1+ is in place and scalable. The process has shown long-term stability and received favorable feedback from the FDA, a key requirement for any product heading toward commercialization. Scancell has also secured a commercial agreement with PharmaJet, giving it a needle-free delivery solution that could be attractive to both patients and providers. Beyond the FDA, the company is maintaining ongoing engagement with regulators such as the MHRA and EMA, and is actively pursuing additional supportive designations including Fast Track and Breakthrough status, which could further streamline development and review timelines.

Diversified Pipeline and Partnered Upside Beyond iSCIB1+

While iSCIB1+ is the flagship asset, Scancell highlighted a broader pipeline that could add value and diversify risk. Modi‑1 is in a Phase II trial in head and neck as well as renal cancers, with new data expected in the first half of the calendar year. The company’s GlyMab antibody portfolio is progressing in preclinical development, with lead candidate SC134 targeting small cell lung cancer and supported by a patented co‑dosing strategy. Two additional antibodies from this platform have been licensed to Genmab and are moving toward the clinic. The Genmab deal carries up to $630 million in potential milestone payments plus low single-digit royalties on sales, offering significant partnered upside if these assets advance successfully.

Upcoming Data and Milestones as Near-Term Catalysts

In the absence of near-term revenue, Scancell is leaning on upcoming data and partnership events as potential value catalysts. The company expects to report Modi‑1 data in the first half of the calendar year, which could help validate its broader cancer vaccine approach. Management also anticipates Genmab-related milestones during the year as partnered antibodies advance, and additional development milestones for SC129 are expected within the same period. These events, while not guaranteed, could provide non-dilutive funding and important proof points for the pipeline.

Cost Discipline Amid Elevated R&D Needs

From a financial standpoint, Scancell displayed a degree of cost control while continuing to invest in R&D. Research and development expenditure for the six months to 31 October 2025 was $6.2 million, down from the prior period, largely reflecting lower manufacturing costs. Administrative expenses were £2.7 million, leading to an operating loss of £8.9 million and a net loss of £5.7 million. Management emphasized their ability to flex discretionary spend, which will be important as they navigate the expensive transition into a large, global Phase III trial.

No Current Revenue and Dependence on Milestones

The company reported no revenue for the interim period, highlighting its status as a clinical-stage biotech with no products yet on the market. Future revenue opportunities are tied primarily to the successful execution of partnered programs, notably milestone receipts from Genmab, and ultimately to the commercial rollout of iSCIB1+ and other pipeline assets if they reach approval. This lack of recurring revenue underscores the importance of capital management and external funding sources in the near and medium term.

Ongoing Losses, Limited Cash Runway and Funding Pressure

Scancell closed the period with a net loss of £5.7 million and an operating loss of £8.9 million. The cash balance as of 31 October 2025 was £8.6 million, including roughly £3.0 million from an R&D tax credit, providing runway into the second half of 2026. While this represents more than a year of funding at current burn rates, it is not sufficient to carry the company through a full Phase III program and toward commercialization. Management acknowledged that additional capital—via financings, partnerships or milestone monetization—will be required to support the development of iSCIB1+ and the broader pipeline.

Partnering, Financing Options and Dilution Risk

Management was candid about the need to explore various funding strategies to support the registrational program. Options under consideration include additional partnering on iSCIB1+, further leveraging existing arrangements such as the Genmab collaboration, and tapping equity or other capital markets. While partnering could offset some of the cost burden and reduce risk, equity financing would likely be dilutive to existing shareholders. Investors will be watching closely to see whether non-dilutive sources—such as milestones and strategic partnerships—can meaningfully extend the company’s cash runway.

Extended Timeline and Limited Interim Efficacy Visibility

The planned Phase III is both long and tightly blinded, with a registrational readout not expected until the second half of 2029. During this period, Scancell will not be able to provide investors with interim efficacy data, only high-level operational updates like enrollment status. This structure is standard for definitive oncology trials, but it means shareholders must weigh the strong early data and regulatory endorsements against an extended period without confirmatory outcomes. The company also reiterated that the apparent PFS advantage for iSCIB1+ is based on comparisons to historic and real-world datasets, which inherently carry uncertainties and must be validated in the randomized Phase III setting.

Commercial Scope and Loss of Orphan Incentives

Scancell noted that iSCIB1+ is designed for a broad melanoma population, targeting around 80% of patients, in contrast to the earlier SCIB1 program, which focused on a narrower HLA A2-positive subgroup that previously qualified for orphan designation. While the shift away from orphan status likely removes some regulatory and commercial incentives, it significantly expands the addressable market should the product succeed. For investors, this trade-off means potentially larger long-term sales opportunity at the expense of the benefits that orphan drugs typically enjoy.

Forward-Looking Guidance and Strategic Outlook

Management’s guidance centers on advancing iSCIB1+ into a registrational, global Phase III trial with approximately 460 patients, supported by FDA-cleared design elements and a surrogate primary endpoint that could enable accelerated approval. The company plans to pursue Fast Track and Breakthrough designations, with decisions expected within a few months of application, and continues to highlight patent protection out to 2041 alongside established, scalable manufacturing and a needle-free delivery partnership. Financially, Scancell expects current cash to support operations into the second half of 2026, while it actively pursues partnering and financing options and looks to upcoming data from Modi‑1 and potential milestones from Genmab and SC129 as important near-term value drivers. Together, these elements frame a strategy that balances ambitious clinical goals with an acknowledged need to secure additional capital.

In summary, Scancell’s earnings call painted a picture of a company with a promising lead asset, strong early clinical and regulatory validation, and a growing pipeline and partnership base, but also one facing the realities of sustained losses, no current revenue, finite cash and an extended timeline to pivotal data. For investors, the story hinges on whether the company can convert its Phase II momentum and FDA alignment into a well-funded, efficiently executed Phase III, while extracting value from near-term milestones and partnerships to limit dilution. The risk profile remains high, but so too does the potential upside if iSCIB1+ ultimately delivers on its early promise in melanoma.