Isofol Medical: Learn from the first, deliver on the second - ABG
Detta är en aktieanalys producerad av tredje part och reflekterar därför nödvändigtvis ej våra åsikter och värderingar
* Targeting a huge unmet medical need
* Revised best-in-class potential
* Fair value range of SEK 0.1-10.5/share
Huge unmet medical needIsofol is developing arfolitixorin, a next-generation active folate designed to enhance standard chemotherapy built around 5-FU (fluorouracil), a widely used backbone treatment in metastatic colorectal cancer (mCRC) expected to remain for the foreseeable future. CRC is the third most-common cancer globally, of which ~20-25% of patients present with metastatic CRC and 5-year survival <15%.
A clear value proposition
Although the Ph 3 AGENT trial failed in 2022, post-hoc analyses and an extensive review identified clear, addressable shortcomings in dosing, timing and protocol adherence. With a revised clinical strategy, a well-defined mechanistic rationale and sharpened organisational focus, we see renewed potential for arfolitixorin to replace leucovorin, the current suboptimal standard of care folate. Unlike leucovorin, which is a pro-drug requiring metabolic activation, arfolitixorin delivers the active folate directly, enabling more predictable and potentially stronger 5-FU enhancement. The ongoing Ph 1b/2 trial addresses prior shortcomings through higher dosing, correct timing and tighter protocol control, supported by renewed management and partner backing. If successful, we expect a late-2032e launch and ~50% peak penetration, supporting peak sales (ABGSCe) of ~SEK 7.7bn (non-risked) and ~SEK 1.5bn (risk-adj.).
Fair value range of SEK 0.1-10.5/share
We value Isofol using a risk-adj. DCF (12% WACC, 0% terminal growth rate), including future dilution. Scenario A assumes clinical failure (LOA 0%) and yields SEK 0.1/share; scenario B reflects a risk-weighted outcome (LOA 20%), with a value of SEK 1.6/share, while scenario C assumes full clinical and commercial success in first-line mCRC (LOA 100%) with a value of SEK 10.5/share. This implies a fair value range of SEK 0.1-10.5/share.
* Revised best-in-class potential
* Fair value range of SEK 0.1-10.5/share
Huge unmet medical needIsofol is developing arfolitixorin, a next-generation active folate designed to enhance standard chemotherapy built around 5-FU (fluorouracil), a widely used backbone treatment in metastatic colorectal cancer (mCRC) expected to remain for the foreseeable future. CRC is the third most-common cancer globally, of which ~20-25% of patients present with metastatic CRC and 5-year survival <15%.
A clear value proposition
Although the Ph 3 AGENT trial failed in 2022, post-hoc analyses and an extensive review identified clear, addressable shortcomings in dosing, timing and protocol adherence. With a revised clinical strategy, a well-defined mechanistic rationale and sharpened organisational focus, we see renewed potential for arfolitixorin to replace leucovorin, the current suboptimal standard of care folate. Unlike leucovorin, which is a pro-drug requiring metabolic activation, arfolitixorin delivers the active folate directly, enabling more predictable and potentially stronger 5-FU enhancement. The ongoing Ph 1b/2 trial addresses prior shortcomings through higher dosing, correct timing and tighter protocol control, supported by renewed management and partner backing. If successful, we expect a late-2032e launch and ~50% peak penetration, supporting peak sales (ABGSCe) of ~SEK 7.7bn (non-risked) and ~SEK 1.5bn (risk-adj.).
Fair value range of SEK 0.1-10.5/share
We value Isofol using a risk-adj. DCF (12% WACC, 0% terminal growth rate), including future dilution. Scenario A assumes clinical failure (LOA 0%) and yields SEK 0.1/share; scenario B reflects a risk-weighted outcome (LOA 20%), with a value of SEK 1.6/share, while scenario C assumes full clinical and commercial success in first-line mCRC (LOA 100%) with a value of SEK 10.5/share. This implies a fair value range of SEK 0.1-10.5/share.