[Edaily Reporter Kim Jin-soo] #FutureChem has decided on a final round of fundraising ahead of its full-scale revenue generation and has secured a cash cow, allowing it to accelerate the development of FC705, a radiopharmaceutical for prostate cancer treatment—the final piece of the puzzle in its theranostics business structure, which spans from diagnosis to treatment.

FutureChem believes that the likelihood of successfully developing FC705 has significantly increased following the approval of FC303, a radiopharmaceutical (RPT) for prostate cancer diagnosis. Through this, FutureChem plans to complete its business structure spanning from diagnosis to treatment.

Driving the Development of FC705, the Final Piece of the Theranostics Puzzle

FutureChem is pursuing a capital increase of approximately 40 billion won through a rights offering followed by a public offering of unsubscribed shares to accelerate the global commercialization of FC705, its core pipeline radiopharmaceutical for prostate cancer treatment, and to secure future growth engines. According to FutureChem, this fundraising is viewed not merely as a means to secure R&D funds, but as a growth investment aimed at maximizing the global value of FC705 and its potential for technology transfer.

This funding round is expected to be FutureChem’s final large-scale capital raise. This is because FC303, a diagnostic drug that recently received marketing authorization from the Ministry of Food and Drug Safety, is projected to serve as a cash cow going forward.

FC303, which has secured the title of Korea’s 43rd new drug, is the fourth prostate cancer diagnostic drug to be approved worldwide, following Blue Earth Diagnostics’ Posruma and others. FC303’s positive predictive value (PPV) reaches 86.96%. This is higher than the 81.9% PPV of Pillari-P, the global standard diagnostic agent from Lantheus. FC303 is competitive because it can detect even microscopic metastatic lesions that were difficult to identify with existing imaging tests such as computed tomography (CT) and magnetic resonance imaging (MRI).

FutureChem has already signed licensing and joint development agreements for FC303 in China and Europe and is currently conducting Phase 3 clinical trials. In the U.S. and Europe, prostate-specific membrane antigen (PSMA) positron emission tomography (PET) diagnostic agents have already established themselves as the standard of care. The fact that this is a blockbuster market with over 400,000 annual scans in the U.S. alone further enhances the value of FC303.

According to Business Research Insights, the global PSMA PET imaging and therapy market is expected to grow at a compound annual growth rate (CAGR) of 33.47%, expanding from $1.61 billion (approximately 2.44 trillion won) this year. Consequently, the market is projected to reach $21.71 billion (approximately 32.91 trillion won) by 2035.

A FutureChem official stated, “This will be our final round of fundraising,” adding, “We expect FC303 sales to begin in the domestic market starting in the second half of this year, and U.S. sales of prostate cancer diagnostic agents similar to FC303 amount to approximately 800 billion won. Rather than limiting ourselves to the domestic market, we are targeting the global market.”

Accelerating Development of Therapeutic Radiopharmaceuticals Based on Diagnostic Sales

FutureChem plans to

accelerate the development

of FC705

using

the funds raised and the revenue from FC303, which is expected to begin in the second half of this year. FC705 is currently undergoing a Phase 2a clinical trial in the U.S. and a Phase 3 clinical trial in Korea. Data from the U.S. Phase 2a trial is expected to be released in the second half of this year. The first dose for the Korean clinical trial was administered earlier this year.

Both FC303 and FC705 are based on a GUL (Glu-Urea-Lys) compound structure that identifies and binds to the PSMA protein, which is overexpressed in prostate cancer cells. The difference between the two lies in the radioactive isotope linked via a linker. Since the purpose of FC303 is to obtain PET images, it uses fluorine-18, which has a relatively short half-life. FC705, on the other hand, targets cancer cells directly and emits powerful beta rays, so it uses lutetium-177, which has a long half-life of approximately seven days.

In other words, since FC303 and FC705 share the same structure for locating and binding to proteins, FC705 is expected to be highly competitive, given the excellent efficacy demonstrated by FC303. If FC705 receives final approval, FutureChem will become Korea’s first comprehensive radiopharmaceutical company to offer both diagnosis and treatment in the field of prostate cancer.

This will enable an integrated “diagnosis-treatment-follow-up” solution: using FC303 to accurately confirm PSMA expression and lesion location in patients, administering FC705 to suitable patients for targeted therapy, and then using FC303 again to monitor the treatment response.

A FutureChem official stated, “FC705 is currently at a very critical stage of research and development,” adding, “The approval of FC705 will be a pivotal milestone in the process that extends from diagnosis with FC303 through to treatment.”