[Edaily Reporter KIM SUNG-JIN ] Attention is focusing on the reasons behind the sharp rise in clinical development costs at Voronoi, Inc.(310210), a developer of new lung cancer drugs, even though the company reduced its target patient enrollment for global clinical trials by about 35%. While Voronoi, Inc. maintains that it needed additional funding due to a higher-than-expected number of patient enrollment requests from overseas medical professionals, some observers point out that it is difficult to understand why costs actually increased despite the significant reduction in the target patient enrollment.

Pushing for

80 Billion Won in Convertible Bonds… “Demand for Global Clinical Trial Participation Exceeds Expectations”

According to industry sources on the 28th, Voronoi, Inc. is moving forward with the issuance of

convertible bonds

(CBs) worth approximately 80 billion won. Following last year’s fundraising of over 130 billion won, the company’s renewed efforts to secure external funding have led to assessments that the financial burden of its in-house new drug development is growing.

The funds raised this time are scheduled to be used for the global clinical development of “VRN11 (VRN110755),” the company’s flagship drug candidate. VRN11 is a fourth-generation lung cancer treatment that targets epidermal growth factor receptor (EGFR) mutations. It is being developed for patients with non-small cell lung cancer (NSCLC), ranging from those who have developed resistance to Tagrisso (generic name: osimertinib), an existing EGFR-targeted therapy, to treatment-naive patients.

Voronoi, Inc. received approval for a Phase 1 clinical trial of VRN11 in South Korea in 2023 and has since been conducting global clinical trials. In the Phase 1a trial, the company evaluated safety and initial efficacy while gradually increasing the dosage. Development is currently expanding to a Phase 1b trial to determine the optimal dose and a Phase 2 trial to further validate therapeutic efficacy.

Early clinical results are positive. According to the Phase 1 clinical trial results presented by Voronoi, Inc. today at the European Society for Medical Oncology (ESMO), objective responses were observed in 7 out of 8 patients with the C797S resistance mutation. The objective response rate was 87.5%, and the median progression-free survival was 11 months.

Among 20 C797S-negative patients with brain metastases, the intracranial disease control rate was 95%. Of these, four patients achieved complete remission, with their brain lesions completely disappearing. However, as these are early clinical results based on a limited number of patients, analysts suggest that the treatment’s efficacy and safety must be verified in a larger patient population.

Target Enrollment Reduced from 391 to 255… Clinical Costs Actually Surge

Notably, Voronoi, Inc. recently significantly reduced the target patient enrollment for its clinical trial. Last September, Voronoi, Inc. applied for approval to amend the clinical trial protocol, changing the target enrollment for the global Phase 1/2 trial of VRN11 from 391 to 255 patients. This represents a reduction of 136 patients (34.8%) compared to the original plan.

However, this directly contradicts Voronoi, Inc.’s explanation that the recent push for fundraising was driven by an increase in the number of clinical trial patients. This is because, despite announcing the reduction in the clinical trial plan through a public disclosure, the company is now claiming that the need for fundraising has actually grown due to a recent rise in the number of patients.

In response, Voronoi, Inc. maintains that the reduction in the target number of clinical trial participants and the actual increase in clinical development costs should be viewed separately. The company explains that while the target number of participants stated in the clinical trial plan represents the overall plan—including patients to be recruited in the future—actual costs can vary depending on the stage of the trial, the pace of patient enrollment, and the operational conditions at trial sites.

Voronoi, Inc. official explained, “The target number of patients stated in the regulatory filing represents a rough estimate of the total number of patients to be enrolled when the clinical trial is submitted,” adding, “We make adjustments based on the situation as the actual trial progresses.”

The representative added, “The recent increase in the number of clinical trial patients is separate from the overall plan that was scaled back this time; rather, it stems from a higher-than-expected number of patient enrollment requests from global principal investigators (PIs) in the currently ongoing clinical phase, which has led to an increase in the funding required to proceed with the trial.” Currently, Voronoi, Inc. is conducting clinical trials at 29 sites across 10 countries, including South Korea, Taiwan, Malaysia, Spain, and France.

Growing Financial Burden from In-House Clinical Trials… Timing of Technology Transfer Is Key

The issue is that significant funding may still be required going forward. The VRN11 Phase 1 safety analysis presented by Voronoi, Inc. on the 27th at the European Society for Medical Oncology (ESMO) included a total of 82 subjects. Compared to the original target patient count of 255, as stated in the amendment application, this represents approximately 32 percent, meaning there is still a recruitment target of more than 170 patients remaining.

Above all, given that Voronoi, Inc. recently scaled back the overall clinical trial size, it is estimated that even more funding would have been required had the company maintained its original plan.

Consequently, there is interest in when Voronoi, Inc. might pursue a technology transfer. While Voronoi, Inc. has previously licensed out candidate compounds at relatively early stages, the company has pursued a strategy for VRN11 of retaining global rights and enhancing its value through in-house clinical trials. Although the intent is to increase the scale of the technology transfer agreement based on early clinical results, the structure of the project means that the costs the company must bear directly increase as development continues.

Voronoi, Inc. maintains that it is currently in discussions with global pharmaceutical companies regarding technology transfer. A Voronoi, Inc. official stated regarding the technology export plan, “Several major global pharmaceutical companies are currently showing interest, and discussions are underway.”

While some market observers have speculated that Voronoi, Inc. initially planned to raise 130 billion won but later scaled back the amount, the company has denied these claims, calling them “groundless.”