[Photo and Text by Lee Daily Reporter Lim Jeong-yeo ] “I believe this will be our final attempt at an IPO. We are approaching this very cautiously, with the mindset that there will be no more chances.” (Choi Seong-gu, President of FINO INC.)

PinoBio, a developer of new antibody-drug conjugate (ADC) therapies, is making another attempt to list on the KOSDAQ market in the second half of this year. Having prepared all the human proof-of-concept data and technology transfer records that were previously flagged during last year’s technology evaluation stage, the company is going all out this time. As this marks FINO INC.’s fourth attempt at a KOSDAQ IPO since 2021, the stakes are particularly high. E-Daily’s premium pharma and biotech content platform, Pharm E-Daily, met with FINO INC.’s clinical and business development executives to discuss the company’s roadmap moving forward.

Appointment of President Choi Seong-gu to Strengthen Clinical Capabilities

FINO INC. strengthened its clinical development capabilities last October by appointing President Choi Seong-gu as Chief Medical Officer (CMO). The company determined that he was an indispensable figure for sustaining research and development (R&D) even after going public.

President Choi is a board-certified psychiatrist who earned his bachelor’s degree in medicine from Seoul National University and his master’s degree in medicine from Chungbuk National University. President Choi began his career at Johnson & Johnson, where he worked for 15 years. He gained extensive experience spanning Phase 1 through Phase 3 clinical development, as well as sales and marketing, while serving in roles at Johnson & Johnson’s Korean office, its U.S. headquarters, as Head of the Asia-Pacific Region, and later as Head of the Korean Business Unit.

The areas Mr. Choi was responsible for at Johnson & Johnson, categorized by indications, were diverse and included △oncology △central nervous system (CNS) disorders △viral diseases △and the entire tuberculosis business unit. Subsequently, Mr. Choi served as Director of Medical Affairs at the National Center for Mental Health under the Ministry of Health and Welfare, gaining experience in the government sector. From 2018 to 2024, Mr. Choi served as President of ILDONG PHARM(249420) and CEO of Unovia, Il Dong’s new drug development subsidiary, where he was responsible for research and development, including early-stage compound discovery.

After leaving ILDONG PHARM, CEO Choi briefly ran a private psychiatry practice before joining FINO INC. as an outside director through an introduction by an investor in the company; he subsequently took on the role of CMO.

“At Johnson & Johnson, I gained extensive experience in clinical development (the back end), and at ILDONG PHARM, I focused on compound discovery (the front end),” he said. “ILDONG PHARM developed both small molecules and antibodies. I built a professional network through collaborations with global companies, and all of this is proving helpful at FINO INC.”

He continued, “Initially, I was recommended to serve as an outside director. Upon reviewing FINO INC., I noticed that while resources were concentrated on research, there was a noticeable shortage of personnel in regulatory and clinical affairs.” He explained, “I joined to establish a division of labor: Founder and CEO Jeong Doo-young would oversee research, while I would handle business development (BD)—including technology transfer—as well as attracting new investments and recruiting talent.”

Preparing for Clinical Trials of In-House Pipeline Candidate PBX-004

FINO INC.’s commercialization achievements to date have centered on technology transfers of its platform. Under these agreements, partner companies directly utilize FINO INC.’s platform to discover and develop their own drug candidate pipelines; as a result, the upfront payments received by FINO INC. are relatively small, and it takes a long time to receive milestone-based technology fees.

FINO INC. is currently developing its own drug pipeline (assets) to enable the signing of technology agreements on a larger scale. Its most advanced in-house ADC pipeline, PBX-004, is currently undergoing Good Laboratory Practice (GLP)-compliant toxicity testing. The indication is squamous non-small cell lung cancer, and the drug is set to enter Phase 1 clinical trials next year as a fourth-line treatment.

CEO Choi stated, “We have a lot of work to do. We need to secure funding and prepare for an initial public offering (IPO).” He added, “At the same time, we must build a backup pipeline in addition to our lead drug pipeline. We currently have a staff of 16, but we will need to expand this team as well.”

FINO INC.’s most recent funding round was a 130억 won pre-IPO equity investment round completed last October. At that time, the company raised funds at a price of 1만8000 won per share. As of the end of last year, FINO INC. held 14.5 billion won in cash. A company official said, “FINO INC. has plans to expand its workforce and proceed with clinical trials for PBX-004. We plan to conduct the Phase 1 clinical trial in Korea and are also considering China.”

Once PBX-004 enters Phase 1 clinical trials, the company plans to pursue a technology transfer agreement that would secure a significant upfront payment. The company believes that securing a substantial technology transfer agreement would provide strong momentum for its IPO efforts.

He said, “We are currently deliberating on whether to apply for a technology evaluation by highlighting that we have reached a cumulative total of 10 billion won through milestone payments received from Celltrion(068270)and various smaller deals, or whether to pursue successful global business development using PBX-004, which employs the same platform technology that Celltrion utilized.”

He added, “With ADCs, even a single misstep in production can result in a loss of several months,” noting that “PBX-004 targets integrin beta-6 (ITGB6) and uses a topoisomerase 1 (TOP1) payload.”

He continued, “Since there are competitors in the global market—such as Sutro and Seegene Inc.—that are ahead in terms of speed, we intend to use a reliable contract manufacturing organization (CMO) to ensure there are no delays, however minor.”

PinoBio’s shareholder base consists of approximately 20 financial investors (FIs), including △Shinhan Venture Investment △Stonebridge Ventures, Inc. △BNH Investment △IMM Investment △KB Investment △Yuanta Investment △Union Investment Partners. Strategic investors (SI) include △AHN-GOOK PHARMACEUTICAL Co., Ltd.(001540) △ST Pharm Co., Ltd.(237690) △Lotte Biologics △HK inno.N Corporation(195940) △Celltrion(068270).

Celltrion to Announce Clinical Data in Q3–Q4

FINO INC.’s technology transfer partner, Celltrion(068270), will release Phase 1 clinical data between September and October. FINO INC. is indirectly validating the technical capabilities of its ADC platform through Celltrion.

Previously, in October 2022, FINO INC. licensed its Pino-ADC platform to Celltrion for a total of $1.242 billion (approximately 1.9 trillion won), including an upfront payment of 1 billion won. Celltrion has secured a technology license option allowing it to apply FINO INC.’s linker-payload platform technology to up to 15 targets. To date, Celltrion has identified and is conducting R&D on four pipeline candidates.

Specifically, the pipeline candidates that Celltrion has advanced to clinical trials using FINO INC.’s platform are identified as △CT-P70 (cMET ADC), △CT-P71 (Nectin4 ADC), and △CT-P73 (TF ADC). Once Phase 1 clinical trials are completed, Celltrion will pay additional milestone royalties to FINO INC. Furthermore, Celltrion will obtain data confirming that FINO INC.’s linker-payload is safe and effective in humans.

CEO Choi stated, “The biggest concern with ADCs is that we cannot know in advance whether the drug will work properly in humans,” adding, “It is daunting—and requires enormous funding—to verify, after administering the drug to humans, whether the linker cleaves as confirmed in preclinical studies and whether the mechanism functions as expected within the cells.”

He added, “In animal models where tumors are artificially created by implanting cancer cells, the cancer tissue forms acutely, so the area is rich in blood vessels and there is no surrounding fibrosis.” He continued, “Most drugs show good results in these models. However, real cancer in the human body has been growing for decades, so it has developed various defense mechanisms—such as mechanisms to neutralize the immune system and fibrosis—over that time. This is why it is difficult to translate findings from animals to humans,” he said.

He also noted, “Currently, Celltrion is successfully conducting dose escalation trials in cancer patients using PinoBio’s linker and payload,” adding, “Celltrion’s Phase 1 completion announcement, expected in the second half of this year, is significant not only because it will generate milestone royalty payments for PinoBio but also because it will prove that our linker-payload system works in humans.”

Finally, he said, “Since the subjects entering the Phase 1 clinical trial are very late-stage cancer patients who have failed other treatments, I don’t have high expectations,” adding, “Still, even if we see a partial remission that extends survival, it would be a valuable result.”