[Edaily Reporter Kim Jinsoo ] On the 26th, shares of Cellid Co., Ltd.(299660) surged significantly in the pharmaceutical and biotech sector amid expectations for the announcement of clinical trial results for a vaccine currently in development. However, after the market closed, news of the failure of its Phase 3 clinical trial emerged, causing Cellid Co., Ltd. to close at the after-hours lower price limit. Furthermore, a decline on the next trading day is expected to be inevitable.

Shaperon Inc.(378800) Similarly, the stock price fell sharply for two consecutive trading days following news of the clinical trial failure. However, the company is hoping for a turnaround after unveiling strategies to continue the clinical trials.

#ROKIT HEALTHCARE Inc.’s stock price rose on news of smooth progress in R&D, the completion of an integrated medical platform combining AI-driven prediction, prevention, and regeneration, and reports that its subsidiary’s Nasdaq listing is imminent.

Cellid Co., Ltd.: Decline Inevitable Following Failure of Phase 3 COVID-19 Vaccine Trial

According to KG Zeroin’s MP Doctor (formerly Marketpoint), Cellid Co., Ltd.’s stock price closed at 2,785 won today—up 14.61% from the previous day—driven by anticipation of the announcement of clinical trial results for its COVID-19 vaccine candidate “AdCLD-CoV19-1 OMI.”

However, after the market closed, Cellid Co., Ltd. announced that it had failed to secure meaningful data from its Phase 3 clinical trial, causing the stock to close at 2,510 won in after-hours trading—a 9.87% decline from the regular market closing price.

On the 26th, Cellid Co., Ltd. announced that it had failed to demonstrate non-inferiority for the primary immunogenicity endpoint in the global Phase 3 clinical trial of its COVID-19 vaccine candidate, “AdCLD-CoV19-1 OMI.”

This clinical trial was conducted to demonstrate immunogenicity non-inferiority by administering either AdCLD-CoV19-1 OMI or Pfizer’s COVID-19 vaccine, “Comirnaty 2-dose,” to participants. The study involved 4,000 adults aged 19 and older.

The primary endpoint was “evaluation of immunogenicity through the confirmation of neutralizing antibodies and seroconversion rates.” The seroconversion rate (SRR)—the proportion of participants whose neutralizing antibody titers increased by at least fourfold compared to baseline—was 17.12% (139 out of 812) in the test group and 42.64% (171 out of 401) in the control group. The difference between the test group and the control group was –25.51%. Since this value is greater than the –10% non-inferiority margin specified in the clinical trial protocol, the test group failed to demonstrate non-inferiority compared to the control group.

However, in terms of safety, no serious adverse drug reactions were reported following vaccination with AdCLD-CoV19-1 OMI, and it was confirmed that the vaccine met the predicted safety profile.

AdCLD-CoV19-1 OMI had garnered attention as a purely domestically developed vaccine combining a proprietary adenovirus vector platform with antigen platform technology, but this clinical failure is expected to deal a significant blow to the project.

Cellid Co., Ltd. stated, “Based on the safety results we have obtained, we plan to continue developing a COVID-19 preventive vaccine, and we are reviewing various approaches for additional clinical trial designs and strategies to address the immunogenicity results.”

Shaperon Inc. Plummets for Two Consecutive Days Following Clinical Trial Failure

On that day

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Shaperon Inc.’s stock price fell 25.16% from the previous day to 568 won. Shaperon Inc. had also hit the daily price limit down on the previous trading day. The decline in Shaperon Inc.’s stock price is believed to be due to its failure to meet the primary endpoint in the Phase 2 clinical trial of its atopic dermatitis treatment currently under development.

On the 24th, Shaperon Inc. announced that its atopic dermatitis treatment candidate “NuGel” had failed to meet the primary endpoint in its global Phase 2b clinical trial.

NuGel is a non-steroidal topical treatment for atopic dermatitis developed using Shaperon Inc.’s GPCR19-based inflammatory complex modulation platform. Shaperon Inc. conducted a Phase 2 clinical trial in patients with mild to moderate atopic dermatitis, setting the degree of improvement in the EASI (Eczema Severity Assessment Index) at Week 8 compared to the placebo group as the primary endpoint.

According to the clinical results, the difference in the primary endpoint between the Nugel treatment group and the placebo group did not meet the pre-specified statistical significance level (two-sided 0.025).

Consequently, Shaperon Inc. plans to conduct additional analyses with a contract research organization (CRO) by September and establish a future development strategy in consultation with regulatory authorities and external experts.

Shaperon Inc. stated, “During the Phase 2b clinical trial, we provided patients with moisturizers for unrestricted use, which may have diluted the difference in efficacy,” adding, “We are also considering the introduction of a quasi-registrational study to review future approval strategies and the possibility of advancing to Phase 3 clinical trials.”

ROKIT HEALTHCARE Inc.: Stock Rises on Smooth R&D Progress and Expectations for Subsidiary’s NASDAQ

Listing
ROKIT HEALTHCARE Inc.’s stock price closed at 44,500 won today, up 11.25% from the previous day. Analysts attribute the rise to expectations of continued positive developments.

On the same day, Lee Seon-kyung, an analyst at SKSecurities, commented on ROKIT HEALTHCARE Inc., saying, “Key momentum is expected to continue in the second half of the year, including the kidney regeneration clinical trial and the signing of a formal agreement with Northwell Health in the U.S.” The analyst predicted that revenue growth would gain full momentum starting next year.

She noted that Rokit Healthcare recently announced the results of a four-year long-term follow-up clinical trial for cartilage regeneration and a three-year long-term follow-up trial for skin regeneration conducted in Egypt, and that the company received approval for the world’s first human clinical trial plan for kidney regeneration, demonstrating its technological capabilities and potential for expanding indications. Furthermore, he projected that momentum would continue, noting that the company signed a Mutual Confidentiality Agreement (MCA) with Northwell Health in the U.S. this past February and is currently in discussions aimed at finalizing a formal agreement in the second half of the year.

However, profitability is expected to remain under pressure this year due to increased investment in research and development. The analyst noted, “Although the company returned to profitability last year, it recorded an operating loss of 2.35 billion won in the first quarter of this year due to rising R&D expenses. Given the numerous clinical trials currently underway, R&D expenses are expected to continue rising for the time being.”

In other news, it was reported that the subsidiary “Rokit America” has completed the procedures related to the S-1 registration statement filed with the U.S. Securities and Exchange Commission (SEC) and has entered the final stage of its Nasdaq listing.

Rokit America’s estimated market capitalization at the time of listing is approximately 400 billion won. The company is currently conducting a bookbuilding process targeting overseas institutional investors and plans to proceed with the allocation of shares, determination of the offering price, and commencement of trading thereafter.

ROKIT HEALTHCARE Inc. official stated, “Rokit America’s Nasdaq listing will be the first among subsidiaries of KOSDAQ-listed biotech companies in Korea,” adding, “Based on the capital and global credibility secured through the Nasdaq Global Market listing, we will secure a leading position in the North American market and complete the commercialization of our technology in a timely manner to become a ‘first mover’ leading the global regenerative medicine market.”