DanDi Bioscience

​http://www.dailyinvest.kr/news/articleView.html?idxno=48369

This post has been translated from the original article dated 11/30/2022. 

Kiwoom Securities "If DD-S052P phase 1 clinical trial results are positive, profit of 1 trillion won as L/O" 

[Daily Invest = Reporter Lee Do-heun] Bio new drug development company HLB Science has signed a business agreement with bio company Theranochem. Theranochem is a company that develops intractable innovative new drugs based on original mitochondrial targeting platform technology. HLB Science is also accelerating the development of 'DD-S052P', a new drug candidate for sepsis treatment. Currently, phase 1 clinical trials are underway, and stock markets are evaluating that technology transfer (L/O) of DD-S052P to major domestic and foreign pharmaceutical companies is expected in the future. Attention is focusing on whether the stock price, which has been steadily declining since the end of May, can rebound.

HLB Science was established as Dandi Bioscience in April 2016 and listed on the KONEX market in April 2020. It changed its name to HLB Science in March of this year, and is engaged in the development of new bio drugs as its main business.

Infectious diseases (bacterial infectious sepsis, infection-induced Alzheimer's dementia) and autoimmune disease research results centered on immuno-anticancer drug delivery technology and vaccine efficacy enhancers are developed as innovative new drugs. Based on this, it was also xxxselected as a technology development project for prevention and treatment of infectious diseases by the Ministry of Health and Welfare in 2020.

Representative pipelines include DD-S052P and Alzheimer's treatment 'DD-A279'. They are treatments based on Dual Function Peptide (DFPep), and are in phase 1 clinical trials and candidate substance extraction stages, respectively.

HLB Science, which was traded at 5,300 won in early June, fell to 4,700 won in mid-June and then collapsed to 3,700 won in late June. After that, it fluctuated between 3700 and 3800 won until the end of July. In early August, the stock price rose slightly and rose to the 4,200 won level in mid-August. However, after immediately turning to a downward trend, it recently sank to the 2,800 won level. On the 29th, it closed at 2860 won, up 0.18% (5 won) from the previous day.

On the 9th, HLB Science announced that it had signed a research agreement with Theranochem, which has technology for synthesizing small-molecule drugs and mitochondria-targeted platforms. Through the agreement, HLB Science plans to develop anticancer drugs for various cancer types, including lung cancer and liver cancer, including triple-negative breast cancer, and enter clinical trials.

The contract partner, Theranochem, is the world's first antibiotic-based company that developed an anti-cancer drug that targets the difference in mitochondrial membrane potential.

Park Young-min, CEO of HLB Science, said, "Through cooperation with Theranochem, which has secured unrivaled platform technology related to mitochondria, we plan to discover powerful new drug substances that act on intractable cancer with high unmet demand." We will increase the corporate value through this.”

On September 23, it was announced that the results of basic and preclinical studies on DD-S052P would be presented in the form of a poster at the Korean Society for Molecular and Cell Biology (KSMCB) held at the Jeju International Convention Center.

The Korean Society for Molecular and Cell Biology (KSMCB) was held on September 28-30, and HLB Science said, "According to the preclinical results, an experiment using uninfected organs as a control removed bacteria from infected organs and reduced LPS and inflammatory cytokine levels. showed the effect of lowering it to a normal level."

On July 27, it announced that it had received approval from the French Ministry of Food and Drug Safety (ANSM) for a phase 1 clinical trial plan (IND) for DD-S052P for the development of new drugs for sepsis and gram-negative superbacterial infections. This was approved for clinical initiation in about a month after applying to ANSM for phase 1 clinical trial IND of DD-S052P on June 13.

Phase 1 clinical trial was conducted with 72 subjects at Eurofiins Optimed in France. and blood drug dynamics will be confirmed.”

CEO Park Young-min said, “Sepsis is a serious disease with a mortality rate of 30-50% because there is no cure, even though 11 million people die every year.” It can treat sepsis caused by

HLB Science recorded poor performance last year. There was no sales, and operating loss was 4.82 billion won, up 11.21% from 4.31781 billion won in the same period last year. The net loss for the current period was 5.05196 billion won, up 17.26% from 4.3839 billion won in the same period last year.

Nevertheless, the stock market is putting out a rather positive report on HLB Science. On the 10th, Kiwoom Securities analyzed that, in the case of DD-S052P, as it is planning L/O along with entering phase 1 clinical trial, future clinical results are attracting attention. It did not disclose a rating or target price.

“DD-S052P, a sepsis treatment, has an excellent therapeutic effect,” said Heohemin Kiwoom Securities Researcher. , suppression of cytokine storm, and prevention of organ failure, etc., improved the treatment effect of sepsis.”

“We are conducting phase 1 clinical trials for sepsis and super bacteria at the same time, and we have signed a clinical trial contract with Eurofins Optimed, a French global clinical trial agency,” he said. “Phase 2 clinical trials are planned for 2023, It seems that clinical trials will be conducted individually,” he added.

He said, “If positive results are confirmed in the phase 1 clinical trial of DD-S052P, L/O is expected for major domestic and foreign pharmaceutical companies.” It is expected to be around 114 billion won.”

“The global sepsis treatment market is expected to reach 8.7 trillion won in 2029, and we aim for a profit of 274 billion won, assuming that the ratio of the US and Europe target markets is 50% and HLB Science’s target securing ratio is 3.15%. “The global superbacteria treatment market is expected to reach 22.4 trillion won by 2030, and assuming that the target markets, the US and Europe, account for 75% and HLB Science’s share of the available market is 3.75%, we aim for a profit of 840 billion won. to,” he explained.

DD-A279, an Alzheimer's treatment, was evaluated as being aimed at fundamental treatment. According to researcher Heo, the original infection hypothesis of Alzheimer's was found in abnormal aggregation of amyloid beta and tau proteins, but HLB Science found the cause in endotoxin present in the outer wall of Gram-negative bacteria.

He said, “After the endotoxin present on the outer wall of Gram-negative bacteria passes through the Blood-Brain Barrier, the resulting abnormal amyloid beta-aggregated plaques destroy synapses, and Alzheimer's occurs. Accordingly, HLB Science is developing a treatment through direct gram-negative bacteria antibacterial and endotoxin control.” said.

He also mentioned ‘DD-A514’, an in vitro diagnostic kit for Alzheimer’s disease being developed by HLB Science. He said, “Existing Alzheimer’s diagnostic kits have limitations in being able to identify at the stage of symptom manifestation, so the need for early diagnosis has emerged.” “So, HLB Science developed a peptide-based drug that binds to Alzheimer’s biomarkers and endotoxin in the blood. We are developing a kit that can be diagnosed earlier than existing diagnostic kits by using materials.”

He added, "It has the advantage of being able to diagnose Alzheimer's early by finding the fundamental disease-causing factors through endotoxin diagnosis. In March of last year, we signed a cooperation contract with Pleasense, a diagnostic kit platform developer, and the development is in progress."

In the global Alzheimer's disease treatment, HLB Science's target profit was expected to be 880.4 billion won. Researcher Heo explained, “This is a profit calculated assuming that the global Alzheimer’s dementia treatment market is 12.4 trillion won in 2027, the target market, the US and Europe, accounts for 70%, and HLB Science accounts for 7.1% of the total market.” .

Source: Daily Invest (http://www.dailyinvest.kr)