Company: OSRH
Filing Date: 2025-01-31
Form Type: 424B3
Source: 0001213900-25-008874
Chunk: 292

Company: OSR Holdings, Inc.
Filing Date: 2025-01-31
Form: 424B3
Chunk 292
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    4.16 |     |    2.89 |     |    1.89 |     |     1.1 |     |     0.5 |

In addition to the foregoing, the BLAC M&A Committee noted that Darnatein conducted a clinical study in Korea as a Drug -DeviceConvergence Medical Product, a relatively new regulatory pathway implemented by the Ministry of Food and Drug Safety (MFDS) of Korea, of DRT102 (formerly known as AB204), a bone regenerative program also based on the DA BMP chimera platform for the treatment of spinal disorders. A confirmatory trial for DRT102 was conducted in three study sites in Korea, which includes the Seoul National University Hospital. This study was originally designed to be conducted with a patient group of n=154, however the trial experienced difficulties in recruiting patients during the Covid -19pandemic leading to a smaller patient group of 15. While the size of patient group of n=15 is too small to indicate the trial’s results in any statistically meaningful way, the clinical study report prepared by Dt&CRO Co., Ltd indicates that there was a 75% (bone fusion) success rate for the test group while the success rate for the control group was 28.57% with no signs of severe adverse effects observed from the 24 thweek post -operationsafety follow -upexaminations. However, the BLAC M&A Committee noted that the valuation report excluded DRT102 (with clinical data) from its valuation model because the DRT102 clinical trial was abandoned due to a lack of financial resources, leaving only DRT101, a preclinical asset, as the single source of cash flow projection. As mentioned above, the valuation model of Darnatein was built on projected cash flows solely from the company’s cartilage regenerative program (DRT101) over a long -termperiod of 30 years (2023 – 2052) with a total out -licensingvalue of USD 2.16 billion given the large addressable market (approximately $6.75 billion in 2020 estimated to reach $15.7 billion by 2030, according to Allied Markets Research 10) and no effective disease -modifyingOA drugs (DMOADs) approved by regulatory bodies so far 11. The projected period of 30 years is based on the patent -protectedperiod of 20 years 12which is followed by additional 10 years with scaling -downrevenues