Korea / Special Sits, Pairs, Index Rebalancing, Clepsydra Capital

Sanghyun Park

Korea / Special Sits, Pairs, Index Rebalancing

Equity Capital Markets

Kolon TissueGene  / Equity Capital Markets

<a href="https://www.smartkarma.com/entities/25907" target="_blank" data-smartkarma-citation="entities:25907:1">TissueGene Inc. (950160 KS)</a> is 'still' clearly saying that its Invossa (TG-C) has the following three significant features.<div class="content-highlight"><ol><li>Requires only a single injection (which is very convenient)</li><li>Regenerates cartilage (this is the most important and debatable point)</li><li>Treats osteoarthritis (this means Invossa makes you feel your OA pain less)</li></ol></div>Below is directly from TissueGene's corporate website. (Even now) the company is making it very clear that Invossa (again its codename is TG-C) not only relieves/improves knee pain/function but also restores cartilage.<div class="content-caption">(Courtesy TissueGene)</div><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/034/732/original/1.png?1506930304" class="editor-image img-responsive" data-smartkarma-image-id="34732"></figure>Restoring cartilage is the key word that has long branded the company. Obviously, lessening pain and treating disease itself are vastly different in terms of commercial value. TissueGene has garnered a lot of attention from the market mainly because its Invossa has long been thought to become a disease modifying drug for osteoarthritis (DMOAD for short).Unfortunately, this became exactly what caused the huge controversy that hit the market back in July. Even now, Invossa's true capability of 'cartilage regeneration' is still a source of concern. The Korea Ministry of Food and Drug Safety (MFDS) gave domestic marketing approval for TissueGene's Invossa back in July this year, but specifically mentioned that that there wasn't a 'sufficient amount of statistically meaningful data' that could prove the true efficacy of Invossa's 'cartilage regeneration'.<div class="content-highlight">What the Korea MFDS is basically saying is:Invossa is proven to be a pain killer for OA patients, but not a cartilage regenerator.* Below news article (written in English) is a good summary about this (from Business Korea).<a href="http://www.businesskorea.co.kr/english/news/industry/18637-gene-therapy-drug-kolon-life-science-sees-%E2%80%98invossa%E2%80%99-bear-fruit-19-years" target="_blank">http://www.businesskorea.co.kr/english/news/industry/18637-gene-therapy-drug-kolon-life-science-sees-‘invossa’-bear-fruit-19-years</a></div>

TissueGene Inc. (950160 KS) is 'still' clearly saying that its Invossa (TG-C) has the following three significant features.Requires only a single injection (which is very convenient)Regenerates cartilage (this is the most important and debatable point)Treats osteoarthritis (this means Invossa makes you feel your OA pain less)Below is directly from TissueGene's corporate website. (Even now) the company is making it very clear that Invossa (again its codename is TG-C) not only relieves/improves knee pain/function but also restores cartilage.(Courtesy TissueGene)Restoring cartilage is the key word that has long branded the company. Obviously, lessening pain and treating disease itself are vastly different in terms of commercial value. TissueGene has garnered a lot of attention from the market mainly because its Invossa has long been thought to become a disease modifying drug for osteoarthritis (DMOAD for short).Unfortunately, this became exactly what caused the huge controversy that hit the market back in July. Even now, Invossa's true capability of 'cartilage regeneration' is still a source of concern. The Korea Ministry of Food and Drug Safety (MFDS) gave domestic marketing approval for TissueGene's Invossa back in July this year, but specifically mentioned that that there wasn't a 'sufficient amount of statistically meaningful data' that could prove the true efficacy of Invossa's 'cartilage regeneration'.What the Korea MFDS is basically saying is:Invossa is proven to be a pain killer for OA patients, but not a cartilage regenerator.* Below news article (written in English) is a good summary about this (from Business Korea).http://www.businesskorea.co.kr/english/news/industry/18637-gene-therapy-drug-kolon-life-science-sees-‘invossa’-bear-fruit-19-years

TissueGene IPO Part 2 - Facts About Cartilage Regeneration & US Clinical Trial

What is Korea's hottest stock now? I guess many investors will have <a href="https://www.smartkarma.com/entities/22838" target="_blank" data-smartkarma-citation="entities:22838:1">SillaJen, Inc. (0908477D KS)</a> in their mind when asked this question. SillaJen's YTD return is a whopping 217%. Now, we have another SillaJen-like company that is about to test Korea's IPO market. It is <a href="https://www.smartkarma.com/entities/25907" target="_blank" data-smartkarma-citation="entities:25907:1">TissueGene Inc. (950160 KS)</a>. The company is actually based in Maryland, US. But this is a direct subsidiary of one of Korea's conglomerates named 'Kolon Group'. <a href="https://www.smartkarma.com/entities/9914" target="_blank" data-smartkarma-citation="entities:9914:1">Kolon Corp (002020 KS)</a> owns a 31.16% stake. In addition, Kolon Corp's largest single shareholder and Kolon Group chairman Lee Woong-ryeol owns a 20.38% stake. Another Kolon affiliate company called <a href="https://www.smartkarma.com/entities/4805" target="_blank" data-smartkarma-citation="entities:4805:1">Kolon Life Science Inc (102940 KS)</a> owns a 14.37% stake. So, Kolon Group currently controls a total of 71.13% stake in TissueGene.So, what does exactly this company do?Founded in 1999, the company basically develops medicines for the treatment of various orthopedic disorders (also called osteoarthritis or simply OA).<div class="content-caption">(Osteoarthritis - The photo below is taken from TissueGene's corporate website)</div><figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/034/068/original/2.png?1505986750" class="editor-image img-responsive" data-smartkarma-image-id="34068"></figure>Then, what's so special about this company?Well, TissueGene's approach is a bit unique and different. The company employs a form of cell therapy to deliver therapeutic proteins directly to localized areas of damaged tissue. In a simple phrase? It is developing regenerative therapies for the treatment of various orthopedic disorders. Below is its product pipeline. It now has four products in its pipeline. But the only thing that matters at this point is TG-C (INVOSSA™), which is for cartilage regeneration.<figure class="editor-figure mceNonEditable"><img src="https://static-prod.smartkarma.com/images/media/000/034/069/original/1.jpg?1505987138" class="editor-image img-responsive" data-smartkarma-image-id="34069"></figure>What is the progress of Invossa clinical trial and commercialization?Two months ago, Kolon Life Science, TissueGene’s exclusive licensee for Asia including Korea, received marketing approval for Invossa from  the Korea Ministry of Food and Drug Safety (MFDS). In fact, this is the world's first cell and gene therapy for degenerative arthritis. Yes, all of Invossa's clinical trials in Korea are completed and is ready to hit the market later next month.<div class="content-highlight">More about this, here is TissueGene's official press release.<a href="http://www.tissuegene.com/download/TGI%20PR_Invossa_Korea_approval%2007122017%20final_PRpage.pdf" target="_blank">http://www.tissuegene.com/download/TGI%20PR_Invossa_Korea_approval%2007122017%20final_PRpage.pdf</a></div>In the US, Invossa is currently in Phase III clinical trials. TissueGene plan to use the results of Phase III clinical trials to seek a DMOAD designation for Invossa from the US FDA). What does this mean? Invossa has a chance to become the world's first cell and gene therapy for osteoarthritis of the knee. TissueGene plans to complete Phase III clinical trials by 2021, and obtain BLA approval by 2022 and go on sale in the US in 2023.<div class="content-highlight">BTW, in Japan, Kolon Life Science signed a sub-license agreement with Mitsubishi Tanabe Pharmaceutical Corporation, and Mitsubishi Tanabe Pharma is proceeding with the preparation of clinical trials through its exclusive development and commercialization rights in Japan. Target year for Invossa commercialization in Japan is 2023 as well.</div>

What is Korea's hottest stock now? I guess many investors will have SillaJen, Inc. (0908477D KS) in their mind when asked this question. SillaJen's YTD return is a whopping 217%. Now, we have another SillaJen-like company that is about to test Korea's IPO market. It is TissueGene Inc. (950160 KS). The company is actually based in Maryland, US. But this is a direct subsidiary of one of Korea's conglomerates named 'Kolon Group'. Kolon Corp (002020 KS) owns a 31.16% stake. In addition, Kolon Corp's largest single shareholder and Kolon Group chairman Lee Woong-ryeol owns a 20.38% stake. Another Kolon affiliate company called Kolon Life Science Inc (102940 KS) owns a 14.37% stake. So, Kolon Group currently controls a total of 71.13% stake in TissueGene.So, what does exactly this company do?Founded in 1999, the company basically develops medicines for the treatment of various orthopedic disorders (also called osteoarthritis or simply OA).(Osteoarthritis - The photo below is taken from TissueGene's corporate website)Then, what's so special about this company?Well, TissueGene's approach is a bit unique and different. The company employs a form of cell therapy to deliver therapeutic proteins directly to localized areas of damaged tissue. In a simple phrase? It is developing regenerative therapies for the treatment of various orthopedic disorders. Below is its product pipeline. It now has four products in its pipeline. But the only thing that matters at this point is TG-C (INVOSSA™), which is for cartilage regeneration.What is the progress of Invossa clinical trial and commercialization?Two months ago, Kolon Life Science, TissueGene’s exclusive licensee for Asia including Korea, received marketing approval for Invossa from  the Korea Ministry of Food and Drug Safety (MFDS). In fact, this is the world's first cell and gene therapy for degenerative arthritis. Yes, all of Invossa's clinical trials in Korea are completed and is ready to hit the market later next month.More about this, here is TissueGene's official press release.http://www.tissuegene.com/download/TGI%20PR_Invossa_Korea_approval%2007122017%20final_PRpage.pdfIn the US, Invossa is currently in Phase III clinical trials. TissueGene plan to use the results of Phase III clinical trials to seek a DMOAD designation for Invossa from the US FDA). What does this mean? Invossa has a chance to become the world's first cell and gene therapy for osteoarthritis of the knee. TissueGene plans to complete Phase III clinical trials by 2021, and obtain BLA approval by 2022 and go on sale in the US in 2023.BTW, in Japan, Kolon Life Science signed a sub-license agreement with Mitsubishi Tanabe Pharmaceutical Corporation, and Mitsubishi Tanabe Pharma is proceeding with the preparation of clinical trials through its exclusive development and commercialization rights in Japan. Target year for Invossa commercialization in Japan is 2023 as well.

TissueGene IPO Part 1 - IPO Prospectus Summary

United States

Kolon TissueGene, Inc. operates as a biopharmaceutical company. The Company develops novel advanced orthopedic disorders cell therapies, novel cell and gene therapies drugs, and other related products. Kolon TissueGene offers services worldwide.

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Kolon TissueGene (950160 KS)

TissueGene IPO Part 2 - Facts About Cartilage Regeneration & US Clinical Trial

TissueGene Inc. (950160 KS) is 'still' clearly saying that its Invossa (TG-C) has the following three significant features. Requires only a single...

Sanghyun Park

TissueGene IPO Part 1 - IPO Prospectus Summary

What is Korea's hottest stock now? I guess many investors will have SillaJen, Inc. (0908477D KS) in their mind when asked this question. SillaJen's...

Sanghyun Park

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