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D.Western Therapeutics Institute Inc. / Equity Bottom-Up

<ul><li>Major milestones with high expectations coming in the next 2-3 years: 1) Phase IIb US trials for H-1337 as “first choice as a second-line Glaucoma drug” for patients who do not respond to PGs</li><li>2) 2023 application, 2024 approval and 2025 launch of DW-1002 in Japan, 2023 application/approval/launch in China, as well as expedited development of combination formula MembraneBlue-DualR (DW-1002 + trypan blue) in the US [NEW]</li><li>3) clinical trials in 2024 in Japan and application for approval in 2025 of regenerative cell medicine DWR-2206 </li></ul>

Major milestones with high expectations coming in the next 2-3 years: 1) Phase IIb US trials for H-1337 as “first choice as a second-line Glaucoma drug” for patients who do not respond to PGs2) 2023 application, 2024 approval and 2025 launch of DW-1002 in Japan, 2023 application/approval/launch in China, as well as expedited development of combination formula MembraneBlue-DualR (DW-1002 + trypan blue) in the US [NEW]3) clinical trials in 2024 in Japan and application for approval in 2025 of regenerative cell medicine DWR-2206 

3Q Follow-Up - D. Western Therapeutics Institute (DWTI)  (4576 JP)

<ul><li>Major milestones with high expectations coming in the next 2-3 years: 1) Phase IIb US trials for H-1337 as “first choice as a second-line Glaucoma drug” for patients who do not respond to PGs, 2) 2023 application, 2024 approval and 2025 launch of DW-1002 in Japan, 2023 application/approval/launch in China, as well as expedited development of combination formula MembraneBlue-DualR (DW-1002 + trypan blue) in the US [NEW], 3) 2023 approval and subsequent 2024 launch of DW-5LBT lidocaine patch for treatment of neuropathic pain in the US, and 4) clinical trials in 2024 in Japan and application for approval in 2025 of regenerative cell medicine DWR-2206 [NEW].</li><li>Coming into the 3Q, DWTI announced 2 updates not included in its “Business Plan and Growth Potential.”</li><li>On 7/13, DWTI announced the development plan for regenerative cell medicine DWR-2206, aiming to submit a notification of clinical trial at the end of 2023, start clinical trials in 2024, and submit application for approval (NDA) in 2025 (using the expedited conditional and term-limited approval system for regenerative therapeutics).</li></ul>

Major milestones with high expectations coming in the next 2-3 years: 1) Phase IIb US trials for H-1337 as “first choice as a second-line Glaucoma drug” for patients who do not respond to PGs, 2) 2023 application, 2024 approval and 2025 launch of DW-1002 in Japan, 2023 application/approval/launch in China, as well as expedited development of combination formula MembraneBlue-DualR (DW-1002 + trypan blue) in the US [NEW], 3) 2023 approval and subsequent 2024 launch of DW-5LBT lidocaine patch for treatment of neuropathic pain in the US, and 4) clinical trials in 2024 in Japan and application for approval in 2025 of regenerative cell medicine DWR-2206 [NEW].Coming into the 3Q, DWTI announced 2 updates not included in its “Business Plan and Growth Potential.”On 7/13, DWTI announced the development plan for regenerative cell medicine DWR-2206, aiming to submit a notification of clinical trial at the end of 2023, start clinical trials in 2024, and submit application for approval (NDA) in 2025 (using the expedited conditional and term-limited approval system for regenerative therapeutics).

2Q Follow-Up - D. Western Therapeutics Institute (DWTI) (4576 JP)

<div><div><div><div><ul><li>DWTI announced that it has updated its development pipeline on DW-1002 licensee Dutch Ophthalmic Research Center (DORC) announcing its decision to develop MEMBRANEBLUE-DUAL® in the US for the indication of ILM and ERM membrane staining during vitreoretinal surgery.</li><li>Since the DW-1002 single-agent formulation TissueBlueTM was launched in the US in 2020, it has been used in over 100,000 surgeries and is preferred by over 40% of U.S. retinal surgeons.</li><li>Combination ophthalmic surgical aid MEMBRANE BLUE-DUAL® (DW-1002 Brilliant Blue G + Trypan Blue) has been used in over 500,000 surgeries in Europe since its launch in 2010. </li></ul></div></div></div></div>

DWTI announced that it has updated its development pipeline on DW-1002 licensee Dutch Ophthalmic Research Center (DORC) announcing its decision to develop MEMBRANEBLUE-DUAL® in the US for the indication of ILM and ERM membrane staining during vitreoretinal surgery.Since the DW-1002 single-agent formulation TissueBlueTM was launched in the US in 2020, it has been used in over 100,000 surgeries and is preferred by over 40% of U.S. retinal surgeons.Combination ophthalmic surgical aid MEMBRANE BLUE-DUAL® (DW-1002 Brilliant Blue G + Trypan Blue) has been used in over 500,000 surgeries in Europe since its launch in 2010. 

News Flash - D. Western Therapeutics Institute (4576 JP)

<ul><li>DWTI announced that out-license partner Dutch Ophthalmic Research Center (International) B.V. (DORC) has submitted a new drug application for approval of DW1002 to the National Medical Products Administration (NMPA) of China for the indication of ILM staining in vitreoretinal surgery (May 30 local time).</li><li>No milestone will be received as a result of this transaction, and there will be no change to the forecast of financial results for the fiscal year ending December 31, 2023.</li><li>DWTI granted an exclusive sublicense for DW-1002 for all regions worldwide outside Japan to DORC, which has been manufacturing and selling the product in Europe and other countries since September 2010.</li></ul>

DWTI announced that out-license partner Dutch Ophthalmic Research Center (International) B.V. (DORC) has submitted a new drug application for approval of DW1002 to the National Medical Products Administration (NMPA) of China for the indication of ILM staining in vitreoretinal surgery (May 30 local time).No milestone will be received as a result of this transaction, and there will be no change to the forecast of financial results for the fiscal year ending December 31, 2023.DWTI granted an exclusive sublicense for DW-1002 for all regions worldwide outside Japan to DORC, which has been manufacturing and selling the product in Europe and other countries since September 2010.

D. Western Therapeutics Institute (4576 JP) - News Flash

<ul><li>According to “Ophthalmology Drugs Global Market Report 2021: COVID 19 Impact and Recovery to 2030” issued by the Business Research Company in Feb-2021, the global ophthalmology drugs market is expected to grow from $22.03 billion in 2020 to $32.64 billion in 2025 (+8.2% CAGR).</li><li>M&amp;A in this segment has become active in recent years, with global eye care leader Alcon (SIX/NYSE:ALC) acquiring DWTI’s closest rival in the US, Aerie Pharmaceuticals, Inc. in Nov-2022, adding Rhopressa® (similar to DWTI’s GLANATEC®) among others, and Aerie’s development pipeline.</li><li>Over time with progress in execution of the development pipeline, and as part of growth strategy to diversify revenue streams, DWTI’s basic business model of drug discovery and early out-licensing has evolved to include 1) from 2015, in-licensing of later stage development products, 2) from 2018, collaborative drug creation applying DWTI’s technical expertise to assist in joint R&amp;D of products of other firms, and 3) from 2018, extending development of original in-house products beyond early out-licensing as far as proof of concept (PoC) through Phase IIb.</li></ul>

According to “Ophthalmology Drugs Global Market Report 2021: COVID 19 Impact and Recovery to 2030” issued by the Business Research Company in Feb-2021, the global ophthalmology drugs market is expected to grow from $22.03 billion in 2020 to $32.64 billion in 2025 (+8.2% CAGR).M&amp;A in this segment has become active in recent years, with global eye care leader Alcon (SIX/NYSE:ALC) acquiring DWTI’s closest rival in the US, Aerie Pharmaceuticals, Inc. in Nov-2022, adding Rhopressa® (similar to DWTI’s GLANATEC®) among others, and Aerie’s development pipeline.Over time with progress in execution of the development pipeline, and as part of growth strategy to diversify revenue streams, DWTI’s basic business model of drug discovery and early out-licensing has evolved to include 1) from 2015, in-licensing of later stage development products, 2) from 2018, collaborative drug creation applying DWTI’s technical expertise to assist in joint R&amp;D of products of other firms, and 3) from 2018, extending development of original in-house products beyond early out-licensing as far as proof of concept (PoC) through Phase IIb.

D. Western Therapeutics Institute (DWTI) (4576 JP) - 1Q Follow-Up

Japan

D.Western Therapeutics Institute Inc.(DWTI) is a biotechnology (bio-venture) company that focuses on development of new drugs. The Company's focus is on protein kinase inhibitors. DWTI discovers and develops several drugs, such as antiglaucoma, antihypertensive, neuroprotective, antithrombogenic, antiatherosclerosis and anticancer.

D.Western Therapeutics Institute Inc. (4576 JP)

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D.Western Therapeutics Institute Inc. (4576 JP)

3Q Follow-Up - D. Western Therapeutics Institute (DWTI) (4576 JP)

Major milestones with high expectations coming in the next 2-3 years: 1) Phase IIb US trials for H-1337 as “first choice as a second-line Glaucoma...

Sessa Investment Research

2Q Follow-Up - D. Western Therapeutics Institute (DWTI) (4576 JP)

Flurry of pipeline activity continuing in the 3Q. Expedited development plans for DWR-2206, dual formula DW-1002 in the US, and commenced dosing of...

Sessa Investment Research

News Flash - D. Western Therapeutics Institute (4576 JP)

DW-1002 licensee DORC announces decision to develop MEMBRANEBLUE-DUAL® in the US, received orphan drug designation from the US FDA for expedited...

Sessa Investment Research

D. Western Therapeutics Institute (4576 JP) - News Flash

DWTI announced that out-license partner Dutch Ophthalmic Research Center (International) B.V. (DORC) has submitted a new drug application for...

Sessa Investment Research

D. Western Therapeutics Institute (DWTI) (4576 JP) - 1Q Follow-Up

Development pipeline is steadily expanding FY23/12 initiatives: conducting H-1337 phase IIb trials in the US, DW-1002 approval/launch in China and...

Sessa Investment Research

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