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

D.Western Therapeutics Institute Inc. (4576 JP)

<ul><li>DWTI announced that ophthalmic surgical aid product “DW-1002” has been approved by the National Medical Products Administration (NMPA) in China for the indication of staining of the internal limiting membrane (ILM) during vitreous surgery, as reported by the Company’s sublicensee Dutch Ophthalmic Research Center International B.V. (DORC).</li><li>This drug is already being sold in 76 countries and regions around the world, including Europe and the United States, and sales are progressing favorably.</li><li>The graph below shows the annual trend of DW-1002 royalty income to DWTI from DORC. In China, it is scheduled to be launched under the product name ILM-BlueⓇ</li></ul>

DWTI announced that ophthalmic surgical aid product “DW-1002” has been approved by the National Medical Products Administration (NMPA) in China for the indication of staining of the internal limiting membrane (ILM) during vitreous surgery, as reported by the Company’s sublicensee Dutch Ophthalmic Research Center International B.V. (DORC).This drug is already being sold in 76 countries and regions around the world, including Europe and the United States, and sales are progressing favorably.The graph below shows the annual trend of DW-1002 royalty income to DWTI from DORC. In China, it is scheduled to be launched under the product name ILM-BlueⓇ

4576 JP - Notice of Approval of Ophthalmic Surgical Aid “DW-1002” in China

<ul><li>In light of recent performance trends, DWTI has revised its initial earnings forecasts announced on February 9, 2024.</li><li>In addition, the Company is recording an extraordinary loss in its non-consolidated financial results for the fiscal year ending December 2024.</li><li>Net sales are expected to increase due to strong royalty income from ophthalmic surgical aid “DW-1002” in Europe, the United States, etc.</li></ul>

In light of recent performance trends, DWTI has revised its initial earnings forecasts announced on February 9, 2024.In addition, the Company is recording an extraordinary loss in its non-consolidated financial results for the fiscal year ending December 2024.Net sales are expected to increase due to strong royalty income from ophthalmic surgical aid “DW-1002” in Europe, the United States, etc.

4576 JP - Announced Revisions to FY24/12 Earnings Forecasts

<ul><li>For H-1337, DWTI completed dosing of subjects in the Phase IIb clinical trial in August, and top-line data was announced on November 18.</li><li>All three doses of H- 1337 achieved clinically and statistically significant decreases of up to 30% in intraocular pressure (IOP) which was in the same range as the positive control, existing beta-blocker timolol (p &lt;0.001), and DWTI expects H-1337 will proceed to Phase 3 study based on these results (see P10 for details).</li><li>For DWR-2206, DWTI submitted a notification of clinical trial plan for domestic Phase II clinical trials to the PMDA in March, and the transplant for the first subject was performed in July.</li></ul>

For H-1337, DWTI completed dosing of subjects in the Phase IIb clinical trial in August, and top-line data was announced on November 18.All three doses of H- 1337 achieved clinically and statistically significant decreases of up to 30% in intraocular pressure (IOP) which was in the same range as the positive control, existing beta-blocker timolol (p &lt;0.001), and DWTI expects H-1337 will proceed to Phase 3 study based on these results (see P10 for details).For DWR-2206, DWTI submitted a notification of clinical trial plan for domestic Phase II clinical trials to the PMDA in March, and the transplant for the first subject was performed in July.

D. Western Therapeutics Institute (DWTI) (4576 JP) - Q3 Follow-Up

<ul><li>DWTI announced topline results from its Phase 2B clinical trial of its H-1337 Ophthalmic Solution, for the treatment of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.</li><li>This study was a double-masked, active- controlled, dose-response study in 201 subjects with primary open-angle glaucoma or ocular hypertension, where subjects were dosed for 28 days during the period from August 2023 – August 2024.</li><li>The study was designed to evaluate the ocular safety and hypotensive efficacy of three doses of multi-kinase inhibitor H-1337 Ophthalmic Solution: 0.6% twice-daily, 1.0% twice daily, and 1.0% once-daily. </li></ul>

DWTI announced topline results from its Phase 2B clinical trial of its H-1337 Ophthalmic Solution, for the treatment of elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.This study was a double-masked, active- controlled, dose-response study in 201 subjects with primary open-angle glaucoma or ocular hypertension, where subjects were dosed for 28 days during the period from August 2023 – August 2024.The study was designed to evaluate the ocular safety and hypotensive efficacy of three doses of multi-kinase inhibitor H-1337 Ophthalmic Solution: 0.6% twice-daily, 1.0% twice daily, and 1.0% once-daily. 

D. Western Therapeutics Institute (4576 JP) - News Flash - November 19, 2024

<ul><li>DWTI announced that the first transplant was performed in a domestic Phase II clinical study of DWR-2206 (Indication: bullous keratopathy, see Note 1 below), a regenerative medicine cell product being developed jointly by DWTI and ActualEyes Inc., and as a result of the follow-up monitoring, the safety of DWR-2206 has been confirmed in order to proceed to a second and subsequent transplants.</li><li>This study is being conducted to evaluate the safety and efficacy of DWR-2206 transplants in patients with bullous keratopathy.</li><li>The first transplant took place in July 2024, and the patient’s progress since the transplant has been smooth. </li></ul>

DWTI announced that the first transplant was performed in a domestic Phase II clinical study of DWR-2206 (Indication: bullous keratopathy, see Note 1 below), a regenerative medicine cell product being developed jointly by DWTI and ActualEyes Inc., and as a result of the follow-up monitoring, the safety of DWR-2206 has been confirmed in order to proceed to a second and subsequent transplants.This study is being conducted to evaluate the safety and efficacy of DWR-2206 transplants in patients with bullous keratopathy.The first transplant took place in July 2024, and the patient’s progress since the transplant has been smooth. 

D. Western Therapeutics Institute (4576 JP) - News Flash - Sep 5, 2024

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.

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D.Western Therapeutics Institute Inc. (4576 JP)

4576 JP - Notice of Approval of Ophthalmic Surgical Aid “DW-1002” in China

The graph below shows the annual trend of DW-1002 royalty income to DWTI from DORC. In China, it is scheduled to be launched under the product name...

Sessa Investment Research

4576 JP - Announced Revisions to FY24/12 Earnings Forecasts

Net sales are expected to increase due to strong royalty income from ophthalmic surgical aid “DW-1002” in Europe, the United States, etc.

Sessa Investment Research

D. Western Therapeutics Institute (DWTI) (4576 JP) - Q3 Follow-Up

For H-1337, DWTI completed dosing of subjects in the Phase IIb clinical trial in August, and top-line data was announced on November 18.

Sessa Investment Research

D. Western Therapeutics Institute (4576 JP) - News Flash - November 19, 2024

DWTI announced topline results from its Phase 2B clinical trial of its H-1337 Ophthalmic Solution, for the treatment of elevated intraocular...

Sessa Investment Research

D. Western Therapeutics Institute (4576 JP) - News Flash - Sep 5, 2024

DWTI announced that the first transplant was performed in a domestic Phase II clinical study of DWR-2206 (Indication: bullous keratopathy)

Sessa Investment Research

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