Note:This document has been translated from the Japanese original for reference purposes only. In the event of any
discrepancy between this translated document and the Japanese original, the original shall prevail.

Q2 FY12/24
Financial Results Briefing Materials
August 9, 2024
D. Western Therapeutics Institute, Inc.
Stock Code: 4576
Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved.

Table of Contents
1. Q2 FY12/24 Financial Results
2. Progress of Business in FY12/24
3. FY12/24 Forecast(Reference) Business Overview

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2

1. Q2 FY12/24 Financial Results
January 1 – June 30, 2024

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3

Consolidated Statement of Income (vs. full-year forecast)（JPYmn）

FY 12/23

FY 12/24
YOYchange1H results

FY results

1H results

Net sales

187

428

223

35

SG&A expenses

431

1,190654

223

FY forecast(out Feb.13)

400

Primary factors

55.9％ • Storong royalties for DW-1002 andGLANATEC FAMILY• Development expenses for H-1337
was less than expected. It will be
32.6％
expensed upon completionR&D expenses

294

930

521

226

Other SG&Aexpenses

136

259

133

(3)

Operating loss

(258)

(798)

(449)

(191)

(1,500)－Ordinary loss

(254)

(796)

(459)

(204)

(1,510)－(1,510)• Loss on redemption of convertible
bonds of JPY60mn in extraordinary－losses

Loss attributable toowners of parent for
the interim period(247)

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(812)

(520)

1,600

Progress(272)
5

Consolidated Statement of Income
As of June 30, 2024
(change compared to December 31, 2023)（JPYmn）
Current liabilities

95（-98）Cash and deposits

 Declined due mainly to R&D expenditures
 Funding for immediate business development activities is secured., supported inpart by the exercise of Series 12 Stock Acquisition Rights

Supplies

 JPY260mn increase in advance payments to suppliers due to H-1337
development

Cash and deposits

1,301（-566）

Non-current assets
Non-current liabilities

1,113（+214）

 JPY20mn in amortization of intangible assets related to the licensing agreementfor DW-1002 (Europe)

Current liabilities

 JPY112mn decline in accounts payable due to H-1337 and DWR-2206
development costs
 JPY9mn increase in current portion of long-term borrowings

Non-current liabilities
Accounts
receivable trade
Other current
assetsNon-current
assets123（+6）423（＋269）
217（-17）

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Net assets
856（-423）

 JPY160mn increase in long-term borrowings due to loans to fund thedevelopment of DWR-2206
 JPY53mn increase due to difference between issuance of bonds payable ofJPY660mn and redemption of convertible bonds of JPY60mnNet assets

 Recorded a loss attributable to owners of parent of JPY520mn
 Recorded JPY45mn each in capital and capital reserves due to exercise of stockacquisition rights
62. Progress of Business in FY12/24

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9

Development Pipeline in 2024 1H
products on market
GLANATEC®（Single drug）
GLA-ALPHA®（Combination drug）

RegionCurrent state

Japan, Asia
Japan

Decrease slightly due to launch of compounded drugs
Launched in December 2022, Strong sales

DW-1002（Single drug）

Europe, U.S.

Strong due to yen depreciation

DW-1002（Combination drug）

Europe, etc.

Strong due to yen depreciation

ProductsK-321

Non-clinical

P-I

P-Il

P-Ill

U.S., etc.
Combination

DW-1002

RegionSingleApplication Approval

Current state
Global Phase III ongoing

U.S.
ChinaRegulatory review underway

Japan

Negotiations with the regulatory authority andexamination underway for application filing

DW-1001Japan

H-1337

U.S.

Phase IIb ongoing

DW-5LBT

U.S.

Reapplied in January 2024, received CRL inJuly

DWR-2206

Japan

Submitted a Clinical Trial plan Notification forPhase II in March

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102-1．Successful launch (commercialization)

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2-2．Development Pipeline

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14Regenerative Cell Therapy DWR-2206
 Submitted a Clinical Trial plan
Notification for Phase II in Japan

Phase II trial design Published on jRCT on June 11,2024 (jRCT2043240040)
Overview:

Joint development productTargeting bullous keratopathy, cultured human corneal
endothelial cells and a suspension containing ROCK
inhibitor are injected into the anterior chamber of the eye
to regenerate corneal endothelium

Warmed to thaw,
and injected

Frozen corneal endothelial
cell preparation

Cultured corneal
endothelial cells＋ROCK inhibitor Multi-center, open-label, uncontrolled study to determine
the safety and efficacy of DWR-2206 in patients withbullous keratopathy
Target numberof patients

6Evaluation andmonitoring
period48 weeks after transplantation of the investigational productPrimary
endpoints

Number of cases and incidence rate (%) of adverse eventsand adverse events that cannot be ruled out as related to theinvestigational productSecondaryendpoints

・Monitoring and evaluation of safety endpoints
・Number and incidence rate (%) of significant adverse
events・Improvement in visual acuity at 24 weeks after
transplantation of the investigational product・Change in best corrected visual acuity over time
・Change in corneal thickness over time
・Change in corneal endothelial cell density over time

【State of Progress 】
Submitted a Clinical Trial plan Notification in March→Preparations underway, including patient screening

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3. FY12/24 Forecast

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Consolidated Earnings Forecast for FY12/24 (released February 9, 2024)(JPYmn)FY12/23
FY results

FY12/24
FY forecast

YoY change

Primary factors

428400(28)• Royalty income from GLANATEC® will end, but sales of DW-1002 areexpected to increase.
• The main breakdown is as follows.
⁃Royalty income: DW-1002 (Europe, US, China, etc.), GLANATEC®,
GLA-ALPHA®
⁃ Milestone revenue: DW-1002 (Japan)

Operating loss

（798）

(1,500)(702)• Increase in R&D expenses• Other SG&A expenses are expected to be approximately the same as
the previous year.

Ordinary loss

（796）

(1,510)(714)

Loss attributable toowners of parent（812）(1,510)(698)

Net sales

R&D expenses

930

1,600

• Increase expenses to prepare for Phase Ⅲ clinical trials of H-1337 inthe U.S.
• Increase expenses for R&D activities to create new drugs(In-housedrug discovery and collaborative research).

670

Fund procurement through the issue of stock acquisition rights ongoing (until June 3, 2027)
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26

(Reference) Business Overview

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30

Core Technologies to Create New Drugs
 DWTI’s drug discovery engine is an original core technology that enables us to continuously create new drugs
 A kinase is an enzyme that phosphorylates proteins; excessive phosphorylation is a factor that contributes tothe onset of various diseases (kinases regulate protein activity)
Drug discovery engine

Potential uses of kinase inhibitors

Compound library

Various indications Superior new drug seeds

 Kinases play a critical role in a variety of diseases

 Includes three launched drugs

 Kinase inhibitors are primarily used in anti-cancer agents;
development of kinase inhibitors to treat immune,
neurodegenerative, and inflammatory diseases is also underconsideration

Drug design Ability to create new drugs from compounds in ourlibrary (experience, data)

Large market scale

Drug-Western MethodTool for exploring mechanisms of action of new drugsEnhance value by estimating mechanisms(estimate safety and elements of therapeutic effects)

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 Total annual sales of kinase inhibitors exceed JPY2tn
DWTI is a pioneer in the field of kinase inhibitors
 Launched in 1995, fasudil is the world’s first kinase inhibitor(and is included in our compound library)33 These materials have been created with the goal of facilitating understanding regarding the company and were notproduced for the purpose of soliciting investment in the company.
 Earnings forecasts and projections regarding future events included within these materials are based on determinations
made by the company using information that was available at the time at which these materials were produced and are
therefore subject to impact from potential risks and uncertainties. Consequently, actual results may differ significantly fromthese forecasts and projections due to a variety of factors, including changes in business environment.
 Information related to other companies included in these materials has been taken from publicly available information andother sources. The company has not verified the accuracy or suitability of this information and therefore provides nocorresponding guarantees.

D. Western Therapeutics Institute, Inc.

Copyright D. Western Therapeutics Institute, Inc. All Rights Reserved.