Developing Anti-Fibrotic Therapeutics for Chronic Organ Diseases

Corporate Presentation

May 2024

1

Forward Looking Statements

This presentation contains "forward-looking statements" within the meaning of the federal securities laws regarding the current plans, expectations and strategies of Gyre Therapeutics, Inc. and its subsidiaries ("Gyre"), which statements are subject to substantial risks and uncertainties and are based on management's estimates and assumptions. All statements, other than statements of historical facts included in this presentation, are forward-looking statements, including statements concerning: Gyre's plans, objectives, goals, strategies, future events, or intentions relating to Gyre's products and markets; the safety, efficacy and clinical benefits of Gyre's product candidates;

the anticipated timing and design of any planned or ongoing preclinical studies and clinical trials; Gyre's research and development efforts; management's plans and objectives for future operations and future results of anticipated product development efforts; potential addressable market size; and Gyre's liquidity and capital resources and business trends. In some cases, you can identify forward-looking statements by terms such as "believe," "can," "could," "design," "estimate," "expect," "forecast," "intend," "may," "might," "plan," "potential," "predict," "objective," "should," "strategy," "will," "would," or the negative of these terms, and similar expressions intended to identify forward- looking statements. These statements involve known and unknown risks, uncertainties and other factors that could cause Gyre's actual results to differ materially from the forward-looking statements expressed or implied in this presentation, such as the uncertainties inherent in the clinical drug development process, the regulatory approval process, the timing of any regulatory filings, the potential for substantial delays, the risk that earlier study results may not be predictive of future study results, manufacturing

risks, and competition from other therapies or products, as well as those described in "Risk Factors" and "Management's Discussion and Analysis of Financial Condition" in Gyre's Annual Report on Form 10-K for the year ended December 31, 2023 filed on March 27, 2024 with the Securities and Exchange Commission (the "SEC") and elsewhere in such filing and in Gyre's other periodic reports and subsequent disclosure documents filed with the SEC.

Gyre cannot assure you that it will realize the results, benefits or developments that it expects or anticipates or, even if substantially realized, that they will result in the expected consequences or affect Gyre or its business in the ways expected. Forward-looking statements are not historical facts, and reflect management's current views with respect to future events. Given the significant uncertainties, you should evaluate all forward-looking statements made in this presentation in the context of these risks and uncertainties and not place undue reliance on these forward-looking statements as predictions of future events. All forward-looking statements in this presentation apply only as of the date made and are expressly qualified in their entirety by the cautionary statements included in this presentation. Gyre has no intention to publicly update or revise any forward-looking statements to reflect subsequent events or circumstances, except as required by law. Gyre obtained the data used throughout this presentation from its own internal estimates and research, as well as from research, surveys and studies conducted by third parties. Internal estimates are derived from publicly available information and Gyre's own internal research and experience, and are based on assumptions made by management based on such data and its knowledge, which it believes to be reasonable. In addition, while Gyre believes the data included in this presentation is reliable and based on reasonable assumptions, Gyre has not independently verified any third-party information, and all such data involve risks and uncertainties and are subject to change based on various factors.

This presentation concerns a discussion of investigational drugs that are under preclinical and/or clinical investigation and which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by Federal law to investigational use, and no representations are made as to their safety or effectiveness for the purposes for which they are being investigated.

2

Gyre Therapeutics - Investment Highlights

1

Strong track record: developed ETUARY® (Pirfenidone) from research to commercialization. Sales are re-invested to fund Gyre's clinical development pipeline.

2

Robust Phase 2 proof-of-concept clinical dataset improves relative risk profile of F351, a derivative of ETUARY® (Pirfenidone), and positions it as a promising oral therapy for the treatment of NASH*-associated liver fibrosis.

3

Phase 3 China trial in Chronic Hepatitis B (CHB)-associated liver fibrosis expected to confirm promising safety and efficacy profiles of F351, guiding initiation of Phase 2a U.S. trial in NASH-associated liver fibrosis.

4

NASH is experiencing significant tailwinds following resmetirom approval and robust data readouts, which have reduced risk in the space and increased investor interest.

5

Financial backing from China-based subsidiary Gyre Pharmaceuticals and majority shareholder GNI Group.

*NASH: nonalcoholic steatohepatitis

3

Leveraging Profitable Business to Fund Pipeline

Corporate Structure

Growth Strategy

GNI Group (Japan)

85%

65%

Gyre Pharmaceuticals (China)

Optimize

existing

drug

targeting

fibrosis

Generate

revenue

Trials in China to improve therapeutic approach

Positive

data from

China

Expand

indications and begin U.S. trials

*Simplified structure diagram for illustrative purposes

4

Innovative Pipeline

Candidate

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Marketed

Location

F351

NASH-Associated Liver Fibrosis

Plan to initiate Phase 2a trial in 2025

United States

(Hydronidone)

CHB-Associated Liver Fibrosis

Phase 3 results

expected by early 2025

Idiopathic Pulmonary Fibrosis (IPF)

Dermatomyositis Interstitial Lung

Disease (DM-ILD)

ETUARY®

Systemic Sclerosis-associated

(Pirfenidone)

Interstitial Lung Disease (SSc-ILD)

Pneumoconiosis

China1

Diabetic Kidney Disease (DKD)

F573

ALF/ACLF

F528

Chronic Obstructive Pulmonary

Disease (COPD)

F230

Pulmonary Arterial Hypertension (PAH)

1. Product/product candidate of Gyre Pharmaceuticals

5

Gyre Pharmaceuticals Successfully Transitioned ETUARY® (Pirfenidone) from Research to Commercialization

ETUARY® (Pirfenidone) Overview

✓ Effective oral treatment for IPF

✓ Early entry into fibrosis therapy market in China

since 2014

✓ Demonstrates anti-fibrotic,anti-inflammatory,

and anti-oxidationproperties

FY2023

✓ Significant market potentials through indication

Revenue

US $112.1m

expansion in interstitial lung diseases, DKD, and

pneumoconiosis

✓ Multiple Phase 3 trials ongoing in China

Significant Market Opportunities

China Prevalence in 2031E

Major Diseases Causing Pulmonary Fibrosis

332,000 1,014,000 2,574,000

IPF

Pneumoconiosis

CTD-ILD

Approved

Ongoing Phase 3 Trials

Established and Market-Dominant Commercialization

China Pulmonary Fibrosis Drug Market Share*

7.4%

Gyre

Boehringer

37.3%55.3% Ingelheim

Beijing Kaiwin

*Frost and Sullivan, June 2023

6

F351 (Hydronidone) - Lead Product Candidate Targeting Liver Fibrosis

7

F351 (Hydronidone)- Lead Product Candidate Targeting Liver Fibrosis Designed to Improve Upon Approved Drug Pirfenidone

Hydronidone (F351) Overview

Differentiated Product Profile

  • A structural derivative of marketed antifibrotic drug Pirfenidone
  • Pleiotropic anti-fibroticTGF-β-targeting mechanism of action, expected to ameliorate liver fibrosis by inhibiting activation of hepatic stellate cells via
    Smad7 mediated degradation of TGFβR
  • Possible to reduce its potential for idiosyncratic liver toxicity via phase II metabolism(1)
  • Obtained breakthrough therapy designation status for CHB-associatedliver fibrosis in China

Clinical Development in the U.S.

  • Well tolerated as single and repeated oral doses with no SAEs

Phase 1

✓

Safety profile consistent with data from clinical trails for CHB-

associated liver fibrosis in China

Phase 2

✓

Met primary endpoint of proportion of Ishak of liver fibrosis

(Proof-of

decreased by ≥ 1 point

Concept)

✓

Well tolerated with safety profile comparable to placebo

▪

Confirmatory China Phase 3 trial for CHB-associated liver

Next

fibrosis expected to be complete by 2H 2024

Milestones

▪

Initiate U.S. Phase 2a trial in NASH-associated liver fibrosis

Market Opportunities

Global Liver Fibrosis Market

Global NASH Market

$15 Billion

$108 Billion+

in 2022(2)

in 2030(4)

(1) Zhou S et al., J Med Chem 2020. (2) Source: Coherent Market Insights. (4) Vantage Market Research.

8

U.S. Phase 1 Trial Has Shown That F351 Is Well-Tolerated in Healthy Volunteers, Consistent With Safety Data from Three China Trials

Trial Design

Part I: single ascending dose, sequential cohort study of oral capsules of Hydronidone at 30 mg and 120 mg (n=12 subjects)

Part II: multiple ascending dose, sequential cohort study of oral capsules of Hydronidone at 30 mg 3x daily (TID) for 7 days (n=12 subjects) and 120 mg 3x daily (TID) for 7 days (n=12 subjects)

Objectives

Assess pharmacokinetics and evaluate safety and tolerability of Hydronidone

Single Ascending Doses

Multiple Ascending Doses

Hydronidone

Hydronidone

All Subjects

Hydronidone

Hydronidone

All Subjects

30 mg

120 mg

30 mg TID × 7

120 mg TID × 7

Category

(N=24)

(N=24)

(N=12)

(N=12)

(N=12)

(N=12)

n (%)

n (%)

n (%)

n (%)

n (%)

n (%)

Number of Adverse Events (AE), n

4

5

9

16

12

28

Subjects with Any AE

3 (25.0)

3 (25.0)

6 (25.0)

6 (50.0)

7 (58.3)

13 (54.2)

Number of Treatment Emergent AE

4

5

9

16

12

28

(TEAE), n

Subjects with Any TEAE

3 (25.0)

3 (25.0)

6 (25.0)

6 (50.0)

7 (58.3)

13 (54.2)

Subjects with Severe TEAE

0

0

0

0

0

0

Subjects with Serious AE (SAE)

0

0

0

0

0

0

Subjects with Serious TEAE

0

0

0

0

0

0

Subjects Discontinued Due to AE

0

0

0

0

0

0

Subjects with AEs Resulting in Death

0

0

0

0

0

0

n (%) = number and percent of subjects in the specified group; N = number of subjects in the specified study population under each treatment.

Hydronidone was well tolerated as single and repeated oral doses with no SAEs

9

Phase 2 Double Blind, Randomized, Placebo-controlled Trial of F351 in Chinese Patients with Chronic Hepatitis B-associated Liver Fibrosis

Design

Basic Treatment

Primary Endpoint

Secondary Endpoints

Randomized, double-blind,placebo-controlled, multicenter, entecavir-based,dose-exploration Phase 2 trial of Hydronidone capsules for the treatment CHB-associated liver fibrosis

Entecavir administered continuously for 52 weeks

Proportion of liver fibrosis Ishak scores that decreased ≥ 1 point after treatment compared to pre- treatment

  • Conversion rate and decrease of HBV DNA after treatment
  • Proportion of decrease in liver transient elastography values after treatment compared to pre- treatment
  • Proportion of liver tissue inflammation grading decreased ≥ grade 1 after treatment compared to pre- treatment without worsening fibrosis
  • Improvement of liver function ALT index

FAS (n=167*)

Hydronidone 180mg (n=42)

Hydronidone 270mg (n=41)

Hydronidone 360mg (n=41)

Placebo (n=43)

*Target enrollment was 168 participants. One patient was excluded from the 270 mg cohort after three days of treatment

as they did not meet the inclusion criteria.

10

Attachments

  • Original Link
  • Original Document
  • Permalink

Disclaimer

Catalyst Biosciences Inc. published this content on 30 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 May 2024 09:35:59 UTC.