FibroGen Reports First Quarter 2024 Financial Results

May 6, 2024

Forward-Looking Statements

This presentation contains "forward-looking" statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regarding our future financial condition, business strategy, and plans, and objectives of management for future operations, are forward looking statements. These forward-looking statements can generally be identified by terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "or potentially," or by the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places throughout this presentation and include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, our ongoing and planned development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for roxadustat, pamrevlumab, and our other product candidates, the potential safety, efficacy, reimbursement, convenience, or clinical and pharmaco-economic benefits of our product candidates, including in China, the potential markets for any of our product candidates, our ability to develop commercial functions, results of commercial operations, or our ability to operate in China, expectations regarding clinical trial data, our results of operations, cash needs, spending of proceeds from our public offerings, financial condition, liquidity, prospects, growth, and strategies, the industry in which we operate, and the trends that may affect the industry or us.

Forward-looking statements involve known and unknown risks, uncertainties, assumptions, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements, including the other risks and uncertainties that are described in the Risk Factors section of our most recent annual report on Form 10-K or quarterly report on Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements represent our management's beliefs and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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FibroGen Strategic Pillars and Investment Highlights

Pamrevlumab readouts for pancreatic cancer, targeting a significant unmet medical need and

Pamrevlumab

representing a multi-billion-dollar revenue opportunity:

Pivotal Clinical Trial

Precision PromiseSM Phase 2/3 topline expected mid-2024

Readouts

LAPIS Phase 3 topline expected 3Q 2024

Growing revenue and cash flow stream from roxadustat; approved in > 40 countries and

Growing Roxadustat

commercialized by AstraZeneca and Astellas.

sNDA accepted in China for chemotherapy induced anemia, approval decision expected in 2H 2024.

Revenue and Cash Flow

FibroGen regains rights to roxadustat in AZ territories (excluding China and South Korea): creating

potential partnership opportunities in indications such as anemia in patients with LR-MDS.

FG-3246 (CD46-targetingADC) for mCRPC: Data from multiple Phase 1 studies in 2024. Initiation

Early-Stage Oncology

of Phase 2 monotherapy dose optimization study in 2H 2024.

Pipeline

FG-3165(Galectin-9 targeting mAb) for solid tumors: IND submitted in April.

FG-3175 (CCR8 targeting mAb) for solid tumors: IND in 2025.

$214.7M in cash, cash equivalents, investments, and accounts receivable as of March 31, 2024.

Strong Balance Sheet

Expected to fund operating plans into 2026.

ADC=antibody drug conjugate; CIA=chemotherapy-induced anemia; IND=investigational new drug; mAb=monoclonal antibody;

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mCPRC=metastatic castration-resistant prostate cancer.

Pamrevlumab

mAb targeting connective tissue growth factor (CTGF) for pancreatic cancer treatment

Pamrevlumab:

A First-in-ClassCTGF-targeting mAb in Late-Stage Development

Novel, differentiated anti-tumor MOA

Demonstrated in vivo efficacy in multiple pancreatic cancer preclinical models

  • Increased survival
  • Promoted tumor cell apoptosis
  • Reduced cell proliferation
  • Decreased tumor vascularization

Positive early clinical-stage outcomes in PDAC support continued investigation to address serious unmet medical needs

  • Phase 1/2 (includes metastatic and LAPC patients): Higher pamrevlumab drug exposure and lower baseline CTGF level were independently and significantly associated with prolonged PFS and OS (median survival and 1-Year OS rate)
  • Phase 1/2 (includes LAPC patients): Well-tolerated with dose and exposure-related response, trend for improved resection rate, and increased completion of chemotherapy cycles

Significant commercial opportunity

  • Pancreatic cancer has a high unmet medical need with limited late-stage competitive intensity
  • PDAC represents a potential multi-billion-dollar revenue opportunity

Key pre-clinical and clinical safety and efficacy studies available in SEC filing

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MOA=mechanism of action; OS=overall survival; PDAC=pancreatic ductal adenocarcinoma; PFS = progression free survival.

Pancreatic Cancer is in Dire Need of Novel Targets and Treatment Options

3rd leading cause of

cancer mortality in the U.S.1

Most common form is pancreatic ductal adenocarcinoma (PDAC)

Usually diagnosed at an advanced stage of disease

~60,000 patients/year are expected to be diagnosed with PDAC in the

U.S. alone2

Causing 50,550 deaths a year in 20232

Lowest survival rate among all cancers

5-yeardisease-free survival in pancreatic cancer only 12.5%2 and as low as ~3%3 in metastatic cancer

90% of patients experience recurrence after curative resection4

No major therapeutic advances in decades

Chemotherapy5 (e.g., gemcitabine) +/- radiation is the established standard of care across stages of disease

Few therapies are available for specific sub-populations of patients,

offering only limited improvements

in OS and PFS5

Major therapy classes such as

immunotherapies have failed to demonstrate additional survival

benefits

OS=overall survival; PFS=progression free survival.

1. Hirshberg Foundation for Pancreatic Cancer Research. Pancreatic Cancer Facts. https://pancreatic.org/pancreatic-cancer/pancreatic-cancer-facts/. 2. National Cancer Institute.

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Cancer Stat Facts: Pancreatic Cancer. https://seer.cancer.gov/statfacts/html/pancreas.html. 3. Cancer.Net. Pancreatic Cancer: Statistics. https://www.cancer.net/cancer-

types/pancreatic-cancer/statistics. 4. Shi XY, et al. Sci Rep. 2023;13(1):4856. 5. NCCN guidelines 2021

Pamrevlumab Has Novel and Differentiated Anti-Tumor Activity

CTGF expression is elevated in pancreatic cancer1

CTGF drives multiple biological processes including cancer cell proliferation, migration, invasion, and metastasis that contribute to pancreatic tumor growth and disease progression1,2

Pancreatic tumor preclinical models demonstrate that CTGF:

  • Promotes proliferation
  • Decreases apoptosis and promotes tumor cell survival
  • Supports invasion
  • Stimulates fibroblast activation, proliferation, and ECM deposition
  • Overexpression contributes to pancreatic tumor growth

Pamrevlumab has multiple effects in pancreatic cancer preclinical models:

  • Increased survival
  • Promoted tumor cell apoptosis
  • Reduced cell proliferation
  • Decreased tumor vascularization

CTGF=connective tissue growth factor; ECM=extracellular matrix.

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1. Shen YW, et al. Trends in Molecular Medicine. 2020;26(12):1064-1067. 2. Shen YW, et al. Trends in Cancer. 2021;7(6):511-524.

Phase 1/2 Study of Pamrevlumab in Advanced Pancreatic Cancer Showed Exposure Related Increases in Survival

Relationship of Survival to Pamrevlumab

Dose and Exposure/Survival Response in Combination with Gemcitabine and Erlotinib

Results in Advanced Disease (N=75; 88% metastatic)

Exposure related increase in survival

Positive exposure response relationship with

pamrevlumab plasma level Cmin ≥150 µg/mL

2x median survival (9.4 vs. 4.8 months)

(p=0.025)

Percent Overall Survival

100

80

60

40

20

Day 15 Plasma Levels

Pamrevlumab ≥150 μg/mL; n=38 (p=0.025)

Pamrevlumab <150 μg/mL; n=37

>3x one-year survival (37% vs.11%) (p=0.01)

0

0

5

10

15

20

25

30

35

40

45

Overall Survival Time (Months)

Picozzi VJ et al., J Cancer Clin Trials 2017, 2:1.

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Precision Promise is a New Paradigm in Pancreatic Cancer Drug Development from the Pancreatic Cancer Action Network (PanCAN)

FibroGen established a standard research

Pamrevlumab Precision Promise Ph 2/3 study

agreement with PanCAN with no royalties or equity

and regulatory path

Precision Promise is PanCAN's groundbreaking trial aiming for more efficient and faster time to new treatments for pancreatic cancer patients

Financial and operational support from PanCAN

FDA-aligned registrational study design:

  • Trial design developed based on FDA 2020 'Complex Innovative Designs' guidance1

Complete trial support from PanCan including facilitated FDA discussions throughout design, regulatory submission and review

Includes 1st and 2nd line metastatic PDAC patients in Phase 2 and potentially included in Phase 3

Independently conducted by renowned experts in Pancreatic Cancer, trial strategy and statistical methods

KOL engagement throughout study: ~100 pancreatic cancer scientific & clinical leaders supporting the study

Topline Data Expected Mid-2024

1. https://www.fda.gov/media/130897/download

NCT04229004

Precision Promise: An Adaptive Multi-Arm Registration Trial in Metastatic PDAC1

~50 patients accrued to

Seamless transition from Stage 1 to Stage 2

Patient accrual continues

investigational arm

Participating company notified of graduation decision

Stage 1 AccrualPhase 2/3

Investigational Arm

70%

(across all

investigational arms)

Stage 1

Stage 2

(100 patients)

(75 patients)

15%

Control Arm 1: Gemcitabine + nab-paclitaxel

15%

Control Arm 2: mFOLFIRINOX

Monthly analyses for futility by Statistical Monitoring

Committee starting at 50 patients

12-monthfollow-up

prior to final

analysis

PDAC=pancreatic ductal adenocarcinoma.

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1 Picozzi V, et al. J Clin Oncol 40, 2022. no. 16_suppl (June 01, 2022) TPS4188-TPS4188.

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FibroGen Inc. published this content on 06 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 May 2024 23:55:06 UTC.