FIBROGEN, INC. FibroGen, Inc. Corporate Presentation
February 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
Pivotal Readouts
Growing Roxadustat Revenue and Cash Flow
Pamrevlumab readouts for pancreatic cancer: Precision PromiseSM Phase 2/3 topline and LAPIS Phase 3 topline expected 2Q 2024, targeting a significant unmet medical need and representing a multi-billion-dollarrevenue opportunity.
Growing revenue and cash flow stream from roxadustat; approved in > 40 countries and commercialized by AstraZeneca and Astellas.
sNDA accepted in China for Anemia associated with CIA, approval decision expected in mid-2024.
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-targeting ADC) for mCRPC: data from Phase 1 studies in 2024, including additional | ||
Early-Stage Oncology | data from Phase 1 monotherapy trial in 1Q 2024. | ||
Pipeline | FG-3165 | (Galectin-9 targeting mAb) for solid tumors: IND in 1Q 2024. | |
FG-3175 | (CCR8 targeting mAb) for solid tumors: IND in 2025. | ||
Strong Balance Sheet
$248.1M in cash, cash equivalents, and accounts receivable as of December 31, 2023. Sufficient to fund operating plans into 2026.
ADC=antibody drug conjugate; CIA=chemotherapy-induced anemia; IND=investigational new drug; mAb=monoclonal antibody; | 3 |
mCPRC=metastatic castration-resistant prostate cancer. | |
Accomplished Leadership Team that is Highly Experienced in Bringing Medicines to Market
Thane Wettig
Chief Executive Officer
John Hunter, PhD
Chief Scientific Officer
Kirk Christoffersen
Chief Business Officer
Juan Graham
Chief Financial Officer
Elizabeth Bearby, PharmD
SVP Regulatory, Biometrics, Scientific Communications, and Clinical Project Management
Christine Chung
SVP China Operations
Rahul Rajan Kaushik, PhD
SVP Pharmaceutical Development, Technical Operations and Manufacturing
Michael D. Lowenstein, JD
Chief Legal Officer
Tricia Stewart
Chief People Officer
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Robust Portfolio With Marketed and Late-Stage Assets
Status/ | |||||||
Program | Indication | Preclinical | Phase 1 | Phase 2 | Phase 3 | Commercialized Anticipated Milestone | |
Metastatic Pancreatic Cancer | Precision PromiseSM (PanCAN Phase 2/3 Design) | Topline Data Expected | |||||
Pamrevlumab | 2Q 2024 | ||||||
Monoclonal antibody against | |||||||
Locally Advanced Unresectable | Topline Data Expected | ||||||
connective tissue growth factor (CTGF) | LAPIS | ||||||
Pancreatic Cancer (LAPC) | 2Q 2024 | ||||||
Anemia of Chronic Kidney | EVRENZOTM,爱瑞卓®️ Marketed* | ||||||
Roxadustat | Disease (CKD) | ||||||
Small molecule HIF-PHI | Chemotherapy-Induced | CHINA Label | Expansion Study | Approval Decision | |||
Anemia (CIA) | Expected Mid-2024 | ||||||
FG-3246(FOR46) | Metastatic Castration-Resistant | Additional Phase 1 Results | |||||
1Q 2024. Phase 2 Initiation | |||||||
CD46-targeting ADC | Prostate Cancer (mCRPC) | ||||||
2H 2024 | |||||||
FG-3165 | Solid Tumors | IND 1Q 2024 | |||||
Monoclonal antibody against Galectin- | |||||||
9 (Gal-9) | |||||||
FG-3175 | Solid Tumors | IND 2025 | |||||
Monoclonal antibody against C-C Motif | |||||||
Chemokine Receptor 8 (CCR8) | |||||||
In-Licensed Commercial Partner Wholly-Owned
*Currently marketed in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and patients not on dialysis. | 5 |
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: 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: 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. | 8 |
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. | 9 |
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. |
Significant Commercial Opportunity in the U.S. for Pamrevlumab in Pancreatic Cancer
60,000 PDAC Cases/Year1
52% metastatic | 36% LAPC
52,800 patients
Average Annual Cost of Therapy
$200,000
Total Addressable Market2
> $8B
Revenue ($M) | average rebate) |
Potential Net | (Based on 20% |
6,000
5,000
4,000
3,000
2,000
1,000
-
Metastatic | LAPC | |
2,070
1,730 | |||||||
1,380 | |||||||
1,040 | |||||||
690 | 2,500 | 3,000 | |||||
2,000 | |||||||
1,500 | |||||||
350 | 1,000 | ||||||
500 | |||||||
10% | 20% | 30% | 40% | 50% | 60% | ||
Penetration Rate |
Pancreatic Cancer represents a multi-billion-dollar commercial opportunity for pamrevlumab in the U.S.
PDAC=pancreatic ductal adenocarcinoma; LAPC=locally advanced pancreatic cancer. | 10 |
1. Cancer.Net (link), 2. Internal estimates based on industry comparables | |
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FibroGen Inc. published this content on 06 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 March 2024 16:37:04 UTC.
