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; | 3 |
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
5
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. | 6 |
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. | 7 |
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. | 8 |
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. | 10 |
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.