SAN FRANCISCO, March 11, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced the appointment of Deyaa Adib, M.D., an executive leader with almost three decades of oncology development experience, as Senior Vice President & Chief Medical Officer to oversee all global clinical development activities. The appointment is effective March 11, 2024. "Deyaa's leadership and expertise in oncology research and clinical development, particularly in bringing oncology therapeutics to market, will be ke ...

| --- | --- | |-------------------------------------------------------------------------|---------------------------------------| | | | | Pancreatic tumor preclinical models demonstrate that CTGF: | Pamrevlumab has multiple effects in | | • Promotes proliferation | pancreatic cancer preclinical models: | | • Decreases apoptosis and promotes survival | • Increased survival | | • Supports invasion | • Promoted tumor cell apoptosis | | • Stimulates fibroblast activation, proliferation, and ECM deposition | • R ...

Product Dependence - The company is heavily reliant on the success of its lead products, pamrevlumab and roxadustat, for future growth[22] - The company faces substantial competition in the discovery, development, and commercialization of product candidates[22] Regulatory Environment - The regulatory approval process for product candidates is highly uncertain, and the company may not obtain necessary approvals in various jurisdictions[26] - The pharmaceutical industry in China is highly regulated, and changes in regulations could materially affect the company's operations[26] International Operations - The company operates in China through FibroGen Beijing, which holds regulatory licenses for roxadustat and has a drug product manufacturing facility[25] - The company has established operations in China and is seeking to commercialize product candidates outside the U.S., facing various international operational risks[26] Financial Management - As of December 31, 2023, the company reported no material financial assets and liabilities denominated in foreign currencies, indicating low foreign currency risk[596] - The company aims to preserve capital while maximizing income from cash and cash equivalents, primarily investing in commercial paper and money market funds[597] - The company has not entered into any hedging arrangements regarding foreign currency risk or other derivative financial instruments[598] - The company’s future financial condition and results of operations may be adversely affected by fluctuations in foreign currency exchange rates[595]

Exhibit 99.1 FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results SAN FRANCISCO, February 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2023 and provided an update on the company's recent developments. "We are extremely excited about the company's prospects in 2024," said Thane Wettig, Chief Executive Officer, FibroGen. "In this year alone, we will obtain data read-outs from our two late-stage pancreatic cance ...

SAN FRANCISCO, Feb. 05, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ:FGEN) today announced it will host Part I of a virtual KOL investor event series on Tuesday, February 13, 2024 at 10:30 AM ET. To register, click here. The event will feature Andrew Ko, MD (University of California San Francisco (UCSF), UCSF's Helen Diller Family Comprehensive Cancer Center) and Vincent Picozzi, MD, MMM (Virginia Mason Digestive Disease and Cancer Institutes, Virginia Mason Medical Center), who will discuss the unmet me ...

Significant commercial potential • PDAC: Safe and well tolerated with dose and exposure-related response, trend for improved resection rate, and increased completion of chemotherapy cycles • Phase 3 programs in areas of high unmet medical need with limited late-stage competitive intensity • PDAC: Multi-billion-dollar revenue opportunity, if successful 5 Recently Announced and Upcoming Pamrevlumab Milestones 3Q 2023 1H 2024 • Announced negative topline results from phase 3 LELANTOS-2 trial in ambulatory DMD ...

Financial Performance - Revenue for Q3 2023 was $40.1 million, a 155.5% increase from $15.7 million in Q3 2022[163] - Net loss for Q3 2023 was $63.6 million, compared to a net loss of $91.7 million in Q3 2022, reflecting improved revenue and reduced operating costs[165] - Total revenue increased by $24.4 million, or 155%, for the three months ended September 30, 2023, and increased by $14.2 million, or 13%, for the nine months ended September 30, 2023 compared to the same periods a year ago[217] - Loss before income taxes for the three months ended September 30, 2023, was $64.2 million, compared to a loss of $91.9 million in the same period of 2022[265] - The company anticipates continued net losses for the foreseeable future despite expected increases in revenues from commercial sales of roxadustat[285] Cash and Investments - Cash and cash equivalents totaled $120.9 million as of September 30, 2023, down from $155.7 million at the end of 2022[167] - Cash and investments decreased by $159.6 million from December 31, 2022, primarily due to cash used in operations[167] - As of September 30, 2023, the company had short-term investments of $130.4 million, down from $266.3 million as of December 31, 2022[273] - Net cash used in operating activities for the nine months ended September 30, 2023, was $296.7 million, significantly higher than the $93.4 million used in the same period of 2022[275] - Net cash provided by investing activities for the nine months ended September 30, 2023, was $143.4 million, primarily from $300.5 million of proceeds from maturities of investments[280] - Net cash provided by financing activities for the nine months ended September 30, 2023, was $123.0 million, including $71.3 million from senior secured term loan facilities[283] Operating Costs - Total operating costs for Q3 2023 were $103.6 million, a decrease from $109.4 million in Q3 2022[163] - Total operating costs and expenses decreased by $5.8 million, or 5%, for the three months ended September 30, 2023, but increased by $7.0 million, or 2%, for the nine months ended September 30, 2023, compared to the same periods a year ago[245] - Research and development expenses decreased by $14.0 million, or 19%, for the three months ended September 30, 2023, and decreased by $4.0 million, or 2%, for the nine months ended September 30, 2023, compared to the same periods a year ago[254] - Selling, general and administrative expenses decreased by $4.3 million, or 14%, for the three months ended September 30, 2023, compared to the same period a year ago[255] - A restructuring charge of $12.6 million was recorded during the three months ended September 30, 2023, primarily consisting of severance payments and employee benefits contributions[257] Product Revenue - Roxadustat generated $29.4 million in net product revenue in Q3 2022, with ongoing commercialization efforts in China and other approved markets[164] - The company recognized $29.4 million in net product revenue from roxadustat for the three months ended September 30, 2023, compared to $17.4 million for the same period in 2022[209] - Total product revenue, net increased by $12.0 million, or 69% for the three months ended September 30, 2023, and increased by $17.9 million, or 30% for the nine months ended September 30, 2023, compared to the same periods a year ago[228] - Drug product revenue, net for the three months ended September 30, 2023 was $1,320,000, representing a 132% increase compared to a loss of $4,077,000 in the same period of 2022[211] - Sales to Falikang revenue, net increased by $11.5 million, or 77% for the three months ended September 30, 2023, and increased by $17.5 million, or 34% for the nine months ended September 30, 2023, compared to the same periods a year ago[232] Clinical Development - Pamrevlumab is in Phase 3 clinical development for locally advanced unresectable pancreatic cancer, with topline data expected in Q1 2024[171] - Pamrevlumab did not meet primary endpoints in the Phase 3 trial for Duchenne Muscular Dystrophy, but preliminary safety data indicated it was generally well tolerated[173][174] - In a Phase 3 clinical study for chemotherapy-induced anemia, roxadustat demonstrated non-inferiority to recombinant erythropoietin alfa on the primary endpoint of hemoglobin change[178] - FG-3246 showed a PSA50 interim response rate of 45% and an objective partial response rate of 19% in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[184] - The company plans to initiate a PET biomarker driven Phase 2 trial of FG-3246 in the second half of 2024[185] Collaborations and Agreements - The company entered into an exclusive option agreement to acquire Fortis Therapeutics for $80 million, with potential contingent payments of up to $200 million[194] - The collaboration agreements with Astellas and AstraZeneca have generated a total consideration of $790.1 million and $516.2 million, respectively, through September 30, 2023[200][204] - AstraZeneca collaboration agreements contributed a total of $1,625,700,000 in cash consideration, with $516,200,000 received and $1,109,500,000 in potential cash payments[210] - License revenue for the three months ended September 30, 2023 was $2,649,000, a decrease of 57% compared to $22,590,000 for the same period in 2022[218] - The company does not expect to receive most or all of the additional potential milestones under the Astellas Japan Agreement, Astellas Europe Agreement, and AstraZeneca U.S./RoW Agreement based on current development plans[210] Future Outlook and Risks - The company anticipates needing additional capital beyond the next 12 months, with potential dilution of existing stockholders if equity is issued[287] - The company may incur additional expenses related to the workforce reduction, impacting future financial resources[287] - The company has established a full valuation allowance against its net deferred tax assets due to uncertainty in realization[266] - Future milestone payments under license agreements could total up to approximately $697.9 million, contingent on achieving specific developmental milestones[292] - The company expects costs of goods sold to increase in relation to drug product revenue as inventories are depleted[248]

Financial Data and Key Metrics Changes - For Q2 2023, total revenue was $44.3 million, a 49% increase from $29.8 million in Q2 2022 [53] - Roxadustat net sales in China reached $76.4 million, up 44% from $53.1 million in Q2 2022 [85] - The company recorded a net loss of $87.7 million, compared to a net loss of $72.6 million in Q2 2022 [59] - Operating costs for Q2 2023 were $132.4 million, up from $108 million in Q2 2022, primarily due to a one-time charge of $24.6 million related to an asset acquisition [57][58] Business Line Data and Key Metrics Changes - Roxadustat generated $14.3 million in drug product revenue for the bulk drug product sold to Astellas, compared to $1.1 million in Q2 2022 [54] - Development revenue associated with roxadustat co-development efforts was $4.1 million, down from $5.2 million in Q2 2022 [54] - The net transfer price from roxadustat sales in China was $23.8 million, an increase of 31% year-over-year [56] Market Data and Key Metrics Changes - Roxadustat's market share in China rose to 39% in Q2 2023, marking the highest since its launch [45] - The company anticipates that the approval of roxadustat for chemotherapy-induced anemia could lead to over $500 million in annual net sales in China [44] Company Strategy and Development Direction - The company focuses on four strategic pillars: pamrevlumab, roxadustat, early-stage oncology pipeline, and maintaining a strong cash position [15][28] - Pamrevlumab is being developed for multiple indications, including Duchenne muscular dystrophy and pancreatic cancer, with upcoming late-stage readouts expected [34][92] - The company has implemented a cost reduction plan to extend its cash runway into 2026, allowing for continued investment in its pipeline [27][91] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about the company's opportunities despite recent setbacks, highlighting the potential of pamrevlumab and the strong performance of roxadustat in China [4][28] - The company expects to achieve significant savings from its restructuring efforts and maintain sufficient cash to fund operations into 2026 [89][91] Other Important Information - The company has filed a supplemental new drug application for roxadustat in patients with chemotherapy-induced anemia, expecting approval in mid-2024 [44] - The company is pursuing IND filings for two innovative oncology molecules in 2024 [26][64] Q&A Session Summary Question: What is your base case for the timing of a potential generic entry for roxadustat? - The composition matter patent expires in mid-2024, and generics are not expected until after that date [69] Question: Why are you excited about the FOR46 ADC program? - The program has shown a partial response rate of about 20% in a difficult-to-treat patient population, which is promising [71] Question: Can you provide insights on the LAPIS trial and its potential use of event-free survival as a surrogate for accelerated approval? - The primary endpoint is overall survival, and interim analysis for event-free survival did not meet the necessary criteria [118] Question: What are the avenues for filing secondary benefits from the North Star assessment in the ambulatory DMD trial? - Any positive data from the ambulatory trial will be explored for regulatory pathways with the FDA [127] Question: Can you clarify the status of the term loan with Morgan Stanley Tactical Value? - The loan has a maturation date of May 2026, and there are no current plans for early repayment [129]

FibroGen Reports Second Quarter 2023 Financial Results August 7, 2023 Forward-Looking Statements 2 This presentation contains forward-looking statements regarding FibroGen's strategy, future plans and prospects, including statements regarding the development and commercialization of the company's product candidates, the potential safety and efficacy profile of its product candidates, and its clinical programs. These forward-looking statements include, but are not limited to, statements under the caption "Up ...

Financial Performance - Revenue for Q2 2023 was $44.3 million, a 48.8% increase from $29.8 million in Q2 2022[152]. - Net loss for Q2 2023 was $87.7 million, compared to a net loss of $72.6 million in Q2 2022, resulting in a net loss per share of $0.90[156]. - Total revenue for the three months ended June 30, 2023, increased by $14.5 million, or 49%, compared to the same period in 2022, while total revenue for the six months decreased by $10.2 million, or 11%[210]. - License revenue for the three months ended June 30, 2023, was $1.0 million, a decrease of 69% compared to $3.2 million in the same period of 2022[211]. - Development and other revenue decreased by $0.3 million, or 5%, for the three months ended June 30, 2023, and decreased by $8.2 million, or 47%, for the six months ended June 30, 2023[214]. - Product revenue, net for the three months ended June 30, 2023, was $23.9 million, an increase of 3% compared to $23.3 million in the same period of 2022[204]. - Drug product revenue, net for the three months ended June 30, 2023, was $14.3 million, a 6% increase compared to $1.1 million in the same period of 2022[208]. - Other revenue for the three months ended June 30, 2023, was $1.0 million, a 274% increase compared to $0.3 million in the same period of 2022[214]. - Total product revenue, net increased by $0.6 million, or 3% for the three months ended June 30, 2023, and increased by $5.9 million, or 14% for the six months ended June 30, 2023, compared to the same periods a year ago[219]. Operating Costs - Operating costs for Q2 2023 were $132.4 million, up from $108.0 million in Q2 2022, primarily due to increased product revenue and clinical trial expenses[154]. - Total operating costs and expenses increased by $24.3 million, or 23% for the three months ended June 30, 2023, and increased by $12.8 million, or 6% for the six months ended June 30, 2023, respectively[236]. - Research and development expenses increased by $24.5 million, or 35% for the three months ended June 30, 2023, compared to the same period a year ago[236]. - Selling, general and administrative expenses increased by $923,000, or 3% for the three months ended June 30, 2023, compared to the same period a year ago[236]. - Cost of goods sold decreased by $1.1 million, or 16% for the three months ended June 30, 2023, and decreased by $1.8 million, or 17% for the six months ended June 30, 2023, respectively[237]. - Cost of goods sold associated with roxadustat commercial sales in China was $3.6 million for Q2 2023, a decrease of $1.3 million, or 26% year-over-year[238]. Cash and Investments - Cash and cash equivalents totaled $152.6 million as of June 30, 2023, a decrease of $3.1 million from $155.7 million at the end of 2022[158]. - Total cash, cash equivalents, and investments decreased by $81.3 million from December 31, 2022, primarily due to cash used in operations[158]. - As of June 30, 2023, the company had short-term investments of $183.1 million, down from $266.3 million as of December 31, 2022[262]. - Net cash used in operating activities was $212.2 million for the six months ended June 30, 2023, compared to $41.5 million for the same period in 2022[265][267]. - Net cash provided by investing activities was $89.2 million for the six months ended June 30, 2023, primarily from $192.9 million of proceeds from maturities of investments[268]. - Net cash provided by financing activities was $123.0 million for the six months ended June 30, 2023, mainly from $71.3 million net proceeds from senior secured term loan facilities[271]. Clinical Development - Roxadustat generated $23.9 million in net product revenue from commercial sales in China during Q2 2023[154]. - Pamrevlumab is in Phase 3 clinical development for locally advanced unresectable pancreatic cancer, with topline data expected in Q1 2024[162]. - The Phase 3 trial for pamrevlumab in ambulatory Duchenne muscular dystrophy (DMD) completed enrollment of 73 patients, with topline data expected in August 2023[164]. - The Phase 3 trial for pamrevlumab in idiopathic pulmonary fibrosis did not meet its primary endpoint, with a mean decline in FVC of 260 ml compared to 330 ml in the placebo group[167]. - In a Phase 3 study for chemotherapy-induced anemia, Roxadustat demonstrated non-inferiority to recombinant erythropoietin alfa on the primary endpoint of hemoglobin change[171]. - FG-3246 showed a PSA50 response rate of 45% and an objective partial response rate of 19% in a Phase 1 clinical study for metastatic castration-resistant prostate cancer[177]. - The company is developing a PET biomarker for FG-3246 in collaboration with UCSF, with a Phase 2 trial anticipated to start in the second half of 2024[178]. Financing and Agreements - A financing agreement was established for a $75 million senior secured term loan to support ongoing operations[183]. - An exclusive option agreement was signed to acquire Fortis Therapeutics, with a potential payment of $80 million upon acquisition and up to $200 million in contingent payments[187]. - The company recognized $1 million in upfront payments under the Eluminex Agreement during Q2 2023, with additional milestone payments recognized[190]. - Total cash consideration received through June 30, 2023, from collaboration agreements amounted to $1,306.3 million, with potential cash consideration of $1,237.0 million, totaling $2,543.3 million[203]. - Future milestone payments under license agreements could total approximately $697.9 million, contingent on achieving specific developmental milestones[280]. Future Outlook - The company anticipates needing substantial additional funding for ongoing operations and research and development efforts[274][275]. - The company expects future development services to continue through 2024, with co-development services in China expected to continue through 2028[206]. - The company anticipates fluctuations in revenue generated from collaboration agreements due to the uncertain timing and amount of payments and sales[209]. - The liquidity position of FibroGen Beijing is influenced by various factors, including potential future cash distributions and debt obligations[263]. - The company has not made any debt repayments or distributions from FibroGen Beijing to entities outside of China to date[263].