FG-3246 demonstrated efficacy in adenocarcinoma selected cohorts receiving biologically active doses of FG-3246 at ≥ 1.2 mg/kg in heavily pre-treated, biomarker unselected patients: Median radiographic progression free survival of 8.7 months PSA50 response in 36% of patients Confirmed radiographic objective response rate of 20%, with a median duration of response of 7.5 months FG-3246 demonstrated an acceptable safety profile; adverse events consistent with those observed in other antibody drug conjugate th ...

Stocks are at the mercy of many factors, and often, prices are just a poor earnings report or a negative headline away from a significant drop. There are times when nobody has any way of preparing. In many instances, however, early signs of trouble creep in. Sensible investors can identify potential issues from declining financial reports, brewing service problems, poorly managed spending, or questionable business decisions. Unfortunately, these three companies all show these signs, which may mean things ar ...

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 ...

Pamrevlumab in Pancreatic Cancer - Pamrevlumab promotes tumor cell apoptosis and reduces cell proliferation in pancreatic cancer preclinical models[1] - A Phase 1/2 study showed a positive exposure response relationship with pamrevlumab plasma level Cmin ≥150 µg/mL, resulting in a 2x increase in median survival (9.4 vs 4.8 months) (p=0.025) and a >3x increase in one-year survival (37% vs 11%) (p=0.01) [3] - Pamrevlumab is currently in two late-stage studies addressing approximately 90% of diagnosed pancreatic cancer patients [8, 39] - FibroGen has established a standard research agreement with PanCAN for the Pamrevlumab Precision Promise Phase 2/3 study [15] - Topline data from the Precision Promise Phase 2/3 study and the LAPIS Phase 3 study are expected in 2Q 2024 [16, 38] - In the U S, pancreatic cancer represents a multi-billion-dollar commercial opportunity for pamrevlumab [27, 44] Roxadustat - Roxadustat net sales to distributors in China reached $284.1 million in full year 2023, a 36% increase compared to $208.8 million a year ago [49] - Roxadustat maintains category leadership based on dollar sales in the ESA + HIF market [54] - A sNDA for Roxadustat has been accepted in China for Anemia associated with CIA, with an approval decision expected in mid-2024 [61, 88] - In MATTERHORN Phase III Trial, 44.4% of Roxadustat arm achieved TI for ≥56 days by EOT, compared to 19.2% in the placebo arm (p=0.048) [65] FG-3246 - Interim data from a Phase 1 study of FG-3246 in heavily pretreated mCRPC patients showed a 19% ORR and a median duration of response ≥ 16 weeks [74, 79]

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 ...

Financial Data and Key Metrics Changes - For Q3 2023, total revenue was $40.1 million, a significant increase of 155% year-over-year compared to $15.7 million in Q3 2022 [51] - The net loss for Q3 2023 was $63.6 million, or $0.65 per share, an improvement from a net loss of $91.7 million, or $0.98 per share, in Q3 2022 [67] - Cash balance as of September 30 was $283 million, reflecting a change of $78.1 million from the previous quarter [17] Business Line Data and Key Metrics Changes - Roxadustat net sales in China for Q3 2023 were $77.1 million, a 31% increase from $59 million in Q3 2022, with FibroGen's net transfer price from sales being $24.2 million, up 24% year-over-year [34][35] - Pamrevlumab has been studied in over 1,000 patients and is in pivotal trials for pancreatic cancer, with upcoming results expected in early 2024 [10][11] Market Data and Key Metrics Changes - The total addressable market for pancreatic cancer in the U.S. is projected to be a multibillion-dollar opportunity if Pamrevlumab demonstrates significant improvement in overall survival [40] - Roxadustat continues to expand its market share in China, achieving a 42% value share in the category [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 [4][105] - The company anticipates filing INDs for two innovative oncology antibodies in 2024, indicating a commitment to expanding its pipeline [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the near-term prospects and the potential for significant shareholder value creation through their assets and strong balance sheet [7][22] - The company expects to achieve 75% to 85% of its quarterly savings target in Q4 2023, reflecting a disciplined approach to cost management [16] Other Important Information - The company has successfully executed a cost reduction plan, now forecasting a reduction of approximately $120 million in total annualized expenses [16] - Roxadustat's launch in Europe is accelerating, with expectations for continued growth due to its competitive position [47] Q&A Session Summary Question: What are the expectations regarding the impact of generic competition for Roxadustat in China? - Management indicated that the impact of generic competition is difficult to predict due to the unique dynamics in China, but they expect a continued strong revenue stream for the originator product even with generics entering the market [91][92] Question: How does the company plan to position FG-3246? - The company plans to position FG-3246 in the pre-chemo setting, while also considering the recent success of competing therapies [81] Question: What percentage of the patient population is expected to express CD46? - Management estimates that between 50% and 70% of patients with metastatic castration-resistant prostate cancer will be CD46 positive, with ongoing efforts to gather more data [87]

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]