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 ...

FibroGen, Inc. (NASDAQ:FGEN) Q4 2023 Earnings Conference Call February 26, 2024 5:00 PM ET Company Participants David DeLucia - Head of Corporate FP&A / Investor Relations Thane Wettig - Chief Executive Officer John Hunter - Chief Scientific Officer Juan Graham - Chief Financial Officer Conference Call Participants Andy Hsieh - William Blair Paul Choi - Goldman Sachs Operator Thank you for standing by and welcome to FibroGen's Fourth Quarter and Full Year 2023 Earnings Conference Call. [Operator Instruction ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission file number: 001-36740 FIBROGEN, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 409 Illinois Street (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...

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 ...

FibroGen, Inc. (NASDAQ:FGEN) Q3 2023 Earnings Conference Call November 6, 2023 5:00 PM ET Company Participants David DeLucia - Head of Corporate FP&A / Investor Relations Thane Wettig - Chief Executive Officer Juan Graham - Chief Financial Officer John Hunter - Chief Scientific Officer Mark Eisner - Chief Medical Officer Chris Chung - Senior Vice President of China Operations Conference Call Participants Operator Hello and welcome to the FibroGen's Third Quarter 2023 Earnings Call. At this time, all partici ...

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]

FibroGen, Inc. (NASDAQ:FGEN) Q2 2023 Earnings Conference Call August 7, 2023 5:00 PM ET Company Participants David DeLucia - Head of Corporate FP&A / Investor Relations Enrique Conterno - Chief Executive Officer Thane Wettig - Interim Chief Executive Officer Juan Graham - Chief Financial Officer Chris Chung - Senior Vice President of China Operations Mark Eisner - Chief Medical Officer John Hunter - Chief Scientific Officer Conference Call Participants Jason Gerberry - Bank of America Annabel Samimy - Stife ...