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Announced sale of FibroGen China to AstraZeneca for a total consideration of approximately $160 million Transaction expected to close by mid-2025 Transaction expected to close by mid-2025 Upon close of sale of FibroGen China, cash runway extended into 2027 Initiation of the Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC), expected by mid-2025 Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 2H 2025 FibroGen to host conference call and webcast presentation today at 5:00 PM ET SAN FRANCISCO , March 17, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2024 and provided an update on the company’s recent developments. “We entered 2025 optimistic about our future, highlighted by the planned initiation of the Phase 2 monotherapy trial of FG-3246, our first-in-class ADC targeting CD46 for the treatment of mCRPC, by mid-2025,” said Thane Wettig , Chief Executive Officer. “Through the successful implementation of our cost reduction plan, and upon the closing of our recently announced sale of FibroGen China, we will be a leaner and more focused organization, with a stronger financial position and a cash runway that takes us into 2027, with multiple potential value-creating milestones in sight.” Recent Developments and Key Highlights of 2024: Announced the sale of FibroGen China to AstraZeneca for a total consideration of approximately $160 million , representing an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $75 million . The transaction is expected to close by mid-2025. Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure. FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China , South Korea , and those licensed to Astellas. Appointed David DeLucia , CFA, as Senior Vice President and Chief Financial Officer. Completed previously announced cost reduction program. Upon closing, FibroGen will repay its term loan to Morgan Stanley Tactical Value, further simplifying the Company’s capital structure. FibroGen maintains its rights to roxadustat in the U.S. and in all markets outside of China , South Korea , and those licensed to Astellas. Upcoming Milestones: FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC by mid-2025. Phase 2 trial will include a sub-study of FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246. Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 2H 2025. Phase 2 portion of the study will include data on FG-3180. Phase 2 trial will include a sub-study of FG-3180 to enable assessment of its diagnostic performance and the potential correlation between CD46 expression and response to FG-3246. Phase 2 portion of the study will include data on FG-3180. Roxadustat Plan to meet with FDA in 2Q 2025 to determine the potential next steps for the development of roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS), an indication with significant unmet medical need, in the U.S. Financial: Total revenue from continuing operations for the fourth quarter of 2024 was $3.1 million , as compared to $3.6 million for the fourth quarter of 2023. Total revenue from continuing operations for the full year 2024 was $29.6 million , as compared to $46.8 million for the full year 2023. Net loss from continuing operations for the fourth quarter of 2024 was $8.7 million , or $0.08 net loss per basic and diluted share, compared to a net loss of $62.5 million , or $0.63 net loss per basic and diluted share, one year ago. Net loss from continuing operations for the full year 2024 was $153.1 million , or $1.53 net loss per basic and diluted share, compared to a net loss of $323.0 million , or $3.32 net loss per basic and diluted share, for the full year 2023. At December 31, 2024 , FibroGen reported $51.0 million in cash, cash equivalents and accounts receivable in the U.S. and $121.1 million in total consolidated cash, cash equivalents and accounts receivable. Upon closing of the announced sale of FibroGen China, the Company expects its cash, cash equivalents and accounts receivable to be sufficient to fund operations into 2027. Conference Call and Webcast Presentation The FibroGen management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on FibroGen’s website. About FG-3246 FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by FibroGen for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3246 is currently in an ongoing Phase 1b/2 study being conducted at UCSF as an investigator-sponsored trial to evaluate FG-3246 in combination with enzalutamide. An additional investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 positron emission tomography (PET) tracer for CD46 that utilizes the YS5 antibody is also underway at UCSF. The initiation of the Phase 2 monotherapy dose optimization trial for FG-3246 in metastatic castration-resistant prostate cancer is anticipated by mid-2025. FG-3246 is an investigational drug and not approved for marketing by any regulatory authority. About Roxadustat Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority . Roxadustat is approved in China , Europe , Japan , and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). FibroGen has the sole rights to roxadustat in the United States , Canada , Mexico , and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and FibroGen are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan , Europe , Turkey , Russia , and the Commonwealth of Independent States, the Middle East , and South Africa . About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on development of novel therapies at the frontiers of cancer biology and anemia. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China , Europe , Japan , and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate a development plan for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.fibrogen.com. Forward-Looking Statements This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, the net cash portion of the purchase price and closing of the sale of FibroGen China as well as the payoff of the Morgan Stanley Tactical Value term loan, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen’s operating plans into 2027, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law. Condensed Consolidated Balance Sheets(In thousands) Condensed Consolidated Statements of Operations(In thousands, except per share data) For Investor Inquiries: David DeLucia , CFASenior Vice President and Chief Financial Officerir@fibrogen.com Source: FibroGen, Inc.

OSAKA, Japan I March 11, 2025 I Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “ONO”) announced that it has entered into a license agreement with Ionis Pharmaceuticals, Inc. (Carlsbad, CA,U.S.; CEO, Brett P. Monia, Ph.D.; “Ionis”) for sapablursen, an investigational RNA-targeted medicine for the treatment of polycythemia vera (PV). Sapablursen is currently being evaluated in adult patients with PV in the fully enrolled Phase 2 IMPRSSION study. Sapablursen was granted Fast Track designation in January 2024 and orphan drug designation in August 2024 by the U.S. Food and Drug Administration (FDA). Under the agreement, ONO will obtain an exclusive license to develop and commercialize sapablursen worldwide. Ionis will remain responsible for the completion of the ongoing Phase 2 IMPRSSION study, while ONO will be solely responsible for subsequent development, regulatory filings and commercialization. ONO will make an upfront payment of 280 million US dollars, with up to a maximum of 660 million US dollars in additional payments based on the achievement of development, regulatory and sales milestones. ONO will also pay to Ionis royalties in the mid-teens on annual net sales of sapablursen. The transaction is subject to the requirements of the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act). “We are delighted to enter into this collaboration with Ionis Pharmaceuticals, a pioneer in RNA-targeted medicines, for sapablursen. This partnership aligns with our strategy to strengthen our pipeline in hematology. We expect sapablursen to become a new treatment option for PV patients worldwide,” said Toichi Takino, President and COO of ONO. “Ionis and ONO share a commitment to advancing innovative medicines to help meet the needs of people living with serious diseases. We are pleased to entrust sapablursen to ONO, whose unique capabilities will help maximize its value by ensuring broad access for people living with PV,” said Brett P. Monia, Ph.D., CEO of Ionis. The impact of this matter on the Company’s consolidated financial results for the current fiscal year ending March 31, 2025, is expected to be minor. Should there be any events to be disclosed in the future, we will announce them in a timely manner. About Sapablursen Sapablursen is designed to reduce the production of TMPRSS6 resulting in increased expression of hepcidin, which is the key regulator of iron homeostasis. By increasing production of hepcidin, sapablursen has the potential to positively impact blood diseases such as PV. About Polycythemia Vera Polycythemia Vera (PV) is a rare and potentially life-threatening hematologic disease characterized by the overproduction of red blood cells, which significantly increases the risk of serious blood clots, especially in critical organs like the lungs, heart and brain. Patients with PV also experience severe iron deficiency and commonly have symptoms of fatigue, which can lead to reduce quality of life (QOL). About Ionis Pharmaceuticals Inc. For three decades, Ionis has invented medicines that bring better futures to people with serious diseases. Ionis currently has six marketed medicines and a leading pipeline in neurology, cardiology, and select areas of high patient need. As the pioneer in RNA-targeted medicines, Ionis continues to drive innovation in RNA therapies in addition to advancing new approaches in gene editing. A deep understanding of disease biology and industry-leading technology propels our work, coupled with a passion and urgency to deliver life-changing advances for patients. For further information, visit https://www.ionis.com/ . SOURCE: Ono Pharmaceutical Co

Ionis Pharmaceuticals previously investigated sapablursen in another blood disorder called beta thalassemia.\n Japan\'s Ono Pharmaceutical is handing over $280 million upfront to acquire Ionis Pharmaceuticals’ phase 2-stage antisense oligonucleotide for a rare type of blood cancer.The RNA-targeted medicine, called sapablursen, is designed to reduce the production of a protein called TMPRSS6. The idea is that this increases the expression of hepcidin, which is the key regulator of iron homeostasis, thereby helping treat various blood diseases.Sapablursen is currently in a phase 2 trial for polycythemia vera (PV), a rare blood condition characterized by the overproduction of red blood cells. As part of the licensing deal with Ono, Ionis will remain responsible for the midstage study.Beyond that, Ono will become solely responsible for sapablursen’s development, regulatory filings and commercialization, according to a post-market release March 11.In return, Ono is handing over $280 million upfront, with potentially up to $660 million to follow in additional development, regulatory and sales milestones, along with mid-teen royalties on annual net sales.Ionis had previously investigated sapablursen in another blood disorder called beta thalassemia before ending those plans in 2023 after looking at midphase efficacy data and instead focusing on PV.At the time, Ionis CEO Brett Monia, Ph.D., said the company had seen “quite remarkable” target engagement in phase 1 plus “very significant elevations in hepcidin levels.” However, “in beta-thalassemia intermedia, we didn\'t see those changes,” the CEO explained back in 2023.In yesterday’s release, Monia said the company was “pleased to entrust sapablursen to Ono, whose unique capabilities will help maximize its value by ensuring broad access for people living with PV.” Ionis recently became a commercial-stage company as a result of the approval of Tryngolza to treat the rare genetic disorder familial chylomicronemia syndrome in December.“Ionis remains committed to advancing the wholly owned medicines we choose to commercialize ourselves, which includes our first independent launch currently underway and three additional anticipated launches in the next three years,” Monia added. “Streamlining our Ionis-owned portfolio provides financial flexibility, supporting our commitment to invest in and focus on our near and mid-term commercial opportunities and generate substantial revenue growth.”Meanwhile, Ono—which codeveloped blockbuster cancer immunotherapy Opdivo with Bristol Myers Squibb—is active in the oncology space, where it is working on a slate of antibodies as well as some multispecific molecules and cell therapies. Last year, the biotech got in on the antibody-drug conjugate action via a $700 million biobucks deal with LigaChem Biosciences.The partnership with Ionis “aligns with our strategy to strengthen our pipeline in hematology,” said Ono President and Chief Operating Officer Toichi Takino, who added that the company “expects sapablursen to become a new treatment option for PV patients worldwide.”The deal comes a week after Takeda and Protagonist Therapeutics posted a phase 3 win for their own PV prospect, an injectable hepcidin mimetic called rusfertide.“While rusfertide is likely to be first to market in the hepcidin-boosting drug class, we see sapablursen as a potential improvement in treatment regimen that will be attractive to patients and healthcare providers,“ William Blair analysts said in a March 12 note, adding that Ono\'s deal with Ionis was “positive for both sides.“