Pancreatic carcinoma non-resectable

GRAND CAYMAN, Cayman Island--( BUSINESS WIRE )--Silexion Therapeutics Corp. (NASDAQ: SLXN) (“Silexion” or the “Company”), a clinical-stage biotech developing RNA interference (RNAi) therapies for KRAS-driven cancers, today announced significant new findings from its Phase 2 trial of LODER™ in patients with non-resectable locally advanced pancreatic cancer (LAPC) which bear the KRAS G12D or G12V mutation (approximately 70% of pancreatic cancer patients). Overall the updated analysis reveals a 56% objective response rate (ORR) in patients treated with LODER, with the ORR increasing to 67% in patients whose previously non-resectable tumors became resectable. This marks a significant step forward in potentially improving surgical outcomes for LAPC patients. Silexion had previously reported that patients treated with LODER in combination with standard-of-care (SoC) chemotherapy experienced a 9.3-month improvement in overall survival (OS) compared to chemotherapy alone. The new data now underscores LODERs additional potential to increase the resectability of tumors, opening up more surgical options for patients with otherwise inoperable pancreatic cancer. Silexion is also progressing with the development of its next generation product, SIL-204, which builds upon the efficacy of the LODER. SIL-204 is designed to target a broader range of KRAS mutations, covering pan- G12x and G13D, as well as the previously reported findings of properties which should make it more effective clinically such as improved stability and enhanced ability to get to the site of action for silencing the KRAS oncogene. These improved properties demonstrated in preclinical models position SIL-204 as a promising option for the treatment of difficult-to-treat cancers such as locally advanced pancreatic cancer. Silexion continues to proceed with the development of this optimized candidate. "We are very encouraged by these new findings, which demonstrate LODER's ability to significantly improve tumor resectability in patients with non-resectable pancreatic cancer, and the improved profile of SIL-204" said Ilan Hadar, Chairman and CEO of Silexion. "As we advance our broader pipeline to address KRAS-driven cancers, this data further validates our oncogene silencing approach." About the Phase 2 Trial of LODER The open-label Phase 2 trial enrolled 48 patients in the mITT population with non-resectable locally advanced pancreatic cancer (LAPC) and borderline resectable pancreatic cancer (BRPC) across the U.S. and Israel. The trial was conducted in two parts: Cohort 1 (n=29) : Patients were randomized 1:1 to receive either LODER with SoC chemotherapy or SoC chemotherapy alone. The primary endpoint was overall survival (OS), with 16 patients confirmed to harbor the KRAS G12D/V mutation. Cohort 2 (n=19) : This cohort enrolled patients with non-resectable tumors, LAPC or BRPC, with the key endpoints focused on ORR and safety. Seven patients in this cohort were confirmed to have KRAS G12D/V mutations. Objective Response Rate for 23 patients confirmed with KRAS G12D/V (Cohorts 1+2) About Silexion Therapeutics Silexion Therapeutics (NASDAQ: SLXN) is a pioneering clinical-stage, oncology-focused biotechnology company developing innovative RNA interference (RNAi) therapies to treat solid tumors driven by KRAS mutations, the most common oncogenic driver in human cancers. The company's first-generation product, LODER, has shown promising results in a Phase 2 trial for non-resectable pancreatic cancer. Silexion is also advancing its next-generation siRNA candidate, SIL-204, designed to target a broader range of KRAS mutations and showing significant potential in preclinical studies. The company remains committed to pushing the boundaries of therapeutic innovation in oncology, with a focus on improving outcomes for patients with difficult-to-treat cancers. For more information please visit: https://silexion.com Forward-Looking Statements This press release contains forward-looking statements within the meaning of the federal securities laws. All statements other than statements of historical fact contained in this communication, including statements regarding Silexion’s business strategy and plans and objectives of management for future operations, are forward-looking statements. These forward-looking statements are generally identified by terminology such as “pro forma”, “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements involve a number of risks, uncertainties, and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) Silexion’s market opportunity; (ii) Silexion’s strategy, future operations, financial position, projected costs, prospects and plans; (iii) the impact of the regulatory environment and complexities with compliance related to such environment; (iv) expectations regarding future partnerships or other relationships with third parties; (v) Silexion’s future capital requirements and sources and uses of cash, including Silexion’s ability to obtain additional capital in the future; and (vi) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by the company, including the proxy statement/prospectus filed with the SEC on July 17, 2024. Silexion cautions you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the date they are made. Silexion undertakes no obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs, except as otherwise required by law.

LONDON--( BUSINESS WIRE )-- Silexion Therapeutics (NASDAQ: SLXN) has emerged an intriguing yet under the radar player in the precision oncology space, focusing on developing innovative RNA interference (RNAi) therapies for KRAS-driven cancers. As a recently de-SPACed company following its merger with Moringa Acquisition Corp (NASDAQ: MACA), Silexion presents an interesting opportunity in the rapidly growing field of targeted cancer treatments, particularly in addressing the challenges of pancreatic and potentially other KRAS-driven cancers. Technology Deep Dive: LODER™ and SIL-204 At the core of Silexion's approach is its proprietary LODER™ (Local Drug EluteR) platform, which has demonstrated encouraging results in Phase 2 clinical trials for locally advanced pancreatic cancer. The company's technology stands out due to two key pharmacological functions: oncogene silencing and localized delivery. Silexion's siRNA actively prevents cells from producing oncogenic proteins, contrasting with small molecule KRAS inhibitors that target already-oncogenic proteins. Additionally, the LODER™ system bypasses the tumor barrier, allowing for higher concentrations of treatment directly within the tumor, enhancing efficacy while reducing systemic side effects. Silexion's second-generation improved product, SIL-204, is an optimized siRNA formulation expected to enter Phase 2/3 clinical trials in 2025-2026. SIL-204 represents a significant advancement in RNAi technology, with the potential to target a broader range of KRAS mutations (pan KRAS G12x). This is particularly important as it addresses a wider spectrum of KRAS-driven cancers compared to current small molecule KRAS inhibitors, which are limited to targeting KRAS G12C (found in only 1-2% of pancreatic cancer cases). The Context: The Challenges in Treating Pancreatic Cancer Pancreatic cancer remains one of the most challenging malignancies to treat, with a dismal five-year survival rate of just 12.8%. Several factors contribute to the difficulty in treating this aggressive cancer. Late detection is a major issue, as pancreatic cancer is often diagnosed at advanced stages due to a lack of early symptoms and effective screening methods. The aggressive nature of pancreatic tumors, characterized by rapid growth and early metastasis, further complicates treatment efforts. The dense tumor microenvironment of pancreatic cancer creates a significant barrier to drug penetration, reducing the effectiveness of traditional chemotherapies. Additionally, the genetic complexity of pancreatic cancer, with KRAS mutations present in over 90% of cases, has proven difficult to target effectively with conventional therapies. Compounding these challenges is the tendency of pancreatic cancer cells to develop resistance to standard chemotherapies, leading to poor long-term outcomes. Silexion's LODER™ and SIL-204 technologies are designed to address these challenges directly. By silencing KRAS mutations at the genetic level and delivering treatment locally, Silexion's approach has the potential to overcome the barriers that have historically limited the effectiveness of pancreatic cancer treatments. Clinical Progress and Future Potential Silexion's LODER™ technology has already shown promising results in Phase 2 clinical trials for locally advanced pancreatic cancer. Key findings include a 9.3-month improvement in overall survival when LODER™ was combined with standard chemotherapy, compared to chemotherapy alone in patients with non-resectable pancreatic cancer harboring KRAS G12D/V mutations. The study also revealed an increased objective response rate (ORR) of 55% with LODER™ plus chemotherapy, compared to 20% for standard chemotherapy alone. Notably, the ORR increased to 64% when considering tumors that were initially non-resectable becoming resectable. These results are particularly encouraging given the historically poor outcomes in pancreatic cancer treatment. As SIL-204 moves into Phase 2/3 trials, there is potential for even greater efficacy due to its optimized formulation and broader targeting of KRAS mutation. Expanding Beyond Pancreatic Cancer: Treating Other KRAS-Driven Cancers While Silexion's initial focus has been on pancreatic cancer, the company's innovative RNAi technology and LODER™ platform have significant potential for application in other KRAS-driven cancers. This broader applicability could substantially expand Silexion's market opportunity and impact in the field of precision oncology. The company's pipeline includes plans to target additional types of pancreatic cancer as well as other cancers driven by KRAS mutations. One notable area of potential expansion is colorectal cancer, which is often associated with KRAS mutations and represents a significant unmet medical need. The ability of Silexion's technology to target a broader range of KRAS mutations (pan KRAS G12x) compared to current small molecule inhibitors positions the company favorably for addressing multiple cancer types. This versatility could prove particularly valuable as KRAS mutations are found in various cancers beyond pancreatic, including lung and colorectal cancers. Moreover, the localized delivery system of the LODER™ platform could potentially be adapted for use in other solid tumors, offering a unique advantage in treating cancers that are challenging to target with systemic therapies. This adaptability could open up new avenues for Silexion in treating a wider array of difficult-to-treat cancers. As Silexion advances its clinical trials and potentially expands into these additional indications, it could significantly broaden its addressable market. This expansion potential not only enhances the company's value proposition but also aligns with the growing trend in precision medicine towards developing versatile platforms that can address multiple cancer types driven by similar genetic mutations. Market Potential: Big Pharma's Growing Appetite for Precision Oncology The precision medicine market, particularly in oncology, is experiencing explosive growth, with major pharmaceutical companies like Pfizer aggressively seeking innovative assets to bolster their pipelines. This trend is driven by the projected expansion of the global precision medicine market from $102.17 billion in 2024 to a staggering $470.53 billion by 2034, growing at a CAGR of 16.5%. Within this broader market, KRAS-driven cancers represent a substantial unmet need, with the market for KRAS inhibitors expected to grow at an impressive 36% CAGR, reaching $10 billion by 2032. This rapid growth has sparked a flurry of M&A activity in the precision oncology space, as exemplified by several high-profile acquisitions. For example , Pfizer's landmark $43 billion acquisition of Seagen in 2023, which doubled Pfizer's oncology pipeline and highlighted the growing importance of antibody-drug conjugates (ADCs) and precision oncology treatments. Similarly, AbbVie's $10.1 billion purchase of Immunogen, following the FDA approval of Elahere, a targeted therapy for ovarian cancer, demonstrating the high value placed on innovative, precision-targeted treatments. These deals underscore the willingness of big pharma to invest heavily in cutting-edge oncology assets, particularly those addressing difficult-to-treat cancers with novel approaches. Silexion's focus on RNAi technology for KRAS-driven cancers, especially its innovative approach to pancreatic cancer treatment, positions it as a potentially attractive acquisition target in this landscape. The company's technologies, which have shown initial promising results in clinical trials, seem to align well with the industry trend towards more targeted and personalized cancer therapies. As large pharmaceutical companies continue to seek differentiated assets to fill gaps in their oncology portfolios, Silexion's unique technology and focus on high-unmet-need cancers could make it a valuable addition to a larger company's pipeline. Moreover, with major pharmaceutical companies collectively holding over $170 billion in cash reserves, according to recent reports , the M&A environment seems highly favourable for innovative companies like Silexion. This trend, combined with Silexion's potential to address the challenges of pancreatic cancer - a disease with a dismal five-year survival rate of just 12.8% - positions the company at the intersection of high market demand and critical unmet medical need. Looking Ahead Silexion Therapeutics represents a unique approach in the fight against KRAS-driven cancers, particularly pancreatic cancer. Its innovative RNAi technology, delivered via the LODER™ platform and the promising SIL-204, seems to address many of the challenges that have historically limited progress in treating these aggressive cancers. As the company advances its clinical trials and potentially potential eyes other KRAS-driven cancers, it stands at the forefront of a new era in precision oncology. While the road ahead in drug development is always challenging, Silexion's progress to date and the potential of its technology make it a company to watch in the evolving landscape of cancer treatment. As with any early-stage biotech company, potential stakeholders should conduct thorough due diligence, considering both the promising technology and market opportunity alongside the inherent risks in drug development. PESG Research is a digital research and coverage brand, offering commentary and exploration into the current and future state of the Pharma, BioTech and Sustainability and other industries. * * * This report is for informational purposes only and is not intended to serve as medical financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the text is subject to. PESG Research is a digital brand that has been compensated to publish and syndicate commentary and exploration into innovative companies and industries and it is subject to conflicts of interest as detailed in the full documentation. 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Company implementing significant cost reduction plan in the U.S. due to results in late-stage pamrevlumab pancreatic cancer trials, including a reduction of U.S. workforce by approximately 75%Focus R&D investment on FG-3246 and PET46, a first-in-class anti-CD46 antibody-drug conjugate and companion PET imaging agent for metastatic castration-resistant prostate cancer (mCRPC) Presented compelling preliminary data from dose escalation portion of Phase 1b/2 investigator-sponsored study of FG-3246, in combination with enzalutamide, in patients with mCRPC at the 2024 American Society of Clinical Oncology Annual Meeting Topline results from Phase 2 portion of the study expected in 1H 2025 Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025Second quarter net revenue growth of 14% year over year, driven by strong performance of roxadustat in China, with robust year over year volume growth of 33% Raising full year net product revenue guidance to $135 million to $150 million, representing full year total roxadustat net sales in China1 between $320 million to $350 million Cash, cash equivalents and accounts receivable balance of $147.1 million; cash runway projected into 2026 SAN FRANCISCO, Aug. 06, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the second quarter 2024 and provided an update on the company’s recent developments. “While we are disappointed with the results from the pamrevlumab pancreatic cancer trials, we continue to be very excited about the prospects of FG-3246 and PET46, our CD46 targeted antibody-drug conjugate and companion PET imaging agent. We have released compelling Phase 1 data on FG-3246 as a monotherapy and in combination with enzalutamide in metastatic castration-resistant prostate cancer. In addition, roxadustat continues its strong momentum in China, exceeding $92 million in net sales in the second quarter,” said Thane Wettig, Chief Executive Officer, FibroGen. “Looking ahead, we expect topline data from the Phase 2 portion of the FG-3246 + enzalutamide combination study in mCRPC in the first half of 2025 and plan on initiating our Phase 2 monotherapy study in mCRPC in the first quarter of 2025 with a more focused and streamlined organization. I would like to express my deepest gratitude to our FibroGen colleagues who have dedicated so much of their time and energy for the prospect of bringing much needed therapies to some of the most challenging and deadly diseases affecting humanity.” Recent Developments and Key Events of Second Quarter 2024: Implementing significant cost reduction plan in the U.S. Headcount in the U.S. will be reduced by approximately 75%. Focusing R&D investment on FG-3246 and PET46, a first-in-class antibody-drug conjugate and companion PET imaging agent for mCRPC.Announced positive interim results from the dose escalation portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 (FOR46), a potential first-in-class anti-CD46 antibody drug conjugate (ADC) with a MMAE-containing payload, in combination with enzalutamide in patients with metastatic castration resistant prostate cancer (mCRPC) at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation included data from 17 biomarker unselected patients in the dose escalation portion of the trial. Over 70% of the patients in the study received at least two prior ARSIs, which included prior enzalutamide treatment.The primary endpoint was determination of the maximally tolerated dose (MTD) of FG-3246 in combination with enzalutamide. The MTD was established at 2.1 mg/kg ABW, with primary G-CSF prophylaxis, in combination with enzalutamide 160 mg/day. The combination treatment demonstrated an encouraging preliminary estimate of median radiographic progression free survival (rPFS) of 10.2 months with prostate-specific antigen (PSA) declines observed in 71% (12/17) of evaluable patients. Additional data from a total of 56 biomarker unselected and heavily pre-treated patients in a Phase 1 monotherapy study of FG-3246 in mCRPC reported. Efficacy analysis (includes adenocarcinoma patients receiving doses ≥ 1.2 mg/kg): The median radiographic progression free survival (rPFS) in this patient population was 8.7 months.For RECIST evaluable patients, 20% met the criteria of a partial response, or measurable tumor reduction in size of ≥ 30%, with a median duration of response of 7.5 months.PSA reductions of ≥ 50% were observed in 36% of PSA evaluable patients. Safety analysis: The most frequent adverse events were consistent with other MMAE-based antibody drug conjugates and included infusion-related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy. Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint. Upcoming Milestones: Roxadustat Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca. Oncology Pipeline Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by the University of California San Francisco of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025. China: Second quarter FibroGen net product revenue under U.S. GAAP from the sale of roxadustat in China was $49.6 million compared to $23.9 million in the first quarter of 2023, an increase of 108% year over year.Second quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $92.3 million, compared to $76.4 million in the second quarter of 2023, an increase of 21% year over year, driven by a 33% increase in volume.Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.For 2024, FibroGen’s expected full year net product revenue under U.S. GAAP is raised to a range between $135 million to $150 million, representing expected full year roxadustat net sales in China1 by FibroGen and the JDE of $320 million to $350 million, due to continued strong performance in China. Financial: Total revenue for the second quarter of 2024 was $50.6 million, as compared to $44.3 million for the second quarter of 2023, an increase of 14% year over year. Total revenue increase was driven by strong performance of roxadustat in China and changes in net product revenue assumptions under U.S. GAAP.Net loss for the second quarter of 2024 was $15.5 million, or $0.16 net loss per basic and diluted share, compared to a net loss of $87.7 million, or $0.90 net loss per basic and diluted share one year ago.At June 30, 2024, FibroGen reported $147.1 million in cash, cash equivalents and accounts receivable.We expect our cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into 2026. Conference Call and Webcast Details FibroGen management will host a conference call and webcast today, Tuesday, August 6, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access the conference call by dialing 1-877-300-8521 (in the U.S.) or 1-412-317-6026 (outside the U.S.). The call will be available via webcast by clicking here or on the “Events and Presentation” page on the FibroGen website. About RoxadustatRoxadustat, 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). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca, to regulatory authorities across the globe, and are currently under review. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China. About FibroGen FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Roxadustat (爱瑞卓®, EVRENZOTM) 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. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. 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 an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. 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”, statements regarding the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund FibroGen’s operating plans into 2026, 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, 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. ________________________1 Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements. Condensed Consolidated Balance Sheets(In thousands) June 30, 2024 December 31, 2023 (Unaudited) (1) Assets Current assets: Cash and cash equivalents$140,714 $113,688 Short-term investments - 121,898 Accounts receivable, net 6,412 12,553 Inventory 25,397 41,565 Prepaid expenses and other current assets 36,936 41,855 Total current assets 209,459 331,559 Restricted time deposits 1,658 1,658 Property and equipment, net 10,917 13,126 Equity method investment in unconsolidated variable interest entity 6,912 5,290 Operating lease right-of-use assets 61,212 68,093 Other assets 3,045 3,803 Total assets$293,203 $423,529 Liabilities, stockholders’ equity and non-controlling interests Current liabilities: Accounts payable$9,938 $17,960 Accrued and other liabilities 113,574 172,891 Deferred revenue 9,546 12,740 Operating lease liabilities, current 15,531 14,077 Total current liabilities 148,589 217,668 Product development obligations 17,397 17,763 Deferred revenue, net of current 131,192 157,555 Operating lease liabilities, non-current 58,376 66,537 Senior secured term loan facilities, non-current 72,478 71,934 Liability related to sale of future revenues, non-current 54,532 51,413 Other long-term liabilities 1,012 2,858 Total liabilities 483,576 585,728 Redeemable non-controlling interests 21,480 21,480 Total stockholders’ deficit attributable to FibroGen (232,340) (204,166)Nonredeemable non-controlling interests 20,487 20,487 Total deficit (211,853) (183,679)Total liabilities, redeemable non-controlling interests and deficit$293,203 $423,529 (1) The condensed consolidated balance sheet amounts at December 31, 2023 are derived from audited financial statements. Condensed Consolidated Statements of Operations(In thousands, except per share data) Three Months Ended June 30, Six Months Ended June 30, 2024 2023 2024 2023 (Unaudited) Revenue: License revenue $— $1,000 $— $7,000 Development and other revenue 269 5,158 1,147 9,050 Product revenue, net 49,643 23,889 80,181 48,049 Drug product revenue, net 729 14,272 25,216 16,381 Total revenue 50,641 44,319 106,544 80,480 Operating costs and expenses: Cost of goods sold 5,178 5,708 30,931 9,199 Research and development 34,106 95,478 72,498 169,964 Selling, general and administrative 22,276 31,181 45,097 65,455 Total operating costs and expenses 61,560 132,367 148,526 244,618 Loss from operations (10,919) (88,048) (41,982) (164,138) Interest and other, net: Interest expense (4,783) (3,069) (9,779) (5,441)Interest income and other income (expenses), net (1,281) 2,652 1,289 3,687 Total interest and other, net (6,064) (417) (8,490) (1,754) Loss before income taxes (16,983) (88,465) (50,472) (165,892)Benefit from income taxes (262) (235) (229) (161)Investment income in unconsolidated variable interest entity 1,177 550 1,766 1,346 Net loss $(15,544) $(87,680) $(48,477) $(164,385) Net loss per share - basic and diluted $(0.16) $(0.90) $(0.49) $(1.71) Weighted average number of common shares used to calculate net loss per share - basic and diluted 99,835 97,729 99,408 96,218 For Investor Inquiries:David DeLucia, CFAVice President of Corporate FP&A / Investor Relationsir@fibrogen.com For Media Inquiries:Simon MillerVice President, Marketing and Corporate Communicationsmedia@fibrogen.com