Fourth Quarter and Full Year 2025 Financial Results March 16, 2026 Forward-Looking Statements This presentation contains forward-looking statements regarding Kyntra Bio's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its 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 Kyntra Bio products and pr ...

Kyntra Bio Conference Call Summary Company Overview - **Company Name**: Kyntra Bio (formerly FibroGen) - **Ticker**: NasdaqGS:FGEN - **Event**: 2026 Conference on March 11, 2026 Key Highlights Company Transformation - Kyntra Bio transitioned from FibroGen to enhance impact for patients and shareholders [2] Financial Developments - Completed the sale of FibroGen China to AstraZeneca for approximately $220 million, including $135 million in cash [3] - Paid off a $75 million term loan facility and extended cash runway into 2028 [3] Product Pipeline FG-3246 and FG-3180 - FG-3246 is a potential first-in-class therapy targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC) [4] - FG-3180 is a PET imaging agent in clinical development for patient selection [4] - Phase II trial for FG-3246 has commenced, focusing on mCRPC patients [5] Roxadustat - Roxadustat is a phase III-ready treatment for anemia associated with lower risk myelodysplastic syndrome (MDS) [5] - Approved in over 40 countries for anemia related to chronic kidney disease [5] - Kyntra Bio owns Roxadustat in North America, South America, and Australia [5] Clinical Trials and Data FG-3246 Phase 1 Results - Phase 1 trial showed an rPFS of 8.7 months and a 36% PSA50 response rate in heavily pretreated mCRPC patients [17] - Notable adverse events included 36% grade three or above neutropenia and 34% peripheral neuropathy [18] FG-3246 and Enzalutamide Combination - Phase 1B/2 trial showed 7 months rPFS across the entire cohort and 10.1 months for patients who progressed on one prior ARPI [21] - Strong correlation between CD46 tumor uptake and PSA50 response [23] Regulatory and Market Opportunities - Received orphan drug designation from the FDA for myelodysplastic syndrome, providing seven years of regulatory exclusivity upon approval [6] - Roxadustat aims to address unmet needs in lower risk MDS, with a focus on patients requiring 4 or more RBC units [31][36] - The worldwide MDS market is projected to exceed $4 billion in the next five years, presenting a significant commercial opportunity [38] Strategic Focus - Kyntra Bio is exploring multiple lines of therapy in prostate cancer and aims to leverage the unique properties of FG-3246 and FG-3180 [29] - The company is committed to developing Roxadustat as an oral alternative for elderly patients with MDS, addressing convenience and efficacy across different patient populations [37] Conclusion Kyntra Bio is positioned to capitalize on significant opportunities in oncology and hematology, with a robust pipeline and strategic focus on addressing unmet medical needs in mCRPC and lower risk MDS. The company is actively advancing its clinical trials and regulatory strategies to enhance its market presence and shareholder value.

Forward-Looking Statements This presentation contains forward-looking statements regarding Kyntra Bio's strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its 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 Kyntra Bio products and product candidates, statements under the caption "Recent and Near-Ter ...

Summary of Kyntra Bio Conference Call Company Overview - **Company Name**: Kyntra Bio (formerly FibroGen) - **Focus**: Transitioned from fibrosis and collagen to oncology and rare diseases, reflecting a strategic transformation to leverage current momentum in these areas [1][2] Financial Highlights - **Sale of FibroGen China**: Completed sale to AstraZeneca for $220 million, which helped pay off senior secured debt and simplified capital structure [2][3] - **Cash Runway**: Extended into 2028, allowing for continued development of clinical programs [3] Clinical Development Programs FG-3246 and FG-3180 - **Indication**: Metastatic castration-resistant prostate cancer (mCRPC) - **Phase 2 Trial**: Initiated for FG-3246 (first-in-class targeting CD46) and FG-3180 (companion PET imaging agent) with interim results expected later this year [3][4] - **Clinical Responses**: Previous studies indicated meaningful clinical responses; 50%-70% of mCRPC patients express CD46 [10][53] Roxadustat - **Indication**: Anemia associated with lower-risk myelodysplastic syndromes (MDS) - **Commercial Opportunity**: Competing against luspatercept, which is projected to generate $2.3 billion in revenue by 2025, primarily in the U.S. [26] - **Regulatory Path**: Received orphan drug designation and is preparing for a phase 3 trial [5][31] Clinical Trial Insights - **Phase 1 Monotherapy Results**: Demonstrated a radiographic progression-free survival (RPFS) of 8.7 months in heavily pre-treated patients [13] - **Adverse Events**: Notable rates of neutropenia and peripheral neuropathy observed; strategies to mitigate these effects are being implemented [14][15][18] - **PET Imaging Correlation**: Evidence of correlation between CD46 expression and treatment response, which will be further evaluated in ongoing trials [20][21][54] Market Position and Strategy - **Unmet Need**: Significant unmet need in mCRPC, particularly for patients ineligible for or who have progressed on existing therapies [6][8] - **Targeted Approach**: Focus on non-PSMA approaches and the potential for combination therapies to enhance treatment efficacy [7][46] - **Patient Selection**: Utilizing PET imaging to select patients with high CD46 expression for better treatment outcomes [50][53] Future Outlook - **Upcoming Catalysts**: Anticipated interim results from ongoing trials and potential regulatory feedback on phase 3 protocols [5][6][32] - **Strategic Partnerships**: Engaging in discussions for potential business development opportunities while considering self-funding for trials [32] Conclusion Kyntra Bio is positioned to capitalize on its innovative oncology pipeline, particularly in mCRPC and MDS, with a strong focus on leveraging clinical data and strategic partnerships to enhance its market presence and patient outcomes [32][33]

Core Insights - FibroGen's roxadustat has received Orphan Drug Designation from the FDA for treating myelodysplastic syndromes (MDS), indicating a significant treatment gap in this area [2][3] - The company plans to submit the Phase 3 protocol for roxadustat in the fourth quarter of 2025 [1][2] Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies for cancer and anemia [7][8] - Roxadustat is already approved in Europe, Japan, and other countries for treating anemia in chronic kidney disease (CKD) patients [6][8] Treatment Landscape - Approximately 58,000 patients in the U.S. are diagnosed with lower-risk MDS (LR-MDS), with 85% suffering from anemia [2] - Current first-line treatments achieve transfusion independence in less than 50% of patients, highlighting the need for more effective options [2][4] - Roxadustat has shown benefits in transfusion independence compared to placebo in patients with high transfusion burden [2][4] Drug Mechanism - Roxadustat is an oral medication that promotes red blood cell production by increasing endogenous erythropoietin, improving iron absorption, and downregulating hepcidin [5] Market Potential - The FDA's Orphan Drug Designation provides benefits such as market exclusivity for seven years post-approval, which could enhance the commercial prospects for roxadustat [3]

Financial Data and Key Metrics Changes - For Q3 2025, total revenue was $1.1 million, a significant increase from $0.1 million in Q3 2024 [22] - Total operating costs and expenses decreased to $6.5 million from $47.8 million year-over-year, representing an 86% reduction [23] - Net loss from continuing operations was $13.1 million, compared to a net loss of $48.3 million in Q3 2024 [23] - Cash, cash equivalents, and investments as of September 30, 2025, totaled $121.1 million, extending the cash runway into 2028 [24] Business Line Data and Key Metrics Changes - The sale of FibroGen China to AstraZeneca was completed for approximately $220 million, providing access to cash and extending the company's runway [5][21] - The company is progressing with FG3246 and FG3180 in metastatic castration-resistant prostate cancer (MCRPC), with a phase two trial initiated [5][10] - Roxadustat is on track for a pivotal phase three trial for lower-risk myelodysplastic syndromes (MDS), with a regulatory path established following a successful FDA meeting [18][19] Market Data and Key Metrics Changes - The total addressable market for FG3246 in MCRPC is estimated to be over $5 billion annually [8] - Approximately 49,000 patients in the US are affected by anemia associated with lower-risk MDS, highlighting a significant market opportunity for Roxadustat [16] Company Strategy and Development Direction - The company aims to advance its mid and late-stage clinical development programs for FG3246 and Roxadustat, focusing on innovative treatment options for cancer and anemia [25] - The strategy includes leveraging the sale of FibroGen China to support US development initiatives and reduce fixed costs [24][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position to advance meaningful therapeutic options and create shareholder value [6] - The company anticipates reporting top-line results from the investigator-sponsored trial of FG3246 in combination with enzalutamide in Q1 2026 [25] Other Important Information - The company has a clear regulatory path for Roxadustat, with plans to submit the phase three trial protocol by the end of 2025 [19][25] - The company has reduced its total operating costs and expenses guidance for 2025 to between $50 million and $60 million, reflecting a 70% reduction from 2024 [24] Q&A Session Summary Question: Congratulations on closing the $220 million deal with AstraZeneca - Management acknowledged the transformative nature of the transaction [26] Question: What proportion of patients might be screened out due to thrombotic risk in the Roxadustat trial? - Management indicated that it is too early to estimate the proportion, as it depends on FDA alignment and trial data [29] Question: What is the estimated cost of the phase three trial for Roxadustat? - The estimated cost is between $50 to $60 million, assuming an enrollment of about 200 patients [29] Question: Can you provide more details on the top-line data expectations from the IST study for FG3246? - Management expects encouraging results consistent with previous efficacy estimates, particularly focusing on patient history with ARPIs [37] Question: Is the $63 million liability related to milestone payments for the ADC asset? - Management clarified that the liability is related to royalties from the royalty financing with NovaQuest Capital Management [39] Question: When will the decision be made regarding the phase three trial for Roxadustat? - Management expects to have clarity on the path forward by the second quarter of next year [44]

Financial Highlights - FibroGen completed the sale of FibroGen China to AstraZeneca for approximately $220 million[3, 50] - The sale included an enterprise value of $85 million and approximately $135 million of FibroGen net cash held in China[50] - The company successfully repaid its term loan to Morgan Stanley Tactical Value[3, 50] - FibroGen extended its cash runway into 2028[3, 50] FG-3246 and FG-3180 Program (Prostate Cancer) - Phase 2 monotherapy trial of FG-3246 and FG-3180 in mCRPC (post-ARPI / pre-chemo setting) has been initiated, with interim results expected in 2H 2026[3, 17, 18] - In a Phase 1 monotherapy study, FG-3246 showed a median rPFS of 8.7 months and a PSA decline of >50% in approximately 36% of patients[15] - In a Phase 1b combination study with enzalutamide, FG-3246 showed a preliminary estimate of median rPFS of 10.2 months and PSA declines in 71% of evaluable patients[15] - Topline results from an investigator-sponsored trial (IST) of FG-3246 in combination with enzalutamide in mCRPC are expected in 1Q 2026[3, 15] Roxadustat (Anemia of LR-MDS) - Roxadustat is being developed as a late-stage development opportunity for anemia due to LR-MDS and high red blood cell transfusion burden[3, 36] - In a post-hoc analysis of the MATTERHORN Phase 3 trial, roxadustat showed promising transfusion independence (TI) benefits compared to placebo in patients with high transfusion burden, with 36% achieving 8-week RBC-TI within 28 weeks compared to 7% for placebo[37, 38] - Phase 3 protocol submission is anticipated in 4Q 2025 for roxadustat in anemia of LR-MDS, with potential Phase 3 initiation in 2026[3, 45]

Core Insights - FibroGen has initiated a Phase 2 monotherapy, dose-optimization trial for FG-3246, targeting metastatic castration-resistant prostate cancer (mCRPC) [1][2] - The trial will also evaluate FG-3180, a companion PET imaging agent, for its ability to identify mCRPC lesions and predict responses to FG-3246 [1][2] Company Developments - FibroGen has completed its transformation into a U.S.-focused organization and has a cash runway extending into 2028 [2] - The Phase 2 trial will enroll 75 patients who have progressed after androgen receptor signaling inhibitor (ARSI) treatment and have not received chemotherapy [2][6] - Interim analysis results from the Phase 2 study are expected in the second half of 2026 [2][6] Clinical Trial Details - The Phase 2 trial is a randomized, open-label study designed to determine the optimal dose of FG-3246 based on efficacy, safety, and pharmacokinetics [2][5] - Patients will be randomized to receive one of three doses: 1.8, 2.4, or 2.7 mg/kg AJBW of FG-3246 [2] - Secondary endpoints include radiographic progression-free survival (rPFS) and prostate-specific antigen (PSA) response rates [2][6] Product Information - FG-3246 is a first-in-class fully human antibody-drug conjugate (ADC) targeting CD46, which is highly expressed in prostate cancer [4][8] - The drug is linked to the anti-mitotic agent MMAE, which has shown anti-tumor activity in both preclinical and clinical studies [4][8] Market Context - Prostate cancer is the second most common malignancy in men, with approximately 13% of men diagnosed during their lifetime [7] - There are about 65,000 drug-treatable mCRPC cases annually in the U.S., with a 5-year survival rate of approximately 30% [7]

Financial Highlights - FibroGen China sale预计总对价约为2.1亿美元，比最初的指导增加了5000万美元[3] - 通过出售FibroGen China，公司预计可以获得约1.25亿美元的净现金，并将现金流延长至2028年[3] - 公司将偿还Morgan Stanley Tactical Value定期贷款[3] FG-3246 & FG-3180 Program - FG-3246在既往接受大量治疗的转移性去势抵抗性前列腺癌(mCRPC)患者的1期单药治疗研究中，显示出有意义的临床活性，中位rPFS为8.7个月[14, 17] - 在FG-3246联合恩杂鲁胺治疗mCRPC的1b期研究中，观察到有临床意义的疗效信号，初步估计的中位rPFS为10.2个月，71%的可评估患者PSA下降[19] - FG-3246的2期单药治疗试验预计将于2025年第三季度启动，中期结果预计在2026年下半年公布[3, 38] Roxadustat - 在MATTERHORN 3期试验的事后亚组分析中，对于高输血负担的患者，Roxadustat与安慰剂相比显示出输血独立(TI)的益处，在28周内，Roxadustat组有36%的患者达到8周RBC-TI，而安慰剂组只有7%[49, 50] - 计划的关键性3期试验的最终方案预计将于2025年第四季度提交[3, 52]

Core Insights - FibroGen reported financial results for Q2 2025, showing total revenue of $1.3 million, an increase from $1.0 million in Q2 2024, and a net loss of $13.7 million compared to a net loss of $47.1 million in the same period last year [16][21]. Recent Developments - The company is advancing its clinical pipeline, with the Phase 2 monotherapy trial of FG-3246 expected to start in Q3 2025 [2][6]. - FibroGen reached an agreement with the FDA to advance roxadustat towards a pivotal Phase 3 trial for lower-risk myelodysplastic syndromes (LR-MDS) [2][7]. - The sale of FibroGen China to AstraZeneca is expected to close in Q3 2025 for approximately $210 million, which includes $125 million in net cash [6][7]. Financial Overview - As of June 30, 2025, FibroGen reported $23.5 million in cash and cash equivalents in the U.S. and $142.1 million in total consolidated cash [16]. - The company expects its cash runway to extend into 2028 following the sale of FibroGen China [6][16]. Upcoming Milestones - The initiation of the Phase 2 trial for FG-3246 is anticipated in Q3 2025, with topline results from an investigator-sponsored study expected in Q4 2025 [6][8]. - FibroGen plans to file the pivotal Phase 3 clinical trial protocol for roxadustat in Q4 2025 [8]. Product Development - FG-3246 is a potential first-in-class antibody-drug conjugate targeting CD46, currently in a Phase 1b/2 study in combination with enzalutamide for metastatic castration-resistant prostate cancer [11][12]. - Roxadustat is in clinical development for chemotherapy-induced anemia and is already approved in several countries for treating anemia in chronic kidney disease [13][14].