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]

FG-3246 and enzalutamide combination therapy, in biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve metastatic castration-resistant prostate cancer (mCRPC), led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, with median rPFS of 10.1 months observed in patients who progressed on only one prior ARPIHigher tumor uptake of FG-3180, a CD46 directed PET imaging agent, demonstrated a trend towards higher probabil ...

Core Insights - FibroGen, Inc. is rebranding to Kyntra Bio, focusing on oncology and rare disease assets, with trading under the new Nasdaq symbol "KYNB" starting January 8, 2026 [1][6] Company Transformation - 2025 was a pivotal year for the company, marked by the sale of FibroGen China, repayment of a senior secured term loan, and extending its cash runway into 2028 [2] - The rebranding reflects a sharpened focus on mid- and late-stage assets, particularly FG-3246, a CD46 targeting antibody drug conjugate, and FG-3180, a companion PET imaging agent in a Phase 2 trial for prostate cancer [2][4] Product Development and Clinical Trials - Roxadustat, approved in multiple countries for treating anemia in chronic kidney disease, is being evaluated for a Phase 3 trial in the U.S. for lower-risk myelodysplastic syndromes [4] - FG-3246 is in Phase 2 development for metastatic castration-resistant prostate cancer, with interim results from the ongoing monotherapy trial expected in the second half of 2026 [7] - The company has received Orphan Drug Designation from the FDA for myelodysplastic syndromes and submitted a pivotal Phase 3 clinical trial protocol for roxadustat [7] Corporate Strategy - The company is refreshing its corporate website to align with its new strategic direction [3] - Kyntra Bio aims to create a significant impact for patients and shareholders through its focused approach on novel therapies [2][6]

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]

Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies in cancer biology and anemia [3] - Roxadustat (爱瑞卓®, EVRENZO™) is approved in Europe, Japan, and other countries for treating anemia in chronic kidney disease (CKD) patients, both on and not on dialysis [3] - The company is evaluating a Phase 3 trial for roxadustat in anemia associated with lower-risk myelodysplastic syndrome (LR-MDS) in the U.S. [3] - FG-3246 (FOR46), a first-in-class antibody-drug conjugate targeting CD46, is in Phase 2 development for metastatic castration-resistant prostate cancer [3] - The development program also includes FG-3180, a CD46-targeted PET biomarker [3] Upcoming Events - FibroGen will present at the Oppenheimer Movers in Rare Disease Summit on December 11, 2025, in New York [1] - CEO Thane Wettig will participate in a panel discussing potential stock-moving catalysts for rare disease companies [1] - The management team will be available for one-on-one meetings during the conference for interested investors [2]

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Core Insights - FibroGen reported a quarterly loss of $1.61 per share, significantly better than the Zacks Consensus Estimate of a loss of $4.01, marking an earnings surprise of +59.85% [1] - The company's revenues for the quarter were $1.08 million, missing the Zacks Consensus Estimate by 34.39%, and a substantial decline from $46.33 million in the same quarter last year [2] - FibroGen shares have underperformed the market, losing about 16.7% year-to-date compared to the S&P 500's gain of 14.4% [3] Financial Performance - Over the last four quarters, FibroGen has surpassed consensus EPS estimates only once [2] - The current consensus EPS estimate for the upcoming quarter is -$4.17 on revenues of $1.67 million, and for the current fiscal year, it is -$5.59 on revenues of $6.85 million [7] Market Outlook - The sustainability of FibroGen's stock price movement will depend on management's commentary during the earnings call and future earnings expectations [3][4] - The Zacks Rank for FibroGen is currently 3 (Hold), indicating that the shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Drugs industry, to which FibroGen belongs, is currently in the top 37% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which could impact FibroGen's performance [5]

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]

Financial Performance - For the three months ended September 30, 2025, revenue was $1.1 million, a decrease from $5.2 million in the same period in 2024[149]. - Loss from continuing operations for the three months ended September 30, 2025, was $13.1 million, or $3.25 per share, compared to a loss of $48.3 million, or $12.01 per share, in the same period in 2024[153]. - For the three months ended September 30, 2025, total revenue increased by $1.0 million, or 775%, compared to the same period in 2024, while for the nine months, it decreased by $21.3 million, or 81%[204]. - Net drug product revenue for the three months ended September 30, 2025, was $957,000, a 465% increase, while for the nine months, it was $4.8 million, an 81% decrease compared to the same periods in 2024[206]. - The company recorded net product revenue of $167.2 million for the three months ended September 30, 2025, compared to $46.2 million in 2024, and $226.7 million for the nine months ended September 30, 2025, compared to $126.4 million in 2024[199]. Operating Costs and Expenses - Operating costs and expenses for the three months ended September 30, 2025, were $6.5 million, down from $47.8 million in the same period in 2024, primarily due to a $18.6 million restructuring charge in Q3 2024[150]. - Total operating costs and expenses decreased by $41.3 million, or 86%, for the three months ended September 30, 2025, and decreased by $132.2 million, or 78%, for the nine months ended September 30, 2025, compared to the same periods a year ago[216]. - Research and development expenses decreased by $18.8 million, or 94%, for the three months ended September 30, 2025, and decreased by $72.6 million, or 82%, for the nine months ended September 30, 2025, compared to the same periods a year ago[220]. - Selling, general and administrative expenses decreased by $4.1 million, or 43%, for the three months ended September 30, 2025, and decreased by $20.5 million, or 50%, for the nine months ended September 30, 2025, compared to the same periods a year ago[221]. Cash and Investments - Cash and cash equivalents increased to $118.0 million as of September 30, 2025, from $50.5 million at December 31, 2024, following the sale of China operations[154]. - Cash and cash equivalents, investments, and accounts receivable totaled $121.1 million at September 30, 2025[238]. - Net cash provided by operating activities was $13.6 million for the nine months ended September 30, 2025, primarily due to a net income of $197.7 million adjusted for non-operating cash items[240]. - Net cash used in financing activities was $86.0 million for the nine months ended September 30, 2025, including $75.0 million to pay off senior secured term loan facilities[248]. - Net cash provided by investing activities was $87.1 million for the nine months ended September 30, 2025, mainly from $90.2 million net proceeds from the divestiture of FibroGen International[245]. Business Developments - The company initiated a Phase 2 monotherapy dose optimization study of FG-3246 for metastatic castration-resistant prostate cancer (mCRPC) in Q3 2025, with interim results expected in the second half of 2026[163]. - The Phase 2 trial will enroll 75 patients and evaluate the optimal dose of FG-3246 based on efficacy, safety, and pharmacokinetics[164]. - The company plans to submit the Phase 3 trial protocol for roxadustat in anemia associated with lower-risk myelodysplastic syndromes to the FDA in Q4 2025[148]. - The planned Phase 3 trial for roxadustat will involve approximately 200 patients with lower-risk MDS, focusing on safety and efficacy[169]. - FibroGen is developing FG-3180, a companion PET imaging agent, to assess the diagnostic performance in identifying mCRPC lesions[163]. Collaborations and Agreements - The collaboration agreements with Astellas and AstraZeneca have generated a total of $790.1 million through September 30, 2025[188]. - FibroGen terminated the AstraZeneca U.S./RoW Agreement on February 25, 2024, returning all non-China roxadustat rights, with total consideration received of $439.0 million[192]. - The company retains rights to roxadustat in the U.S., Canada, and Mexico, while Astellas is commercializing it in Europe and Japan[147]. - FibroGen recognized a cumulative catch-up net adjustment of $25.7 million to drug product revenue in Q1 2024 due to the termination of the AstraZeneca U.S./RoW Agreement[215]. Discontinued Operations - The operating results related to FibroGen International are classified as discontinued operations in the condensed consolidated statements of operations[232]. - The company entered into a Share Purchase Agreement with AstraZeneca to sell all equity interests of FibroGen International, which closed on August 29, 2025[231]. - FibroGen received $210.4 million in cash at the closing of the sale of FibroGen International to AstraZeneca on August 29, 2025, with an additional $10.0 million subject to holdbacks[234]. Future Outlook - FibroGen expects future revenues to fluctuate due to the uncertain timing and amount of collaboration agreement payments and drug product sales[203]. - The company anticipates needing substantial additional funding for ongoing operations and development efforts[251]. - As of September 30, 2025, the company had $65.0 million of liability related to the sale of future revenues under the RIFA with NovaQuest[253].