Financial Data and Key Metrics Changes - The company reported Q4 product revenue of $1.2 million from TECELRA, with expectations to invoice approximately six to eight patients in Q1 2025, significantly higher than the previous quarter [9][10][17] - The consensus analyst forecast for 2025 sales is approximately $25 million, which the company believes is achievable based on current performance metrics [17][30] Business Line Data and Key Metrics Changes - The launch of TECELRA has seen strong momentum, with 20 authorized treatment centers (ATCs) established, ahead of the planned 30 by the end of 2025 [6][8] - The company has a pipeline of around 20 biomarker-positive patients expected to be treated in Q2 and Q3 2025, with over 80 patients having completed MAGE-A4 testing [11][12] Market Data and Key Metrics Changes - Over 70% of commercial and Medicare lives have established reimbursement policies for TECELRA, with no denials reported to date [12] - The company anticipates that Lete-cel will expand the sarcoma franchise, potentially doubling the number of treatable patients annually in the US [25] Company Strategy and Development Direction - The company aims to achieve cash flow breakeven by 2027, with a focus on building a successful business around two FDA-approved products in sarcoma [26][30] - The company is exploring strategic options, including partnerships and collaborations, to optimize shareholder value and ensure financial stability [28][56] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the accelerating sales of TECELRA and the anticipated launch of Lete-cel, which is expected to leverage existing commercial infrastructure [17][30] - The company is focused on managing costs effectively while pushing towards profitability in 2027, with a commitment to exploring all financial opportunities [30][56] Other Important Information - The company has paused spending on preclinical programs targeting PRAME and CD70, which is expected to reduce cash flow demands by approximately $75 million to $100 million through 2028 [27][68] - The company is part of the PRIME scheme in Europe for TECELRA and plans to submit a marketing application based on comprehensive trial results [80] Q&A Session Summary Question: Can you comment on the pace of apheresis during Q1? - The pace of apheresis has been increasing, with more patients being treated as additional ATCs come online [35] Question: What are the assumptions for profitability in 2027? - The company has not provided specific revenue guidance but expects to achieve profitability through the combination of TECELRA and Lete-cel sales [36][50] Question: What is the status of the ex-US strategy? - The primary focus remains on establishing a commercially viable business in the US, with discussions ongoing for potential partnerships in ex-US markets [66] Question: Can you provide insights on the financials for the quarter? - The company is finalizing its 10-K filing and expects to publish it soon, with anticipated cost reductions from restructuring [68] Question: Are there any capacity constraints affecting patient infusions? - There are currently no capacity limitations reported, and the company is confident in meeting its goals [111][112]

Core Insights - Adaptimmune is experiencing accelerating momentum with the launch of its first commercial product, Tecelra, aimed at treating sarcoma [3][5] - The company is on track to initiate a rolling Biologics License Application (BLA) submission for its next product, lete-cel, by late 2025, with approval anticipated in 2026 [5][9] - A corporate restructure was completed in February 2025, with additional cost reductions being implemented for the PRAME and CD70 programs to enhance financial sustainability [5][6] Financial Performance - As of the end of 2024, Adaptimmune reported total liquidity of $152 million, which includes cash and cash equivalents of $91.1 million and marketable securities of $60.5 million [7] - The company achieved a product revenue of $1.2 million in Q4 2024, having aphereseed 3 patients in 2024 and 10 patients in 2025 to date [5] - A significant reduction in headcount by 29% was executed in Q1 2025 as part of a broader strategy to achieve approximately $300 million in cost savings over the next four years [5] Strategic Initiatives - The company is evaluating all strategic options to maximize shareholder value amid current capital market conditions [2][5] - Adaptimmune has engaged TD Cowen to assist in evaluating strategic options for the company and its programs [5] - The company is on track to have a full network of approximately 30 Authorized Treatment Centers (ATCs) operational by the end of 2025 [5] Upcoming Milestones - The pivotal trial for Tecelra met its primary endpoint with a 42% overall response rate, including 6 complete responses [5] - The company plans to file its 2024 Annual Report on Form 10-K, which will disclose substantial doubt about its ability to continue as a going concern [6] - Adaptimmune has received recognition for its innovative contributions, including awards from Forbes and the Life Sciences PA Patient Impact Award [10]

Financial Data and Key Metrics Changes - In Q4 2024, Legend Biotech reported total net sales of CARVYKTI at approximately $334 million, representing a 110% increase year-over-year and a 17% increase from Q3 2024 [13][23] - Total revenues for Q4 were $187 million, consisting of $168 million from collaboration revenue and $18 million from license revenue [24] - The net profit for Q4 was $26 million, or $0.07 per share, compared to a net loss of $145 million, or $0.40 per share, for the same period last year [24][25] - Adjusted net loss for Q4 was $59 million, or $0.16 per share, compared to an adjusted net loss of $89 million, or $0.24 per share, for the same period last year [32] Business Line Data and Key Metrics Changes - CARVYKTI's sales trajectory has been attributed to its unique profile and strong manufacturing and commercial execution, with a significant increase in outpatient administration [15][19] - The company has treated over 5,000 patients with CARVYKTI, creating a comprehensive patient dataset in multiple myeloma [17] Market Data and Key Metrics Changes - In the U.S., the number of certified hospitals to treat with CARVYKTI has increased to 104, with outpatient administration expected to account for a majority of the volume by the end of the year [15][19] - Internationally, sales outside the U.S. reached $31 million, a 138% increase year-over-year, driven by capacity increases and launches in several countries [14] Company Strategy and Development Direction - The company aims to achieve operational breakeven for CARVYKTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses [8] - Legend Biotech is expanding its pipeline programs to include blood cancers, next-generation multiple myeloma therapies, solid tumor programs, and autoimmune diseases [20][21] - A new research facility is being built in Philadelphia to support pipeline investments, expected to open later this year [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the demand for CARVYKTI, particularly in the outpatient setting, and highlighted the importance of educating community physicians [108][111] - The company anticipates that supply constraints will be alleviated by the end of 2025, allowing supply to meet demand [124] Other Important Information - The FDA approved the Novartis facility for commercial production of CARVYKTI, with clinical production expected to begin soon [11] - The company has received reimbursement approval for CARVYKTI in Spain, enhancing its market presence [13][101] Q&A Session Summary Question: Safety profile and trial management for CARVYKTI - Management discussed ongoing efforts to manage ICANS and neurotoxicity through predictive biomarkers and upcoming investigator-initiated trials [36][40] Question: Commercial revenue breakdown and demand for CAR-T therapy - The company reported strong receptivity to CARTITUDE-4 data, with nearly 60% of usage converted to earlier lines of therapy [53][55] Question: Share count and pipeline data expectations - The increase in share count was clarified as a result of net profit calculations, and management provided insights into upcoming data from early pipeline programs [58][62] Question: Revenue growth cadence and capacity expectations - Management indicated that Q1 growth may be modest due to seasonal factors, with more significant growth expected in Q2 and Q3 [70] Question: Positioning of CAR-T therapies in solid tumor treatment - Management highlighted ongoing efforts to innovate in solid tumors and the importance of safety and efficacy in driving commercial success [80][81] Question: Demand fulfillment in Europe - The company is working to meet demand in Europe through its facilities, with recent approvals expected to enhance supply capabilities [145]

Financial Data and Key Metrics Changes - As of December 31, 2024, the company reported year-end cash, cash equivalents, and marketable securities of $47.8 million, along with approximately $5.5 million in net proceeds from a financing event [40] - Total revenues for Q4 2024 were approximately $2.9 million, a net increase of $0.8 million compared to $2.1 million for the same period in 2023 [43] - The net loss attributable to the company for Q4 was $3.3 million or $0.02 per share, compared to a net loss of $4.8 million or $0.03 per share for the same period in 2023 [46] Business Line Data and Key Metrics Changes - R&D expenses for Q4 2024 were $3.4 million, a decrease of $0.5 million compared to $3.9 million for the same period in 2023, primarily driven by a decrease in OPC1 program expenses [44] - Total operating expenses for Q4 were $7.8 million, a decrease of $0.4 million compared to $8.2 million for the same period in 2023 [44] Market Data and Key Metrics Changes - The company noted an increase in OpRegen activity, with Roche and Genentech entering into an additional agreement to provide services for manufacturing and long-term follow-up of Phase 1/2a patients [11][12] - The ongoing GAlette Study has been enrolling for nearly two years, indicating a significant amount of data should be available for decision-making [10] Company Strategy and Development Direction - The company is focused on scalable GMP manufacturing, which is crucial for the success of allogeneic cell therapy products [22][30] - The company aims to establish a leading position in allogeneic process development and production, emphasizing the need for large-scale production capabilities [29][30] - The company is advancing its second clinical stage allogeneic program, OPC1, with plans for a larger clinical trial in spinal cord injury [31][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for OpRegen to drive positive clinical outcomes in dry AMD, supported by independent evidence from other RPE transplant trials [52] - The company is strategically balancing cost and investment while exploring other potential funding sources, including milestone payments and program grants [42][90] Other Important Information - The company has continued to add value to its patent portfolio, with two additional OpRegen patents issued earlier this year [38] - The company is preparing for a clinical study called the DOSED Study to test a novel delivery device for OPC1, which is expected to enhance the administration process [34][37] Q&A Session Summary Question: What is the company doing to protect its market leadership in RPE cell placements? - Management emphasized the importance of having the right attributes for success, highlighting the combination of Lineage's manufacturing, Genentech's product development, and Roche's commercialization capabilities as a competitive advantage [59][61] Question: When will the updated three-year data for OpRegen be available? - Management indicated that inquiries regarding the timeline for the three-year data should be directed to Genentech, as they control the announcement schedule [64] Question: Can you describe any changes in logistics for getting patients to the surgical suite faster? - Management noted improvements in training and the development of an immediate use formulation to streamline the process, reducing preparation time for cell administration [77][78] Question: Will the FDA require proof of device safety before fully enrolling across all planned sites for the DOSED study? - Management confirmed that there is a staging process, starting with a few patients before moving to broader enrollment [83] Question: What are the plans for the resonance program given market uncertainty? - Management stated that while the resonance program remains important, they are being prudent with investment decisions in the current market environment [88][90]

As filed with the Securities and Exchange Commission on June 4, 2024. Delaware 2834 86-3329066 Registration No. 333-278938 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 775 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT FibroBiologics, Inc. (Exact name of registrant as specified in its charter) As filed with the Securities and Exchange Commission on May 15, 2024. Registration No. 333-278938 UNDER THE SECURITIES ACT OF 1933 (State or other jurisdiction of (Primary Standard Industrial Delaware 2834 86-3329066 (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 775 ...

As filed with the Securities and Exchange Commission on April 25, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3329066 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 455 E. Medical Cente ...

As filed with the Securities and Exchange Commission on March 26, 2024. Registration No. 333-277019 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3329066 (I.R.S. Employer Identification Num ...

As filed with the Securities and Exchange Commission on March 15, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Registration No. 333-277019 Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3329066 (I.R.S. Employer Identification Num ...

As filed with the Securities and Exchange Commission on February 12, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3329066 (I.R.S. Employer Identification Number) 455 E. Medical Ce ...