IOVANCE BIOTHERAPEUTICS INC

Previous wording

In addition to the U.S., we plan to launch Amtagvi TM into additional markets with a high prevalence of advanced melanoma, including the European Union, United Kingdom, Canada, and Australia. In June 2024, we submitted a marketing authorization application to the European Medicines Agency, or the EMA, for lifileucel. If approved, lifileucel would be the first and only approved therapy in this treatment setting in all European Union member states. Across the U.S. and other targeted global markets, Amtagvi TM has the potential to address more than 20,000 previously treated advanced melanoma patients annually.

Current wording

In addition to the U.S., we plan to launch Amtagvi TM into additional markets with a high prevalence of advanced melanoma, including the European Union, or EU, United Kingdom, Canada, Switzerland, and Australia. In June 2024, we submitted a centralized marketing authorization application, or MAA, to the European Medicines Agency, or the EMA, for lifileucel. In August 2024, the MAA was validated and accepted for review by the EMA. In October 2024, an MAA was submitted to the Medicines and Healthcare products Regulatory Agency in the United Kingdom, and a new drug submission, or NDS, was deemed eligible for Notice of Compliance with Conditions or NOC/c by Health Canada. The NOC/c policy includes a prioritized 200-day review process for potential NDS approval in mid-2025. If approved, lifileucel is expected to be the first and only approved therapy in this treatment setting in these markets. Across the U.S. and other targeted global markets, Amtagvi TM has the potential to address more than 20,000 previously treated advanced melanoma patients annually.

Previous wording

We manufacture Amtagvi™ and our investigational TIL cell therapies using a centralized, scalable and proprietary 22-day manufacturing process which rejuvenates and multiplies polyclonal T cells unique to each patient into the billions and yields a cryopreserved, individualized therapy.

Current wording

We manufacture Amtagvi™ and our investigational TIL cell therapies using centralized, scalable, and proprietary manufacturing processes which rejuvenate and multiply polyclonal T cells unique to each patient into the billions and yields a cryopreserved, individualized therapy. Amtagvi™ is manufactured for commercial use at our manufacturing facility, the Iovance Cell Therapy Center, or theiCTC, and by a contract manufacturing organization, or CMO.

Previous wording

Our development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings for solid tumor cancers. We are investigating TIL monotherapies for patients with later stage disease who were previously treated with standard of care therapies and TIL combinations with standard of care therapies to potentially improve outcomes in patients who are earlier in their disease. We are conducting two ongoing registrational trials to support a supplementary BLA, or sBLA, of our TIL cell therapies in frontline advanced melanoma and in advanced non-small cell lung cancer, or NSCLC, following standard of care chemo-immunotherapy. We are also developing next generation therapies, such as genetically modified TIL cell therapy and next generation cytokines.

Current wording

Our development pipeline includes multicenter trials of TIL cell therapies in additional treatment settings for solid tumor cancers. We are investigating TIL monotherapies for patients with later stage disease who were previously treated with standard of care therapies and TIL combinations with standard of care therapies to potentially improve outcomes in patients who are earlier in their disease. We are conducting two ongoing registrational trials to support a supplementary BLA, or sBLA, of our TIL cell therapies in frontline advanced melanoma and in advanced non-small cell lung cancer, or NSCLC, following standard of care chemo-immunotherapy. We are also developing next generation therapies, such as genetically modified and gene edited TIL cell therapy and next generation cytokines.

Previous wording

Our top priority is commercialization of Amtagvi™ in the U.S. for the treatment of patients with post-anti-PD-1 advanced melanoma, for which we received FDA approval on February 16, 2024. We have experienced marketing, payer access and distribution teams, as well as a sales force with extensive experience in oncology and cell therapy. Our medical affairs team is also in the field educating key opinion leaders, or KOLs, about Amtagvi™ and TIL cell therapy, as well as presenting and publishing our clinical results. More than half of the members of our field teams have prior cell therapy experience.

Current wording

Our top priority is commercialization of Amtagvi™ in the U.S. for the treatment of patients with post-anti-PD-1 advanced melanoma, for which we received FDA approval on February 16, 2024. We have experienced marketing, payer access and distribution teams, as well as a sales force with extensive experience in oncology and cell therapy. Our medical affairs team is also in the field educating key opinion leaders, or KOLs, about Amtagvi™ and TIL cell therapy, as well as presenting and publishing our clinical results.

Previous wording

We are the first company to obtain FDA approval for a TIL cell therapy product. We believe that we are the only company in the U.S. to have a centralized, scalable, and commercially viable TIL manufacturing process. To date, more than 700 patients have been treated in clinical trials with Iovance TIL cell therapy products manufactured using our proprietary processes across multiple indications. Iovance TIL cell therapies are manufactured for commercial use and clinical trials at our manufacturing facility, the Iovance Cell Therapy Center, or theiCTC, and by a contract manufacturing organization, or CMO. Amtagvi™ is FDA-approved for commercial manufacturing at theiCTC. In addition, our CMO is FDA-approved for additional capacity to supplement our internal manufacturing. The two facilities together have capacity as built to treat several thousands of cancer patients annually.

Current wording

We are the first company to obtain FDA approval for a TIL cell therapy product. We believe that we are the only company in the U.S. to have a centralized, scalable, and commercially viable TIL manufacturing process. In clinical trials prior to FDA approval, more than 700 patients were treated with Iovance TIL cell therapy products manufactured using our proprietary processes across multiple indications. Iovance TIL cell therapies are manufactured for commercial use and clinical trials at our manufacturing facility, theiCTC, and by a CMO.iCTC is FDA-approved for commercial manufacturing of Amtagvi™. In addition, our CMO is FDA-approved for additional capacity to supplement our internal manufacturing. The two facilities together have capacity as built to treat several thousands of cancer patients annually.

Previous wording

TheiCTC is the first centralized and scalable current Good Manufacturing Practice, or cGMP, manufacturing facility dedicated to producing TIL, as well as the first FDA-approved facility for commercial TIL cell therapy. Located in Philadelphia, Pennsylvania, the 136,000 square footiCTC is also among the largest cell therapy manufacturing facilities. Expansion at theiCTC is underway, which will increase capacity to supply several thousands of additional patients, with a long-term goal of establishing a manufacturing network to address tens of thousands of patients. The proximity of theiCTC to multiple airports facilitates delivery of TIL cell therapies to treatment centers, with theiCTC expected to cover logistics and delivery of TIL cell therapies in both North America and Europe. Owning our own facility allows us to control manufacturing capacity and product quality, manage logistics around supply and delivery, implement process improvement and realize potential cost efficiencies for TIL cell therapies that we may develop and commercialize. We are also exploring future TIL manufacturing processes, as well as next-generation treatments and technologies, which may further streamline development timelines and costs. TheiCTC has a flexible design that allows future expansion within existing shell space and an option to build on an adjacent lot to support future growth and capacity needs.

Current wording

TheiCTC is the first centralized and scalable current Good Manufacturing Practice, or cGMP, manufacturing facility dedicated to producing TIL, as well as the first FDA-approved facility for commercial TIL cell therapy. Located in Philadelphia, Pennsylvania, the 136,000 square footiCTC is also among the largest cell therapy manufacturing facilities. Expansion at theiCTC is underway, which is expected to increase capacity to supply over five thousand patients annually, with a long-term goal of establishing a manufacturing network to supply TIL therapy to over ten thousand patients per year. The proximity of theiCTC to multiple airports facilitates delivery of TIL cell therapies to treatment centers, with theiCTC expected to cover logistics and delivery of TIL cell therapies in both North America and Europe. Owning our own facility allows us to control manufacturing capacity and product quality, manage logistics around supply and delivery, implement process improvement and realize potential cost efficiencies for TIL cell therapies that we may develop and commercialize. We are also exploring future TIL manufacturing processes, as well as next-generation treatments and technologies, which may further streamline development timelines and costs. TheiCTC has a flexible design that allows expansion within existing shell space and an option to build on an adjacent lot to support future growth and capacity needs.

Previous wording

In 2018, we began using our Gen 2 TIL manufacturing process, which reduced TIL manufacturing time to 22 days while producing a cryopreserved TIL product. The Gen 2 process was used to manufacture Amtagvi™ for the clinical trial that supported FDA approval, and most of our ongoing clinical trials use the Gen 2 process.

Current wording

In 2018, we began using our Gen 2 TIL manufacturing process, which reduced TIL manufacturing time to about 22 days while producing a cryopreserved TIL product. The Gen 2 process was used to manufacture Amtagvi™ for the clinical trial that supported FDA approval, and most of our ongoing clinical trials use the Gen 2 process.

Previous wording

●**Step 2: Manufacturing.**Patient-specific TIL are manufactured using our commercial Gen 2 manufacturing process. Upon arrival at the facility, TIL are separated from other cells within the patient’s tumor tissue sample. Over the next 22 days, the cells are multiplied into the billions, so they can be returned to the patient to fight cancer cells. Upon completion of manufacturing, Amtagvi™ is quality tested to meet specific product release criteria. The final product is cryopreserved and sent back to the ATC for administration to the patient. Additional details on the Gen 2 manufacturing process are provided in the Manufacturing Process section of our Quarterly Report on Form 10-Q.

Current wording

●**Step 2: Manufacturing.**Patient-specific TIL are manufactured using our commercial Gen 2 manufacturing process. Upon arrival at the facility, TIL are separated from other cells within the patient’s tumor tissue sample. The cells are then multiplied into the billions, so they can be returned to the patient to fight cancer cells. Upon completion of manufacturing, Amtagvi™ is quality tested to meet specific product release criteria. The final product is cryopreserved and sent back to the ATC for administration to the patient.

Previous wording

TIL cell therapy is a T cell-based immunotherapy technology platform that leverages patient-specific cells to recognize and attack diverse cancer cells that are unique to each patient. Unlike other cell therapies that act on a single or small number of shared antigen targets common to certain tumors, our individualized T cell therapies are polyclonal or designed to target a variety of

Current wording

TIL cell therapy is a T cell-based immunotherapy technology platform that leverages patient-specific cells to recognize and attack diverse cancer cells that are unique to each patient. Unlike other cell therapies that act on a single or small number of shared antigen targets common to certain tumors, our individualized T cell therapies are polyclonal or designed to target a variety of neoantigens that are unique to the patient and tumor. We believe this polyclonal cell therapy is potentially applicable to many solid

Previous wording

neoantigens that are unique to the patient and tumor. We believe this polyclonal cell therapy is potentially applicable to many solid tumor cancers, where the majority of immune targets are patient specific. Our TIL cell therapy platform and manufacturing process have been initially validated through the FDA approval of Amtagvi™.

Current wording

tumor cancers, where the majority of immune targets are patient specific. Our TIL cell therapy platform and manufacturing process have been initially validated through the FDA approval of Amtagvi™.

Previous wording

We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 210 granted or allowed U.S. and international patents and patent applications pertaining to Amtagvi™ and other TIL-related technologies that are expected to provide Amtagvi™ with exclusivity through at least 2042. More than 70 U.S. patents are related to TIL cell therapy, including patents directed to compositions and methods of treatment in a broad range of cancers, such as U.S. Patent Nos.10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,398,734; 10,420,799; 10,463,697; 10,517,894; 10,537,595; 10,639,330; 10,646,517; 10,653,723; 10,695,372; 10,894,063; 10,905,718; 10,918,666; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,007,226; 11,013,770; 11,026,974; 11,040,070; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,438; 11,168,303; 11,168,304; 11,179,419; 11,202,803; 11,202,804; 11,220,670; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,304,979; 11,304,980; 11,311,578; 11,337,998; 11,344,579; 11,344,580; 11,344,581; 11,351,197; 11,351,198; 11,351,199; 11,364,266; 11,369,637; 11,384,337; 11,433,097; 11,517,592; 11,529,372 ; 11,541,077; 11,713,446; 11,819,517; 11,857,573; 11,865,140; 11,866,688; 11,939,596; 11,969,444; 11,975,028; 12,024,718; and 12,031,157. More than 40 of these patents are related to our Gen 2 TIL manufacturing processes and have terms that we anticipate will extend to October 2037 or January 2038, not including any patent term extensions or adjustments that may be available. Our owned and licensed intellectual property portfolio also includes patents and patent applications relating to TIL, marrow-infiltrating lymphocytes, or MIL, and peripheral blood lymphocyte, or PBL, therapies; frozen tumor-based TIL technologies; remnant TIL and digest TIL compositions, methods and processes; methods of manufacturing TIL, MIL, and PBL therapies; the use of costimulatory and T cell modulating molecules in TIL cell therapy and manufacturing; stable and transient genetically-modified TIL cell therapies, including genetic knockouts of immune checkpoints; cytokine-tethered TIL cell therapies; methods of using ICIs in combination with TIL cell therapies; TIL selection technologies; and methods of treating patient subpopulations.

Current wording

We have established a leading intellectual property portfolio developed internally and licensed from third parties. We currently own more than 230 granted or allowed U.S. and international patents and patent applications pertaining to Amtagvi™ and other TIL-related technologies that are expected to provide Amtagvi™ with exclusivity into 2042. More than 70 U.S. patents are related to TIL cell therapy, including patents directed to compositions and methods of treatment in a broad range of cancers, such as U.S. Patent Nos.10,130,659; 10,166,257; 10,272,113; 10,363,273; 10,398,734; 10,420,799; 10,463,697; 10,517,894; 10,537,595; 10,639,330; 10,646,517; 10,653,723; 10,695,372; 10,894,063; 10,905,718; 10,918,666; 10,925,900; 10,933,094; 10,946,044; 10,946,045; 10,953,046; 10,953,047; 11,007,225; 11,007,226; 11,013,770; 11,026,974; 11,040,070; 11,052,115; 11,052,116; 11,058,728; 11,083,752; 11,123,371; 11,141,438; 11,168,303; 11,168,304; 11,179,419; 11,202,803; 11,202,804; 11,220,670; 11,241,456; 11,254,913; 11,266,694; 11,273,180; 11,273,181; 11,291,687; 11,304,979; 11,304,980; 11,311,578; 11,337,998; 11,344,579; 11,344,580; 11,344,581; 11,351,197; 11,351,198; 11,351,199; 11,364,266; 11,369,637; 11,384,337; 11,433,097; 11,517,592; 11,529,372 ; 11,541,077; 11,713,446; 11,819,517; 11,857,573; 11,865,140; 11,866,688; 11,939,596; 11,969,444; 11,975,028; 12,024,718; and 12,031,157. More than 40 of these patents are related to our Gen 2 TIL manufacturing processes and have terms that we anticipate will extend to October 2037 or January 2038, not including any patent term extensions or adjustments that may be available. Our owned and licensed intellectual property portfolio also includes patents and patent applications relating to TIL, marrow-infiltrating lymphocytes, or MIL, and peripheral blood lymphocyte, or PBL, therapies; frozen tumor-based TIL technologies; remnant TIL and digest TIL compositions, methods and processes; methods of manufacturing TIL, MIL, and PBL therapies; the use of costimulatory and T cell modulating molecules in TIL cell therapy and manufacturing; stable and transient genetically-modified TIL cell therapies, including genetic knockouts of immune checkpoints; cytokine-tethered TIL cell therapies; methods of using ICIs in combination with TIL cell therapies; TIL selection technologies; and methods of treating patient subpopulations.

Previous wording

Revenues for the three and six months ended June 30, 2024 represent product sales of Amtagvi™, as well as Proleukin®, which during the three months ended June 30, 2024 were primarily driven from sales in the United States to support the ongoing commercial launch of Amtagvi™, which received FDA approval in February 2024. Proleukin®, which we acquired the worldwide rights to in May 2023, is also sold in markets outside the United States, primarily in the European Union and United Kingdom. Prior to May 2023, we had not recognized any revenue.

Current wording

Revenues for the three and nine months ended September 30, 2024 represent product sales of Amtagvi™, as well as Proleukin®, primarily driven from sales in the United States to support the ongoing commercial launch of Amtagvi™, which received FDA approval in February 2024. Proleukin®, which we acquired the worldwide rights to in May 2023, is also sold in markets outside the United States, primarily in the EU and United Kingdom. Prior to May 2023, we had not recognized any revenue.

Previous wording

Revenue is reduced at the time of recognition for expected chargebacks, discounts, rebates, and sales allowances, collectively referred to as gross to net adjustments, or GTN adjustments. In the U.S., these GTN adjustments are attributable to various commercial arrangements and government programs. In addition, non-U.S. government programs include different pricing schemes such as cost caps and volume discounts.

Current wording

Amtagvi™ revenue is recognized upon patient infusion, while Proleukin® revenue is recognized upon delivery to specialty distributors, clinical manufacturers, and ATCs. Revenue is reduced at the time of recognition for expected chargebacks, discounts, rebates, and sales allowances, collectively referred to as gross to net adjustments, or GTN adjustments. In the U.S., these GTN adjustments are attributable to various commercial arrangements and government programs. In addition, non-U.S. government programs include different pricing schemes such as cost caps and volume discounts.

Previous wording

Cost of sales includes inventory and period costs related to overhead and manufacturing costs of Amtagvi™ during the period from approval through June 30, 2024, as well as the cost of inventories and other costs that are directly associated with the purchase and sales of Proleukin®. In addition, cost of sales includes royalties payable on sales of our products, as well as amortization expense for the fair value step-up of acquired Proleukin® inventory, the acquired intangible asset related to developed technology, and the intellectual property license intangible assets.

Current wording

Cost of sales includes inventory and period costs, as well as non-cash expenses, related to overhead and manufacturing costs of Amtagvi™ during the period from approval through September 30, 2024, as well as the cost of inventories and other costs, and non-cash expenses that are directly associated with the purchase and sales of Proleukin®. In addition, cost of sales includes royalties payable on sales of our products, as well as non-cash expenses including amortization of the fair value step-up of acquired Proleukin® inventory which is recognized as the acquired inventory units are sold, amortization expense for the developed technology intangible asset and the milestone payment recorded as part of the Acquisition, and the intellectual property license intangible assets.

Previous wording

The manufacturing process for Amtagvi™ is highly complex and subject to stringent FDA guidelines and requirements, as well as internal specifications and quality guidelines. Our ability to successfully manufacture Amtagvi™ and deliver finished product to ATCs for infusion into patients is dependent on several factors, including patient selection and quality of tumors provided by the treatment centers for use in the manufacturing of Amtagvi™. We focus significant effort and attention on working with the treatment centers during the onboarding process regarding these matters, as well as on our internal manufacturing processes, but in the event that the manufactured product does not meet specifications or a patient is unable to receive the infusion, the Amtagvi™ product is destroyed and the costs associated with manufacturing and inventory associated with the product is generally required to be expensed as cost of sales unless the out-of-spec product is able to be utilized in an expanded or early access program, or single-patient IND, as requested by the treating physician, in which case the costs of the product are recorded as research and development expense based on the fact that we receive clinical data.

Current wording

The manufacturing process for Amtagvi™ is highly complex and subject to stringent FDA guidelines and requirements, as well as internal specifications and quality guidelines. Our ability to successfully manufacture Amtagvi™ and deliver finished product to ATCs for infusion into patients is dependent on several factors, including patient selection and quality of tumors provided by the treatment centers for use in the manufacturing of Amtagvi™. We focus significant effort and attention on working with the treatment centers during the onboarding process regarding these matters, as well as on our internal manufacturing processes.

Previous wording

Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs and other consulting services. Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability.

Current wording

Research and development expenses include personnel and facility-related expenses, outside contracted services including clinical trial costs, including Amtagvi™ infusions under expanded access programs or single-patient INDs, manufacturing and process development costs, research costs, and other consulting services. Research and development costs are expensed as incurred. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and amortized over the period that the goods are delivered, or the related services are performed, subject to an assessment of recoverability.

Previous wording

Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites. The duration, costs and timing of our clinical trials and development of our product candidates will depend on a number of factors that include, but are not limited to, the number of patients that enroll in the trial, per patient trial costs, number of sites included in the trial, discontinuation rates of patients, duration of patient follow-up, efficacy and safety profile of the product candidate, and the length of time required to enroll eligible patients.

Current wording

Clinical development costs are a significant component of research and development expenses. We have a history of contracting with third parties that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon estimates of work completed to date of the individual trial in accordance with agreements established with contract research organizations and clinical trial sites. The duration, costs and timing of our clinical trials and development of our product candidates will depend on a number of factors that include, but are not limited to, the number of patients that enroll in the trial, per patient trial

Previous wording

We anticipate selling, general and administrative expenses will increase as we execute the launch of Amtagvi™ and market Proleukin®, as well as execute an expected expansion of the internal selling, general and administrative team to support the overall growth in our business.

Current wording

We anticipate selling, general and administrative expenses will increase as we execute the launch of Amtagvi™ and market Proleukin®, as well as execute an expected expansion in the U.S. market and outside of the U.S. of the internal selling, general and administrative team to support the overall growth in our business.

Previous wording

Results of Operations for the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Results of Operations for the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

Revenue for the three and six months ended June 30, 2024 increased by $30.9 million, or 12,970%, and $31.6 million, or 13,270%, compared to the same periods in 2023, respectively. The increase can be attributed to the completion of the acquisition of worldwide rights to Proleukin® in May 2023, or the Acquisition, as well as the commercial launch of Amtagvi™ in February 2024. Through the first quarter of 2024, product revenue was comprised entirely of product sales of Proleukin® in markets outside of the U.S. With the BLA approval of Amtagvi™ in February 2024, we began generating revenue for Amtagvi™ during the three months ended June 30, 2024 as infusions occurred at our ATCs. Furthermore, during the three months ended June 30, 2024, we began selling Proleukin® in the U.S. market. The Proleukin® inventory that was previously with distributors at the time of the acquisition to support the U.S. market has been substantially sold, and as a result we experienced significant re-stocking demand from specialty distributors in the second quarter of 2024 to support ongoing and anticipated infusions related to the strong commercial launch of Amtagvi™. GTN adjustments did not materially affect net product revenue in the three and six months ended June 30, 2024 and 2023.

Current wording

Revenue for the three and nine months ended September 30, 2024 increased by $58.1 million, or 12,385%, and $89.7 million, or 12,683%, compared to the same periods in 2023, respectively. The increase was driven by the completion of the acquisition of worldwide rights to Proleukin® in May 2023, or the Acquisition, as well as the commercial launch of Amtagvi™ in February 2024. Through the first quarter of 2024, product revenue was comprised entirely of product sales of Proleukin® in markets outside of the U.S. With the BLA approval of Amtagvi™ in February 2024, we began generating revenue for Amtagvi™ in the second quarter of 2024 as infusions occurred at our ATCs. Furthermore, in the second quarter of 2024, we began selling Proleukin® in the U.S. market. The Proleukin® inventory that was previously with distributors at the time of the acquisition to support the U.S. market has been substantially sold, and as a result we experienced significant re-stocking demand from specialty distributors in both the second and third quarter of 2024 to support ongoing and anticipated infusions related to the strong commercial launch of Amtagvi™. GTN adjustments did not materially affect net product revenue in the three and nine months ended September 30, 2024 and 2023.

Previous wording

As it relates to revenue timing for our products, Amtagvi™ infusions are expected to lag behind Amtagvi™ related Proleukin®sales by 2-3 months, and we expect ATCs to utilize 15-18 vials per infusion. While such sales are not directly indicative of future Amtagvi™ revenues because of the timing of stocking activities by specialty distributors and because of sales that are not related to

Current wording

As it relates to revenue timing for our products, Amtagvi™ infusions are expected to lag behind Amtagvi™ related Proleukin®sales by 2-3 months, and we expect ATCs to utilize 15-18 Proleukin® vials per Amtagvi™ infusion. While such Proleukin® sales are not directly indicative of future Amtagvi™ revenues because of the timing of stocking activities by specialty distributors and because of sales that are not related to Amtagvi™ infusions, such as sales of Proleukin®utilized in clinical manufacturing or clinical trials, such sales are one indicator of future Amtagvi™ revenues.

Previous wording

Cost of sales for the three and six months ended June 30, 2024 increased by $29.3 million, or 1,430%, and $36.6 million, or 1,784%, respectively, driven by the increase in sales of Amtagvi™ and Proleukin®, as well as costs related to the manufacturing of Amtagvi™. Cost of sales included $5.4 million and $10.0 million for the three and six months ended June 30, 2024, respectively, compared to $1.9 million for each of the three and six months ended June 30, 2023, which was attributable to amortization expense for the developed technology intangible asset recorded as part of the Acquisition. Furthermore, cost of sales included $4.2 million of royalties payable related to sales of our products in the three and six months ended June 30, 2024. There were no royalties payable in the three and six months ended June 30, 2023.

Current wording

Cost of sales for the three and nine months ended September 30, 2024 increased by $35.5 million, or 818%, and $72.1 million, or 1,128%, respectively, driven by the increase in sales of Amtagvi™ and Proleukin®, as well as costs related to the manufacturing of Amtagvi™. Cost of sales included $5.5 million and $15.5 million for the three and nine months ended September 30, 2024, respectively, compared to $4.0 million and $5.9 million for the three and nine months ended September 30, 2023, of non-cash amortization expense for the developed technology intangible asset and the milestone payment recorded as part of the Acquisition as well as intellectual property license intangible assets. In addition, cost of sales included non-cash expense for the amortization of the fair value step-up of acquired Proleukin® inventory sold of $1.4 million and $4.8 million for the three and nine months ended September 30, 2024, respectively, compared to $0.1 million for each of the three and nine months ended September 30, 2023. This expense is recorded as the units acquired in the Acquisition are sold, and we expect this amount to decrease over the next six to twelve months as this inventory is sold. In addition to the non-cash amortization expense, cost of sales included $3.9 million and $8.2 million, respectively, of royalties payable related to sales of our products in the three and nine months ended September 30, 2024. There were no royalties payable in the three and nine months ended September 30, 2023.

Previous wording

Cost of sales for the three and six months ended June 30, 2024 also included $8.7 million and $10.6 million, respectively, of period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi™ treatment, as well as manufacturing results that did not meet required specifications, resulting in increased scrap costs in the period. In addition, to a lesser extent such costs included period costs related to overhead and manufacturing costs at theiCTC during the period from approval resulting from under absorption of overhead costs during the period, which was driven by our decision to launch with capacity sufficient to address anticipated commercial demand in 2024 and beyond. We continue to focus on manufacturing execution as the launch of Amtagvi™ continues but expect to incur such period costs through the upcoming fiscal quarters while we continue to implement initiatives associated with manufacturing quality and until such time that we can fully utilize our manufacturing capacity.

Current wording

Cost of sales for the three and nine months ended September 30, 2024 also included $8.3 million and $17.2 million, respectively, of period costs primarily related to patient drop-off driven by patient health and ability to receive the Amtagvi™ treatment, as well as manufacturing results that did not meet required specifications, and were not otherwise utilized under an expanded access program or single-patient IND to generate clinical data, resulting in manufacturing costs in the period for which we were not able to recognize revenue. In addition, to a lesser extent such costs included period costs related to overhead and manufacturing costs at theiCTC during the period from approval resulting from under absorption of overhead costs during the period, which was driven by our decision to launch with capacity sufficient to address anticipated commercial demand in 2024 and beyond. We continue to focus on manufacturing execution as the launch of Amtagvi™ continues but expect to incur such period costs through the upcoming fiscal quarters while we continue to implement initiatives associated with manufacturing quality and until such time that we can fully utilize our manufacturing capacity.

Previous wording

Research and development expense for the three months ended June 30, 2024 decreased by $24.3 million, or 28%, compared to the same period in 2023. The decrease was primarily attributable to (i) a $27.8 million decrease in clinical manufacturing costs, driven by capitalization of qualified costs for Amtagvi™ manufacturing resulting from our BLA approval and transition to commercial manufacturing to support the commercial launch of Amtagvi™, and (ii) a $2.1 million decrease in payroll costs driven by the reclassification of costs of certain employees supporting Amtagvi TM into general and administrative expenses upon BLA approval based on their functional activities and by the timing of certain non-recurring incentive bonus programs the prior year, as well as (iii) a $2.2 million decrease in other costs, driven primarily by reduced clinical costs resulting from lower patient enrollment across certain studies and decreased costs associated with qualifyingiCTC suites for commercial manufacturing readiness, driven by the completion of such activities in prior periods. These decreases were partially offset by (i) a $7.2 million increase in stock-based compensation expenses, primarily driven by an increase in the number of employees and the number of stock awards granted at a higher average stock price, and (ii) a $0.6 million increase in other costs, including lab and consumable costs to develop the next generation candidates.

Current wording

Research and development expense for the three months ended September 30, 2024 decreased by $19.3 million, or 22%, compared to the same period in 2023. The decrease was primarily attributable to (i) a $28.7 million decrease in clinical manufacturing costs, driven by capitalization of qualified costs for Amtagvi™ manufacturing resulting from our BLA approval and the transition to commercial manufacturing to support the commercial launch of Amtagvi™, (ii) a $1.5 million decrease in clinical and other costs, driven primarily by lower patient enrollment across certain studies, and (iii) a $1.4 million decrease in costs associated with qualifyingiCTC suites for commercial manufacturing readiness, driven by the completion of such activities in prior periods. These decreases were partially offset by (i) a $10.9 million increase in payroll and related costs, including stock-based compensation, primarily driven by an increase in the number of employees and the number of stock awards granted at a higher average stock price, and a (ii) $1.4 million increase in lab and consumable costs to develop next generation candidates.

Previous wording

Research and development expense for the six months ended June 30, 2024 decreased by $27.2 million, or 16%, compared to the same period in 2023. The decrease was primarily attributable to (i) a $32.6 million decrease in clinical manufacturing costs, driven by capitalization of qualified costs for Amtagvi™ manufacturing resulting from our BLA approval and the transition to commercial manufacturing to support the commercial launch of Amtagvi™, (ii) a $2.6 million decrease in payroll and related costs, driven by the reclassification of costs of certain employees supporting Amtagvi™ into general and administrative expenses upon BLA approval based on their functional activities, and (iii) a $1.8 million decrease in clinical costs due to lower patient enrollment across certain studies. These decreases were partially offset by (i) a $7.9 million increase in stock-based compensation expenses, primarily driven by

Current wording

Research and development expense for the nine months ended September 30, 2024 decreased by $46.5 million, or 18%, compared to the same period in 2023. The decrease was primarily attributable to (i) a $61.2 million decrease in clinical manufacturing costs, driven by capitalization of qualified costs for Amtagvi™ manufacturing resulting from our BLA approval and the transition to commercial manufacturing to support the commercial launch of Amtagvi™, (ii) a $3.8 million decrease in clinical costs, driven primarily by lower patient enrollment across certain studies, and (iii) a $1.1 million decrease in costs associated with the reclassification of certain activities supporting Amtagvi™ into general and administrative expenses upon BLA approval based on their function. These decreases were partially offset by (i) a $16.1 million increase in payroll and related costs, including stock-based compensation, primarily driven by an increase in the number of employees and the number of stock awards granted at a higher average stock price, (ii) a $2.5 million increase in lab and consumable costs to develop next generation candidates, and (iii) a $1.0 million increase in license costs related to the expansion of our information technology infrastructure to support our clinical activities.

Previous wording

Selling, general and administrative expenses for the three months ended June 30, 2024 increased by $17.6 million, or 80%, compared to the same period in 2023. The increase was primarily attributable to (i) a $7.8 million increase in stock-based compensation expenses, driven by an increase in headcount to support the commercialization of Amtagvi™, as well as the increased number of stock awards granted at a higher average stock price, (ii) a $3.8 million increase in legal costs driven by a reduction in legal costs in 2023 resulting from the capitalization of previously expensed costs directly associated with the Acquisition, (iii) a $2.5 million increase in payroll and related expenses resulting from increased headcount to support growth in the overall business, (iv) a $1.8 million increase in costs incurred in support of the distribution and commercialization of Amtagvi™ and Proleukin®, and (v) a $1.7 million increase in other costs, including costs associated with marketing and advertising to support the commercialization and launch of Amtagvi™, and software license costs related to the expansion of our information technology infrastructure.

Current wording

Selling, general and administrative expenses for the three months ended September 30, 2024 increased by $12.6 million, or 47%, compared to the same period in 2023. The increase was primarily attributable to (i) a $8.8 million increase in payroll and related expense, including stock-based compensation, driven by an increase in headcount to support the growth in the overall business as well as to support the commercialization of Amtagvi™, and an increased number of stock awards granted at a higher average stock price, (ii) a $1.3 million increase in costs incurred in support of the distribution and commercialization of Amtagvi™ and Proleukin®, (iii) a $0.8 million increase in legal costs driven by a reduction in legal costs in 2023 resulting from the capitalization of previously expensed costs directly associated with the Acquisition, and (iv) a $1.7 million increase in other costs, including costs associated with software license costs related to the expansion of our information technology infrastructure and professional fees.

Previous wording

Selling, general and administrative expenses for the six months ended June 30, 2024 increased by $20.9 million, or 42%, compared to the same period in 2023. The increase was primarily attributable to (i) a $9.3 million increase in stock-based compensation expenses, driven by an increase in headcount, as well as the increased number of stock awards granted at a higher average stock price, (ii) a $3.1 million increase in legal costs driven by a reduction in legal costs in 2023 resulting from the capitalization of previously expensed costs directly associated with the Acquisition, (iii) a $2.9 million increase in payroll and related expenses, driven by increased headcount to support growth in the overall business, as well as a reclassification of costs of certain employees previously supporting research and development activities into general administrative expense upon BLA approval based on their functional activities, (iv) a $2.7 million increase in costs incurred in support of the distribution and commercialization of Amtagvi™ and Proleukin®, and (v) a $2.9 million increase in other costs, including costs associated with marketing and advertising to support the commercialization and launch of Amtagvi TM, and increased travel and software licenses related to the expansion of our information technology.

Current wording

Selling, general and administrative expenses for the nine months ended September 30, 2024 increased by $33.5 million, or 44%, compared to the same period in 2023. The increase was primarily attributable to (i) a $21.0 million increase in payroll and related expense, including stock-based compensation, driven by an increase in headcount to support the growth in the overall business as well as to support the commercialization of Amtagvi™, an increased number of stock awards granted at a higher average stock price, and the reclassification of costs of certain employees previously supporting research and development activities into general administrative expense upon BLA approval based on their functional activities, (ii) a $3.9 million increase in legal costs driven by a reduction in legal costs in 2023 resulting from the capitalization of previously expensed costs directly associated with the Acquisition, (iii) a $6.0 million increase in costs incurred in support of the distribution and commercialization of Amtagvi™ and Proleukin®, and (iv) a $2.6 million increase in other costs, including costs associated with increased travel, software licenses related to the expansion of our information technology, and professional fees.

Previous wording

Interest income, net for the three and six months ended June 30, 2024 increased by $0.3 million, or 9%, and $0.1 million, or 2%, compared to the same periods in 2023, respectively. The increase was primarily driven by an increase in average investment balances, resulting from net proceeds from recent public and at-the-market financings as well as a higher rate of return on our investments.

Current wording

Interest income, net for the three and nine months ended September 30, 2024 increased by $0.6 million, or 19%, and $0.8 million, or 8%, compared to the same periods in 2023, respectively. The increase was primarily driven by an increase in average investment balances, resulting from net proceeds from recent public and at-the-market financings as well as a higher rate of return on our investments.

Previous wording

Income tax benefit for the three and six months ended June 30, 2024 was $1.5 million and $2.9 million, respectively, as a result of the tax benefit from the realization of the related deferred taxes for operations in the United Kingdom. Income tax benefit resulting from the realization of the related deferred taxes of operations in the United Kingdom for the three and six months ended June 30, 2023 was $0.5 million.

Current wording

Income tax benefit for the three and nine months ended September 30, 2024 increased by $0.3 million, or 22%, and $2.7 million, or 155%, respectively, compared to the same periods in 2023, respectively. This increase was the result of additional deferred tax liabilities recorded for the milestone payment made under the Acquisition and the related tax benefit from the realization of these deferred taxes for operations in the United Kingdom.

Previous wording

Net loss for the three and six months ended June 30, 2024 increased by $9.4 million, or 9%, and $3.8 million, or 2%, compared to the same periods in 2023, respectively. The increase in our net loss was due to the overall growth in our workforce and corporate infrastructure to support the ongoing launch of Amtagvi™ in the U.S. and anticipated expansion in additional markets as well as continued sales of Proleukin®, continued expansion of our research and development activities, and ongoing and newly initiated clinical trials. We anticipate that we will continue to incur net losses in the future as we further invest in our clinical and internal research and development programs, as well as execution of the launch of Amtagvi™.

Current wording

Net loss for the three and nine months ended September 30, 2024 increased by $30.2 million, or 27%, and $34.0 million, or 10%, compared to the same periods in 2023, respectively. The increase in our net loss was due to the overall growth in our workforce and corporate infrastructure to support the ongoing launch of Amtagvi™ in the U.S. and anticipated expansion in additional markets as well as continued sales of Proleukin®, continued expansion of our research and development activities, and ongoing and newly

Previous wording

income. Since 2017, our primary source of funds has been from the public sale of our common stock. With the recent approval of our BLA, we expect to continue to generate revenue from the sale of our first internally developed product, Amtagvi™, in the remaining quarters of 2024. Furthermore, as Proleukin®inventory that was previously with distributors in the U.S. market at the time of the acquisition of the worldwide rights to Proleukin®in May 2023 has been substantially depleted, we also began to sell Proleukin®into the U.S. market, where product margins are substantially higher than in other markets, to support ongoing and anticipated infusions related to the continued strong commercial launch of Amtagvi™. However, such revenues for Amtagvi™ and Proleukin® may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Quarterly Report on Form 10-Q is filed.

Current wording

As of September 30, 2024, we had $403.8 million in cash, cash equivalents, investments, and restricted cash ($164.2 million of cash and cash equivalents, $233.3 million in short-term investments, and $6.4 million in restricted cash). We have incurred losses and generated negative cash flows from operations since inception. Historically, we have funded our operations from various public and private offerings of our equity securities, both common stock and preferred stock, from option and warrant exercises, and from interest income. Since 2017, our primary source of funds has been from the public sale of our common stock. With the recent approval of our BLA, we expect to continue to generate revenue from the sale of our first internally developed product, Amtagvi™, in the remaining quarters of 2024. Furthermore, as Proleukin®inventory that was previously with distributors in the U.S. market at the time of the acquisition of the worldwide rights to Proleukin®in May 2023 has been substantially depleted, we also began to sell Proleukin®into the U.S. market, where product margins are substantially higher than in other markets, to support ongoing and anticipated infusions related to the continued strong commercial launch of Amtagvi™. However, such revenues for Amtagvi™ and Proleukin® may not be material enough to generate positive operational cash flows during the 12 months from the date the condensed consolidated financial statements are issued and this Quarterly Report on Form 10-Q is filed.

Previous wording

We expect to continue to incur significant expenses to support our execution of the commercial launch of Amtagvi™, fund ongoing clinical programs, including our NSCLC registration study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the six months ended June 30, 2024 are issued, we believe that we have sufficient capital to fund our anticipated operating expenses and capital expenditures as planned for at least the twelve months following the issuance of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Current wording

We expect to continue to incur significant expenses to support our execution of the commercial launch of Amtagvi™, fund ongoing clinical programs, including our NSCLC registration study, IOV-LUN-202, and our frontline advanced melanoma Phase 3 confirmatory trial, TILVANCE-301, continue the development of our pipeline candidates, and for other general corporate purposes. Based on the funds we have available as of the date our condensed consolidated financial statements for the three and nine months ended September 30, 2024 are issued, we believe that we have sufficient capital to fund our anticipated operating expenses and capital expenditures as planned for at least the twelve months following the issuance of our condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

Previous wording

As of June 30, 2024, we had outstanding 297,305,999 shares of our $0.000041666 par value common stock, 194 shares of our $0.001 par value Series A Convertible Preferred Stock, and 2,842,158 shares of our $0.001 par value Series B Convertible Preferred Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 2,842,158 shares of our common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.

Current wording

As of September 30, 2024, we had outstanding 304,620,470 shares of our $0.000041666 par value common stock, 194 shares of our $0.001 par value Series A Convertible Preferred Stock, and 2,842,158 shares of our $0.001 par value Series B Convertible Preferred Stock. The outstanding shares of Series A Convertible Preferred Stock are currently convertible into 97,000 shares of our common stock, and the outstanding shares of Series B Convertible Preferred Stock are currently convertible into 2,842,158 shares of our common stock. The shares of Series A Convertible Preferred Stock and Series B Convertible Preferred Stock do not have voting rights or accrue dividends.

Previous wording

On June 16, 2023, we entered into a new Open Market Sale Agreement, or the 2023 Sale Agreement, with Jefferies with respect to an “at the market” offering program. Under the terms of the 2023 Sale Agreement, we may, from time to time, in our sole discretion, issue and sell up to $450.0 million of shares of our common stock pursuant to the “at the market” offering program. The 2023 Sale Agreement superseded and replaced in its entirety the 2022 Sale Agreement, which was terminated by the Company. The issuance and sale, if any, of shares of our common stock under the 2023 Sale Agreement was or will be made pursuant to a prospectus supplement dated June 16, 2023 to our Registration Statement on Form S-3ASR, which became effective immediately upon filing with the U.S. Securities and Exchange Commission on June 16, 2023. We received $301.7 million in proceeds, net of offering costs, through the sale of 44,080,226 shares of our common stock during the year ended December 31, 2023 through the 2022 Sale Agreement and the 2023 Sale Agreement.

Current wording

On June 16, 2023, we entered into a new Open Market Sale Agreement, or the 2023 Sale Agreement, with Jefferies with respect to an “at the market” offering program. Under the terms of the 2023 Sale Agreement, we may, from time to time, in our sole discretion, issue and sell up to $450.0 million of shares of our common stock pursuant to the “at the market” offering program. The 2023 Sale Agreement superseded and replaced in its entirety the 2022 Sale Agreement, which was terminated by the Company. The issuance and sale, if any, of shares of our common stock under the 2023 Sale Agreement was or will be made pursuant to a prospectus supplement dated June 16, 2023 to our Registration Statement on Form S-3ASR, which became effective immediately upon filing with the U.S. Securities and Exchange Commission on June 16, 2023. We received $301.7 million in proceeds, net of offering costs, through the sale of 44,080,226 shares of our common stock for the nine months ended September 30, 2023 through the 2022 Sale Agreement and the 2023 Sale Agreement.

Previous wording

During the second quarter of 2024, we received approximately $152.4 million in net proceeds, after offering costs, through the sale of 17,017,492 shares of common stock through the 2023 Sale Agreement.

Current wording

During the three months ended September 30, 2024, we received approximately $47.5 million in net proceeds, after offering costs, through the sale of 6,110,234 shares of common stock through the 2023 Sale Agreement. During the nine months ended September 30, 2024, we received approximately $200.0 million in net proceeds, after offering costs, through the sale of 23,127,726 shares of common stock through the 2023 Sale Agreement.

Previous wording

Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the six months ended June 30, 2024 was $220.7 million as compared to $193.8 million for the same period in 2023. The $26.9 million increase in cash used in operating activities was driven by a $3.8 million increase in net loss related to increased costs associated with our commercialization and manufacturing activities for Amtagvi™ and overall growth in our workforce and corporate infrastructure. In addition, it reflects a net increase in non-cash charges of $16.2 million, primarily driven by higher stock-based compensation expense and amortization of intangible assets, the latter of which is driven primarily by the amortization associated with the developed technology intangible asset recorded as part of the Acquisition and intellectual property license intangible assets associated with Amtagvi™. The increase in non-cash charges was partially offset by a decrease in accretion of discounts on investments and deferred tax benefits resulting from the realization of the related deferred taxes for operations in the United Kingdom. Further, net cash used in operating activities related to changes in operating assets and liabilities increased by $59.7 million, driven primarily by an increase in trade accounts receivable, resulting from the sale of our products and a decrease in accounts payable and accrued expenses, resulting from cash utilized for payments associated with the continued growth in the business, including our increased workforce, timing of vendor invoicing and related payments, and cash used for purchases of raw material inventory in support of the commercial launch of Amtagvi™. These increases in the use of cash were partially offset by a $12.7 million decrease in cash used for prepaid expenses, other assets, and long-term assets in the current period compared to the corresponding period in 2023, which resulted from the timing of payments made, as well as the receipt of cash for other miscellaneous receivables.

Current wording

Net cash used in operating activities for the periods presented represents cash disbursements related to all activities other than investing and financing activities. Operating cash flow is derived by adjusting our net loss for non-cash items and changes in operating assets and liabilities. Net cash used in operating activities for the nine months ended September 30, 2024 was $279.7 million as compared to $277.9 million for the same period in 2023. The $1.8 million increase in cash used in operating activities was driven by a $34.0 million increase in net loss related to increased costs associated with our commercialization and manufacturing activities for Amtagvi™ and overall growth in our workforce and corporate infrastructure. In addition, it reflects a net increase in non-cash charges of $30.3 million, primarily driven by higher stock-based compensation expense and amortization of intangible assets, the latter of which is driven primarily by the amortization associated with the developed technology intangible asset recorded as part of the Acquisition and intellectual property license intangible assets associated with Amtagvi™. The increase in non-cash charges was partially offset by a decrease in accretion of discounts on investments and deferred tax benefits resulting from the realization of the related deferred taxes for operations in the United Kingdom. Further, net cash used in operating activities related to changes in operating assets and liabilities increased by $74.2 million, driven primarily by an increase in trade accounts receivable, resulting from the sale of our products and a decrease in accounts payable and accrued expenses, resulting from cash utilized for payments associated with the continued growth in the business, including our increased workforce, timing of vendor invoicing and related payments, and cash used for purchases of raw material inventory in support of the commercial launch of Amtagvi™. These increases in the use of cash were partially offset by a $8.1 million decrease in cash used for prepaid expenses, other assets, and long-term assets in the current period compared to the corresponding period in 2023, which resulted from the timing of payments made, as well as the receipt of cash for other miscellaneous receivables.

Previous wording

Net cash used in investing activities for the periods presented primarily relates to the cash utilized to fund the Acquisition, the purchase and maturity of investments, and capital expenditures. Net cash used in investing activities for the six months ended June 30, 2024 was $71.7 million, compared to net cash used by investing activities of $3.4 million for the same period in 2023. The increase in cash used of $67.9 million was driven by a $235.4 million increase associated with changes in the timing of maturities and purchases of investments, which was partially offset by a $156.9 million decrease in cash used for the Acquisition in May 2023 and a $10.6 million decrease in capital expenditures.

Current wording

September 30, 2024 was $120.1 million, compared to net cash used by investing activities of $82.4 million for the same period in 2023. The increase in cash used of $37.7 million was driven by a $209.9 million increase associated with changes in the timing of maturities and purchases of investments, which was partially offset by a $160.3 million decrease in cash used for the Acquisition in May 2023 and a $11.9 million decrease in capital expenditures.

Previous wording

Net cash provided by financing activities for the six months ended June 2024 was $346.4 million compared to net cash provided of $259.2 million for the same period in 2023. The increase in net cash provided by financing activities of $87.2 million was primarily driven by an increase in net proceeds of $89.7 million received from our public offering in February 2024 and through the sales of common stock through our “at the market” offering program in the second quarter of 2024, as compared to the net proceeds

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $388.4 million compared to net cash provided of $462.0 million for the same period in 2023. The decrease in net cash provided by financing activities of $73.6 million was primarily driven by a decrease in net proceeds of $66.0 million received from our public offering in February 2024 and through the sales of common stock through our “at the market” offering program during the nine months ended September 30, 2024, as compared to the net proceeds received through the at the market offering program in the first quarter of 2023. This was offset by a $9.4 million increase in tax payments related to shares withheld for vested restricted stock units and by a $1.7 million increase in proceeds from the issuance of common stock upon the exercise of stock options and from our employee stock purchase plan program.

Previous wording

Our accounting policies are more fully described in Note 2 of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. As described in Note 2, the preparation of our condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We base our estimates on historical experience and on various market-specific and other relevant assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Estimates are assessed each period and updated to reflect current information. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our accounting policies are more fully described in Note 2 of the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q. As described in Note 2, the preparation of our condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of our financial statements, as well as the reported revenues and expenses during the reported periods. We

Previous wording

Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. We have a history of contracting with third parties, including CROs, independent clinical investigators, and CMOs, that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon the work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators.

Current wording

Research and development costs are expensed as incurred. Clinical development costs compose a significant component of research and development costs. We have a history of contracting with third parties, including CROs, independent clinical investigators, and CMOs, that perform various clinical trial activities on our behalf in connection with the ongoing development of our product candidates. The financial terms of these contracts are subject to negotiations and may vary from contract to contract and may result in uneven payment flow. We accrue and expense costs for clinical trial activities performed by third parties based upon the work completed to date for each clinical trial in accordance with agreements established with CROs, hospitals, and clinical investigators. Accruals for CROs and CMOs are recorded based on services received and efforts expended pursuant to agreements established with CROs, CMOs, and other outside service providers. We determine our costs through discussions with internal clinical stakeholders and outside service providers as to the progress or stage of completion of clinical trials or services and the contracted fee to be paid for such services.