Atara Biotherapeutics Inc

Previous wording

ATA3219: Allogeneic CAR T targeting CD19, currently in Phase 1 development is being developed as a potential best-in-class product intended to target B-cell malignancies and autoimmune diseases, based on a next generation 1XX co-stimulatory domain and the innate advantages of EBV T cells as the foundation for an allogeneic CAR T platform

Current wording

ATA3219: Allogeneic CAR T targeting CD19, currently in Phase 1 development is being developed as a potential best-in-class product intended to target B-cell malignancies and autoimmune diseases, based on a next generation 1XX signaling domain and the innate advantages of EBV T cells as the foundation for an allogeneic CAR T platform.

Previous wording

In addition to the aforementioned strategic priorities, we also have a number of preclinical programs, including ATA3431, an allogeneic dual CAR T immunotherapy targeting both CD19 and CD20 for B-cell malignancies; and a potential next generation EBV vaccine which is differentiated from earlier EBV vaccine efforts that solely focused on B cell responses to EBV. We have paused development on ATA188, an allogeneic T-cell immunotherapy targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS), while we explore strategic options for this asset.

Current wording

In addition to the aforementioned strategic priorities, we also have a number of preclinical programs, including ATA3431, an allogeneic dual CAR T immunotherapy targeting both CD19 and CD20 for B-cell malignancies; and a potential next generation EBV vaccine which is differentiated from earlier EBV vaccine efforts that solely focused on B cell responses to EBV. We have stopped development on ATA188, an allogeneic T-cell immunotherapy targeting multiple sclerosis (MS).

Previous wording

Our T-cell immunotherapy platform is potentially applicable to a broad array of targets and diseases. Our off-the-shelf, allogeneic T-cell platform allows for rapid delivery of a T-cell immunotherapy product manufactured in advance of patient need and stored in inventory, with each manufactured lot of cells providing therapy for numerous potential patients. This differs from autologous treatments, in which each patient’s own cells must be extracted, genetically modified outside the body and then delivered back to the patient, requiring a complex logistics network. We select the appropriate set of cells for use based on a patient’s unique immune profile. We estimate that only four and six unique ATA3219 lots will be needed to cover approximately 90% of U.S. NHL and lupus patients, respectively. One of our contract manufacturing organizations (CMOs) has completed commercial production qualification activities for tab-cel and another of our CMOs is currently in the process of completing commercial production qualification activities for tab-cel while we manufacture inventory according to Pierre Fabre’s commercial product supply strategy.

Current wording

Our T-cell immunotherapy platform is potentially applicable to a broad array of targets and diseases. Our off-the-shelf, allogeneic T-cell platform allows for rapid delivery of a T-cell immunotherapy product manufactured in advance of patient need and stored in inventory, with each manufactured lot of cells providing therapy for numerous potential patients. This differs from autologous treatments, in which each patient’s own cells must be extracted, genetically modified outside the body and then delivered back to the patient, requiring a complex logistics network. We select the appropriate set of cells for use based on a patient’s unique immune profile. We estimate that only four and six unique ATA3219 lots will be needed to cover approximately 90% of U.S. NHL and lupus patients, respectively. One of our contract manufacturing organizations (CMOs) has completed commercial production qualification activities for tab-cel commercialization in the EEA and is in the process of completing commercial production qualification activities in the US. Another of our CMOs is currently in the process of completing commercial production qualification activities for tab-cel in the EEA. We continue to manufacture inventory according to Pierre Fabre’s commercial product supply strategy.

Previous wording

Prior to the transfer of manufacturing responsibility to Pierre Fabre, we will be responsible for manufacturing and supplying tab-cel to Pierre Fabre for commercialization in the Territory at cost plus a margin for orders placed after December 31, 2023, subject to a maximum annual increase. Pierre Fabre will assume the responsibility and cost for the manufacture and supply of tab-cel in the Territory upon the Manufacturing Transition Date, which is defined as the earlier of i) the date on which all activities relating to the transfer of tab-cel manufacturing, pursuant to the A&R Commercialization Agreement, from Atara to Pierre Fabre have been completed to the reasonable satisfaction of both parties, or ii) December 31, 2025, throughout the remainder of the term of the A&R Commercialization Agreement. Pierre Fabre and we are to use commercially reasonable efforts to achieve this prior to the earlier transfer date from Atara to Pierre Fabre of the first marketing authorization in the Additional Territory or the first BLA, which transfer could potentially occur as early as the first quarter of 2025.

Current wording

Prior to the transfer of manufacturing responsibility to Pierre Fabre, we will be responsible for manufacturing and supplying tab-cel to Pierre Fabre for commercialization in the Territory at cost plus a margin for orders placed after December 31, 2023, subject to a maximum annual increase. Pierre Fabre will assume the responsibility and cost for the manufacture and supply of tab-cel in the Territory upon the Manufacturing Transition Date, which is defined as the earlier of i) the date on which all activities relating to the transfer of tab-cel manufacturing, pursuant to the A&R Commercialization Agreement, from Atara to Pierre Fabre have been completed to the reasonable satisfaction of both parties, or ii) December 31, 2025, throughout the remainder of the term of the A&R Commercialization Agreement. Pierre Fabre and we are to use commercially reasonable efforts to achieve this prior to the earlier transfer date from Atara to Pierre Fabre of the first marketing authorization in the Additional Territory or the first BLA, which transfer could potentially occur as early as the first quarter of 2025. Any delays in completing the manufacturing transfer to Pierre Fabre will cause us to incur additional costs in order to meet our supply obligations.

Previous wording

We also work with Charles River Laboratories (CRL) pursuant to a Commercial Manufacturing Services Agreement (CRL MSA) that we entered into in December 2019. Pursuant to the CRL MSA, CRL provides manufacturing services for our product and certain intermediates. We further amended the CRL MSA to extend the term until the earlier of August 31, 2024 or upon receipt of certain batches of our product and product candidates. We are currently in negotiations with CRL for a new commercial drug product supply agreement to be effective upon the expiration of the CRL MSA. However, there can be no assurance that we will be able to enter into a new commercial drug product supply agreement with CRL on terms favorable or acceptable to us, or at all. If we are unable to enter into a new commercial drug product supply agreement or extend the CRL MSA, we may need to identify alternative sources of drug product supply.

Current wording

We also work with Charles River Laboratories (CRL) pursuant to a Commercial Manufacturing Services Agreement (CRL MSA) that we entered into in December 2019. Pursuant to the CRL MSA, CRL provides manufacturing services for our product and certain intermediates. The CRL MSA expired on August 31, 2024. We are currently in negotiations with CRL for an amendment to further extend the term of the CRL MSA and for a new commercial drug product supply agreement. However, there can be no assurance that we will be able to further extend the CRL MSA or enter into a new commercial drug product supply agreement with CRL on terms favorable or acceptable to us, or at all. If we are unable to enter into a new commercial drug product supply agreement or extend the CRL MSA, we may need to identify alternative sources of drug product supply.

Previous wording

In November 2023, we announced a reduction in force of approximately 30% of our workforce at that time. This workforce reduction resulted in total restructuring charges of $6.7 million, comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California Worker Adjustment and Retraining Notification (WARN) Act. In most cases, the severance payments were paid as a lump sum in January 2024. All of the severance costs represent cash expenditures.

Current wording

In November 2023, we announced a reduction in force of approximately 30% of our workforce at that time. This workforce reduction resulted in total restructuring charges of $6.7 million, comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California Worker Adjustment and Retraining Notification (WARN) Act. In most cases, the severance payments were paid as a lump sum in January 2024. As of September 2024, there are no remaining payments for the November 2023 reduction in workforce. All of the costs were cash expenditures and represent one-time termination benefits.

Previous wording

In January 2024, we announced a strategic reduction in workforce of approximately 25%. The workforce reduction resulted in total restructuring charges of $5.1 million, comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance payments are being paid during the first half of 2024. Certain of the notified employees had employment agreements that provided for separation benefits in the form of salary continuation, which are being paid from February 2024 through January 2025. As of June 30, 2024, approximately $0.8 million of further separation payments and benefits are required for the January 2024 reduction in workforce. The majority of the associated costs are cash expenditures and primarily represent one-time termination benefits.

Current wording

In January 2024, we announced a strategic reduction in workforce of approximately 25%. The workforce reduction resulted in total restructuring charges of $5.1 million, comprised primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance payments are being paid during the first half of 2024. Certain of the notified employees had employment agreements that provided for separation benefits in the form of salary continuation, which are being paid from February 2024 through January 2025. As of September 30, 2024, approximately $0.2 million of further separation payments and benefits are required for the January 2024 reduction in workforce. The majority of the associated costs are cash expenditures and primarily represent one-time termination benefits.

Previous wording

In July 2024, the FDA accepted the tab-cel BLA and granted priority review with a Prescription Drug User Fee Act target action date of January 15, 2025.

Current wording

In July 2024, the FDA accepted the tab-cel BLA and we believe the tab-cel BLA is on track with a Prescription Drug User Fee Act target action date of January 15, 2025.

Previous wording

We are developing ATA3219, a potential best-in-class, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies and autoimmune diseases, leveraging our next-generation 1XX CAR co-stimulatory signaling domain and EBV T-cell platform and does not require TCR or human leukocyte antigen (HLA) gene editing.

Current wording

We are developing ATA3219, a potential best-in-class, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies and autoimmune diseases, leveraging our next-generation 1XX CAR signaling domain and EBV T-cell platform and does not require TCR or human leukocyte antigen (HLA) gene editing.

Previous wording

Study) with initial clinical data anticipated in the middle of 2025. We may potentially expand the Phase 1 LN Study into additional autoimmune indications via the same IND previously cleared for the Phase 1 LN study.

Current wording

We plan to initiate a Phase 1 study of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis (LN)) by the end of 2024 (Phase 1 LN Study) with initial clinical data anticipated in the middle of 2025. We may potentially expand the Phase 1 LN Study into additional autoimmune indications via the same IND previously cleared for the Phase 1 LN study.

Previous wording

We plan to expand the Phase 1 LN Study and add a new cohort in severe SLE without lymphodepletion (LD) in the fourth quarter of 2024 with initial clinical data anticipated in the middle of 2025. The elimination of LD is designed to further simplify the treatment regimen and to potentially provide a differentiated safety profile to patients without compromising efficacy which may improve patient access.

Current wording

We plan to expand the Phase 1 LN Study and add a new cohort in extrarenal SLE without lymphodepletion (LD) by the end of 2024 with initial clinical data anticipated in the middle of 2025. The elimination of LD is designed to further simplify the treatment regimen and to potentially provide a differentiated safety profile to patients without compromising efficacy which may improve patient access.

Previous wording

We continue to open sites and to initiate enrollment in our multi-center, Phase 1 open-label, dose escalation clinical trial for ATA3219 in NHL, including large B-cell lymphomas, follicular lymphoma, or mantle cell lymphoma, with initial clinical data anticipated in the first quarter of 2025.

Current wording

We treated the first patient and continue to open sites and initiate enrollment of patients in our multi-center, Phase 1 open-label, dose escalation clinical trial for ATA3219 in NHL, including large B-cell lymphomas, follicular lymphoma, or mantle cell lymphoma, with initial clinical data anticipated in the first quarter of 2025.

Previous wording

Our CAR T immunotherapy pipeline includes ATA3431, an allogeneic, bispecific CAR directed against CD19 and CD20 for B-cell malignancies and autoimmune disease, leveraging our 1XX CAR co-stimulatory domain and EBV T-cell platform and does not require gene TCR or HLA gene editing. Preclinical data presented at the American Society of Hematology 2023 demonstrated potential for potent antitumor activity, long-term persistence, and superior tumor growth inhibition compared to an autologous CD19/CD20 CAR T benchmark. We are progressing toward an IND submission and expect to file an IND submission for ATA3431 in the second half of 2025.

Current wording

Our CAR T immunotherapy pipeline includes ATA3431, an allogeneic, bispecific CAR directed against CD19 and CD20 for B-cell malignancies and autoimmune disease, leveraging our 1XX CAR signaling domain and EBV T-cell platform and does not require gene TCR or HLA gene editing. Preclinical data presented at the American Society of Hematology 2023 demonstrated potential for potent antitumor activity, long-term persistence, and superior tumor growth inhibition compared to an autologous CD19/CD20 CAR T benchmark. We are progressing toward an IND submission and expect to file an IND submission for ATA3431 in the fourth quarter of 2025.

Previous wording

We are also collaborating with QIMR Berghofer to develop a potential next generation EBV vaccine which is differentiated from earlier EBV vaccine efforts that solely focused on B cell responses to EBV. We also retain the rights to ATA188, an allogeneic T-cell immunotherapy targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS). We have paused development on ATA188 while we explore strategic options for this asset. We have also discontinued some programs and will return the programs to our collaborators. For example, in March 2024, we returned the ATA2271 and ATA3271 programs targeting mesothelin to MSK.

Current wording

We are also collaborating with QIMR Berghofer to develop a potential next generation EBV vaccine which is differentiated from earlier EBV vaccine efforts that solely focused on B cell responses to EBV. While we retain the rights to ATA188, we have stopped development of ATA188. We have discontinued some other programs and returned the programs to our collaborators. For example, in March 2024, we returned the ATA2271 and ATA3271 programs targeting mesothelin to MSK.

Previous wording

We also work with CRL pursuant to the CRL MSA. CRL provides manufacturing services for our product and certain intermediates. We further amended the CRL MSA to extend the term until the earlier of August 31, 2024 or upon receipt of certain batches of our product and intermediates. We are currently in negotiations with CRL for a new commercial drug product supply agreement to be effective upon the expiration of the CRL MSA. However, there can be no assurance that we will be able to enter into a new commercial drug product supply agreement with CRL on terms favorable or acceptable to us, or at all. If we are unable to enter into a new commercial drug product supply agreement or extend the CRL MSA, we may need to identify alternative sources of drug product supply.

Current wording

We also work with CRL pursuant to the CRL MSA. CRL provides manufacturing services for our product and certain intermediates. The CRL MSA expired on August 31, 2024. We are currently in negotiations with CRL for an amendment to further extend the term of the CRL MSA and for a new commercial drug product supply agreement. However, there can be no assurance that we will be able to further extend the CRL MSA or enter into a new commercial drug product supply agreement with CRL on terms favorable or acceptable to us, or at all. If we are unable to enter into a new commercial drug product supply agreement or extend the CRL MSA, we may need to identify alternative sources of drug product supply.

Previous wording

Our net losses were $50.8 million and $145.9 million for the six months ended June 30, 2024 and 2023, respectively. As of June 30, 2024, we had an accumulated deficit of $2.0 billion. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative expenses associated with our operations. As of June 30, 2024, our cash, cash equivalents and short-term investments totaled $35.3 million, which we intend to use to fund our operations.

Current wording

Our net losses were $72.7 million and $215.7 million for the nine months ended September 30, 2024 and 2023, respectively. As of September 30, 2024, we had an accumulated deficit of $2.0 billion. Substantially all of our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative expenses associated with our operations. As of September 30, 2024, our cash, cash equivalents and short-term investments totaled $67.2 million, which we intend to use to fund our operations.

Previous wording

There have been no significant changes to our critical accounting policies and significant judgments and estimates during the six months ended June 30, 2024 from those disclosed in our management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 28, 2024.

Current wording

There have been no significant changes to our critical accounting policies and significant judgments and estimates during the nine months ended September 30, 2024 from those disclosed in our management’s discussion and analysis of financial condition and results of operations included in our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on March 28, 2024.

Previous wording

Comparison of the Three and Six Months Ended June 30, 2024 and 2023

Current wording

Comparison of the Three and Nine Months Ended September 30, 2024 and 2023

Previous wording

Commercialization revenues were $28.6 million and $56.0 million for the three and six months ended June 30, 2024, respectively, as compared to $0.8 million and $1.7 million in the respective comparative 2023 periods. The increases in the 2024 periods were primarily due to revenue recognized as a result of the additional performance obligations identified pursuant to the A&R Commercialization Agreement, including $11.5 million and $23.8 million in fees related to transition plan activities, for the three and six months ended June 30, 2024, respectively, and the acceleration of the recognition period of the existing performance obligation related to the Initial Territory from the Pierre Fabre Commercialization Agreement.

Current wording

Commercialization revenues were $40.2 million and $96.2 million for the three and nine months ended September 30, 2024, respectively, as compared to $2.0 million and $3.7 million in the respective comparative 2023 periods. The increases in the 2024 periods were primarily due to revenue recognized as a result of the additional performance obligations identified pursuant to the A&R Commercialization Agreement, including, but not limited to, the $12.2 million and $36.0 million in fees related to transition plan activities, for the three and nine months ended September 30, 2024, respectively, and the acceleration of the recognition period of the existing performance obligation related to the Initial Territory from the Pierre Fabre Commercialization Agreement.

Previous wording

Cost of commercialization revenue was $4.6 million and $6.6 million for the three and six months ended June 30, 2024, respectively, as compared to $2.9 million and $3.1 million in the respective comparative 2023 periods. The balances in the respective periods were primarily related to adjustments to reflect inventory at net realizable value. Prior to receiving EC regulatory approval for Ebvallo in the EEA in December 2022, we recorded all costs incurred in the manufacture of Ebvallo to be sold upon commercialization as research and development expense. As a result, Ebvallo inventories manufactured before EC regulatory approval, referred to as zero cost inventories, were expensed as research and development and are therefore excluded from the cost of commercialization revenue. Ebvallo manufacturing costs incurred after EC regulatory approval are capitalized into inventory. The majority of commercialization revenue recognized to date associated with the sale of Ebvallo has related to zero cost inventories.

Current wording

Cost of commercialization revenue was $7.6 million and $14.2 million for the three and nine months ended September 30, 2024, respectively, as compared to $2.6 million and $5.7 million in the respective comparative 2023 periods. The increases in the 2024 periods were primarily related to higher charges associated with adjustments to reflect inventory at net realizable value, partially offset by a reduction of in-license sales-related milestone expense. Prior to receiving EC regulatory approval for Ebvallo in the EEA in December 2022, we recorded all costs incurred in the manufacture of Ebvallo to be sold upon commercialization as research and development expense. As a result, Ebvallo inventories manufactured before EC regulatory approval, referred to as zero cost inventories, were expensed as research and development and are therefore excluded from the cost of commercialization revenue. Ebvallo manufacturing costs incurred after EC regulatory approval are capitalized into inventory and recorded into cost of commercialization revenue as the related commercialization revenue is recognized. The majority of commercialization revenue recognized to date associated with the sale of Ebvallo has related to zero cost inventories.

Previous wording

Tab-cel expenses were $5.3 million and $11.8 million in the three and six months ended June 30, 2024, respectively, as compared to $4.5 million and $8.5 million in the respective comparative 2023 periods. The increases were primarily driven by expenses in support of tab-cel process science and BLA filing activities. Pursuant to the A&R Commercialization Agreement, Pierre Fabre is required to pay us for the majority of these tab-cel expenses incurred.

Current wording

Tab-cel expenses were $14.0 million and $25.9 million in the three and nine months ended September 30, 2024, respectively, as compared to $6.1 million and $14.6 million in the respective comparative 2023 periods. The increases were primarily driven by a $6.0 million sub-licensing payment made in the third quarter of 2024, as well as higher expenses in support of tab-cel process development, BLA filing and BLA pre-approval inspection activities. Pursuant to the A&R Commercialization Agreement, Pierre Fabre is required to pay us for the majority of these tab-cel expenses incurred.

Previous wording

ATA188 expenses were $0.3 million and $2.3 million in the three and six months ended June 30, 2024, respectively, as compared to $6.0 million and $11.9 million in the respective comparative 2023 periods. The decreases were due to pausing all clinical trial, development and manufacturing activities related to ATA188 following the announcement in November 2023 that the Phase 2 EMBOLD clinical trial did not meet its primary endpoint. We expect ATA188 expenses to continue to decline in 2024, as we complete the close-out activities of the Phase 2 EMBOLD clinical trial.

Current wording

ATA188 expenses were $0.2 million and $2.5 million in the three and nine months ended September 30, 2024, respectively, as compared to $5.8 million and $17.6 million in the respective comparative 2023 periods. The decreases were due to pausing all clinical trial, development and manufacturing activities related to ATA188 following the announcement in November 2023 that the Phase 2 EMBOLD clinical trial did not meet its primary endpoint. We expect ATA188 expenses to continue to decline in 2024, as we complete the close-out activities of the Phase 2 EMBOLD clinical trial.

Previous wording

CAR T and other program expenses were $2.8 million and $4.9 million in the three and six months ended June 30, 2024, respectively, materially consistent with the $2.6 million and $5.2 million in the respective comparative 2023 periods.

Current wording

CAR T and other program expenses were $3.6 million and $8.5 million in the three and nine months ended September 30, 2024, respectively, materially consistent with the $3.4 million and $8.6 million in the respective comparative 2023 periods.

Previous wording

Non program-specific expenses were $25.0 million and $59.8 million in the three and six months ended June 30, 2024, respectively, as compared to $43.0 million and $92.7 million in the respective comparative 2023 periods. The decreases were primarily due to lower payroll and related costs, driven by the November 2023 and January 2024 reductions in force, as well as lower CMO expenses driven by a decrease in amounts accrued related to minimum commitments. Relative to the 2023 comparative period, for the three months ended June 30, 2024, payroll and related costs decreased by $11.9 million; facility-related costs decreased by $1.4 million; outside services costs decreased by $2.2 million; and other non-program specific costs decreased by $2.6 million. Relative to the 2023 comparative period, for the six months ended June 30, 2024, payroll and related costs decreased by $17.9 million; facility-related costs decreased by $1.1 million; outside services costs decreased by $10.4 million; and other non-program specific costs decreased by $3.5 million.

Current wording

Non program-specific expenses were $26.1 million and $85.9 million in the three and nine months ended September 30, 2024, respectively, as compared to $41.6 million and $134.3 million in the respective comparative 2023 periods. The decreases were primarily due to lower payroll and related costs, driven by the November 2023 and January 2024 reductions in force, as well as lower CMO expenses driven by a decrease in amounts accrued related to minimum commitments. Relative to the 2023 comparative period, for the three months ended September 30, 2024, payroll and related costs decreased by $9.7 million; facility-related costs decreased by $2.3 million; outside services costs decreased by $1.8 million; and other non-program specific costs decreased by $1.7 million. Relative to the 2023 comparative period, for the nine months ended September 30, 2024, payroll and related costs decreased by $27.6 million; facility-related costs decreased by $3.4 million; outside services costs decreased by $12.2 million; and other non-program specific costs decreased by $5.2 million.

Previous wording

General and administrative expenses were $8.9 million and $20.0 million in the three and six months ended June 30, 2024, respectively, as compared to $13.3 million and $27.2 million in the respective comparative 2023 periods. The decreases in the 2024 periods were primarily due to lower payroll and compensation-related costs as a result of the November 2023 and January 2024 reductions in force.

Current wording

General and administrative expenses were $10.4 million and $30.4 million in the three and nine months ended September 30, 2024, respectively, as compared to $12.2 million and $39.5 million in the respective comparative 2023 periods. The decreases in the 2024 periods were primarily due to lower payroll and compensation-related costs as a result of the November 2023 and January 2024 reductions in force.

Previous wording

Interest income was $0.5 million and $1.1 million in the three and six months ended June 30, 2024, respectively, as compared to $1.7 million and $3.5 million in the respective comparative 2023 periods. The decreases in the 2024 periods were primarily due to lower balances of cash, cash equivalents and available-for-sale securities.

Current wording

Interest income was $0.5 million and $1.5 million in the three and nine months ended September 30, 2024, respectively, as compared to $1.2 million and $4.7 million in the respective comparative 2023 periods. The decreases in the 2024 periods were primarily due to lower average balances of cash, cash equivalents and available-for-sale securities.

Previous wording

During the six months ended June 30, 2024, we sold an aggregate of 492,855 shares of common stock under the 2023 ATM Facility, at an average price of $19.23 per share for gross proceeds of $9.5 million and net proceeds of $9.3 million, after deducting commissions and other offering expenses payable by us.

Current wording

During the nine months ended September 30, 2024, we sold an aggregate of 492,855 shares of common stock under the 2023 ATM Facility, at an average price of $19.23 per share for gross proceeds of $9.5 million and net proceeds of $9.3 million, after deducting commissions and other offering expenses payable by us.

Previous wording

Net cash used in operating activities was $40.3 million in the six months ended June 30, 2024 as compared to $91.2 million in the comparative 2023 period. The decrease of $51.0 million was primarily due to lower operating expenditures, including lower cash compensation-related costs from a decrease in headcount resulting from the November 2023 and January 2024 reductions in force, with the remaining variance due to changes in net working capital.

Current wording

Net cash used in operating activities was $44.2 million in the nine months ended September 30, 2024 as compared to $142.6 million in the comparative 2023 period. The decrease of $98.3 million was partially due to increased payments received from Pierre Fabre pursuant to the A&R Commercialization Agreement, including $33.8 million in transition services fees and $20 million higher cash received for upfront and milestone fees. The remaining decrease resulted from lower net operating expenditures, including, but not limited to, lower cash compensation-related costs from a decrease in headcount resulting from the November 2023 and January 2024 reductions in force.

Previous wording

Net cash provided by investing activities in the six months ended June 30, 2024 consisted primarily of $22.1 million received from maturities and sales of available-for-sale securities. Net cash provided by investing activities in the comparative 2023 period primarily consisted of $128.0 million received from maturities and sales of available-for-sale securities, partially offset by $83.6 million used to purchase available-for-sale securities.

Current wording

Net cash provided by investing activities in the nine months ended September 30, 2024 consisted primarily of $25.1 million received from maturities and sales of available-for-sale securities, partially offset by $19.7 million used to purchase available-for-sale securities. Net cash provided by investing activities in the comparative 2023 period primarily consisted of $198.7 million received from maturities and sales of available-for-sale securities, partially offset by $83.6 million used to purchase available-for-sale securities.

Previous wording

Net cash provided by financing activities in the six months ended June 30, 2024 primarily consisted of $14.8 million of net proceeds received from the issuance of pre-funded warrants in a direct registered offering and $9.3 million of net proceeds received from the 2023 ATM Facility. Net cash provided by financing activities in the comparative 2023 period consisted primarily of $0.7 million from employee stock award transactions and $0.6 million of net proceeds received from the 2021 ATM Facility, partially offset by $0.5 million in principal payments on finance lease obligations.

Current wording

Net cash provided by financing activities in the nine months ended September 30, 2024 primarily consisted of $50.8 million of net proceeds received from the issuance of common stock and pre-funded warrants to purchase common stock in direct registered offerings and $9.3 million of net proceeds received from the 2023 ATM Facility. Net cash provided by financing activities in the comparative 2023 period consisted primarily of $0.7 million from employee stock award transactions and $0.6 million of net proceeds received from the 2021 ATM Facility, partially offset by $0.7 million in principal payments on finance lease obligations.