Atara Biotherapeutics Inc

Previous wording

Atara Biotherapeutics is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune disease. Tab-cel (tabelecleucel), our lead program in Phase 3 clinical development in the U.S., has received marketing authorization approval (MAA) under the proprietary name Ebvallo™ for commercial sale in the European Union (EU) by the European Commission (EC) and for commercial sale and use in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA). We are the most advanced allogeneic T-cell immunotherapy company and intend to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-driven diseases or other serious diseases through incorporation of engineered chimeric antigen receptors (CARs) or T-cell receptors (TCRs). We are applying this one platform, that does not require TCR or human leukocyte antigen (HLA) gene editing, to create a robust pipeline. Our strategic priorities are:

Current wording

Atara Biotherapeutics is a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune disease. Tab-cel (tabelecleucel), our lead program in Phase 3 clinical development in the U.S., has received marketing authorization approval (MAA) under the proprietary name Ebvallo™ for commercial sale in the European Economic Area (EEA) by the European Commission (EC), for commercial sale and use in the United Kingdom (UK) by the Medicines and Healthcare products Regulatory Agency (MHRA), and for commercial sale and use in Switzerland by Swissmedic. We are the most advanced allogeneic T-cell immunotherapy company and intend to rapidly deliver off-the-shelf treatments to patients with high unmet medical need. Our platform leverages the unique biology of EBV T cells and has the capability to treat a wide range of EBV-driven diseases or other serious diseases through incorporation of engineered chimeric antigen receptors (CARs) or T-cell receptors (TCRs). We are applying this one platform, that does not require TCR or human leukocyte antigen (HLA) gene editing, to create a robust pipeline. Our strategic priorities are:

Previous wording

Tab-cel®: Our most advanced T-cell immunotherapy program, tab-cel, has received MAA for commercial sale in the EU and the UK under the proprietary name Ebvallo and is partnered with Pierre Fabre Medicament (Pierre Fabre) for commercialization in Europe and potential commercialization, if approved, worldwide, including in the U.S. Tab-cel is currently in Phase 3 development in the U.S. for patients with EBV- associated post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed rituximab or rituximab plus chemotherapy, as well as other EBV-driven diseases; and

Current wording

Tab-cel®: Our most advanced T-cell immunotherapy program, tab-cel, has received MAA for commercial sale in the EEA, the UK, and Switzerland under the proprietary name Ebvallo and is partnered with Pierre Fabre Medicament (Pierre Fabre) for commercialization in Europe and potential commercialization, if approved, worldwide, including in the U.S. Tab-cel is currently in Phase 3 development in the U.S. for patients with EBV- associated post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed rituximab or rituximab plus chemotherapy, as well as other EBV-driven diseases; and

Previous wording

On October 31, 2023, we entered into an amended and restated Pierre Fabre Commercialization Agreement (A&R Commercialization Agreement), pursuant to which we expanded Pierre Fabre’s exclusive rights to research, develop, manufacture, commercialize and distribute tab-cel (Ebvallo) to include all other countries in the world (Additional Territory) in addition to the Initial Territory (together, the Territory), subject to our performance of certain obligations as described below. In December 2023, upon the effective date of the A&R Commercialization Agreement, we met the contractual right to receive an additional upfront cash payment of $20.0 million for the expanded exclusive license grant, for which the cash was received in January 2024. In March 2024, we met the contractual right to receive $20.0 million in milestone payments upon achieving a regulatory milestone, for which the cash was received in April 2024. We will also be entitled to receive an aggregate of up to $600.0 million in additional milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel in the Additional Territory including up to $80.0 million in potential regulatory milestones through approval by the United States Food and Drug Administration (FDA) of a biologics license application (BLA) for tab-cel. Of the $80.0 million in potential regulatory milestones, we expect to receive $20.0 million in connection with BLA acceptance and up to $60.0 million in potential regulatory milestones in connection with BLA approval. We are eligible to receive significant double-digit tiered royalties as a percentage of net sales of tab-cel (Ebvallo) in the Territory until the later of 12 years after the first commercial sale in each such country, the expiration of specified patent rights in each such country, or the expiration of all regulatory exclusivity for tab-cel in each such country. Royalty payments may be reduced in certain specified customary circumstances. Royalties and milestones from the commercialization of Ebvallo in the Initial Territory remain subject to the HCRx Agreement.

Current wording

On October 31, 2023, we entered into an amended and restated Pierre Fabre Commercialization Agreement (A&R Commercialization Agreement), pursuant to which we expanded Pierre Fabre’s exclusive rights to research, develop, manufacture, commercialize and distribute tab-cel (Ebvallo) to include all other countries in the world (Additional Territory) in addition to the Initial Territory (together, the Territory), subject to our performance of certain obligations as described below. In December 2023, upon the effective date of the A&R Commercialization Agreement, we met the contractual right to receive an additional upfront cash payment of $20.0 million for the expanded exclusive license grant, for which the cash was received in January 2024. In March 2024, we met the contractual right to receive $20.0 million in milestone payments upon achieving a regulatory milestone, for which the cash was received in April 2024. In July 2024, we met the contractual right to receive an additional $20.0 million in milestone payments upon achieving acceptance of our biologics license application (BLA) for tab-cel by the United States Food and Drug Administration (FDA) and we received the cash in August 2024. We will also be entitled to receive an aggregate of up to $580.0 million in additional milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel in the Additional Territory including up to $60.0 million in potential regulatory milestones in connection with the approval by the FDA of a BLA for tab-cel. We are eligible to receive significant double-digit tiered royalties as a percentage of net sales of tab-cel (Ebvallo) in the Territory until the later of 12 years after the first commercial sale in each such country, the expiration of specified patent rights in each such country, or the expiration of all regulatory exclusivity for tab-cel in each such country. Royalty payments may be reduced in certain specified customary circumstances. Royalties and milestones from the commercialization of Ebvallo in the Initial Territory remain subject to the HCRx Agreement.

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 April 30, 2024 or upon receipt of certain batches of our product and product candidates. We are currently in negotiations with CRL for an amendment to further extend the term of the CRL MSA and 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 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.

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. 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.

Previous wording

In January 2024, we announced a strategic reduction in workforce of approximately 25%. The workforce reduction resulted in total restructuring charges of $4.8 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 March 31, 2024, approximately $1.8 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 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.

Previous wording

Our most advanced T-cell immunotherapy program, tab-cel, is approved by the EC for commercial sale and use in the EU and the UK under the proprietary name Ebvallo. We continue to advance development of tab-cel in the U.S. in a Phase 3 clinical trial for patients with EBV+ PTLD (ALLELE). Tab-cel has received Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with EBV+ PTLD after hematopoietic cell transplants (HCT) who have failed rituximab and orphan drug designation in the U.S. and UK for the treatment of patients with EBV+ PTLD following HCT or solid organ transplants (SOT).

Current wording

Our most advanced T-cell immunotherapy program, tab-cel, is approved for commercial sale and use in the EEA, the UK and Switzerland under the proprietary name Ebvallo. We continue to advance development of tab-cel in the U.S. in a Phase 3 clinical trial for patients with EBV+ PTLD (ALLELE). Tab-cel has received Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of patients with EBV+ PTLD after hematopoietic cell transplants (HCT) who have failed rituximab and orphan drug designation in the U.S. and UK for the treatment of patients with EBV+ PTLD following HCT or solid organ transplants (SOT).

Previous wording

In March 2024, we held a pre-BLA meeting with the FDA to discuss various aspects of our proposed BLA submission for tab-cel and we plan to submit the tab-cel BLA in the second quarter of 2024 as a monotherapy for the treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. The BLA includes pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple diseases.

Current wording

In May 2024, we submitted the tab-cel BLA as a monotherapy for the treatment of adult and pediatric patients two years of age and older with EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. The data package for the BLA included pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple diseases.

Previous wording

In February 2024, we received a Safe to Proceed letter from the FDA in response to our IND submission for use of ATA3219 as a monotherapy for the treatment of systemic lupus erythematosus (SLE) with kidney involvement (lupus nephritis (LN)) and we plan to initiate a Phase 1 study of ATA3219 as a monotherapy for the treatment of SLE with kidney involvement (LN) in the fourth quarter of 2024 (Phase 1 LN Study) with initial clinical data anticipated in the first half 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)) in the fourth quarter of 2024 (Phase 1 LN

Previous wording

We plan to expand the Phase 1 LN Study and add a new cohort in severe SLE without lymphodepletion (LD) in Q4 2024 with initial clinical data anticipated in the second half of 2025. The elimination of LD is designed to further simplify the treatment regiment 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 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.

Previous wording

Preclinical data supporting the potential of ATA3219 in SLE is planned to be presented in poster presentation at the upcoming International Society for Cell & Gene Therapy meeting to be held May 29-June 1, 2024. The data demonstrate that ATA3219 CAR T cells led to complete CD19-specific B-cell depletion against SLE or multiple sclerosis patient peripheral blood mononuclear cells. This preclinical data also shows that ATA3219 CAR T cells, with its 1XX costimulatory domain, release lower levels of pro-inflammatory cytokines while maintaining cytotoxic function as potent as observed with autologous CAR T controls in response to stimulation with CD19+ target cells. Mitigating inflammatory cytokine release that is typically seen with standard CD19 CAR T signaling may lead to reduced toxicity and better tolerability if confirmed in clinical trials.

Current wording

Preclinical data supporting the potential of ATA3219 in SLE was presented in poster presentation at the International Society for Cell & Gene Therapy meeting held May 29-June 1, 2024. The data demonstrate that ATA3219 CAR T cells led to complete CD19-specific B-cell depletion against SLE or multiple sclerosis patient peripheral blood mononuclear cells. This preclinical data also shows that ATA3219 CAR T cells, with its 1XX costimulatory domain, release lower levels of pro-inflammatory cytokines while maintaining cytotoxic function as potent as observed with autologous CAR T controls in response to stimulation with CD19+ target cells. Mitigating inflammatory cytokine release that is typically seen with standard CD19 CAR T signaling may lead to reduced toxicity and better tolerability if confirmed in clinical trials.

Previous wording

We initiated enrollment of a 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 fourth quarter of 2024.

Current 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.

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 April 30, 2024 or upon receipt of certain batches of our product and intermediates. We are currently in negotiations with CRL for an amendment to further extend the term of the CRL MSA and 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 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.

Current 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.

Previous wording

Our net losses were $31.8 million and $74.8 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 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 March 31, 2024, our cash, cash equivalents and short-term investments totaled $46.2 million, which we intend to use to fund our operations.

Current 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.

Previous wording

We expect that any revenue we generate from the A&R Commercialization Agreement, subject to the terms of the HCRx Agreement, will fluctuate from period to period as a result of the timing and number of inventory purchases by Pierre Fabre, royalties from sales by Pierre Fabre potential milestone achievement, any potential regulatory approvals and the timing of manufacturing and cell selection technology transfer to Pierre Fabre.

Current wording

We expect that any revenue we generate from the A&R Commercialization Agreement, subject to the terms of the HCRx Agreement, will fluctuate from period to period as a result of the timing and amount of inventory purchases by Pierre Fabre, royalties from sales by Pierre Fabre, any potential regulatory approvals or milestone achievements and the timing of manufacturing and cell selection technology transfer to Pierre Fabre.

Previous wording

The largest component of our total operating expenses since inception has been our investment in research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits for research and development and regulatory support employees, including stock-based compensation; expenses incurred under agreements with contract research organizations and investigative sites that conduct preclinical and clinical studies; the costs of acquiring and manufacturing clinical study materials and other supplies, including expenses incurred under agreements with CMOs for the manufacture of product candidates prior to receiving regulatory approval to manufacture commercial product; payments under licensing and research and development agreements; other outside services and consulting costs; and facilities, information technology and overhead expenses. Research and development costs are expensed as incurred.

Current wording

The largest component of our total operating expenses since inception has been our investment in research and development activities, including the preclinical and clinical development of our product candidates. Research and development expenses consist primarily of compensation and benefits for research and development and regulatory support employees, including stock-based compensation; expenses incurred under agreements with contract research organizations and investigative sites that conduct preclinical and clinical studies; the costs of acquiring and manufacturing clinical study materials and other supplies, including expenses incurred under agreements with CMOs for the manufacture of product candidates prior to receiving regulatory approval to manufacture commercial product in a qualified manufacturing facility; payments under licensing and research and development agreements; other outside services and consulting costs; and certain information technology and overhead expenses. Research and development costs are expensed as incurred.

Previous wording

General and administrative expenses consist primarily of compensation and benefits for legal, human resources, finance and other general and administrative employees, including stock-based compensation; professional services costs, including legal, patent, human resources, audit and accounting services; other outside services and consulting costs; and information technology and overhead expenses.

Current wording

General and administrative expenses consist primarily of compensation and benefits for executive, legal, human resources, finance and other general and administrative employees, including stock-based compensation; professional services costs, including legal, patent, human resources, audit fees, tax and accounting services; other outside services; consulting costs; and certain information technology and overhead expenses.

Previous wording

There have been no significant changes to our critical accounting policies and significant judgments and estimates during the three months ended March 31, 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 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.

Previous wording

Comparison of the Three Months Ended March 31, 2024 and 2023

Current wording

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

Previous wording

Commercialization revenues were $27.4 million for the three months ended March 31, 2024, as compared to $0.9 million in the comparative 2023 period. The increase in the 2024 period was primarily due to revenue recognized as a result of the additional performance obligations identified pursuant to the A&R Commercialization Agreement, including $12.3 million in fees related to transition plan activities, 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 $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.

Previous wording

Cost of commercialization revenue was $2.0 million for the three months ended March 31, 2024, as compared to $0.2 million in the comparative 2023 period. The increase was primarily related to adjustments to reflect inventory at net realizable value. Prior to receiving EC regulatory approval for Ebvallo in the EU 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 relates to zero cost inventories.

Current 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.

Previous wording

Tab-cel expenses were $6.5 million in the three months ended March 31, 2024, as compared to $4.0 million in the comparative 2023 period. The increase was 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 $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.

Previous wording

ATA188 expenses were $2.0 million for the three months ended March 31, 2024, as compared to $5.9 million in the comparative 2023 period. The decrease was primarily 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 $0.3 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.

Previous wording

CAR T and other program expenses were $2.1 million in the three months ended March 31, 2024, materially consistent with the $2.6 million in the comparative 2023 period.

Current 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.

Previous wording

Non program-specific expenses were $34.8 million in the three months ended March 31, 2024, as compared to $49.7 million in the comparative 2023 period. The decrease was primarily due to lower CMO expenses driven by a decrease in amounts accrued related to minimum commitments, as well as lower payroll and related costs, driven by the November 2023 and January 2024 reductions in force. Relative to the 2023 comparative period, for the three months ended March 31, 2024, payroll and related costs decreased by $6.1 million; facility-related costs remained materially consistent; outside services costs decreased by $8.2 million; and other non-program specific costs decreased by $0.9 million.

Current 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.

Previous wording

General and administrative expenses were $11.1 million in the three months ended March 31, 2024, as compared to $13.9 million in the comparative 2023 period. The decrease in the 2024 period was primarily due to lower payroll and related costs as a result of the November 2023 and January 2024 reductions in force.

Current 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.

Previous wording

Interest income was $0.6 million in the three months ended March 31, 2024, as compared to $1.8 million in the comparative 2023 period. The decrease in the 2024 period was primarily due to lower balances of cash, cash equivalents and available-for-sale securities.

Current 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.

Previous wording

During the three months ended March 31, 2024, we sold an aggregate of 12,321,365 shares of common stock under the 2023 ATM Facility, at an average price of $0.77 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 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.

Previous wording

We have incurred losses and negative cash flows from operations in each year since inception and have only just begun to generate commercialization revenues from the A&R Commercialization Agreement, following the December 2022 EU regulatory approval of Ebvallo, which is subject to the terms of the HCRx Agreement. We do not maintain any meaningful milestone or royalty payments from Pierre Fabre relative to the Initial Territory until the applicable royalty cap under the HCRx Agreement is met, if at all. We continue to incur significant research and development and other expenses related to our ongoing operations and expect to incur losses for the foreseeable future. As a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding and other collaborations, strategic alliances and partnering arrangements. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to additional funds through additional public or private equity offerings or debt financings including by utilizing the 2023 ATM Facility, through potential collaboration, partnering or other strategic arrangements, or a combination of the foregoing. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies or grant licenses or other rights on terms that are not favorable to us.

Current wording

We have incurred losses and negative cash flows from operations in each year since inception and have only just begun to generate commercialization revenues from the A&R Commercialization Agreement, following the December 2022 EU regulatory approval of Ebvallo, which is subject to the terms of the HCRx Agreement. We do not retain any meaningful milestone or royalty payments from Pierre Fabre relative to the Initial Territory until the applicable royalty cap under the HCRx Agreement is met, if at all. We continue to incur significant research and development and other expenses related to our ongoing operations and expect to incur losses for the foreseeable future. As a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding and other collaborations, strategic alliances and partnering arrangements. We may borrow funds on terms that may include restrictive covenants, including covenants that restrict the operation of our business, liens on assets, high effective interest rates and repayment provisions that reduce cash resources and limit future access to capital markets. In addition, we expect to continue to opportunistically seek access to additional funds through additional public or private equity offerings or debt financings including by utilizing the 2023 ATM Facility, through potential collaboration, partnering or other strategic arrangements, or a combination of the foregoing. To the extent that we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. To the extent that we raise additional funds through collaboration or partnering arrangements, we may be required to relinquish some of our rights to our technologies or rights to market and sell our products in certain geographies or grant licenses or other rights on terms that are not favorable to us.

Previous wording

Net cash used in operating activities was $29.6 million in the three months ended March 31, 2024 as compared to $38.4 million in the comparative 2023 period. The decrease of $8.8 million was primarily due to lower operating expenditures, including lower cash compensation-related costs from a decrease in headcount resulting from the November 2023 reduction in force, partially offset by lower cash received from Pierre Fabre for upfront and milestone payments pursuant to the A&R Commercialization Agreement.

Current 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.

Previous wording

Net cash provided by investing activities in the three months ended March 31, 2024 consisted primarily of $14.8 million received from maturities and sales of available-for-sale securities. Net cash used in investing activities in the comparative 2023 period primarily consisted of $67.9 million used to purchase available-for-sale securities, partially offset by $62.3 million received from maturities and sales of available-for-sale securities.

Current 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.

Previous wording

Net cash provided by financing activities in the three months ended March 31, 2024 primarily consisted of $15.0 million of proceeds received from the issuance of prefunded warrants in a direct registered offering and $9.4 million of net proceeds received from the 2023 ATM Facility, partially offset by $0.2 million in principal payments on finance lease obligations. Net cash provided by financing activities in the comparative 2023 period consisted primarily of $0.6 million of net proceeds received from the 2021 ATM Facility, partially offset by $0.3 million in principal payments on finance lease obligations.

Current 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.

Previous wording

We expect that existing cash, cash equivalents and short-term investments, combined with certain anticipated payments from the A&R Commercialization Agreement, as well as cost reductions from completed workforce reductions and operating efficiencies resulting from our planned transition of substantially all activities relating to tab-cel at the time of the BLA transfer to Pierre Fabre, will enable us to fund our planned operations into 2027. Such anticipated payments are estimates based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include the receipt of future payments that are dependent upon the successful filing and approval of the tab-cel BLA, as well as the completion of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time. We do not know when, or if, we will generate sufficient revenue from commercialization to offset our operating expenses. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the accumulated losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks inherent in the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need to raise substantial additional funding to finance our planned operations in the long-term.

Current wording

We expect that existing cash, cash equivalents and short-term investments, combined with certain anticipated payments from the A&R Commercialization Agreement, as well as cost reductions from completed workforce reductions and operating efficiencies resulting from our planned transition of substantially all activities relating to tab-cel at the time of the BLA transfer to Pierre Fabre, will enable us to fund our planned operations into 2027. Such anticipated payments are estimates based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include the receipt of future payments that are dependent upon the successful acceptance and approval of the tab-cel BLA, as well as the completion of specific development and regulatory activities by us and actions taken by third parties, and are, therefore, uncertain at this time. We do not know when, or if, we will generate sufficient revenue from commercialization to offset our operating expenses. We anticipate that we will continue to generate losses for the foreseeable future, and we expect the accumulated losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates and begin to commercialize any approved products. We are subject to all of the risks inherent in the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. We anticipate that we will need to raise substantial additional funding to finance our planned operations in the long-term.