What changed in this filing

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Item 2. Management’s Discussion and Analysis

2021-08-09 compared with 2021-05-04 · 88 added, 76 removed, 215 unchanged (43% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes included elsewhere in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2021.

This discussion and other parts of this Quarterly Report contain forward-looking statements that involve risk and uncertainties, such as statements of our plans, objectives, expectations and intentions.

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Our strategic priorities are:

Atara’s most advanced T-cell immunotherapy, tab-cel ® (tabelecleucel), currently in Phase 3 development for patients with EBV-driven post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed rituximab or rituximab plus chemotherapy, as well as other EBV-driven diseases;

Atara’s most advanced T-cell immunotherapy program, tab-cel ® (tabelecleucel), currently in Phase 3 development for patients with EBV-driven post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed rituximab or rituximab plus chemotherapy, as well as other EBV-driven diseases;

T-cell immunotherapy targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis;

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Autologous CAR T immunotherapy targeting solid tumors expressing the tumor antigen mesothelin, which is partnered with Bayer AG (Bayer);

Allogeneic CAR T therapy targeting mesothelin, which is partnered with Bayer;

Allogeneic CAR T targeting CD19, being developed as a potential best-in-class product, 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.

Allogeneic CAR T therapy currently in preclinical development targeting mesothelin, which is partnered with Bayer;

Allogeneic CAR T targeting CD19, currently in preclinical development, and being developed as a potential best-in-class product, 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.

Our T-cell immunotherapy platform includes the capability to progress both allogeneic and autologous programs and is potentially applicable to a broad array of targets and diseases.

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Lee Moffitt Cancer Center and Research Institute (Moffitt) pursuant to which we acquired rights to novel and proprietary technologies and programs.

We continue to advance development of tab-cel ® in a Phase 3 clinical trial for patients with EBV+ PTLD, which has received Breakthrough Therapy Designation (BTD) in the U.S.

and PRIority MEdicines (PRIME) designation in the European Union (EU).

We are in active discussions with the FDA and progressing toward alignment on the content of chemistry, manufacturing and controls (CMC) module 3, including methodologies to assess comparability between the product used in the pivotal ALLELE study and the intended commercial product.

We are working toward completing a BLA submission in the third quarter of 2021 pending alignment with the FDA.

A recent analysis shows that duration of response in the ALLELE study is maturing as anticipated with a larger number of responders followed for at least six months and a safety profile consistent with previously published data with no new safety signals.

In January 2021, we presented transcriptional data for tab-cel ® at the 2021 Transplantation & Cellular Therapy Meeting demonstrating consistency of the product’s activation profile irrespective of donor and consistent enrichment of receptors targeting EBV-driven diseases.

We have data at two medical congresses (presented at the Annual Meeting of the European Society for Blood and Marrow Transplantation in March 2021, and an abstract at the upcoming American Transplant Congress in June 2021) from a combined long-term overall survival (OS) analysis from three clinical studies of tab-cel ® demonstrating that patients with EBV+ PTLD, following both HCT (hematopoietic cell transplantation) and SOT (solid organ transplant), that is relapsed or refractory to initial treatment, derived similar OS benefit greater than 80 percent at two years whether they achieved complete or partial response with tab-cel ® .

We expect to present data from the pivotal ALLELE study at an appropriate congress in the fourth quarter of 2021.

We have submitted a letter of intent to the European Medicines Agency (EMA), starting the process for a submission of an EU marketing authorization application (MAA) for tab-cel ® in patients with EBV+ PTLD in the fourth quarter of 2021.

We anticipate an approval decision with respect to of the MAA in the second half of 2022.

We are continuing our preparations and investing further in commercial readiness activities in anticipation of potential approval and commercialization of tab-cel ® in the U.S in the first half of 2022.

We are in discussions with potential partners for the commercialization of tab-cel ® in Europe.

We continue to pursue development of tab-cel ® in earlier lines of therapy, with an initial focus on immunodeficiency-associated lymphoproliferative diseases (IA-LPDs), given the commonality of their EBV-driven mechanism of disease in immunocompromised patients, high unmet medical need and positive clinical data to date with tab-cel ® .

We are actively opening sites in our Phase 2 multi-cohort study, which will evaluate both treatment-naïve and previously treated patients in six patient populations, including four within IA-LPDs and two in other EBV-driven diseases, in both the U.S.

We continue to advance development of tab-cel ® in a Phase 3 clinical trial for patients with EBV+ PTLD (ALLELE), which has received Breakthrough Therapy Designation (BTD) in the U.S.

for treatment of rituximab-refractory EBV-associated lymphoproliferative disorders, PRIority MEdicines (PRIME) designation in the European Union (EU), and orphan drug designation in the U.S.

for treatment of EBV+ PTLD.

Based on recent meetings and interactions with the FDA we have gained clarity on specific next steps required for submission of the BLA, including on key methodologies for evaluating comparability between the product used in the pivotal ALLELE study and the intended commercial product.

The FDA provided feedback on specific next steps required for submission of the BLA, which are:

(i) Type B CMC meeting where we will provide data on substantially all lots made to date, which we believe should enable the FDA to make a final determination on the data package to support comparability;

and (ii) Type B clinical meeting to review updated clinical data from the ALLELE study.

We have requested such meetings with the FDA in order to progress towards BLA submission.

The FDA decided it cannot make a determination of comparability between material used in non-pivotal and pivotal studies, as analytical data is not available and cannot be generated for all lots manufactured at MSK and used in non-pivotal studies.

Consequently, we plan to submit clinical data from the pivotal ALLELE study and the non-pivotal studies as separate, non-pooled analyses in the anticipated BLA submission.

We completed a new data analysis from our ALLELE study as previously discussed with the FDA.

Top-line data with additional patients confirm a strong objective response rate (ORR) in line with prior results while demonstrating durability.

There were no new safety signals, consistent with previously published data.

We plan to discuss this new data with the FDA in the requested Type B clinical meeting.

We also plan to present this new data at an appropriate congress in the fourth quarter of 2021.

Based on the outcome of our recent and anticipated interactions with the FDA, we expect to complete the BLA submission for tab-cel ® in the first quarter of 2022.

We have adapted our investment in pre-commercial activities and are continuing our commercial readiness activities in anticipation of potential approval and commercialization of tab-cel ® in the U.S in the second half of 2022.

We presented an abstract at the American Transplant Congress in June 2021 from a combined long-term overall survival (OS) analysis from three clinical studies of tab-cel ® demonstrating that patients with EBV+ PTLD, following SOT (solid organ transplant), that is relapsed or refractory to initial treatment, derived similar OS benefit of greater than 80 percent at two years whether they achieved complete or partial response with tab-cel ® .

Following recent Rapporteur, Co-Rapporteur and pre-submission meetings with the EMA, we have completed the necessary regulatory and compliance steps needed to, and we expect to, submit an EU marketing authorization application (MAA) for tab-cel ® in patients with EBV+ PTLD in November 2021.

We anticipate a decision with respect to potential approval of the MAA in the second half of 2022.

We are in ongoing discussions with potential partners for the commercialization of tab-cel ® in Europe.

We continue to pursue development of tab-cel ® in additional patient populations, with an initial focus on immunodeficiency-associated lymphoproliferative diseases (IA-LPDs), given the commonality of their EBV-driven mechanism of disease in immunocompromised patients, high unmet medical need and positive clinical data to date with tab-cel ® .

We are actively opening sites and enrolling patients in our Phase 2 multi-cohort study in six patient populations, including four within IA-LPDs and two in other EBV-driven diseases, in both the U.S.

Data from this study is expected in 2023.

Our phase 1b study of tab-cel ® in combination with Merck’s anti-PD1 (programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or recurrent EBV-driven nasopharyngeal carcinoma (NPC) achieved its safety endpoints and stable diseases in some patients.

We intend to generate additional translational data in NPC in 2021 for this patient population.

We intend to generate additional translational data in EBV-driven nasopharyngeal carcinoma (NPC) in 2021 for patients with platinum-resistant or recurrent EBV-driven NPC.

We plan to share data from the NPC study at an appropriate forum in the future.

We continue to progress our development of ATA188, an allogeneic T-cell immunotherapy targeting EBV antigens believed to be important for the potential treatment of multiple sclerosis (MS).

We are currently progressing an open-label extension (OLE) of our open label, single arm, multi-center, multi-national Phase 1 study with allogeneic ATA188 for patients with progressive MS (PMS).

Based on encouraging data from the study to date, all patients will be treated or re-treated with the Cohort 4 dose moving forward.

In January 2021, we presented a poster at the 2021 Transplantation & Cellular Therapy Meeting an innovative testing solution that enables detection and quantification of non-engineered allogeneic T-cell therapies for use in ATA188 clinical development.

We plan to present long-term two-year clinical data from the OLE and translation data from the Phase 1 study in the second half of 2021 .

We also continue to enroll patients in a randomized, double-blind, placebo-controlled trial (Phase 2 RCT) evaluating the efficacy and safety of ATA188 in patients with PMS .

In the first quarter of 2021, we filed and received approval of a Clinical Trial Application for the Phase 2 RCT in Canada.

We plan to conduct an interim analysis of the Phase 2 RCT in the first half of 2022 to assess efficacy and safety.

Following the interim analysis, we expect to complete planned enrollment in the first half of 2022.

We are currently progressing an open-label extension (OLE) of our open label, single arm, multi-center, multi-national Phase 1 study with allogeneic ATA188 for patients with progressive forms of MS (PMS).

We will present long-term two-year clinical data from the OLE and translation data from the Phase 1 study in October 2021 at the 37 th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

The ECTRIMS presentation will feature updated clinical and new imaging biomarker data considered to reflect the state of myelination in the central nervous system, known as magnetization transfer ratio (MTR).

MTR may provide important insights into the mechanism of expanded disability status scale (EDSS) improvement in our clinical assessment of ATA188.

We continue to enroll patients in a Phase 2, randomized, double-blind, placebo-controlled trial (EMBOLD) evaluating the efficacy and safety of ATA188 in patients with PMS .

We plan to conduct an interim analysis of the EMBOLD study in the first half of 2022 to assess efficacy and safety.

We expect to complete planned enrollment in the first half of 2022.

We will present a poster on PMS fatigue and an oral presentation on the ongoing EMBOLD study at the upcoming 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) in October.

ATA2271/ATA3271

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Both programs were licensed to Bayer in December 2020, pursuant to an exclusive, field-limited license (the Bayer License Agreement).

In March 2021, as contemplated by the Bayer License Agreement, we entered into (i) the Bayer Manufacturing Agreement;

(ii) a Pharmacovigilance Agreement;

(iii) a Quality Agreement;

and (iv) the Bayer Tech Transfer Agreement, in each case, with Bayer, to further advance our collaboration with Bayer.

In September 2020, MSK initiated an open-label, single-arm Phase 1 clinical study of ATA2271 for patients with advanced mesothelioma.

MSK has completed enrollment of the first cohort of this study and we anticipate presentation of first clinical data from this study to be presented in the fourth quarter of 2021.

We have also initiated IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T therapy targeting mesothelin using a PD-1 DNR and 1XX CAR co-stimulatory signaling domain through our EBV T-cell platform, and we expect to file the IND in the second or third quarter of 2022.

Enrollment has been completed for the first cohort and is nearly complete for the second cohort of this study.

We anticipate the first update on clinical data from this study to be presented at an appropriate forum in the fourth quarter of 2021.

We continue to make progress on IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T therapy targeting mesothelin using a PD-1 DNR and 1XX CAR co-stimulatory signaling domain through our EBV T-cell platform, and we expect our partner Bayer to file the IND in the second half of 2022.

We plan to present preclinical data for ATA3271 at an appropriate forum in the fourth quarter of 2021.

We are also developing ATA3219, an off-the-shelf, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies, as a potential best-in-class therapy without the need for TCR gene editing, using our next-generation 1XX CAR co-stimulatory domain and EBV T-cell platform.

We have initiated IND-enabling studies and plan to submit an IND for ATA3219 for patients with B-cell malignancies in the fourth quarter of 2021 or first quarter of 2022 .

We continue to make progress on IND-enabling studies and plan to submit an IND for ATA3219 for patients with B-cell malignancies in the first quarter of 2022 .

Additional Programs and Platform Expansion Activities

In addition to the prioritized programs described above, we have a number of preclinical programs.

We are collaborating with Moffitt to develop multi-targeted CAR T immunotherapies to adverse cell types that often become resistant to treatment, such as those targeting acute myeloid leukemia (AML) (ATA2321) and B-cell malignancies (ATA2431).

We are collaborating with Moffitt to develop ATA2431, a multi-targeted CAR T immunotherapy targeting B-cell malignancies.

We plan to return the acute myeloid leukemia (AML) program to Moffitt.

We are also collaborating with QIMR Berghofer on the development of ATA368 for patients with human papillomavirus (HPV) associated cancers.

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COVID-19 Business Update

We continue to closely monitor the impact of the ongoing COVID-19 pandemic on our business and operations and have taken steps to ensure the health and safety of our employees, staff, clinical site staff and patients and to maintain business continuity.

We continue to closely monitor the impact of the ongoing and evolving COVID-19 pandemic on our business and operations and have taken steps designed to ensure the health and safety of our employees, staff, clinical site staff and patients and to maintain business continuity.

Based on guidance issued by federal, state and local authorities, we have temporarily transitioned most of our workforce to a remote, work-from-home model, while maintaining essential in-person manufacturing and laboratory functions in order to advance key research, development and manufacturing priorities.

We implemented safety protocols and procedures to support our onsite workforce.

In addition to implementing measures to protect the health and safety of our workforce, our clinical study and operational teams are working closely with clinical sites to ensure the safety of site staff and patients as well as preserve data integrity and access to treatment as appropriate.

In addition to implementing measures designed to protect the health and safety of our workforce, our clinical study and operational teams are working closely with clinical sites to support the safety of site staff and patients as well as preserve data integrity and access to treatment as appropriate.

Where needed, remote study visits, leveraged tele-medicine, home health care, and other methods have been established to ensure continuity of care for patients while preserving key endpoint data.

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We have experienced, and may continue to experience, some transient delays in clinical study operations, as a result of the evolving impact of the ongoing COVID-19 pandemic.

For example, due to the COVID-19 pandemic, in April 2020 we temporarily paused the screening and enrollment of patients in our RCT for ATA188.

For example, due to the COVID-19 pandemic, in April 2020 we temporarily paused the screening and enrollment of patients in our EMBOLD study.

We were able to resume such activities and enrolled the first patient in the study in June 2020.

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Since our inception in 2012, we have devoted substantially all of our resources to identify, acquire and develop our product candidates, including conducting preclinical and clinical studies, acquiring or manufacturing materials for clinical studies, constructing our manufacturing facility and providing general and administrative support for these operations.

Our net losses were $78.3 million and $73.5 million for the three months ended March 31, 2021 and 2020, respectively.

As of March 31, 2021, we had an accumulated deficit of $1.2 billion.

Our net losses were $162.1 million and $151.0 million for the six months ended June 30, 2021 and 2020, respectively.

As of June 30, 2021, we had an accumulated deficit of $1.3 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, 2021, our cash, cash equivalents and short-term investments totaled $435.2 million, which we intend to use to fund our operations.

As of June 30, 2021, our cash, cash equivalents and short-term investments totaled $373.4 million, which we intend to use to fund our operations.

We have never generated revenues from the sale of products and have incurred losses since inception.

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Our revenues to date are derived solely from agreements with Bayer related to upfront license fees, fees for research, process development and translational activities and technology transfer fees.

We expect that any revenue we generate from our Bayer License Agreement and any future collaboration and research and license partners will fluctuate from year to year as a result of the timing and number of milestones and other payments.

We expect that any revenue we generate from our Bayer Agreements and any future collaboration and research and license partners will fluctuate from year to year as a result of the timing and number of milestones and other payments.

Research and Development Expenses

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process development, testing and manufacturing of drug supply to support clinical studies and IND-enabling studies;

continuing development of ATA188 in progressive MS;

continuing development of ATA188 in PMS;

continuing to develop product candidates based on our next-generation CAR T programs;

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Critical Accounting Policies and Significant Judgments and Estimates

There have been no significant changes to our critical accounting policies and significant judgments and estimates during the three months ended March 31, 2021 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, 2020 filed with the SEC on March 1, 2021.

There have been no significant changes to our critical accounting policies and significant judgments and estimates during the six months ended June 30, 2021 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, 2020 filed with the SEC on March 1, 2021.

Results of Operations

Comparison of the Three Months Ended March 31, 2021 and 2020

Comparison of the Three and Six Months Ended June 30, 2021 and 2020

Revenue consisted of the following in the periods presented:

Three Months Ended

Six Months Ended

(in thousands)

License and collaboration revenue

License and collaboration revenue for the three months ended March 31, 2021 consisted of revenue related to the recognition of upfront license fees, fees for research, process development and translational activities and technology transfer fees under the Bayer License Agreement and Bayer Tech Transfer Agreement.

License and collaboration revenue for the three months and six months ended June 30, 2021 consisted of revenue related to the recognition of upfront license fees, fees for research, process development and translational activities, and technology transfer and manufacturing service fees under the Bayer Agreements.

No revenue was recognized in 2020.

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Three Months Ended

Six Months Ended

(in thousands)

Tab-cel ® expenses

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Total research and development expenses

Tab-cel ® expenses were $12.0 million in the three months ended March 31, 2021, as compared to $14.8 million in the comparative 2020 period.

The decrease in 2021 was primarily due to higher production activities in 2020 related to the build-up of our tab-cel ® inventory.

ATA188, CAR T and other program expenses were $9.1 million in the three months ended March 31, 2021, as compared to $4.1 million in the comparative 2020 period.

The increase was primarily related to milestone and license fees due to MSK and an increase in research and clinical trial costs to further advance ATA188 and our CAR T programs .

Employee and overhead expenses were $43.0 million in the three months ended March 31, 2021, as compared to $38.7 million in the comparative 2020 period.

The increase was primarily due to higher compensation-related costs from increased headcount and higher facility-related costs in support of our continuing expansion of research and development activities.

Relative to the 2020 comparative period, for the three months ended March 31, 2021, payroll and related costs increased by $2.8 million, facility-related costs increased by $1.2 million and outside services costs remained consistent.

Total research and development expenses for the three months ended March 31, 2021 and 2020 were not significantly impacted as a result of the COVID-19 pandemic.

Tab-cel ® expenses were $12.8 million and $24.7 million in the three and six months ended June 30, 2021, respectively, as compared to $14.9 million and $29.7 million in the comparative 2020 periods.

The decreases in 2021 were primarily due to higher production activities in 2020 related to the build-up of our tab-cel ® inventory.

ATA188, CAR T and other program expenses were $7.6 million and $16.7 million in the three and six months ended June 30, 2021, respectively, as compared to $6.1 million and $10.2 million in the comparative 2020 periods.

The increases were primarily related to milestone and license fees due to MSK and QIMR, and an increase in research and clinical trial costs to further advance ATA188 and our CAR T programs .

Employee and overhead expenses were $48.1 million and $91.1 million in the three and six months ended June 30, 2021, respectively, as compared to $40.6 million and $79.3 million in the comparative 2020 periods.

The increases were primarily due to higher compensation-related costs from increased headcount, higher outside services, and higher facility-related costs in support of our continuing expansion of research and development activities.

Relative to the 2020 comparative period, for the three months ended June 30, 2021, payroll and related costs increased by $3.4 million, facility-related costs increased by $2.7 million and outside services costs increased by $1.4 million.

Relative to the 2020 comparative period, for the six months ended June 30, 2021, payroll and related costs increased by $6.2 million, facility-related costs increased by $3.9 million and outside services costs increased by $1.7 million.

Total research and development expenses for the six months ended June 30, 2021 and 2020 were not significantly impacted as a result of the COVID-19 pandemic.

General and administrative expenses

Three Months Ended

Six Months Ended

(in thousands)

General and administrative expenses

General and administrative expenses increased to $17.7 million in the three months ended March 31, 2021 as compared to $17.0 million in the comparative 2020 period.

The increase was primarily driven by activities to support our anticipated tab-cel ® launch.

Total general and administrative expenses for the three months ended March 31, 2021 and 2020 were not significantly impacted as a result of the COVID-19 pandemic.

General and administrative expenses increased to $19.4 million and $37.1 million in the three and six months ended June 30, 2021, respectively, as compared to $16.4 million and $33.4 million in the comparative 2020 periods.

The increases were primarily driven by activities to support our anticipated tab-cel ® launch.

Total general and administrative expenses for the six months ended June 30, 2021 and 2020 were not significantly impacted as a result of the COVID-19 pandemic.

Liquidity and Capital Resources

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We pay a commission of up to 3.0% of gross sales proceeds of any common stock sold under the 2020 ATM Facility.

During the three months ended March 31, 2021, we sold an aggregate of 145,630 shares of common stock under the 2020 ATM Facility, at an average price of $17.31 per share for net proceeds of $2.4 million, after deducting commissions and other offering expenses payable by us.

As of March 31, 2021, we have $77.1 million of common stock remained available to be sold under the 2020 ATM Facility, subject to certain conditions as specified in the agreement.

During the six months ended June 30, 2021, we sold an aggregate of 145,630 shares of common stock under the 2020 ATM Facility, at an average price of $17.31 per share for net proceeds of $2.4 million, after deducting commissions and other offering expenses payable by us.

As of June 30, 2021, we have $77.1 million of common stock remained available to be sold under the 2020 ATM Facility, subject to certain conditions as specified in the agreement.

We have incurred losses and negative cash flows from operations in each year since inception.

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As such, we anticipate that we will continue to incur losses in the foreseeable future.

Additionally, as a result of the COVID-19 pandemic, we have experienced, and may experience in the future, disruptions that could severely impact our business, preclinical studies and clinical trials.

Additionally, as a result of the ongoing and evolving COVID-19 pandemic, we have experienced, and may experience in the future, disruptions that could severely impact our business, preclinical studies and clinical trials.

We expect that our operating expenses will continue to increase.

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Treasury, government agency and corporate debt obligations, commercial paper and asset-backed securities.

We expect that existing cash, cash equivalents and short-term investments as of March 31, 2021, together with projected revenue from U.S.

tab-cel ® sales, if approved, will be sufficient to fund our planned operations into 2023, including expenses related to the BLA filing and potential commercial launch of tab-cel ® in the U.S.

We expect that existing cash, cash equivalents and short-term investments as of June 30, 2021, will be sufficient to fund our planned operations into 2023.

Our cash, cash equivalents and short-term investments balances as of the dates indicated were as follows:

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Total cash, cash equivalents and short-term investments

Comparison of the Three Months Ended March 31, 2021 and 2020

Comparison of the Six Months Ended June 30, 2021 and 2020

The following table details the primary sources and uses of cash for each of the periods set forth below:

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

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Financing activities

Net decrease in cash, cash equivalents and restricted cash

Net (decrease) increase in cash, cash equivalents and restricted cash

Operating activities

Net cash used in operating activities was $65.7 million in the 2021 period as compared to $67.0 million in the 2020 period.

The decrease of $1.3 million was primarily due to a $5.9 million increase in net operating liabilities, partially offset by a $4.8 million increase in net loss.

Net cash used in operating activities was $127.3 million in the six months ended June 30, 2021 as compared to $123.7 million in the comparative 2020 period.

The increase of $3.6 million was primarily due to a $11.2 million increase in net loss, partially offset by a $6.9 million decrease in net working capital usage.

Investing activities

Net cash provided by investing activities in the 2021 period consisted of $109.8 million received from maturities and sales of available-for-sale securities, partially offset by $94.1 million used to purchase available-for-sale securities and $2.2 million in purchases of property and equipment.

Net cash provided by investing activities in the 2020 period consisted primarily of $97.2 million received from maturities and sales of available-for-sale securities, partially offset by $56.9 million used to purchase available-for-sale securities and $1.3 million in purchases of property and equipment.

Net cash provided by investing activities in the six months ended June 30, 2021 consisted of $208.5 million received from maturities and sales of available-for-sale securities, partially offset by $158.9 million used to purchase available-for-sale securities and $4.3 million in purchases of property and equipment.

Net cash used in investing activities in the comparative 2020 period consisted of $228.2 million used to purchase available-for-sale securities and $3.4 million in purchases of property and equipment, partially offset by $140.2 million received from maturities and sales of available-for-sale securities.

Financing activities

Net cash provided by financing activities in the 2021 period consisted primarily of $2.5 million of net proceeds received from the ATM facilities and $1.7 million of net proceeds from employee stock award transactions, partially offset by $1.2 million of taxes paid related to the net share settlement of RSUs.

Net cash provided by financing activities in the 2020 period consisted primarily of $24 .3 million of net proceeds from ATM facilities and $1.3 million of net proceeds from employee stock award transactions, partially offset by $1.4 million of taxes paid related to the net share settlement of RSUs.

Net cash provided by financing activities in the six months ended June 30, 2021 consisted primarily of $2.4 million of net proceeds received from ATM facilities and $4.3 million from employee stock award transactions, partially offset by $1.2 million of taxes paid related to the net share settlement of RSUs.

Net cash provided by financing activities in the comparative 2020 period consisted primarily of $189.6 million of net proceeds received from an underwritten public offering of common stock and pre-funded warrants, $24.2 million of net proceeds received from ATM facilities and $3.2 million from employee stock award transactions, partially offset by $1.4 million of taxes paid related to the net share settlement of RSUs.

Operating Capital Requirements and Plan of Operations

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We anticipate that we will need to raise substantial additional funding in connection with our continuing and expected expansion of our operations.

We expect that our existing cash, cash equivalents and short-term investments as of March 31, 2021, together with projected revenue from U.S.

tab-cel ® sales, if approved, will be sufficient to fund our operations into 2023, including expenses related to the BLA filing and potential commercial launch of tab-cel ® in the U.S.

We expect that our existing cash, cash equivalents and short-term investments as of June 30, 2021 will be sufficient to fund our planned operations into 2023.

In order to complete the process of obtaining regulatory approval for any of our product candidates and to build the sales, marketing and distribution infrastructure that we believe will be necessary to commercialize our product candidates, if approved, we will require substantial additional funding.

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In March 2021, we entered into a new lease agreement for approximately 3 3 ,659 square feet of office, lab and warehouse space in Thousand Oaks, California.

The initial 10.5-year term of this lease is scheduled to commence in July 2021 and the contractual obligations during the initial term are $19.1 million in aggregate.

The initial 10.5-year term of this lease is scheduled to commence in August 2021 and the contractual obligations during the initial term are $ 19.1 million in aggregate.

We have the option to extend this lease for two additional five-year periods after the initial term.

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Quantitative and Qualitative Disclosures about Market Risk

During the three months ended March 31, 2021, there were no material changes to our interest rate risk disclosures, market risk disclosures and foreign currency exchange rate risk disclosures reported in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 1, 2021.

During the six months ended June 30, 2021, there were no material changes to our interest rate risk disclosures, market risk disclosures and foreign currency exchange rate risk disclosures reported in our Annual Report on Form 10-K for the year ended December 31, 2020 filed with the SEC on March 1, 2021.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis