•

Atara remains on track to initiate a biologics license application (BLA) submission for patients with EBV+ PTLD by the end of 2020.

•

The Company continues to advance development of tab-cel® in Phase 3 for patients with EBV+ PTLD, for which the Company has obtained Breakthrough Therapy Designation (BTD) in the United States (U.S.) and PRIority MEdicines (PRIME) designation in the European Union (EU).

•

The Company plans to conduct an interim analysis of the tab-cel® Phase 3 study in the third quarter of 2020 and then discuss the totality of tab-cel® data with the U.S. Food and Drug Administration (FDA) in a pre-BLA meeting prior to initiating the BLA submission.

•

Atara is in active discussions with the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) regarding a Pediatric Investigation Plan (PIP). Following discussion with the PRIME team and after EMA approval of the PIP, Atara plans to submit an EU marketing authorization application (MAA) for patients with EBV+ PTLD in 2021.

•

In the U.S., Europe and Australia, more than 40 clinical study sites are available for enrollment, with new sites in Spain, Austria and Belgium.

•

Given the severity of previously treated PTLD, time sensitivity for treatment and promising clinical results to date with tab-cel®, Atara continues to provide tab-cel® to patients in need under its expanded access protocol (EAP) and single patient use (SPU) programs.

•

Atara remains on track to initiate enrollment in the second half of 2020 in a tab-cel® Phase 2 multi-cohort study, enriching the evidence base with the goal of expanding the potential label in PTLD and closely related diseases.  

•

Atara will focus on extending further into IA-LPDs (immunodeficiency-associated lymphoproliferative diseases) as the next step in the tab-cel® potential label expansion 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®.

•

The multi-cohort study will evaluate both treatment-naïve and previously treated patients in six patient populations, including within IA-LPDs, two cohorts addressing front-line EBV+ PTLD patients with significant unmet need as well as two cohorts addressing EBV+ LPDs arising out of primary or acquired immune deficiencies including AID-LPD and PID-LPD (EBV+ acquired immunodeficiency-associated lymphoproliferative disease and EBV+ primary immunodeficiency-associated lymphoproliferative disease).

•

Altogether these populations represent an additional few thousand patients with addressable EBV-driven diseases in the U.S. alone.

•

Previously reported clinical data from ASH (2018) and ESMO (2018) suggest that tab-cel® may provide benefit for patients with other EBV-driven diseases. Atara will publish tab-cel® efficacy and safety data in AID-LPD and PID-LPD in an e-poster accepted at ESMO 2020.

•

Based on a strategic prioritization to expand tab-cel® business potential through the significant opportunity  in IA-LPDs, the Company will now focus its tab-cel® efforts on  the initiation of the multi-cohort Phase 2 study and the planned BLA initiation in EBV+ PTLD.

•

The Company's Phase 1b study of tab-cel® in combination with anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) achieved its safety endpoints and stable disease in a subset of patients. These data will be presented at an appropriate forum in the future.  

•

At this time, Atara will not initiate the Phase 2 portion of the NPC study in combination with pembrolizumab but will generate additional translational data in NPC to further inform the Company's strategy for this patient population.

•

Atara’s Phase 1a clinical study of off-the-shelf, allogeneic ATA188 in patients with progressive forms of MS is ongoing across clinical sites in the U.S. and Australia.

o

Safety and sustained disability improvement (SDI) 12-month data for cohorts 1-3, and six-month data for cohort 4, were presented at the 2020 European Academy of Neurology Virtual Congress (EAN) held in May 2020.

•

All patients in cohorts 1-3 showing SDI at six months maintained improvement at 12 months and there was a higher proportion of patients showing SDI with increasing dose. SDI is defined as clinically significant improvement in Expanded Disability Status Scale (EDSS) or timed 25-foot walk (T25FW) observed at two consecutive time points. While these data will need to be confirmed in a double-blind, placebo-controlled, randomized study, they indicate the potential for the first treatment option in progressive MS to halt or reverse the progression of disease. These results align with the body of evidence supporting the important role of EBV-infected B cells in the chronic autoimmune pathology of MS.

•

ATA188 was well-tolerated in patients with progressive forms of MS and no dose-limiting toxicities and no fatal adverse events (AEs) have been reported. ATA188 treatment showed no clinically meaningful effect on cytokine levels and no dose-related safety trends were identified.  Rhinorrhea (runny nose) is the only treatment-related event that occurred in more than one subject.

o

Atara expects to present 12-month clinical results for cohort 4 at an appropriate forum in the second half of 2020.

o

Atara is re-treating patients in the open-label extension (OLE) of the Phase 1a study and expects to present preliminary OLE data, at an appropriate forum in the second half of 2020.

•

Based on the promising data presented at EAN, the cohort 3 dose from the Phase 1a study was selected for the double-blind, randomized placebo-controlled study evaluating the efficacy and safety of ATA188 in patients with progressive forms of MS. The study design allows for addition of the cohort 4 dose, if desired, based on the 12-month data for cohort 4 that will be available in the third quarter of 2020.

o

The study enrolled its first patient in June 2020. In addition to measuring change in disability measures compared to baseline, especially sustained disability improvement over time, the study will also include multiple measures of patients’ function as well as various biomarkers.

•

Atara’s next generation CAR T immunotherapy programs include autologous ATA2271 targeting mesothelin--a tumor antigen expressed on a number of solid tumors including mesothelioma, ovarian cancer, pancreatic cancer, non-small cell lung cancer, and other tumors over-expressing mesothelin.

o

ATA2271 is designed to improve efficacy, persistence, and durability of response versus CD28/CD3z-based CARs in using a novel 1XX CAR co-stimulatory signaling domain and cell intrinsic checkpoint inhibition technology with a PD-1 dominant negative receptor (DNR).

o

Data from IND-enabling studies for ATA2271 were presented at the American Association for Cancer Research (AACR) Virtual Annual Meeting II in June 2020. These data support the first application of the combination of 1XX CAR co-stimulatory domain and cell intrinsic checkpoint inhibition technology with a PD-1 DNR, that are associated with less cell exhaustion, improvements in functional persistence, serial cell killing, and in vivo efficacy which was maintained through multiple tumor re-challenges when compared with first-generation CD28/CD3z-based mesothelin CAR.

o

ATA2271 collaborators at Memorial Sloan Kettering Cancer Center (MSK) recently submitted an Investigational New Drug (IND) application to the FDA for patients with advanced mesothelioma.

•

Atara is also developing and has initiated IND-enabling studies for ATA3271, an off-the-shelf, allogeneic CAR T immunotherapy targeting mesothelin using its novel combination of 1XX CAR co-stimulatory signaling domain and cell intrinsic checkpoint inhibition technology with a PD-1 DNR through its EBV T-cell platform.

•

Atara is developing ATA3219, an off-the-shelf, allogeneic CD19 CAR T immunotherapy targeting B-cell malignancies as a potential best-in-class therapy using the next-generation 1XX CAR co-stimulatory domain and EBV T-cell platform. Atara intends to leverage the differentiation of 1XX and allogeneic EBV T cell to address remaining unmet need despite currently approved autologous CD19 CAR T and other allogeneic CD19 cell therapies in development.

•

Findings from an academic, off-the-shelf, allogeneic CD19 CAR T clinical study using an allogeneic EBV T-cell construct and CD28/CD3z co-stimulatory domain for patients with relapsed/refractory B-cell malignancies provided initial clinical proof-of-principle that an EBV T-cell platform has the potential to generate off-the-shelf, allogeneic CAR T immunotherapies with high response rates, durable responses, and low risk of toxicity. These results were presented in February at the 2020 Transplantation and Cellular Therapy Meetings.

•

The Company has initiated IND-enabling studies for ATA3219 and anticipates filing an IND in 2021.

•

Atara continues to advance key elements of its off-the-shelf, allogeneic T-cell immunotherapy platform.

o

Atara is completing the manufacturing process validation activities for tab-cel® while building inventory according to its commercial product supply strategy.

o

Atara continues to scale its EBV T-cell manufacturing platform to improve product yields from a single donor leukapheresis.  The Company has generated data confirming the use of stirred-tank perfusion bioreactors to improve yield and cell growth productivity.

•

These data confirm that ATA188 can be manufactured in stirred-tank perfusion bioreactors, with the potential to produce up to 40,000 doses per donor leukapheresis.

•

Atara’s scale-up technology is a key enabler to deliver biologic-like cost of goods manufactured and will be leveraged across its portfolio, including the Company’s CAR T programs.

o

Despite the challenges of the COVID-19 environment, Atara continues to consistently deliver product from inventory to clinical sites on time.

•

Two scientific leaders in the field of cell and gene therapy recently joined Atara in its mission to leverage its novel, allogeneic EBV T-cell platform to develop transformative therapies for patients with severe diseases:

o

Jakob Dupont, M.D. was named Executive Vice President, Global Head of R&D. He possesses deep and diverse expertise from cell therapy research to oncology clinical development and global regulatory approvals. Dr. Dupont joined Atara from Gossamer Bio where he served as Chief Medical Officer, and held previous roles at Genentech/Roche and OncoMed. At Memorial Sloan Kettering Cancer Center (MSK), Dr. Dupont served on faculty and worked in the laboratories of Richard O’Reilly, M.D., the scientific inventor of tab-cel®, and Michel Sadelain, M.D., Ph.D, Atara’s collaborator on multiple next generation CAR T programs.

o

Maria Grazia Roncarolo, M.D. was appointed to the Board of Directors. Dr. Roncarolo holds several professorships and director roles at Stanford University, and in 2014 established the Stanford Center for Definitive and Curative Medicine. The center is dedicated to the development of innovative stem cell and gene therapies for patients with currently incurable diseases. Dr. Roncarolo is one of the world’s leading experts in immunology and T cells and has a record of translating scientific discoveries in cell and gene therapy into novel treatments.

•

Cash, cash equivalents and short-term investments as of June 30, 2020 totaled $347.7 million, as compared to $214.6 million as of March 31, 2020.

o

June 30, 2020 cash balance of $347.7 million included aggregate net proceeds of $189.3 million from the sale of 14,958,039 shares of common stock and pre-funded warrants to purchase 2,866,961 shares of common stock in May and June of 2020 in an underwritten public offering, including the full exercise of the  option to purchase additional shares by the underwriters.

o

Atara believes that its cash, cash equivalents and short-term investments as of June 30, 2020 are sufficient to fund planned operations into 2022.

•

Net cash used in operating activities was $56.6 million for the second quarter of 2020, as compared to $54.6 million for the same period in 2019.

•

The number of outstanding shares of common stock and pre-funded common stock warrants as of June 30, 2020 was 74,307,894 shares and warrants to purchase 5,755,487 shares, respectively.

•

Atara reported net losses of $77.5 million, or $1.14 per share, for the second quarter of 2020, as compared to $74.3 million, or $1.60 per share, for the same period in 2019. 

•

Total operating expenses include non-cash expenses of $15.9 million for the second quarter 2020, as compared to $16.9 million for the same period in 2019. 

•

Research and development expenses were $61.6 million for the second quarter of 2020, as compared to $52.3 million for the same period in 2019. The increase in the 2020 period was due to costs associated with the Company’s continuing expansion of research and development activities, including: 

o

Clinical study, manufacturing and process performance qualification activities related to tab-cel^®. 

o

Higher employee-related costs from increased headcount.

•

Research and development expenses include $8.5 million of non-cash stock-based compensation expenses for the second quarter of 2020, as compared to $6.7 million for the same period in 2019. 

•

General and administrative expenses were $16.4 million for the second quarter of 2020, as compared to $23.3 million for the same period in 2019. The decrease in the 2020 period was primarily due to a decrease in outside services costs and non-cash stock-based compensation expenses. 

•

General and administrative expenses include $5.4 million of non-cash stock-based compensation expenses for the second quarter of 2020, as compared to $8.5 million for the same period in 2019.

June 30,

December 31,

2020

2019

Assets

Current assets:

Cash and cash equivalents

$

74,511

$

74,317

Short-term investments

273,201

184,792

Restricted cash - short-term

194

194

Prepaid expenses and other current assets

11,081

13,689

Total current assets

358,987

272,992

Property and equipment, net

53,587

54,176

Operating lease assets

13,321

14,007

Restricted cash - long-term

1,200

1,200

Other assets

1,016

567

Total assets

$

428,111

$

342,942

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

5,106

$

7,963

Accrued compensation

12,657

14,706

Accrued research and development expenses

8,244

8,341

Other current liabilities

5,677

5,733

Total current liabilities

31,684

36,743

Operating lease liabilities - long-term

13,420

14,136

Other long-term liabilities

1,882

1,282

Total liabilities

46,986

52,161

Commitments and contingencies

Stockholders’ equity:

Common stock

7

6

Additional paid-in capital

1,349,234

1,108,516

Accumulated other comprehensive income

810

220

Accumulated deficit

(968,926

)

(817,961

)

Total stockholders’ equity

381,125

290,781

Total liabilities and stockholders’ equity

$

428,111

$

342,942

Three Months Ended June 30,

Six Months Ended June 30,

2020

2019

2020

2019

Operating expenses:

Research and development

$

61,560

$

52,251

$

119,219

$

100,919

General and administrative

16,392

23,284

33,430

42,507

Total operating expenses

77,952

75,535

152,649

143,426

Loss from operations

(77,952

)

(75,535

)

(152,649

)

(143,426

)

Interest and other income, net

497

1,207

1,685

2,841

Loss before provision for income taxes

(77,455

)

(74,328

)

(150,964

)

(140,585

)

Provision for income taxes

1

—

1

—

Net loss

$

(77,456

)

$

(74,328

)

$

(150,965

)

$

(140,585

)

Other comprehensive loss:

Unrealized gain (loss) on available-for-sale securities

606

135

590

513

Comprehensive loss

$

(76,850

)

$

(74,193

)

$

(150,375

)

$

(140,072

)

Net loss per common share:

Basic and diluted net loss per common share

$

(1.14

)

$

(1.60

)

$

(2.34

)

$

(3.04

)

Weighted-average shares outstanding used to calculate

   basic and diluted net loss per common share

67,975

46,426

64,592

46,276