Atara Biotherapeutics, Inc.

Previous wording

In March 2025, we announced our decision to pause development of our allogeneic CAR T cell programs and to discontinue development operations for our CAR T programs, including all clinical trials evaluating ATA3219 and development operations for ATA3431. We expect to complete wind-down activities for the CAR T programs by the end of the second quarter of 2025. We have also stopped development on ATA188, an allogeneic T-cell immunotherapy targeting multiple sclerosis (MS).

Current wording

In March 2025, we announced our decision to pause development of our allogeneic CAR T cell programs and to discontinue development operations for our CAR T programs, including all clinical trials evaluating ATA3219 and development operations for ATA3431. We have completed nearly all wind-down activities for the CAR T programs. We have also stopped development on ATA188, an allogeneic T-cell immunotherapy targeting multiple sclerosis (MS).

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. 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. In March 2025, we completed the transfer of all manufacturing responsibility to Pierre Fabre under the A&R Commercialization Agreement Amendment. Pierre Fabre is now responsible for manufacturing and supplying tabelecleucel for development and commercialization worldwide at its cost. Pursuant to the A&R Commercialization Agreement Amendment, Pierre Fabre has also agreed to assume the costs related to remediation of the third-party manufacturing facility to address the FDA's requests to support resubmission of the BLA for tab-cel. In exchange for accelerating the transfer of all manufacturing responsibility and assumption of such remediation costs by Pierre Fabre, among other things, we agreed to reduce the amount of certain potential future regulatory and commercial milestone payments under the A&R Commercialization Agreement. Under the terms of the A&R Commercialization Agreement, as amended by the A&R Commercialization Agreement Amendment, we are entitled to receive an aggregate of up to $308.0 million in remaining milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel in the Initial Territory, and an aggregate of up to $550.0 million in additional potential milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel in the Additional Territory, including up to $40.0 million in potential regulatory milestones in connection with the approval by the FDA of a BLA for tab-cel. We are also 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 r…

Excerpt shortened here; the source contains the full paragraph.

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. In March 2025, we completed the transfer of all manufacturing responsibility to Pierre Fabre under the A&R Commercialization Agreement Amendment. Pierre Fabre is now responsible for manufacturing and supplying tabelecleucel for development and commercialization worldwide at its cost. Pursuant to the A&R Commercialization Agreement Amendment, Pierre Fabre has also agreed to assume the costs related to remediation of the third-party manufacturing facility to address the FDA's requests to support resubmission of the BLA for tab-cel. In exchange for accelerating the transfer of all manufacturing responsibility and assumption of such remediation costs by Pierre Fabre, among other things, we agreed to reduce the amount of certain potential future regulatory and commercial milestone payments under the A&R Commercialization Agreement. In July 2025, we further amended the A&R Commercialization Agreement and completed the transfer of all clinical (including sponsorship of the ALLELE and tab-cel multi-cohort studies) and development responsibility to Pierre Fabre. Pierre Fabre is, at its cost, responsible for all clinical (including sponsorship of the ALLELE and tab-cel multi-cohort studies) and development activities (other than responsibility for regulatory activities) for tabelecleucel worldwide. Under the terms of the A&R Commercialization Agreement, as amended by the A&R Commercialization Agreement Amendment, we are entitled to receive an aggregate of up to $308.0 million in remaining milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel in the Initial Territory, and an aggregate of up to $550.0 million in additional potential milestone payments upon achieving certain regulatory and commercial milestones relating to tab-cel i…

Excerpt shortened here; the source contains the full paragraph.

Previous wording

We have also entered into research collaborations with leading academic institutions such as Memorial Sloan Kettering Cancer Center (MSK) and the Council of the Queensland Institute of Medical Research (QIMR Berghofer) pursuant to which we acquired rights to novel and proprietary technologies and programs.

Current wording

We entered into research collaborations with leading academic institutions such as Memorial Sloan Kettering Cancer Center (MSK) and the Council of the Queensland Institute of Medical Research (QIMR Berghofer) pursuant to which we acquired rights to novel and proprietary technologies and programs. In May 2025, we returned the rights to the ATA188 and EBV Vaccine programs to QIMR.

Previous wording

We have non-cancellable minimum commitments for products and services, subject to agreements with a term of greater than one year, with CROs and CMOs. In March 2025, these agreements have been assigned to Pierre Fabre as part of the A&R Commercialization Agreement Amendment.

Current wording

We had non-cancellable minimum commitments for products and services, subject to agreements with a term of greater than one year, with CROs and CMOs. In March 2025, these agreements have been assigned to Pierre Fabre as part of the A&R Commercialization Agreement Amendment and have been relieved of our obligations under these agreements as of June 30, 2025.

Previous wording

In January 2024, we announced a 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 were paid from February 2024 through January 2025. As of March 31, 2025, there are no remaining payments 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 reduction in workforce at that time 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 were 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 were paid from February 2024 through January 2025. As of June 30, 2025, there are no remaining payments for the January 2024 reduction in workforce. The majority of the associated costs are cash expenditures and primarily represent one-time termination benefits.

Previous wording

In January 2025, we announced another reduction in workforce of approximately 50%. We recognized approximately $7.1 million in total severance and related benefits as a result of this reduction in force, consisting primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance will be paid in the first half of 2025. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits will be paid from April 2025 through May 2026. The majority of the associated costs represent cash expenditures.

Current wording

In January 2025, we announced another reduction in workforce at that time of approximately 50%. We recognized approximately $7.1 million in total severance and related benefits as a result of this reduction in force, consisting primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance was paid in the first half of 2025. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits will be paid from April 2025 through May 2026. The majority of the associated costs represent cash expenditures.

Previous wording

In March 2025, we announced a further reduction in workforce of approximately 50%, retaining approximately 35 employees essential to executing on our strategic priorities. We recognized approximately $2.7 million in total severance and related benefits as a result of this reduction in force, consisting primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance will be paid in the first half of 2025. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits will be paid from May 2025 through May 2026. The majority of the associated costs represent cash expenditures.

Current wording

In March 2025, we announced a further reduction in workforce at that time of approximately 50%, retaining approximately 35 employees essential to execute on our strategic priorities. We recognized approximately $2.7 million in total severance and related benefits as a result of this reduction in force, consisting primarily of severance payments and wages for the 60-day notice period in accordance with the California WARN Act. In most cases, the severance was paid in the first half of 2025. Certain of the notified employees had employment agreements which provided for separation benefits in the form of salary continuation; these benefits will be paid from May 2025 through May 2026. The majority of the associated costs represent cash expenditures.

Previous wording

Our board of directors regularly reviews our strategic plan, priorities, and opportunities as part of its commitment to act in the best interest of the Company and its stockholders. In January 2025, we announced that we had previously engaged a well-known financial advisor to support the assessment of opportunities to advance and realize value from our CAR-T assets, for which we announced in March 2025 that we paused development. The advisor’s scope was expanded to include a wider range of additional strategic alternatives which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, or other strategic transactions. Through this process, we were in active discussions with several potential parties. However, there can be no assurance regarding the results or outcome of this process. It is possible that we may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, it will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated. In April 2025, we temporarily paused our review of strategic alternatives pending our meeting with the FDA in the second quarter of 2025 to discuss the resubmission of the BLA for tab-cel.

Current wording

Our board of directors regularly reviews our strategic plan, priorities, and opportunities as part of its commitment to act in the best interest of the Company and its stockholders. In January 2025, we announced that we had previously engaged a well-known financial advisor to support the assessment of opportunities to advance and realize value from our CAR-T assets, for which we announced in March 2025 that we paused development. The advisor’s scope was expanded to include a wider range of additional strategic alternatives which may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, sale of assets, licensing, or other strategic transactions. Through this process, we were in active discussions with several potential parties. However, there can be no assurance regarding the results or outcome of this process. It is possible that we may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, it will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated. In April 2025, we temporarily paused our review of strategic alternatives pending resubmission of the tab-cel BLA. Our board of directors has resumed the review of strategic alternatives following the resubmission of the tab-cel BLA.

Previous wording

In January 2025, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (Response Letter) for the Biologics License Application (BLA) for tab-cel as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen. The Response Letter only cited findings that arose during a pre-license inspection of a third-party manufacturing facility for tab-cel. The Response Letter did not identify any deficiencies related to the manufacturing process, the clinical efficacy, or clinical safety data in the BLA, and the FDA did not request any new clinical trials to support a potential approval of tab-cel.

Current wording

In January 2025, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (Response Letter) for the Biologics License Application (BLA) for tab-cel as monotherapy treatment for adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy including an anti-CD20 containing regimen. In May 2025, we aligned with the FDA on a plan to address the issues raised by the FDA in the Response Letter and the path forward for resubmission of the tab-cel BLA at a Type A meeting.

Previous wording

In May 2025, the FDA notified us that we have satisfactorily addressed all clinical hold issues and the FDA has lifted the clinical holds for the ALLELE study and the tab-cel multi-cohort study. We are working with Pierre Fabre and our clinical sites to restart enrollment in the ALLELE study and the tab-cel multi-cohort study.

Current wording

In January 2025, the FDA also placed clinical holds on Atara’s active Investigational New Drug (IND) applications due to inadequately addressed Good Manufacturing Practices (GMP) compliance issues referenced in the Response Letter. In May 2025, the FDA notified us that we have satisfactorily addressed all clinical hold issues and the FDA has lifted the clinical holds for the tab-cel program. We restarted enrollment in the ALLELE study and the tab-cel multi-cohort study in June 2025.

Previous wording

In January 2025, the FDA placed a clinical hold on Atara’s active IND applications. These INDs include ATA3219 for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus. The clinical hold is directly linked to inadequately addressed GMP compliance issues referenced in the Response Letter. While ATA3219 drug product is manufactured at a separate facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the Response Letter.

Current wording

In January 2025, the FDA placed a clinical hold on Atara’s active IND applications. These INDs include ATA3219 for the treatment of non-Hodgkin’s lymphoma and systemic lupus erythematosus. The clinical hold was directly linked to inadequately addressed GMP compliance issues referenced in the Response Letter. While ATA3219 drug product is manufactured at a separate facility, the starting materials used in its production are affected by the compliance issues at the same third-party facility referenced in the Response Letter. In May 2025, the FDA notified us that we have satisfactorily addressed all clinical hold issues and the FDA has lifted the clinical holds for the ATA3219 program.

Previous wording

In March 2025, we announced our decision to pause development of our allogeneic CAR T cell programs and to discontinue development operations for our CAR T programs, including all clinical trials evaluating ATA3219 and development operations for ATA3431. We expect to complete wind-down activities for the CAR T programs by the end of the second quarter of 2025.

Current wording

In March 2025, we announced our decision to pause development of our allogeneic CAR T cell programs and to discontinue development operations for our CAR T programs, including all clinical trials evaluating ATA3219 and development operations for ATA3431. We completed nearly all wind-down activities for the CAR T programs.

Previous wording

We are in discussions with QIMR Berghofer to return the rights to the ATA188 and EBV Vaccine programs to QIMR. We have discontinued some other programs and returned the programs to our collaborators. For example, in March 2024, we returned the ATA2271 and ATA3271 programs targeting mesothelin to MSK.

Current wording

In May 2025, we returned the rights to the ATA188 and EBV Vaccine programs to QIMR. We have discontinued some other programs and returned the programs to our collaborators. For example, in March 2024, we returned the ATA2271 and ATA3271 programs targeting mesothelin to MSK.

Previous wording

Our net income (loss) was $38.0 million and $(31.8) million for the three months ended March 31, 2025 and 2024, respectively. As of March 31, 2025, 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, 2025, our cash, cash equivalents and short-term investments totaled $13.8 million, which we intend to use to fund our operations.

Current wording

Our net income (loss) was $40.4 million and $(50.8) million for the six months ended June 30, 2025 and 2024, respectively. As of June 30, 2025, 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, 2025, our cash, cash equivalents and short-term investments totaled $22.3 million, which we intend to use to fund our operations.

Previous wording

There have been no significant changes to our critical accounting policies and significant judgments and estimates during the three months ended March 31, 2025 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, 2024 filed with the SEC on March 7, 2025.

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, 2025 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, 2024 filed with the SEC on March 7, 2025.

Previous wording

Comparison of the Three Months Ended March 31, 2025 and 2024

Current wording

Comparison of the Three and Six Months Ended June 30, 2025 and 2024

Previous wording

Commercialization revenues were $98.1 million for the three months ended March 31, 2025 as compared to $27.4 million in the comparative 2024 period. The increase in the 2025 period was primarily due to revenue recognized as a result of the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025.

Current wording

Commercialization revenues were $17.6 million and $115.7 million for the three and six months ended June 30, 2025 as compared to $28.6 million and $56.0 million in the comparative 2024 periods. The decrease in the three month comparative period was primarily due to there being no revenue associated with the Initial Territory Obligation in the 2025 period, as all remaining revenue for this obligation was recognized as of March 31, 2025. The increase in the six month comparative period was primarily due to revenue recognized as a result of the transfer of manufacturing responsibilities to Pierre Fabre as of March 31, 2025.

Previous wording

Cost of commercialization revenue was $20.4 million for the three months ended March 31, 2025, as compared to $2.0 million in the comparative 2024 period. The increase in the 2025 period was primarily due to the cost of inventory sold to Pierre Fabre on March 31, 2025 according to the A&R Commercialization Agreement Amendment.

Current wording

Cost of commercialization revenue was $0.6 million and $21.0 million for the three and six months ended June 30, 2025, as compared to $4.6 million and $6.6 million in the comparative 2024 periods. The decrease in the three month comparative period is primarily due to there being no manufacturing activities in the 2025 period following the transfer of such activities to Pierre Fabre as of March 31, 2025. The increase in the six month comparative period was primarily due to the cost of inventory sold to Pierre Fabre on March 31, 2025 according to the A&R Commercialization Agreement Amendment.

Previous wording

Medical and safety expense were $5.3 million in the three months ended March 31, 2025, as compared to $13.5 million in the comparative 2024 period. The decrease in 2025 is primarily due to the $3.0 million MSK sublicensing fee refund received in the first quarter 2025 and decreased trial costs due to close out of the ATA188 Phase 2 EMBOLD study after it did not meet its primary endpoint.

Current wording

Medical and safety expenses were $3.6 million and $9.0 million in the three and six months ended June 30, 2025, as compared to $8.3 million and $21.8 million in the comparative 2024 periods. The decreases in the 2025 periods were primarily due to reduced headcount following the January and March 2025 reductions in force and a decrease in CAR T research and development activities after the decision to pause the CAR T programs. The decrease in the six month period was also due to the $3.0 million MSK sublicensing fee refund received in the first quarter 2025 and decreased trial costs due to the close-out of the ATA188 Phase 2 EMBOLD study after it did not meet its primary endpoint.

Previous wording

Interest income was $0.2 million in the three months ended March 31, 2025, as compared to $0.6 million in the comparative 2024 period. The decrease in the 2025 period was primarily due to lower average balances of cash, cash equivalents and available-for-sale securities.

Current wording

Interest income was $0.1 million and $0.4 million in the three and six months ended June 30, 2025, as compared to $0.5 million and $1.1 million in the comparative 2024 periods. The decreases in 2025 were primarily due to lower average balances of cash, cash equivalents and available-for-sale securities.

Previous wording

Interest expense and other income (expense), net remained materially consistent with the comparative period.

Current wording

Other income (expense), net remained materially consistent with the comparative period.

Previous wording

During the three months ended March 31, 2025, we did not sell any shares of common stock under the 2023 ATM Facility.

Current wording

During the six months ended June 30, 2025, we did not sell any shares of common stock under the 2023 ATM Facility.

Previous wording

Net cash used in operating activities was $28.1 million in the three months ended March 31, 2025 as compared to $29.6 million in the comparative 2024 period. The decrease of $1.5 million was primarily due to changes in net working capital following the transfer of manufacturing responsibilities to Pierre Fabre in the first quarter of 2025.

Current wording

Net cash used in operating activities was $35.5 million in the six months ended June 30, 2025 as compared to $40.3 million in the comparative 2024 period. The decrease of $4.8 million was primarily due to changes in net working capital following the transfer of manufacturing responsibilities to Pierre Fabre in the first quarter of 2025.

Previous wording

Net cash provided by investing activities in the three months ended March 31, 2025 consisted primarily of $17.2 million received from maturities and sales of available-for-sale securities. Net cash provided by investing activities in the comparative 2024 period primarily consisted primarily of $14.8 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, 2025 consisted primarily of $17.2 million received from maturities and sales of available-for-sale securities. Net cash provided by investing activities in the comparative 2024 period primarily consisted primarily of $22.1 million received from maturities and sales of available-for-sale securities.

Previous wording

Net cash used in financing activities in the three months ended March 31, 2025 primarily consisted of $0.3 million in principal payments on finance lease obligations. Net cash provided by financing activities in the comparative 2024 period 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.

Current wording

Net cash provided by financing activities in the six months ended June 30, 2025 primarily consisted of $15.3 million in proceeds from the issuance of prefunded warrants and shares in a underwritten registered direct offering, net of discount. Net cash provided by financing activities in the comparative 2024 period primarily consisted of $14.8 million of proceeds received from the issuance of prefunded warrants in a direct registered offering and $9.3 million of net proceeds received from the 2023 ATM Facility.

Previous wording

We expect that cash, cash equivalents and short-term investments as of March 31, 2025, combined with $15.0 million in net proceeds we expect to receive from the issuance and sale of shares of our common stock and pre-funded warrants in an underwritten registered direct offering pursuant to an underwriting agreement dated May 14, 2025, the cost reductions from the announced workforce reductions in January, March and May 2025 and the operating efficiencies resulting from the transition of tab-cel manufacturing responsibilities to Pierre Fabre, will enable us to fund our planned operations through potential BLA approval. Such estimates are based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include 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 candidate. 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 in the near term to finance our planned operations.

Current wording

We expect that cash, cash equivalents and short-term investments as of June 30, 2025, combined with the anticipated $40 million milestone payment from Pierre Fabre upon approval of the tab-cel BLA, will provide significant cash runway and flexibility for the company to execute on its strategic priorities. Such estimates are based on assumptions and plans that are subject to change and such changes could materially impact our expected cash runway. These assumptions include the completion of specific 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 candidate. 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 in the near term to finance our planned operations.