On August 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported second quarter 2026 financial results and provided a corporate update.

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"In only its second full quarter of launch, KOMZIFTI established early leadership in relapsed or refractory NPM1-mutant AML, achieving a majority share of new patient starts in the menin inhibitor class," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Increasing physician preference for KOMZIFTI, combined with outstanding commercial execution and encouraging frontline data, establish a strong foundation for ziftomenib as a potential market leader throughout the AML treatment continuum. In parallel, darlifarnib is emerging as a differentiated precision combination platform across multiple targeted therapies in major solid tumor indications. Together, these programs position Kura to build long-term value while advancing innovative therapies for patients with significant unmet need."

Recent Developments

KOMZIFTI Commercial Launch

Commercial highlights for the quarter included:

·
$9.1 million in net product revenue, a 57% increase from 1Q 2026

·
Approximately 115 new patient starts (NPS), a 35% increase from 1Q 2026

·
More than 250 total prescriptions (TRx) in 2Q 2026, including repeat prescriptions, a 59% increase from 1Q 2026

·
In its second full quarter on the market, KOMZIFTI achieved a majority share of new patient starts in the R/R NPM1-m AML menin inhibitor class

New patient starts are a key indicator of physician preference, future prescription growth, and overall market leadership. Additional indicators of KOMZIFTI’s commercial momentum included broader adoption across academic and community treatment centers, increasing repeat prescribing, and physician-directed use of KOMZIFTI in combination with established standards of care.

Advancing Ziftomenib Across the Broader AML Treatment Landscape

•
EHA 2026

Long-term KOMET-007 data demonstrated high and durable clinical activity with 600 mg ziftomenib plus intensive chemotherapy (7+3) in 99 patients with newly diagnosed NPM1-m or KMT2A-r AML, including:

o
CRc rates of 96% and 90%, respectively
o
12-month OS rates of 94% and 71%, respectively
o
Deep MRD negativity, no new safety signals, and median overall survival not reached in either molecular subgroup

•
Blood Publication (June 2026)

Updated KOMET-007 results demonstrated deep and durable responses with 600 mg ziftomenib plus venetoclax and azacitidine in R/R NPM1-m AML. Venetoclax-naïve patients achieved an 87% ORR and 70% CRc rate, with 75% of composite complete responders achieving central MRD negativity. Median duration of CRc was 9.2 months. Median OS in these patients was not reached after 10.7 months of follow-up. The regimen was generally well tolerated, with low rates of differentiation syndrome and QTc prolongation.

Together, these results support the potential of ziftomenib in combination with standard-of-care regimens, increasing confidence in the ongoing KOMET-017 frontline program.

•
Registrational and Combination Programs

o
Site activation and patient enrollment across KOMET-017 frontline registrational studies for intensive and non-intensive chemotherapy eligible patients ongoing
o
Enrollment in KOMET-008 evaluating ziftomenib plus gilteritinib in patients with R/R FLT3-ITD/NPM1 co-mutated AML continues
o
Enrollment in the KOMET-007 cohort evaluating ziftomenib plus quizartinib and intensive chemotherapy in patients with newly diagnosed FLT3/NPM1 co-mutated AML ongoing

Advancing Darlifarnib as a Precision Combination Platform Across Solid Tumors

•
KRAS G12C-mutated Solid Tumors (ASCO 2026)

First-in-human Phase 1 FIT-001 data evaluating darlifarnib plus adagrasib provided clinical proof of mechanism, including tumor shrinkage in 77% of response-evaluable patients and confirmed ORRs of:

o
67% in pancreatic cancer
o
50% in non-small cell lung cancer
o
29% in KRAS inhibitor-naïve colorectal cancer

•
Cabozantinib-naïve Clear Cell Renal Cell Carcinoma (KCRS 2026)

Updated Phase 1 FIT-001 results demonstrated encouraging and durable clinical activity with darlifarnib plus cabozantinib, with ORRs of up to 50% across dose levels and an mPFS of 13 months.

•
Cabozantinib-exposed Clear Cell Renal Cell Carcinoma (IKCS 2026)

Phase 1 FIT-001 data demonstrated darlifarnib’s potential to overcome resistance to VEGFR-targeted therapy. Despite prior cabozantinib exposure, patients on the combination of darlifarnib plus cabozantinib, across multiple dose levels of each, achieved a:

o
44% ORR
o
94% disease control rate (DCR)
o
Tumor shrinkage in 75% of patients

Collectively, these data continue to support darlifarnib’s potential as a precision combination platform capable of enhancing multiple targeted therapy classes while creating opportunities for future development opportunities, potential strategic collaborations and multiple registrational paths.

•
FIT-001 Phase 1b Dose Expansion
Enrollment continues in the global, randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib versus cabozantinib alone to establish the recommended Phase 3 dose in patients with cabozantinib-naïve ccRCC.

Anticipated Milestones: Commercial and Development Priorities

Kura expects multiple commercial and clinical catalysts over the next 12 to 18 months.

KOMZIFTI 2026 Commercial Execution

•
Expand physician adoption across academic and community treatment centers
•
Increase repeat prescribing and broaden physician adoption
•
Deliver sustained quarter-over-quarter growth
•
Strengthen leadership within R/R NPM1-m AML menin inhibitor market

Building on Emerging Leadership Across the AML Treatment Continuum

Kura’s strategy is to build on KOMZIFTI’s early commercial success by moving ziftomenib into earlier lines of therapy, combining it with multiple standards of care and expanding its use across genetically defined AML populations.

Key near-term milestones include anticipated presentation of:

•
Updated long-term KOMET-007 Phase 1b data evaluating ziftomenib with venetoclax and azacitidine in newly diagnosed, intensive chemotherapy-ineligible NPM1-m AML patients, including durability, survival, and MRD outcomes – 2H 2026
•
Initial data from the KOMET-007 Phase 1b study evaluating ziftomenib with 7+3 intensive chemotherapy and quizartinib in patients with newly diagnosed NPM1-m/ FLT3-ITD AML– 2H 2026
•
Initial KOMET-008 data evaluating ziftomenib with gilteritinib in patients with R/R NPM1-m/FLT3-m AML, including activity in patients previously treated with FLT3 inhibitors– 2H 2026
•
An exploratory analysis from the KOMET-001 study evaluating ziftomenib monotherapy activity in molecularly defined, MEIS1-associated AML subtypes beyond NPM1-m and KMT2A-r disease – 2H 2026

Ziftomenib and Menin Inhibition – Expansion Beyond AML

•
Continue enrollment of KOMET-015 study evaluating ziftomenib plus imatinib in patients with gastrointestinal stromal tumors
•
Progress preclinical development of next-generation menin inhibitor for use in other solid tumors

KO-7246 (Next-Generation Menin Inhibitor)

•
Advance KO-7246, a next-generation menin inhibitor specifically designed for use in diabetes and cardiometabolic disease, into IND-enabling studies

•
Present additional scientific data characterizing menin inhibitors in preclinical models of diabetes

Darlifarnib – Precision Combination Platform in Solid Tumors

•
Complete enrollment in the randomized FIT-001 Phase 1b study evaluating darlifarnib plus cabozantinib in cabozantinib-naïve ccRCC in 1H 2027 and report initial clinical data in 2H 2027
•
Initiate a platform study of darlifarnib plus daraxonrasib in patients with KRAS-mutant 2L+ PDAC in 1H 2027
•
Advance darlifarnib as a precision combination platform across additional targeted therapy classes

Second Quarter 2026 Financial Results

•
Net product revenue: $9.1 million, compared to none for 2Q 2025
•
Collaboration revenue: $11.8 million, compared to $15.3 million for 2Q 2025
•
R&D expenses: $61.9 million, compared to $62.8 million for 2Q 2025
•
SG&A expenses: $31.8 million, compared to $25.2 million for 2Q 2025
•
Net loss: $68.3 million, compared to $66.1 million for 2Q 2025. Net loss includes $8.2 million in non-cash, share-based compensation expense compared to $6.9 million for the same period in 2025.
As of June 30, 2026, Kura had $519.0 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.

Combined with $180 million in anticipated collaboration payments from Kyowa Kirin, the Company believes its current cash resources will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 trial, anticipated in 2028.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 12, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available on the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, AUG 12, 2026, View Source [SID1234670006])

On August 12, 2026 Cypherpunk Technologies Inc., (Nasdaq: CYPH) ("Cypherpunk"), reported financial results for the second quarter ended June 30, 2026.

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"In the second quarter, Cypherpunk built upon the momentum established earlier this year through the disciplined execution of our Zcash digital asset treasury strategy, increasing our treasury holdings to 323,394.38 ZEC, and welcoming Dev Ojha, founder of Valar Group, as an Advisor," said Douglas E. Onsi, President and CEO of Cypherpunk Technologies. "Our Leap Therapeutics subsidiary reached alignment with the FDA on a proposed Phase 3 trial in a DKK1-high, second-line, metastatic colorectal cancer population, with objective response rate as the primary endpoint to support accelerated approval and overall survival to support full approval in the United States and registration globally. We are conducting a strategic process to determine the best path to advance sirexatamab, whether as an independently financed spin-out company or with a partner who shares our commitment to cancer patients."

"In an increasingly AI-driven economy, the demand for true privacy is moving from a technical preference to a civilizational necessity. Our execution in the second quarter reinforces Cypherpunk’s conviction in Zcash as a foundational monetary asset. By growing our ZEC treasury, expanding our world-class advisory team, and continuing to back core infrastructure developers like ZODL, we are systematically positioning Cypherpunk to capture the long-term value of digital privacy adoption," said Will McEvoy, Chief Investment Officer of Cypherpunk.

Cypherpunk Highlights:

· Zcash treasury holdings increased to 323,394.38 ZEC

o As of August 11, 2026, Cypherpunk held a total of 323,394.38 ZEC at an average purchase price of $341.83, representing approximately 1.92% of the total circulating supply of the Zcash network.

o ZEC is a digital currency that can be transmitted over a peer-to-peer payment system. Zcash uses a cryptographic method called "zero-knowledge proofs" to allow users to engage in financial transactions while maintaining greater privacy.

· Dev Ojha Appointed as an Advisor

o Cypherpunk appointed Dev Ojha, the founder of Valar Group, a leading development and research team focused on the Zcash Network, as an Advisor. Valar Group has taken a significant role in developing Zakura, a high-performance full node software designed for massive scalability of Zcash, and on the Ironwood shielded pool. Dev also serves as an official ZIP Editor for Zcash protocol standards. Cypherpunk’s Advisory Team also includes: Arjun Khemani, Zcash key opinion leader; Josh Swihart, CEO of ZODL; Jeff Tiller, Chief of Staff of Gemini; and Zooko Wilcox, Founder of Zcash and Chief Product Officer at Shielded Labs.

Leap Therapeutics Subsidiary Highlights:

· Publication of randomized Phase 2 DeFianCe study in Clinical Cancer Research

o Leap Therapeutics announced the publication of results from the randomized Phase 2 DeFianCe (NCT05480306) study of sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in Clinical Cancer Research. The publication, "Sirexatamab in Combination with Bevacizumab and Chemotherapy as Second-Line Therapy for Advanced Colorectal Adenocarcinoma: the Phase II DeFianCe Trial," reported the complete efficacy, safety, and biomarker analyses from the study and details the statistical basis for the DKK1 biomarker finding.

o The peer-reviewed analyses establish that, while the prespecified primary endpoint was not met in the intent-to-treat population, the benefit of sirexatamab increases as a patient’s baseline plasma DKK1 level rises — a relationship confirmed by independent statistical approaches and reinforced by the observation that high DKK1 predicts poorer outcomes on standard of care alone. Together, these findings define DKK1-high metastatic colorectal cancer (mCRC) as a biologically distinct population with high unmet need.

· Reached FDA alignment on registrational Phase 3 trial in DKK1-high colorectal cancer

o Leap Therapeutics held a Type C meeting with the FDA to discuss the DeFianCe results and proposed registrational path for sirexatamab in DKK1-high, second-line mCRC. Leap presented its proposed Phase 3 trial design, and the FDA provided feedback supporting key elements of that design, including the use of a DKK1 biomarker-selected patient population and a dual-endpoint structure intended to support both accelerated and full approval.

o Leap Therapeutics reached alignment with the FDA on a randomized, controlled Phase 3 trial evaluating sirexatamab in combination with investigator’s-choice fluoropyrimidine-based chemotherapy (FOLFIRI or mFOLFOX6) plus bevacizumab, compared with chemotherapy and bevacizumab alone. Approximately 270 patients with mCRC whose disease has progressed following one prior line of systemic therapy prospectively identified as DKK1-high using a baseline plasma DKK1 assay cut point are expected to be enrolled and randomized 1:1. Potential accelerated approval in the United States could be determined by objective response rate (ORR) in an initial group of approximately 160 patients, and overall survival (OS) will be evaluated in the full study population intended to support a filing for full approval in the United States and to support registration in markets outside the United States.

o A blood-based companion diagnostic would be developed in parallel to identify DKK1-high patients in routine clinical practice.

· Sirexatamab received Fast Track designation from FDA

o In May 2026, the FDA granted Fast Track designation to sirexatamab in combination with fluoropyrimidine plus oxaliplatin- or irinotecan-based chemotherapy and bevacizumab, for the treatment of patients with DKK1-high mCRC whose disease has progressed following one prior systemic therapy.

o The Fast Track program is intended to facilitate the development and expedite the review of drug candidates and vaccines that treat serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from frequent communication with the FDA, in addition to a rolling submission of the marketing application.

· Business update

o Leap Therapeutics has initiated a strategic process to identify the best path forward for sirexatamab and to secure the resources required to advance the program into Phase 3 development. The process is expected to consider a range of alternatives, which may include financing the program as an independent entity, or a strategic transaction with a pharmaceutical or biotechnology company, including a partnership, license, collaboration, sale, or other business combination.

o There can be no assurance that the strategic process will result in any transaction or financing, or that any transaction or financing that is completed will be on terms favorable to the Company or its stockholders. The Company has not set a timetable for the conclusion of the process and does not intend to disclose developments unless and until it determines that further disclosure is appropriate or required.

Selected Second Quarter 2026 Financial Results

Net income was $39.4 million, or $0.18 per diluted share, for the second quarter of 2026, compared to a net loss of $16.6 million for the second quarter of 2025. The change was primarily due to a $46.0 million unrealized gain on the fair value of the Company’s ZEC treasury holdings during the second quarter of 2026, which are marked to market at the end of each period. During the second quarter of 2026, the price of ZEC increased from $243.35 to $400.09.

Research and development expenses were $0.2 million for the three months ended June 30, 2026, compared to $10.5 million for the same period in 2025. The decrease was primarily due to a decrease in clinical trial and manufacturing expenses due to the completion of the clinical trials, together with a decrease in payroll and related expenses associated with the 2025 reduction in force.

General and administrative expenses were $4.5 million for the three months ended June 30, 2026, compared to $1.8 million for the same period in 2025. The increase of $2.7 million for the three months ended June 30, 2026 was primarily due to a $1.7 million increase in stock-based compensation related to restricted stock units granted to general and administrative employees and directors in the fourth quarter of 2025, a $0.8 million increase in payroll and related expenses, and a $0.2 million increase in professional fees.

During the three months ended June 30, 2026, the Company recorded a $46.0 million unrealized gain on the change in fair value of the Company’s ZEC treasury holdings as the price of ZEC increased during the second quarter of 2026 from $243.35 to $400.09.

Cash and cash equivalents totaled $7.6 million on June 30, 2026, and ZEC treasury holdings, categorized as digital asset receivable, totaled $129.4 million based on the ZEC price of $400.09 on June 30, 2026.

(Press release, Cypherpunk Technologies, AUG 12, 2026, View Source [SID1234670005])

On August 12, 2026 Century Therapeutics, Inc. (‘Century’, NASDAQ: IPSC), a biotechnology company developing induced pluripotent stem cell (iPSC)-derived cell therapies for autoimmune diseases, including T1D, and cancer, reported financial results for the second quarter ended June 30, 2026, and recent business highlights.

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"We are executing with speed against key development milestones, reinforcing our confidence in delivering on our ambition to transform diseases like T1D by creating functional cures at scale," said Brent Pfeiffenberger, Pharm.D., Chief Executive Officer of Century Therapeutics. "With CNTY-813, our preclinical data at ADA 2026 continue to support its potential as a functional T1D cure, and we have established our Phase 1 manufacturing process, demonstrating consistent product quality across independent batches. Our recent pre-IND meeting with the FDA builds on that progress yielding alignment with the FDA on our nonclinical data package, manufacturing strategy, and proposed Phase 1/2 trial design, keeping CNTY-813’s IND submission on track for the fourth quarter of 2026. In addition, CNTY-308 remains on track to enter the clinic in 2026."

Second Quarter 2026 and Recent Highlights

Pre-IND meeting with the FDA supports regulatory and initial clinical path for CNTY-813

· Following a recent pre-IND meeting with the FDA, Century remains on track to submit an IND for CNTY-813 in the fourth quarter of 2026.

· Century and the FDA reached general alignment on the nonclinical data package, the proposed Phase 1 manufacturing process and the Phase 1/2 clinical trial design which includes alignment on:

o GLP toxicology study, which is ongoing and on track to support the planned submission.

o Phase 1 manufacturing process and testing plan that includes cell bank, intermediate, and final drug product release tests.

o Proposed Phase 1/2 clinical trial including dosing and patient eligibility criteria.

· New preclinical data further support CNTY-813 as a potential functional cure for T1D; data were presented at the 2026 American Diabetes Association (ADA) Scientific Sessions in June (link to press release HERE).

Data demonstrated key advancements for CNTY-813 including:

o Durable in vivo glucose control maintained for more than eight months and immune evasion under allogeneic immune pressure without immunosuppression.

o Consistent and scalable product quality and performance at Phase 1 clinical trial scale.

· IND submission remains on track for 4Q 2026, with initial clinical data expected in 2H 2027.

CNTY-813 Phase 1 manufacturing process established

· Century has established its Phase 1 clinical manufacturing bioreactor process for CNTY-813, demonstrating consistent process performance and product quality, endocrine purity, and optimal islet cell content across independent batches run at the same scale intended for the Phase 1 clinical trial.

CNTY-813 preclinical data selected for oral presentations at congresses this fall

· 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD 2026; Milan, Italy; Presentation #225, Paris Hall, October 2nd, 2026, 10-11 AM CEST)

· Breakthrough T1D Clinical & Research Congress 2026 (CRC 2026; Philadelphia, Pennsylvania; Presentation #341, Hall 1, October 9th, 2026, 3:50- 4:50 PM EST)

· Both presentations will highlight CNTY-813, Century’s iPSC-derived islet replacement therapy program engineered with Allo-Evasion 5.0 for patients with T1D.

CNTY-308 clinical trial planned to initiate in 2026

· Century remains on track, after aligning on nonclinical, manufacturing and Phase 1 clinical trial parameters with health authorities, to complete IND-enabling activities for CNTY-308, a CD19-targeted CD4⁺/CD8⁺ αβ CAR-iT cell therapy engineered with Allo-Evasion 5.0 for B-cell-mediated diseases. CNTY-308 is anticipated to enter the clinic in 2026.

· Preclinical data showed functional comparability to primary CAR-T cells, including target-driven proliferation, cytokine secretion, and durable persistence. Collectively, these results and the expanding clinical validation of CAR-T therapy support Century’s confidence that CNTY-308 could deliver autologous-like benefits in an allogeneic, patient-centric format designed to broaden access.

Second Quarter 2026 Financial Results

· Cash Position: Cash, cash equivalents, and investments were $197.2 million as of June 30, 2026, as compared to $117.1 million as of December 31, 2025. The company estimates its cash, cash equivalents, and investments as of June 30, 2026 will support operations into 1Q 2029.

· Research and Development (R&D) Expenses: R&D expenses were $19.6 million for the quarter ended June 30, 2026, compared to $26.9 million for the same period in 2025. The decrease was primarily the result of a reduction in personnel and a reduction in facility costs as a result of our previously announced portfolio prioritization.

· General and Administrative (G&A) Expenses: G&A expenses were $5.8 million for the quarter ended June 30, 2026, compared to $7.8 million for the same period in 2025.

· Net Income (Loss): Net (loss) was $34.6 million for the quarter ended June 30, 2026, compared to net (loss) of $32.5 million for the same period in 2025.

(Press release, Century Therapeutics, AUG 12, 2026, View Source [SID1234670004])

On August 12, 2026 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CANF), a clinical-stage biotechnology company developing a pipeline of proprietary small molecule drugs targeting oncological and inflammatory diseases, reported an update on the regulatory status of its two lead drug candidates, Piclidenoson and Namodenoson. Both drug candidates are being advanced in Phase III clinical development programs under regulatory frameworks established with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), providing defined regulatory pathways toward potential marketing approval.

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Namodenoson, Can-Fite’s orally administered A3 adenosine receptor (A3AR) agonist, is currently being evaluated in a pivotal Phase III study for the treatment of patients with advanced liver cancer, hepatocellular carcinoma (HCC) and underlying Child-Pugh B7 liver cirrhosis. The Phase III study is being conducted under regulatory guidance from both the FDA and EMA and is designed to support potential marketing authorization applications in the United States and Europe, if the study meets its predefined efficacy and safety endpoints.

Piclidenoson, Can-Fite’s oral A3AR agonist for inflammatory diseases, is currently being evaluated in a Phase III clinical program for the treatment of moderate-to-severe plaque psoriasis.

Can-Fite’s clinical development strategy is focused on advancing its lead drug candidates through late-stage clinical development under regulatory pathways established with leading regulatory authorities.

Namodenoson’s FDA Fast Track and FDA and EMA Orphan Drug designations provide additional regulatory advantages as the Company advances its pivotal HCC program, while Piclidenoson is progressing through Phase III development in psoriasis.

Can-Fite believes that the advanced regulatory status of both programs significantly strengthens the Company’s late-stage clinical pipeline and provides a clear framework for advancing Piclidenoson and Namodenoson toward potential regulatory submissions and commercialization.

"Can-Fite has reached an important stage in its development, with both of our lead drug candidates in Phase III programs and with established regulatory pathways in the United States and Europe," stated Dr. Pnina Fishman, Can-Fite’s Chief Scientific Officer and Executive Chairperson. "Namodenoson’s Fast Track and Orphan Drug designations, together with our ongoing pivotal Phase III HCC study, and the Phase III development of Piclidenoson in psoriasis, demonstrate the maturity of our clinical pipeline. We believe these regulatory achievements provide greater clarity regarding the development and potential approval pathways for our drug candidates and bring us closer to our goal of delivering new oral therapies to patients with significant unmet medical needs."

(Press release, Can-Fite BioPharma, AUG 12, 2026, View Source [SID1234670003])

On August 12, 2026 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), 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 diseases, reported financial results for the second quarter 2026 and business updates.

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"This was an important quarter for Atara. We and our partners, Pierre Fabre Pharmaceuticals (PFP), had a productive Type A meeting with the FDA where we confirmed the opportunity to resubmit the tabelecleucel BLA based on the existing Phase 3 single arm ALLELE trial. We are actively working with and supporting PFP in a resubmission that includes an updated dataset with additional patients and longer follow-up. Patients are still dying from EBV-driven PTLD, and we remain fully committed to ensuring that they have access to this new medicine," said Cokey Nguyen, President and Chief Executive Officer of Atara. "We continue to believe that tab-cel has significant commercial potential in the US, and we have taken steps to control expenses with the goal of protecting and maximizing shareholder value and enhancing our strategic flexibility."

Tabelecleucel (tab-cel or EBVALLO) for Post-Transplant Lymphoproliferative Disease (PTLD)

As previously communicated, PFP has indicated they intend to submit an updated dataset with additional patients and longer follow-up from the pivotal Phase 3 single arm ALLELE study as well as supportive data. Atara anticipates providing a further regulatory update later this quarter.

Under its commercialization agreement with Pierre Fabre Laboratories, Atara is eligible to receive a $31 million milestone payment upon FDA approval of the tabelecleucel BLA, as well as significant double-digit tiered royalties as a percentage of net sales, and milestones related to commercial sales of EBVALLO.

Second Quarter 2026 Financial Results:

Cash, cash equivalents and short-term investments as of June 30, 2026, totaled $9.9 million, as compared to $8.4 million as of March 31, 2026.
Net cash used in operating activities was $3.3 million for the second quarter 2026, as compared to $7.4 million in the same period in 2025.
Total revenues were $0.6 million for the second quarter 2026, as compared to $17.6 million for the same period in 2025. Total revenues decreased by $17.0 million year-over-year, primarily due to the accelerated recognition of deferred revenue in 2025 following the transition of development activities to Pierre Fabre Laboratories. As a result, less deferred revenue remained available for recognition in the comparative period.
Total costs and operating expenses include non-cash stock-based compensation, depreciation and amortization expenses of $0.4 million for the second quarter 2026, as compared to $3.0 million for the same period in 2025.
Research and development expenses were $1.3 million for the second quarter 2026, as compared to $7.3 million for the same period in 2025.
Research and development expenses include $0.1 million of non-cash stock-based compensation expenses for the second quarter 2026, as compared to $0.7 million for the same period in 2025.
General and administrative expenses were $3.8 million for the second quarter 2026, as compared to $6.5 million for the same period in 2025.
General and administrative expenses include $0.3 million of non-cash stock-based compensation expenses for the second quarter 2026, as compared to $2.1 million for the same period in 2025.
Atara reported a net loss of $4.8 million, or ($0.32) basic and diluted loss per share, for the second quarter 2026, as compared to net income of $2.4 million, or $0.20 basic earnings per share and $0.19 diluted earnings per share, for the same period in 2025.
2026 Outlook and Cash Runway:

Operating expenses are expected to decline significantly year-over-year, reflecting the full-year benefit of cost-reduction initiatives implemented in 2025 and first half of 2026.
Atara expects its cash, cash equivalents, and short-term investments as of June 30, 2026, combined with operating efficiencies achieved in 2025 and first half of 2026, will be sufficient to fund planned operations into mid-2027.

(Press release, Atara Biotherapeutics, AUG 12, 2026, View Source [SID1234670002])