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Business Wire
11-08-2025
- Business
- Business Wire
Atara Biotherapeutics Announces Second Quarter Financial Results and Operational Progress
THOUSAND OAKS, Calif.--(BUSINESS WIRE)-- 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, today reported financial results for the second quarter 2025 and business updates. Tabelecleucel (tab-cel ® or Ebvallo™) for Post-Transplant Lymphoproliferative Disease (PTLD) The U.S. Food and Drug Administration (FDA) has accepted the filing of Atara's Biologics License Application (BLA) for tabelecleucel (tab-cel ®) indicated as monotherapy for treatment of 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. There are no FDA approved therapies in this treatment setting. The BLA has been granted Priority Review with a Class 2 Resubmission Prescription Drug User Fee Act (PDUFA) target action date of January 10, 2026. In July, the Company completed transferring substantially all operational activities and associated costs related to tab-cel to Pierre Fabre Laboratories. The sponsorship of the BLA continues to be maintained by the Company. Corporate Updates Strategic Options Evaluation: In April 2025, the Company temporarily paused its review of strategic alternatives pending resubmission of the tab-cel BLA. The Company has resumed its evaluation of strategic options following the resubmission of the tab-cel BLA. These options may include, but are not limited to, an acquisition, merger, reverse merger, other business combinations, licensing, sale of assets, or other strategic transactions. It is possible that Atara may not pursue a strategic alternative or transaction or that any strategic alternative or transaction, if pursued, will not be completed on attractive terms, or that a strategic alternative or transaction may not ultimately be consummated. Financial Update: Second Quarter 2025 Financial Results: Cash, cash equivalents and short-term investments as of June 30, 2025, totaled $22.3 million, as compared to $13.8 million as of March 31, 2025 Net cash used in operating activities was $7.4 million for the second quarter 2025, as compared to $10.6 million in the same period in 2024 Total revenues were $17.6 million for the second quarter 2025, as compared to $28.6 million for the same period in 2024. Total revenues decreased by $11.0 million year-over-year, primarily due to the accelerated recognition of deferred revenue in the first quarter 2025 following the transition of manufacturing responsibilities 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 $3.0 million for the second quarter 2025, as compared to $7.7 million for the same period in 2024 Research and development expenses were $7.3 million for the second quarter 2025, as compared to $33.3 million for the same period in 2024 Research and development expenses include $0.7 million of non-cash stock-based compensation expenses for the second quarter 2025, as compared to $3.3 million for the same period in 2024 General and administrative expenses were $6.5 million for the second quarter 2025, as compared to $8.9 million for the same period in 2024 General and administrative expenses include $2.1 million of non-cash stock-based compensation expenses for the second quarter 2025, as compared to $3.0 million for the same period in 2024 Atara reported net income of $2.4 million, or $0.20 basic earnings per share and $0.19 diluted earnings per share for the second quarter 2025. The net income position is due to the acceleration of revenue recognized following the transition of tab-cel development and safety responsibilities to Pierre Fabre Laboratories in July 2025 2025 Outlook and Cash Runway: Under its commercialization agreement with Pierre Fabre Medicament, Atara is eligible to receive a $40 million milestone payment upon FDA approval of the tab-cel BLA. In addition, Atara will be eligible to receive double-digit tiered royalties as a percentage of net sales and milestones related to commercial sales of EBVALLO. We anticipate the full-year 2025 operating expenses will decrease by at least 60% compared to 2024, driven by the transition of substantially all tab-cel activities and associated costs to Pierre Fabre Laboratories as well as the implementation of operational efficiencies in the first half of the year. Atara projects that cash, cash equivalents and short-term investments as of June 30, 2025, combined with the proceeds of the milestone payment upon tab-cel BLA approval under its commercialization agreement with Pierre Fabre Medicament, will provide significant cash runway and flexibility for the company to execute on its strategic priorities. About Atara Biotherapeutics, Inc. Atara is harnessing the natural power of the immune system to develop off-the-shelf cell therapies for difficult-to-treat cancers and autoimmune conditions that can be rapidly delivered to patients from inventory. With cutting-edge science and differentiated approach, Atara is the first company in the world to receive regulatory approval of an allogeneic T-cell immunotherapy. Our advanced and versatile T-cell platform does not require T-cell receptor or HLA gene editing and forms the basis of a diverse portfolio of investigational therapies that target EBV, the root cause of certain diseases. Atara is headquartered in Southern California. For more information, visit and follow @Atarabio on X and LinkedIn. Forward-Looking Statements This press release contains or may imply 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, forward-looking statements include statements regarding: (1) the development, timing and progress of tab-cel, including the timing for FDA review of the resubmission of the BLA, the potential characteristics and benefits of tab-cel, and the results of, and prospects for, the global partnership with Pierre Fabre Medicament involving tab-cel, and the potential financial benefits to Atara as a result of the global partnership with Pierre Fabre Medicament, including the receipt, timing and amount of any payments to be received by Atara thereunder; (2) Atara's cash runway, receipt of potential milestone payments, and estimated reduction in operating expenses; and (3) Atara's evaluation of strategic alternatives and ability to consummate one or more strategic transactions. Because such statements deal with future events and are based on Atara's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Atara could differ materially from those described in or implied by the statements in this press release. These forward-looking statements are subject to risks and uncertainties, including, without limitation, risks and uncertainties associated with the costly and time-consuming pharmaceutical product development process and the uncertainty of clinical success; risks related to FDA's review of the resubmitted BLA for tab-cel; our ability to access capital, and the sufficiency of Atara's cash resources and access to additional capital on favorable terms or at all; the timing of the strategic review process; whether Atara will pursue any strategic alternatives; in the event Atara pursues a strategic alternative, that the strategic alternative may not be attractive or ultimately consummated; whether any strategic alternative will result in additional value for Atara and its stockholders; whether the process will have an adverse impact on Atara and other risks and uncertainties affecting Atara, including those discussed in Atara's filings with the Securities and Exchange Commission, including in the 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of the Company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings and in the documents incorporated by reference therein. Except as otherwise required by law, Atara disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise. ATARA BIOTHERAPEUTICS, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Commercialization revenue $ 17,575 $ 28,640 $ 115,724 $ 55,997 Costs and operating expenses: Cost of commercialization revenue 554 4,627 20,993 6,612 Research and development expenses 7,310 33,332 34,743 78,838 General and administrative expenses 6,514 8,912 17,989 20,025 Total costs and operating expenses 14,378 46,871 73,725 105,475 Income (loss) from operations 3,197 (18,231 ) 41,999 (49,478 ) Interest and other income (expense), net (807 ) (818 ) (1,599 ) (1,299 ) Loss before provision for income taxes 2,390 (19,049 ) 40,400 (50,777 ) Provision for income taxes 3 — 3 24 Net income (loss) $ 2,387 $ (19,049 ) $ 40,397 $ (50,801 ) Other comprehensive gain (loss): Unrealized gain (loss) on available-for-sale securities — 41 (8 ) 190 Comprehensive income (loss) $ 2,387 $ (19,008 ) $ 40,389 $ (50,611 ) Basic net income (loss) per common share $ 0.20 $ (3.10 ) $ 3.52 $ (8.64 ) Diluted net income (loss) per common share $ 0.19 $ (3.10 ) $ 3.49 $ (8.64 ) Basic weighted-average shares outstanding 12,197 6,143 11,484 5,883 Diluted weighted-average shares outstanding 12,310 6,143 11,576 5,883 Expand
Epoch Times
09-05-2025
- Health
- Epoch Times
Old Antibiotic Shows Promise Against Lyme Disease at Ultra-Low Doses
Scientists may be closing in on two major advances in the fight against Lyme disease: an overlooked antibiotic that eliminates the infection at exceptionally low doses and new insights into why symptoms often persist long after treatment. In a pair of Unlike doxycycline, piperacillin targets the Lyme disease bacteria specifically, sparing the gut microbiome from the disruption that typically accompanies doxycycline use. 'What was remarkable to us was how well piperacillin worked at really low doses,' Brandon L. Jutras, a professor in the microbiology-immunology department at Northwestern University Feinberg School of Medicine and lead researcher, told The Epoch Times. 'We don't need to provide it at a concentration that could kill other microbes.' The team also found that remnants of the Lyme bacteria can remain in the body after being treated with antibiotics, which may Peptidoglycan—a component of Lyme bacteria's cell wall—can linger in the body, triggering prolonged immune reactions and helping explain the symptoms of post-treatment Lyme disease (PTLD), where some patients continue to experience symptoms for months or even years after the infection is thought to be cleared. A More Targeted Approach Lyme disease is an infectious illness that is spread to people through the bites of infected black-legged ticks and can lead to neurological and heart complications if untreated. Related Stories 10/22/2023 11/13/2024 Piperacillin works by interfering with the unique way Borrelia burgdorferi, the bacterium responsible for Lyme disease, builds its cell walls—a process essential for bacterial survival. Because of this targeted mechanism, researchers believe piperacillin will spare the gut microbiome, which is often disrupted by broader-spectrum antibiotics like doxycycline. However, whether this more targeted approach could help prevent PTLD wasn't addressed in the study. Jutras' team screened nearly 500 FDA-approved drugs, tracking how each compound affected the bacteria's ability to build its distinctive cell wall. 'We could literally watch what happened to the cell wall when we added antibiotics,' Jutras said. 'Piperacillin disrupted that process in a way that was incredibly specific to Borrelia.' Currently, piperacillin is used to treat pneumonia and urinary tract infections and is not approved for use against Lyme disease in humans. Beyond treatment, the researchers also see promise in piperacillin as a potential preventive measure. The idea is that one dose, received right after a tick bite, could stop the infection before it starts. Early diagnosis is challenging since small tick bites may often go unnoticed, early symptoms may not appear for days or weeks, and not all patients develop the telltale bull's-eye rash. Diagnostic tests often rely on antibodies that take time to form, resulting in false negatives during early infection. 'You get bit by a tick. You go to your doctor. Right now, they might tell you to wait for symptoms or a positive test result,' Jutras said. 'But with piperacillin, the idea is that you could receive a single prophylactic dose. It wouldn't harm your microbiome, and it might prevent illness altogether.' Jutras noted that while the findings make piperacillin a promising option, it must first be tested and proven effective in human trials before physicians can prescribe it. Some experts also caution that any antibiotic—even at low doses—can contribute to antibiotic resistance. 'The question is: does the benefit of potentially preventing Lyme disease outweigh the risk to that person's microbiome and the collective antibiotic resistance concern that we collectively face?' 'If piperacillin is proven to be highly effective, then that is a no-brainer in favor of preventing this potentially debilitating medical condition,' he said, adding that piperacillin is only available in intravenous or intramuscular form, so it's unlikely to be practical for widespread preventive use after a tick bite. Side effects of doxycycline may include gastrointestinal discomfort, increased sensitivity to sunlight, and potential risks to bone and tooth development in children. It's also avoided during pregnancy. Piperacillin, commonly used to treat pneumonia and urinary tract infections in combination with another antibiotic (tazobactam), carries risks of allergic reactions or changes in liver function. However, researchers note that the much lower dose used in this study—and the fact that it was not combined with a second antibiotic—may result in a safer profile. Why Lyme Symptoms Persist Lyme disease is now the most common vector-borne disease in the United States, with the Centers for Disease Control and Prevention estimating that approximately 500,000 Americans are diagnosed and treated Unlike most infections, where the concern is primarily the initial acute phase, a significant worry with Lyme disease is that even after treatment, some people develop chronic symptoms of fatigue, pain, and brain fog that don't respond to further treatment. A 2022 There is currently no single approved treatment for PTLD. Management typically focuses on relieving symptoms such as fatigue, joint pain, and brain fog through a combination of supportive care, lifestyle changes, and in some cases, extended or repeated antibiotic courses. Jutras and his team believe that lingering bacterial debris may trigger an immune response that mimics chronic illness, even when no live bacteria remain. These peptidoglycan fragments were found in the liver and in joint fluid of patients with Lyme arthritis, where they continue to provoke an immune response. Compared to other bacteria, Lyme bacteria's peptidoglycan is more resistant to breakdown, possibly due to its unique structure—a feature that scientists say is altered by the tick's biology. Holistic Approaches for Prevention To help reduce the risk of persistent symptoms, many doctors who specialize in Lyme treatment take a holistic approach to prevention and recovery. By lowering the number of lingering pathogens and supporting immune function, these strategies can help manage and even reduce the chances of developing PTLD. Bell highlighted the importance of identifying co-infections, such as Bartonella, Babesia, Ehrlichia, Anaplasma, or Rocky Mountain spotted fever, as well as addressing mold exposure and mycotoxins. 'If co-infections or mold toxins are present and go untreated, the patient will have a much more challenging time recovering from Lyme,' he said. Herbal remedies such as Cryptolepsis and Japanese knotweed Once symptoms indicating an acute infection are gone, these two botanicals may be a superior choice to antibiotics for long-term maintenance therapy after infection, Bell said. In addition to herbal treatments, lifestyle changes—such as prioritizing quality sleep, engaging in gentle movement like walking or yoga, and minimizing exposure to environmental toxins—are a key part of recovery. Clean tick bites with soap and water, and remove any attached ticks by using tweezers to pull them upward—without twisting or crushing them. Early symptoms of Lyme disease, occurring 3 to 30 days after exposure, include: Bull's-eye rash (erythema migrans) Fever, chills, or fatigue Muscle aches and joint pain Swollen lymph nodes Later symptoms, which may occur weeks to months after infection, include: Severe joint swelling or pain Drooping on one side of the face (facial palsy) Numbness or tingling Irregular heartbeat Cognitive issues, such as memory loss
