Bird flu could be heading north this spring with fewer federal health officials working to stop it
The outbreak of bird flu that has been ravaging farms nationwide had started to slow over the past few weeks — but as wild birds migrate north, scientists say the virus may follow.
At the same time, the United States will have fewer people leading the national effort to stop avian influenza.
The sweeping cuts this week to the federal Department of Health and Human Services include the Food and Drug Administration's chief medical officer, who was helping to lead the federal government's bird flu response, and senior staff from the FDA's Center for Veterinary Medicine, which linked bird flu cases to raw pet food, leading to several recalls.
'We no longer are going to have the same eyes on this virus,' said Dr. Meghan Davis, a former dairy veterinarian and associate professor at the Johns Hopkins Bloomberg School of Public Health. She said active surveillance of and investigation into how the virus spreads are a necessity, but local health officials and veterinarians will no longer have the same support from the federal government.
The ongoing outbreak of bird flu — the worst in U.S. history — picked up steam through the fall and winter, pushing egg prices to record highs. While outbreaks in both poultry and cattle have fallen, along with the average price of eggs, health experts say that cases could rise again amid the spring migration, which typically peaks in May and June in the continental U.S.
Quantifying the scope of bird flu in the U.S. is complicated. The number of confirmed outbreaks in poultry fell to 53 flocks last month after reaching 133 flocks in January. Outbreaks in cattle fell to 21 herds last month, after peaking at 253 in November. Detections in other mammals, wild birds and humans are tracked separately. And the 168 million domestic birds affected so far include many slaughtered because any detection on a poultry farm requires culling all the birds on the premises.
The current outbreak has also been notoriously difficult to predict and contain, jumping to cattle for the first time last year and spreading to other species. Limited data on cases and testing has made it even harder to track the virus's spread and evolution, experts said, which could mean the virus could surge and new variants could emerge with little warning.
'We cannot let our guard down — now is not the time to do that,' said Stacey Schultz-Cherry, an influenza researcher at St. Jude's Children's Research Hospital.
Wild birds are a major pathway for the virus when they land and mingle with domestic animals. Schultz-Cherry warned that the birds currently migrating northward might introduce new variants of the virus from South America to the U.S., giving the virus more opportunities to evolve in potentially dangerous ways. 'That's what we worry about — is this something new?'
Variants of concern have already been emerging. In March, the U.S. confirmed the detection of a bird flu variant known as H7N9 on a Mississippi poultry farm. It was the first time since 2017 that the strain — which is especially deadly to humans — had been detected in a commercial U.S. poultry flock. In January, another variant linked to a handful of severe and fatal human infections was found in U.S. cattle for the first time.
This week, more than 140 staff members from the FDA's Center for Veterinary Medicine, which oversees animal food and medicine, were among the roughly 10,000 staff terminated from the Department of Health and Human Services, according to Alex Saint, who was an FDA communications specialist until she, too, was terminated. The cuts are part of the Trump administration's broader effort to shrink the federal government.
The FDA has become increasingly involved in the bird flu response as the virus has spread beyond birds. More than 120 domestic cats have been infected with bird flu since 2022, according to the U.S. Agriculture Department, and FDA staff helped link some of the cases to raw pet food.
The agency also helped to develop better diagnostic tests for the virus and has conducted extensive bird flu studies showing that pasteurization effectively inactivated the virus, making milk products safe for consumption.
Already, the staff cuts prompted the FDA to suspend an effort to improve testing of pet food and dairy products for bird flu, according to a person familiar with the matter who was not authorized to speak to the media and who spoke to NBC News on the condition of anonymity.
'It's nothing short of devastating to veterinary medicine,' said Dr. K. Fred Gingrich II, executive director of the American Association of Bovine Practitioners, which represents cow veterinarians. 'They were absolutely critical — not just for the bird flu response, but for developing protocols for research and drug development.'
The Department of Health and Human Services said in a statement that the cuts were limited to administrative staff and intended 'to make the agency more efficient and responsive.'
'The FDA and HHS continue to prioritize public health and animal health, including ongoing efforts to monitor and respond" to bird flu, the agency added.
In February, the USDA accidentally fired officials working on bird flu and then moved to rehire them. Later that month, the agency announced a $1 billion effort to combat the virus and lower egg prices.
The risk remains low to the public, with 70 confirmed human cases in the U.S. and one death. But the unchecked spread of bird flu increases the chances that the virus could mutate into a strain that is far more deadly to humans and easily transmissible among them.
Experts warn that the broader Department of Health and Human Services cuts also could hamper the country's ability to track and contain the virus among both humans and animals, particularly when outbreaks spread across state lines.
Among the concerns are the ongoing spread of bird flu to different species of mammals, after jumping to cattle last year. Along with domestic cats, the Agriculture Department reported, bird flu infections were found in foxes, skunks, mice, bears, raccoons, seals, and dolphins in March.
'We should be doing a lot more in terms of aggressively seeking out this virus in animal and human populations, doing much more active surveillance, and much more aggressive testing,' said Dr. James Lawler, an infectious disease expert and professor at the University of Nebraska Medical Center. He stressed the need to monitor both farms and workers to detect the virus before large-scale outbreaks happen — and to ensure that the nation's health care system is prepared if the virus suddenly becomes a bigger threat to humans.
'I don't see us doing a whole lot of that — I see us dismantling the agencies in charge,' he added.
This article was originally published on NBCNews.com
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Cash, cash equivalents and marketable securities of $330.1 million as of March 31, 2025 support advancing pipeline into 2027 through multiple clinical milestones. SOUTH SAN FRANCISCO, Calif., May 13, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, today reported financial results and business highlights for the first quarter ended March 31, 2025. Lyell's lead clinical program, LYL314 (formerly known as IMPT-314), is an autologous CD19/CD20 dual-targeting CAR T-cell product candidate under evaluation in a Phase 1/2 trial enrolling patients with relapsed and/or refractory large B-cell lymphoma (LBCL). LYL314 was recently granted RMAT designation by the United States FDA in recognition of its potential to address significant unmet needs in patients with aggressive LBCL in the third- or later-line setting. 'We are pleased with the progress we are making with our LYL314 clinical development strategy and look forward to presenting new clinical data from patients with aggressive large B-cell lymphoma who have not previously received CAR T-cell therapy at the International Conference on Malignant Lymphoma in Lugano, Switzerland in June,' said Lynn Seely, M.D., President and CEO of Lyell. 'Based on promising clinical data, Lyell remains on track to initiate two pivotal programs for LYL314: one for patients in the third- or later-line setting by mid-2025 and a second for patients in the second-line setting by early 2026. In addition, our LyFE Manufacturing Center in Bothell, Washington is now manufacturing the LYL314 clinical supply following completion of a successful technology transfer and FDA clearance of an IND amendment.' First Quarter Updates and Recent Business Highlights Lyell is advancing a pipeline of next-generation CAR T-cell product candidates. Its lead program, LYL314, is in Phase 1/2 clinical development for relapsed and/or refractory LBCL and its preclinical programs target solid tumor indications. Lyell's programs target cancers with large unmet need with substantial patient is an autologous CAR T-cell product candidate with a true 'OR' logic gate to target B cells that express either CD19 or CD20 with full potency and that is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. LYL314 is currently being evaluated in a multi-center, open-label trial that is enrolling patients in the third- or later-line and second-line settings who have not previously received CAR T-cell therapy. The trial is designed to evaluate the tolerability and clinical benefit of LYL314 in patients with relapsed and/or refractory LBCL and determine a recommended Phase 2 dose. The FDA has granted LYL314 RMAT and Fast Track designations for the treatment of relapsed and/or refractory diffuse LBCL in the third- or later-line setting. RMAT provides all the benefits of the Fast Track and Breakthrough Therapy designation programs and enables increased frequency of communications with the FDA on the development of LYL314. New clinical data from the Phase 1/2 multi-center clinical trial of LYL314 in patients with relapsed and/or refractory LBCL will be presented at the 18th International Conference on Malignant Lymphoma in June, including more mature data from patients treated in the third- or later-line setting and initial data from patients treated in the second-line setting. The data will be highlighted in an oral presentation titled 'LYL314, a CD19/CD20 CAR T-cell candidate enriched for CD62L+ stem-like cells, achieves high rates of durable complete responses in R/R large B-cell lymphoma' to be presented on June 18th at 5:40 pm CEST. Initial clinical data in 23 patients treated with LYL314 from the ongoing Phase 1/2 clinical trial were presented at the American Society for Hematology 2024 Annual Meeting on December 9, 2024. The efficacy evaluable population consisted of 17 patients with relapsed and/or refractory LBCL in the third- or later-line setting who had not previously received a CAR T-cell therapy prior to LYL314 administration. The overall response rate was 94% (16/17) of patients, and 71% (12/17) of patients achieved a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients experienced a response at last follow-up. In the safety evaluable population of 23 patients, no event of Grade 3 or greater cytokine release syndrome was reported. Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 13% (3/23) of patients with a median time to ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy. LYL314 clinical supply is now manufactured at the LyFE Manufacturing Center in Bothell, Washington following successful technology transfer and clearance by the FDA of an IND amendment. LyFE is a state-of-the-art cell therapy manufacturing facility with the capacity to provide drug supply for Lyell's ongoing and planned pivotal trials and through potential commercial launch, with a capacity over 1,000 CAR T-cell therapy doses per year. A pivotal trial in the third- or later-line setting is expected to be initiated in mid-2025 in patients with relapsed and/or refractory LBCL who have not previously received CAR T-cell therapy. More mature data from the ongoing Phase 1/2 trial in the second-line setting are expected to be presented in late-2025. A pivotal trial in the second-line setting is expected to be initiated by early 2026 in patients with relapsed and/or refractory LBCL who have not previously received CAR T-cell therapy. Preclinical Pipeline, Technologies and Manufacturing Protocols Lyell is advancing next-generation fully-armed CAR T-cell product candidates, each including multiple technologies, designed to overcome T-cell exhaustion and lack of durable stemness, as well as immune suppression within the hostile tumor microenvironment. The first IND for a fully-armed CAR T-cell product candidate with an undisclosed target for solid tumors is expected in 2026. An abstract titled 'Engineered T Cells Combining Stackable Reprogramming Technologies Enable Durable Anti‑tumor Activity in Xenograft Solid Tumors' has been accepted for an oral presentation at the 28th Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT), on May 16, 2025, in New Orleans, LA. 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First Quarter 2025 Financial Results Lyell reported a net loss of $52.2 million for the first quarter ended March 31, 2025, compared to a net loss of $60.7 million for the same period in 2024. The $8.5 million decrease in net loss was primarily driven by $13.0 million in impairment expenses recognized in the prior year period that did not occur in 2025, partially offset by lower interest income of $3.0 million primarily driven by lower interest rates in 2025, coupled with lower cash equivalent and marketable securities balances. Non‑GAAP net loss, which excludes stock-based compensation, non-cash expenses related to the change in the estimated fair value of success payment liabilities and certain non-cash investment gains and charges, increased to $46.3 million for the first quarter ended March 31, 2025, compared to $37.5 million for the same period in 2024 due primarily to increased personnel costs and lower interest income in 2025. GAAP and Non-GAAP Operating Expenses Research and development (R&D) expenses were $43.4 million for the first quarter ended March 31, 2025, compared to $43.2 million for the same period in 2024. The increase in first quarter 2025 R&D expenses of $0.3 million was primarily due to a $3.1 million increase in personnel expenses, due primarily to severance expenses resulting from Lyell's 2025 workforce reduction related to the closure of the West Hills manufacturing facility acquired as part of Lyell's acquisition of ImmPACT in 2024, partially offset by reductions in collaboration agreement and leasehold improvement depreciation costs. Non‑GAAP R&D expenses, which exclude non-cash stock-based compensation and non-cash expenses related to the change in the estimated fair value of success payment liabilities for the first quarter ended March 31, 2025 were $41.1 million compared to $38.9 million for the same period in 2024. General and administrative (G&A) expenses were $14.0 million for the first quarter ended March 31, 2025, respectively, compared to $13.5 million for the same period in 2024. The increase in first quarter 2025 G&A expenses of $0.6 million was primarily driven by an increase of $2.4 million in personnel‑related expenses due to higher headcount associated with Lyell's acquisition of ImmPACT and severance expenses related to the West Hills facility closure, partially offset by $1.7 million in decreased stock-based compensation expense due to a decrease in the value of awards granted. Non‑GAAP G&A expenses, which exclude non-cash stock‑based compensation, for the first quarter ended March 31, 2025 were $10.4 million, compared to $8.1 million for the same period in 2024. The $2.3 million increase in first quarter 2025 non-GAAP G&A expenses was primarily driven by increased headcount and severance expenses. 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Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: Lyell's plans to present new LYL314 clinical data from the ongoing Phase 1/2 trial of LYL314; the anticipated benefits of RMAT designation for LYL314; the sufficiency of the capacity of LyFE to manufacture drug supply for Lyell's ongoing and planned pivotal trials and through potential commercial launch; Lyell's initiation of pivotal trials in 2025 and 2026 for LYL314; expectations around enrollment and the timing of additional clinical data from Lyell's Phase 1/2 trials for LYL314; timing of Lyell's submission of a new IND in 2026 for a CAR T-cell product candidate with an undisclosed target for solid tumors; Lyell's anticipated progress, business plans, business strategy and clinical trials; Lyell's advancement of its pipeline and its research, development and clinical capabilities; the potential clinical benefits and therapeutic potential of Lyell's product candidates; the advancement of Lyell's technology platform; Lyell's expectation that its financial position and cash runway will support advancement of its pipeline through multiple clinical milestones and meet working capital and capital expenditure needs into 2027; and other statements that are not historical fact. These statements are based on Lyell's current plans, objectives, estimates, expectations and intentions, are not guarantees of future performance and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the complexity of manufacturing cellular therapies, which subjects us to a multitude of manufacturing risks, any of which could substantially increase our costs, delay our programs or limit supply of our product candidates; RMAT designation may not actually lead to faster development, regulatory review or approval process, and does not assure ultimate FDA approval; the effects of macroeconomic conditions, including the effects of disruption between the U.S. and its trading partners due to tariffs or other policies, any geopolitical instability and actual or perceived changes in interest rates and economic inflation; Lyell's ability to submit planned INDs or initiate or progress clinical trials on the anticipated timelines, if at all; Lyell's limited experience as a company in enrolling and conducting clinical trials, and lack of experience in completing clinical trials; the nonclinical profiles of Lyell's product candidates or technology not translating in clinical trials; the potential for results from clinical trials to differ from nonclinical, early clinical, preliminary or expected results; significant adverse events, toxicities or other undesirable side effects associated with Lyell's product candidates; the significant uncertainty associated with Lyell's product candidates ever receiving any regulatory approvals; Lyell's ability to obtain, maintain or protect intellectual property rights related to its product candidates; implementation of Lyell's strategic plans for its business and product candidates; the sufficiency of Lyell's capital resources and need for additional capital to achieve its goals; and other risks, including those described under the heading 'Risk Factors' in Lyell's Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on March 11, 2025, and Lyell's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, being filed with the SEC today. Forward-looking statements contained in this press release are made as of this date, and Lyell undertakes no duty to update such information except as required under applicable law. Lyell Immunopharma, Selected Consolidated Financial Data(in thousands) Statement of Operations Data: Three Months Ended March 31, 2025 2024 Revenue $ 7 $ 3 Operating expenses: Research and development(1) 43,447 43,174 General and administrative 14,046 13,494 Other operating income, net (119 ) (1,090 ) Total operating expenses 57,374 55,578 Loss from operations (57,367 ) (55,575 ) Interest income, net 3,862 6,819 Other income, net(1) 1,310 1,090 Impairment of other investments — (13,001 ) Total other income (loss), net 5,172 (5,092 ) Net loss $ (52,195 ) $ (60,667 ) (1) As of October 1, 2024, the Company's success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2025 was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Fred Hutch success payment liabilities was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Balance Sheet Data: As of March 31, As of December 31, 2025 2024 Cash, cash equivalents and marketable securities $ 330,126 $ 383,541 Property and equipment, net $ 44,195 $ 48,200 Total assets $ 429,798 $ 490,859 Total stockholders' equity $ 336,521 $ 382,824 Non-GAAP Financial Measures To supplement our financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), we present non-GAAP net loss, non-GAAP R&D expenses and non-GAAP G&A expenses. Non‑GAAP net loss and non-GAAP R&D expenses exclude non-cash stock-based compensation expense and non-cash expenses related to the change in the estimated fair value of success payment liabilities from GAAP net loss and GAAP R&D expenses. Non-GAAP net loss further adjusts non‑cash investment gains and charges, as applicable. Non‑GAAP G&A expenses exclude non-cash stock-based compensation expense from GAAP G&A expenses. We believe that these non‑GAAP financial measures, when considered together with our financial information prepared in accordance with GAAP, can enhance investors' and analysts' ability to meaningfully compare our results from period to period, and to identify operating trends in our business. We have excluded stock-based compensation expense, changes in the estimated fair value of success payment liabilities, and non-cash investment gains and charges from our non‑GAAP financial measures because they are non-cash gains and charges that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. We also regularly use these non‑GAAP financial measures internally to understand, manage and evaluate our business and to make operating decisions. These non-GAAP financial measures are in addition to, and not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non‑GAAP financial measures have no standardized meaning prescribed by GAAP and are not prepared under any comprehensive set of accounting rules or principles and, therefore, have limits in their usefulness to investors. We encourage investors to carefully consider our results under GAAP, as well as our supplemental non-GAAP financial information, to more fully understand our business. Lyell Immunopharma, Reconciliation of GAAP to Non-GAAP Net Loss(in thousands) Three Months Ended March 31, 2025 2024 Net loss - GAAP $ (52,195 ) $ (60,667 ) Adjustments: Stock-based compensation expense 6,024 9,155 Change in the estimated fair value of success payment liabilities (125 ) 968 Impairment of other investments — 13,001 Net loss - Non-GAAP(1) $ (46,296 ) $ (37,543 ) (1) There was no income tax effect related to the adjustments made to calculate non-GAAP net loss because of the full valuation allowance on our net deferred tax assets for all periods presented. Lyell Immunopharma, Reconciliation of GAAP to Non-GAAP Research and Development Expenses(in thousands) Three Months Ended March 31, 2025 2024 Research and development - GAAP $ 43,447 $ 43,174 Adjustments: Stock-based compensation expense (2,388 ) (3,792 ) Change in the estimated fair value of success payment liabilities(1) — (525 ) Research and development - Non-GAAP $ 41,059 $ 38,857 (1) As of October 1, 2024, the Company's success payment liability was recognized at fair value as Stanford had provided the requisite service obligation to earn the potential success payment consideration. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2025 was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Stanford success payment liabilities in the first quarter of 2024 was recognized within research and development expenses in the Condensed Consolidated Statements of Operations and Comprehensive Loss. The change in the estimated fair value of Fred Hutch success payment liabilities was recognized within other income, net in the Condensed Consolidated Statements of Operations and Comprehensive Loss. Lyell Immunopharma, Reconciliation of GAAP to Non-GAAP General and Administrative Expenses(in thousands) Three Months Ended March 31, 2025 2024 General and administrative - GAAP $ 14,046 $ 13,494 Adjustments: Stock-based compensation expense (3,636 ) (5,363 ) General and administrative - Non-GAAP $ 10,410 $ 8,131 Contact:Ellen RoseSenior Vice President, Communications and Investor Relationserose@
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