Store cookies being recalled for possible wood contamination. What to know
A Canadian manufacturer is recalling hundreds of cases of sugar cookies sold at Target due to potential contamination of a "foreign material," according to a Food and Drug Administration notice.
The voluntary recall was initiated on July 22 and categorized as a Class II recall on Aug. 4. The 803 recalled cases were distributed across 20 states and Washington, D.C.
The Favorite Day Bakery Frosted Sugar Cookies, 10 count, were distributed by Target and produced in Canada.
The recalled cases have a net weight of 13.5 oz (383g), a unique product code of 85239-41250 3 and a lot code of 25195.
The FDA says the cookies' Best By Date can vary, as they were applied by retailers after being removed from the freezer.
The cookies were shipped to three distribution centers in Connecticut, Maryland and Ohio and sold at retail stores in the following states:
The cookies are being recalled due to a possible contamination of wood.
The administration defines a Class II recall as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote."
This is the second most serious type of recall, just under a Class I recall, according to the administration.
The FDA recommends that consumers who purchased recalled products do the following:
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Denali Therapeutics Reports Second Quarter 2025 Financial Results and Business Highlights
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'The FDA's priority review of our BLA for tividenofusp alfa and alignment on an accelerated approval path for DNL126 are key milestones highlighting the potential of our Transport Vehicle (TV) platform to catalyze a new class of blood-brain barrier-crossing therapeutics,' said Ryan Watts, Ph.D., CEO of Denali Therapeutics. 'With launch readiness in motion and a growing portfolio of TV-enabled enzyme, antibody, and oligonucleotide programs, Denali is poised to deliver meaningful treatments for people living with lysosomal, neurodegenerative, and other serious diseases.' Second Quarter 2025 and Recent Program Updates CLINICAL PROGRAMS Tividenofusp alfa (DNL310, ETV:IDS) for Hunter syndrome (MPS II) In July 2025, Denali announced that the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for tividenofusp alfa for priority review, assigning a Prescription Drug User Fee Act (PDUFA) target action date of January 5, 2026. The BLA seeks accelerated approval based on a data package including results from the Phase 1/2 study in individuals with Hunter syndrome. Tividenofusp alfa is an investigational, next-generation enzyme replacement therapy designed to cross the blood-brain barrier (BBB) and deliver the iduronate-2-sulfatase (IDS) enzyme throughout the body and brain. The FDA previously granted tividenofusp alfa Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Denali continues to prepare for commercial launch and is conducting the Phase 2/3 COMPASS study to support global regulatory submissions. DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA) Today, Denali announced that it has reached alignment with the FDA's Center for Drug Evaluation and Research (CDER) that cerebrospinal fluid heparan sulfate (CSF HS) may be considered a reasonably likely surrogate endpoint to predict clinical benefit and may therefore be used to support accelerated approval of DNL126 for MPS IIIA. Additional 49-week data from the ongoing open-label Phase 1/2 study are consistent with previously announced 25-week data, demonstrating a significant reduction in CSF HS from baseline, including normalization, and a safety profile that supports continued development. Enrollment in the Phase 1/2 study is nearly complete, and planning is underway for a confirmatory global Phase 3 study. TAK-594/DNL593 (PTV:PGRN) for GRN-related frontotemporal dementia Denali and Takeda continue their collaboration to develop DNL593, an investigational therapeutic designed to deliver progranulin across the BBB for the treatment of granulin (GRN) mutation-associated frontotemporal dementia (FTD-GRN). A Phase 1/2 study is ongoing. BIIB122/DNL151 (small molecule LRRK2 inhibitor) for the treatment of Parkinson's disease (PD) Denali and Biogen are co-developing LRRK2 inhibitors for Parkinson's disease. In May 2025, Biogen announced that the Phase 2b LUMA study of BIIB122 completed enrollment, with a readout expected in 2026. Denali is also conducting the Phase 2a BEACON study focused on LRRK2-associated PD. IND-ENABLING STAGE PROGRAMS Denali expects to submit regulatory applications to begin clinical testing of one to two TV-enabled programs each year over the next three years across its Enzyme TV (ETV), Antibody TV (ATV), and Oligonucleotide TV (OTV) franchises. The most advanced programs include: DNL952 (ETV:GAA) for Pompe disease; DNL111 (ETV:GCase) for Parkinson's/Gaucher disease; DNL622 (ETV:IDUA) for MPS I; DNL921 (ATV:Abeta) for Alzheimer's disease; DNL628 (OTV:MAPT) for Alzheimer's disease; and DNL422 (OTV:SNCA) for Parkinson's disease. Denali announced publication of preclinical data on ATV:Abeta in the August 7, 2025, issue of the journal Science. The research demonstrated that delivering an anti-amyloid beta antibody across the BBB using Denali's TV platform improved brain distribution and reduced the risk of amyloid-related imaging abnormality (ARIA) in a mouse model of Alzheimer's disease, compared to conventional antibody treatment. The findings suggest that TV platform-enabled brain delivery of immunotherapy bypasses amyloid-laden large vessels by traveling through smaller capillaries, offering a potential strategy to mitigate ARIA risk seen with first-generation anti-amyloid therapies. The Science article can be accessed here. Participation in Upcoming Investor Conferences Cantor Global Healthcare Conference 2025, September 3 - 5 (New York City) Morgan Stanley 23rd Annual Global Healthcare Conference, September 8 - 10 (New York City) Baird 2025 Global Healthcare Conference, September 9 - 10 (New York City) H.C. Wainwright 27th Annual Global Investment Conference, September 8 - 10 (New York City) Deutsche Bank BioPharm Corporate Day, September 18 - 19 (Austria) Stifel 2025 Healthcare Conference, November 11 - 13 (New York City) Jefferies Global Healthcare Conference, November 17 - 20 (London) Second Quarter 2025 Financial Results Net loss was $124.1 million for the quarter ended June 30, 2025, compared to net loss of $99.0 million for the quarter ended June 30, 2024. Total research and development expenses were $102.7 million for the quarter ended June 30, 2025, compared to $91.4 million for the quarter ended June 30, 2024. The increase of approximately $11.3 million was attributable to an increase of $7.3 million in TV program external research and development expenses, primarily driven by increased spend on multiple preclinical programs, and increases of $7.6 million and $6.2 million in other research and development expenses and personnel-related expenses, respectively, both driven by the commencement of operations at Denali's large molecule manufacturing facility in Salt Lake City, Utah. These increases were partially offset by a $9.8 million decrease in small molecule programs, primarily due to the winding down of activities related to the Phase 2/3 HEALEY ALS Platform Trial. General and administrative expenses were $32.3 million for the quarter ended June 30, 2025, compared to $25.2 million for the quarter ended June 30, 2024. The increase of $7.1 million was primarily driven by activities related to preparations for a potential commercial launch for tividenofusp alfa. Cash, cash equivalents, and marketable securities were approximately $977.4 million as of June 30, 2025. About Denali Therapeutics Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for the treatment of neurodegenerative diseases and lysosomal storage diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB, and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For additional information, please visit Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding expectations for Denali's TV platform and its therapeutics and commercial potential; statements made by Denali's Chief Executive Officer; plans, timelines, and expectations relating to DNL310, including the PDUFA target action date and the timing, likelihood of, and scope of regulatory approval, the ongoing global Phase 2/3 COMPASS study and the likelihood of global approvals, and planned commercial launch; plans, timelines, and expectations related to DNL126, including enrollment in the ongoing Phase 1/2 study, plans regarding the confirmatory global Phase 3 study, planned engagement with the FDA, and the likelihood and scope of regulatory approvals; plans regarding DNL593 and the ongoing Phase 1/2 study; plans, timelines, and expectations regarding DNL151, including with respect to the ongoing Phase 2b LUMA study and the timing and likelihood of readout, and the ongoing Phase 2a BEACON study; plans and expectations for Denali's preclinical programs, including the timing of advancement to clinical studies; the findings from Denali's recent Science publication and their therapeutic potential regarding ARIA risk; Denali's participation in upcoming investor conferences; and Denali's future operating expenses and anticipated cash runway. All drugs currently being developed by Denali are investigational and have not received regulatory approval for any indication. Actual results are subject to risks and uncertainties and may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to, risks related to: the impact of adverse economic conditions, tariffs, and inflation on Denali's business and operations; the occurrence of any event, change, or other circumstance that could give rise to the termination of Denali's agreements with Sanofi, Takeda, Biogen, or other collaborators; Denali's transition to a late-stage clinical drug development company; Denali's and its collaborators' ability to complete the development and, if approved, commercialization of its product candidates; Denali's and its collaborators' ability to enroll patients in its ongoing and future clinical trials; Denali's reliance on third parties for the manufacture and supply of its product candidates for clinical trials; Denali's dependence on successful development of its blood-brain barrier platform technology and its programs and product candidates; Denali's and its collaborators' ability to conduct or complete clinical trials on expected timelines; the risk that preclinical profiles of Denali's product candidates may not translate in clinical trials; the potential for clinical trials to differ from preclinical, early clinical, preliminary or expected results; the risk of significant adverse events, toxicities, or other undesirable side effects; the uncertainty that product candidates will receive regulatory approval necessary to be commercialized; Denali's ability to continue to create a pipeline of product candidates or commercialize products; developments relating to Denali's competitors and its industry, including competing product candidates and therapies; Denali's ability to obtain, maintain, or protect intellectual property rights related to its product candidates; implementation of Denali's strategic plans for its business, product candidates, and blood-brain barrier platform technology; Denali's ability to obtain additional capital to finance its operations, as needed; Denali's ability to accurately forecast future financial results and hedge against financial risk in the current environment; and other risks and uncertainties, including those described in Denali's most recent Annual Report and Quarterly Reports on Forms 10-K and 10-Q filed with the Securities and Exchange Commission (SEC) on February 27, 2025 and May 6, 2025, and Denali's future reports to be filed with the SEC. Denali does not undertake any obligation to update or revise any forward-looking statements, to conform these statements to actual results, or to make changes in Denali's expectations, except as required by law. Denali Therapeutics Consolidated Statements of Operations(Unaudited)(In thousands, except share and per share amounts) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 Operating expenses: Research and development $ 102,696 $ 91,399 218,923 198,415 General and administrative 32,267 25,194 61,620 50,430 Total operating expenses 134,963 116,593 280,543 248,845 Gain from divestiture of small molecule programs — — — 14,537 Loss from operations (134,963 ) (116,593 ) (280,543 ) (234,308 ) Interest and other income, net 10,844 17,567 23,454 33,480 Net loss $ (124,119 ) $ (99,026 ) $ (257,089 ) $ (200,828 ) Net loss per share, basic and diluted $ (0.72 ) $ (0.59 ) $ (1.50 ) $ (1.26 ) Weighted average number of shares outstanding, basic and diluted 171,449,847 168,831,329 171,336,568 159,117,759 Denali Therapeutics Consolidated Balance Sheets(Unaudited)(In thousands) June 30, 2025 December 31, 2024 Assets Current assets: Cash and cash equivalents $ 141,207 $ 174,960 Short-term marketable securities 757,745 657,371 Prepaid expenses and other current assets 35,754 32,105 Total current assets 934,706 864,436 Long-term marketable securities 78,463 359,373 Property and equipment, net 58,717 55,236 Finance lease right-of-use asset 50,363 47,533 Operating lease right-of-use asset 21,022 22,861 Other non-current assets 22,970 24,741 Total assets $ 1,166,241 $ 1,374,180 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 10,844 $ 11,137 Accrued compensation 12,068 24,728 Accrued clinical and other research & development costs 23,379 22,822 Accrued manufacturing costs 9,028 12,779 Operating lease liability, current 8,871 8,308 Deferred research and development funding liability, current 19,861 14,129 Other accrued costs and current liabilities 7,006 8,305 Total current liabilities 91,057 102,208 Operating lease liability, less current portion 32,110 36,673 Finance lease liability, less current portion 5,577 5,615 Deferred research funding and development liability, less current portion 10,444 — Total liabilities 139,188 144,496 Total stockholders' equity 1,027,053 1,229,684 Total liabilities and stockholders' equity $ 1,166,241 $ 1,374,180 Investor Contact:Laura Hansen, Media Contact:Erin Pattonepatton@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
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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
Business Wire
14 minutes ago
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Quince Therapeutics Provides Business Update and Reports Second Quarter 2025 Financial Results
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, today provided an update on the company's development pipeline and reported financial results for the second quarter ended June 30, 2025. Dirk Thye, M.D., Quince's Chief Executive Officer and Chief Medical Officer, said, 'We achieved many critical milestones over the last quarter that significantly advance our research programs and strengthen our business model. Specifically, we completed enrollment in our pivotal Phase 3 NEAT clinical trial, secured additional financing to extend our operating runway sufficiently beyond topline results, and solidified our commercial development planning through our strategic partnership with Option Care Health. Quince remains confident in our ability to deliver topline results in the first quarter of 2026 and subsequent NDA submission in the second half of 2026, assuming positive study results.' Pivotal Phase 3 NEAT Clinical Trial Quince completed enrollment in its pivotal Phase 3 NEAT (N eurological E ffects of eDSP on Subjects with A - T; NCT06193200 / IEDAT-04-2022) clinical trial with a total of 105 participants, including 83 participants in the six to nine year-old primary analysis population and 22 participants aged 10 years and older. Quince expects to report topline results from its Phase 3 NEAT clinical trial in the first quarter of 2026. Concluding the NEAT study with 83 enrolled participants in the six to nine year-old primary analysis population reflects powering of approximately 90% to determine statistical significance of the primary endpoint. All 50 NEAT participants to date have elected to transition to the open label extension (OLE) study (NCT06664853 / IEDAT-04-2022). Participants who complete the full treatment period, complete study assessments, and provide informed consent are eligible to transition to the OLE study. The Phase 3 NEAT clinical trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). Assuming positive study results, the company plans to submit a New Drug Application (NDA) to the FDA in the second half of 2026. Quince was granted FDA Fast Track designation for the company's eDSP System for the treatment of patients with A-T based on the potential to address a high unmet medical need. NEAT is an international, multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the neurological effects of Quince's lead asset, eDSP (dexamethasone sodium phosphate [DSP] encapsulated in autologous red blood cells; previously referred to as EryDex) in patients with A-T. Participants are randomized (1:1) between eDSP or placebo and treatment consists of six infusions scheduled once every 21 to 30 days. The primary efficacy endpoint will be measured by the change from baseline to last efficacy visit using the Rescored modified International Cooperative Ataxia Rating Scale (RmICARS) compared to placebo. Pipeline and Corporate Updates Announced a strategic relationship with Option Care Health, Inc. (Nasdaq: OPCH), the nation's largest independent provider of home and ambulatory infusion services, to support the commercial development and efficient launch of Quince's lead asset, eDSP, in the U.S. The strategic relationship will leverage Option Care's robust network of specialty pharmacy and ambulatory infusion suites to provide for the administration of eDSP in an effective and efficient way while delivering this innovative treatment to patients with greater geographic flexibility. Closed a private placement of common stock and accompanying warrants in June 2025 led by healthcare-focused institutional investor Nantahala Capital with participation from existing Quince stockholders including ADAR1 Capital Management, Legend Capital Partners, and Lagfin S.C.A., new stockholder Second Line Capital, along with members of Quince's senior management. Priced at a more than a 10% premium to the market price of Quince's common stock, the financing resulted in approximately $11.5 million in upfront proceeds and potential additional proceeds of up to $10.4 million, if the accompanying warrants are exercised in full, before deducting placement agent fees and other private placement expenses. Finalized Phase 2 clinical trial study designs to evaluate eDSP for the potential treatment of patients with Duchenne muscular dystrophy (DMD), the company's second targeted indication for its lead asset, eDSP. Quince plans to prioritize capital efficient study approaches, including potential investigator-initiated trials (IITs), to advance the evaluation of DMD as a second targeted eDSP indication. Initiated Study #3 in the company's European Union pediatric investigational plan (PIP) – named the P ediatric E ncapsulated D examethasone Sodium Phosphate (PeD) study – to evaluate the safety and pharmacokinetics of eDSP in younger patients with A-T who weigh between nine and 15 kilograms. Participated at the 2025 A-T Clinical Research Conference organized by the A-T Society, a leading A-T patient advocacy group based in the United Kingdom, where key opinion leaders (KOLs) presented post hoc data analyses from the company's prior Phase 3 ATTeST clinical trial, in addition to Quince management providing an overview of the Phase 3 NEAT clinical trial. Appointed Dr. Hassan Abolhassani, Assistant Professor of Clinical Immunology and Research Specialists in the Department of Medical Biochemistry and Biophysics at the Karolinska Institutet in Stockholm, Sweden, to the company's Scientific Advisory Board (SAB). Dr. Abolhassani becomes the ninth member to join Quince's SAB, which is comprised of leading experts in A-T, biochemistry, neurology, immunology, genetic, hematology, pharmacology, and clinical practice. Second Quarter 2025 Financial Results Reported cash, cash equivalents, and short-term investments of $34.7 million for the second quarter ended June 30, 2025. Quince expects its existing cash runway to be sufficient to fund the company's capital efficient development plan through Phase 3 NEAT topline results into the second quarter of 2026. If warrants related to the company's recent financing are exercised in full for cash, Quince's cash runway would extend into the second half of 2026. Reported research and development (R&D) expenses of $6.6 million for the second quarter ended June 30, 2025. R&D expenses primarily included costs related to ongoing Phase 3 NEAT clinical trial activities and related manufacturing costs. Reported general and administrative (G&A) expenses of $3.3 million for the second quarter ended June 30, 2025. G&A expenses primarily included personnel-related and stock-based compensation expenses, commercial planning and new product planning expenses, and other professional administrative costs. Reported a net loss of $16.1 million, or a net loss of $0.34 per basic and diluted share, for the second quarter ended June 30, 2025. Weighted average shares outstanding for the year were 46.7 million. Reported net cash used in operating activities of $21.0 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to net loss of $31.1 million for the period, adjusted for $9.9 million of non-cash items, including $4.5 million change in the fair value of warrants, $2.7 million in stock-based compensation, $2.5 million change in the fair value of contingent consideration liabilities, $0.8 million change in the fair value of the European Investment Bank loan, and a net decrease in operating assets of $0.5 million, offset by a net increase in accounts payable, and accrued expenses, and other current liabilities of $0.3 million. About Quince Therapeutics Quince Therapeutics, Inc. (Nasdaq: QNCX) is a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases. For more information on the company and its latest news, visit and follow Quince on social media platforms LinkedIn, Facebook, X, and YouTube. Forward-looking Statements Statements in this news release contain 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 as contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the 'safe harbor' created by those sections. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements contained in this news release may be identified by the use of words such as 'believe,' 'may,' 'should,' 'expect,' 'anticipate,' 'plan,' 'believe,' 'estimated,' 'potential,' 'intend,' 'will,' 'can,' 'seek,' or other similar words. Examples of forward-looking statements include, among others, statements relating to the timing, success, and reporting of results of the clinical trials and related data, including expected timing of Phase 3 NEAT topline results and submission of a related NDA; expected cash position and operating runway, including cash potentially receivable upon the exercise of warrants; current and future clinical development of eDSP, including for the potential treatment of Ataxia-Telangiectasia (A-T), Duchenne muscular dystrophy (DMD), and other potential indications; the strategic development path for eDSP, including the anticipated benefits of the strategic partnership with Option Care Health; planned regulatory agency submissions and clinical trials and timeline, prospects, and milestone expectations; and the potential benefits of eDSP and the company's market opportunity. Forward-looking statements are based on Quince's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict and could cause actual results to differ materially from what the company expects. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, but are not limited to, the risks and uncertainties described in the section titled 'Risk Factors' in the company's Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 24, 2025, Quarterly Report on Form 10-Q filed with the SEC on May 13, 2025, and other reports as filed with the SEC. Forward-looking statements contained in this news release are made as of this date, and Quince undertakes no duty to update such information except as required under applicable law.
