Financial Performance - The company reported net losses of $54.8 million and $45.8 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of $235.9 million as of September 30, 2025[85]. - For the three months ended September 30, 2025, total operating expenses decreased by $4.2 million to $23.8 million from $27.9 million in the same period of 2024[106]. - Research and development expenses decreased by $8.5 million to $16.0 million for the three months ended September 30, 2025, primarily due to a decrease in unallocated research and development expenses[107]. - For the nine months ended September 30, 2025, total operating expenses increased by $12.9 million to $65.4 million from $52.4 million in the same period of 2024[111]. - General and administrative expenses increased by $10.9 million to $20.3 million for the nine months ended September 30, 2025, primarily due to increased personnel-related expenses[114]. - Net cash used in operating activities was $49.7 million for the nine months ended September 30, 2025, primarily due to a net loss of $54.8 million[122]. - Interest income increased by $1.1 million to $3.5 million for the three months ended September 30, 2025, driven by increased investment in debt securities[109]. - Interest income increased by $4.0 million to $10.1 million for the nine months ended September 30, 2025, primarily due to increased investment in debt securities[117]. Funding and Capital - The company has raised aggregate net proceeds of $330.4 million from the sale and issuance of preferred stock since its inception in 2019, and $199.6 million from its IPO in February 2025[84]. - Net cash provided by financing activities was $204.1 million during the nine months ended September 30, 2025, primarily due to net proceeds from the IPO[126]. - The company expects existing cash and marketable securities to fund operations into 2028, but will need to raise additional capital in the future[127]. - As of September 30, 2025, the company had $325.0 million in cash, cash equivalents, and marketable securities[120]. Research and Development - The company anticipates that its research and development expenses will increase substantially as it advances its product candidates into later-stage development efforts[96]. - The company has initiated a Phase 2a trial for SION-719 in CF patients, with topline data expected in mid-2026[81]. - The company in-licensed three clinical-stage compounds from AbbVie to expand its portfolio, including galicaftor (SION-2222) which has completed Phase 2 trials[82]. - The company is currently engaged in discovery, preclinical studies, and clinical trials for its product candidates, with ongoing assessments of costs and timelines[129]. Regulatory and Compliance - The company has not generated any revenue to date and does not expect to do so for several years, if ever, pending regulatory approvals for its product candidates[88]. - The company expects general and administrative expenses to increase to support research and development activities and compliance with public company reporting[101]. - The company is classified as an "emerging growth company" and may utilize certain exemptions from reporting requirements until it no longer meets the criteria[136]. - The company will remain an emerging growth company until it achieves total annual gross revenue of at least $1.235 billion or meets other specified conditions[136]. - The company is also classified as a "smaller reporting company," allowing it to take advantage of scaled disclosures until certain revenue and market capitalization thresholds are met[138]. Risks and Uncertainties - The company may face negative impacts on its financial condition if it fails to raise additional funds or enter into strategic agreements[130]. - The company has the potential to delay or limit product development if it is unable to secure additional funding[131]. - The company is required to make estimates and assumptions that affect the reported amounts in its financial statements, which may differ from actual results[133]. - The company has elected to use an extended transition period for complying with new accounting standards, which may affect comparability with other public companies[136]. - There were no material changes to the company's critical accounting estimates during the nine months ended September 30, 2025[134]. - There were no material changes to the company's contractual obligations and commitments during the nine months ended September 30, 2025[132].

Financial Performance - Cash, cash equivalents, and investments totaled $349.0 million as of September 30, 2025, expected to fund operations into mid-2027[15] - Net loss for Q3 2025 was $54.9 million, compared to a net loss of $42.6 million in Q3 2024, indicating a 29% increase in losses year-over-year[15] - For the three months ended September 30, 2025, Centessa Pharmaceuticals reported a net loss of $54,891,000, compared to a net loss of $42,566,000 for the same period in 2024, representing a 29% increase in losses year-over-year[24] - Total assets decreased to $448,300,000 as of September 30, 2025, down from $576,798,000 at the end of 2024, reflecting a 22% decline[26] - Cash and cash equivalents significantly dropped to $50,811,000 from $383,221,000, marking an 87% decrease[26] - The company reported total liabilities of $146,726,000 as of September 30, 2025, down from $175,253,000 at the end of 2024, a reduction of 16%[26] - Interest and investment income for the nine months ended September 30, 2025, was $16,035,000, compared to $9,171,000 in the same period of 2024, showing a 75% increase[24] - The weighted average ordinary shares outstanding increased to 134,163,492 for the three months ended September 30, 2025, compared to 116,253,902 for the same period in 2024, a rise of 15%[24] Research and Development - Research & Development (R&D) expenses were $41.6 million for Q3 2025, up from $33.9 million in Q3 2024, representing a 22% increase[15] - Research and development expenses for the nine months ended September 30, 2025, were $117,747,000, up from $89,370,000 in the same period of 2024, indicating a 32% increase[24] - ORX750 achieved a >20 minute change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT) at Week 2 in the 1.5 mg cohort (p-value = 0.0026)[6] - In the 1.5 mg cohort for NT2, ORX750 showed a mean Epworth Sleepiness Scale (ESS) total score of 5.1 compared to 18.7 with placebo at Week 2 (p-value = 0.0001)[6] - ORX750 demonstrated an 87% relative reduction in Weekly Cataplexy Rate (WCR) in the 1.5 mg cohort compared to placebo (p-value = 0.0025)[6] - ORX142 Phase 1 study included 89 healthy volunteers, showing statistically significant and dose-dependent improvements in mean sleep latency on the MWT[9] - The registrational program for ORX750 is expected to be initiated in Q1 2026[10] - ORX489 is advancing through IND-enabling studies, with clinical studies expected to begin in Q1 2026, subject to IND clearance[15] - The company has ongoing clinical trials for product candidates ORX750, ORX142, and ORX489, with expectations for future results being subject to various risks and uncertainties[20] Funding and Risks - Centessa Pharmaceuticals has a financing facility with Oxford Finance to support its planned clinical trials and other expenses, indicating a focus on securing adequate funding[20] - The company is facing various risks including regulatory, economic, and competitive challenges that could impact its clinical development and commercialization efforts[20] Administrative Expenses - General & Administrative (G&A) expenses were $12.2 million for Q3 2025, slightly down from $12.5 million in Q3 2024[15]

Revenue Performance - Anika reported third quarter revenue from continuing operations of $27.8 million, a 6% decrease compared to the same period in 2024[3]. - Commercial Channel revenue increased 22% year over year to $12.0 million, while OEM Channel revenue decreased 20% to $15.8 million[3][17]. - Regenerative Solutions revenue in the Commercial Channel grew 25% in the quarter, driven by strong performance of the Integrity Implant System and international Hyalofast growth[4]. - International Sales revenue grew 21% year over year, contributing to a year-to-date revenue increase of 6%[6]. - Revenue for the three months ended September 30, 2025, was $27,817 million, a decrease of 6% from $29,559 million in the same period of 2024[25]. - The OEM Channel revenue decreased by 20% to $15,844 million for the three months ended September 30, 2025, compared to $19,764 million in 2024[36]. - The Commercial Channel revenue increased by 22% to $11,973 million for the three months ended September 30, 2025, compared to $9,795 million in 2024[36]. Financial Guidance - Anika maintains its fiscal 2025 revenue guidance, projecting Commercial Channel revenue of $47 to $49.5 million, up 12% to 18% year over year, and OEM Channel revenue of $62 to $65 million, down 16% to 20% year over year[12][17]. Operating Expenses - Operating expenses decreased by 3% year over year to $18.8 million, with Selling, General and Administrative expenses down 12%[4][17]. - Operating expenses totaled $18,817 million for the three months ended September 30, 2025, compared to $19,489 million in 2024, a decrease of 3%[25]. Profitability - Anika reported a loss from continuing operations of $3.2 million, or $0.22 per share, with adjusted net income of $0.7 million, or $0.04 per share[17]. - Gross profit for the three months ended September 30, 2025, was $15,584 million, down from $19,408 million in 2024, reflecting a decline of 20%[25]. - The net loss for the three months ended September 30, 2025, was $2,329 million, significantly improved from a net loss of $29,918 million in the same period of 2024[25]. - Adjusted EBITDA for the three months ended September 30, 2025, was $865 million, down from $4,542 million in 2024[29]. Asset and Liability Management - Total current assets as of September 30, 2025, were $101,590 million, down from $113,652 million as of December 31, 2024[27]. - Total liabilities as of September 30, 2025, were $42,632 million, compared to $48,000 million as of December 31, 2024[27]. - Stockholders' equity decreased to $146,805 million as of September 30, 2025, from $153,989 million as of December 31, 2024[27]. Regulatory and Strategic Developments - Anika submitted the third and final module of the Hyalofast PMA application to the FDA, with positive clinical data released from the Phase III FastTRACK trial[7][8]. - The company is advancing towards filing the NDA for Cingal, with key activities including the completion of a toxicity study and initiation of a bioequivalence study[9]. - The company is commencing a $15 million 10b5-1 share repurchase program, expected to be completed by June 2026[13].

Revenue and Earnings - 3Q 2025 revenues were $790.6 million, an increase from $762.3 million in 2Q 2025 and $735.4 million in 3Q 2024[7] - For the nine months ended September 27, 2025, net revenues were $2.27 billion, compared to $2.22 billion for the same period in 2024[15] - 3Q 2025 GAAP loss per share was $(0.06), while adjusted EPS was $0.04[7] - The company reported a free cash flow of $(142,691,000) for the nine fiscal months ended September 27, 2025, compared to $(67,732,000) for the same period in 2024[20] - The adjusted net earnings for the nine fiscal months ended September 27, 2025, were $(7,600,000), compared to $65,473,000 for the same period in 2024[19] Margins and Ratios - Gross margin for 3Q 2025 was 19.5%, impacted by approximately 150 basis points related to Newport[7] - Operating income for 3Q 2025 was $19.1 million, with an operating margin of 2.4%[14] - Adjusted EBITDA for the nine fiscal months ended September 27, 2025, was $193,972,000, with an adjusted EBITDA margin of 9.6%[21] - Book-to-bill ratio for 3Q 2025 was 0.97, with 0.96 for semiconductors and 0.98 for passive components[7] Assets and Liabilities - Total assets as of September 27, 2025, were $4.20 billion, up from $4.11 billion at the end of 2024[16] - Total current liabilities increased slightly to $710,676,000 in September 2025 from $708,348,000 in December 2024, while total liabilities rose to $2,112,912,000 from $2,081,734,000[17] - The total equity increased to $2,083,064,000 in September 2025 from $2,028,962,000 in December 2024[17] Cash Flow and Expenditures - Cash and cash equivalents decreased to $443.9 million from $590.3 million at the end of 2024[16] - Cash and cash equivalents decreased to $443,858,000 at the end of the period from $590,286,000 at the beginning of the period, reflecting a net decrease of $146,428,000[18] - Capital expenditures for the nine fiscal months ended September 27, 2025, were $178,491,000, compared to $175,175,000 for the same period in 2024[18] Payroll and Expenses - The company experienced a significant increase in payroll and related expenses, rising to $179,492,000 in September 2025 from $137,101,000 in December 2024[17] - The company reported a depreciation and amortization expense of $167,036,000 for the nine fiscal months ended September 27, 2025, compared to $155,272,000 for the same period in 2024[18] Future Outlook - Management expects 4Q 2025 revenues in the range of $790 million +/- $20 million, with a gross profit margin of 19.5% +/- 50 basis points[4] - The backlog at the end of 3Q 2025 was 4.4 months[7]

Financial Performance - Net earnings for Q3 2025 reached $215 million, up from $174 million in Q2 2025, representing a 23.5% increase[3] - Core net operating earnings for Q3 2025 were $224 million, compared to $179 million in Q2 2025, reflecting a 25.1% growth[3] - Diluted earnings per share for Q3 2025 were $2.58, an increase from $2.07 in Q2 2025, which is a 24.6% growth[7] - Annualized return on equity improved to 18.2% in Q3 2025, up from 15.0% in Q2 2025[3] - For the three months ended September 30, 2025, the underwriting profit for Property and Casualty Insurance was $138 million, compared to $113 million for the previous quarter[8] - Underwriting profit for the three months ended September 30, 2025, was $33 million, down from $63 million in the same period last year, showing a decline of 47.6%[13] Premiums and Underwriting - Property and Casualty net written premiums increased to $2,252 million in Q3 2025, up from $1,803 million in Q2 2025, marking a 24.8% rise[3] - Gross written premiums for the Specialty segment reached $3,665 million for the three months ended September 30, 2025, up from $2,653 million in the previous quarter, representing a 38% increase[10] - The net earned premiums for the Specialty segment were $2,013 million for the three months ended September 30, 2025, compared to $1,647 million in the previous quarter, reflecting a 22% increase[10] - The combined ratio for the Property and Transportation segment was 94.1% for the three months ended September 30, 2025, improving from 95.2% in the previous quarter[11] - The combined ratio for the three months ended September 30, 2025, was 95.8%, slightly higher than 91.1% in the same period last year, indicating a deterioration in underwriting performance[13] Investment Income and Assets - Net investment income for Q3 2025 was $205 million, up from $179 million in Q2 2025, reflecting a 14.6% increase[6] - Total assets increased to $33,834 million as of September 30, 2025, compared to $30,669 million at the end of Q2 2025, a growth of 10.7%[3] - Total cash and investments reached $16,761 million as of September 30, 2025, up from $15,852 million at December 31, 2024, marking a 5.7% increase[19] - Total Property & Casualty net investment income for the three months ended September 30, 2025, was $43 million, compared to $8 million in the previous quarter[23] Shareholder Equity and Book Value - Book value per share, excluding AOCI, was $57.59 as of September 30, 2025, compared to $55.74 at the end of Q2 2025, indicating a 3.3% increase[3] - Shareholders' equity as of September 30, 2025, was $4,730 million, a slight decrease from $4,708 million in the same period last year, indicating a decline of 0.5%[15] - The book value per share as of September 30, 2025, was $56.72, up from $56.10 a year ago, representing an increase of 1.1%[16] Debt and Liabilities - Total liabilities increased to $29,104 million as of September 30, 2025, compared to $27,883 million a year ago, reflecting a rise of 4.4%[15] - Total principal amount of long-term debt increased to $1,848 million as of September 30, 2025, up from $1,498 million at December 31, 2024, reflecting a 23.4% increase[17] - The ratio of debt to total capital, excluding accumulated other comprehensive income (AOCI), was 27.8% including subordinated debt and 17.6% excluding subordinated debt as of September 30, 2025[17] Loss Ratios and Catastrophe Losses - The loss and LAE ratio for the Specialty segment was 67.2% for the three months ended September 30, 2025, compared to 61.1% in the previous quarter[10] - Catastrophe losses for the current accident year totaled $23 million for the three months ended September 30, 2025, down from $38 million in the previous quarter[10] - The loss and LAE ratio for the three months ended September 30, 2025, was 66.8%, compared to 63.4% in the same period last year, indicating an increase in loss costs[13] Investment Portfolio - Average yield on the overall investment portfolio, net, was 5.09% for the three months ended September 30, 2025, compared to 4.96% for the three months ended December 31, 2024[20] - The total cash and investments in fixed maturities available for sale was $10,518 million as of September 30, 2025, accounting for 63% of the total investment portfolio[19] - Investment grade securities accounted for 96% of the total fair value of fixed maturities as of September 30, 2025[27] Real Estate Investments - Real estate-related investments accounted for using the equity method total $1,422 million, with multi-family investments making up 88%[39] - The occupancy rate for multi-family investments is 92%, with a collection rate of 96%[39] - The total book value of real estate investments is $1,392 million, with multi-family investments again representing 88%[43]

Revenue Performance - Third-quarter revenue for Charles River Laboratories was $1.00 billion, a decrease of 0.5% from $1.01 billion in Q3 2024[1] - Organic revenue declined by 1.6%, with lower revenue in the Discovery and Safety Assessment (DSA) and Manufacturing Solutions segments, partially offset by growth in the Research Models and Services (RMS) segment[2] - Total revenue for the three months ended September 27, 2025, was $1,004,852,000, a slight decrease of 0.1% compared to $1,009,763,000 for the same period in 2024[26] - Reported revenue growth for the total company in Q3 2025 was a decrease of 0.5%, with the RMS segment growing by 7.9% while the DSA and MS segments declined by 2.3% and 3.1%, respectively[36] - For the nine months ended September 27, 2025, reported revenue growth was a decrease of 0.9%, with the RMS segment growing by 2.4% and the DSA and MS segments declining by 2.0% and 0.8%, respectively[36] Income and Earnings - GAAP net income for Q3 2025 was $54.4 million, or $1.10 per diluted share, down from $68.7 million, or $1.33 per diluted share in Q3 2024[3] - Non-GAAP net income decreased by 10.0% to $120.3 million, with diluted earnings per share of $2.43, a decrease of 6.2% from $2.59 in Q3 2024[4] - Net income attributable to Charles River Laboratories for the three months ended September 27, 2025, was $54,422,000, a decrease of 22% from $69,657,000 in the same period last year[26] - Basic earnings per share for Q3 2025 was $1.11, down from $1.34 in Q3 2024, while diluted earnings per share was $1.10 compared to $1.33 in the prior year[34] - Basic earnings per share, excluding non-GAAP adjustments, was $2.45 for Q3 2025, compared to $2.60 in Q3 2024, indicating a decrease of 5.8%[34] Segment Performance - RMS segment revenue increased by 7.9% to $213.5 million, with organic revenue growth of 6.5% driven by large research model products[6] - DSA segment revenue decreased by 2.3% to $600.7 million, with organic revenue down 3.1% due to lower sales volume[8] - Manufacturing segment revenue decreased by 3.1% to $190.7 million, with organic revenue down 5.1% primarily from lower revenue in CDMO and Biologics Testing[10] - Discovery and Safety Assessment revenue decreased to $600,685,000 for the three months ended September 27, 2025, down from $615,060,000 for the same period in 2024, a decline of 2.3%[29] - Manufacturing Solutions revenue decreased to $190,693,000 for the three months ended September 27, 2025, down from $196,879,000 for the same period in 2024, a decline of 3.1%[30] Guidance and Projections - The company updated its 2025 guidance, narrowing revenue growth expectations to a range of (1.5)% to (0.5)%[12] - Non-GAAP EPS estimate for 2025 is now projected at $10.10 to $10.30, up from the previous range of $9.90 to $10.30[13] Cash Flow and Assets - Cash flows from operating activities for the nine months ended September 27, 2025, were $590,126,000, compared to $575,215,000 for the same period in 2024[28] - Total current assets increased to $1,532,104,000 as of September 27, 2025, from $1,403,071,000 as of December 28, 2024[27] - Long-term debt, net and finance leases, decreased to $2,185,453,000 as of September 27, 2025, from $2,240,205,000 as of December 28, 2024[27] - Cash and cash equivalents increased to $207,097,000 as of September 27, 2025, from $194,606,000 as of December 28, 2024[27] Investment Activities - The company experienced a net cash used in investing activities of $116,514,000 for the nine months ended September 27, 2025, compared to $168,982,000 in the prior year[28] - The company reported a gain of $20.201 million from venture capital and strategic equity investments in Q3 2025, compared to a loss of $2.507 million in Q3 2024[34] Operating Performance - Operating income for the nine months ended September 27, 2025, was $308,602,000, down 21.9% from $395,034,000 in the previous year[26] - The company reported an operating income of $133,799,000 for the three months ended September 27, 2025, which is 13.3% of revenue, compared to 11.6% for the same period in 2024[30] - Non-GAAP operating income for the total company was $197,725,000, which is 19.7% of revenue for the three months ended September 27, 2025, compared to 19.9% for the same period in 2024[30] Strategic Focus - The company remains focused on differentiating itself through innovative solutions and unlocking value in drug development and manufacturing programs[5] - The company intends to continue assessing the potential value of reporting non-GAAP results consistent with applicable rules and regulations[30]

Financial Performance - Net loss for Q3 2025 was $20.3 million, compared to a net loss of $25.4 million in Q3 2024[8] - Total operating expenses for Q3 2025 were $23.8 million, compared to $28.0 million in Q3 2024[15] Research and Development - Research and development expenses for Q3 2025 were $16.0 million, down from $24.6 million in Q3 2024, primarily due to one-time charges in the prior year[7] - Initiated PreciSION CF Phase 2a trial for SION-719 in October 2025, with topline data anticipated in mid-2026[4] - Initiated Phase 1 trial for SION-451 in dual combinations in August 2025, with topline data also expected in mid-2026[4] - The FDA cleared an Investigational New Drug (IND) application for SION-451, supporting its advancement to later-stage development[4] - SION-719 and SION-451 were generally well tolerated in Phase 1 trials, exceeding target exposure levels[5] Administrative Expenses - General and administrative expenses increased to $7.8 million in Q3 2025 from $3.4 million in Q3 2024, mainly due to personnel-related costs and professional fees[8] Cash and Assets - Cash, cash equivalents, and marketable securities totaled $325.0 million as of September 30, 2025, expected to fund operations into 2028[9] - Total assets as of September 30, 2025, were $339.3 million, up from $185.8 million at the end of 2024[17]

Financial Performance - Net income for Q3 2025 was $137 million, a significant increase from $2 million in Q3 2024[3] - Adjusted EBITDA for Q3 2025 was $489 million, compared to $456 million in Q3 2024, with one-time transaction-related expenses of $7 million and $14 million respectively[3] - Distributable Cash Flow, as adjusted, for Q3 2025 was $326 million, down from $349 million in Q3 2024[3] - Net income for the three months ended September 30, 2025, was $137 million, a significant increase from $2 million in the same period of 2024[18] - Adjusted EBITDA for the same period was $489 million, up from $456 million year-over-year, while Adjusted EBITDA excluding transaction-related expenses was $496 million compared to $470 million[18] - Distributable Cash Flow for Q3 2025 was $319 million, slightly down from $335 million in Q3 2024, while Distributable Cash Flow, as adjusted, was $326 million compared to $349 million[18] Segment Performance - Fuel Distribution segment's adjusted EBITDA was $232 million in Q3 2025, down from $253 million in Q3 2024, with fuel margin at 10.7 cents per gallon[3] - Pipeline Systems segment's adjusted EBITDA increased to $182 million in Q3 2025 from $136 million in Q3 2024, with throughput averaging 1.3 million barrels per day[3] - Fuel Distribution segment profit increased to $329 million in Q3 2025 from $164 million in Q3 2024, driven by higher motor fuel gallons sold[27] - Pipeline Systems segment profit rose to $189 million in Q3 2025 from $159 million in Q3 2024, with throughput increasing to 1,296 thousand barrels per day from 1,165 thousand barrels per day[29] - Terminals segment profit increased to $128 million in Q3 2025 from $101 million in Q3 2024, despite a decrease in throughput to 656 thousand barrels per day from 694 thousand barrels per day[32] Capital Expenditures and Debt - Total capital expenditures in Q3 2025 were $157 million, including $115 million for growth capital[8] - Long-term debt as of September 30, 2025, was approximately $9.5 billion, with a leverage ratio of 3.9 times[7] Distributions - Quarterly distribution declared at $0.9202 per unit, representing a 1.25% increase compared to the previous quarter[4] - Since 2022, distributions have increased by approximately 11%, with a target annual growth rate of at least 5% for 2025[5] - Total distributions to partners increased to $168 million in Q3 2025 from $155 million in Q3 2024[18] Acquisitions - The acquisition of Parkland Corporation has been completed, and the acquisition of TanQuid is expected to be finalized in Q4 2025[7] Transaction-related Expenses - Transaction-related expenses decreased to $7 million in Q3 2025 from $14 million in Q3 2024[24] Motor Fuel Sales - Motor fuel gallons sold increased to 2,295 million in Q3 2025 from 2,138 million in Q3 2024, although motor fuel profit per gallon decreased to 10.7 cents from 12.8 cents[28]

Financial Position - The company has an accumulated deficit of $246.8 million as of September 30, 2025, and expects to continue incurring losses for the foreseeable future [98]. - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $117.6 million, expected to fund operations into the first half of 2028 [99][100]. - The company reported an accumulated deficit of $246.8 million as of September 30, 2025, and anticipates continued significant operating losses in the foreseeable future [132]. - The company has no committed sources of capital and plans to finance future cash needs primarily through equity offerings and debt financings [134]. Revenue Generation - The company has not generated any revenue to date and does not expect to do so until regulatory approval for its ecDTx is obtained [101]. - The company expects to incur significant commercialization expenses if regulatory approval for any ecDTx is obtained, impacting future financial performance [132]. Fundraising and Cash Flow - The company raised a total of $353.8 million to fund operations, including $100.0 million from its IPO in April 2024 [99]. - The company entered into an Open Market Sale Agreement in April 2025, allowing for potential future sales of common stock [130]. - Net cash used in operating activities was $36.6 million for the nine months ended September 30, 2025, a decrease from $45.3 million in the same period of 2024, primarily due to reduced third-party spending [136]. - Financing activities provided net cash of $0.1 million during the nine months ended September 30, 2025, significantly lower than $89.7 million in the same period of 2024, primarily due to IPO proceeds [139]. Operating Expenses - Research and development (R&D) expenses decreased to $10.7 million for the three months ended September 30, 2025, down from $14.1 million in 2024, a reduction of $3.4 million [121]. - General and administrative (G&A) expenses were $4.5 million for the three months ended September 30, 2025, compared to $4.6 million in 2024, reflecting a decrease of $0.2 million [122]. - Total operating expenses for the three months ended September 30, 2025, were $15.1 million, down from $18.7 million in 2024, a decrease of $3.6 million [120]. - For the nine months ended September 30, 2025, R&D expenses totaled $35.0 million, down from $42.0 million in 2024, a decrease of $6.9 million [126]. - G&A expenses for the nine months ended September 30, 2025, increased to $14.5 million from $13.0 million in 2024, an increase of $1.5 million [127]. - Total operating expenses for the nine months ended September 30, 2025, were $49.6 million, down from $55.0 million in 2024, a decrease of $5.4 million [125]. - Other income, net for the three months ended September 30, 2025, was $1.3 million, down from $2.2 million in 2024, a decrease of $0.9 million [123]. Clinical Trials and Development - The company opened the BBI-355/BBI-825 combination arm of the POTENTIATE trial for enrollment in Q3 2025, with initial proof-of-concept data expected within the existing cash runway timeline [93]. - The company plans to submit an IND for BBI-940 in the first half of 2026 and anticipates delivering initial proof-of-concept clinical data within the existing cash runway timeline [94]. - The company has developed an ecDNA diagnostic called ECHO to detect ecDNA in patient tumor samples, currently used in the POTENTIATE trial [95]. - The company discontinued the monotherapy arm and combination arms of BBI-355 with third-party therapies in the POTENTIATE trial based on initial data, focusing on BBI-355 in combination with BBI-825 [96]. - The company has incurred substantial costs related to clinical trials, preclinical studies, and research and development activities, with cash flow fluctuations expected based on these activities [136]. Risks and Uncertainties - The company faces significant risks from macroeconomic and regulatory uncertainties that could adversely affect its operations and ability to raise capital [105][106]. - The company remains classified as an emerging growth company, allowing it to delay compliance with certain accounting standards until it meets specific revenue or market value thresholds [145]. Lease Obligations - Future minimum lease payment obligations under a non-cancellable lease agreement total $71.6 million as of September 30, 2025, with base rent payments commencing in July 2025 [140].

Financial Performance - As of September 30, 2025, the company reported net losses of $33.7 million for the three months ended September 30, 2025, compared to $16.0 million for the same period in 2024, indicating a 110.6% increase in losses year-over-year[114] - The company has incurred significant net operating losses and negative cash flows since inception, with net losses of $101.0 million for the nine months ended September 30, 2025, compared to $41.6 million for the same period in 2024, representing a 142.4% increase[114] - The net loss for the nine months ended September 30, 2025, was $101.0 million, compared to a net loss of $41.6 million in 2024, reflecting an increase of 143.0%[153] Revenue and Collaboration - The company has not generated any revenue from product sales since inception and does not expect to do so in the foreseeable future, relying instead on collaboration revenue from the Maruho License Agreement[129] - During the nine months ended September 30, 2025, the company received $2.1 million from Maruho, compared to $1.2 million during the same period in 2024, reflecting a 75% increase[127] - Collaboration revenue for the three months ended September 30, 2025, was $0.7 million, an increase of 12.5% from $0.6 million in the same period of 2024[146] - For the nine months ended September 30, 2025, collaboration revenue was $2.2 million, up 24.4% from $1.8 million in 2024[154] Expenses - Research and development expenses for the three months ended September 30, 2025, were $33.0 million, up 113.6% from $15.4 million in 2024, primarily due to increased costs associated with the verekitug program[147] - Research and development expenses for the nine months ended September 30, 2025, totaled $96.6 million, a 134.7% increase from $41.2 million in 2024, driven by higher costs in the verekitug program[155] - General and administrative expenses increased to $5.5 million for the three months ended September 30, 2025, compared to $4.1 million in 2024, reflecting a rise of 36.3% driven by higher personnel costs[151] - General and administrative expenses totaled $19.7 million for the nine months ended September 30, 2025, up from $12.0 million in 2024, reflecting a $7.7 million increase[159][160] - Total operating expenses for the nine months ended September 30, 2025, were $116.4 million, a significant increase of 118.9% from $53.2 million in 2024[153] Cash and Investments - The company has an accumulated deficit of $291.8 million and cash, cash equivalents, and short-term investments totaling $372.4 million as of September 30, 2025, which is expected to fund operations through 2027[114] - Net cash used in operating activities was $102.6 million for the nine months ended September 30, 2025, compared to $39.6 million in 2024[164][165] - Net cash used in investing activities was $152.4 million for the nine months ended September 30, 2025, compared to $101.4 million in 2024[168][169] - Interest income rose to $4.1 million for the three months ended September 30, 2025, a 41.4% increase from $2.9 million in 2024, attributed to higher balances in investments[152] - Interest income increased to $13.3 million for the nine months ended September 30, 2025, compared to $7.0 million in 2024, an increase of $6.3 million[162] Future Expectations - The company expects general and administrative expenses to rise as it increases headcount and expands infrastructure to support ongoing research and development[137] - The company anticipates increased R&D and administrative expenses as it advances verekitug through clinical trials and potential future product candidates[172] - The company expects to fund operations through a combination of equity offerings, debt financings, and collaborations, as it does not expect to generate revenue from product sales for several years[172][175] Clinical Development - The company reported positive top-line results in the Phase 2 trial for chronic rhinosinusitis with nasal polyps (CRSwNP) in September 2025 and anticipates reporting data from the severe asthma Phase 2 trial in Q1 2026[112] - Research and development expenses are expected to increase significantly as the company advances verekitug through clinical trials, with costs associated with later-stage trials generally being higher[131] - The company has incurred approximately $86.8 million in direct external expenses for the development of verekitug for severe asthma, COPD, and CRSwNP since their development candidate nominations[158] Agreements and Royalties - The company is required to pay mid-single-digit percentage royalties on aggregate worldwide net sales of any product developed that contains the compound verekitug as an ingredient[124] - The company has entered into multiple agreements, including the Astellas Asset Purchase Agreement and the Maruho License Agreement, to support the development and commercialization of verekitug[120][125] Company Classification - The company is classified as an "emerging growth company" under the JOBS Act, allowing it to adopt new accounting standards at the same time as private companies[190] - The company is also a "smaller reporting company," which may continue if its market value is below $250 million or annual revenue is below $100 million[191] - As a smaller reporting company, the company can present only the two most recent fiscal years of audited financial statements in its Annual Report on Form 10-K[191] - The company has reduced disclosure obligations regarding executive compensation due to its status as a smaller reporting company[191] - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company[192]