Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________ to _______________ Commission file number: 001-35994 Scorpius Holdings, Inc. (Exact name of registrant as specified in its charter) Delaware (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended J ...

Revenue and Operations - The company generated minimal revenue of $0.2 million for the three months ended June 30, 2025, a decrease of $0.6 million compared to the same period in 2024, due to the cancellation or suspension of four customer contracts [159]. - Revenue decreased by $3.9 million to $0.4 million for the six months ended June 30, 2025, compared to the same period in 2024, primarily due to the loss of a major customer [166]. - The company has ceased operations as of the filing date of the Quarterly Report, with no current business activities being conducted [131]. - The company does not expect to generate revenue unless a strategic transaction, such as a merger or asset acquisition, is consummated [158]. - The company has ceased operations and does not anticipate generating any revenue for the remainder of 2025 [166][177]. Financial Position - The outstanding amount of the December 2024 Secured Convertible Notes was $14,460,205 as of January 12, 2026, including principal, accrued interest, and other fees [138]. - The company received a notice of default on September 9, 2025, due to failure to maintain an effective registration statement and other compliance issues, leading to $19,376,084 being due under the December 2024 Secured Convertible Notes [135][137]. - As of June 30, 2025, the company had approximately $0.5 million in cash and cash equivalents, which decreased to less than $0.1 million by January 12, 2026 [174][189]. - The accumulated deficit reached approximately $302.0 million through June 30, 2025 [175]. Expenses and Losses - Cost of revenues decreased by $1.2 million to $0.6 million for the six months ended June 30, 2025, attributed to lower production levels [167]. - Research and development expenses decreased by $1.5 million to $6.0 million for the six months ended June 30, 2025, compared to the same period in 2024 [168]. - Selling, general and administrative expenses decreased by $3.0 million to $7.0 million for the six months ended June 30, 2025, due to cost-cutting measures [169]. - The company incurred a net loss of $15.6 million for the six months ended June 30, 2025 [186]. Strategic Actions - The company sold its CDMO biomanufacturing facility assets for $16,253,147 on December 10, 2025, resulting in nominal operations and assets, classifying it as a "Shell Company" [129][130]. - The company has entered into a twelve-month credit facility to borrow up to $5.0 million, with terms similar to existing non-convertible promissory notes [149]. - The company anticipates potential bankruptcy or liquidation if it cannot secure financing or a strategic alternative [158]. - The company is exploring strategic alternatives to raise capital and avoid bankruptcy [178][186]. Stock and Compliance - The company issued 48,755,000 shares of common stock at a price of $0.04 per share, raising $1,942,650 in a private placement on April 30, 2025 [151]. - The company’s common stock was delisted from the NYSE American on May 1, 2025, due to non-compliance with listing standards and began trading on the OTC Markets Pink Limited exchange [153][155].

Financial Projections - Net revenue for Q4 2025 is expected to be between $1.46 billion and $1.47 billion, with full year 2025 net revenue projected between $5.645 billion and $5.655 billion[3]. - GAAP net income for Q4 2025 is anticipated to be between $59.1 million and $62.4 million, while full year 2025 GAAP net income is expected to range from $208.2 million to $211.5 million[3]. - Adjusted diluted EPS for Q4 2025 is projected to be between $0.46 and $0.49, and for full year 2025, it is expected to be between $1.72 and $1.76[3]. - Adjusted EBITDA for Q4 2025 is expected to be between $123.7 million and $127.7 million, while for full year 2025, it is projected to be between $469.0 million and $473.0 million[3]. - Cash flow from operations is expected to be below $320 million for full year 2025[3]. - Preliminary financial guidance for full year 2026 includes net revenue expected to be between $5.8 billion and $6.0 billion, with adjusted diluted EPS projected between $1.82 and $1.92[3]. Share Repurchase Program - The company has expanded its share repurchase program authorization from $500 million to $1.0 billion, with approximately $95 million repurchased in Q4 2025 and $307 million for the full year 2025[4][5]. Future Events - The company will provide further details on its full year 2026 financial guidance during the fourth quarter earnings call in February[2]. - The company is participating in the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026, to present its financial outlook[6]. Financial Data Disclaimer - The preliminary financial data is subject to completion of year-end close procedures and may change before finalization[12].

Financial Results - Allurion Technologies, Inc. announced preliminary financial results for Q4 and the year ended December 31, 2025[7]. - The financial results include selected preliminary data, but specific figures are not disclosed in the provided content[7]. - The report does not include detailed user data or future guidance[8]. Company Classification and Compliance - The company is classified as an emerging growth company under the Securities Act of 1933[6]. - The filing is intended to satisfy the requirements of the Securities Exchange Act of 1934[8]. - The company has not opted to use the extended transition period for new financial accounting standards[6]. Stock Information - The common stock of Allurion is traded on the New York Stock Exchange under the symbol ALUR[5]. Press Release and Signatory - The press release detailing financial results was issued on January 12, 2026[7]. - The report was signed by Brendan Gibbons, Chief Legal and People Officer[13]. Product and Market Information - There is no mention of new products, technologies, market expansion, or acquisitions in the available content[8].

Revenue Performance - Preliminary, unaudited ORLADEYO net revenue for Q4 2025 was $151 million, representing a 22% year-over-year increase and a 36% increase on a comparable basis, excluding European ORLADEYO revenue for Q4 2024[12] - Preliminary, unaudited ORLADEYO net revenue for the full year 2025 was $601 million, reflecting a 37% year-over-year growth; excluding European ORLADEYO revenue, the net revenue was $563 million, marking a 43% increase on a comparable basis[12] Financial Position - As of December 31, 2025, the company reported preliminary, unaudited cash, cash equivalents, restricted cash, and investments totaling $338 million[12]

Financial Results - Health Catalyst, Inc. published preliminary unaudited estimated financial results for 2025 on January 12, 2026[4] - The financial results are subject to change upon completion of the company's accounting and annual audit procedures[4] - Additional information and disclosures will be required for a complete understanding of the company's financial condition as of December 31, 2025[4]

Financial Performance - Exelixis reported preliminary U.S. net product revenues of approximately $2.123 billion for fiscal year 2025[1]. - The company provided fiscal year 2026 net product revenues guidance of $2.325 billion to $2.425 billion[2]. - Total revenues for fiscal year 2025 are estimated at around $2.320 billion, with guidance for 2026 set at $2.525 billion to $2.625 billion[4]. - The effective tax rate for fiscal year 2026 is projected to be between 21% and 23%[4]. - Exelixis' preliminary financial results for FY 2025 are being finalized, with the company cautioning that these results are based on preliminary information and may differ from audited results[22]. Research and Development - Research and development expenses for fiscal year 2025 are approximately $825 million, with guidance for 2026 ranging from $875 million to $925 million[4]. - Exelixis anticipates continued growth in the cabozantinib franchise, which is the leading tyrosine kinase inhibitor in renal cell carcinoma and neuroendocrine tumors[8]. - The company expects to initiate the STELLAR-316 trial in mid-2026, evaluating zanzalintinib in patients with resected stage II/III colorectal cancer[14]. - Exelixis plans to advance two programs into clinical development in 2026, including LITESPARK-033 and STELLAR-201[14]. - The company is progressing XL309, XB010, XB628, and XB371 into full development as part of its strategy to build next-generation oncology franchises[21]. - The company is focused on advancing its pipeline, including the clinical development of XL557 and XB773, contingent on supportive phase 1 data[21]. Commercial Strategy - Exelixis anticipates 2026 to be a significant year for clinical, regulatory, and commercial progress, focusing on expanding its cabozantinib business and developing zanzalintinib[20]. - The company aims to establish lasting franchises in renal cell carcinoma (RCC), neuroendocrine tumors (NET), and colorectal cancer (CRC), while driving sustained growth and returning capital to shareholders[20]. - Exelixis expects continued strong commercial performance of cabozantinib, with anticipated growth in RCC and NET in 2026, including plans to expand its gastrointestinal (GI) sales team[20]. - The regulatory review process for zanzalintinib's NDA for previously metastatic CRC in combination with atezolizumab is underway, with potential first commercial launch planned[20]. - Exelixis plans to initiate several pivotal trials, including STELLAR-316 and STELLAR-301, in 2026, and expects clinical data readouts from STELLAR-303 and STELLAR-304[20]. - The company emphasizes the importance of maintaining adequate sales, marketing, and distribution capabilities for its products to ensure market acceptance[21]. Shareholder Returns - Exelixis has repurchased a total of $2.16 billion of its common stock since March 2023, retiring 76.7 million shares[16].

Drug Development and Regulatory Plans - Larimar is developing nomlabofusp as the first potential disease-modifying therapy for Friedreich's ataxia (FA), targeting a patient population of approximately 20,000 globally, with around 5,000 in the U.S.[3] - The company plans to submit a Biologics License Application (BLA) for nomlabofusp in Q2 2026, with a U.S. launch targeted for early 2027, following FDA recommendations for accelerated approval based on frataxin levels as a surrogate endpoint[7] - The company has received multiple regulatory designations for nomlabofusp, including Orphan Drug and Fast Track designations in the U.S., and PRIME designation in the EU[7] - The START Pilot Program continues to expedite the clinical and regulatory development of Nomlabofusp, selected as one of 7 novel drug development programs by the FDA[54] - The FDA's new milestone-driven program launched in September 2023 aims to accelerate the development of therapies for rare diseases, providing more frequent and rapid interactions with the FDA[54] - The program is designed to facilitate the development of programs to the pre-BLA meeting stage, ensuring high-quality and reliable data for BLA support[54] Clinical Study Results - Data from a long-term open-label study indicates that 100% of participants at Day 180 had skin frataxin (FXN) levels greater than 50% of healthy volunteers, demonstrating sustained increases over time[11] - The median skin FXN levels increased from 2.70 pg/µg at baseline to 13.44 pg/µg at Day 180, indicating significant improvement in treatment efficacy[12] - Nomlabofusp demonstrated a median improvement of -2.25 in mFARS scores compared to a worsening of 1.00 in the FACOMS reference group after one year of treatment[18] - 10 out of 10 participants in the open-label study achieved skin FXN levels over 50% of median levels in healthy volunteers after 6 months of treatment[20] - The ongoing long-term open-label study has shown consistent directional improvement across four key clinical outcomes after one year of treatment[20] - In a cardiac mouse model, nomlabofusp increased median survival from 98 days (vehicle) to 166 days, demonstrating its potential efficacy[26] Safety and Tolerability - Safety observations from the open-label study showed that the most common adverse events were mild to moderate injection site reactions, with 7 participants experiencing anaphylaxis, all of whom recovered without complications[14] - The dosing regimen for nomlabofusp has been revised to a test dose of 5 mg followed by 25 mg daily for the first 30 days, then increasing to 50 mg daily, aimed at reducing the severity of potential anaphylaxis[15] - Nomlabofusp has shown a long-term safety profile with most adverse events being mild to moderate and not leading to withdrawals[19] - The Phase 2 study was generally well tolerated, with mild to moderate injection site reactions being the most common adverse events[40] Patient Population and Unmet Need - A national survey of clinicians treating FA patients indicated that 98% believe there is a need for treatments targeting frataxin levels directly, highlighting the high unmet medical need in this area[5] - The global Phase 3 study will include 100-150 ambulatory participants aged 2-40 years, focusing on safety and tolerability as well as upright stability and mFARS as primary outcomes[21] - The trial population included a broad representation of adults with Friedreich's Ataxia, with over 50% being non-ambulatory at baseline[48] Intellectual Property and Market Position - Larimar's intellectual property portfolio for nomlabofusp includes patents extending into 2040, providing a strong foundation for market exclusivity upon approval[8] Collaboration and Data Access - Larimar has established a strong relationship with FARA, joining the TRACK-FA Neuroimaging Consortium as an industry partner[57] - FARA provides access to a Global Patient Registry with demographic and clinical information on over 1,000 FA patients, aiding in patient recruitment and education[57] - The TRACK-FA initiative collects natural history data to establish disease-specific neuroimaging biomarkers for potential use in clinical trials[57] - Larimar will have access to all study data from TRACK-FA for regulatory filings as appropriate[57]

Financial Projections - Total net revenue projected to exceed $1 billion in 2026, representing a year-over-year increase of over 26%[4] - Cortrophin Gel net revenue for 2025 reached $348 million, reflecting a 76% year-over-year growth[6] - Adjusted non-GAAP EBITDA for 2025 estimated between $221 million and $228 million, showing a growth of over 42% year-over-year[6] - Adjusted non-GAAP diluted EPS for 2025 projected between $7.37 and $7.64, indicating a year-over-year increase of over 42%[6] - 2026 adjusted non-GAAP gross margin expected to be between 59.3% and 60.3%[8] - The total revenue for 2026 is projected to exceed $1 billion, representing a 26% year-over-year growth[24] Product Performance and Growth - Rare Disease business expected to account for approximately 60% of total revenues in 2026[4] - Cortrophin Gel anticipated to drive long-term growth by addressing unmet needs in nephrology, neurology, rheumatology, and pulmonology[7] - ILUVIEN net revenue for 2025 estimated at $75 million, with growth initiatives planned for 2026[6] - Rare Disease net revenues expected to grow significantly, with Cortrophin Gel and ILUVIEN contributing to this expansion[10] - Cortrophin Gel is expected to deliver over 60% year-over-year growth in 2026, contributing significantly to the company's revenue growth strategy[24] - The ACTH market is projected to reach approximately $992 million in 2025, reflecting a 45% year-over-year increase[11] Generics Business Strategy - Generics business projected to maintain a cadence of 10-15 product launches annually[7] - The company aims to launch 10-15 new products annually, investing a high single-digit percentage of Generics revenue into R&D[19] - The Generics business is expected to generate net revenues of $301 million in 2024, with a year-over-year growth rate exceeding 20%[19] - The Generics business has manufactured and supplied over 2.5 billion doses of therapeutics in the last 12 months[19] Market Research and Patient Insights - The addressable patient population for Cortrophin Gel includes approximately 285,000 patients for acute gout flares, with only 36% receiving treatment annually[13] - ANI Pharmaceuticals is focusing on expanding its addressable patient population for Cortrophin Gel, targeting conditions such as gout, multiple sclerosis, rheumatoid arthritis, sarcoidosis, and nephrotic syndrome[1] - The company has conducted extensive market research, indicating significant disease burden and treatment gaps in the U.S. for multiple sclerosis, with a prevalence rate of approximately 0.1%[5] - ANI's analysis shows that the burden of gout in the U.S. is substantial, with a notable percentage of patients experiencing frequent flares[3] - The company is actively exploring new treatment patterns for sarcoidosis, with recent studies highlighting variability in disease management across the U.S.[16] - ANI is leveraging data from multiple studies to inform its strategies for addressing steroid-resistant nephrotic syndrome, which remains a challenging area in pediatric care[21] - The company aims to enhance its product offerings by focusing on innovative therapies for chronic diseases, as indicated by its ongoing research initiatives[17] - ANI is committed to improving patient outcomes through targeted therapies, as evidenced by its focus on conditions with high unmet medical needs[19] - The company is analyzing treatment patterns and patient insights to refine its approach to managing rheumatoid arthritis, particularly in patients with low disease activity[11] - ANI's market research indicates a growing prevalence of sarcoidosis, necessitating new treatment strategies to address patient needs effectively[15] - The company is positioned to capitalize on the increasing demand for effective therapies in chronic disease management, supported by its comprehensive data analysis and research efforts[18]

Revenue Performance - For the three months ended November 28, 2025, revenues decreased by $3.6 million (27%) to $13.5 million, primarily due to lower shipments of contactors amid soft demand for electric vehicles [93]. - For the six months ended November 28, 2025, revenues decreased by $5.7 million (22%) to $20.9 million, with contactors revenue down by $14.6 million, partially offset by an increase in systems revenue of $8.3 million [94]. Profitability - Gross profit for the three months ended November 28, 2025, decreased by $2.9 million (53%) to $2.5 million, with gross margin dropping by 14.4 percentage points to 25.7% [98]. Expenses - Research and development expenses increased by $0.7 million (31%) for the three months ended November 28, 2025, totaling $3.0 million, representing 30.1% of total revenues [100]. - Selling, general and administrative expenses remained consistent at $4.4 million for the three months ended November 28, 2025, accounting for 44.9% of total revenues [101]. Interest and Tax - Interest income, net, decreased by $34,000 (15%) for the three months ended November 28, 2025, totaling $194,000, primarily due to lower average cash balances [107]. - The company recognized an income tax benefit of $1.2 million for the three months ended November 28, 2025, compared to a benefit of $217,000 in the prior year, reflecting losses in the United States [110]. Cash and Cash Flow - Cash, cash equivalents, and restricted cash were $31.0 million as of November 28, 2025, down from $35.2 million as of November 29, 2024 [114]. - Operating activities resulted in a cash outflow of $1.5 million for the six months ended November 28, 2025, compared to an outflow of $3.5 million in the prior year [115]. - The net increase in cash, cash equivalents, and restricted cash was $4.5 million for the six months ended November 28, 2025, compared to a decrease of $14.1 million in the prior year [115]. - Cash flows from operating activities increased by $2.0 million for the six months ended November 28, 2025, compared to the same period in the prior year [116]. - Net cash used in investing activities decreased by $7.5 million for the six months ended November 28, 2025, primarily due to a $10.6 million payment for the acquisition of Incal in the prior period [117]. - Net cash provided by financing activities increased by $9.1 million for the six months ended November 28, 2025, driven by net proceeds of $9.4 million from the issuance of common stock [118]. Off-Balance Sheet and Market Risk - There are no off-balance sheet arrangements or undisclosed borrowings reported by the company [119]. - The company is not required to provide quantitative and qualitative disclosures about market risk as a smaller reporting company [120].