Financial Results Announcement - Elutia Inc. announced preliminary results for Q4 2025, subject to year-end accounting and audit procedures[4] - The press release detailing these results was issued on January 12, 2026[4] Financial Statements - The financial statements and exhibits related to the report are included as Exhibit 99.1 and Exhibit 104 respectively[7]

Core Insights - Elutia Inc. reported a 16% year-over-year increase in fourth quarter revenue, reaching approximately $3.3 million, and eliminated $26.9 million of secured debt, ending the year with total cash and escrowed proceeds of $44.3 million [1][8]. Company Developments - The company is advancing its NXT-41x antibiotic-eluting biomatrix program, which is expected to improve outcomes in breast reconstruction, a market valued at $1.5 billion with a post-operative infection rate of 15-25% [2][5]. - Elutia plans to submit an FDA filing for NXT-41 in the first half of 2026, with anticipated FDA clearance in the second half of 2026, followed by FDA clearance for NXT-41x in the first half of 2027 [3]. Financial Position - As of December 31, 2025, Elutia had approximately $36.3 million in cash, with an additional $8.0 million from the BioEnvelope divestiture held in escrow, expected to be released in 2026 [8]. - The company has a strong balance sheet, having repaid its outstanding debt, which will significantly reduce interest expenses moving forward [8].

Core Insights - Elutia Inc. is participating in the inaugural Global BioInnovation Forum during the JP Morgan Healthcare Conference on January 13, 2026, to present its advancements in drug-eluting biomatrix technologies [1][5] Company Overview - Elutia is focused on developing and commercializing drug-eluting biomatrix products aimed at improving compatibility between medical devices and patients [6] - The company aims to address the growing need for implantable technologies, emphasizing its mission to humanize medicine [6] Product Development - Elutia will showcase its NXT-41x program, a next-generation antibiotic-eluting biomatrix designed for plastic and reconstructive surgery, which builds on its established biomatrix technology platform [2] - The NXT-41x program is positioned to meet significant unmet needs in breast reconstruction, where postoperative infection rates can reach up to 25% and serious complications affect one in three patients [4] Expert Involvement - Randy Mills, CEO of Elutia, will present alongside Dr. Christopher Reid, a plastic surgeon with expertise in microsurgery and breast reconstruction, who will discuss strategies to mitigate postoperative complications [3] Industry Context - The Global BioInnovation Forum aims to bring together leaders in biotechnology, digital health, and life sciences to discuss innovations that are shaping the future of healthcare [5]

Core Viewpoint - Elutia Inc. (ELUT) has received an upgrade to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1][2]. - Changes in earnings estimates are strongly correlated with near-term stock price movements, particularly due to the actions of institutional investors who adjust their valuations based on these estimates [4]. Business Outlook - The upgrade in Zacks Rank for Elutia Inc. suggests an improvement in the company's underlying business, which could lead to an increase in stock price as investors respond positively to this trend [5][10]. - Over the past three months, the Zacks Consensus Estimate for Elutia Inc. has increased by 23.1%, indicating a positive revision in earnings expectations [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have generated an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places Elutia Inc. in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

Core Insights - Several biotechnology and life sciences companies experienced significant gains in after-hours trading, indicating strong investor interest in recent clinical and corporate developments [1] Company Summaries - Kura Oncology, Inc. (KURA) saw its shares rise to $10.57, an increase of 7.42% (+0.73), likely due to positive investor sentiment following the announcement of new data from its KOMET-007 Phase 1a/1b trial, which showed a favorable safety profile and encouraging antileukemic activity for its treatment regimen in acute myeloid leukemia patients [2] - SOPHiA GENETICS SA (SOPH) closed after hours at $4.85, gaining 5.21% (+0.24), with continued investor interest stemming from its collaboration with Complete Genomics to co-market precision oncology testing solutions [3] - Elutia Inc. (ELUT) experienced modest gains, with shares rising to $0.6045, up 3.10% (+0.0182), reflecting steady investor interest in the micro-cap biotech sector [4] - RenovoRx, Inc. (RNXT) added 2.47% (+0.02) to close at $0.9530, with recent news of its abstract submission acceptance for the ASCO Gastrointestinal Cancers Symposium 2026, where it will present findings from its ongoing Phase III trial [5] - Kodiak Sciences Inc. (KOD) posted a notable gain, climbing to $27.41, up 5.42% (+1.41), following the successful closing of a public offering that generated approximately $184 million in gross proceeds [6] - Day One Biopharmaceuticals, Inc. (DAWN) rose to $9.55, gaining 3.35% (+0.31), continuing to attract investor attention focused on oncology innovation [7] - Quantum BioPharma Ltd. (QNTM) advanced to $9.23, up 3.82% (+0.34), following the closing of a non-brokered private placement that raised gross proceeds of $750 [8]

Financial Performance - Net sales for the three months ended September 30, 2025, were $3,323,000, a decrease of 9.2% compared to $3,662,000 for the same period in 2024[29]. - Gross profit for the nine months ended September 30, 2025, was $4,682,000, down 13.2% from $5,393,000 in the same period of 2024[29]. - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $3,868,000, compared to a net income of $1,286,000 in the same period of 2024[29]. - For the nine months ended September 30, 2025, the net loss was $17.411 million, compared to a net loss of $44.888 million for the same period in 2024, indicating a significant improvement[34]. - The company reported a net loss of $17.4 million for the nine months ended September 30, 2025, a decrease of $27.5 million or 61.2% compared to the prior year[208]. Assets and Liabilities - Total current assets decreased from $26,172,000 as of December 31, 2024, to $18,378,000 as of September 30, 2025, representing a decline of approximately 29.7%[27]. - Cash and cash equivalents decreased significantly from $13,239,000 as of December 31, 2024, to $4,721,000 as of September 30, 2025, a decline of approximately 64.3%[27]. - The total liabilities decreased from $82,387,000 as of December 31, 2024, to $73,325,000 as of September 30, 2025, a reduction of approximately 11%[27]. - The accumulated deficit increased from $(229,593,000) as of December 31, 2024, to $(247,004,000) as of September 30, 2025, reflecting a worsening of approximately 7.5%[27]. Operating Expenses - Total operating expenses for the three months ended September 30, 2025, were $7,061,000, a decrease of 35.5% compared to $10,966,000 in the prior year[29]. - Research and development expenses increased to $1,088,000 for the three months ended September 30, 2025, up 55% from $702,000 in the same period of 2024[29]. - General and administrative expenses decreased by $3.0 million, or 22.0%, to $10.8 million for the nine months ended September 30, 2025, primarily due to lower non-cash equity compensation[214]. - Sales and marketing expenses increased by 29.0% to $1.6 million in Q3 2025, representing 48.2% of net sales[201]. Cash Flow and Financing - The company experienced a net cash used in operating activities of $19.996 million for the nine months ended September 30, 2025, compared to $10.400 million for the same period in 2024[34]. - The company believes its existing cash and cash equivalents, along with proceeds from the sale of its CIED Business, will be sufficient to fund operations for at least one year after the issuance of the financial statements[51]. - The company may seek to raise additional capital through equity issuance or asset sales, but such transactions may not be successful[49]. - The company raised approximately $15.0 million from the 2025 Registered Offering by selling 5,520,000 shares of Class A common stock at $2.50 per share[124]. Discontinued Operations - The company sold its cardiac implantable electronic device (CIED) business to Boston Scientific Corporation and Cardiac Pacemakers Inc. for up to $88 million in cash on October 1, 2025[167]. - The sale of the CIED Business is classified as Discontinued Operations, impacting the financial statements for the periods presented[182]. - The company completed the sale of its Orthobiologics segment for approximately $14.6 million, with potential earn-out payments of up to $20 million based on future revenues from specified products[46]. Litigation and Legal Matters - As of September 30, 2025, the Company recorded a liability of $12.7 million related to the FiberCel Litigation, which includes $12.0 million for settled cases not yet paid and $0.7 million for unsettled cases[145][146]. - The Company has settled 64 cases in the FiberCel Litigation for a total cash outlay of $22.5 million, with $9.6 million covered by insurance proceeds[144]. - The company is involved in ongoing litigation with Medtronic regarding breach of the Tissue Product Supply Agreement, with discovery still ongoing[141]. Product Development and Market Position - The company continues to market its biologic products, including SimpliDerm, which is a key component of the Women's Health segment[168]. - The company is advancing its proprietary drug-eluting biomatrix (DEB) platform, with the first commercial product, EluPro, aimed at reducing device-related complications[169]. - Research and development efforts are focusing on lead development programs NXT-41 and NXT-41x, following the FDA clearance of EluPro in June 2024[194]. Stock and Equity - The total number of shares outstanding as of September 30, 2025, was 40,198,920 for Class A and 2,351,246 for Class B[31]. - The Company has a compliance period until May 6, 2026, to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share[39]. - The Employee Stock Purchase Plan (ESPP) had 763,965 shares remaining available for future issuance as of September 30, 2025[105].

Financial Data and Key Metrics Changes - Elutia reported Q3 2025 revenue of $3.3 million, down from $3.6 million in the same quarter last year, but gross margin improved to 55.8% from 49% a year ago [39][40] - Adjusted gross margin, excluding non-cash amortization, was 64% compared to 56% in the prior year [40] - Operating expenses decreased to $7.1 million from $11 million a year ago, resulting in a loss from operations of $5.2 million, down from $9 million [40] Business Line Data and Key Metrics Changes - SimpliDerm revenue increased by 18% from Q2 2025 to $2.4 million, although it was down from the previous year due to various factors [35] - Cardiovascular product sales reached $900,000 in Q3 2025, up 68% year-over-year and 28% sequentially [38] Market Data and Key Metrics Changes - The breast reconstruction market is valued at $1.5 billion, with 162,000 procedures performed annually in the U.S. [11][12] - Post-operative infection rates in breast reconstruction are reported to be between 15%-20%, highlighting a significant unmet medical need [10][11] Company Strategy and Development Direction - Elutia aims to leverage its validated technology platform to address the unmet medical need in breast reconstruction through the development of NXT 41 and NXT 41X products [10][29] - The company plans to utilize its existing commercial infrastructure from SimpliDerm to support the launch of NXT 41 and NXT 41X [49] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future, emphasizing the importance of the recent sale of the bio-envelope business to Boston Scientific for $88 million, which strengthens the balance sheet and operational efficiency [32][33] - The company is focused on resolving legacy litigation issues, with only six cases remaining from an initial 110, indicating a move towards a cleaner operational slate [42] Other Important Information - The company has a robust manufacturing facility in Gaithersburg, Maryland, which is expected to support the production of NXT 41 and NXT 41X without delays [55] - Elutia has resolved seven legacy litigation cases in the quarter, reducing the total to six remaining cases with an estimated liability of $700,000 [42] Q&A Session Summary Question: Insights from Eliupro's development to commercial rollout - Management highlighted the importance of having a strong team and commercial infrastructure in place, which contributed to Eliupro's successful market entry [46][47] Question: Leveraging SimpliDerm for NXT - The existing relationships and commercial presence from SimpliDerm will be utilized to facilitate the adoption of NXT 41X, as both products target the same customer base [49] Question: Clinical evidence and data generation for NXT - While there is no requirement for clinical data for the 510(k) pathway, the company plans to generate strong clinical evidence to support the product's market adoption [51][53] Question: Manufacturing plans for NXT and 41X - The manufacturing of NXT and 41X will occur in a separate GMP facility, ensuring compliance with regulations and readiness for production [54][55] Question: Current run rate and growth sustainability for cardiovascular business - The cardiovascular business is expected to achieve steady growth, with a current run rate of approximately $1 million per quarter, benefiting from high gross margins [57]

Business Overview - Elutia sold its BioEnvelope business to Boston Scientific for $88 million [11, 59] - The BioEnvelope business financials are now reported as "Discontinued Operations" [60] - Elutia is targeting the $1.5 billion breast reconstruction market with its technology platform [14, 17, 18, 70] Market Opportunity - Biologics represent 65% of the $1.5 billion US breast reconstruction market [18, 19, 20] - Biologic mesh is used in over 90% of breast reconstruction cases [20] - 15-20% of breast reconstruction patients experience infection [17, 22] - The average economic cost to the hospital of breast reconstruction infection is $48,344 [23] Financial Performance - Q3 2025 net sales were $3.3 million compared to $3.6 million in Q3 2024 [68] - Q3 2025 GAAP gross margin was 55.8% compared to 48.9% in Q3 2024 [68] - Q3 2025 adjusted gross margin was 63.9% compared to 56.3% in Q3 2024 [68] - The company received $49 million in cash at closing from the BioEnvelope sale, net of expenses and debt repayment [68] - The estimated liability of the remaining 6 FiberCel litigation cases is $0.7 million [68]

Financial Performance - Overall net sales for Q3 2025 were $3.3 million, a decrease from $3.7 million in Q3 2024, excluding contributions from the BioEnvelope business[5] - Net sales of SimpliDerm were $2.4 million, down from $3.1 million in Q3 2024[5] - Net sales for Q3 2025 were $3,323 million, a decrease of 9.3% compared to $3,662 million in Q3 2024[17] - Gross profit for Q3 2025 was $1,853 million, representing a gross margin of 55.8%, up from 48.9% in Q3 2024[18] - The net loss for Q3 2025 was $(3,868) million, compared to a net income of $1,286 million in Q3 2024[20] - EBITDA (Non-GAAP) for Q3 2025 was $(3,316) million, compared to $1,705 million in Q3 2024[20] - The company reported a loss from discontinued operations of $(3,485) million in Q3 2025, compared to $(2,053) million in Q3 2024[20] Cost Management - Total operating expenses decreased to $7.1 million, down from $11.0 million in Q3 2024[10] - Total operating expenses for Q3 2025 were $7,061 million, down from $10,966 million in Q3 2024, primarily due to reduced litigation costs[17] - Loss from operations narrowed to $5.2 million, compared to $9.2 million in the same period last year[10] Gross Margin Improvement - Gross margin on a GAAP basis improved to 55.8%, compared to 48.9% in the previous year[10] - Adjusted gross margin increased to 63.9%, up from 56.3% in Q3 2024[10] - Adjusted gross profit (Non-GAAP) for Q3 2025 was $2,122 million, with an adjusted gross margin of 63.9%[18] Cash and Funding - Cash balance as of September 30, 2025, was $4.7 million, with an additional $80.3 million received from the BioEnvelope business sale[10] - Elutia's balance sheet was strengthened by the sale, allowing full funding for the NXT-41x platform development without shareholder dilution[4] Research and Development - Research and development expenses increased to $1,088 million in Q3 2025 from $702 million in Q3 2024, reflecting a focus on new product development[17] Future Outlook - FDA clearance for the base matrix of NXT-41x is anticipated in the second half of 2026, with the drug-eluting version expected in the first half of 2027[4] - The company anticipates continued challenges in the market, with a focus on cost reduction and strategic investments in technology[21] Shareholder Information - The weighted average common shares outstanding for basic shares increased to 42,431,314 in Q3 2025 from 32,520,134 in Q3 2024[17] Business Transactions - Elutia sold its BioEnvelope business to Boston Scientific Corporation for $88 million, with proceeds used to eliminate debt and fund the NXT-41x development program[4]

Core Insights - Elutia Inc. is advancing its NXT-41x biomatrix technology to address a significant unmet medical need in plastic and reconstructive surgery, targeting a market opportunity estimated at $1.5 billion in the U.S. [1][5] Business Highlights - The CEO emphasized the importance of addressing infection in breast reconstruction, which affects 15-20% of cases, and highlighted the company's antibiotic-eluting technology aimed at preventing such infections [4]. - Elutia sold its BioEnvelope business to Boston Scientific for $88 million, with proceeds allocated to eliminate debt and fund the NXT-41x development program [5]. - The company is progressing with the NXT-41x biomatrix, which is expected to receive FDA clearance for the base matrix in the second half of 2026 and for the drug-eluting version in the first half of 2027 [5]. - Elutia's balance sheet has been strengthened through the sale of the BioEnvelope business, allowing for the full funding of the NXT-41x platform development without shareholder dilution [5]. - Guido J. Neels has been appointed to the Board of Directors, bringing experience from his previous role as COO of Guidant Corporation [5]. Financial Results - For Q3 2025, Elutia reported net sales of $3.3 million, a decrease from $3.7 million in Q3 2024, with SimpliDerm sales at $2.4 million and cardiovascular products at $0.9 million [6]. - The gross margin on a GAAP basis improved to 55.8% from 48.9% year-over-year, while the adjusted gross margin rose to 63.9% from 56.3% [6][20]. - Total operating expenses decreased to $7.1 million from $11.0 million, resulting in a loss from operations of $5.2 million, down from $9.2 million in the prior year [6]. - The net loss from continuing operations was $0.4 million, compared to a net income of $3.3 million in Q3 2024 [6]. - As of September 30, 2025, the cash balance was $4.7 million, bolstered by $80.3 million received from the BioEnvelope business sale [7]. Market Opportunity - The NXT-41x biomatrix is positioned to tackle serious complications faced by one in three patients undergoing breast reconstruction, addressing a critical need in the $1.5 billion U.S. market [5].