Financial Performance - Net sales for the three months ended September 30, 2024, were $5,922,000, a decrease of 3.4% compared to $6,127,000 for the same period in 2023[28]. - Gross profit for the nine months ended September 30, 2024, was $8,383,000, slightly down from $8,927,000 in 2023, indicating a decline of 6.1%[28]. - The net loss attributable to common stockholders for the three months ended September 30, 2024, was $11,755,000, compared to a loss of $9,747,000 in 2023, reflecting a 20.6% increase in losses[28]. - Net loss for the nine months ended September 30, 2024, was $44.888 million, compared to a net loss of $28.342 million for the same period in 2023[33]. - Total net sales for Q3 2024 were $5.922 million, slightly down from $6.127 million in Q3 2023, with Device Protection sales at $2.260 million and Women's Health at $3.100 million[142]. - Gross profit for Q3 2024 was $2.741 million, compared to $2.841 million in Q3 2023, with the gross profit excluding intangible asset amortization at $3.590 million[143]. - Total net sales decreased by $0.2 million, or 3.3%, to $5.9 million for the three months ended September 30, 2024, compared to $6.1 million in the same period of 2023[171]. Assets and Liabilities - Total current assets increased to $37,318,000 as of September 30, 2024, from $31,253,000 as of December 31, 2023, representing a growth of 19.7%[26]. - Cash and cash equivalents increased to $25,741,000 as of September 30, 2024, from $19,276,000 as of December 31, 2023, a rise of 33.6%[26]. - Total liabilities increased to $88,645,000 as of September 30, 2024, from $82,028,000 as of December 31, 2023, marking a growth of 8.1%[26]. - The accumulated deficit increased to $220,532,000 as of September 30, 2024, from $175,644,000 as of December 31, 2023, indicating a rise of 25.5%[26]. - As of September 30, 2024, long-term debt amounted to $22.641 million, a decrease from $23.677 million as of December 31, 2023[106]. - The company’s total stockholders' equity (deficit) as of September 30, 2024, was $(40.238) million, compared to $(29.473) million as of September 30, 2023[33]. Operating Expenses - Total operating expenses rose to $12,971,000 for the three months ended September 30, 2024, compared to $10,212,000 in 2023, an increase of 27.2%[28]. - General and administrative expenses increased by 64.0% to $4.52 million for the three months ended September 30, 2024, compared to $2.76 million in the same period of 2023[170]. - Total operating expenses increased by 15.0% to $35.6 million for the nine months ended September 30, 2024, leading to a loss from operations of $27.2 million[180]. - Sales and marketing expenses decreased by $0.9 million, or 8.4%, to $9.6 million for the nine months ended September 30, 2024, representing 50.9% of net sales[185]. - General and administrative expenses rose by $4.1 million, or 40.7%, to $14.3 million for the nine months ended September 30, 2024, accounting for 75.5% of net sales[186]. Cash Flow - Net cash used in operating activities for the nine months ended September 30, 2024, was $10.400 million, compared to $12.678 million for the same period in 2023[33]. - Net cash provided by financing activities for the nine months ended September 30, 2024, was $17.2 million, compared to $10.5 million in 2023, primarily due to warrant exercises yielding proceeds of $15.7 million[207]. - The company used $10.4 million of cash in operating activities during the nine months ended September 30, 2024, and expects to continue incurring cash outflows[42]. Capital and Financing - The company may seek to raise capital through the issuance of common stock or pursue asset sales, but there is uncertainty regarding the success of these transactions[43]. - The company raised approximately $13.3 million in gross proceeds from a registered direct offering on June 16, 2024, selling 3,175,000 shares of Class A common stock[112]. - The company entered into a senior secured term loan facility for an aggregate principal amount of $25 million, with an initial draw of $21 million in August 2022 and an additional $4 million in December 2022[100]. - The SWK Loan Facility has an outstanding balance of $22.6 million as of September 30, 2024, with a maturity date of August 10, 2027[209]. - The Revenue Interest Obligation requires the company to pay Ligand Pharmaceuticals 5.0% of future sales of specific products, with annual minimum payments of $4.4 million through May 31, 2027[221]. Product Development and Sales - EluPro, a new product cleared by the FDA in June 2024, is expected to address approximately 600,000 procedures annually in the U.S. implantable electronic device protection market[149]. - Revenue from Device Protection and Cardiovascular products reached $7.3 million in the nine months ended September 30, 2024[150]. - The company operates in three segments: Device Protection, Women's Health, and Cardiovascular, following the sale of the Orthobiologics Business[141]. - Device protection revenue increased by 1.5% to $7.3 million, while women's health revenue rose by 26.4% to $9.2 million for the nine months ended September 30, 2024[181][182]. - Cardiovascular revenue decreased by 45.3% to $2.4 million due to a distribution agreement with LeMaitre Vascular that changed pricing structures[182][183]. Legal and Regulatory Matters - The company is involved in ongoing legal proceedings, including the FiberCel and VBM litigations, which may have material financial implications[135]. - The Company has filed a complaint against Medtronic for breach of contract related to the 2019 Tissue Product Supply Agreement, with ongoing litigation expected[124]. - Elutia has settled liabilities in 31 cases of the FiberCel Litigation for a total cash outlay of $9.6 million, with an estimated probable loss of $20.4 million recorded for the remaining 79 cases as of September 30, 2024[125]. - The Company has settled liabilities in nine cases of the VBM Litigation for approximately $1.0 million, with an estimated probable loss of $3.9 million recorded for the remaining 26 cases as of September 30, 2024[127]. Going Concern and Future Outlook - There is substantial doubt about the Company's ability to continue as a going concern within one year after the issuance of the condensed consolidated financial statements[43]. - The company expects to continue incurring losses for the foreseeable future, with uncertainty regarding achieving profitability[201]. - The company anticipates that additional capital may be needed sooner than expected due to changing operating plans[224]. - The company may need to delay product development or commercialization if it cannot raise additional funds[224].

Elutia Announces Strong Third Quarter Results, Accelerating Toward Full Launch of EluPro Antibiotic-Eluting BioEnvelope in 2025 Over 100 EluPro VAC Submissions and 19% SimpliDerm Growth Drive Momentum into 2025 SILVER SPRING, Md., November 14, 2024 — Elutia Inc. (Nasdaq: ELUT) ("Elutia" or the "Company"), a pioneer in drug-eluting biomatrix products, today provided a business update and financial results for the third quarter ended September 30, 2024. Business Highlights: Exhibit 99.1 "We achieved several s ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ 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: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incor ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ 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: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of inco ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2023 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For transition period from to Commission File Number: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ 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: 001-39577 Elutia Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ 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: 001-39577 Aziyo Biologics, Inc. (Exact name of registrant as specified in its charter) (Former name, former addres ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ 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: 001-39577 Aziyo Biologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdicti ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ Annual report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended December 31, 2022 or ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For transition period from to Commission File Number: 001-39577 Aziyo Biologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of inc ...