| (a)(1) | Financial Statements. |
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The following consolidated financial statements of iMDx are filed as part of this Report:
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| Report of Independent Registered Public Accounting Firm (CBIZ CPAs P.C., PCAOB ID 199) | F-1 |
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| Report of Independent Registered Public Accounting Firm (Marcum LLP, PCAOB ID 688) | F-3 |
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| Consolidated Balance Sheets | F-4 |
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| Consolidated Statements of Operations | F-5 |
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| Consolidated Statements of Comprehensive Loss | F-6 |
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| Consolidated Statements of Series A Redeemable Convertible Preferred Stock and Shareholders’ Deficit | F-7 |
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| Consolidated Statements of Cash Flows | F-8 |
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| Notes to Consolidated Financial Statements | F-9 |
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| (a)(2) | Financial Statement Schedules. |
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Financial statement schedules are omitted because they are not applicable or the required information is shown in the Financial Statements or the Notes thereto.
Refer to Item 15(b) below.
| (b) | Exhibits. The following exhibits are either filed herewith or incorporated herein by reference: |
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| ExhibitNumbers | Exhibit Description |
| 2.1 | Agreement and Plan of Merger, dated January 10, 2020, by and among Insight Molecular Diagnostics Inc., Cancer DX Sub, Inc., Insight Genetics, Inc., the Shareholders who became a Party to the Merger Agreement and the Equityholder Representative. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 5, 2020) |
| 2.2 | Agreement and Plan of Merger dated February 2, 2021, amended February 23, 2021, and amended and restated as of April 15, 2021, by and among Insight Molecular Diagnostics Inc., CNI Monitor Sub, Inc., Chronix Biomedical, Inc., the Stockholders who became a party to the Merger Agreement and the Equityholder Representative (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 19, 2021) |
| 2.3 | Amendment No. 1 to Amended and Restated Agreement and Plan of Merger dated February 8, 2023, by and between Insight Molecular Diagnostics Inc. and David MacKenzie, solely in his capacity as Equityholder Representative (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 3, 2023) |
| 2.4 | Stock Purchase Agreement, dated December 15, 2022, by and among Dragon Scientific, LLC, Insight Molecular Diagnostics Inc. and Razor Genomics Inc. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 21, 2022) |
| 2.5 | First Amendment to Stock Purchase Agreement, dated December 15, 2022, by and among Dragon Scientific, LLC, Insight Molecular Diagnostics Inc. and Razor Genomics Inc. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 13, 2023) |
| 2.6 | Second Amendment to Stock Purchase Agreement, dated February 16, 2023, by and among Dragon Scientific, LLC, Insight Molecular Diagnostics Inc. and Razor Genomics Inc. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 23, 2023) |
| 3.1 | Articles of Incorporation with all amendments (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Registration Statement on Form S-3 filed with the Securities and Exchange Commission on July 14, 2021) |
| 3.2 | Certificate of Amendment of Articles of Incorporation of Insight Molecular Diagnostics Inc., as filed with the Secretary of State of the State of California on July 24, 2023 (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 24, 2023) |
| 3.3 | Certificate of Ownership, as filed with the Secretary of State of the State of California on June 13, 2025 (incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 17, 2025) |
| 3.4 | Certificate of Determination of Preferences, Rights and Limitations of Series A Convertible Preferred Stock (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 13, 2022) |
| 3.5 | Third Amended and Restated Bylaws of Insight Molecular Diagnostics Inc.(incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 17, 2025) |
| 4.1 | Specimen of Common Stock Certificate (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) filed with the Securities and Exchange Commission on November 23, 2015) |
| 4.2 | Silicon Valley Bank Warrant (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2017) |
| 4.3 | Warrant to Purchase Common Stock, dated October 17, 2019, between Insight Molecular Diagnostics Inc. and Silicon Valley Bank (Incorporated by Reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2019) |
| 4.4 | Form of Common Stock Warrant (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 19, 2022) |
| 4.5 | Form of Pre-Funded Warrant (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 12, 2024) |
| 4.6 | Form of Pre-Funded Warrant (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 10, 2025) |
| 4.7 | Form of Pre-Funded Warrant, dated February 10, 2026 (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 12, 2026) |
| 4.8* | Description of Securities |
| 10.1# | 2010 Stock Option Plan (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(g) filed with the Securities and Exchange Commission on October 7, 2015) |
| 10.2# | 2017 Amendment to 2010 Stock Option Plan (Incorporated by reference to Registration Statement on Form S-8, File Number 333-219109 filed with the Securities and Exchange Commission on June 30, 2017) |
| 10.3# | Form of Stock Option Agreement (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) filed with the Securities and Exchange Commission on November 23, 2015) |
| 10.4# | Form of Incentive Stock Option Agreement (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) filed with the Securities and Exchange Commission on November 23, 2015) |
| 10.5# | Amended and Restated 2018 Equity Incentive Plan (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 15, 2024) |
| 10.6# | Form of 2018 Equity Incentive Plan Employee Stock Option Agreement (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 29, 2018) |
| 10.7# | Form of 2018 Equity Incentive Plan Non-Employee Director Stock Option Agreement (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 29, 2018) |
| 10.8# | Form of 2018 Equity Incentive Plan Restricted Stock Unit Agreement (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on August 29, 2018) |
| 10.9# | Insight Molecular Diagnostics Inc. Change in Control and Severance Plan (Incorporated by Reference to Annual Report on Form 10-K Filed with the Securities and Exchange Commission on March 26, 2020) |
| 10.10# | Form of Change in Control and Severance Agreement (Incorporated by Reference to Annual Report on Form 10-K Filed with the Securities and Exchange Commission on March 26, 2020) |
| 10.11# | Amended and Restated Employment Agreement, dated June 6, 2023, by and between Insight Molecular Diagnostics Inc. and Joshua Riggs (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on June 9, 2023) |
| 10.12# | Amendment to Amended and Restated Employment Agreement, dated July 13, 2023, by and between Insight Molecular Diagnostics Inc. and Joshua Riggs (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 14, 2023) |
| 10.13 | Registration Rights Agreement dated October 15, 2009 (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) filed with the Securities and Exchange Commission on November 23, 2015) |
| 10.14 | Amendment of Registration Rights Agreement, dated August 23, 2011 (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) filed with the Securities and Exchange Commission on November 23, 2015) |
| 10.15 | Second Amendment of Registration Rights Agreement, dated May 8, 2015 (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) filed with the Securities and Exchange Commission on November 23, 2015) |
| 10.16 | Third Amendment to Registration Rights Agreement, dated November 16, 2015 (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Form 10 12(b) A-1 filed with the Securities and Exchange Commission on December 29, 2015) |
| 10.17 | Loan and Security Agreement, dated February 21, 2017, by and between Insight Molecular Diagnostics Inc. and Silicon Valley Bank (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2017) |
| 10.18+ | First Amendment to Loan and Security Agreement, dated October 17, 2019, between Insight Molecular Diagnostics Inc. and Silicon Valley Bank (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 21, 2019) |
| 10.19 | Loan Deferral Agreement, dated April 2, 2020, by and between Insight Molecular Diagnostics Inc. and Silicon Valley Bank (Incorporated by Reference to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2020) |
| 10.20 | Office Lease Agreement, dated December 23, 2019, as amended between Insight Molecular Diagnostics Inc. and Cushing Ventures, LLC (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 27, 2019) |
| 10.21 | Amendment to and Waiver of Right to Extend Original Lease, dated as of December 26, 2024, effective as of January 2, 2025, by and among Insight Molecular Diagnostics Inc., Induce Biologics USA, Inc. and Cushing Ventures, LLC (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 8, 2025) |
| 10.22 | Sublease Agreement, dated August 8, 2023, by and between Insight Molecular Diagnostics Inc. and Induce Biologics USA, Inc. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2023) |
| 10.23 | Lease Agreement for Suite 103, dated January 1, 2024, between Insight Genetics, Inc. and MPC Holdings, LLC (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2024) |
| 10.24 | Lease Agreement for Suite 410, dated January 1, 2024, between Insight Genetics, Inc. and MPC Holdings, LLC (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2024) |
| 10.25 | Lease Agreement for Suite 510, dated January 1, 2024, between Insight Genetics, Inc. and MPC Holdings, LLC (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2024) |
| 10.26 | Form of Securities Purchase Agreement dated April 13, 2022, by and among Insight Molecular Diagnostics Inc. and certain investors (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 13, 2022) |
| 10.27 | Securities Purchase Agreement, dated April 3, 2023, by and among Insight Molecular Diagnostics Inc. and each purchaser identified on the signatures pages thereto (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 6, 2023) |
| 10.28 | Securities Purchase Agreement, dated April 11, 2024, by and among the Company and the investors signatory thereto (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on April 12, 2024) |
| 10.29# | Employment Agreement, dated May 20, 2024, by and between Insight Molecular Diagnostics Inc. and Ekkehard Schütz (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2024) |
| 10.30# | Employment Agreement, dated June 17, 2024, by and between Insight Molecular Diagnostics Inc. and Andrea James (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2024) |
| 10.31+ | Securities Purchase Agreement, dated October 2, 2024, by and among the Company and the investors signatory thereto (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 3, 2024) |
| 10.32+ | Collaboration Agreement, dated April 5, 2024, between the Company and Bio-Rad Laboratories, Inc. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2024) |
| 10.33+ | Memorandum of Understanding, dated November 8, 2024, between the Company and Bio-Rad Laboratories, Inc. (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 12, 2024) |
| 10.34 | Amendment to and Waiver of Right to Extend Original Lease, dated as of December 26, 2024, effective as of January 2, 2025, by and among Insight Molecular Diagnostics Inc., Induce Biologics USA, Inc. and Cushing Ventures, LLC (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 8, 2025) |
| 10.35+ | Securities Purchase Agreement, dated February 7, 2025, by and among the Company and the investors signatory thereto (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 10, 2025) |
| 10.36+ | Securities Purchase Agreement, dated February 7, 2025, by and among the Company and the investors signatory thereto (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 10, 2025) |
| 10.37# | Amendment to Employment Agreement, effective September 29, 2025, by and between Insight Molecular Diagnostics Inc. and Ekkehard Schütz (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on October 2, 2025) |
| 10.38+ | Form of Securities Purchase Agreement, dated as of February 10, 2026, by and between the Company and the purchasers thereto (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 12, 2026) |
| 19.1 | Insider Trading Policy (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 24, 2025) |
| 21 | Subsidiaries (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 12, 2023) |
| 23.1* | Consent of CBIZ CPAs P.C. |
| 23.2* | Consent of Marcum LLP |
| 31.1* | Certification of the Principal Executive Officer of Insight Molecular Diagnostics Inc. pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Rule 302 of the Sarbanes-Oxley Act of 2002 |
| 31.2* | Certification of the Principal Financial Officer of Insight Molecular Diagnostics Inc. pursuant to Rule 13a-14 of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Rule 302 of the Sarbanes-Oxley Act of 2002 |
| 32.1** | Certifications pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
| 97.1 | Insight Molecular Diagnostics Inc. Clawback Policy (Incorporated by reference to Insight Molecular Diagnostics Inc.’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2024) |
| 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document |
| 101.SCH | Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
** The certifications attached as Exhibit 32.1 that accompany this Report are not deemed filed with the SEC and are not to be incorporated by reference into any filing of iMDx under the Securities Act, or the Exchange Act, whether made before or after the date of this Report, regardless of any general incorporation language contained in any filing.
