Item 9A. Controls and Procedures
Item 9A. Controls and Procedures
Limitations on Effectiveness of Controls and Procedures
The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
106
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and principal financial officer, evaluated, as of the end of the period covered by this Annual Report on Form 10-K, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934). Based on that evaluation, our Chief Executive Officer and our principal financial officer concluded that our disclosure controls and procedures were not effective at the reasonable assurance level as of December 31, 2023, because of the identified material weaknesses in our internal control over financial reporting described below.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s Board, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
• Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and
• Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation. Projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the Internal Control-Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation, management concluded that the Company’s internal control over financial reporting was not effective as of December 31, 2023 as a result of the material weakness discussed below.
We identified material weaknesses in our internal control over financial reporting. A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a possibility that a material misstatement of our financial statements will not be prevented or detected on a timely basis. The material weaknesses primarily related to the accounting for the business combination with Lung Therapeutics, Inc., specifically the (i) lack of sufficient accounting and supervisory personnel to maintain appropriate segregation of duties relating to user access of the financial accounting system and who have the appropriate level of technical accounting experience and training, (ii) lack of evidence over reviews of account reconciliations and supporting schedules, and (iii) lack of adequate procedures and controls to ensure that accurate financial statements could have been prepared and reviewed on a timely basis for annual reporting purposes. In the year ended December 31, 2023, management identified material weaknesses related to the accounting for our acquisition of Lung, including a lack of
107
sufficient precision in the performance of reviews supporting the purchase price allocation accounting, and a lack of timely oversight over third-party specialists and the reports they produced to support the accounting for the acquisition.
We are implementing procedures to remediate these material weaknesses, including the hiring of a full-time additional employee in our accounting department, integration into one accounting system, third party accounting specialists and a more streamlined process in order to prepare and review financial information, however, our control environment needs improvement, and as a result we may be exposed to errors. Our remediation plan also includes the hiring of additional accounting employees and/or consultants with the specific technical accounting experience necessary to assist with complex, non-routine transactions and to support the timely completion of financial close procedures, the implementation of robust processes, and to assist with the preparation of financial statements and our compliance with SEC reporting obligations. Additionally, we intend to develop and implement consistent accounting policies, internal control procedures and provide additional training to our accounting and financial reporting personnel. While we are working to remediate such weakness as quickly and efficiently as possible, we cannot at this time, provide an estimate of the timeframe we expect in connection with implementing our plan to remediate the material weaknesses.
Changes in Internal Control Over Financial Reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) has occurred during the quarter ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B. Other Information
Rule 10b5-1 Trading Plans
During the three months ended December 31, 2023, none of the Company’s directors or executive officers adopted , modified or terminated any contract, instruction or written plan for the purchase or sale of Company securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any “non-Rule 10b5-1 trading arrangement” (as defined in Item 408(c) of Regulation S-K).
Ite m 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections
None.
108
PART III
Item 10. Directors, Executive Off icers and Corporate Governance
The information required by this Item 10 will be included in our definitive proxy statement to be filed with the Securities and Exchange Commission, or SEC, with respect to our 2024 Annual Meeting of Stockholders, which is expected to be filed no later than 120 days after the end of our last fiscal year ended December 31, 2023 and is incorporated herein by reference.
We have adopted a Code of Business Conduct and Ethics that applies to our officers, including our principal executive, financial and accounting officers, and our directors and employees. We have posted the text of our Code of Business Conduct and Ethics under the “Investors & Media — Governance” section of our website, www.aileronrx.com. We intend to disclose on our website any amendments to, or waivers from, the Code of Business Conduct and Ethics that are required to be disclosed pursuant to the disclosure requirements of Item 5.05 of Form 8-K.
Item 11. Executiv e Compensation
The information required by this Item 11 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2024 Annual Meeting of Stockholders, which is expected to be filed no later than 120 days after the end of our last fiscal year ended December 31, 2023 and is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Own ers and Management and Related Stockholder Matters.
The information required by this Item 12 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2024 Annual Meeting of Stockholders, which is expected to be filed no later than 120 days after the end of our last fiscal year ended December 31, 2023 and is incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information required by this Item 13 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2024 Annual Meeting of Stockholders, which is expected to be filed no later than 120 days after the end of our last fiscal year ended December 31, 2023 and is incorporated herein by reference.
Item 14. Principal Accoun ting Fees and Services
The information required by this Item 14 will be included in our definitive proxy statement to be filed with the SEC with respect to our 2024 Annual Meeting of Stockholders, which is expected to be filed no later than 120 days after the end of our last fiscal year ended December 31, 2023 and is incorporated herein by reference.
109
PART IV
Item 15. Exhibits, Financ ial Statement Schedules
The following documents are filed as part of this Report:
(a) Financial Statements . The following documents are included on pages F2-F35 attached hereto and are filed as part of this Annual Report on Form 10-K:
(b) Financial Statement Schedules . Schedules have been omitted since they are either not required or not applicable or the information is otherwise included herein.
(c) Exhibits . The exhibits filed as part of this Annual Report on Form 10-K are set forth on the Exhibit Index below. The Exhibit Index is incorporated herein by reference.
Ite m 16. Form 10-K Summary
None.
Exhibit Index
Incorporation by Reference
Exhibit
Number
Description
Form
Date of Filing
Exhibit
Number
Filed
Herewith
2.1#
Agreement and Plan of Merger, dated October 31, 2023, by and among Aileron Therapeutics, Inc., AT Merger Sub I, Inc., AT Merger Sub II, LLC and Lung Therapeutics, Inc.
8-K
10/31/2023
2.1
3.1
Restated Certificate of Incorporation of the Registrant, as amended
10-Q
8/11/2021
3.1
3.2
Certificate of Amendment of Restated Certificate of Incorporation of the Registrant, dated as of November 10, 2022
8-K
11/10/2022
3.1
3.3
Certificate of Amendment of Restated Certificate of Incorporation of the Registrant, dated as of February, 29, 2024
X
3.4
Amended and Restated By-laws of the Registrant
8-K
7/5/2017
3.2
4.1
Specimen stock certificate evidencing shares of common stock
S-1^
6/19/2017
4.1
4.2
Description of Securities of the Registrant
X
4.3
Certificate of Designation of Series X Non-Voting Convertible Preferred Stock
8-K
10/31/2023
3.1
4.4
Form of Warrant to Purchase Common Stock issued pursuant to the Stock and Warrant Purchase Agreement
8-K
10/31/2023
4.1
10.1*
2006 Stock Incentive Plan, as amended
S-1^
6/2/2017
10.1
10.2*
Form of Incentive Stock Option Agreement under 2006 Stock Incentive Plan
S-1^
6/2/2017
10.2
110
10.3*
Form of Nonstatutory Stock Option Agreement under 2006 Stock Incentive Plan
S-1^
6/2/2017
10.3
10.4*
2016 Stock Incentive Plan
S-1^
6/2/2017
10.4
10.5*
Form of Incentive Stock Option Agreement under 2016 Stock Incentive Plan
S-1^
6/2/2017
10.5
10.6*
Form of Nonstatutory Stock Option Agreement under 2016 Stock Incentive Plan
S-1^
6/2/2017
10.6
10.7*
2017 Stock Incentive Plan
S-1^
6/19/2017
10.8
10.8*
Form of Incentive Stock Option Agreement under 2017 Stock Incentive Plan
S-1^
6/19/2017
10.9
10.9*
Form of Nonstatutory Stock Option Agreement under 2017 Stock Incentive Plan
S-1^
6/19/2017
10.10
10.10*
2017 Employee Stock Purchase Plan
S-1^
6/19/2017
10.11
10.11*
Aileron Therapeutics, Inc. 2021 Stock Incentive Plan, as amended
X
10.12*
Form of Stock Option Agreement under 2021 Stock Incentive Plan
10-K
3/20/2023
10.12
10.13*
Form of Restricted Stock Unit Agreement under 2021 Stock Incentive Plan
10-K
3/20/2023
10.13
10.14
Form of Director and Officer Indemnification Agreement
S-1^
6/19/2017
10.12
10.15
License Agreement, dated as of December 31, 2006, by and between the Registrant and Materia, Inc. (now Umicore Precious Metals Chemistry USA, LLC)
S-1^
6/2/2017
10.13
10.16++
Amended and Restated License Agreement, dated as of February 19, 2010, by and among the Registrant, President and Fellows of Harvard College and Dana-Farber Cancer Institute, Inc.
S-1^
6/19/2017
10.14
10.17*
Amended and Restated Employment Agreement, dated as of September 6, 2018, between the Registrant and Manuel C. Alves Aivado, M.D., Ph.D.
10-Q
11/7/2018
10.2
10.18*
Severance Agreement, dated as of September 6, 2018, between the Registrant and Manuel C. Alves Aivado, M.D., Ph.D.
10-Q
11/7/2018
10.3
10.19*
Offer Letter, dated as of November 15, 2007, between the Registrant and D. Allen Annis, Ph.D.
10-K
3/29/2019
10.21
10.20*
Severance Agreement, dated as of November 5, 2018, between the Registrant and D. Allen Annis, Ph.D.
10-K
3/29/2019
10.22
10.21
Securities Purchase Agreement, dated March 28, 2019, by and among the Registrant and the persons party thereto
8-K
4/1/2019
10.1
10.22
Registration Rights Agreement, dated March 28, 2019, by and among the Registrant and the persons party thereto
8-K
4/1/2019
10.4
111
10.23
Form of Warrant to Purchase Common Stock
8-K
4/1/2019
10.3
10.24
Purchase Agreement, dated as of September 21, 2020, by and between the Company and Lincoln Park Capital Fund, LLC
8-K
9/22/2020
10.1
10.25
Registration Rights Agreement, dated as of September 21, 2020, by and between the Company and Lincoln Park Capital Fund, LLC
8-K
9/22/2020
10.2
10.26
Capital on Demand Sales Agreement, dated January 29, 2021, by and among Aileron Therapeutics, Inc. and JonesTrading Institutional Services LLC and William Blair & Company, L.L.C.
8-K
1/29/2021
1.1
10.27
Sublease Agreement, dated March 26, 2021, by and among the Company, Vittoria Industries North America, Inc. and Waterfront Equity Partners, LLC
10-Q
5/11/2021
10.1
10.28*
Separation and Release of Claims Agreement, dated July 8, 2022, by and between the Company and Vojislav Vukovic, M.D., Ph.D.
10-Q
8/15/2022
10.1
10.29*
Separation and Release of Claims Agreement, dated as of April 24, 2023, between the Registrant and D. Allen Annis, Ph.D.
10-Q
5/8/2023
10.1
10.30*
Consulting Agreement, dated as of April 15, 2023, between the Registrant and D. Allen Annis, Ph.D.
10-Q
5/8/2023
10.2
10.31
Waiver Under Amended and Restated License Agreement, dated as of February 19, 2010, by and among the Registrant, President and Fellows of Harvard College and Dana-Farber Cancer Institute, Inc.
10-Q
10/13/2023
10.1
10.32#
Stock and Warrant Purchase Agreement, dated as of October 31, 2023, by and among Aileron Therapeutics, Inc. and each purchaser identified on Annex A thereto
8-K
10/31/2023
10.1
10.33
Form of Registration Rights Agreement, by and among Aileron Therapeutics, Inc. and certain purchasers named therein
8-K
10/31/2023
10.2
10.34*
Executive Employment Agreement, dated as of February 1, 2014, by and between Lung Therapeutics, Inc. and Brian Windsor, Ph.D., as amended
8-K
10/31/2023
10.3
10.35*
Letter Agreement, dated as of February 11, 2023, by and between Lung Therapeutics, Inc. and Brian Windsor, Ph.D.
8-K
10/31/2023
10.4
10.36*
Letter Agreement, dated as of October 30, 2023, by and between Lung Therapeutics, Inc. and Brian Windsor, Ph.D.
8-K
10/31/2023
10.5
10.37+#
Exclusive License Agreement, dated as of November 12, 2020, by and between Lung Therapeutics, Inc. and Taiho Pharmaceutical Co. Ltd.
8-K
1/25/2024
10.1
112
10.38+
Amended and Restated Patent and Technology License Agreement, effective as of December 19, 2013, by and between Lung Therapeutics, Inc. and the Board of Regents of The University of Texas System, on behalf of The University of Texas Health Science Center at Tyler, as amended by First Amendment, effective as of May 4, 2017.
8-K
1/25/2024
10.2
10.39+
Patent License Agreement, effective as of May 21, 2015, by and between Lung Therapeutics, Inc. and the University of Texas at Austin, on behalf of The University of Texas System, as amended by Amendment #1, dated as of January 26, 2017, Amendment #2, dated as of November 19, 2018, Amendment #3, effective as of June 20, 2019, and Amendment #4, dated as of April 28, 2023.
8-K
1/25/2024
10.3
10.40+
Amended and Restated License Agreement, effective as of September 1, 2018, by and between Lung Therapeutics, Inc. and Medical University of South Carolina Foundation for Research Development.
8-K
1/25/2024
10.4
10.41+
License Agreement, effective as of March 8, 2018, by and between Lung Therapeutics, Inc. and Vivarta Therapeutics, L.L.C.
8-K
1/25/2024
10.5
10.42*
Lung Therapeutics, Inc.2013 Long-Term Incentive Plan, as amended
X
16.1
Letter from PricewaterhouseCoopers LLP regarding change in certifying accountant
8-K
10/31/2023
16.1
21.1
Subsidiaries of Aileron Therapeutics, Inc.
X
23.1
Consent of PricewaterhouseCoopers LLP, independent registered public accounting firm.
X
23.2
Consent of Marcum LLP, independent registered public accounting firm.
X
31.1
Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
31.2
Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
X
32.1
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
113
32.2
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
X
97.1
Aileron Therapeutics, Inc. Compensation Recovery Policy
X
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)
* Indicates management contract or compensatory plan.
+ In accordance with Item 601(b)(10)(iv) of Regulation S-K, certain information (indicated by “[**]”) has been excluded from this exhibit because it is both not material and private or confidential. A copy of the omitted portion will be furnished to the SEC upon request.
++ Confidential treatment has been requested and/or granted as to certain portions, which portions have been omitted and filed separately with the SEC.
# Certain schedules and similar attachments have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant undertakes to furnish supplemental copies of any of the omitted schedules upon request by the SEC.
^ SEC File No. 333-218474
114
SIGNAT URES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized .
Aileron Therapeutics, Inc.
Date: April 15, 2024
By:
/s/ Brian Windsor, Ph.D.
Brian Windsor, Ph.D.
President and Chief Executive Officer
(principal executive officer)
POWER OF ATTORNEY
Each person whose signature appears below constitutes and appoints Brian Windsor, Ph.D. and Charles T. Garner, each or any of them, such person's true and lawful attorney-in-fact and agent with full power of substitution and resubstitution for such person and in such person's name, place and stead, in any and all capacities, to sign any and all amendments to this report on Form 10-K, and to file the same with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing necessary or desirable to be done in and about the premises, as fully to all intents and purposes as such person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them or his or their substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities and on the dates indicated.
Name
Title
Date
/s/ Brian Windsor, Ph.D.
President, Chief Executive Officer and Director (principal executive officer)
April 15, 2024
Brian Windsor, Ph.D.
/s/ Charles T. Garner
Senior Vice President, Finance
(principal financial officer and principal accounting officer)
April 15, 2024
Charles T. Garner
/s/ Josef H. Von Rickenbach
Chairman of the Board of Directors
April 15, 2024
Josef H. Von Rickenbach
/s/ Manuel C. Aivado
Director
April 15, 2024
Manuel C. Aivado, M.D. Ph. D.
/s/ Reinhard J. Ambros, Ph.D.
Director
April 15, 2024
Reinhard J. Ambros, Ph.D.
/s/ William C. Fairey
Director
April 15, 2024
William C. Fairey
/s/ Alan Musso
Director
April 15, 2024
Alan Musso
115
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm (PCAOB ID 238)
F- 1
Report of Independent Registered Public Accounting Firm (PCAOB ID 688 )
F- 2
Consolidated Balance Sheets as of December 31, 2023 and 2022
F- 5
Consolidated Statements of Operations and Comprehensive Loss for the Years ended December 31, 2023 and 2022
F- 6
Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders’ Equity for the Years ended December 31, 2023 and 2022
F- 7
Consolidated Statements of Cash Flows for the Years ended December 31, 2023 and 2022
F- 8
Notes to Consolidated Financial Statements
F- 9
116
Report of Indepe ndent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Aileron Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the balance sheet of Aileron Therapeutics, Inc. (the “Company”) as of December 31, 2022, and the related statements of operations and comprehensive loss, of stockholders’ equity and of cash flows for the year then ended, including the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022, and the results of its operations and its cash flows for the year then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred losses and negative cash flows from operations and had an accumulated deficit that raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit of these financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
March 20, 2023
We served as the Company’s auditor from 2009 to 2023
F- 1
Report of Inde pendent Registered Public Accounting Firm
To the Shareholders and Board of Directors of
Aileron Therapeutics, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Aileron Therapeutics, Inc. (the “Company”) as of December 31, 2023, the related consolidated statements of operations and comprehensive loss, changes in convertible preferred stock and stockholders’ equity and cash flows for the year ended December 31, 2023, and the related notes (collectively referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023, and the results of its operations and its cash flows for the year ended December 31, 2023 in conformity with accounting principles generally accepted in the United States of America.
Explanatory Paragraph – Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 1, the Company has a significant working capital deficiency, has incurred significant losses and needs to raise additional funds to meet its obligations and sustain its operations. These conditions raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts
F- 2
and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Business Combination
Critical Audit Matter Description
As described in Note 3 to the financial statements, the Company acquired Lung Therapeutics, Inc. on October 31, 2023. This acquisition was accounted for as a business combination. We identified the evaluation of the acquisition-date fair value of the intangible assets acquired as a critical audit matter.
The principal consideration for our determination that the evaluation of the acquisition-date fair values of the intangible assets acquired was a critical audit matter is the high degree of subjective auditor judgment associated with evaluating management’s determination of the fair values of the acquired intangible assets, which is primarily due to the complexity of the valuation models used and the sensitivity of the underlying significant assumptions. The key assumptions used within the valuation models included prospective financial information such as future revenue growth and an applied discount rate. The calculated fair values are sensitive to changes in these key assumptions.
How the Critical Audit Matter was Addressed in the Audit
Our audit procedures related to the evaluation of acquisition-date fair values of intangible assets acquired included the following, among others:
• We evaluated the reasonableness of the purchase price allocation analysis from management and the third-party specialist engaged by management.
• We assessed the qualifications and competence of management and the third-party specialist.
• We evaluated the methodologies used to determine the fair values of the intangible assets.
F- 3
• We tested the assumptions used within the discounted cash flow models to estimate the fair values of the intangible assets, which included key assumptions such as the future revenue growth and the applied discount rate.
• We assessed the reasonableness of management’s forecast by inquiring with management to understand how the forecast was developed and comparing the projections to external sources, including industry trends and peer companies’ historical data.
• We involved our internal valuation specialist who assisted in the evaluation and testing performed on the reasonableness of significant assumptions to the models, including the applied discount rate.
/s/ Marcum LLP
Marcum LLP
We have served as the Company’s auditor since 2024.
New York, NY
April 15, 2024
F- 4
AILERON THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
December 31,
2023
December 31,
2022
Assets
Current assets:
Cash and cash equivalents
$
17,313
$
5,194
Investments
—
16,048
Prepaid expenses and other current assets
882
606
Restricted cash
25
25
Operating lease, right-of-use asset, current portion
46
—
Total current assets
18,266
21,873
Operating lease, right-of-use asset
—
40
Property and equipment, net
19
70
Goodwill
6,330
—
Intangible assets
79,200
—
Other non-current assets
2,193
24
Total assets
$
106,008
$
22,007
Liabilities, Convertible Preferred Stock and Stockholders’ Equity
Current liabilities:
Accounts payable
$
1,190
$
1,720
Accrued expenses and other current liabilities
3,147
1,631
Operating lease liabilities, current portion
48
33
Total current liabilities
4,385
3,384
Deferred tax liability
3,326
—
Total liabilities
7,711
3,384
Commitments and contingencies (Note 15)
Convertible preferred stock, $ 0.001 par value, 5,000,000 shares authorized at December 31, 2023 and at December 31, 2022; 24,610 shares issued and outstanding at December 31, 2023 and no shares issued and outstanding at December 31, 2022
91,410
—
Stockholders’ equity:
Common stock, $ 0.001 par value; 45,000,000 shares authorized at December 31, 2023 and December 31, 2022; 4,885,512 shares and 4,541,167 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively
91
91
Additional paid-in capital
295,376
291,365
Accumulated other comprehensive loss
( 63
)
( 48
)
Accumulated deficit
( 288,517
)
( 272,785
)
Total stockholders’ equity
6,887
18,623
Total liabilities, convertible preferred stock and stockholders’ equity
$
106,008
$
22,007
The accompanying notes are an integral part of these consolidated financial statements.
F- 5
AILERON THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Year Ended December 31,
2023
2022
Revenue
$
—
$
—
Operating expenses:
Research and development
3,991
17,967
General and administrative
11,357
9,680
Restructuring and other costs
928
—
Total operating expenses
16,276
27,647
Loss from operations
( 16,276
)
( 27,647
)
Other income (expense), net
544
318
Net loss
$
( 15,732
)
$
( 27,329
)
Net loss per share—basic and diluted
$
( 3.42
)
$
( 6.02
)
Weighted average common shares outstanding—basic and diluted
4,598,715
4,539,318
Comprehensive loss:
Net loss
$
( 15,732
)
$
( 27,329
)
Other comprehensive gain (loss):
Unrealized gain on short-term investments, net of tax of $ 0
48
( 35
)
Foreign currency translation adjustments
( 63
)
—
Total other comprehensive loss
( 15
)
( 35
)
Total comprehensive loss
$
( 15,747
)
$
( 27,364
)
The accompanying notes are an integral part of these consolidated financial statements.
F- 6
AILERON THERAPEUTICS, INC.
CONSOLIDATED STATEMENT OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS ’ EQUITY
(In thousands, except share data)
Convertible Series X Preferred Stock
Common Stock
Total
Shares
Amount
Shares
Amount
Additional
Paid-in
Capital
Accumulated
Other
Comprehensive
Loss
Accumulated
Deficit
Convertible Preferred Stock and Stockholders'
Equity
Balances at December 31, 2021
—
$
—
4,528,667
$
91
$
289,282
$
( 13
)
$
( 245,456
)
$
43,904
RSUs vested, net of shares repurchased for tax
—
—
12,500
—
—
—
—
—
Stock-based compensation expense
—
—
—
—
2,083
—
—
2,083
Unrealized loss on investments
—
—
—
—
—
( 35
)
—
( 35
)
Net loss
—
—
—
—
—
—
( 27,329
)
( 27,329
)
Balances at December 31, 2022
—
$
—
4,541,167
$
91
$
291,365
$
( 48
)
$
( 272,785
)
$
18,623
Issuance of common stock in connection with business acquisition
—
—
344,345
—
403
—
—
403
Issuance of Series X preferred stock in connection with business acquisition
19,903
74,615
—
—
—
—
—
74,615
Stock options assumed in connection with business acquisition
—
—
—
—
1,050
—
—
1,050
Common stock warrants assumed in connection with business acquisition
—
—
—
—
627
—
—
627
Issuance of Series X preferred stock in connection with the Financing, net of issuance costs of $ 855
4,707
16,795
—
—
—
—
—
16,795
Issuance of common stock warrants in connection with the Financing, net of issuance costs of $ 38
—
—
—
—
741
—
—
741
Stock-based compensation expense
—
—
—
—
1,190
—
—
1,190
Unrealized gain on short-term investments
—
—
—
—
—
48
—
48
Foreign currency translation adjustments
—
—
—
—
—
( 63
)
—
( 63
)
Net loss
—
—
—
—
—
—
( 15,732
)
( 15,732
)
Balances at December 31, 2023
24,610
$
91,410
4,885,512
$
91
$
295,376
$
( 63
)
$
( 288,517
)
$
98,297
The accompanying notes are an integral part of these consolidated financial statements.
F- 7
AILERON THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended December 31,
2023
2022
Cash flows from operating activities:
Net loss
$
( 15,732
)
$
( 27,329
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense
119
169
Net amortization of premiums and discounts on investments
32
( 208
)
Stock-based compensation expense
1,190
2,083
Gain on sale of property and equipment
( 42
)
—
Loss on disposition of property and equipment
6
—
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
51
1,613
Other assets
( 3
)
—
Accounts payable
( 4,982
)
510
Operating lease liabilities
( 65
)
( 129
)
Accrued expenses and other current liabilities
( 382
)
( 1,574
)
Net cash used in operating activities
( 19,808
)
( 24,865
)
Cash flows from investing activities:
Proceeds from sale of property and equipment
42
—
Purchases of investments
—
( 21,850
)
Proceeds from sales or maturities of investments
16,250
48,309
Acquisition, net of cash acquired
( 96
)
0
Net cash provided by investing activities
16,196
26,459
Cash flows from financing activities:
Proceeds from the Financing
15,794
—
Net cash provided by financing activities
15,794
—
Effect of exchange rate changes on cash and cash equivalents
( 63
)
—
Net increase in cash, cash equivalents and restricted cash
12,119
1,594
Cash, cash equivalents and restricted cash at beginning of year
5,219
3,625
Cash, cash equivalents and restricted cash at end of year
$
17,338
$
5,219
Cash and cash equivalents at end of year
$
17,313
$
5,194
Restricted cash at end of year
25
25
Cash, cash equivalents and restricted cash at end of year
$
17,338
$
5,219
Supplemental disclosure of non-cash investing and financing activities:
Unrealized gain on short-term investments
$
48
$
—
Fair value of common shares issued in the Lung Acquisition
$
403
$
—
Fair value of Series X Preferred Stock issued in the Lung Acquisition
$
74,615
$
—
Fair value of options assumed in the Lung Acquisition
$
1,050
$
—
Fair value of warrants assumed in the Lung Acquisition
$
627
$
—
The accompanying notes are an integral part of these consolidated financial statements.
F- 8
A ILERON THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL ST ATEMENTS
(Amounts in thousands, except share and per share data)
1. Nature of the Business
Aileron Therapeutics, Inc. (“Aileron” or the “Company”) was a clinical stage chemoprotection oncology company. The Company's product candidate, ALRN-6924, was a MDM2/MDMX dual inhibitor that leverages its proprietary peptide drug technology. In February 2023, the Company decided to terminate further development of ALRN-6924. Refer to Note 10 for more details on the restructuring event in 2023.
On October 31, 2023, Aileron acquired Lung Therapeutics, Inc. (“Lung Therapeutics” or "Lung") pursuant to an Agreement and Plan of Merger, dated October 31, 2023 (the “Lung Acquisition Agreement”), by and among the Company, AT Merger Sub I, Inc., a Delaware corporation and its wholly owned subsidiary, or First Merger Sub, AT Merger Sub II, LLC, a Delaware limited liability company and its wholly owned subsidiary, or Second Merger Sub, and Lung. Pursuant to the Lung Acquisition Agreement, First Merger Sub merged with and into Lung, pursuant to which Lung was the surviving entity and became its wholly owned subsidiary, or the First Merger. Immediately following the First Merger, Lung merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity, such merger, together with the First Merger, the Lung Acquisition. Lung was incorporated on November 13, 2012 under the laws of the state of Texas. Its principal offices are in Austin, Texas. Following the Lung Acquisition, the Company shifted its operating disease focus to advancing a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications with the potential to greatly improve patient outcomes over currently available treatments. Following expiration of the lease on March 31, 2024, the Company expects to operate virtually for the foreseeable future.
The Company is subject to risks and uncertainties common to clinical-stage companies in the biotechnology industry, including, but not limited to the risk that the Company never achieves profitability, the need for substantial additional financing, the risk of relying on third parties, risks of clinical trial failures, dependence on key personnel, protection of proprietary technology, and compliance with government regulations. The Company’s lead product candidate, LTI-03, is being developed for the treatment of Idiopathic Pulmonary Fibrosis (“IPF”) and has completed a healthy volunteer Phase 1a clinical trial. LTI-03 is currently in a Phase 1b clinical trial in IPF patients. The Company’s second product candidate, LTI-01, is in development for loculated pleural effusion (“LPE”). The Company has completed Phase 1b and Phase 2a clinical trials in LPE patients.
Liquidity and Going Concern
In accordance with Accounting Standards Update (“ASU”) No. 2014-15, Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying consolidated financial statements were issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the consolidated financial statements are issued. When substantial doubt exists, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the company’s ability to continue as a going concern. The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the consolidated financial statements are issued, and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved before the date that the consolidated financial statements are issued.
The Company’s consolidated financial statements have been prepared assuming that the Company will continue to operate as a going concern, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. Through December 31, 2023, the Company has financed its operations primarily through $ 145,467 in net proceeds from sales of common stock and warrants, $ 131,211 from sales of
F- 9
preferred stock prior to its initial public offering (“IPO”), and $ 34,910 from a collaboration agreement in 2010, and $ 18,429 in gross proceeds, less issuance costs of $ 893 , in connection with the financing following the Lung Acquisition, which included the conversion of certain convertible promissory notes in the aggregate principal amount of approximately $ 1,553 issued by Lung to Bios Partners prior to the closing of the Lung Acquisition at a 10 % discount to the per share price of the Series X non-voting convertible preferred stock (“Series X Preferred Stock”), or the Financing, and collectively with the Lung Acquisition, the Transactions.
After the Lung Acquisition, management believes that, based on the Company’s current operating plan, the Company’s cash and cash equivalents of $ 17,313 as of December 31, 2023, will enable Aileron to fund its operating expenses and capital expenditure requirements for at least six months following the date of this Annual Report on Form 10-K. Since its inception, the Company has not generated any revenue from product sales and have never generated an operating profit. The Company has incurred significant losses on an aggregate basis. The Company’s net losses were $ 15,732 and $ 27,329 for the years ended December 31, 2023 and 2022, respectively. A s of December 31, 2023, the Company had an accumulated deficit of $ 288,517 . These losses have resulted primarily from costs incurred in connection with research and development activities, licensing and patent investment and general and administrative costs associated with the Company's operations. In February 2023, the Company discontinued development of ALRN-6924 which substantially reduced its operating expenses. Notwithstanding these events, management expects to continue to incur operating losses for the foreseeable future until the Company completes development and approval of its product candidates. The Company will continue to fund its operations primarily through utilization of its current financial resources and additional raises of capital.
These conditions raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date those consolidated financial statements are issued. The Company plans to address these conditions by raising funds from its current investors, potential outside investors and other funding sources. However, there is no assurance that such funding will be available to the Company, will be obtained on terms favorable to the Company or will provide the Company with sufficient funds to meet its objectives. The Company’s funding estimates are based on assumptions that may prove to be wrong, and the Company could use its available capital resources sooner than it currently expects. The Company’s future viability is dependent on its ability to raise additional capital, enter into a financing, consummate a successful acquisition, merger, business combination, or a sale of assets or other transaction. If the Company becomes unable to continue as a going concern, it may have to liquidate its assets and the values it receives for its assets in liquidation or dissolution could be significantly lower than the values reflected in its consolidated financial statements.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and as amended by ASUs of the Financial Accounting Standards Board (“FASB”).
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries, Lung Therapeutics, LLC, Lung Therapeutics Australia Pty Ltd, and Lung Therapeutics Limited. All intercompany balances and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the accrual for research and development expenses, the value of stock-based
F- 10
compensation, the purchase price allocation for the Lung Acquisition, and the valuation of warrants. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates.
Foreign Currency Transactions
The functional currency for the Company’s wholly owned foreign subsidiary, Lung Therapeutics Australia Pty Ltd., is the United States dollar. All foreign currency transaction gains and losses are recognized in the consolidated statements of operations and comprehensive loss.
Concentration of Credit Risk and of Significant Suppliers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents. Periodically, the Company maintains balances in operating accounts above federally insured limits. The Company deposits its cash in financial institutions that it believes have high credit quality. The Company has not experienced any losses on such accounts and does not believe it is exposed to any significant credit risk on cash and cash equivalents.
The Company is dependent on third-party manufacturers to supply products for research and development activities of its programs, including preclinical and clinical testing. In particular, the Company relied on a small number of manufacturers to supply it with its requirements for the active pharmaceutical ingredients and formulated drugs related to these programs. These programs could have been adversely affected by a significant interruption in the supply of active pharmaceutical ingredients and formulated drugs.
Cash and Cash Equivalents
The Company maintains cash balances in various accounts, including those insured by the Federal Deposit Insurance Corporation (FDIC). The FDIC provides insurance coverage up to applicable limits for deposits held in participating financial institutions.
The Company considers all short-term, highly liquid investments with original maturities of 90 days or less at the acquisition date to be cash equivalents. The Company’s cash equivalents are comprised of funds held in money market accounts and are measured at fair value on a recurring basis .
Restricted Cash
As of December 31, 2023 and December 31, 2022 , restricted cash of $ 25 consisted of cash deposited in a separate restricted bank account as a security deposit for the Company’s corporate credit cards.
Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. ASC 820, Fair Value Measurement (“ASC 820”), establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable.
• Level 1—Quoted prices in active markets for identical assets or liabilities.
• Level 2—Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
F- 11
• Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.
The Company’s cash equivalents are carried at fair value, determined according to the fair value hierarchy described above (see Note 3). The carrying values of the Company’s accounts payable and accrued expenses approximate their fair value due to the short-term nature of these liabilities.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives:
Computer equipment and software
Furniture and fixtures
3 to 5 years
7 years
Expenditures for repairs and maintenance of assets are charged to expense as incurred. Upon retirement or sale, the cost and related accumulated depreciation and amortization of assets disposed of are removed from the accounts and any resulting gain or loss is included in the consolidated statements of operations and comprehensive loss.
Leases
The Company accounts for leases under ASC Topic 842, Leases (“ASC 842”). Under ASC 842, at inception of a contract, the Company determines whether an arrangement is or contains a lease. For all leases, the Company determines the classification as either operating leases or financing leases. Operating leases are included in operating lease right-of-use assets and operating lease liabilities in the Company’s consolidated balance sheets.
Lease recognition occurs at the commencement date and lease liability amounts are based on the present value of lease payments over the lease term. The lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. If a lease does not provide information to determine an implicit interest rate, the Company uses its incremental borrowing rate in determining the present value of lease payments. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments under the lease. ROU assets also include any lease payments made prior to the commencement date and exclude lease incentives received. Operating lease payments are expensed using the straight-line method as a general and administrative expense over the lease term. The depreciable life of assets and leasehold improvements are limited by the expected lease term unless there is a transfer of title or purchase option reasonably certain of exercise. The Company has elected to apply the practical short-term expedient to leases with a lease term of 12 months or less, which does not subject the leases to capitalization.
The Company has an operating lease of office space, which has a remaining lease term of less than one year and includes one or more options to renew or terminate early. The Company determines if an arrangement contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at commencement date. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued lease payments, initial direct costs paid or incentives received. The Company’s leases do not contain an implicit rate, and therefore the Company uses an estimated incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Options to extend or terminate the lease are reflected in the calculation when it is reasonably certain that the option will be exercised. The Company has elected to account for lease and non-lease components as a single lease component, however non-lease components that are variable, such as common area maintenance and utilities, are generally paid separately from rent based on actual costs incurred and therefore are not
F- 12
included in the right-of-use asset and operating lease liability and are reflected as an expense in the period incurred. Leases with an initial term of 12 months or less are not recorded on the consolidated balance sheet.
Goodwill and Indefinite-Lived Intangible Assets
Goodwill represents the excess of the purchase price of an acquired business over the amount assigned to the assets acquired and liabilities assumed. The Company's indefinite-lived intangible assets, which consist of in-process research and development ("IPR&D"), acquired in the Lung Acquisition were recorded at fair value on their acquisition date. Goodwill and indefinite-lived intangible assets are not amortized but are subject to impairment testing on an annual basis as of December 31 or more frequently if events or circumstances indicate a potential impairment. The Company accounts for goodwill and indefinite-lived intangible assets in accordance with ASC 350, Intangibles Goodwill and Other, and Accounting Standards Update, or ASU 2017-04, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment. The Company’s goodwill and intangible assets are deductible for tax purposes.
Impairment of Long-Lived Assets
Long-lived assets consist of property and equipment, goodwill and intangible assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows.
In performing the Company’s annual goodwill impairment test, the Company is permitted to first assess qualitative factors to determine whether it is more likely than not that the fair value of the Company’s reporting unit exceeds its carrying amount, including goodwill. In performing the qualitative assessment, the Company considers certain events and circumstances specific to the reporting unit and to the entity as a whole, such as macroeconomic conditions, industry and market considerations, overall financial performance and cost factors when evaluating whether it is more likely than not that the fair value of the reporting unit exceeds its carrying amount. The Company is also permitted to bypass the qualitative assessment and proceed directly to the quantitative assessment. If the Company chooses to undertake the qualitative assessment and concludes that it is more likely than not that the fair value of the reporting unit is less than its carrying amount, the Company would then proceed to the quantitative impairment assessment. In the quantitative assessment, the Company compares the fair value of the reporting unit to its carrying amount, which includes goodwill. If the fair value exceeds the carrying value, no impairment loss exists. If the fair value is less than the carrying amount, a goodwill impairment loss is measured and recorded.
To date, the Company has no t recorded any impairment losses on long-lived assets. For additional details regarding goodwill and intangible assets, refer to Note 7.
Series X Convertible Preferred Stock
The Company has classified its Series X convertible preferred stock, referred to as Series X Preferred Stock, as temporary equity in the accompanying consolidated balance sheets due to terms that allow for redemption of the shares in cash upon certain change in control events that are outside of the Company’s control, including sale or transfer of control of the Company as holders of the Series X Preferred Stock could cause redemption of the shares in these situations. The Company did not accrete the carrying values of the preferred stock to the redemption values since a liquidation event was not considered probable as of December 31, 2023. Subsequent adjustments of the carrying values to the ultimate redemption values will be made only when it becomes probable that such a liquidation event will occur .
F- 13
Research and Development Costs
Research and development costs are expensed as incurred. Research and development expenses are comprised of costs incurred in performing research and development activities, including stock-based compensation and benefits, facilities costs, costs of clinical trials, sponsored research, manufacturing, and external costs of outside vendors engaged to conduct preclinical development activities and trials.
Costs incurred in obtaining technology licenses are immediately recognized as research and development expense if the technology licensed has not reached technological feasibility and has no alternative future uses.
The Company has entered into various research and development and other agreements with commercial firms, researchers, universities, and others for provisions of goods and services. These agreements are generally cancelable, and the related costs are recorded as research and development expenses as incurred. Research and development expenses include costs for salaries, employee benefits, subcontractors, facility-related expenses, depreciation and amortization, stock-based compensation, laboratory supplies, and external costs of outside vendors engaged to conduct discovery, preclinical and clinical development activities, and clinical trials as well as to manufacture clinical trial materials, and other costs. The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies or clinical trials, including the phase or completion of events, invoices received and contracted costs. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ materially from the Company’s estimates. Nonrefundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such prepaid expenses are recognized as an expense when the goods have been delivered or the related services have been performed, or when it is no longer expected that the goods will be delivered, or the services rendered.
Upfront payments, milestone payments and annual maintenance fees under license agreements are expensed in the period in which they are incurred in the consolidated statements of operations and comprehensive loss.
Patent Costs
All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses.
Accounting for Stock-Based Compensation
The Company measures all stock options and other stock-based awards granted to employees, directors and non-employee consultants based on the fair value on the date of the grant and recognizes compensation expense of those awards, net of forfeitures, over the requisite service period, which is generally the vesting period of the respective award. The Company applies the straight-line method of expense recognition to all awards with only service-based vesting conditions and applies the graded vesting method to all awards with performance-based vesting conditions or both service-based and performance-based vesting conditions.
The Company recognizes compensation expense for only the portion of awards that are expected to vest. The Company accounts for forfeitures as they occur. For performance-based awards, the Company does not recognize expense until the underlying vesting conditions are deemed to be probable of occurrence.
The Company classifies share-based compensation expenses in its statement of operations and comprehensive loss in the same manner in which the award recipient's payroll costs are classified or in which the award recipient's service payments are classified, either to general and administrative expenses or research and development expenses.
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company estimates its expected stock volatility based on the historical volatility of its own traded stock price. For options with service-based vesting conditions, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of
F- 14
stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The quoted market price of the Company’s common stock is used to estimate the fair value of the stock-based awards at grant date.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse.
The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of the deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense. Changes in valuation allowances from period to period are included in the Company’s tax provision in the period of change. Potential for recovery of deferred tax assets is evaluated by estimating the future taxable profits expected and considering prudent and feasible tax planning strategies.
The Company accounts for uncertainty in income taxes recognized in the financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate as well as the related net interest and penalties.
Inflation Reduction Act of 2022
On August 16, 2022, the Inflation Reduction Act of 2022 (the “IR Act”) was signed into federal law. The IR Act provides for, among other things, a new U.S. federal 1 % excise tax on certain repurchases of stock by publicly traded U.S. domestic corporations and certain U.S. domestic subsidiaries of publicly traded foreign corporations occurring on or after January 1, 2023. The excise tax is imposed on the repurchasing corporation itself, not its shareholders from which shares are repurchased. The amount of the excise tax is generally 1 % of the fair market value of the shares repurchased at the time of the repurchase. However, for purposes of calculating the excise tax, repurchasing corporations are permitted to net the fair market value of certain new stock issuances against the fair market value of stock repurchases during the same taxable year. In addition, certain exceptions apply to the excise tax. The U.S. Department of the Treasury (the “Treasury”) has been given authority to provide regulations and other guidance to carry out and prevent the abuse or avoidance of the excise tax.
Any redemption or other repurchase that occurs after December 31, 2022, in connection with a business combination, extension vote or otherwise, may be subject to the excise tax. Whether and to what extent the Company would be subject to the excise tax in connection with a business combination, extension vote or otherwise would depend on a number of factors, including (i) the fair market value of the redemptions and repurchases in connection with the business combination, extension or otherwise, (ii) the structure of a business combination, (iii) the nature and amount of any private investment in public equity ( “PIPE”) or other equity issuances in connection with a business combination (or otherwise issued not in connection with a business combination but issued within the same taxable year of a business combination) and (iv) the content of regulations and other guidance from the Treasury. In addition, because the excise tax would be payable by the Company and not by the redeeming holder, the mechanics of any required payment of the excise tax have not been determined. The foregoing could cause a reduction in the cash available on hand to complete a business combination and in the Company’s ability to complete a business combination.
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Segment Information
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on developing novel therapies for the treatment of orphan pulmonary and fibrosis indications with no approved or limited effective treatments . All of the Company’s tangible assets are held in the United States. The Company views its operations and manages its business in one operating segment operating exclusively in the United States.
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that result from transactions and economic events other than those with stockholders. The Company’s other comprehensive loss in all periods presented includes unrealized gains (losses) on available-for-sale investments and foreign currency translation adjustments.
Net Loss per Share
Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting loss per share attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities. Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period, including potential dilutive common shares. For purpose of this calculation, outstanding options and warrants to purchase common stock are considered potential dilutive common shares.
Acquisition Accounting
The fair value of the consideration exchanged in a business combination is allocated to tangible assets and identifiable intangible assets acquired and liabilities assumed at acquisition date fair value. Goodwill is measured as the excess of the consideration transferred over the net fair value of identifiable assets acquired and liabilities assumed. The accounting for an acquisition involves a considerable amount of judgment and estimation. Cost, income, market or a combination of approaches may be used to establish the fair value of consideration exchanged, assets acquired, and liabilities assumed, depending on the nature of those items. The valuation approach is determined in accordance with generally accepted valuation methods. Key areas of estimation and judgment may include the selection of valuation approaches, cost of capital, market characteristics, cost structure, impacts of synergies, and estimates of terminal value, among other factors.
While the Company uses estimates and assumptions as part of the purchase price allocation process to estimate the fair value of assets acquired and liabilities assumed, estimates are inherently uncertain and subject to refinement. During the measurement period, which may be up to one year from the acquisition date, the Company may record adjustments to the assets acquired and liabilities assumed, with a corresponding offset to goodwill, to the extent that adjustments are identified to the preliminary purchase price allocation. Upon conclusion of the measurement period, or final determination of the value of the assets acquired and liabilities assumed, whichever comes first, any subsequent adjustments are recorded to results of operations.
Recently Adopted Accounting Pronouncements
On January 1, 2023, the Company adopted ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, for the fiscal year beginning January 1, 2023 using the modified retrospective approach, and no cumulative effect adjustment to accumulated deficit was needed as of the adoption date. Additionally, no prior period amounts were adjusted. The new standard adjusts the accounting for assets held on an amortized cost basis, including short-term investments accounted for as available-for-sale, and receivables. The standard eliminates the probable initial recognition threshold and requires an entity to reflect its current estimate of all expected credit losses. The allowance for credit losses is a valuation account that is deducted from the amortized
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cost basis of the financial assets to present the net amount expected to be collected. The adoption of this standard did no t have a material impact on the Company’s consolidated financial statements and related disclosures.
Accounting Pronouncements Not Yet Adopted
In October 2023, the FASB issued ASU 2023-06—Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, to clarify or improve disclosure and presentation requirements of a variety of Topics. ASU 2023-06 adds 14 of the 27 identified disclosure or presentation requirements to the Codification. However, each amendment in the ASU will only become effective if the SEC removes the related disclosure or presentation requirement from its existing regulations by June 30, 2027. The effective dates of ASU 2023-06 will depend, in part, on whether an entity is already subject to the SEC’s current disclosure requirements. For such entities and those that must “file or furnish financial statements with or to the SEC in preparation for the sale of or for purposes of issuing securities that are not subject to contractual restrictions on transfer,” the effective date for each amendment will be the date on which the SEC’s removal of that related disclosure requirement from Regulation S-X or Regulation S-K becomes effective, with early adoption prohibited. For all other entities, the amendments will be effective two years after the date of such removal. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In November 2023, the FASB issued ASU 2023-07—Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, to improve the disclosures about a public entity’s reportable segments and address requests from investors for additional, more detailed information about a reportable segment’s expenses. All public entities will be required to report segment information in accordance with the new guidance starting in annual periods beginning after December 15, 2023. The Company plans to adopt the ASU for the fiscal year beginning January 1, 2024. Since the Company has only one reportable segment, the Company will need to disclose the title and position of the chief operating decision maker (“CODM”) and an explanation of how the CODM uses the reported measures of segment profit or loss in assessing segment performance and deciding how to allocate resources, as well as disclose, on an annual and interim basis, significant segment expenses that are regularly provided to the CODM. The Company is currently assessing the effect of this ASU on its consolidated financial statements and related disclosures.
In December 2023, the FASB issued ASU 2023-09—Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information as well as certain other amendments to improve the effectiveness of income tax disclosures. The amendments in this update are effective for annual periods beginning after December 15, 2024. The Company does not expect adoption of this ASU to have a material impact on its results of operations, financial condition, and its consolidated financial statements other than adding new disclosures, which the Company is currently evaluating, as the Company has not recorded any net tax provision for the periods presented due to the losses incurred and the need for a full valuation allowance on net deferred tax assets.
Other accounting standards that have been issued or proposed by the FASB or other standards-setting bodies that do not require adoption until a future date are not expected to have a material impact on the Company’s consolidated financial statements and related disclosures upon adoption.
3. Business Acquisition
On October 31, 2023, Aileron acquired 100 % of Lung, pursuant to the Lung Acquisition Agreement. At the closing of the Lung Acquisition, Aileron issued to the stockholders of Lung 344,345 shares of its common stock (excluding 221 fractional shares from the total 344,566 shares pursuant to the Lung Acquisition Agreement) and 19,903 shares of its newly designated Series X Preferred Stock (excluding 238 fractional shares from the total 20,141 shares pursuant to the Lung Acquisition Agreement). Each share of Series X Preferred Stock is convertible into 1,000 shares of common stock. The Company paid $ 290 cash in lieu of fractional shares of both common stock and Series X Preferred Stock. In addition, Aileron assumed all Lung's stock options ( 1,780,459 ) and all warrants ( 726,437 )
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exercisable for Lung common stock immediately outstanding prior to the closing of the Lung Acquisition, each subject to adjustment pursuant to the terms of the Lung Acquisition Agreement.
Immediately following the closing of the Lung Acquisition, on October 31, 2023, Aileron entered into a Stock and Warrant Purchase Agreement (the “Purchase Agreement” or the "PIPE") with a group of accredited investors, pursuant to which Aileron issued and sold (i) an aggregate of 4,707 shares of Series X Preferred Stock, and (ii) warrants (the “Warrants”) to purchase up to an aggregate of 2,353,500 shares of Aileron common stock (the “Warrant Shares”), for an aggregate purchase price of approximately $ 18,429 , which included the conversion of certain convertible promissory notes in the aggregate principal amount of $ 1,553 issued by Lung to Bios Partners, the majority stockholder of Lung prior to the closing of the Lung Acquisition, at a 10 % discount to the per share price of the Series X Preferred Stock. The Financing closed on November 2, 2023. Subject to stockholder approval for the conversion rights of the Series X Preferred Stock, each share of Series X Preferred Stock is convertible into 1,000 shares of common stock.
The net proceeds from the Financing of approximately $ 17,536 are expected to be used to advance Aileron’s clinical development pipeline, business development activities, working capital and other general corporate purposes.
The Lung Acquisition was accounted for under the acquisition method of accounting under ASC 805. Under the acquisition method, the total purchase price of the acquisition is allocated to the net tangible and identifiable intangible assets acquired and liabilities assumed based on the fair values as of the date of the acquisition. Consideration transferred is the sum of the acquisition-date fair values of the assets transferred, the liabilities incurred by the acquirer to the former owners of the acquiree, and the equity interests issued by the acquirer to the former owners of the acquiree (except for the measurement of share-based payment awards). The total purchase price consideration consisted of the following:
Fair value of common stock issued to Lung stockholders
$
403
Fair value of Series X Preferred Stock issued to Lung stockholders
74,615
Cash in lieu of fractional shares
290
Fair value of the options assumed
1,050
Fair value of the warrants assumed
627
Total purchase price consideration
$
76,985
The Company recorded the assets acquired and liabilities assumed as of the date of the Lung Acquisition based on the information available at that date. The following table presents the allocation of the purchase price to the estimated fair values of the assets acquired and liabilities assumed as of the Lung Acquisition date:
Assets acquired:
Cash and cash equivalents
$
194
Prepaid expenses and other current assets
2,465
Property and equipment, net
3
Operating right-of-use assets
76
Goodwill
6,330
Indefinite-lived intangible assets
79,200
Other assets
27
88,295
Liabilities assumed:
Accounts Payable
4,452
Accrued expenses and other current liabilities
1,899
Operating lease liabilities, current
80
Convertible notes payable
1,553
Deferred tax liability
3,326
11,310
Net assets acquired
$
76,985
Pro Forma Financial Information
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The following pro forma financial information reflects the consolidated results of operations of the Company for the years ended December 31, 2023 and 2022, as if the Lung Acquisition had taken place on January 1, 2022. The unaudited pro forma financial information is not necessarily indicative of the results of operations as they would have been had the transactions been effected on the assumed date.
Year Ended December 31,
2023
2022
Total net revenue
$
153
$
688
Net loss
( 28,232
)
( 51,610
)
The unaudited pro forma financial information above gives effect primarily to the following:
• The exclusion of Lung Acquisition related transaction costs from the year ended December 31, 2023, and the addition of these items to the year ended December 31, 2022.
4. Fair Value of Financial Assets
The following tables present information about the Company’s assets that are measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values:
December 31,
2023
Level 1
Level 2
Level 3
Total
Cash equivalents:
Money market funds
$
10,322
$
—
$
—
$
10,322
$
10,322
$
—
$
—
$
10,322
December 31,
2022
Level 1
Level 2
Level 3
Total
Cash equivalents:
Money market funds
$
1,661
$
—
$
—
$
1,661
Investments:
Commercial paper
—
12,814
—
12,814
Treasury bills
—
3,234
—
3,234
$
1,661
$
16,048
$
—
$
17,709
During the years ended December 31, 2023 and 2022, there were no transfers between levels.
5. Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following:
December 31,
2023
2022
Prepaid research and development
$
207
$
—
Other current assets
675
606
Total prepaid expenses and other current assets
$
882
$
606
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6. Property and Equipment, Net
Property and equipment, net consisted of the following:
December 31,
2023
2022
Computer equipment and software
$
323
$
340
Furniture and fixtures
54
—
377
340
Less: Accumulated depreciation and amortization
( 358
)
( 270
)
$
19
$
70
Depreciation expense for the years ended December 31, 2023 and 2022 w as $ 49 and $ 169 , respectively . During the year ended December 31, 2023, the Company received payment for disposed, fully depreciated assets, resulting in a gain on sales of $ 42 .
7. Goodwill and Indefinite-Lived Intangible Assets
$ 6,330 of goodwill and $ 79,200 of indefinite-lived intangible assets acquired in the Lung Acquisition were recorded at fair value on the Lung Acquisition date (refer to Note 3 for more information). The Company performed a qualitative assessment of goodwill and indefinite-lived intangible assets for potential impairment as of December 31, 2023, and concluded that there was no goodwill or intangible assets impairment as of December 31, 2023.
8. Other Assets
Other assets consisted of the following:
December 31,
2023
2022
Non-current prepaid research and development
$
2,140
$
—
Other assets
53
24
Total other non-current assets
$
2,193
$
24
9. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following:
December 31,
2023
2022
External research and development services
$
1,110
$
533
Payroll and payroll-related costs
1,178
425
Professional fees
653
492
Other
206
181
Total accrued expenses and other current liabilities
$
3,147
$
1,631
10. Restructuring and Other Costs
On February 16, 2023, the Board of Directors of the Company determined to reduce the Company’s remaining workforce from nine to three full-time employees. The determination to effect the workforce reduction was made in connection with the Company’s decision to terminate its Phase 1b breast cancer trial of ALRN-6924 and further development of ALRN-6924.
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As a result of the above restructuring initiatives, the Company incurred restructuring-related charges of $ 928 for the year ended December 31, 2023. Restructuring-related charges were comprised of one-time termination costs in connection with the reduction-in-workforce, including severance, benefits, and related costs.
The Company paid all restructuring-related charges during the year ended December 31, 2023.
11. Preferred Stock
As of December 31, 2023, the Company had 5,000,000 shares of preferred stock, par value $ 0.001 per share, authorized, out of which 24,610 shares of Series X Preferred Stock were issued and outstanding. As of December 31, 2022, the Company had 5,000,000 shares of preferred stock, par value $ 0.001 per share, authorized, and no shares of preferred stock issued or outstanding.
On October 31, 2023 Aileron acquired Lung. Under the terms of the Lung Acquisition Agreement, at the closing of the Lung Acquisition, Aileron issued to the stockholders of Lung 344,345 shares of the common stock of Aileron, par value $ 0.001 per share, and 19,903 shares of Series X Preferred Stock.
Immediately following the closing of the Lung Acquisition, on October 31, 2023, Aileron entered into the Purchase Agreement with a group of accredited investors, pursuant to which Aileron issued and sold 4,707 shares of Series X Preferred Stock and Warrants to purchase up to an aggregate of 2,353,500 shares of Aileron common stock. Refer to Note 3 for more details on the Financing in connection with the Purchase Agreement.
Since the Series X Preferred Stock was sold as a unit with the Warrants according to the Purchase Agreement, the proceeds received were allocated to each instrument on a relative fair value basis. Total gross proceeds of $ 18,429 reduced by $ 893 of the issuance costs were allocated as follows: $ 16,795 to the Series X Preferred Stock and $ 741 to the Warrants. The Series X Preferred Stock and the Warrants issued in the Financing were recorded at par value of $ 0.001 .
The Company evaluated the Series X Preferred Stock for liability classification in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity ("ASC 480"), and determined that equity treatment was appropriate because the Series X Preferred Stock did not meet the definition of the liability instruments. Specifically, the Series X Preferred Stock is not mandatorily redeemable and does not embody an obligation to buy back the shares outside of the Company’s control in a manner that could require the transfer of assets. The Company determined that the Series X Preferred Stock would be recorded as temporary equity, based on the guidance of ASC 480, given that it is contingently redeemable (see below).
Subject to stockholders’ approval, each share of Series X Preferred Stock is convertible into 1,000 shares of Common Stock. The preferences, rights, and limitations initially applicable to the Series X Preferred Stock are set forth in the Certificate of Designation.
The Series X Preferred Stock has the following characteristics:
Voting
Except as otherwise required by law, the Series X Preferred Stock does not have voting rights. However, as long as any shares of Series X Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series X Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series X Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Certificate of Incorporation or by-laws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, if such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series X Preferred Stock, (ii) issue further shares of Series X Preferred Stock or increase or decrease (other than by conversion) the number of authorized shares of Series X Preferred Stock, or (iii) enter into any agreement with respect to any of the foregoing. Additionally, the approval of the holders of a
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majority of the Series X Preferred Stock is required for certain change of control transactions, provided that this approval right will terminate upon stockholders’ approval of the conversion proposal.
Dividends
Holders of Series X Preferred Stock are entitled to receive dividends on shares of Series X Preferred Stock equal, on an as-if-converted-to-common-stock basis, and in the same form as dividends actually paid on shares of the common stock. Such dividends are not cumulative. Since the Company’s inception, no dividends have been declared or paid.
Liquidation, dissolution or winding up
The Series X Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.
Upon liquidation, dissolution or winding up of the Company, the Series X preferred stockholders shall be entitled to receive an equivalent amount of distributions as would be paid on the common stock underlying the Series X Preferred Stock, determined on an as-converted basis, pari passu with any distributions to the common stock shareholders.
Conversion
Subject to stockholders’ approval of the conversion proposal, the Series X Preferred Stock is convertible into common stock at a rate of 1,000 shares of common stock for every one share of Series X Preferred Stock that is converted. The Series X Preferred Stock is subject to certain beneficial ownership limitations, including that a holder of Series X Preferred Stock is prohibited from converting shares of Series X Preferred Stock into shares of common stock if, as a result of such conversion, such holder (together with its affiliates and any other persons acting as a group together with the holder or any of its affiliates) would beneficially own more than a specified percentage (to be initially set at 19.99 % and thereafter adjusted by the holder to a number not to exceed 19.99 %) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion.
At the 2023 Annual Meeting on February 28, 2024, the Company’s stockholders approved the issuance of shares of common stock, upon conversion of its outstanding Series X Preferred Stock. Refer to Note 18 for more details on the 2023 Annual Meeting.
Redemption
Shares of the Series X Preferred Stock are not redeemable at the election of the holder except for in the event the Company would have been unable to obtain an affirmative stockholder vote at the 2023 Annual Meeting to permit conversion, each holder of Series X Preferred Stock would have been entitled to elect, at the holder’s option, to have the shares of Series X Preferred Stock be redeemed by the Company and equal to the estimated fair value of the Series X Preferred Stock share at the time of redemption. Due to this redemption feature, as of December 31, 2023, the Series X Preferred Stock was classified within temporary equity on the consolidated balance sheet.
Maturity
The Series X Preferred Stock shall be perpetual unless converted.
12. Common Stock
As of December 31, 2023 and 2022, the Company was authorized to issue 45,000,000 shares of common stock, par value $ 0.001 per share. As of December 31, 2023, the Company had 4,885,512 shares of common stock issued and outstanding. As of December 31, 2022, the Company had 4,541,167 shares of common stock issued and outstanding.
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Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Company’s board of directors, if any. As of December 31, 2023 and 2022, no dividends had been declared.
In the event of liquidation or dissolution, the holders of the common stock are entitled to receive proportionately all assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock.
Issuance of Common Stock
As disclosed above, on October 31, 2023, the Company issued to the stockholders of Lung 344,345 shares of the common stock of Aileron, par value $ 0.001 per share, under the terms of the Lung Acquisition Agreement. In addition, Aileron assumed (i) all Lung stock options immediately outstanding prior to the First Merger, each becoming an option for common stock subject to adjustment pursuant to the terms of the Lung Acquisition Agreement, and (ii) all warrants exercisable for Lung common stock immediately outstanding prior to the First Merger, each becoming a warrant to purchase common stock, subject to adjustment pursuant to the terms of the Lung Acquisition Agreement. Immediately following the closing of the Lung Acquisition, the Company had 4,885,512 shares of common stock issued and outstanding.
As disclosed in the Note 3 above, immediately following the closing of the Lung Acquisition, on October 31, 2023, Aileron entered into the Purchase Agreement with a group of accredited investors, pursuant to which Aileron issued and sold 4,707 shares of Series X Preferred Stock and warrants to purchase up to an aggregate of 2,353,500 shares of Aileron common stock. The exercise price of the Warrants is $ 4.89 per share, subject to certain price and share adjustments, including for stock splits, stock dividends, recapitalizations, subdivisions, combinations, reclassifications, noncash distributions, and cash dividends. The Warrants will be exercisable any time after the later of May 2, 2024, the date the requisite stockholder approval is obtained, and on or prior to May 2, 2027. Payment for Warrant shares upon exercise of the Warrants may be (i) in cash or (ii) in the event that there is no registration statement available for the resale of Warrant shares, by cashless exercise.
Under the terms of the Warrants, the Company shall not effect the exercise of any portion of any Warrant, and a holder shall not have the right to exercise any portion of any Warrant, to the extent that after giving effect to such exercise, the holder (together with its affiliates and any other persons acting as a group together with the holder or any of its affiliates), would beneficially own in excess of a percentage elected by the holder up to 19.99 % of the number of shares of common stock outstanding immediately after giving effect to such exercise, as such percentage ownership is determined in accordance with the terms of the Warrants. However, any holder may, upon written notice to the Company, increase or decrease such percentage to any other percentage not in excess of 19.99 %; provided that any increase or decrease in such percentage will not be effective until 61 days after such notice is delivered to the Company.
The Company has assessed the Warrants for appropriate equity or liability classification and determined the Warrants are freestanding instruments that do not meet the definition of a liability pursuant to ASC 480 and do not meet the definition of a derivative pursuant to ASC 815, Derivatives and Hedging (“ASC 815”) . The Warrants are indexed to the Company’s common stock and meet all other conditions for equity classification under ASC 480 and ASC 815. Accordingly, the Warrants are classified as equity and accounted for as a component of additional paid-in capital at the time of issuance. The Warrants were initially recognized at their relative fair value in the amount of $ 741 at the time of issuance determined using Black-Scholes option-pricing model and will not be remeasured.
Reverse Stock Split
The Company’s stockholders approved a reverse stock split of the Company’s common stock on June 15, 2022. The Company effected the Reverse Stock Split on November 10, 2022. Pursuant to the Reverse Stock Split, every 20 shares of the Company’s issued and outstanding shares of common stock were automatically combined into one issued and outstanding share of common stock, without any change in the par value per share of the common stock. The Reverse Stock Split reduced the authorized number of shares of common stock from 300,000,000 to 15,000,000 and, pursuant to the certificate of amendment, such reduced authorized number of shares of common stock was subsequently multiplied by three, such that following the Reverse Stock Split the Company has 45,000,000 shares of
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common stock authorized. The Reverse Stock Split affected all issued and outstanding shares of the Company’s common stock, and the respective numbers of shares of common stock underlying the Company’s outstanding stock options, outstanding warrants and the Company’s equity incentive plans were proportionately adjusted. All share and per share amounts disclosed give effect to the Reverse Stock Split on a retroactive basis.
As of December 31, 2023, 4,885,512 shares of common stock were issued and outstanding, no shares were held in treasury, and 24,610 shares of Series X Preferred Stock were issued and outstanding. In addition, as of December 31, 2023, there were:
• 24,847,000 shares of common stock reserved for issuance upon conversion of the Series X Preferred Stock;
• 2,212,102 shares of common stock issuable upon the exercise of options under existing equity incentive plans, of which 1,780,459 options were assumed through the Lung Acquisition;
• 416,617 and 7,500 shares of common stock reserved for issuance under the 2021 Plan and 2017 Employee Stock Purchase Plan, respectively, as well as any automatic increases in the number of shares of the common stock reserved under these plans; and
• 3,726,696 shares of common stock reserved for issuance upon exercise of outstanding warrants. The warrants consist of (i) warrants to purchase 646,759 shares of the Company’s common stock, with an exercise price of $ 40.00 per share, which were issued in the April 2019 private placement, which expire on April 2, 2024 ; (ii) warrants to purchase 726,437 shares of the Company’s common stock, with an exercise price of $ 5.66 , which expire on May 20, 2029 , which were assumed in connection with the Lung Acquisition, and (iii) warrants to purchase 2,353,500 shares of the Company’s common stock, which were issued and sold in the Financing as described above.
Accordingly, as of December 31, 2023, out of the 45,000,000 shares of common stock presently authorized, 36,095,427 shares are issued and outstanding or reserved for issuance and 8,904,573 shares of common stock remain available for future issuance.
13. Stock-Based Awards
As of December 31, 2023, the Company had five equity compensation plans, each of which was approved by its stockholders: 2006 Equity Incentive Plan, as amended (the “2006 Plan”), 2016 Stock Incentive Plan (the “2016 Plan”), 2017 Stock Incentive Plan (the “2017 Plan”), 2021 Stock Incentive Plan (the “2021 Plan”), and 2017 Employee Stock Purchase Plan (the “2017 ESPP”). The Company also assumed Lung’s 2013 Long-Term Incentive Plan (the “2013 Plan”) as a result of the Lung Acquisition.
As of December 31, 2023, the Company had 9,482 shares to be issued upon exercise of outstanding options under the 2006 Plan; 8,404 shares to be issued upon exercise of outstanding options under the 2016 Plan, and 130,903 shares to be issued upon exercise of outstanding options under the 2017 Plan. No outstanding options under the 2006 Plan, the 2016 Plan, or the 2017 Plan as of December 31, 2023. As such, no shares remained available for future issuance under the 2006 Plan, the 2016 Plan, or the 2017 Plan as of December 31, 2023.
Shares that are expired, terminated, surrendered or canceled without having been fully exercised will be available for future awards. In addition, shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of shares of common stock available for the grant of awards.
The exercise price for stock options granted may not be less than the fair market value of the common stock as of the date of grant.
2021 Stock Incentive Plan
The Company’s 2021 Plan was approved by the Company’s stockholders on June 15, 2021 and became effective on June 16, 2021. Under the 2021 Plan, the Company may grant incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, awards of restricted stock units and other stock-based awards. The
F- 24
Company’s employees, officers, directors, consultants and advisors are eligible to receive awards under the 2021 Plan; however, incentive stock options may only be granted to employees. The 2021 Plan is administered by the Company’s Board of Directors (the “Board”) or, at the discretion of the Board, by a committee of the Board. The number of shares of common stock covered by options and the date those options become exercisable, type of options to be granted, exercise prices, vesting and other restrictions are determined at the discretion of the Board, or its committee if so delegated.
Stock options granted under the 2021 Plan with service-based vesting conditions generally vest over four years and may not have a duration in excess of ten years , although options have been granted with vesting terms of less than four years .
The total number of shares of common stock that may be issued under the 2021 Plan was 840,254 as of December 31, 2023, of which 416,617 shares remained available for grant. The Company initially reserved 625,000 shares of common stock, plus the number of shares of common stock subject to outstanding awards under the 2017 Plan, the 2016 Plan and the 2006 Plan that expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right up to 314,006 shares.
2017 Stock Incentive Plan
The 2017 Plan was approved by the Company’s stockholders on June 16, 2017, and became effective on June 28, 2017. Under the 2017 Plan, the Company could grant incentive stock options, nonstatutory stock options, stock appreciation rights, restricted stock awards, awards of restricted stock units and other stock-based awards. The Company’s employees, officers, directors, consultants and advisors were eligible to receive awards under the 2017 Plan; however, incentive stock options could only be granted to employees. The 2017 Plan is administered by the Board or, at the discretion of the Board, by a committee of the Board. The number of shares of common stock covered by options and the date those options become exercisable, type of options granted, exercise prices, vesting and other restrictions were determined at the discretion of the Board, or its committee if so delegated.
Stock options granted under the 2017 Plan with service-based vesting conditions generally vest over four years and may not have a duration in excess of ten years , although options have been granted with vesting terms of less than four years . The exercise price for stock options granted may not be less than the fair market value of the common stock as of the date of grant.
As of the effective date of the 2021 Plan, the Board determined to grant no further awards under the 2017 Plan.
Shares that are expired, terminated, surrendered or canceled without having been fully exercised under the 2017 Plan will be available for future awards under the 2021 Plan. In addition, shares of common stock that are tendered to the Company by a participant to exercise an award are added to the number of shares of common stock available for the grant of awards under the 2021 Plan.
2017 Employee Stock Purchase Plan
On June 16, 2017, the Company’s stockholders approved the 2017 ESPP, which became effective on June 28, 2017. Under the 2017 ESPP, the number of shares of common stock that may be issued under the 2017 ESPP will automatically increase on each January 1, beginning with the fiscal year ended December 31, 2018 and continuing for each fiscal year until, and including, the fiscal year ending December 31, 2027, equal to the least of (i) 31,120 shares, (ii) 1 % of the outstanding shares of common stock on such date and (iii) an amount determined by the Company’s Board. On January 1, 2023 and January 1, 2024, no additional shares were reserved for issuance under the 2017 ESPP pursuant to this provision. 7,500 shares remained available for future issuance under the 2017 ESPP as of December 31, 2023.
2013 Stock Incentive Plan
F- 25
The Company assumed the Lung’s 2013 Plan as a result of the Lung Acquisition. In October 2013, Lung’s Board of Directors (“Lung’s Board”) approved the 2013 Plan to provide long-term incentives for its employees, non-employee directors and certain consultants. As of December 31, 2023, 1,780,459 shares were reserved to be issued upon exercise of options outstanding under the 2013 Plan, and 726,437 shares to be issued upon exercise of outstanding warrants under Lung’s 2013 Plan. These options and warrants were assumed by the Company in connection with the Lung Acquisition.
Before the Lung Acquisition, the 2013 Plan was administered by the Lung’s Board or, at the discretion of the Lung’s Board, by a committee of the Lung’s Board. The exercise prices, vesting and other restrictions are determined at the discretion of the Lung’s Board, or its committee if so delegated, except that the exercise price per share of stock options may not be less than 100 % of the fair market value of the share of common stock on the date of grant and the term of stock option may not be greater than ten years . The vesting periods for equity awards are determined by the Board, but generally are four years . The contractual term for stock option awards is ten years . The vesting periods for equity awards were determined by Lung’s Board, but generally are four years . The contractual term for stock option awards is ten years . Following the closing of the Lung Acquisition on October 31, 2023, no further awards can be granted under the 2013 Plan.
Stock Option Valuation
The assumptions that the Company used to determine the grant-date fair value of the stock options granted to employees and directors during the years ended December 31, 2023 and 2022 and at the Lung Acquisition date were as follows, presented on a weighted average basis:
Year Ended December 31,
October 31,
2023
2022
2023
Risk-free interest rate
4.90
%
2.50
%
4.82 - 5.58 %
Expected term (in years)
4.0
6.1
0.42 - 6.28
Expected volatility
94.4
%
94.2
%
75 - 91 %
Expected dividend yield
0
%
0
%
0
%
Stock Options
The following table summarizes the Company’s stock option activity since January 1, 2023:
Number of
Shares
Weighted
Average
Exercise
Price
Weighted
Average
Remaining
Contractual
Term (in years)
Aggregate
Intrinsic
Value
Outstanding at December 31, 2022
537,112
$
29.77
7.9
$
—
Granted
10,900
1.17
—
—
Exercised
—
—
—
—
Forfeited/Canceled
( 57,483
)
14.29
—
10
Expired
( 58,886
)
27.35
—
—
Options assumed through business combination
1,780,459
1.61
6.8
200
Outstanding at December 31, 2023
2,212,102
$
7.42
6.0
$
2,905
Options exercisable at December 31, 2023
1,882,191
$
7.46
5.8
$
2,631
Options vested and expected to vest at December 31, 2023
2,209,420
$
7.41
6.0
$
2,904
Options exercisable at December 31, 2022
288,821
$
40.15
7.1
$
—
Options vested and expected to vest at December 31, 2022
529,549
$
29.95
7.8
$
—
The weighted average grant-date fair value of stock options granted during the year ended December 31, 2023 was $ 0.80 . The weighted average grant-date fair value of stock options granted during the year ended December 31,
F- 26
2022 was $ 7.32 . The aggregate fair value of stock options that vested during the years ended December 31, 2023 and 2022 was $ 1,191 and $ 2,808 , respectively.
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. There were no options exercised during the year ended December 31, 2023. The aggregate intrinsic value of stock options exercised during the year ended December 31, 2022 was $ 0 .
Stock-Based Compensation
The Company recorded stock-based compensation expense related to stock options in the following expense categories of its statements of operations and comprehensive loss:
Year Ended December 31,
2023
2022
Research and development expenses
$
277
$
600
General and administrative expenses
913
1,483
$
1,190
$
2,083
As of December 31, 2023, the Company had an aggregate of $ 1,702 of unrecognized stock-based compensation expense, which it expects to recognize over a weighted average period of 1.73 years.
14. Net Loss per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows :
Year Ended December 31,
2023
2022
Numerator:
Net loss
$
( 15,732
)
$
( 27,329
)
Denominator:
Weighted average common shares
outstanding—basic and diluted
4,598,715
4,539,318
Net loss per share attributable to common
stockholders—basic and diluted
$
( 3.42
)
$
( 6.02
)
The Company’s potential dilutive securities, which include stock options as of December 31, 2023 and 2022 , have been excluded from the computation of diluted net loss per share attributable to common stockholders whenever the effect of including them would be to reduce the net loss per share. In periods where there is a net loss, the weighted average number of shares of common stock outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same. The following potential shares of common stock, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share attributable to common stockholders for the periods indicated because including them would have had an anti-dilutive effect:
Year Ended December 31,
2023
2022
Options to purchase common stock
2,212,102
537,112
Warrants to issue shares of common stock
3,726,696
646,759
Series X Preferred Stock issued and outstanding, as converted
24,610,000
—
Total
30,548,798
1,183,871
15. Commitments and Contingencies
Operating Leases
F- 27
On March 26, 2021, the Company entered into a sublease agreement (the “Sublease”) by and among the Company, Vittoria Industries North America, Inc. (the “Sublessor”) and Waterfront Equity Partners, LLC (the “Lessor”), under which the Company was leasing approximately 3,365 square feet of office space located at 285 Summer Street, Unit 101, Boston, Massachusetts (the “Premises”). The Sublease was subject and subordinate to a lease agreement, dated as of July 13, 2012, by and between the Sublessor and Lessor, pursuant to which the Sublessor is leasing the Premises from the Lessor. The Sublease expired March 31, 2023 , and the Company did not renew the Sublease. Following expiration of the Sublease, the Company is operating virtually, and expects to do so in the foreseeable future.
On August 16, 2021, Lung Therapeutics entered into an operating lease agreement to rent approximately 6,455 square feet of office space for its corporate headquarters in Austin, Texas, beginning on October 1, 2021. The lease agreement is for a 30-month term that ended on March 31, 2024, and includes a rent escalation clause and a rent holiday. In addition to the base rent, the Company was also responsible for its share of operating expenses, electricity and real estate taxes, in accordance with the terms of the lease agreement. Following expiration of the lease, the Company expects to operate virtually for the foreseeable future.
The Company recognizes rent expense on a straight-line basis throughout the remaining term of the lease.
The following table contains a summary of the lease costs recognized and other information pertaining to the Company’s operating leases for the years ended December 31, 2023 and 2022:
Year Ended December 31,
2023
2022
Lease cost
Operating lease cost
$
184
$
125
Total lease cost
$
184
$
125
Other Information
Cash paid for amounts included in the measurement of lease liabilities
$
192
$
143
Weighted average remaining lease term (in years)
0.2
0.3
Weighted average discount rate
7
%
12
%
As of December 31, 2023, future minimum commitments under the Company’s operating leases were as follows:
2023
2024
$
48
2025 and thereafter
-
Total lease payments
48
Less: imputed interest
-
Total operating lease liabilities
$
48
Legal Proceedings
The Company may from time to time be party to litigation arising in the ordinary course of business. As of December 31, 2023 and 2022, the Company was not party to any legal proceedings and no material legal proceedings are currently pending or, to the best of the Company’s knowledge, threatened.
Intellectual Property Licenses
Harvard and Dana-Farber Agreement
In August 2006, the Company entered into an exclusive license agreement with President and Fellows of Harvard College (“Harvard”) and Dana-Farber Cancer Institute (“DFCI”). The agreement granted the Company an exclusive worldwide license, with the right to sublicense, under specified patents and patent applications to develop,
F- 28
obtain regulatory approval for and commercialize specified product candidates based on cell-permeating peptides. Under the agreement, the Company is obligated to use commercially reasonable efforts to develop and commercialize one or more licensed products and to achieve specified milestone events by specified dates. In connection with entering into the agreement, the Company paid an upfront license fee and issued to Harvard and DFCI shares of its common stock.
In February 2010, the agreement was amended and restated (the “Harvard/DFCI agreement”) under which additional patent rights were added to the scope of the license agreement and the annual license maintenance fees were increased. Under the Harvard/DFCI agreement, the Company is obligated to make aggregate milestones payments of up to $ 7,700 per licensed therapeutic product upon the Company’s achievement of specified clinical, regulatory and sales milestones with respect to such product and up to $ 700 per licensed diagnostic product upon the Company’s achievement of specified regulatory and sales milestones with respect to such product. In addition, the Company is obligated to pay royalties of low single-digit percentages on annual net sales of licensed products sold by the Company, its affiliates or its sublicensees. The royalties are payable on a product-by-product and country-by-country basis and may be reduced in specified circumstances. In addition, the agreement obligates the Company to pay a percentage, up to the mid-twenties, of fees received by the Company in connection with its sublicense of the licensed products. In accordance with the terms of the agreement, the Company’s sublicense payment obligations may be subject to specified reductions.
The Harvard/DFCI agreement requires the Company to pay annual license maintenance fees of $ 110 each year. Any payments made in connection with the annual license maintenance fees will be credited against any royalties due.
The Company incurred license maintenance fees of $ 35 and $ 110 during each of the years ended December 31, 2023 and 2022, respectively. In addition, the Company did no t make any milestone payments during the years ended December 31, 2023 and 2022. During the years ended December 31, 2023 and 2022, no milestones were achieved and no liabilities for milestone payments were recorded in the Company’s consolidated financial statements. From 2010 through December 31, 2023 and December 31, 2022, the Company had made non-refundable cash payments, consisting of license and maintenance fees, milestone payments and sublicense fees, totaling $ 5,153 and $ 5,118 , respectively.
As of December 31, 2023, the Company had not developed a commercial product using the licensed technologies and no royalties under the agreement had been paid or were due.
Under the Harvard/DFCI agreement, the Company is responsible for all patent expenses related to the prosecution and maintenance of the licensed patents and applications in-licensed under the agreement as well as cost reimbursement of amounts incurred for all documented patent-related expenses. The agreement will expire on a product-by-product and country-by-country basis upon the last to expire of any valid patent claim pertaining to licensed products covered under the agreement.
Umicore Agreement
In December 2006, the Company entered into a license agreement with Materia, Inc. (“Materia”), under which it was granted a non-exclusive worldwide license, with the right to sublicense, under specified patent and patent applications to utilize Materia’s catalysts to develop, obtain regulatory approval for and commercialize specified peptides owned or controlled by Materia and the right to manufacture specified compositions owned or controlled by Materia. In February 2017, Materia assigned the license agreement (the “Umicore agreement”) to Umicore Precious Metals Chemistry USA, LLC (“Umicore”), and Umicore agreed to continue to supply the Company under the agreement.
The Company incurred license fees of $ 50 during each of the years ended December 31, 2023 and 2022. The Company did no t make any milestone payments during the years ended December 31, 2023 and 2022. During the year ended December 31, 2023, no milestones were achieved and no liabilities for additional milestone payments were recorded in the Company’s consolidated financial statements.
F- 29
The Umicore Agreement terminated in July 2023 with the expiration of the last patent the Company had licensed.
Agreement with the University of Texas Health Science Center at Tyler
In June 2013, Lung entered into a patent and technology license agreement with the Board of Regents of the University of Texas System, or UT System, on behalf of University of Texas Health Science Center at Tyler, or UTHSCT. The patent and technology license agreement with UT System, or the UTHSCT Agreement, provides Lung access to patents and technology related to the development of LTI-01 and LTI-03. As part of the UTHSCT Agreement, Lung has (i) a royalty-bearing, exclusive license under the patent rights to manufacture, distribute, and sell certain intellectual property; (ii) a non-exclusive license under the technology rights to manufacture, distribute and sell the licensed product; and (iii) a sublicensing right that allows Lung to grant sublicenses to affiliates and third parties to use the licensed product in the field of use and approved territories outlined in the UTHSCT Agreement. In December 2013, the UTHSCT Agreement was amended and restated to include certain patents in all fields worldwide. In May 2017, the UTHSCT Agreement was amended and restated to modify the specific milestone criteria.
In consideration of the UTHSCT Agreement, Lung granted UT System (via UTHSCT and UT Horizon Fund affiliates) (i) 2,000,000 shares of Lung common stock and (ii) 400,000 shares of Lung non-convertible preferred stock. On February 6, 2015, UT System exchanged the 400,000 shares of Lung non-convertible preferred stock for 4,000,000 shares of Lung common stock. In addition, Lung agreed to pay past and ongoing patent expenses, and Lung owes UTHSCT sublicensing fees, assignment fees, and single digit royalties on worldwide net product sales, with fixed minimum royalty payments that started in 2015.
Pursuant to the UTHSCT Agreement, Lung is required to use diligent efforts to commercialize the licensed technology as soon as commercially practicable, including maintaining active research and development, regulatory, marketing and sales program, all as commercially reasonable.
The Company may terminate the UTHSCT Agreement for convenience with 90 days’ notice. UTHSCT may also terminate the UTHSCT Agreement, but only if the Company breaches the terms of the agreement.
Agreement with the University of Texas at Austin
In May 2015, Lung entered into a patent license agreement with UT Austin on behalf of the UT System. This license agreement with UT Austin, or the UT Austin 6607 Agreement, relates to the patent rights to polypeptide therapeutics and uses thereof. Pursuant to the UT Austin 6607 Agreement Lung has (i) a royalty-bearing, exclusive license under the patent rights to manufacture, distribute, and sell the licensed product; and (ii) a sublicensing right that allows Lung to grant sublicenses to affiliates and third parties to use the licensed product in the field of use and approved territories outlined in the agreement. The UT Austin 6607 Agreement was amended and restated in January 2017, November 2018, and June 2019. The amendments related to extension of milestone payment dates and specific terminology around the milestone achievement criteria.
In consideration of the UT Austin 6607 Agreement, Lung agreed to pay past and ongoing patent expenses, milestone fees upon certain development and regulatory milestone events, annual license fees, tiered sublicense fees, assignment fees, low single digit royalties on net sales and an FDA Priority Review Voucher fee if Lung sells or transfers this voucher.
Pursuant to the UT Austin 6607 Agreement, Lung is required to use diligent efforts to commercialize the licensed products, including maintaining active research and development, regulatory, marketing and sales program. Moreover, Lung is required to meet certain development and regulatory milestones by specific dates.
The Company may terminate the UT Austin 6607 Agreement for convenience with 90 days’ notice. UT Austin may also terminate the UT Austin 6607 Agreement, but only if the Company breaches the terms of the agreement.
Agreement with Medical University of South Carolina
F- 30
In March 2016, Lung entered into a license agreement with Medical University of South Carolina Foundation for Research Development, or MUSC. Pursuant to this license agreement with MUSC, or the MUSC Agreement, Lung has patent rights related to protecting against lung fibrosis by up regulating Cav1. The MUSC Agreement granted (i) a royalty-bearing, exclusive license under the patent rights to make, use and sell the license product; and (ii) a sublicensing right that allows Lung to grant sublicenses to affiliates and third parties to use the licensed product in the field of use and approved territories outlined in the agreement. In September 2018, the agreement was amended and restated to include definitions of related methods, related products and related rights.
In consideration of the MUSC Agreement, Lung agreed to pay a non-refundable license fee, patent expenses, milestone fees upon certain development, regulatory and commercial milestone events, sublicense fees, assignment fees and low single digit royalties on net sales, with a fixed minimum royalty payment starting in 2019 and a transaction fee upon Lung's liquidation.
Pursuant to the MUSC Agreement, Lung is required to use diligent efforts to develop, manufacture and sell the licensed products.
The Company may terminate the MUSC Agreement for convenience by providing a written notice to MUSC effective 90 days following the receipt of notice, and either party may terminate the agreement for a breach of contract.
Agreement with Vivarta Therapeutics LLC
In March 2018, Lung entered into a license agreement with Vivarta Therapeutics, LLC, or Vivarta. This license agreement with Vivarta, or the Vivarta Agreement, relates to intellectual property relating to epithelial sodium channel inhibitors and methods to treat pulmonary disease. Pursuant to the Vivarta Agreement Lung has (i) a royalty-bearing, exclusive license under the intellectual property rights to make, use and sell the licensed product, and (ii) a sublicensing right that allows Lung to grant sublicenses to affiliates and third parties to use the licensed product in the field of use and approved territories outlined in the agreement.
In consideration for the Vivarta Agreement, Lung agreed to grant Vivarta a warrant to purchase an aggregate of 75,000 shares of Lung common stock for $ 0.12 per share, to pay a license fee of $ 10,000 upon the Vivarta Agreement effective date and $ 40,000 within 30 days of the receipt of a positive freedom to operate analysis from legal counsel. Lung also agreed to pay patent expenses, milestone fees upon certain development and regulatory milestone events, sublicense fees, assignment fees and low single digit royalties on net sales.
Pursuant to the Vivarta Agreement, Lung is required to use diligent efforts to develop, manufacture and sell the licensed products.
The Company may terminate the Vivarta Agreement for convenience by providing a written notice to Vivarta effective 90 days following the receipt of notice, and either party may terminate the agreement for a breach of contract.
Manufacturing Commitments
As of December 31, 2023, the Company has non-cancellable purchase obligations and a prepaid balance with its contract manufacturer in the amount of $ 2,312 and $ 1,432 , respectively.
Aggregate future service and purchase commitments with manufacturer as of December 31, 2023 are as follows:
2023
2024
$
-
2025 and thereafter
2,312
Total purchase commitments
2,312
F- 31
Indemnification Agreements
In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with members of its board of directors and officers that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and it had not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2023 or December 31, 2022.
16. Income Taxes
On October 31, 2023, the Company acquired, in accordance with the terms of the Lung Acquisition Agreement, the stock of Lung Therapeutics ("Target"). In accordance with ASC 805-740-25-3, recognition of deferred tax assets and liabilities is required for substantially all temporary differences and acquired tax carryforwards and credits. The Company has computed estimated temporary differences and acquired tax carryforwards and credits as of the transaction date. The Company will not have tax basis in intangible assets recorded as part of the purchase. For accounting purposes, the intangible assets will not be amortized and subject to impairment review and testing. Though the tax effects may be delayed indefinitely, ASC 740-10-55-63 states that “deferred tax liabilities may not be eliminated or reduced because a reporting entity may be able to delay the settlement of those liabilities by delaying the events that would cause taxable temporary differences to reverse.” As such, the Company has recorded a deferred tax liability for the portion of the liability that cannot be offset with indefinite lived deferred tax assets.
The Company reported no income tax expense or benefit for the year ended December 31, 2023. The reported amount of income tax expense for the years differs from the amount that would result from applying domestic federal statutory tax rates to pretax losses primarily because of changes in valuation allowance.
A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:
Year Ended
December 31,
2023
2022
Federal statutory income tax rate
( 21.0
)%
( 21.0
)%
State taxes, net of federal benefit
108.1
( 5.4
)
Research and development and orphan drug tax credits
31.5
( 2.9
)
Other permanent items
2.4
0.9
Change in deferred tax asset valuation allowance
( 444.9
)
28.4
Loss of federal net operating losses due to 382
323.9
—
Effective income tax rate
—
%
—
%
F- 32
Net deferred tax liabilities as of December 31, 2023 and 2022 consisted of the following:
December 31,
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$
12,387
$
64,959
Research and development and orphan drug tax credit carryforwards
7,825
6,606
Capitalized research and development expenses
9,797
4,380
Accrued expenses and reserves
251
61
Depreciation and amortization
—
—
Lease liability
10
9
Stock compensation
1,514
1,442
Total deferred tax assets
31,784
77,457
Valuation allowance
( 18,506
)
( 77,441
)
Net deferred tax assets
$
13,278
$
16
Deferred tax liabilities:
Depreciation and amortization
$
( 16,594
)
$
( 5
)
Right of use asset
$
( 10
)
$
( 11
)
Total deferred tax liabilities
$
( 16,604
)
$
( 16
)
Net deferred tax asset (liability)
$
( 3,326
)
$
—
As of December 31, 2023, the Company had net operating loss carryforwards for federal and state purposes of $ 56,518 and $ 8,197 , respectively. $ 2,863 of the U.S. federal tax operating loss carryforwards will begin to expire in 2036 . Approximately $ 53,655 of the U.S. federal tax operating losses can be carried forward indefinitely. Of this amount, $ 44,420 of federal net operating losses came over from the Lung Acquisition, of which $ 2,863 will begin to expire in 2036 and the remaining $ 41,557 can be carried forward indefinitely. The state tax operating loss carryforwards expire beginning in 2043 . As of December 31, 2023, the Company also had available research and development tax credit carryforwards for federal income tax purposes of $ 1,094 , which begin to expire in 2035 . As of December 31, 2023, the Company also had available orphan drug credit carryforwards of $ 6,731 for federal income tax purposes, which begin to expire in 2039 . Of this amount, $ 1,064 of research and development credit carryforwards and $ 6,574 of orphan drug credit carryforwards came over from the Lung Acquisition.
On December 22, 2017, the Tax Cuts and Jobs Act (the "TCJA") was signed into law. Under the TCJA provisions, effective with tax years beginning on or after January 1, 2022, taxpayers can no longer immediately expense research and development expenditures. Taxpayers are now required to capitalize and amortize these costs over 5 years for research conducted within the United States or 15 years for research conducted abroad. As a result, the Company capitalized $ 3,639 of research and development expenses for the year ended December 31, 2023 for tax purposes.
Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50 % over a three-year period. As of December 31, 2023, the Company has wound down its original business operations and entered into a merger in the year, which resulted in a significant shift in ownership. The Company expects to have all prior year net operating losses and tax credits of its legacy business to be completely limited going forward due to the lack of continuation in its legacy business. As such, all prior year net operating losses and tax credits have been written down to zero as of December 31, 2023. The remaining net operating losses and tax credits as of December 31, 2023 relate to post-merger activity in the year, as well as acquired attributes as part of the merger in the year. A study has been completed on the Target ownership shifts through December 31, 2023, and multiple ownership changes were determined. As a result, the Company has written down the $ 1,673 portion of the Target net operating losses expected to expire unutilized and include the $ 44,420 of remaining net operating losses and $ 7,638 of federal tax credits as part of its available attributes. As of December 31,
F- 33
2023, the total federal net operating losses are $ 56,518 and federal research and development tax credits are $ 7,825 , which could be subject to future limitations under these rules.
The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management has considered the Company’s cumulative net losses and its lack of commercialization of any products or generation of any revenue from product sales since inception and has concluded that it is more likely than not that the Company will not realize the benefits of the deferred tax assets. The Company maintained a full valuation allowance on its net deferred tax assets as of December 31, 2023. Management reevaluates the positive and negative evidence at each reporting period. The decrease in the valuation allowance relates primarily to the deferred tax liability recognized as a result of the transaction as well as the reduction in prior year deferred tax assets due to Section 382 limitations. The increase in the valuation allowance for deferred tax assets during the year ended December 31, 2023 related primarily to an increase in net operating loss carryforwards. Changes in the valuation allowance were as follows:
Year Ended December 31,
2023
2022
Valuation allowance at beginning of year
$
( 77,441
)
$
( 69,680
)
Decreases/(increases) recorded to income tax provision
69,134
( 7,761
)
Increases recorded to invested capital
( 10,199
)
—
Valuation allowance at end of year
$
( 18,506
)
$
( 77,441
)
The Company has no t recorded any amounts for unrecognized tax benefits as of December 31, 2023 or 2022.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending tax examinations. The Company’s tax years are still open under statute from 2019 to the present. Earlier years may be examined to the extent that tax credit or net operating loss carryforwards are used in future periods. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision. As of December 31, 2023 and 2022, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s consolidated statements of operations and comprehensive loss.
17. Related Party Transactions
Immediately following the closing of the Lung Acquisition, the Company entered into the Purchase Agreement with a group of accredited investors led by Bios Partners, the majority stockholder of Lung prior to the closing of Lung Acquisition, and including Nantahala Capital, as well as additional undisclosed investors, pursuant to which the Company issued and sold (i) an aggregate of 4,707 shares of Series X Preferred Stock, and (ii) up to an aggregate of 2,353,500 Warrant Shares, as described in the Note 3, which included the conversion of convertible promissory notes in the aggregate principal amount of $ 1,553 issued by Lung to Bios Partners prior to the closing of the acquisition at a 10 % discount to the per share price of Series X Preferred Stock. The Financing closed on November 2, 2023.
18. Subsequent Event
On February 28, 2024, the Company held its 2023 annual meeting of stockholders (the “2023 Annual Meeting”) at which the stockholders of the Company approved an amendment (the “Plan Amendment”) to the Aileron’s 2021 Plan to increase the number of shares of common stock issuable under the 2021 Plan by 3,000,000 shares to 3,840,254 . On January 17, 2024, upon the recommendation of the compensation committee and subject to stockholder approval, the Company’s Board of Directors adopted the Plan Amendment. Other than increasing the number of shares issuable under the 2021 Plan, the Plan Amendment does not make any changes to the 2021 Plan. The material terms of the 2021 Plan are described in the Company’s definitive proxy statement for the 2023 Annual Meeting filed with the Securities and Exchange Commission on January 29, 2024 (the “Proxy Statement”).
At the 2023 Annual Meeting, the Company’s stockholders approved an amendment to the Company’s Restated Certificate of Incorporation, as amended, to increase the number of authorized shares of common stock of the Company from 45,000,000 to 100,000,000 shares. The Company filed the Certificate of Amendment to implement
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the increase in the number of authorized shares, which was effective upon filing, with the Secretary of State of the State of Delaware on February 28, 2024. The additional shares of common stock authorized by the Certificate of Amendment have rights identical to the Company’s currently outstanding Common Stock.
At the 2023 Annual Meeting, the Company’s stockholders also approved the issuance, in accordance with Nasdaq Listing Rule 5635(a), of shares of common stock, upon conversion of the Company's outstanding Series X Preferred Stock. Following approval of the conversion of outstanding Series X Preferred Stock, the Company had 29,495,512 shares of common stock issued and outstanding on a pro forma basis, which gives effect to the full conversion of the Series X Preferred Stock as of the date of the 2023 Annual Meeting, without regard to beneficial ownership limitations that may limit the ability of certain holders of Series X Preferred Stock to convert such shares to common stock as such time. On March 5, 2024, based upon existing beneficial ownership limitations, 12,087 shares of Series X Preferred Stock were automatically converted into 12,087,000 shares of common stock. The remaining approximately 12,523 shares of Series X Preferred Stock (which are convertible into 12,523,000 shares of common stock) will remain convertible at the option of the holder thereof, subject to certain beneficial ownership limitations.
On February 29, 2024, the Company received a letter from the Listing Qualifications Department of the Nasdaq Stock Market notifying the Company that it has regained compliance with the annual meeting requirement for continued listing on the Nasdaq Capital Market set forth in Nasdaq Listing Rule 5620.
On March 11, 2024, the Company and Manuel C. Alves-Aivado, M.D., Ph.D., agreed that his employment with the Company would cease and he would resign from his position as Chief Executive Officer of the Company, effective as of March 11, 2024 (the “Separation Date”). Dr. Aivado will remain a member of the Company’s Board. Dr. Aivado’s resignation from the Company was not the result of any disagreement with the Company on any matter relating to its operations, policies or practices.
In connection with Dr. Aivado’s separation from the Company, and in accordance with the severance agreement, dated as of September 6, 2018, between the Company and Dr. Aivado, Dr. Aivado is entitled to receive his base salary for eighteen months of $ 881 following the separation date, payments on Dr. Aivado’s behalf of the monthly premiums for medical insurance coverage under COBRA until the earlier of the date that is eighteen months following the separation date or the date on which Dr. Aivado becomes eligible to receive group health insurance coverage through another employer, a lump sum payment of $ 441 equal to one and one-half times Dr. Aivado’s target bonus for the 2024 calendar year, and acceleration in full of the vesting of any unvested equity awards. Dr. Aivado’s receipt of these post-separation benefits under the severance agreement is conditioned upon his execution of a severance and release of claims agreement with the Company.
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