8-K

AILERON THERAPEUTICS, INC.

Date: November 14, 2024

/s/ Brian Windsor, Ph.D.

Brian Windsor, Ph.D.

President and Chief Executive Officer

0001193125-24-258568.txt : 20241114 0001193125-24-258568.hdr.sgml : 20241114 20241114160801 ACCESSION NUMBER: 0001193125-24-258568 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20241114 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20241114 DATE AS OF CHANGE: 20241114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Aileron Therapeutics, Inc. CENTRAL INDEX KEY: 0001420565 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 134196017 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38130 FILM NUMBER: 241462082 BUSINESS ADDRESS: STREET 1: 12407 N. MOPAC EXPY. STREET 2: SUITE 250 #390 CITY: AUSTIN STATE: TX ZIP: 78758 BUSINESS PHONE: 7378021989 MAIL ADDRESS: STREET 1: 12407 N. MOPAC EXPY. STREET 2: SUITE 250 #390 CITY: AUSTIN STATE: TX ZIP: 78758 FORMER COMPANY: FORMER CONFORMED NAME: AILERON THERAPEUTICS INC DATE OF NAME CHANGE: 20071207 8-K 1 d912402d8k.htm 8-K 8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 14, 2024

Aileron Therapeutics, Inc.

(Exact Name of Registrant as Specified in Charter)

Delaware

001-38130

13-4196017

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

12407 N. Mopac Expy. Suite 250 #390

Austin, Texas

78758

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s telephone number, including area code: (737) 802-1989

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading
Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.001 par value per share

ALRN

The Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02

Results of Operations and Financial Condition

On November 14, 2024, Aileron Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this report on Form 8-K and is hereby incorporated by reference.

Item 9.01

Financial Statements and Exhibits

(d) Exhibits.


Exhibit Number		Document

99.1		Press Release, dated November 14, 2024

104		Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

EX-99.1 2 d912402dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

LOGO

Aileron Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business Highlights

Announced promising safety and positive biomarker data from Cohort 2 (5mg BID) of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients demonstrating dose dependent effects in five biomarkers evaluated compared to low dose LTI-03

Data from Cohort 2 of the Phase 1b clinical trial confirms results from Cohort 1, with four biomarkers achieving statistical significance in the combined Cohort 1 and Cohort 2 data set

Planning is underway for a Phase 2 clinical trial

AUSTIN, Texas, Nov. 14, 2024 (PR NEWSWIRE) – Aileron Therapeutics, Inc. (“Aileron”) (NASDAQ: ALRN), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.

“This past quarter has been one of significant progress for Aileron, as evidenced by our recent announcement of positive data from Cohort 2 of our Phase 1b clinical trial evaluating a higher dose of LTI-03 (5 mg BID) in patients with IPF, in which high dose LTI-03 demonstrated dose dependent effects in five biomarkers,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. “We were highly encouraged that the combined data set from Cohort 1 and 2 achieved statistical significance in four out of eight biomarkers evaluated in the trial, which along with promising safety and tolerability data, reinforce the potential of LTI-03 to improve lung function and reverse the course of the disease.”

Third Quarter 2024 Highlights and Recent Updates

Corporate Updates

•

In October 2024, the Company announced entry into an exclusive option agreement with Advancium Health Network for the acquisition of ALRN-6924, a clinical-stage oncology agent developed by the Company prior to its 2023 merger with Lung Therapeutics, Inc., for retinoblastoma. Under the terms of the agreement, Aileron received a non-refundable fee from Advancium for the exclusive option to acquire ALRN-6924 and related assets. If Advancium exercises its option, Aileron will receive an exercise payment with potential for additional development, regulatory and commercial milestone payments and sales royalties.

Pipeline

•

In November 2024, Aileron announced positive topline data from Cohort 2 of the Phase 1b clinical trial evaluating the safety and tolerability of high dose LTI-03 (5 mg BID) and a set of exploratory biomarkers in patients diagnosed with idiopathic pulmonary fibrosis (IPF). In May, the Company reported positive biomarker data from Cohort 1 which evaluated low dose LTI-03 (2.5 mg BID).

•

In August 2024, Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron, presented an oral presentation at the 8^th Annual IPF Summit, entitled, “Biomarker Strategies in the Clinical Development of LTI-03 in IPF”.

Third Quarter 2024 Financial Results

•

Cash Position: Cash and cash equivalents as of September 30, 2024, were $17.7 million, compared to $21.9 million as of June 30, 2024. The Company expects its existing cash and cash equivalents to be sufficient to fund operations into June 2025.

•

Research and Development (“R&D”) Expenses: R&D expenses for the quarter ended September 30, 2024, were $3.7 million, compared to less than $0.1 million for the quarter ended September 30, 2023. The increase of $3.7 million was primarily a result of the clinical programs acquired as part of the Company’s acquisition of Lung Therapeutics, Inc. in October 2023 (the “Lung Acquisition”). During the quarter ended September 30, 2024, Aileron incurred expenses of $2.1 million on clinical trials, $1.0 million on manufacturing including $0.8 million write-offs due to the temporary delay of clinical development of LTI-01, and $0.1 million on regulatory and development consulting as well as $0.5 million on employee and related expenses associated with clinical programs acquired in the Lung Acquisition.

•

General and Administrative (“G&A”) Expenses: G&A expenses for the quarter ended September 30, 2024, were $2.3 million, compared to $2.0 million for the quarter ended September 30, 2023. The increase of $0.4 million was primarily due to increased employee and related expenses of $0.5 million as a result of increased headcount associated with the Lung Acquisition and severance expense recognized due to departure of former employees, and increased facilities and other expenses of $0.2 million, offset by decreased professional fees of $0.3 million as a result of less external consulting expenses during the quarter ended September 30, 2024 as compared to the quarter ended September 30, 2023.

•

Net Loss: Net loss for the quarter ended September 30, 2024, was $5.8 million, compared to $1.8 million for the quarter ended September 30, 2023. The basic and diluted net loss per share for the quarter ended September 30, 2024 was $0.27 compared to $0.40 for the quarter ended September 30, 2023.

About Aileron Therapeutics

Aileron Therapeutics is a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Aileron’s lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 completed a Phase 1b clinical trial for the treatment of idiopathic pulmonary fibrosis. Aileron’s second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.

Forward-Looking Statements

This press release may contain forward-looking statements of Aileron Therapeutics, Inc. (“Aileron”, the “Company”, “we”, “our” or “us”) within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to: the timing and expectation of a Phase 2 trial of LTI-03; future expectations, plans and prospects for the Company; the sufficiency of the Company’s cash resources; the projected cash runway of the Company; and the potential commercial opportunity of LTI-03 and LTI-01. We use words such as “anticipate,” “believe,” “estimate,” “expect,” “hope,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “would,” “can,” “could,” “should,” “continue,” and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties related to: changes in applicable laws or regulations; the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors, including risks inherent in pharmaceutical research and development, such as: adverse results in the Company’s drug discovery; preclinical and clinical development activities; the risk that the results of preclinical studies and early clinical trials may not be replicated in later clinical trials, including in a Phase 2 trial of LTI-03, or that partial results of a trial will be indicative of the full results of the trial; the Company’s ability to enroll patients in its clinical trials; and the risk that any of its clinical trials may not commence, continue or be completed on time, or at all; decisions made by the U.S. Food and Drug Administration and other regulatory authorities; investigational review boards at clinical trial sites and publication review bodies with respect to the our development candidates; our ability to obtain, maintain and enforce intellectual property rights for our platform and development candidates; competition; the sufficiency of the Company’s cash resources to fund its planned activities for the periods anticipated and the Company’s ability to manage unplanned cash requirements; and general economic and market conditions; as well as the risks and uncertainties discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and the Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, which are on file with the United States Securities and Exchange Commission (the “SEC”) and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company’s view as of any date subsequent to the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Investor Relations & Media Contact:

Argot Partners

aileron@argotpartners.com

212-600-1902

Aileron Therapeutics, Inc.

Balance Sheet Data

(Unaudited)

(In thousands)


	September 30, 2024			December 31, 2023
Cash and cash equivalents	$	17,652		$	17,313
Working capital		13,025			13,881
Total assets		104,217			106,008
Accumulated deficit		(310,419	)		(288,517	)
Total stockholders’ equity	$	50,227		$	6,887

Aileron Therapeutics, Inc.

Condensed Consolidated Statement of Operations

(Unaudited)

(In thousands, except share and per share data)


	Three Months Ended September 30,
	2024			2023
Revenue	$	—		$	—

Operating expenses:
Research and development		3,722			22
General and administrative		2,349			1,955
Restructuring and other costs		—			6

Total operating expenses		6,071			1,983

Loss from operations		(6,071	)		(1,983	)
Other income, net		224			156

Net loss		(5,847	)		(1,827	)

Net loss per share—basic and diluted	$	(0.27	)	$	(0.40	)

Weighted average common shares outstanding—basic and diluted		21,663,089			4,541,167

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Document and Entity Information	Nov. 14, 2024
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Entity Central Index Key	0001420565
Document Type	8-K
Document Period End Date	Nov. 14, 2024
Entity Registrant Name	Aileron Therapeutics, Inc.
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Entity File Number	001-38130
Entity Tax Identification Number	13-4196017
Entity Address, Address Line One	12407 N. Mopac Expy.
Entity Address, Address Line Two	Suite 250
Entity Address, Address Line Three	#390
Entity Address, City or Town	Austin
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Written Communications	false
Soliciting Material	false
Pre Commencement Tender Offer	false
Pre Commencement Issuer Tender Offer	false
Security 12b Title	Common Stock, $0.001 par value per share
Trading Symbol	ALRN
Entity Emerging Growth Company	false

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