SEC 8-K filings with transcript text
May 15, 2025
Nov 14, 2024
Aug 14, 2024
8-K
NASDAQ false 0001420565 0001420565 2024-08-14 2024-08-14
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): August 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
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 August 14, 2024, Aileron Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01
Financial Statements and Exhibits
(d) Exhibits.
Exhibit
Number
Document
99.1
Press Release, dated August 14, 2024
104
Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document.
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.
Date: August 14, 2024
By:
/s/ Brian Windsor, Ph.D.
Brian Windsor, Ph.D.
President and Chief Executive Officer
May 15, 2024
2 d825172dex991.htm
Exhibit 99.1
Aileron Therapeutics Reports First Quarter 2024 Financial Results and
Business Highlights
Announced positive data from Cohort 1 of the Phase 1b clinical trial of LTI-03 in idiopathic pulmonary fibrosis (IPF) patients with positive trends observed in seven of the eight biomarkers evaluated
Topline results from Cohort 2 evaluating high-dose LTI-03 (5 mg BID) expected in the third quarter of 2024
AUSTIN, Texas, May 15, 2024 (GLOBE NEWSWIRE) – Aileron Therapeutics, Inc. (“Aileron” or the “Company”) (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 first quarter ended March 31, 2024, and provided a business update.
“In the first quarter, we made steady progress against our key priorities of advancing LTI-03 and generating data from Cohort 1in IPF,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. “We are encouraged that low dose LTI-03 achieved statistical significance in three out of eight biomarkers evaluated in the trial, along with promising safety and tolerability that reinforce the potential of LTI-03 to improve lung function and reverse the course of the disease. We expect to report topline results from Cohort 2 in the ongoing Phase 1b study in the third quarter of this year.”
First Quarter 2024 Highlights and Recent Updates
Financing and Management Updates
•
In May 2024, the Company closed on an underwritten registered direct offering of 4,273,505 shares of its common stock and accompanying warrants to purchase an aggregate of 4,273,505 shares of common stock resulting in aggregate gross proceeds to the Company of approximately $20 million, before deducting underwriting discounts and commissions and other offering expenses payable by the Company, and excluding any proceeds that may be received from exercise of the warrants. Each share of common stock and accompanying warrant were sold together at a combined public offering price of $4.68 The exercise of the warrants issued in the offering has the potential to result in additional proceeds to the Company of up to approximately $20 million.
•
In March 2024, the Company announced the appointment of Brian Windsor, Ph.D., as President and Chief Executive Officer and to the Board of Directors. Dr. Windsor previously served as the Company’s Chief Operating Officer and President, and Chief Executive Officer and director of Lung Therapeutics, Inc. (“Lung”).
Pipeline
•
Announced positive Cohort 1 data from the Phase 1b clinical trial evaluating the safety and tolerability of inhaled LTI-03 in patients diagnosed with IPF.
•
Following inhaled administration of low dose LTI-03 (2.5 mg BID, or twice
daily) in twelve patients, a positive trend was observed in seven out of eight biomarkers with evidence of reduced expression among profibrotic proteins produced by basal-like cells and fibroblasts that contribute to the progression of IPF, including data from three out of eight biomarkers that were statistically significant, reinforcing the potential of LTI-03 to improve lung function and reverse the course of IPF.
•
LTI-03 was also found to stimulate production of solRAGE, a factor
indicative of type I epithelial cell health that is a critically important aspect of IPF and has gone largely unaddressed. Results show LTI-03 to be generally well-tolerated with no serious adverse events (SAEs) reported.
•
The Phase 1b study is ongoing, with topline results from the high-dose cohort expected in the third quarter of 2024.
•
On May 1, 2024, the Company hosted a pulmonary care expert call to discuss the Cohort 1 Phase 1b results of LTI-03, featuring pulmonary care expert Andreas Günther, M.D., Head of the Center for Interstitial and Rare Lung Diseases at the Justus Liebig University in Giessen, Germany. A replay of the event can be accessed at https://investors.aileronrx.com/events-presentations/investor-events.
First Quarter 2024 Financial Results
•
Cash Position: Cash and cash equivalents on March 31, 2024, were $12.0 million, compared to $17.3 million on December 31, 2023. After including the net proceeds raised from the May 2024 offering and based on its current operating plan, the Company expects its existing cash and cash equivalents to fund operations into the second half of 2025.
•
Research and Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2024, were $3.5 million, compared to $1.8 million for the quarter ended March 31, 2023. The increase of $1.7 million was primarily a result of the Company’s acquisition of Lung in October 2023. During the quarter ended March 31, 2024, Aileron spent $1.1 million on clinical trials, $1.6 million on manufacturing, and $0.2 million on regulatory and development consulting as well as $0.6 million on employee and related expen
May 1, 2024
8-K
NASDAQ false 0001420565 0001420565 2024-05-01 2024-05-01
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 1, 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
Not applicable
(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:
☐
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
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
The information disclosed under the heading “Cash and Cash Equivalents as of March 31, 2024” under Item 8.01 of this Current Report on Form 8-K is herein incorporated by reference.
Item 8.01.
Other Events.
Data from Cohort 1 of Phase 1b Clinical Trial of LTI-03
On May 1, 2024, Aileron Therapeutics, Inc. (the “Company”) announced positive data from cohort 1 of the ongoing Phase 1b clinical trial evaluating the safety and tolerability of inhaled LTI-03 in patients diagnosed with idiopathic pulmonary fibrosis, or IPF.
The Phase 1b trial of LTI-03 is a randomized, double-blind, placebo-controlled, Phase 1b clinical trial of LTI-03 in IPF patients, which is being conducted at 11 centers in the United States, the United Kingdom, Belgium, Germany and Australia. The Company plans to enroll a total of 24 patients. In the trial, these patients have a bronchoscopy at a baseline screening followed by either LTI-03 or placebo twice a day for 14 days. On day 14, shortly after the final dose, patients receive a second bronchoscopy and are monitored thereafter for seven days. In cohort 1, patients in the active arm inhaled a single 2.5 mg capsule of LTI-03 twice daily. In cohort 2, patients will receive two 2.5 mg capsules of LTI-03 for inhalation twice daily.
Of the twelve patients enrolled in cohort 1 of the trial, three were randomized to the placebo arm and nine to the active arm. In addition to the safety and tolerability of LTI-03, in the trial, various biomarkers relating to epithelial damage, fibrosis and inflammation in blood cells were assessed. The eight biomarkers that the Company evaluated in cohort 1 included: thymic stromal lymphopoietin (TSLP), galectin-7 (GAL-7), interleukin-11 (IL-11), collagen 1 alpha chain (Col-1α1), phosphorylated SMAD2/3 (pSMAD2/3/tSMAD2/3), phosphorylated AKT kinase (pAKT), soluble (sol) receptor for advanced glycation end-products (solRAGE), and CXC chemokine 7 (CXCL7).
In cohort 1, a positive trend was observed in seven out of the eight biomarkers with data from three biomarkers being statistically significant (based on a one-tailed t-test). The findings from cohort 1 include:
•
LTI-03 reduced expression of multiple profibrotic proteins in both pathologic basal-like cells and fibroblasts, with statistically significant decreases observed in three biomarkers — GAL-7 (p=0.0014, SEM 0.901), TSLP (p=0.0223, SEM 5.163) and Col-1α1 (p=0.0489, SEM 0.7102) — supporting the potential of LTI-03 to reduce fibrosis, inflammation and associated changes in the lung.
•
LTI-03 stimulated production of solRAGE (p=0.1407, SEM 0.3269), a factor indicative of type I epithelial cell health that is a critically important aspect of IPF and has gone largely unaddressed.
•
LTI-03 did not induce inflammation in peripheral blood mononuclear cells as measured by pAKT (p=0.358, SE
Apr 15, 2024
2 d817402dex991.htm
Exhibit 99.1
Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
Topline results from Phase 1b study of LTI-03, a novel Caveolin-1-related peptide in development for the treatment of idiopathic pulmonary fibrosis, expected to be reported in the third quarter of 2024
Cash runway expected to fund operations and key milestones into the fourth quarter of 2024
AUSTIN, Texas, April 15, 2024 (GLOBE NEWSWIRE) – Aileron Therapeutics, Inc. (“Aileron”, the “Company”, “we”, “our” or “us”) (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 fourth quarter and full year ended December 31, 2023 and provided a business update.
“We ended the year in a solid position after the successful completion of our merger with Lung Therapeutics, which provided a focused pipeline of promising clinical-stage candidates for life-threatening lung conditions, coupled with a strengthened balance sheet from the successful closure of a $18.4 million financing,” said Brian Windsor, Ph.D., President and Chief Executive Officer of Aileron. “We anticipate 2024 as a pivotal year of execution as we continue to progress our lead product candidate, LTI-03. We expect to report topline results from the ongoing Phase 1b study of LTI-03 in the third quarter of this year. LTI-03 and its potential dual mechanism of action on both epithelial cells and fibroblasts is gaining support from the medical community, and we look forward to building upon encouraging preclinical data that LTI-03 has the potential to protect healthy lung epithelial cells and to reduce pro-fibrotic signaling.”
Recent Business Highlights and Upcoming Milestones
Corporate Updates
•
In October 2023, Aileron acquired Lung Therapeutics, Inc. (“Lung”), shifting the Company’s disease focus to advance a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis diseases. The Company’s lead clinical programs include LTI-03 for idiopathic pulmonary fibrosis (IPF) and LTI-01 for loculated pleural effusion (LPE).
•
Immediately following the closing of Aileron’s acquisition of Lung (“Lung Acquisition”), the Company entered into a definitive agreement for the sale of shares of its Series X non-voting convertible preferred stock and warrants to purchase shares of Aileron common stock in a private placement to a group of accredited investors led by Bios Partners, the majority stockholder of Lung prior to the Lung Acquisition, and including Nantahala Capital, as well as additional undisclosed investors. The private placement resulted in gross proceeds to Aileron of approximately $18 million before deducting placement agent fees and other offering expenses.
•
In March 2024, the Company announced the appointment of Brian Windsor, Ph.D., as President and Chief Executive Officer and to the Board of Directors. Dr. Windsor previously served as Aileron’s Chief Operating Officer and President, and Chief Executive Officer and director of Lung.
Pipeline
•
In February 2024, Aileron hosted a pulmonary care expert panel to discuss the potential implications of LTI-03 for IPF, featuring pulmonary care experts Fernando J. Martinez, M.D., M.S., Chief of the Pulmonary and Critical Care Medicine Division at Weill Cornell Medicine; Tejaswini Kulkarni, M.D., M.P.H., Associate Professor of Pulmonology, Allergy and Critical Care Medicine and Director of the Interstitial Lung Disease Program at University of Alabama at Birmingham Medicine; and Andreas Günther, M.D., Senior Physician of Pulmonology and Intensive Care Medicine and Chief Physician of Pulmonology and Internal Intensive Care Medicine at Agaplesion Evang. Central Hesse Hospital and Professor of Interstitial and Rare Lung Diseases at Justus Liebig University. A replay of the event can be accessed at https://investors.aileronrx.com/events-presentations/investor-events.
•
LTI-03: a novel Caveolin-1-related (Cav1) peptide with a dual mechanism targeting both alveolar epithelial cell survival as well as inhibition of profibrotic signaling
•
LTI-03 is currently in a randomized, double-blind, placebo-controlled
Phase 1b clinical trial in IPF patients. Aileron expects to report topline results from this trial in the third quarter of 2024.
•
LTI-01: a PAI-1 resistant
plasmin activated proenzyme for loculated pleural effusions
•
LTI-01 has been evaluated in Phase 1b and Phase 2a clinical trials in
patients with infected, non-draining LPEs and is ready for Phase 2b. LTI-01 has received Orphan Drug Designation in the US and EU and Fast Track Designation in the US.
Fourth Quarter and Full Year 2023 Financial Results
•
Cash Position: Cash, cash equivalents, and investments on December 31, 2023, were $17.3 million, compared
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