Aileron Therapeutics Reports First Quarter 2024 Financial Results and Business Highlights
May 15 2024 - 5:13PM
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 1 in 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 expenses related to Lung’s programs acquired
as a result of the Company’s acquisition of Lung in October 2023.
These activities did not exist during the quarter ended March 31,
2023 and were offset by the termination of ALRN-6924 activities
during the quarter ended March 31, 2023.
- General and Administrative (G&A)
Expenses: G&A expenses for the quarter ended
March 31, 2024, were $3.7 million compared to
$2.2 million for the quarter ended March 31, 2023. The
increase of $1.5 million was primarily due to increased
professional fees of $1.0 million and increased employee and
related expenses of $0.3 million in the quarter ended March 31,
2024 as compared to the quarter ended March 31, 2023. The majority
of the increase related to the acquisition of Lung, which closed in
October 2023.
- Net Loss: Net loss for the quarter ended March
31, 2024, was $7.1 million, compared to $4.8 million for the
corresponding quarter in 2023. The basic and diluted net loss per
share for the quarter ended March 31, 2024 was $0.86 compared to
$1.05 for the quarter ended March 31, 2023.
About Aileron Therapeutics
Aileron Therapeutics, Inc. 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. Currently, LTI-03 is being evaluated in 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 within the meaning of the Private Securities
Litigation Reform Act of 1995, including statements with respect
to: the timing and expectation of the topline results from Cohort 2
of the Phase 1b study of LTI-03; the sufficiency of the Company’s
cash resources; the projected cash runway of the Company; the
status and plans for clinical trials, including the timing of data;
future product development; 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: the Company’s ability to maintain the listing of its
common stock on The Nasdaq Capital Stock Market; 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 or that
partial results of a trial such as the Cohort 1 results from the
Company’s ongoing Phase 1b trial may not 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
Company’s 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 Company’s Quarterly Report on Form
10-Q for the period ended March 31, 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 Partnersaileron@argotpartners.com
212-600-1902
|
Aileron Therapeutics, Inc. |
Balance Sheet Data |
(Unaudited) |
(In thousands) |
|
|
|
|
|
March 31,2024 |
|
December 31,2023 |
|
|
|
|
Cash and cash equivalents |
$ |
12,042 |
|
|
$ |
17,313 |
|
Working capital |
|
8,232 |
|
|
|
13,881 |
|
Total assets |
|
99,192 |
|
|
|
106,008 |
|
Accumulated deficit |
|
(295,630 |
) |
|
|
(288,517 |
) |
Total stockholders'
equity |
$ |
44,750 |
|
|
$ |
6,887 |
|
|
|
|
|
|
|
|
|
|
Aileron Therapeutics, Inc. |
Condensed Consolidated Statement of Operations |
(Unaudited) |
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
Revenue |
$ |
- |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
Research and development |
|
3,463 |
|
|
|
1,810 |
|
General and administrative |
|
3,742 |
|
|
|
2,179 |
|
Restructuring and other costs |
|
- |
|
|
|
1,022 |
|
Total operating expenses |
|
7,205 |
|
|
|
5,011 |
|
Loss from operations |
|
(7,205 |
) |
|
|
(5,011 |
) |
Other income (expense),
net |
|
92 |
|
|
|
232 |
|
Net loss |
|
(7,113 |
) |
|
|
(4,779 |
) |
Net loss per share — basic and
diluted |
$ |
(0.86 |
) |
|
$ |
(1.05 |
) |
Weighted average common shares
outstanding—basic and diluted |
|
8,301,798 |
|
|
|
4,541,167 |
|
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