Aileron Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update
April 15 2024 - 5:20PM
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 to $21.2 million on December 31, 2022.
Based on its current operating plan, the Company expects its
existing cash, cash equivalents, and investments will fund
operations into the fourth quarter of 2024.
- Research and Development
(R&D) Expenses: R&D expenses for the quarter ended
December 31, 2023, were $2.0 million, compared to $2.4 million for
the quarter ended December 31, 2022. R&D expenses decreased
primarily due to the termination of R&D activities related to
ALRN-6924. R&D expenses for the full-year 2023 were $4.0
million, compared to $18.0 million for the prior year.
- General and Administrative
(G&A) Expenses: G&A expenses for the quarter ended
December 31, 2023, were $5.3 million compared to $2.3 million for
the quarter ended December 31, 2022. G&A expenses increased due
to the integration and operating activities of Lung. G&A
expenses for the full-year 2023 were $11.4 million, compared to
$9.7 million for the prior year.
- Net Loss: Net loss
for the quarter ended December 31, 2023, was $7.3 million, compared
to $4.5 million for the quarter ended December 31, 2022. The basic
and diluted net loss per share for the quarter ended December 31,
2023 was $1.54 compared to $1.00 for the quarter ended December 31,
2022. The basic and diluted net loss per share for the full-year
2023 was $3.42 compared to $6.02 for the full-year 2022.
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. 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 of the Phase
1b study of LTI-03; future expectations, plans and prospects for
the Company following the merger transaction between the Company
and Lung that closed in the fourth quarter of 2023 (the “Merger”);
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 ability to recognize the
anticipated benefits of the Merger; 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; 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; our ability to obtain, maintain and enforce
intellectual property rights for our platform and development
candidates; our potential dependence on collaboration partners;
competition; uncertainties as to 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, which is on file with the United States
Securities and Exchange Commission and in subsequent filings that
the Company files with the Securities and Exchange Commission.
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) |
|
|
|
|
|
|
|
December 31, 2023 |
|
December 31, 2022 |
|
|
|
|
|
Cash, cash equivalents and investments |
|
$ |
17,313 |
|
|
$ |
21,242 |
|
Working capital |
|
|
13,881 |
|
|
|
18,489 |
|
Total assets |
|
|
106,008 |
|
|
|
22,007 |
|
Accumulated deficit |
|
|
(288,517 |
) |
|
|
(272,785 |
) |
Total stockholders'
equity |
|
|
6,887 |
|
|
|
18,623 |
|
|
Aileron Therapeutics, Inc. |
Condensed Statement of Operations |
(Unaudited) |
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31, |
|
Year EndedDecember 31, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
1,972 |
|
|
|
2,402 |
|
|
|
3,991 |
|
|
|
17,967 |
|
General and administrative |
|
|
5,330 |
|
|
|
2,301 |
|
|
|
11,357 |
|
|
|
9,680 |
|
Restructuring and other |
|
|
(12 |
) |
|
|
- |
|
|
|
928 |
|
|
|
- |
|
Total Operating expenses |
|
|
7,290 |
|
|
|
4,703 |
|
|
|
16,276 |
|
|
|
27,647 |
|
Loss from operations |
|
|
(7,290 |
) |
|
|
(4,703 |
) |
|
|
(16,276 |
) |
|
|
(27,647 |
) |
Other income (expense), net |
|
|
(49 |
) |
|
|
156 |
|
|
|
544 |
|
|
|
318 |
|
Net loss |
|
|
(7,339 |
) |
|
|
(4,547 |
) |
|
|
(15,732 |
) |
|
|
(27,329 |
) |
Net loss per share — basic and
diluted |
|
$ |
(1.54 |
) |
|
$ |
(1.00 |
) |
|
$ |
(3.42 |
) |
|
$ |
(6.02 |
) |
Weighted average common shares
outstanding—basic and diluted |
|
|
4,769,483 |
|
|
|
4,541,167 |
|
|
|
4,598,715 |
|
|
|
4,539,318 |
|
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