Full Press Release Details
Aldeyra Therapeutics Reports First-Quarter 2021 Financial Results and Recent Business Highlights
LEXINGTON, Mass., May 6, 2021 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a clinical-stage biotechnology company focused on the
development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases, today reported financial results for the quarter ended March 31, 2021 and provided recent business highlights.
We expect 2021 to be a catalyst-rich year for Aldeyra as we continue to advance reproxalap, our lead program, toward potential commercialization in
anterior ocular inflammatory disease, stated President and CEO Todd C. Brady, M.D., Ph.D. We recently completed the Phase 3 INVIGORATE Trial of reproxalap, achieving statistically significant superiority over vehicle across all assessed
signs and symptoms of allergic conjunctivitis, including ocular itching and redness. We look forward to meeting with the U.S. Food and Drug Administration in the second half of this year to discuss the INVIGORATE results and the potential submission
of a New Drug Application (NDA). In addition, we remain on track to report top-line results in the second half of this year from the Phase 3 TRANQUILITY and
TRANQUILITY-2 clinical trials of reproxalap in dry eye disease.
We believe we continue to operate from a position of financial strength, Dr. Brady stated.
With the recent follow-on public offering, we expect to have sufficient capital to prepare reproxalap for NDA submission and a potential commercial launch, if approved, while investing in the clinical
development of ADX-629, ADX-2191, and other product candidates in retinal and systemic immunological diseases with unmet medical need.
Recent Highlights and Program Updates
First-Quarter 2021 Financial Summary
Cash and cash equivalents as of March 31, 2021 were $138.4 million. Based on Aldeyra s current operating plan, the company believes that
existing cash and cash equivalents, as of March 31, 2021, together with the net proceeds from the sale of common stock in the underwritten public offering in May 2021, will be sufficient to fund currently projected operating expenses through
the end of 2023, including potential NDA submission for reproxalap; initial commercialization of reproxalap, if approved; and continued early and late-stage development of the company s product candidates in ocular and systemic immune-mediated
For the quarter ended March 31, 2021, Aldeyra reported a net loss of $11.3 million, compared with a net loss of $9.9
million for the quarter ended March 31, 2020. Net loss per share was $0.25 for the quarter ended March 31, 2021, compared with $0.34 for the same period in 2020. Losses have resulted from the costs of
Aldeyra s clinical trials and research and development programs, as well as from general and administrative expenses.
Research and development
(R&D) expenses were $7.7 million for the quarter ended March 31, 2021, compared with $6.6 million for the same period in 2020. The increase of $1.1 million is primarily related to clinical development and
manufacturing costs, partially offset by lower personnel related costs and a decrease in preclinical costs.
General and administrative expenses
were $3.1 million for the quarter ended March 31, 2021, compared with $3.0 million for the quarter ended March 31, 2020.
quarter ended March 31, 2021, total operating expenses were $10.8 million, compared with total operating expenses of $9.6 million for the same period in 2020.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss its first-quarter 2021 financial results and recent highlights. The dial-in numbers are (866) 211-4098 for domestic callers and (647) 689-6613 for international callers. The Conference ID number is
6779202. Due to the expected high demand on our conference call provider, please plan to dial in to the call at least 15 minutes prior to the start time.
A live webcast of the conference call will also be available on the Investor Relations page of the company s website at https://ir.aldeyra.com.
After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.
About Aldeyra Therapeutics,
Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to
improve the lives of patients with immune-mediated diseases. Two of the company s lead product candidates, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and
systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-kB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in
Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company s clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for
Safe Harbor Statement
This release contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding submission of potential New Drug Applications; the anticipated timing of results from
Aldeyra s clinical trials; and Aldeyra s projected cash runway. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities
Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, may, might, will,
objective, intend, should, could, can, would, expect, believe, anticipate, project, on track, scheduled,
target, design, estimate, predict, potential, aim, plan or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such
forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of
development and may not ever have any products that generate significant revenue. All of Aldeyra s development timelines may be subject to adjustment depending on recruitment rate,
regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra s
forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra s clinical trials, the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development
partners; updated or refined data based on Aldeyra s continuing review and quality control analysis of clinical data, Aldeyra s ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities;
delay in or failure to obtain regulatory approval of Aldeyra s product candidates; the ability to maintain regulatory approval of Aldeyra s product candidates, and the labeling for any approved products; the risk that prior results, such
as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra s product candidates in clinical
trials focused on the same or on different indications; the risk that the results from smaller clinical trials or portions of clinical trials may not accurately predict results of larger scale trials or the remainder of a clinical trial; the scope,
progress, expansion, and costs of developing and commercializing Aldeyra s product candidates; uncertainty as to Aldeyra s ability to commercialize (alone or with others) Aldeyra s product candidates following regulatory approval, if
any; the size and growth of the potential markets and pricing for Aldeyra s product candidates and the ability to serve those markets; Aldeyra s expectations regarding Aldeyra s expenses and revenue, the sufficiency or use of
Aldeyra s cash resources and needs for additional financing; political, economic, legal, social and health risks, including the recent COVID-19 outbreak and subsequent public health measures, that may
affect Aldeyra s business or the global economy; the rate and degree of market acceptance of any of Aldeyra s product candidates; Aldeyra s expectations regarding competition; Aldeyra s anticipated growth strategies;
Aldeyra s ability to attract or retain key personnel; Aldeyra s limited sales and marketing infrastructure; Aldeyra s ability to establish and maintain development partnerships; Aldeyra s ability to successfully integrate
acquisitions into its business; Aldeyra s expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra s ability to obtain and maintain
intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra s business and the market in which it operates; and other factors that are described in the Risk Factors and
Management s Discussion and Analysis of Financial Condition and Results of Operations sections of Aldeyra s Annual Report on Form 10-K for the year ended December 31, 2020, which is
on file with the Securities and Exchange Commission (SEC) and available on the SEC s website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra s Quarterly Report on
Form 10-Q for the quarter ended March 31, 2021, expected to be filed with the SEC in the second quarter of 2021.
In addition to the risks described above and in Aldeyra s other filings with the SEC, other
unknown or unpredictable factors also could affect Aldeyra s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date
of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
| March 31, | December 31, | |||||||
| 2021 | 2020 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 88,442,379 | $ | 52,858,311 | ||||
| Cash equivalent - reverse repurchase agreements | 50,000,000 | 25,000,000 | ||||||
| Prepaid expenses and other current assets | 8,630,543 | 5,200,957 | ||||||
| Total current assets | 147,072,922 | 83,059,268 | ||||||
| Right-of-use assets | 175,619 | 233,310 | ||||||
| Fixed assets, net | 57,559 | 59,925 | ||||||
| Total assets | $ | 147,306,100 | $ | 83,352,503 | ||||
| LIABILITIES AND STOCKHOLDERS EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 448,591 | $ | 381,638 | ||||
| Accrued expenses | 5,371,681 | 8,134,765 | ||||||
| Current portion of credit facility | 5,094,938 | 3,659,776 | ||||||
| Current portion of operating lease liabilities | 175,619 | 233,310 | ||||||
| Total current liabilities | 11,090,829 | 12,409,489 | ||||||
| Long-term debt, net of current portion | 10,140,799 | 11,434,456 | ||||||
| Total liabilities | 21,231,628 | 23,843,945 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders equity: | ||||||||
| Common stock, voting, $0.001 par value; 150,000,000 authorized and 47,651,035 and 38,667,491 shares issued and outstanding, respectively | 47,651 | 38,667 | ||||||
| Additional paid-in capital | 374,232,411 | 296,385,619 | ||||||
| Accumulated deficit | (248,205,590 | ) | (236,915,728 | ) | ||||
| Total stockholders equity | 126,074,472 | 59,508,558 | ||||||
| Total liabilities and stockholders equity | $ | 147,306,100 | $ | 83,352,503 |
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Three Months Ended March 31, | ||||||||
| 2021 | 2020 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 7,726,342 | $ | 6,633,603 | ||||
| General and administrative | 3,104,702 | 3,004,841 | ||||||
| Loss from operations | (10,831,044 | ) | (9,638,444 | ) | ||||
| Other income (expense): | ||||||||
| Interest income | 23,762 | 210,100 | ||||||
| Interest expense | (482,580 | ) | (439,816 | ) | ||||
| Total other income (expense), net | (458,818 | ) | (229,716 | ) | ||||
| Net loss | $ | (11,289,862 | ) | $ | (9,868,160 | ) | ||
| Net loss per share - basic and diluted | $ | (0.25 | ) | $ | (0.34 | ) | ||
| Weighted average common shares outstanding - basic and diluted | 45,630,910 | 29,210,889 |
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
Investor & Media Contact:
Sharon Merrill Associates, Inc.