SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 14, 2020
ALDEYRA THERAPEUTICS, INC.
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction
131 Hartwell Avenue, Suite 320
Lexington, MA 02421
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (781) 761-4904
(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
Name of each exchange
on which registered
|Common Stock, $0.001 par value per share||ALDX||The Nasdaq Stock Market, LLC|
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 8.01.|| |
On July 14, 2020, Aldeyra Therapeutics, Inc. (the Company) issued a press release announcing the sale of 4,580,361 shares of its common stock through the at the market offering program with Jefferies, LLC. The shares were sold for a price of $4.25 per share. A copy of the press release is attached as Exhibit 99.1 hereto and incorporated herein by reference.
|Item 9.01.|| |
Financial Statements and Exhibits.
|99.1||Aldeyra Therapeutics, Inc. Press Release dated July 14, 2020.|
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|Dated: July 14, 2020||ALDEYRA THERAPEUTICS, INC.|
/s/ Joshua Reed
Name: Joshua Reed
Title: Chief Financial Officer
Aldeyra Therapeutics Announces Stock Sales to
Perceptive Advisors and Avidity Partners
Gross Proceeds of Approximately $19.5 Million from At-the-Market Offering Program Sufficient
to Extend Operations Through the End of 2022, Including Potential New Drug Application (NDA)
Approvals for Reproxalap in Dry Eye Disease and Allergic Conjunctivitis, Based on Current Operating Plans
LEXINGTON, Mass., July 14, 2020 Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced block sales of an aggregate of 4,580,361 shares of common stock to Perceptive Advisors, LLC and Avidity Partners Management LP, two leading healthcare-focused investment funds, under Aldeyras previously announced at-the-market offering program. The shares were sold for a price of $4.25 per share. Aggregate gross proceeds, before deducting commissions, were approximately $19.5 million. The sales completed Aldeyras previously disclosed at-the-market offering program and no further sales will be made under this program. Jefferies, LLC served as sales agent under the at-the-market offering program.
Aldeyra anticipates using the net proceeds from the sales for the continued development of the companys lead compound reproxalap and other product candidates, as well as for debt maintenance, working capital, and other general corporate purposes. Based on current operating plans, cash, cash equivalents, and marketable securities are sufficient to fund operations through the end of 2022, including potential NDA approvals for reproxalap, a first-in-class topical ocular reactive aldehyde species (RASP) inhibitor, in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results, and planned NDA submissions, acceptances, and approvals. Use of proceeds are also expected to include the continuation of Part 1 of the Phase 3 GUARD Trial for proliferative vitreoretinopathy, a rare retinal disease with no approved therapy, and Phase 2 clinical testing of ADX-629, an orally administered RASP inhibitor, in inflammatory diseases.
This press release does not constitute an offer to sell or the solicitation of an offer to buy the companys common stock nor shall there be any sale of such common stock in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 companys lead compounds, reproxalap and ADX-629, target reactive aldehyde species (RASP), which are elevated in ocular and systemic inflammatory disease, leading to elevated levels of cytokine release via activation of a broad array of inflammatory factors, including NF-ÎºB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The companys clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in Phase 2 testing for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the anticipated use of proceeds from the financing that is the subject of this release; the sufficiency of the companys cash, cash equivalents and marketable securities; and potential clinical outcomes from the companys trials in dry eye disease and allergic conjunctivitis. 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 Aldeyras 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. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete our clinical trials may be delayed. Important factors that could cause actual results to differ materially from those reflected in Aldeyras forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyras 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 Aldeyras continuing review and quality control analysis of clinical data, Aldeyras ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyras product candidates; the ability to maintain regulatory approval of Aldeyras 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 trials involving Aldeyras product candidates; the scope,
progress, expansion, and costs of developing and commercializing Aldeyras product candidates; the current and potential future impact of the COVID-19 pandemic on our business, results of operations and financial position; uncertainty as to Aldeyras ability to commercialize (alone or with others) Aldeyras product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyras product candidates and the ability to serve those markets; Aldeyras expectations regarding Aldeyras expenses and revenue, the sufficiency or use of Aldeyras 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 Aldeyras business or the global economy; the rate and degree of market acceptance of any of Aldeyras product candidates; Aldeyras expectations regarding competition; Aldeyras anticipated growth strategies; Aldeyras ability to attract or retain key personnel; Aldeyras limited sales and marketing infrastructure; Aldeyras ability to establish and maintain development partnerships; Aldeyras ability to successfully integrate acquisitions into its business; Aldeyras expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyras ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyras business and the market in which it operates; and other factors that are described in the Risk Factors and Managements Discussion and Analysis of Financial Condition and Results of Operations sections of Aldeyras Annual Report on Form 10-K for the year ended December 31, 2019 and Aldeyras Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are on file with the Securities and Exchange Commission (SEC) and available on the SECs website at www.sec.gov. Additional factors may be set forth in those sections of Aldeyras Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, expected to be filed with the SEC in the third quarter of 2020.
In addition to the risks described above and in Aldeyras other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyras 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.
|Corporate Contact:||Investor & Media Contact:|
|David McMullin||Scott Solomon|
|Aldeyra Therapeutics, Inc.||Sharon Merrill Associates, Inc.|
|Tel: 781-761-4904 ext. 218||Tel: 617-542-5300|