Aldeyra Therapeutics Announces Second Quarter 2019 Financial Results and Provides Corporate Update
- Part 1 of Adaptive Phase 3 RENEW Trial in Dry Eye Disease Expected to be Completed in Fourth Quarter 2019
- Meeting with FDA Scheduled in Fourth Quarter 2019 to Confirm Design of Second Phase 3 Trial in Allergic Conjunctivitis
- Initiation of the Adaptive Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy Planned for Fourth Quarter 2019
- Part 1 of Adaptive Phase 3 RESET Trial in Sjögren-Larsson Syndrome Completed
“With Part 1 of our first Phase 3 trial in dry eye disease expected to be completed later this year, Aldeyra continues to advance reproxalap, the lead product candidate in our novel RASP inhibitor platform, towards commercialization,” commented
Recent Highlights and Corporate Updates
- Dry Eye Disease – Part 1 of the Adaptive Phase 3 RENEW Trial Expected to be Completed in Fourth Quarter of 2019. Aldeyra announced completion of enrollment in Part 1 of the two-part adaptive Phase 3 RENEW Trial of topical ocular reproxalap in dry eye disease. Following completion of Part 1 of RENEW, expected in the fourth quarter of 2019, Aldeyra plans to report the endpoints, dosing regimen, and sample size for Part 2 of the trial. Top-line results of the RENEW Trial are expected to be announced following completion of Part 2.
- Allergic Conjunctivitis – FDA Meeting Scheduled for Fourth Quarter to Confirm Design of Second Phase 3 Clinical Trial. In
March 2019 , Aldeyra reported positive top-line results from the Phase 3 ALLEVIATE Trial of topical ocular reproxalap in allergic conjunctivitis, and plans to present full results of ALLEVIATE at theAmerican Academy of Ophthalmology 2019 Annual Meeting inOctober 2019 . In addition, in June of 2019, Aldeyra announced results of topical ocular reproxalap in an allergen chamber trial, which demonstrated that ocular itching and redness in reproxalap-treated patients were statistically lower than that of vehicle-treated patients. A meeting with theU.S. Food and Drug Administration (FDA ) has been scheduled in the fourth quarter of 2019 to confirm the design of a second Phase 3 trial.
- Proliferative Vitreoretinopathy – the Adaptive Phase 3 GUARD Clinical Trial of ADX-2191 Expected to Initiate in the Fourth Quarter of 2019. Later this year, Aldeyra expects to initiate the adaptive Phase 3 GUARD Trial of ADX-2191 for the prevention of proliferative vitreoretinopathy (PVR). The trial will compare recurrence rates across patients treated with ADX-2191 or standard of care following surgical repair of retinal detachment due to PVR. PVR is expected to be the first indication in Aldeyra’s retinal disease platform to begin clinical testing.
- Sjögren-Larsson Syndrome – Part 1 of the Phase 3 RESET Trial Completed. In Part 1 of the two-part adaptive Phase 3 RESET trial in Sjögren-Larsson Syndrome, investigator-assessed dermal scaling scores in the six patients treated with 1% reproxalap topical dermatologic formulation were statistically lower than pre-treatment values over six months of therapy, an improvement that was numerically greater than that observed in the three patients treated with vehicle, when adjusted for baseline score. Prior to initiating subsequent clinical testing, Aldeyra plans to discuss the RESET Part 1 results with regulatory authorities. The RESET Trial is a randomized, multi-center, double-masked Phase 3 clinical trial of 1% topical dermal reproxalap for the treatment of ichthyosis, a severe skin disease associated with Sjögren-Larsson Syndrome.
- Programs in Systemic Immune-Mediated Diseases Expected to Begin Clinical Testing in 2019. As Aldeyra expands to the development of therapies for the treatment of systemic immune-mediated disease, a Phase 2 clinical trial of ADX-1612 in post-transplant lymphoproliferative disorder and a Phase 1 clinical trial of ADX-629 for the treatment of systemic autoimmune and metabolic disease remain on track to be initiated in the second half of 2019.
Quarter Ended
For the quarter ended
Research and development expenses were
General and administrative expenses were
For the quarter ended
Cash, cash equivalents, and marketable securities were
Conference Call & Webcast Information
Aldeyra will hold a conference call on
About
Safe Harbor Statement
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Aldeyra's strategy, future operations, future financial position, projected costs and expenses, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including plans relating to current or future clinical development. 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," "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 trials involving Aldeyra's product candidates; 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; 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
In addition to the risks described above and in Aldeyra's other filings with the
| ALDEYRA THERAPEUTICS, INC. | ||||||||
| BALANCE SHEETS | ||||||||
|
June 30, |
||||||||
|
2019 |
December 31, |
|||||||
|
(Unaudited) |
2018 |
|||||||
| ASSETS | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents |
$ |
7,399,564 |
|
$ |
3,357,472 |
|
||
| Cash equivalent - Reverse Repurchase Agreements |
|
32,000,000 |
|
$ |
44,000,000 |
|
||
| Marketable securities |
|
30,057,408 |
|
|
46,242,220 |
|
||
| Prepaid expenses and other current assets |
|
3,398,930 |
|
|
1,169,594 |
|
||
| Total current assets |
|
72,855,902 |
|
|
94,769,286 |
|
||
| Deferred offering costs | — |
|
86,644 |
|
||||
| Debt issuance costs |
|
492,448 |
|
— | ||||
| Right-of-use assets |
|
294,173 |
|
— | ||||
| Fixed assets, net |
|
196,491 |
|
|
235,225 |
|
||
| Total assets |
$ |
73,839,014 |
|
$ |
95,091,155 |
|
||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current liabilities: | ||||||||
| Accounts payable |
$ |
2,773,987 |
|
$ |
3,051,678 |
|
||
| Accrued expenses |
|
3,403,789 |
|
|
5,421,498 |
|
||
| Current portion of operating lease liabilities |
|
211,744 |
|
— | ||||
| Total current liabilities |
|
6,389,520 |
|
|
8,473,176 |
|
||
| Operating lease liabilities, long-term |
|
116,124 |
|
— | ||||
| Total liabilities |
|
6,505,644 |
|
|
8,473,176 |
|
||
| Commitments and contingencies (Notes 14 and 15) | ||||||||
| Stockholders' equity: | ||||||||
| Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and outstanding | — | — | ||||||
| Common stock, voting, $0.001 par value; 150,000,000 authorized and 26,986,936 and 26,244,435 shares issued and outstanding, respectively |
|
26,987 |
|
|
26,244 |
|
||
| Additional paid-in capital |
|
234,779,291 |
|
|
225,136,127 |
|
||
| Accumulated other comprehensive income (loss) |
|
13,453 |
|
|
(9,224 |
) |
||
| Accumulated deficit |
|
(167,486,361 |
) |
|
(138,535,168 |
) |
||
| Total stockholders’ equity |
|
67,333,370 |
|
|
86,617,979 |
|
||
| Total liabilities and stockholders’ equity |
$ |
73,839,014 |
|
$ |
95,091,155 |
|
||
| ALDEYRA THERAPEUTICS, INC. | |||||||||||||||||
| STATEMENTS OF OPERATIONS | |||||||||||||||||
| (Unaudited) | |||||||||||||||||
|
Three Months Ended June 30, |
Six Months Ended June 30, |
||||||||||||||||
|
2019 |
2018 |
2019 |
2018 |
||||||||||||||
| Operating expenses: | |||||||||||||||||
| Research and development |
$ |
10,664,858 |
|
$ |
6,792,974 |
|
$ |
18,513,448 |
|
$ |
13,393,080 |
|
|||||
| Acquired in-process research and development |
|
(49,848 |
) |
— |
|
6,547,703 |
|
— | |||||||||
| General and administrative |
|
3,116,414 |
|
|
2,373,059 |
|
|
6,101,452 |
|
|
4,264,360 |
|
|||||
| Loss from operations |
|
(13,731,424 |
) |
|
(9,166,033 |
) |
|
(31,162,603 |
) |
|
(17,657,440 |
) |
|||||
| Other income (expense): | |||||||||||||||||
| Interest income |
|
432,908 |
|
|
141,956 |
|
|
932,049 |
|
|
264,346 |
|
|||||
| Interest expense |
|
(28,649 |
) |
|
(26,358 |
) |
|
(30,612 |
) |
|
(54,402 |
) |
|||||
| Total other income (expense), net |
|
404,259 |
|
|
115,598 |
|
|
901,437 |
|
|
209,944 |
|
|||||
| Loss before income taxes |
|
(13,327,165 |
) |
|
(9,050,435 |
) |
|
(30,261,166 |
) |
|
(17,447,496 |
) |
|||||
| Income tax benefit |
|
— |
|
— |
|
1,309,973 |
|
— | |||||||||
| Net loss |
$ |
(13,327,165 |
) |
$ |
(9,050,435 |
) |
$ |
(28,951,193 |
) |
$ |
(17,447,496 |
) |
|||||
| Net loss per share - basic and diluted |
$ |
(0.49 |
) |
$ |
(0.46 |
) |
$ |
(1.08 |
) |
$ |
(0.88 |
) |
|||||
| Weighted average common shares outstanding - basic and diluted |
|
26,985,454 |
|
|
19,761,352 |
|
|
26,836,292 |
|
|
19,761,352 |
|
|||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20190808005197/en/
Source:
Corporate Contact:
David McMullin
Aldeyra Therapeutics, Inc.
Tel: 781-761-4904 ext. 218
dmcmullin@aldeyra.com
Investor Contact:
Chris Brinzey
Westwicke, an ICR Company
Tel: 339-970-2843
Chris.brinzey@westwicke.com