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ALDX Aldeyra Therapeutics

Aldeyra Therapeutics, Inc. operates as a biotechnology company. It primarily focuses on the development of new products for immune-mediated, inflammatory, orphan and other diseases that are thought to be caused in part by naturally occurring toxic chemical species known as free aldehydes. The company was founded by Thomas A. Jordan and John E. Dowling on August 13, 2004 and is headquartered in Lexington, MA.

Company profile

Ticker
ALDX
Exchange
Website
CEO
Todd C. Brady
Employees
Incorporated
Location
Fiscal year end
Former names
Aldexa Therapeutics, Inc., Neuron Systems Inc
SEC CIK

ALDX stock data

(
)

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

6 May 21
17 May 21
31 Dec 21
Quarter (USD)
Mar 21 Dec 20 Sep 20 Jun 20
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD)
Dec 20 Dec 19 Dec 18 Dec 17
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS

Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 138.44M 138.44M 138.44M 138.44M 138.44M 138.44M
Cash burn (monthly) (positive/no burn) (positive/no burn) 3.61M 3.25M 4.49M 2.97M
Cash used (since last report) n/a n/a 5.66M 5.1M 7.04M 4.65M
Cash remaining n/a n/a 132.78M 133.34M 131.4M 133.79M
Runway (months of cash) n/a n/a 36.8 41.0 29.3 45.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
3 May 21 Perceptive Advisors Common Stock Buy Aquire P Yes No 12.5 1,200,000 15M 9,903,879
12 Apr 21 Stephen Machatha Employee Stock Option Common Stock Grant Aquire A No No 11.71 116,201 1.36M 116,201
12 Apr 21 Todd C Brady Common Stock Grant Aquire A No No 0 46,619 0 948,835
12 Apr 21 Todd C Brady Employee Stock Option Common Stock Grant Aquire A No No 11.71 250,000 2.93M 250,000
12 Apr 21 Joshua Reed Employee Stock Option Common Stock Grant Aquire A No No 11.71 150,185 1.76M 150,185
19 Jan 21 Perceptive Advisors Common Stock Buy Aquire P Yes No 9.5 1,368,421 13M 8,703,879

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

38.8% owned by funds/institutions
13F holders
Current Prev Q Change
Total holders 96 84 +14.3%
Opened positions 25 23 +8.7%
Closed positions 13 21 -38.1%
Increased positions 28 28
Reduced positions 24 21 +14.3%
13F shares
Current Prev Q Change
Total value 732.76M 185.42M +295.2%
Total shares 22.37M 23.78M -5.9%
Total puts 305.5K 35.3K +765.4%
Total calls 102.2K 112.6K -9.2%
Total put/call ratio 3.0 0.3 +853.5%
Largest owners
Shares Value Change
Perceptive Advisors 6.29M $43.12M 0.0%
Vanguard 1.62M $11.09M -2.2%
Avidity Partners Management 1.44M $9.84M +0.3%
Citadel Advisors 1.33M $9.09M +28.9%
Prosight Management 908.49K $6.23M -16.8%
Point72 Asset Management 858.27K $5.89M +33.7%
BLK Blackrock 780.3K $5.35M +3.9%
Two Sigma Advisers 673.3K $4.62M +12.1%
Two Sigma Investments 666.37K $4.57M -0.5%
Ghost Tree Capital 650K $4.46M -48.0%
Largest transactions
Shares Bought/sold Change
Acuta Capital Partners 192.5K -1.45M -88.3%
IVZ Invesco 0 -624.74K EXIT
Ghost Tree Capital 650K -600K -48.0%
Citadel Advisors 1.33M +296.87K +28.9%
Millennium Management 559.06K +224.44K +67.1%
Point72 Asset Management 858.27K +216.35K +33.7%
Assenagon Asset Management 269.18K -205.09K -43.2%
Prosight Management 908.49K -183.51K -16.8%
ExodusPoint Capital Management 139.52K +128.1K +1121.5%
DB Deutsche Bank AG - Registered Shares 299.63K +119.41K +66.3%

Financial report summary

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Risks
  • Our business is dependent in large part on the success of a single product candidate, reproxalap, for which we are researching multiple indications. We cannot be certain that we will be able to obtain regulatory approval for, or successfully commercialize, reproxalap.
  • Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
  • In order to commercialize our product candidates, we will need to substantially grow the size of our organization. We may encounter difficulties in managing our growth and expanding our operations successfully.
  • We are highly dependent on the services of our senior management team and certain key consultants.
  • If we fail to attract and retain senior management and key commercial personnel, we may be unable to successfully develop or commercialize our product candidates.
  • Our employees or others may engage in misconduct or other improper activities, including noncompliance with regulatory standards, regulatory requirements, and insider trading.
  • Our business is subject to political, economic, legal, and social risks in those markets, which could adversely affect our business.
  • If we engage in an acquisition, reorganization, or business combination, we will incur a variety of risks that could adversely affect our business operations or our stockholders.
  • Our internal computer systems, or those of our development partners, third-party clinical research organizations, or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our product development programs.
  • We have incurred significant operating losses since inception and we expect to incur significant losses for the foreseeable future. We may never become profitable or, if achieved, be able to sustain profitability.
  • We will require substantial additional financing, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development, other operations or commercialization efforts.
  • Raising additional capital may cause dilution to stockholders, restrict our operations or require us to relinquish rights to its technologies or product candidates.
  • We may allocate our cash and cash equivalents in ways that you and other stockholders may not approve.
  • The terms of our secured debt facility require us to meet certain operating covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
  • Our ability to use net operating loss carryforwards and tax credit carryforwards to offset future taxable income may be limited as a result of transactions involving our common stock.
  • Governments may impose price controls, which may adversely affect our future profitability.
  • Business disruptions could seriously harm our future revenues and financial condition and increase our costs and expenses.
  • Our quarterly operating results may fluctuate significantly.
  • Our business has been and will continue to be adversely affected by the COVID-19 pandemic.
  • COVID-19 has and is expected to continue to affect our ability to recruit or retain patients for our clinical trials, disrupt our supply chains, or have other adverse effects on our business and operations.
  • Reproxalap and our other product candidates are subject to extensive regulation, compliance with which is costly and time consuming, and such regulation may cause unanticipated delays, or prevent the receipt of the required approvals to commercialize our product candidates.
  • The results of preclinical studies and earlier clinical trials are not always predictive of future results. Any product candidate we or any of our future development partners advance into clinical trials, including reproxalap, may not have favorable results in later clinical trials, if any, or receive regulatory approval.
  • Because we are developing novel product candidates for the treatment of diseases in a manner which there is little clinical drug development experience and, in some cases, are designing adaptive trials or using new endpoints or methodologies, the regulatory pathways for approval are not well defined, and, as a result, there is greater risk that our clinical trials will not result in our desired outcomes or require additional trials.
  • To preserve trial integrity, clinical data from the initial parts of adaptive clinical trials may not be disclosed.
  • Because some of our product candidates are, to our knowledge, new chemical entities, it is difficult to predict the time and cost of development and our ability to successfully complete clinical development of these product candidates and obtain the necessary regulatory approvals for commercialization.
  • Because RASP is a new objective sign for the treatment of dry eye disease, there is no precedent in measuring and validating the results of studies of RASP in tears, which could impact the timing and cost of development of our trials and delay or prevent the filing of an NDA in dry eye disease.
  • We may find it difficult to enroll patients in our clinical trials or identify patients during commercialization (if our products are approved by regulatory agencies) for product candidates addressing orphan or rare diseases.
  • Any product candidate we or any of our future development partners advance into clinical trials may cause unacceptable adverse events or have other properties that may delay or prevent its regulatory approval or commercialization or limit its commercial potential.
  • Final marketing approval for reproxalap or our other product candidates by the FDA or other regulatory authorities may be delayed, limited, or denied, any of which would adversely affect our ability to generate operating revenues.
  • Even if we obtain marketing approval for reproxalap or any other product candidate, it could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our product candidates, when and if any are approved.
  • Even if we receive regulatory approval for reproxalap or any other product candidate, we still may not be able to successfully commercialize, and the revenue that we generate from its sales, if any, could be limited.
  • If the market opportunities for reproxalap and our product candidates are smaller than we believe they are, and if we are not able to successfully identify patients and achieve significant market share, our revenues may be adversely affected and our business may suffer.
  • If we fail to develop and commercialize other product candidates, we may be unable to grow our business.
  • Orphan drug designation, breakthrough therapy designation, or fast-track designation from the FDA may be difficult or impossible to obtain, and if we are unable to obtain such designations for reproxalap or our other product candidates, regulatory and commercial prospects may be negatively impacted.
  • We are subject to a multitude of manufacturing risks, any of which could substantially increase our costs and limit supply of our products.
  • We may not be successful in executing our sales and marketing strategy for the commercialization of our product candidates. We have no sales, marketing, or distribution capabilities and expect to invest significant financial and management resources to develop these capabilities. If we are unable to establish sales, distribution, and marketing capabilities or enter into agreements with third parties to market, sell, and distribute our product candidates, we may be unable to generate any revenues.
  • If we market products in a manner that violates healthcare fraud and abuse laws, or if we violate government price reporting laws, we may be subject to civil or criminal penalties.
  • The FDA’s ability to review and approve new products may be hindered by a variety of factors, including budget and funding levels, ability to hire and retain key personnel, and statutory, regulatory, and policy changes.
  • Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products abroad.
  • If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of reproxalap or our other product candidates.
  • We and our development partners, third-party manufacturers, and suppliers use biological materials and may use hazardous materials, and any claims relating to improper handling, storage, or disposal of these materials could be time consuming or costly.
  • We and any of our future development partners will be required to report to regulatory authorities if any of our approved products cause or contribute to adverse medical events, and any failure to do so would result in sanctions that would materially harm our business.
  • We rely on third parties to conduct our clinical trials. If any third party does not meet our deadlines or otherwise conduct the trials as required and in accordance with regulations, our clinical development programs could be delayed or unsuccessful and we may not be able to obtain regulatory approval for or commercialize our product candidates when expected, or at all.
  • Some of our product candidates may be studied in clinical trials co-sponsored by organizations or agencies other than us, or in investigator-initiated clinical trials, which means we have minimal or no control over the conduct of such trials.
  • We may not be successful in establishing and maintaining development, commercial, or other strategic partnerships, which could adversely affect our ability to develop and commercialize product candidates.
  • We may not realize the benefits of our current or future strategic alliances.
  • Our success depends on our and our licensors ability to protect our intellectual property and our proprietary technologies.
  • Our issued patents could be found invalid or unenforceable if challenged in court.
  • We may fail to comply with any of our obligations under existing or future agreements pursuant to which we license rights or technology, which could result in the loss of rights or technology that are material to our business.
  • We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees, consultants, or agents have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers.
  • If we do not obtain protection under the Hatch-Waxman Amendments by extending the patent terms and obtaining data exclusivity for our product candidate, our business may be materially harmed.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
  • Changes in United States patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
  • We may not be able to protect our intellectual property rights throughout the world.
  • An active trading market for our common stock may not develop or be sustained and investors may not be able to resell their shares at or above the price at which they purchased them.
  • The trading price of the shares of our common stock has been and is likely to continue to be highly volatile, and purchasers of our common stock could incur substantial losses.
  • Our failure to meet the continued listing requirements of The Nasdaq Capital Market could result in a delisting of our common stock.
  • If our shares become subject to the penny stock rules, it would become more difficult to trade our shares.
  • Because a small number of our existing stockholders own a majority of our voting stock, your ability to influence corporate matters will be limited.
  • We do not intend to pay dividends on our common stock and, consequently, your ability to achieve a return on your investment will depend on appreciation in the price of our common stock.
  • A substantial number of shares of our common stock could be sold into the public market in the near future, which could depress our stock price.
  • We are a smaller reporting company, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our common stock less attractive to investors.
  • We are incurring significant increased costs and demands upon management as a result of operating as a public company.
  • If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our common stock.
  • Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
  • We are subject to litigation risks.
  • We could be subject to securities class action litigation.
  • U.S. federal income tax reform could adversely affect us.
  • Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products.
  • Our business could be negatively affected as a result of the actions of activist stockholders.
Management Discussion
  • We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including the progress of our research and development efforts, the timing and outcome of clinical trials, and regulatory requirements. Our limited operating history makes predictions of future operations difficult or impossible. Since our inception, we have incurred significant losses.
  • Research and development expenses. Research and development expenses were $7.7 million for the three months ended March 31, 2021, compared to $6.6 million for the three months ended March 31, 2020. The increase of $1.1 million is primarily related to the increase in our external clinical research and development expenditures and increases in our manufacturing research activities, partially offset by lower personnel related costs and a decrease in our preclinical research activities. 
  •  General and administrative expenses. General and administrative expenses were $3.1 million for the three months ended March 31, 2021, compared to $3.0 million for the three months ended March 31, 2020. The increase of $0.1 million is primarily due to an increase in personnel related costs and other miscellaneous administrative costs.
Content analysis
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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Good
New words: annum, Biden, bore, CequaTM, clause, cohort, corticosteroid, curb, Fourth, Hatch, heard, iv, lymphoma, November, PVRL, restraining, risky, Secretary, summarized, TRANQUILITY, underwriting, underwritten, unfair, vitreoretinal, Waxman
Removed: American, antipathy, assessed, asthma, atopic, attestation, auditor, authorization, book, Brexit, Cequa, China, content, continuation, cumulative, David, detect, expressed, framework, Gow, harming, importation, imported, inborn, inflammation, Kingdom, McMullin, membership, metabolism, Mexico, move, movement, North, persist, referenda, RENEW, represent, securing, supple, TM, vaccine, Vice

Patents

GRANT
Utility
Compositions and methods of treating retinal disease
9 Feb 21
Compositions and methods for treating macular degeneration and other forms of retinal disease whose etiology involves the accumulation of A2E and/or lipofuscin, and, more specifically, for preventing the formation and/or accumulation of A2E are disclosed
APP
Utility
Toxic Aldehyde Related Diseases and Treatment
25 Nov 20
The present invention provides for the treatment, prevention, and/or reduction of a risk of a disease, disorder, or condition in which aldehyde toxicity is implicated in the pathogenesis, including ocular disorders, skin disorders, conditions associated with injurious effects from blister agents, and autoimmune, inflammatory, neurological and cardiovascular diseases by the use of a primary amine to scavenge toxic aldehydes, such as MDA and HNE.
APP
Utility
Ophthalmic Formulations and Uses Thereof
14 Oct 20
The present invention provides a reproxalap ophthalmic solution, and methods of using the same for treating a disease or disorder such as allergic conjunctivitis.
APP
Utility
Aldehyde Conjugates and Uses Thereof
5 Aug 20
The present invention provides compounds and methods of use thereof for the treatment, prevention, and/or reduction of a risk of a disease, disorder, or condition in which aldehyde toxicity is implicated in the pathogenesis, including ocular disorders, skin disorders, conditions associated with injurious effects from blister agents, and autoimmune, inflammatory, neurological and cardiovascular diseases by the use of a primary amine to scavenge toxic aldehydes, such as MDA and HNE.
APP
Utility
Deuterated Compounds and Uses Thereof
24 Jun 20
The present invention provides for the treatment, prevention, and/or reduction of a risk of a disease, disorder, or condition in which aldehyde toxicity is implicated in the pathogenesis, including ocular disorders, skin disorders, conditions associated with injurious effects from blister agents, and autoimmune, inflammatory, neurological and cardiovascular diseases by the use of a primary amine to scavenge toxic aldehydes, such as MDA and HNE.