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I added 3,500 shares on 10/16 as well below $1.80. I wish I leaned in more. I am a holder and still see long-term upside from here.
ALDX: Just crossed the (dangerous) 1.5-Hrs-Into-The-Open-Rubicon, and movin' UP from there!! (Not easy to do for ANY stock.)
Nice grab. It's good to be the early bird. I knew nothing about the company, just saw the news.
Yep. I snatched up some of this pre-market.
ALDX: Could have a good day here; 'Dry Eye' syndrome afflicts MILLIONS worldwide!
I bought to average down today, it seems a sensible move.
With the pending readouts and relatively short trials that may provide additional support, I agree.
Also, the company has some breathing room with > $2 per share in cash after all liabilities as of 6/30 and only burning ~ $0.20 per share quarterly.
The current sub $2 share price looks attractive to me.
Ouch indeed, but it isn’t over for dry eye and we are expecting one other different P3 indication readout this year.
A not so great day yesterday for $ALDX.
Small potential indication costing the 25% run up we have in expectation of H2 events.
It isn’t over for ADX-2191 yet though…
I have been invested here (smaller position than in AVXL) also. Binary/inflection points appear to be ahead mid-2023. We appear to have several shots on goal.
Yet another great day for aldeyra.
No one invested here?
Another great day for Aldeyra. In due course probably pay handsomely.
That’s biotech.
what I meant was the time line
mid 2022
Agree and believe that is what I just said.
yeah but heres the kicker
ALDX
So TRANQUILITY-2 endpoints to be changed to meet either Redness or Schirmer for potential approval.
Could be fine not least given that secondary p-value.
Still hope!
NEWS HALT ))) 12/20/2021 16:00:34 ALDX Aldeyra Therapeutics Cmn Stk NASDAQ
T1
Looks like the market finally clicked that ocular redness is the primary endpoint over the conventional Schirmer’s test as agreed by the FDA trial protocol.
ADX-1612 and ADX-1615, Chaperome Inhibitors
Last summer I dove into the mechanism of action for ADX-1612 and spent a fair amount of time looking at HSP90 on PubMed. It is a widely recognized target. It will be interesting to see how the numerous assets at ALDX are managed. It's challenging to put a market cap and time to reach that value but they have great potential, no doubt. Current market conditions will probably make for a wild ride. Good Luck!
https://pubmed.ncbi.nlm.nih.gov/?term=hsp90+inhibitor
I agree, ALDX has great potential.
RASP-INHIBITION IN SYSTEMIC DISEASES
ADX-629 became a topic in the recent conference call so I did a revisit of that therapeutic. Glad I did since ADX-629 offers an impressive opportunity to further RASP inhibition. Several nuggets to pass along from a quick review of ADX-629:
The clinical trial NCT04847544 for Treatment of COVID-19 was initiated in April. It is recruiting N=30 and estimated completion this year.
https://clinicaltrials.gov/ct2/show/NCT04847544?term=aldeyra&recrs=abdf&draw=2&rank=1
Secondly, the phase 1 results showed target engagement "Also Improved Lipid Profiles". Lipid therapeutics have a large market, i.e., cardiovascular disease. Look at slide #17.
https://ir.aldeyra.com/static-files/33742ce3-ebdc-4569-9f65-b5b7bd8c73eb
The asthma trial is also on the trial list.
https://clinicaltrials.gov/ct2/results?term=aldeyra&recrs=b&recrs=a&recrs=f&recrs=d&age_v=&gndr=&type=&rslt=&Search=Apply%5D
Six ongoing clinical trials explains the recent raise in capital and great timing on that. Kudos to management!
Perceptive Advisors SEC form 4
3 May 2021 shows 1,200,000 shares bought at $12.50 = $15,000,000
They now have a total of 9.9 million shares which at $12.50 = $123,750,000. They have been adding since July 2020. Safe to say they have a positive outlook, eh?
It will stay above the $12.50 offer price just like last time especially given the great P3 trial readout.
I wouldn't touch this personally with a ten foot stick for a while not bashing but that's a heck of a lot of dilution coming out. 125 million dollars and able to add a lot more.
Bought in again @$12.89.
Huge $125,000,000 offering & can add another $18,750,000 million
Sold today avg $15.07. Figured they’d needmore funding and the price would dip waiting for a NDA filing and next P3 readout in H2.
Plenty time to buy back in cheaper, which should be a nice long term hold.
* * $ALDX Video Chart 04-27-2021 * *
Link to Video - click here to watch the technical chart video
Good volume. When it slows it'll fade hard imho Wish could get locates some where. 4x highest volume day ever
Yes, usually have something going on or at least some kind revenues from something. Not just spending money.
You seem surprised. Ever invested in pre-revenue biotechs?
Hmmm 0 profit, 0 revenus, debt, negative cash flow, with a $1.52 book value.
Profitability
Profit Margin 0.00%
Operating Margin (ttm) 0.00%
Management Effectiveness
Return on Assets (ttm) -27.28%
Return on Equity (ttm) -69.81%
Income Statement
Revenue (ttm) N/A
Revenue Per Share (ttm) N/A
Quarterly Revenue Growth (yoy) N/A
Gross Profit (ttm) N/A
EBITDA -34.61M
Net Income Avi to Common (ttm) -37.55M
Diluted EPS (ttm) -1.11
Quarterly Earnings Growth (yoy) N/A
Balance Sheet
Total Cash Per Share (mrq) 1.12
Total Debt (mrq) 15.33M
Total Debt/Equity (mrq) 25.76
Current Ratio (mrq) 6.69
Book Value Per Share (mrq) 1.54
Cash Flow Statement
Operating Cash Flow (ttm) -37.49M
Levered Free Cash Flow (ttm) -20.28M
This article supports the narrative that ALDX provides, namely, the current products for dry eye take a long time to have any effect and hard to keep people from discontinuing use.
https://www.ajmc.com/view/evolving-knowledge-of-the-unmet-needs-in-dry-eye-disease
The close on Friday, 3/19/2021
I watched the market on Fidelity Active Trader Pro and ALDX was at ~500,000 shares at 3:40 today and hit 1,000,000 by 3:58. When I looked at it after the close, 4,200,000 so in the last minute or two, 3 million shares at $12/share or $36 million. What's up with that? Somebody wanted 3 million shares without moving the price? How can that volume be executed in a minute or two? I could believe 50 - 100 k shares but 3 million? An issue with Fidelity showing volume? Please enlighten me.
ALDX $14.45 looks very good now. Strong breakout setting for next big upward move
ALDX $15 June calls are flying off the shelf along with the stock this morning. Fidelity ATP shows 2,044 contracts traded at 10:50 am on 2/16/2021 @ $4.00 per.
$400 x 2,044 = $817,600
Seems like a lot of $$ into those calls. Somebody thinks $20 is possible, eh?
Revenue estimate based on Xiidera:
I was somewhat shocked by the monthly cost of $553/month
https://www.goodrx.com/xiidra
I was also curious about how tough it will be to capture market share and, based on the reviews, it looks like that will be fairly easy.
"Xiidra has an average rating of 3.9 out of 10 from a total of 180 ratings for the treatment of Dry Eye Disease. 22% of those users who reviewed Xiidra reported a positive effect, while 58% reported a negative effect"
https://www.drugs.com/comments/lifitegrast-ophthalmic/xiidra-for-dry-eye-disease.html?page=2#:~:text=Xiidra%20has%20an%20average%20rating,58%25%20reported%20a%20negative%20effect.
Seems expensive for those results but anyway I plugged in the following numbers.
30 million affected with dry eye. 1% = 300,000
300,000 x $500/month x 12 = $1.8 B annually
$1.8 B x 0.15 (net margins) = $270,000,000 net
It certainly looks like there is substantial opportunity to bring a new, more effective treatment onto the market. The revenue projections are highly speculative. Time will tell. I cannot find Xiidera revenue in the Novartis annual report since it was recently launched. Probably pretty low. I would guess it'll take 5 years to get the MD's to prescribe anything close to the $270 M number. So start with $50 M net annually as a guesstimate.
$50 M per year net and 37 M shares = $1.35 earnings per share
PE of 20 gets the share price to $27. Lots of variables and moving parts but I like these numbers. I was surprised how close they are to what the analysts provide.
ALDX NEWS >>> Aldeyra Therapeutics Announces Phase 3 TRANQUILITY Dry Eye Disease Trial Design
February 04 2021
TRANQUILITY to Utilize Two-Day Treatment and Challenge Design
Consistent with Previously Announced Top-Line TRANQUILITY Run-In Cohort Results, Ocular Redness Selected as Primary Endpoint
Tear RASP Levels Reduced After Single Doses of Reproxalap in Run-In Cohort of TRANQUILITY and Selected as Secondary Endpoint for Confirmation of Mechanism of Action
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 announced the finalization of the design of the Phase 3 TRANQUILITY Trial of 0.25% reproxalap ophthalmic solution for the treatment of dry eye disease. Consistent with previously announced results from the run-in cohort of TRANQUILITY, ocular redness over 90 minutes in a dry eye chamber will be the primary endpoint. Approximately 150 dry eye disease patients are expected to be enrolled per arm. The TRANQUILITY protocol will utilize the two-day dosing paradigm, dry eye challenge design, and enrollment criteria of the run-in cohort.
Tear RASP levels from the TRANQUILITY run-in cohort were reduced after single doses of the novel RASP inhibitor reproxalap, as assessed by enzyme-linked immunosorbent assay (ELISA) of 4-hydroxynonenal protein adducts (HNE), a RASP selected based on results from a natural history study of dry eye patients conducted by Aldeyra. For subjects with sufficient tear volumes for analysis, across the two doses where tear RASP levels were assessed before and after drug administration, HNE levels declined by an average of 1018 picograms/milliliter (pg/mL) in reproxalap-treated patients (n=9) versus an increase of 32 pg/mL in vehicle-treated patients (n=7). Accordingly, tear RASP levels have been selected as a secondary endpoint for confirmation of mechanism of action. HNE is well-characterized in the scientific literature as a critical pro-inflammatory RASP,1 and ocular levels of HNE correlate with the signs and symptoms of dry eye disease.2
“The rapid activity of reproxalap demonstrated in the run-in cohort of TRANQUILITY in improving ocular redness, potentially the only dry eye disease sign of interest to patients, allows for the use of a two-day challenge design — a time and cost-efficient model for Phase 3 clinical testing,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Consistent with the observed rapid improvement in dry eye disease signs and symptoms, the reduction of tear RASP levels was evident after single doses of reproxalap, representing, to our knowledge, the first confirmation of drug mechanism in clinical trials of a topical ocular dry eye disease drug.”
TRANQUILITY and the confirmatory Phase 3 TRANQUILITY-2 Trial are expected to initiate in the first half of 2021. Results from both trials are expected in the second half of 2021.
seems ALDX going in position for a breakout. $25 next days? if sudden a big News drop ALDX good for a multipler short term. something must be in the air. looking forward
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