Ocular Therapeutix Inc (OCUL) 銘柄情報

WASHINGTON, April 1 (Reuters) - The Trump administration began mass layoffs of 10,000 staffers at U.S. health agencies on Tuesday, according to multiple sources familiar with the situation, with security guards barring entry to some employees just hours after they received dismissal notices.
The cuts, which affect several high-profile agencies under the Department of Health and Human Services, including the FDA, CDC and the National Institutes of Health, are part of a broad plan by President Donald Trump and billionaire ally Elon Musk to shrink the federal government and slash spending.
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Drug approvals likely delayed , Co's burn more cash on hand
Kiwi

Ocular Therapeutix Axpaxli Advances In Phase 3 For Wet AMD, Analyst Forecasts Huge Upside

Needham initiated coverage on Ocular Therapeutix Inc ( OCUL ) , noting the company’s lead asset, Axpaxli, an investigational axitinib-based intravitreal implant for wet age-related macular degeneration (wet AMD).
Axpaxli is the company’s key value driver and is under evaluation in two phase 3 trials. If positive, these trials could support approval with a product label that enables maintenance treatment with Q6M (every 6 months)-Q12M (every 12 months) dosing, which would represent a significant improvement over current treatment options that offer up to Q2M (every two months)-Q4M (every 4 months) dosing.
Also Read: Analyst Sees Wendy’s Playing Catch-Up, Needs Stronger Focus on Tech, Talent & Global Expansion
Ocular Therapeutix ( OCUL ) has completed randomization in the first wet AMD trial, SOL-1. The company expects topline results for SOL-1 to be available in the fourth quarter of 2025.
The company has enrolled 311 subjects in SOL-R, Ocular’s second registrational trial of Axpaxli in wet AMD. The company also plans to seek FDA feedback in the first half of 2025 on clinical trial design for Axpaxli in non-proliferative diabetic retinopathy (NPDR).
The analyst Serge Belanger has initiated with a Buy rating and a price target of $15.
Needham writes that intravitreally injected anti-VEGFs make up the ~$15 billion retinal disease market.
The analyst expects Axpaxli to play a role as a second-line treatment in the ~40% of 1.65 million wet AMD patients treated with anti-VEGFs who fail to adequately respond to anti-VEGFs and/or are dissatisfied with the high number of required IVT injections. Needham expects peak sales of around $1.5 billion based on a 15-20% share of this second-line AMD patient population.
“We believe Axpaxli’s product profile and unique pivotal ph 3 program offer substantial advantageous differentiation over other products in development seeking to provide long-term treatment duration,” Needham writes.
Ocular Therapeutix ( OCUL ) reported a fourth-quarter loss of 29 cents per share, compared to a consensus of 24 cents, with sales of $17.1 million.
The company expects its cash balance of $392.1 million to fund operations into 2028 without raising additional capital.

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Kiwi

N7. suggest you listen to the OCUL presentation today
Kiwi

Forwarded from Worst Case on Biotech Values

Raymond James reiterated $OCUL Strong Buy-$19, says it sees near term pressure on stock, however they view the updates as constructive toward achieving an earlier NDA submission and more robust label.
$EYPT $SRZN $APLS $REGN $ALPMY
BofA⬇️the PT on $OCUL to $17 was $18, says it thinks the changes should streamline the overall timeline to an NDA filing despite delaying the SOL-1 readout.

Raymond James:
"Monday before Market Open, Ocular Therapeutix reported 4Q24 results.
Management hosted a call to discuss progress.
The company reported $17.1M in total revenue vs. our estimated $17.8M and diluted EPS of $(0.29) vs. our projected $(0.26). Revenues came primarily from Dextenza (+11% q/q, +16% y/y). The ~$392M in cash and equivalents to end FY2024 is guided
to fund operations into 2028.

The most notable update was the change in SOL-1 trial design with accompanying FDA approval of an
amendment to the SPA agreement for the trial, now inclusive of a 52 and 76 week redosing. The unmasking of the study and report of the primary endpoint (still 36 weeks) will come 1Q26 vs the prior guidance of 4Q25. Additionally, SOL-R will be downsized to 555 patients from 825, accelerating the trial timeline.

We anticipate near term pressure as considerable interest was placed on the SOL-1 topline which will now be three months later, however we view the updates as constructive toward achieving an earlier NDA submission and more robust label (q6m-q12m dosing).

Based on our positive view of Axpaxli's drug product profile relative to competing sustained release TKI platforms and the strategic design of the SOL-1 and SOL-R studies we maintain our Strong Buy rating and price target of $19."

BofA:
"Ocular ( $OCUL ) reported an amendment to the SPA for SOL-1 to include re-dosing at weeks 52 and 76.
Mgmt underscored the 9-month primary endpoint remains unchanged, but masking is now required through week 52 shifting the topline readout to 1Q26 (prev. 4Q).

The changes will provide additional insights into the long-term durability of Axpaxli in wAMD and potentially support flexible 6-12-month dosing on the label.

These changes also allowed for downsizing of SOL-R, which should accelerate enrollment completion.

In our view, these changes should streamline the overall timeline to an NDA filing despite delaying the SOL-1 readout. We remain bullish on Axpaxli's differentiated long-acting profile with potential to significantly reduce treatment burden in several retinal diseases. We reiterate our Buy with new $17 PO."

Kiwi

N7. I tend to avoid trading , using trailing stops to take me out of positions if down 20% or so from my purchase price or recent high .
These stops are just breaks ...forces me to re evaluate etc and I may re enter later as I often do .
OCUL down about 14% as I type on a headline delay of trial results ....but as others have noted ( they need both SOL-1 and SOL-R ) ...may make little difference in when they are in a position to actually file for approval .
So I'll add back at these levels....$6.20 ... ,some of what I was stopped out of previously
JMO ...not investment advice
Kiwi

OT. suggest you look at APP at these levels . Short report is not credible .
Kiwi

Well I wish I could have got you , RMB and a few others into APP .
Huge move after hrs
Kiwi

Kiwi, Good luck to you as well.
Sleven,

N7. While there are many things I like about OCUL , if it starts trading below $7 it will start to trigger stop loss's I have in place.
Simple portfolio management .
Most of my biotechs are down ...and AI related software stocks ( PLTR, APP ) and cyber security stocks ( CRWD, CYBR ) are up .....so staying with strength and getting stopped out of weakness .
Good luck
Kiwi

Kiwi, That is Why I wanted to move from eypt to ocular. I expected the positive phase 2 study would give me the opportunity.
Sleven,

Cantor Fitzgerald (pre-mkt) reit'd $EYPT Overweight, says "there's nothing here that makes us less positive on the DME data/opportunity - if anything, it gives us higher confidence in the POS for a less clinically risky non-inferiority pivotal program:"
$OCUL $REGN $SRZN $XBI
TD Cowen reiterated $EYPT Buy-$20, says the 24-week benefit should still be enough to achieve Phase III success—and if the Phase III is successful with Q6M dosing, DME is a blockbuster opportunity that is not far off from wet AMD:


Cantor and Cowan still positive on EYPT . From a Quick Look at their trial ...small numbers and one patient that appeared to drop out then was " rescued " may have skewed results .
OCUL tho IMHO is further ahead , has a P 3 readout in Q4 with 1 fully enrolled P 3 trial and a second recruiting , their previous trials indicated benefit in DME and they have plenty of cash .
Some think they have the stronger drug
They also will have first mover advantage
JMO
Kiwi

BofA reiterated $OCUL Buy-$18-Top Small-Cap after its Meeting w/ MGMT in SF.
$EYPT $REGN

"We caught with $OCUL management to set expectations and discuss the strategic outlook for 2025. Management highlighted their continued focus on their registrational wet age-related macular degeneration (wAMD) program for Axpaxli.

Recall, Axpaxli is currently being evaluated in 2 complementary phase 3 studies, SOL-1 and SOL-R. SOL-1, which is evaluating single Axpaxli injection
versus a single injection of 2mg aflibercept, completed randomization in December 2024
with topline data expected to readout in 4Q25.

We reiterate our view that a positive readout is likely based on initial data supporting the long-term durability of Axpaxli in wAMD and the favorable trial design. On SOL-R, which is evaluating repeat Axpaxli
injections every 6 months versus 2mg aflibercept injections every eight weeks, management reported 311 patients have enrolled in the study as of January 10th, 2024 (enrollment initiated in November 2024).

They noted the trial was designed to help inform real-world treatment decisions. We are encouraged by the fast enrollment rate that we think reflects both the company's ability to clinically execute and the high unmet need for less frequently dosed treatment options.
Management commented they expect a positive SOL-1 readout would significantly de-risk SOL-R.

On the entry of aflibercept biosimilars, management said they do not see a direct impact to the commercial opportunity for Axpaxli given the differentiated dosing profile and value proposition.

We currently model $1.14bn in risk-adjusted peak sales for Axpaxli in wAMD contributing $13/sh to our PO.

While management emphasizes their primary focus is currently on wAMD, management highlighted they remain committed to expanding the opportunity in
other ophthalmology indications. They plan to meet with FDA in 1H25 on next steps for clinical study in non-proliferative diabetic retinopathy. They also highlighted that all patients in the HELIOS trial with diabetic macular edema (DME) showed signs of
improvement and they are exploring options in this indication as well.

We maintain our Buy with $18 PO and highlight $OCUL as our top small-cap pick for 2025.

We continue to be encouraged by Axpaxli's differentiated long-acting profile in wAMD with a potential first-to-market path ahead of competitor long-acting tyrosine kinase inhibitors."

Kiwi

N7. sorry to see that with EYPT. I saw the headline that it was a positive trial but apparently some questioned the data on digging deeper
Raymond James reiterated $OCUL Strong Buy-$19.
$REGN $SRZN $APLS
Raymond James said in its note to investors:
"Wednesday, before market open, EyePoint ( $EYPT, not covered ) released 6-month top-line results for the VERONA study of Duravyu in diabetic macular edema (DME).

In our view, the results were neutral to positive for the sustained release VEGFR TKI drug class within DME, but leave plenty of room for Ocular's Axpaxli to improve.

We note that Ocular does not currently have Axpaxli in clinical trials for DME, but has stated intent to pursue a broad development strategy in all indications where anti-VEGF therapies have proven effective.

In our view Axpaxli, which utilizes a more potent TKI axitinib (vs. vorolanib for Duravyu), holds the
advantage on durability and fluid reduction as evidenced by the relative efficacy in NPDR, which should translate well to DME.

OCUL hasn't been acting that great lately so I'm thinking about reducing my position ....need to do some DD
Raggy and RMB are in CADL which has data due this Qt . Hope it works for them .
I generally stay away from Oncology
Kiwi

Kiwi, Positive phase 2 results followed by a massive sell off completely fucked up my trading plan.
Sleven,

Kiwi, I focus on distressed assets. I am not sector focused. I am going to watch MPW until 2026.
Sleven,

Well on rereading that post I need clarify and note I've also owned some huge blow ups ....chk the 5 yr chart of QS.
Taken out 20-25% down from its high .
I try to adhere to a Marty Zweig principal ... "cut your loss's and let your winners run "...or something like that .
Good luck
Kiwi

Kiwi, Thanks for sharing your basic strategy.
Sleven,

N7. an example of disruptive tech ...SOUN.
I had reduced my position in the recent frenzy but will add back in tomorrow . I use voice activation whenever possible in my Tesla . When my son has his Spotify app running ....if you want to listen to Bob Marley music for instance ...you just press a button on the steering wheel and say ...play Bob Marley .
SOUN is mainly in fast food drive thru's and Lucid ...but once you start using it you can appreciate how it saves labor costs at drive thru's ...and ease of use in autos.

Kiwi

MPW ...is that a health care REIT ?
Not something I usually look at .
I mainly look for new disruptive business's / technologies
AMZN ...my biggest holding . Yes Bezos started selling books ...but you could see the wider applications . The only store I go into now ( besides Apple ) is the grocery store . Everything else ( clothes , shoes , toilet paper , tools etc etc ) is usually one day delivery on Amazon for me .
NFLX ...Last time I was in a movie theater was pre Covid ...Now everything is streamed via NFLX , Apple and Amazon
NVDA . I think I argued their case to you in early 2023 . Yes AI was making a lot of mistakes then but the amount of $ and talent going into that area you know it would eventually work . Any debate I have now is all sourced from Perplexity or ChatGPT
PLTR ...from early 2023 ..you could see their " boot camps " gaining traction .
More speculative .. APP ...my eldest son works for a media buying Co in LA ....driving sales thru Meta etc . APP appears to be disrupting part of that market

Then biotech where I may have some first hand experience ...or is in an area my wife deals with ( Kidney disease )

Those are the areas I generally stick to .
Happy to share ideas

Kiwi

Kiwi, I am no fan of biotech. Take a look at MPW. I'd be interested to hear what you think. This is a fairly dead board.
Sleven,

Kiwi, Same to you.
Sleven,

Most of my portfolio is long term holds ...like AMZN for over 10 yrs .
I do speculate in some areas of biotech and tech as you can see on " IHUB boards posted on " .......but thats 20% of my portfolio at most .
So I'm pretty risk adverse
EYPT looks more risk than OCUL ...in my layman analysis . It's down 17% in the past week . If it went below $6.8 I'd probably be out of it if I owned it ..
Re assessing / selling half on a 20-25 % individual stock pull back has saved my portfolio multiple times over the years .

There may be more upside in EYPT vs OCUL ...but its more risk then I want to take .

I'm more willing to take risk with ARDX and UNCY ( UNCY is very risky ) because my wife has patients on serum phosphorous drugs ...and most are no where near serum pho goal. She and the Nephrologists she works with want these drugs for their patients . Each of these have issues ...as you can see being discussed on those boards .
Good luck
Kiwi

Kiwi, Take a look at the share count for both companies.
Sleven,

Kiwi, I agree. I also don't want to spend time in another biotech while it launches a drug. If the eypt p2 trial is successful, (it should be) I intend switching to ocular. They should get a nice bump on p3 outcome. I Will leave and go back for the eypt p3.
What are your thoughts?
Sleven,

Thx for the link ... Saw Citi note
OCUL P 3 data Q4 2025
EYPT. P 3 data in 2026
Expects OCUL to be first to market ...efficacy skews towards EYPT while trial end pts skew towards OCUL ...expect both to meaningfully share in wAMD market with one eventually dominating .
I think OCUL will be submitting data from 2 P 3 trials ...so should have a smoother road to approval.
Dont know how much better EYPT's drug is ( based on data today ) vs OCUL ....but if close , first mover advantage for OCUL IMHO is huge

Kiwi

Kiwi,
https://www.biospace.com/press-releases/eyepoint-provides-company-update-and-anticipated-development-milestones-for-2025#:~:text=Positive%20interim%2016%2Dweek%20data,%2B8.9%20letters%20vs.%20baseline.
Sleven,

Kiwi, Thanks for the information.
Sleven,

N7. Someone U might want to follow on Biotech Values

Worstluck
# 254273
Tuesday, January 14, 2025 10:33:21 AM
Post# of 254288
EYPT

Looked at the slide deck for tonight's JPM and it notes the first P3 is about 1/3 enrolled and the second is "exceeding expectations." Pending color I take that as toplines around Oct and Dec 2026, subject to normal variance.
https://investors.eyepointpharma.com/static-files/09d5a2c6-310f-4820-8890-b6096ca41b3a slide 18

Getting a topline for the OCUL Sol-R trial is kind of tricky given no guidance, the long lead time between enrollment and randomization and allowing for some screen failures during that period. I can envision a topline in the same timeframe as EYPT (Q4 2026) +/- a month best/worst. Again, there are some assumptions built in.

N7. I'll do some more. DD as I have time this week . Thx for the analysis ...my energies been elsewhere last couple of days .
Re timing etc . Poster Chromosome on the AMRN board . He worked at ZS pharma and they were competing with RLYP for a new / better drug for treating high serum potassium in dialysis patients . High serum pot leads to heart arrhythmia's and heart attacks .

Anyway ...ZS Pharma's drug was slightly better than RLYP's drug ...but because their production facility was delayed in getting FDA approval .....RLYP's drug was first on the market .
Now RPYP's drug dominates as most ( including my wife who prescribes it ) are familiar with it , has the codes for ordering etc etc .
Pt being ...huge advantage for first mover ...and OCUL will likely be the first on the market assuming efficacy and safety in their final P3 trials .

To date OCUL's AXPAXLI is just as safe as Eyelea and 80% are " rescue free " out to 10 mths ...I'll chk EYPT's drug for comparison .
Feel free to find holes in my analysis . I'm wrong a lot ...cant afford to let any ego get in the way of correcting course when necessary .

Rosemouthbomber ( from AMRN ) is also in a number of other biotechs I'm in ...RZLT , UNCY and ARDX ...all with their own issues and catalysts in 2025

Kiwi

Kiwi, I think there might be a good play moving between the two companies. Thoughts?
Sleven,

Kiwi, Just to be clear, I don't care who has the better drug. In this case I'm only interested in market reaction and timing. Looking to go from eypt to ocular and back to eypt.
Sleven,

Kiwi, Stay safe. The acceleration of enrollment in the ocular wet-amd trials is why I'm thinking about trading. From what I have read I think the eye point drug is better. Doesn't actually matter to me. Looking for a shift from eypt to ocular after the phase 2 results.
Sleven,

N7. I had looked at EYPT but went with OCUL instead because of the team they had assembled , how fast the trials were enrolling , safety data etc .
OCUL will have the first pivotal P 3 trial data .....SOL-1 in Q4 2025 .
Their SOL-R trial now has 311 randomized ( I need to chk the total number they were aiming for ) . If both trials are successful they will file for approval to treat wet AMD .
Bottom line ....if all goes well they will have an approved drug well before EYPT.

Meanwhile this field is not standing still
VABYSMO seems to be the new eye drug of choice ...lasting 3-4 mths for 78 % of those getting this eye injection . OCUL's AXPAXLI is expected to last up to 10 mths .
My Kaiser eye doc tells me the biggest problem with Eyelea ( Afliberecept ) is most patients won't stick to the repeat dosing if they need an eye injection every 2-3 mths..
I think AXPAXL ( OCUL ) and Eyelea have similar safety profiles .
Its a long term hold for me .
Been distracted with other things recently ( clearing shrubs , brush from around my house , setting up fire suppression sprinklers etc ) I'm in Nth Ca and surround by trees . Area has a history of bad fires ...so everyone here is a little on edge after what happened in LA

Kiwi

Kiwi, I own eypt. Phase 2 trial ends this month. Should be positive. The phase 3 that ocular is running should also be positive. Based on the phase 1 results. Considering a trade.
Sleven,

Hi N7 I generally hold thru trial results and then " sell the news " if positive .
Launching new drugs usually takes more $ and longer then most expect
Company presentation scheduled on Monday, January 13th at 5:15 PM PT

Ocular to provide enrollment update for SOL-R, Ocular’s second registrational trial of AXPAXLI™ in wet AMD, future opportunities for AXPAXLI, and a general corporate overview

If you're interested in Co suggest you listen to the JPM presentation

Kiwi

Kiwi, long term investment, or a trade based on the upcoming clinical trial?
Sleven,

Scotiabank Initiates Coverage On Ocular Therapeutix with Sector Outperform Rating, Announces Price Target of $22

Kiwi

https://investors.ocutx.com/node/13236/pdf...trial enrolling ahead of schedule

Kiwi

As per the recent conference ...recruiting is going well and the speculation is that their trial will be fully enrolled ahead of schedule .
Eyelea ...the drug they will compete with ...is still increasing sales

Kiwi

Anybody out there ? Nice day to have a position in OCUL
Kiwi

OCUL. P2 data 4/5/24
REUTERS
10:03 AM ET 04/06/2024
April 6 (Reuters) - Ocular Therapeutix Inc (OCUL):
* OCULAR THERAPEUTIX™ ANNOUNCES POSITIVE PHASE 2 PAXTRAVA™ GLAUCOMA DATA AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY 2024 ANNUAL MEETING
* OCULAR THERAPEUTIX INC (OCUL) - GENERALLY WELL TOLERATED WITH NO IMPACT ON CORNEAL HEALTH OBSERVED
* OCULAR THERAPEUTIX INC (OCUL) - CLINICALLY MEANINGFUL MEAN IOP REDUCTION OF ABOUT 24-30% FROM BASELINE OBSERVED OVER SIX MONTHS Source text for Eikon: Further company coverage:

Kiwi

OCUL under $10

OCUL 10Q due March 11

OCUL....................................https://stockcharts.com/h-sc/ui?s=OCUL&p=W&b=5&g=0&id=p86431144783

Tard sells $6.00 call option at $0.15 at the close,apparently they were born yesterday.

OCUL..........................................https://stockcharts.com/h-sc/ui?s=OCUL&p=W&b=5&g=0&id=p86431144783

Clueless fool sells $6.00 call option at $0.10 when they were just trading at $0.30,with the big rally going on in the stock today, what a total fool they are.

I chose OCUL to invest in because the market conditions should not effect the PPS(much),plus I can sell covered calls and make some monthly cash,besides they have products that are in demand !!!!

Yes I have noticed that

Ask is super thin wont take much to move. GLTUA