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With pre-commercial biotech, it's hard to know what's going on behind the scenes.
I went back to the Feb 2024 presentation, and if the EU/UK does approve in H1 as hoped by management (or later), that market looks like a great commercial opportunity:
Given today's PPS, it could be simply getting back to a baseline PPS (say around $10 post reverse split) or some 'rumor'. Anyways, I keep being hopeful for the medium term (6 month/2 years) for this investments.
Best of luck with your investments!
Looks like I win AGAIN no matter the stock
Nasdaq Capital Market under the symbol “OTLK” with the new CUSIP number 69012T 305.
The 1 for 20 reverse stock split is part of the Company’s plan to regain compliance with the minimum bid price requirement
Went up even against Biotech Values
DewDiligence who deleted 6 documented cases of MARKET IS RiGGED
In cohoots with AFRAUDSTEIN like all of iHub
ALL those biotechs on 1st day trading
AFTER REV SPLIT 10-50 TIMES
their Outstandng Shares
NAKEDS & DARK FORCES prevailed since 2014!
Why it is useless to deal with INEXPERIENCED EGOTISTICAL onliners
DiFFERENT STROKES for DIFFERENT FOLKS
I’ve seen that too. Really depends on how much they’re wanting to raise. Not sure what quarterly burn is.
They’ve already published the 100mm potential raise on the 2/14 PR stating that should cover trial costs and resubmission. Presentation dated 2/15 states up to $172mm. Not sure what their burn rate is but I could still see this as being fruitful in time. Only thing stopping it could be FDA but that risk seems mitigated?
So $6.46 PS tomorrow morning. I had followed DTIL for their RS. Stock actually went up post PS UNTIL the offering came a few weeks later and the PS sunk. Hope this doesn't happen here.
I imagine they’ll need financing which has been discussed prior here. Just don’t know how much. After the split, how much new dilution would be expected? 50mm shares? New price will be between $6-7 post split. That’s $300-350mm in financing.
Addressable market of what? $6B?
For every billion of market could be looking at ~$15/sh on 65mm OS (assuming 13mm + 50mm + 1-2MM extra).
Could be $50-100 pps ballpark. Any thoughts?
How is all this going to shake out? How much of a hit is the retail investor, like myself, going to take? Should we buy more stock now or wait till after the split and the dust to settle or hold? I do believe after FDA approval late this year that the PPS will increase significantly.
How is all this going to shake out? How much of a hit is the retail investor, like myself, going to take? Should we buy more stock now or wait till after the split and the dust to settle or hold? I do believe after FDA approval late this year that the PPS will increase significantly.
A few more recruiting sites
California Locations
Beverly Hills, California, United States, 90210
Modesto, California, United States, 95356
Poway, California, United States, 92064
Florida Locations
Jacksonville, Florida, United States, 32216
Minnesota Locations
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Mississippi Locations
Jackson, Mississippi, United States, 39202
North Carolina Locations
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
South Carolina Locations
Charleston, South Carolina, United States, 29414
Ladson, South Carolina, United States, 29456
Texas Locations
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Bellaire, Texas, United States, 77401
Dallas, Texas, United States, 75231
Round Rock, Texas, United States, 78681
San Antonio, Texas, United States, 78251
The Woodlands, Texas, United States, 77384
Utah Locations
Salt Lake City, Utah, United States, 84107
Virginia Locations
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Washington Locations
Silverdale, Washington, United States, 98383
See: https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1#contacts-and-locations
Best of luck with your investments!
From the proxy material:
OUTLOOK THERAPEUTICS, INC.
2024 Annual Meeting
To be held Thursday, March 7, 2024
(I am not seeing the in-person address, not that I intend to attend in person).
Best of luck with your investments!
Recruiting Sites: Starting to look the part
I do not believe this is all the sites which will end up recruiting; However, it's starting to look better
See: Contacts and Locations
https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1
California Locations
Beverly Hills, California, United States, 90210
Poway, California, United States, 92064
Minnesota Locations
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
North Carolina Locations
Asheville, North Carolina, United States, 28803
Winston-Salem, North Carolina, United States, 27103
Texas Locations
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Dallas, Texas, United States, 75231
Utah Locations
Salt Lake City, Utah, United States, 84107
Virginia Locations
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
His forecast includes diseases and geographies that mine doesn't. Those are real opportunities, but I didn't bother with them because it doesn't change decisions for me, and that's all I care about. I think he is too aggressive on market share. His share count is low but when he wrote it, it was correct.
yup, that's what I'm worried about.
As things develop, I may increase my valuation expectations, but all sorts of things can happen along the way...good and bad. If I get too aggressive on expectations, it can screw with my head, and I start making more mistakes. 5x return is all I need to know right now.
https://www.reddit.com/r/OTLK_Investors/s/6eLMgsNg5x
Here is one of the posts I’m referring to including a spreadsheet with predictions.
So basically based off what you’re saying if there was a buyout the company would likely price this at a $1.5-$3b valuation, right? On Reddit and other forums these people seem to think this will be acquired by another company once approved and the buyout will range from $5-$10b. Do you think this is completely unrealistic or even possible given not only US, but also Europe market exclusivity?
Wow, thanks for that! This gives me more confidence than ever. I am doubling down my investment once again as we speak !
Internally we've been at $500M - 750M peak sales.
500M x 4x => 2,000M Enterprise Value / 850M shrs => $2.35 / shr. Given it's a one product company with a finite exclusivity period, we will do a DCF when we have time and refine the revenue multiple. For now, whether it's 3x, 4x, ... it doesn't matter.
Guggenheim analyst -- who put a lot of time into his research -- has:
3.5M off-label Avastin injections per year, which is in line with our proprietary retina market model. Conservatively, we think the company will be able to convert ~1/3 of these patients to branded Lytenava for ~1M injections per year. Assuming a WAC price of $500 per injection and a GTN of 20% (in-line with similar products) we estimate peak sales of $560MM
BTIG:
~70% of retinal specialists use compounded bevacizumab as a 1L regimen for their wAMD patients before proceeding to other Tx options. This is largely owed to its attractive price point compared to other anti-VEGF therapies (~$55-$75 per injection vs. ~$2,000 for Eylea and Lucentis vs. ~$1,200 for biosimilar Lucentis) and well-established non-inferior efficacy vs. Lucentis. There are estimated to be over 740k wAMD patients in the US currently pursuing Tx, so the utilization of compounded bevacizumab is substantial despite the disadvantages of the treatment option (discussed further below).
Hi Thermo,
Thank you for this post and all your insight. I love your feedback and learning from you. Any more information you can give us into peak revenues and where you think the price of this stock could fall via commercialization or a buyout at this point in time compared to before?
I meant peak revenues, not peak returns.
- To forecast stock returns, we forecast peak revenues, multiply by not too high a multiple (since this is a one -- not first in line -- product company), and then divide by 750M - 850M shares. This value is a lot lower than it used to be (due to the share count) but still a lot higher than it is now.
I paid $0.35 (or lower if the stock drops...but it doesn't look that it will) for common plus warrants (with a strike 10% above the purchase price). The warrants are callable, so the company can raise a significant amount of additional capital from the warrants.
I was referring to Kurt J Hilzinger.
So, how much did you pay per share in the private placement? And when you said "Another well-known board member bought significant stock in the open market above $1.00.", were you referring to Helzinger, or Hope?
What I've written in the past fairly captures my views. I don't try to promote my stocks. I try to be honest. I don't care if others buy, sell, or short my companies.
- Company management had a serious lapse of judgment in mis-designing their trials historically. They claim they were given informal support (not an SPA) from the FDA in 2018 but the 2023 FDA determined they did not provide adequate support for approval. They lost many people a lot of money including their biggest shareholder, who has a board presence. Another well-known board member bought significant stock in the open market above $1.00. So, clearly the people best positioned to judge, misjudged. It happens.
- I discussed this trial design concern with them historically and I accepted their explanation about feedback they received in 2018. That was a serious lapse of judgement on my part. Most retail investors would be surprised to know how often professional investors make mistakes. I've made lots of mistakes yet have become quite well off. We don't have perfect foresight, but we do know how to manage risk.
- The company now has an SPA, so the odds of approval are high. There's never been much debate regarding the efficacy and safety of the drug.
- Shortly, the debate will shift to what market share the company will achieve upon commercial launch. Longer lasting treatments are better, but insurance companies still utilize step-edit programs to hold down claim costs. These longer lasting treatments could push down pricing of biosimilars, which could pressure OTLK. Can I precisely predict all these effects? No. But I know what to look for and I know that OTLK doesn't need too much share of the total market to achieve meaningful revenue.
- After the recent raise, there are a lot of shares outstanding. About 750M. If you look up the share count from various sources, you'll see a much lower number but those are lagging. We go through the existing placement agreement and the note amendment and model out what the future share count will likely be.
- To forecast stock returns, we forecast peak returns, multiply by not too high a multiple (since this is a one -- not first in line -- product company), and then divide by 750M - 850M shares. This value is a lot lower than it used to be (due to the share count) but still a lot higher than it is now.
- So, even though I 've lost a good amount of money, I'm probably going to make a good amount of money before the fat lady sings. Unless, of course, she falls on me first.
I did lower my cost. I'm one of the participants in the private placement.
OTLK......................................https://stockcharts.com/h-sc/ui?s=OTLK&p=W&b=5&g=0&id=p86431144783
This company tells us what they plan, the expected dates, and they keep executing. The communication is clear and to the point. It's in their DNA, they have been practicing this under Russ T.
I like this type of leadership and how shareholders are informed.
Best of luck with your investments!
Russ Trenary on the progress since the CRL:
We are proud of the recent progress our team has made. In January 2024, we received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA they approved. We also reached agreement that if the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the CRL. Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer. “In addition, through a Type A meeting and additional interactions, we have identified the approaches needed to resolve the CMC comments in the CRL. We are working to address the open items and expect to resolve these comments prior to the expected completion of NORSE EIGHT. Finally, we have entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval, to support our regulatory efforts and launch preparations.
Updated Anticipated Milestones
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-first-quarter-0
Upcoming Anticipated Milestones
* Closing of private placement financing in March 2024, subject to receipt of stockholder approval and other closing conditions;
* MAA decision date in the EU for ONS-5010 targeted for first half of 2024;
* Completion of NORSE EIGHT in the United States anticipated in 2024; and
* Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.
Well then these investors are idiots to give more money to trenary. Moron sat for 2 years doing nothing except giving the same powerpoint lecture around the country on hawaii and ski trips. Had years to do a 2nd adequate trial. Couldnt even ensure "best in class" manufactering went smoothly. Wth does dagnon and evanson do all day long? Cencora? Give me a break. Without an apporoved product who cares. Ema rejection on deck. The fool shouldve pulled ema application until fda concerns were addressed. How do you explain post reverse split+dilution with ema rejection to follow? You going to short this down to 1 after the split? I will. Anyone with a brain should. This c suite is incompetent. How he got ppl to give him more money to drive this into the ground is beyond me. Didnt you hear/read/see the new york academic opthalomologist that is going to lobby the fda to still allow compounding even if lytenava gets approved? Opthalomolgists want to use faricimab and high dose eylea anyway. He still hasnt said when and how hes paying for dme brvo indications. This is a giant train wreck. Thermo....just put your money in the paper shredder instead and recycle.
I’m actually curious on your thoughts about everything going on? I know you’ve been very vocal in the past and provide good feedback. I’m newer to investing and everyone keeps saying this news is extremely disappointing with the reverse split/private placements etc. Any feedback on this for me to learn better in the market and how it affects every day investors?
How are you feeling with the path to success and potential outcome now? I would assume with some big investors coming in that they know it will surely be successful…
You said that after the CRL you lost a substantial amount of money, did you sell your position? I’m curious, as someone that believes there is a clear path to success, why you wouldn’t use the opportunity to lower your cost average instead of selling.
I wouldn't say that. I just know there was a lot of demand and the participants in the transaction are mostly investors, not traders.
Second Recuiting Site: Utah / Salt Lake City
On Feb. 5th, the clinical trial site was updated to indicate a second trial site in "Salt Lake City, Utah, United States, 84107"
Before that, one site was indicated in "Dallas, Texas, United States, 75231"
That's 2 sites that came up online pretty quickly given the January 23 SPA announcement and the first subject only one week ago! OTLK does not lose time.
For comparison,
* Norse 7 had 3 sites
* Norse 3 had 20 sites
* Norse 2 had 39 sites.
"The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. "
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license
So I expect a lot more sites to come online for this study, but I don't know how many to expect. OTLK does forge ahead and I would not be surprised if that number keeps on moving up for the next couple of months. They keep executing!
Best of luck with your investments!
Would you agree they structured the private placement the way they did to incentivize all the hedge funds to push up the price.
First Subject in NORSE EIGHT
After the SPA, after the clinical trial publishing on clinicaltrials.org, after the change of status to recruiting, this step indicates the continued progress of the Company towards their goal.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-doses-first-subject-norse-eight
NORSE EIGHT clinical trial is being conducted under Special Protocol Assessment (SPA) from FDA to support expected resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024, if successful
ISELIN, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration (wet AMD) patients.
The NORSE EIGHT study is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 treatment naive, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint will be mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
“We are pleased with the continued progress of our ONS-5010 development pathway forward. The start of patient enrollment in NORSE EIGHT represents an important step toward potential FDA approval and launch of ONS-5010. Our team remains focused on the successful execution of the study,” commented Russell Trenary, President and Chief Executive Officer.
Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT. The FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL. Outlook Therapeutics is working to address the open CMC items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.
Now recruiting, Study Completion Expected Oct.
https://classic.clinicaltrials.gov/ct2/history/NCT06190093?B=2&A=1&C=merged#StudyPageTop
Best of luck with your investments!
OTLK..................................https://stockcharts.com/h-sc/ui?s=OTLK&p=W&b=5&g=0&id=p86431144783
The SPA is good news (did expect it, but sometimes can drag out),
Norse 8 is a non-inferiority study,. What that means is that they do not have to prove to be better than the ranibizumab, just as good as it. That is very reasonable from a common sense point, but has a tricky stat issue,
There is no such concept as "as good as" in clinical trial stats. Either one is better or not. But we all need the real world concept, so how to fix this?
The trial stat guys came up with a concept of a NI margin. Basically OTLK will be spotted a letter or 2 (do not know the details) and with that must prove to be better. This sounds a bit contorted, but there is no easy way to solve the conundrum
Now back to the FDA.. Obviously if the sponsor just says they want their drug to be spotted some advantage, the FDA may push back. And that is why getting the SPA for a NI trial really matters. The FDA has agreed that whatever NI margin is, is OK by them.
As far as executing the trial, That should be a given. There is ton of data here, we are not talking unknowns.
If they rs this, it will get shorted down to oblivion again like every other pre revenue microcap bio (including those that did get fda approval). Shorted to 1 or less post rs eapecially if they get ema rejection after rs (which they will bc they havent acknowledged solving cmc and i see no reason ema would approve without norse 8 resulrs) This plan is idiotic. I have no idea who is advising these funds to invest. I have no idea why syntone and the jordanians are dumping more in and why they still trust trenary after all the f ups. The fool says things like the bla was "a loveletter to the fda" and goes on twitter to say there will be "a new sheriff in town on august 29th". They have to pay streeter 3 mil per quarter startintlg next quarter which will burn thru this new capital quickly on top of normal cash burn. I can easily seeing this diluted to hundreds of millions of shares again post rs just to keep up w the burn.
I guess they had no other option. There is no "buyer". Whoever is going to start w this nonsense again dont even bother.
I think back to when trenary pulled the bla and still hasnt told us why. At that point it dropped to 67 cents and sling shotted back to 1.20 within a few days. Whoever did that...if they believe in otlk so much....why arent they doing it again now before theres this absurd rs, dilution, extremely toxic debt.
Clinical Trials Site for Norse 8:
https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1
Not recruiting yet. A good site to check from to to time and see the progress.
Best of luck with your investments!
Thank you, H2R!
NORSE EIGHT :
will be a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 newly diagnosed, wet AMD subjects randomized in a 1:1 ratio to receive 1.25 mg ONS-5010 or 0.5 mg ranibizumab intravitreal injections. Subjects will receive injections at Day 0 (randomization), Week 4, and Week 8 visits. The primary endpoint will be mean change in BCVA from baseline to week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.
The FDA SPA agreement is in!
I keep being impressed with management clarity on planning, deadlines, and execution!
Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-501
* Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010
* NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024
* Private placements to top tier institutional investors and insiders include up to $65 million in common stock and up to an additional $107 million upon cash exercise of warrants, subject to closing conditions
*Aggregate financing, subject to achievement of milestones, is expected to be sufficient to take ONS-5010 through potential FDA approval and fund commercial launch
There will be a shareholder vote.
1. approve the shares to be issued in the transaction (since more than 20% are being issue).
2. give the board the ability to enact a reverse to stay on NASDAQ.
The price of the issued shares is the lower of (a) $0.35 and (b) the average price leading up to the shareholder vote. So, if investors focus on the reverse, maybe we can see weakness and "b" above will apply. But this deal brought in a lot of new institutions, and I think most of them don't have a full position. So, this may be one of those rare circumstances where a reverse doesn't hurt the stock.
The demand for the deal was very strong, demand more than 2x greater than supply. Many institutional investors got zero. Others were cut back 50% - 75% (including me).
We now have a clear path to FDA approval.
SPA => short trial => data about Oct 24 => filing Dec 24 / Jan 25 => approval summer/fall 25.
The demand for the deal was very strong, demand more than 2x greater than supply. Many institutional investors got zero. Others were cut back 50% - 75% (including me).
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