Outlook Therapeutics Inc (OTLK)

[goforthebet]

I just bought in today premarket. I was not watching the stock prior to today. thanks. Will do from today on as I have skin in the game :)

[thermo]

$1M is a little under 500k shares which is less than 20% of the volume you reference.

[thermo]

Yes, I'm very bullish on OTLK.

When I first established my position at $1, the stock carried clinical trial risk. The trial was very smartly designed, so I thought the probability of success was 80%+ (way better than most clinical stage life science cos).

The data reported a few days ago was solid. 98% approval odds now. Yet the stock opens up 40% and then gives it all back. What gives? From what I've heard, these are the concerns:

1. The trial proved something that was obvious: (a) bevacizumab is as effective as ranibizumab and (b) monthly dosing is better then quarterly dosing. Yes, these points were obvious! That's why I invested! The data are approvable and that's what I care about. The FDA doesn't award degree of difficulty points but there is 12 years of exclusivity.

2. Aflibercept is the best wAMD drug and will go off patent in 2023. Yes, the market will change. But the current market is $13B for wAMD and other applicable diseases. Baby boomers are retiring. Lytenava (the brand name for OTLK's bevacizumab) is intended to replace off label bevacizumab in the US (representing 50% of US patients) and Europe (about 1/3 of EU patients). They only need to get a portion of the off label market (even if the total market shrinks) to achieve $1B peak sales.

3. OTLK only has $37M cash. They will need more $$. Yeah. So? Doesn't every clinical stage company? This is an area I know a LOT about. It will not be a problem. But, one should always adjust market caps for these things. The current market cap is $380M, so add $120M and think of the company as currently worth $500M.

So, the question for investors: What's $1B in peak sales worth? $2B, $3B, $4B?

OTLK is a great investment.

Here's the article that details the concerns:

https://www.evaluate.com/vantage/articles/news/trial-results/outlook-heads-regulators-eye-friendly-avastin

[goforthebet]

bought 5000 shares premarket at 2.11-2.19..Let´s see where it goes :)

[goforthebet]

gm., you are talking about OTLK. I have seen only volume of 2.961 shares. Where did you buy 1m worth? I am just started doing some DD on the stock. thanks..

[whosleftholdindabag]

Thermo, I remember your alias from the NWBO board! You had so many more(millions) shares than I had, and I owned over 6 million at one time.

I'm curious about OTLK and have followed the drop in price during the trading day. I'm thinking about scaling in tomorrow, still bullish? I'm not concerned about the short-term. GLTA

[thermo]

Bought ~ $800k in the afternoon

[johnreiner]

Actually if it is true of my assumptions , there’s nothing criminal about it! The company successfully completed its phase 3 Norse 2 trials with flying colors and are ready to submit for a BLA with the FDA and needed a cash infusion that in my opinion will pay off long term value wise funding the company all the through to sales , marketing and production! Best of luck….JR

[trendzone]

A we'll planned action by toxic criminals as usual, what these morons didn't take into consideration is that at this point these numb nuts could cure cancer, and no one will touch their stock again.

[johnreiner]

My assessment from yesterday is that the company has exceptional data to report and a need for money! OTLK commonly puts out PR’s in the after hours at the end of the week. Yesterday’s PR come out premarket followed by a 8 am CC , the perfect storm was brewed up and shorts started covering with flippers and Day Traders buying… The company used it newly authorized shares passed at the annual meeting and registered and sold them via shelf offering into the hype! I’m estimating they sold anywhere from 30-40 million shares @ a average of $2.75…. I expect to hear about the new cash on hand during the upcoming earnings report! AIMHO

[biosectinvestor]

[H2R]

Bought another slice :))

I'll probably add on a monthly basis if this stays at this level (or lower).

Cheers!

[H2R]

This is about as good as it gets in terms of clinical trial results.
(Thanks johnreiner)

Primary endpoint, secondary endpoint, solid p value, they can submit a BLA:

In meeting both the primary and key secondary endpoints in NORSE TWO with highly significant clinically relevant results, we have achieved the requirements agreed upon with the FDA, and when combined with our previously reported clinical trial results, this completes the clinical package necessary for the submission of our BLA.

The full data will be available later:

Full data from NORSE TWO will be presented at an ophthalmology conference in the fall of 2022 and submitted for publication in a peer-reviewed journal.

They are already planning for commercial operations:

In anticipation of potential FDA marketing approval in 2022 for ONS-5010, Outlook Therapeutics has begun commercial launch planning, including manufacturing with drug substance manufacturer FUJIFILM Diosynth Biotechnologies and best-in-class drug product manufacturer Aji Biopharma Services, distribution, sales force planning, physician and payor advisory board outreach, key opinion leader support and payor community engagement. To bring ONS-5010 to market in a way that benefits all stakeholders – clinicians, patients and payors – Outlook Therapeutics has already commenced collaborative discussions with payors and the retina community. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, payors and clinicians worldwide for retinal indications.

This is about as good as one can expect in this phase of the company.

Best of luck with your investments

[thermo]

The primary concerns per Evaluate Vantage are shown below in italics.

The dosing schedule seems to be the biggest concern: monthly dosing is better than quarterly. To which I say, of course! OTLK could have done a non inferiority study monthly-vs-monthly (requiring more patients) or a superiority study monthly-vs-quarterly requiring fewer patients. This is a regulatory strategy that the FDA has already approved in OTLK's other disease indications.

Outlook’s job for now is to get ONS-5010 approved, and the Norse Two data might have smoothed the path ahead. The 228-patient study found that the proportion of patients gaining 15 or more letters in best-corrected visual acuity (BCVA) at 11 months, the primary endpoint, was 41% with ONS-5010 versus 23% with Lucentis. The difference was statistically significant with a p value of 0.0052.

ONS-5010-treated patients also gained a mean of 11.2 letters versus 5.8 letters with Lucentis, a secondary endpoint.

However, when asked, Outlook declined to give details of the baseline visual acuity in each arm, and it will be interesting to see if there are any differences here when full data are reported.

A bigger question hovers around the dosing schedules used in Norse Two. ONS-5010 was administered monthly, while Lucentis was given monthly for the first three months, followed by quarterly dosing. Outlook rightly pointed out that this Lucentis dosing schedule is detailed on the drug’s label. However, the label also states that this regimen is not as effective as once-monthly dosing, the recommended schedule, and in fact leads to an average five-letter loss in visual acuity benefit versus monthly dosing.

Finally, the drug to beat these days is not Lucentis but Regeneron/Bayer’s Eylea. If ONS-5010 does make it to market, Outlook could have more cut-price rivals soon: Eylea is set to lose US patent protection in 2023.

ONS-5010 has already shown non-inferiority to Lucentis in the smaller Norse One trial, and Outlook now plans a filing with the FDA in the first quarter of 2022. Perhaps getting approval will be an easier hurdle to clear than marketing the drug, particularly as Outlook only had $37m in cash at the last count.

The fact that the company needs to raise money explains why Outlook’s stock, after soaring 45% in early trading, ended closing up a more muted 7% yesterday – and is down 10% this morning.

[monentum2play]

The 1 mill he bought was Outlook. It is on their board?

[pfelgueiras]

OTLK my view of what's happening to the OTLK price after Phase 3 excellent results:

a) Yesterday with the excellent news from OTLK Phase 3 results, Day Traders they bought in anticipation of high price rise

b) Institutional, as they had small positions (only 9.28% Yahoo Finance), went in the opposite direction with large volumes and doing short selling to avoid price increases and to be able to buy at bargain prices.

c) Price decline caused day trades need to close their open buy positions to minimize losses.

On OTLK Press Release August 3, 2021:

OTLK announced positive clinical and highly statistically significant top-line results, both the primary and key secondary endpoints in NORSE TWO with highly significant clinically relevant results, we have achieved the requirements agreed upon with the FDA.

The successful completion of this trial is the final step needed in our clinical evaluation of ONS-5010 to enable us to submit a Biologics License Application to the FDA.

I am long term investor on OTLK 1 or 2 Years and I believe in the huge potential of OTLK for BIG Profits. I AGREE Market is making a mistake!

I don't Sell I Keep Hold ALL of my OTLK shares.

[thermo]

98% probability of approval

Multi billion dollar market

Payers love it => priced below other approved products

Doc's will love it => well understood product => strong sales ramp

Pre filled syringe approval expected soon after product approval => Doc's will love it more.

Funding needs? Yes, but there will not be a near term discounted stock deal. They have an equity line so can tap that gently if needed. Spoke to management. Confident.

[thermo]

Bought another $1M this morning. Market is making a mistake.

[make it happen]

[crudeoil24]

Outlook Therapeutics Inc (NASDAQ: OTLK) stock is trading higher in premarket session in reaction to positive top-line results from Phase 3 NORSE TWO trial evaluating ONS-5010 / LYTENAVA (bevacizumab) for neovascular age-related macular degeneration (wet AMD).
The primary endpoint for the study was the proportion of patients who gain at least 15 letters in the best-corrected visual acuity (BCVA) at 11 months.
The trial compared ONS-5010 dosed monthly to Roche Holdings AG's (OTC: RHHBY) Lucentis (Ranibizumab), which was dosed monthly for the first three months followed by less frequent dosing.
In the intent-to-treat (ITT) primary dataset, 41% of patients treated with bevacizumab-vikg gained at least 15 letters, versus 23% treated with ranibizumab.
The primary endpoint was also statistically significant and clinically relevant in the secondary per-protocol (PP) dataset, at 24% with ranibizumab and 41% with bevacizumab-vikg.
A mean change in BCVA was observed with ranibizumab of 5.8 letters and 11.2 letters for the treatment arm.
The safety results demonstrated were consistent with previously reported safety results.
In NORSE TWO, there was only a single related ocular serious adverse event reported in the bevacizumab-vikg trial arm, which resolved, and no unanticipated safety signals were detected.
Outlook Therapeutics plans to submit a marketing application in Q1 of 2022.
Complete data from NORSE TWO will be presented at an ophthalmology conference in the fall of 2022 and submitted for publication in a peer-reviewed journal.
Outlook Therapeutics has begun commercial launch planning in anticipation of potential FDA marketing approval in 2022 for ONS-5010.
Outlook Therapeutics expects to initiate registration clinical trials for ONS-5010 for diabetic macular edema and branch retinal vein occlusion later in 2021 or early 2022.
The management will host a conference call today at 8:00 a.m. ET.

[thermo]

Looks solid.

I still see $10+ in a few years. With clinical trial risk behind us... compelling

[johnreiner]

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-efficacy-and-safety-data

[H2R]

topline data expected Q3 2021

(Slide 4).

In this July 2021 corporate presentation (thanks pfelgueiras), OTLK stays the course for the top line data announcement.

Best of luck with your investments!

[H2R]

Russ Trenary in his own words:

https://twitter.com/OutlookTx
(pinned at the top as of now)
same on front page of
https://outlooktherapeutics.com/


* Lots of experience in ophthalmology

* "I've been involved in 4 very large launches in this space"

* "It's not often somebody gets a chance during their career to be involved in changing the standard of care and I believe that's the opportunity we have in front of us"

I'm hopeful.

Best of luck with your investments!

[thermo]

Adverum (potential OTLK competitor) eyes disaster

Despite insisting that diabetic macular oedema and wet AMD had different causes, and that no cases of low eye pressure had been observed in wet AMD patients at any dose, Adverum has also abandoned ADVM-022’s pivotal trial, Optic, in this disease.

Adverum plans to start a new phase 2 trial in wet AMD next year, using lower doses. But SVB Leerink analysts feel that there is no viable path for ’022 in wet AMD, an indication with very low tolerance for safety events and numerous highly effective therapies.

[pfelgueiras]

$OTLK Chartmill "Outlook Therapeutics Inc is a setup today!"
Besides having an excellent technical rating, OTLK also presents a decent setup pattern. Prices have been consolidating lately. There is a very little resistance above the current price. We notice that large players showed an interest for OTLK in the last couple of days, which is a good sign.
The Chartmill team.

[pfelgueiras]

OTLK JULY 2021 Corporate Presentation
https://ir.outlooktherapeutics.com/static-files/fa0db660-47bc-4831-a8b4-0faa1a035833

[johnreiner]

Just as I thought!

https://quantisnow.com/insight/1303930?s=s

[johnreiner]

One would think he would be paid with stock/ options and expecting a positive phase 3 readout to come aboard! Very good sign for the company and he brings a lot of experience !

[thermo]

OTLK appoints new CEO with ophthalmic product commercialization experience.

http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20210707:nGNX7rgLR8&default-theme=true

[pfelgueiras]

OTLK - Today June 25, 2021 after market close OTLK will be add to Russel 2.000 Index.
This gem is ready to a new uptrend!

[pfelgueiras]

Outlook Therapeutics Announces Inclusion in the Russell 2000® Index effective June 25, 2021
https://ir.outlooktherapeutics.com/node/9521/pdf
ISELIN, N.J., June 14, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that as part of the annual reconstitution of the Russell stock indexes, Outlook Therapeutics has been selected to be added to the Russell 2000® Index effective June 25, 2021, after the close of the U.S. equity markets.
“We are very pleased to have been selected for inclusion in the Russell 2000® Index. Our placement in this widely used performance benchmark for small-cap companies reflects the hard work of the Outlook Therapeutics team and the value we have created over the past year. With our inclusion in the Russell 2000® we believe we are well-positioned to continue driving value with this increased market exposure,” said Lawrence A. Kenyon, President, CEO and CFO, Outlook Therapeutics.
The Russell 2000® Index measures the performance of the small-cap segment of the US equity market. The Russell 2000® Index is a subset of the Russell 3000® Index representing approximately 10% of the total market capitalization of that index. It includes approximately 2,000 of the smallest securities based on a combination of their market cap and current index membership.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell’s U.S. indexes which are part of FTSE Russell, a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide.

[johnreiner]

What to expect from OTLK being listed on the Russel3000 June 26th!

https://www.nasdaq.com/articles/what-small-caps-should-know-about-the-russell-rebalance-2020-06-22

[pfelgueiras]

Thanks H2R
Hope Big Profits with OTLK for all of us!
Regards
pfelgueiras

[Perk_Idaho]

maybe by Christmas I'll have enough to buy my son that G.I. Joe with the kung-fu grip - that might turn things around with the wife ;)

[H2R]

Norse 2 TLD: Q3 2021 !!!

They have been consistent in their planning. This is great news.

The Q1 22 for BLA planning is also consistent with a Q3 TLD; It would be a fairly fast submittal, but doable.

Thanks pfelgueiras.

Best of luck with your investments!

[thermo]

Looking good Billy Ray. Feeling good Lewis.

[pfelgueiras]

New OTLK Corporate Presentation June 2021
https://ir.outlooktherapeutics.com/static-files/f1574845-1ba4-4b8d-bc1b-ecb7cb328b89

[pfelgueiras]

OTLK - Outlook Therapeutics Reports Completion of Patient Dosing in the ONS-5010 Pivotal Phase 3

Outlook Therapeutics Reports Completion of Patient Dosing in the ONS-5010 Pivotal Phase 3 NORSE TWO Trial June 8, 2021
Topline readout of data from NORSE TWO (Phase 3-FDA) targeted for calendar Q3 2021
New Biologics License Application (BLA) filing anticipated in calendar Q1 2022
https://ir.outlooktherapeutics.com/node/9516/pdf

[pfelgueiras]

OTLK OUTLOOK THERAPEUTICS will be added to Russell 3000 in JUNE 2021
Good profits on the way!
See the list Russell 3000® Index – Additions in JUNE 2021
https://content.ftserussell.com/sites/default/files/russell_3000_index_additions_-_2021.pdf

[pfelgueiras]

OTLK OUTLOOK THERAPEUTICS is on RUSSEL 3.000
See the list Russell 3000® Index – Additions
https://content.ftserussell.com/sites/default/files/russell_3000_index_additions_-_2021.pdf

[H2R]

Thanks thermo,

It's because of you I'm in OTLK. I bought at $1, when you posted on the NWBO board back when. I looked up OTLK and it went up really quickly. I'm grateful :) !

Best of luck with your investments!

[thermo]

Absolutely! One of my top ideas.

[H2R]

Top Line Data expected Q3 for Norse 2



Looking good!

Best of luck with your investments!

[johnreiner]

https://flashalert.me/?symbol=OTLK&source=PR&referer=https://stocktwits.com/&url=https://www.globenewswire.com/news-release/2021/05/27/2237397/0/en/Virtual-Clinical-Day-Recap-Outlook-Therapeutics-Joined-by-Drs-Mark-Humayun-and-Firas-Rahhal-to-Discuss-Need-for-FDA-Approved-Ophthalmic-Bevacizumab-and-Status-of-ONS-5010.html&s3=OTLK/2021-05-27/08-07-18_000000/glob/6ef19932d584004f44354bd0b8602ed5/Virtual-Clinical-Day-Recap-Outlook-Therapeutics-Joined-by-Drs-Mark-Humayun-and-Firas-Rahhal-to-Discuss-Need-for-FDA-Approved-Ophthalmic-Bevacizumab-and-Status-of-ONS-5010.html

[pfelgueiras]

$OTLK I am very Bullish with good news on May 2021 Corporate Presentation.
https://ir.outlooktherapeutics.com/static-files/324c599d-e8a8-4152-b5ae-51e9eae016c5

[pfelgueiras]

$OTLK Three good news yesterday at $OTLK Virtual Clinical Day:
1) Everything is going well Phase 3 Results 3Q 2021 and BLA Submit 4Q 2021 and BLA approval on 1Q 2022
2) They already have a partnership for China (is one of the investors in OTLK)
3) When the OTLK ONS-5010 will be approved by the FDA, it is no longer allowed the market use the current compound currently uses.

I am Very Bullish with OTLK, my Price Target for 1Q 2022 is $25 (with BLA approval), if a Buyout happen will be above $50.

[pfelgueiras]

$OTLK President, CEO and CFO Lawrence A. Kenyon was featured in a video interview discussing the pivotal Phase 3 NORSE TWO trial and the potential for ONS-5010 ophthalmic bevacizumab to treat #wetAMD.

https://www.proactiveinvestors.com/companies/news/946333/outlook-therapeutics--almost-complete--with-pivotal-phase-3-norse-two-trial-to-treat-wet-amd-946333.html

[pfelgueiras]

Outlook Therapeutics is hoping to become the first and only company to commercialize an FDA-approved ophthalmic formulation of bevacizumab for use in wet AMD

https://www.proactiveinvestors.com/companies/news/947974/outlook-therapeutics-is-bringing-a-treatment-for-retinal-disease-to-the-market-at-the-right-time-947974.html

$OTLK Keep Buying and Holding for BIG PROFITS with the next 3 catalyst events:
1) Ongoing Phase 3 pivotal trial with topline data expected Q3 2021
2) Biologics License Application (BLA) submission on Q4 2021.
3) BLA FDA Approval in 1Q 2022.
After "Phase 3" topline data, OTLK "can have" a Buyout, I estimate it will be above $50,00 (see My View of Profits)

[1sdestiny]

Thanks for the reply. I bought in the 1.80 range. Thanks for the tip. Hoping it works out for all of us.