Outlook Therapeutics Inc (OTLK) News

1 more site -> 56 as of April 24th

-> Lenexa, Kansas, United States, 66215

I also pay attention to the completion dates. They have not moved since the first version on clinical trials. They are:

* Primary Completion: September 2024 [Anticipated]
* Study Completion: October 2024 [Anticipated]

with the resubmittal planned by the end of the year. Even if it moved a bit, say January, that's in the ballpark.

At this stage, OTLK must be seeing the current enrollment and continue to plan accordingly. The completion dates can be updated with each new revision. And they keep being the same.

I'm not sure that all 60 planned sites are necessary for the enrollment. It's now 56 recruiting sites out of 60 planned.

And then, there is the end of May European decision.

Best of luck with your investments!

Hey Thermo! It’s been awhile since I posted and I like to always check in with you and ask how you’re feeling about the current situation. Within the board/company does the outlook seem positive? Any information you can share with the average investor that might help us understand everything happening.

2 more sites -> 55 as of April 16th

Arcadia, California, United States, 91006
Pasadena, California, United States, 91107

Close to the 60 planned sites. Around end of April for the remaining sites sounds doable. If they need them.

Best of luck with your investments!

H2R Thank you. I agree.

Thanks someconcerns

That follows what they announced on March 18:

As previously disclosed, Outlook Therapeutics also entered into a securities purchase agreement with Syntone Ventures, another existing stockholder, to purchase $5 million in shares of common stock and warrants on the same terms as the private placement. The closing of the Syntone investment remains subject to receipt of regulatory approvals and other customary closing conditions.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-closing-private-placement-159

They plan, they execute. I like those guys.

Best of luck with your investments!

Outlook Therapeutics® Announces Closing of Private Placement of $5.0 Million

GlobeNewswire - 21 minutes ago Investment News

Email Facebook. Twitter. LinkedIn. Print

ISELIN, N.J., April 15, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. ( OTLK ) , a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement with Syntone Ventures, LLC, an existing stockholder, for upfront gross proceeds of approximately $5.0 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting offering expenses. In addition, Outlook Therapeutics ( OTLK ) has the potential to receive additional gross proceeds of up to $8 million upon the full cash exercise of the warrants issued in the private placement, before deducting offering expenses.

About the Private Placement

Pursuant to the securities purchase agreement entered into on January 24, 2024, Outlook Therapeutics ( OTLK ) issued to Syntone an aggregate of 714,286 shares of common stock and accompanying warrants to purchase an aggregate of 1,071,429 shares of common stock, at a price of $7.00 per share and accompanying warrant to purchase one and one-half shares of common stock. The warrants have an exercise price of $7.70 per share and are exercisable only for cash until their expiration on the fifth anniversary of the issuance date. The warrants include a feature that allows Outlook Therapeutics to require Syntone to cash exercise the warrants if certain stock price and milestone conditions are met.

All of the securities in the private placement were offered by the Company.

Institutional Trading



BlackRock Inc. raised its stake in shares of Outlook Therapeutics by 14.2% during the second quarter. BlackRock Inc. now owns 9,215,800 shares of the company's stock valued at $16,035,000 after acquiring an additional 1,148,372 shares during the last quarter.

Vanguard Group Inc. raised its stake in shares of Outlook Therapeutics by 4.4% during the fourth quarter. Vanguard Group Inc. now owns 6,560,400 shares of the company's stock valued at $2,585,000 after acquiring an additional 277,326 shares during the last quarter.

State Street Corp raised its stake in shares of Outlook Therapeutics by 36.2% during the second quarter. State Street Corp now owns 2,751,977 shares of the company's stock valued at $4,788,000 after acquiring an additional 731,925 shares during the last quarter.

Finally, Geode Capital Management LLC raised its stake in shares of Outlook Therapeutics by 7.2% during the second quarter. Geode Capital Management LLC now owns 2,720,795 shares of the company's stock valued at $4,734,000 after acquiring an additional 183,120 shares during the last quarter. 11.20% of the stock is currently owned by hedge funds and other institutional investors.

https://www.marketbeat.com/instant-alerts/nasdaq-otlk-consensus-analyst-rating-2024-04-13/

$46.43 Consensus PT from Analysts
https://www.marketbeat.com/instant-alerts/nasdaq-otlk-consensus-analyst-rating-2024-04-13/

A bit similar to the article from 3 weeks ago

https://www.marketbeat.com/instant-alerts/nasdaq-otlk-consensus-analyst-rating-2024-04-13/

Probably generated from data from back then, but still interesting.

Best of luck with your investments.

53 sites as of April 10th

Added sites:
Long Beach, California, United States, 90807
Lexington, Kentucky, United States, 40509

7 to go if they want to reach the full 60, which may or may not be necessary to enroll the planned 400 patients.

Most likely starting in August, I'll be checking the 'Recruiting' status. That should give us a great clue.

Best of luck with your investments!

Update: 51 sites recruiting / 60 planned as of yesterday

Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Modesto, California, United States, 95356
Poway, California, United States, 92064
Sacramento, California, United States, 95841
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Stuart, Florida, United States, 34994
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Albuquerque, New Mexico, United States, 87109
Liverpool, New York, United States, 13088
Rochester, New York, United States, 14620
Westbury, New York, United States, 11590
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Wake Forest, North Carolina, United States, 27587
Winston-Salem, North Carolina, United States, 27103
Edmond, Oklahoma, United States, 73013
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
Bellaire, Texas, United States, 77401

Best of luck with your investments!

45 out of 60 sites are recruiting

I keep an eye on the number of recruiting sites. The March presentation, slide 17, shows a planned number of recruiting sites at 60.
https://ir.outlooktherapeutics.com/static-files/cfa0c7ae-7b5e-4500-b21f-cc1a2243d2aa

As of the latest clinical trial update, March 29th, the number of sites was 45. 15 to go, or at the same cadence, about another month (45 sites in the first three months).

With the March presentation, the FDA timeline is in keeping with the previous PRs and presentations. And OTLK has a history of following timelines. So even if it does not unfold exactly as planned, I expect the timeline to be pretty close, maybe a month off but not 4 months for instance.

The rest of the presentation looks similar to previous ones, with more of a focus on European activities and money raises.

Best of luck with your investments!

Overall Planned MIlestones



Main point for the FDA resubmittal:
* Q3 full enrollment -> Q4 resubmittal

From the March presentation:
https://ir.outlooktherapeutics.com/static-files/cfa0c7ae-7b5e-4500-b21f-cc1a2243d2aa

Best of luck with your investments

Seeking Alpha: Positive Article

https://seekingalpha.com/article/4681360-outlook-therapeutics-de-risked-regulatory-tracks-are-lining-up-for-possible-ons-5010-approval

The article recaps most of the latest developments fairly well. I copied the conclusion below:


Outlook Therapeutics has done well to advance its lead program in its pipeline, which is the use of ONS-5010 for the treatment of patients with Wet age-related macular degeneration [Wet-AMD]. It has already de-risked this asset on two fronts, which would be on possible U.S. and European approvals. With respect to possible U.S. approval of this drug, it is all going to depend upon what the final results from the phase 3 NORSE EIGHT study are going to be. That is, upon whether or not the primary endpoint of BCVA is going to be met with statistical significance in this trial.

However, I believe that an even better opportunity lies with respect to European approval. Why is that? That's because the EC didn't require another study for potential ONS-5010 approval. Not only that, but the CHMP has already pretty much given a positive opinion on it. This doesn't mean that European approval is guaranteed to happen, but it greatly increases the odds of it. With several catalysts on the way in 2024, plus continued regulatory advancement of ONS-5010 on two fronts, I believe that investors could benefit with any potential gains.

That sums it up pretty well.

Best of luck with your investments!

5 more sites added on 3/27/2024, now 44 sites

Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Modesto, California, United States, 95356
Poway, California, United States, 92064
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Oak Forest, Illinois, United States, 60452
Oak Park, Illinois, United States, 03440
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Teaneck, New Jersey, United States, 07666
Liverpool, New York, United States, 13088
Rochester, New York, United States, 14620
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
Charleston, South Carolina, United States, 29414
Florence, South Carolina, United States, 29501
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Abilene, Texas, United States, 79606
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
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
Willow Park, Texas, United States, 79606
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004

Best of luck with your investments!

BTIG: $50 Target Price

https://www.marketbeat.com/instant-alerts/nasdaq-otlk-upgrade-2024-03-27/

A number of analysts are starting to up their price targets. I spaced up for better legibility:

Outlook Therapeutics (NASDAQ:OTLK - Get Free Report) was upgraded by stock analysts at BTIG Research from a "neutral" rating to a "buy" rating in a research note issued on Wednesday, Marketbeat.com reports. The brokerage presently has a $50.00 price target on the stock. BTIG Research's price objective would suggest a potential upside of 476.04% from the company's current price.

OTLK has been the subject of a number of other research reports.
Ascendiant Capital Markets raised their price objective on Outlook Therapeutics from $30.00 to $40.00 and gave the company a "buy" rating in a research note on Friday, December 29th.

Capital One Financial reiterated an "overweight" rating on shares of Outlook Therapeutics in a research report on Friday, February 16th.

Guggenheim upgraded Outlook Therapeutics from a "neutral" rating to a "buy" rating and set a $40.00 target price for the company in a research report on Thursday, January 25th.

Brookline Capital Management upgraded Outlook Therapeutics from a "hold" rating to a "buy" rating and set a $31.40 target price for the company in a research report on Thursday, January 25th.

Finally, HC Wainwright boosted their price objective on Outlook Therapeutics to $30.00 and gave the company a "buy" rating in a research report on Monday.

One equities research analyst has rated the stock with a hold rating and seven have assigned a buy rating to the company.

According to data from MarketBeat.com, Outlook Therapeutics presently has a consensus rating of "Moderate Buy" and a consensus price target of $46.43.

Best of luck with your investments!

now 38 recruiting sites!

Updated 2024-03-26. The sites:

Bakersfield, California, United States, 93309
Beverly Hills, California, United States, 90210
Huntington Beach, California, United States, 92647
Modesto, California, United States, 95356
Poway, California, United States, 92064
Colorado Springs, Colorado, United States, 80909
Lakewood, Colorado, United States, 80228
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Oak Forest, Illinois, United States, 60452
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Liverpool, New York, United States, 13088
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
Charleston, South Carolina, United States, 29414
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Rapid City, South Dakota, United States, 57701
Germantown, Tennessee, United States, 38138
Arlington, Texas, United States, 76012
Austin, Texas, United States, 78705
Beaumont, Texas, United States, 77707
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
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Bellevue, Washington, United States, 98004
Silverdale, Washington, United States, 98383

At this stage, a smidge over 10 patients by site would get OTLK to the target 400 patients. Plus a few more just in case.
The first sites were open for recruitment close to two months ago.

Best of luck with your investments!

Yes, end of May ! Thanks.

Bought another slide today, $8.06.

Best of luck with your investments!

End of May

#OTLK 🔥 watch this week! $otlk

.. 34 sites recruiting.

https://clinicaltrials.gov/study/NCT06190093#contacts-and-locations

Best of luck with your investments!

Looks like a wash?

The next logical news would be approval in a couple of month, say end of June.

A decision from the European Commission is expected around 67 days after the CHMP opinion.

That will give OTLK time to strategize around the sales force, marketing, production prep, etc.

Best of luck with your investments!

Thanks! Link to the news on Nasdaq

https://www.nasdaq.com/articles/outlook-therapeutics-receives-positive-chmp-opinion-for-ons-5010-to-treat-wet-amd

Best of luck with your investments!

I hope you like the taste of dirt you blow tart

Early Barchart 100
https://www.barchart.com/stocks/performance/percent-change/advances?orderBy=percentChange&orderDir=desc

Post split news to dilute. Great short opportunity

Outlook Therapeutics® Receives European Union Positive CHMP Opinion for ONS-5010 as a Treatment for Wet AMD

Now 31 sites recruiting.


Beverly Hills, California, United States, 90210
Modesto, California, United States, 95356
Poway, California, United States, 92064
Colorado Springs, Colorado, United States, 80909
Waterford, Connecticut, United States, 06385
Coral Springs, Florida, United States, 33067
Fort Lauderdale, Florida, United States, 33308
Jacksonville, Florida, United States, 32216
Orlando, Florida, United States, 32806
Edina, Minnesota, United States, 55435
Saint Louis Park, Minnesota, United States, 55416
Jackson, Mississippi, United States, 39202
Liverpool, New York, United States, 13088
Asheville, North Carolina, United States, 28803
Hickory, North Carolina, United States, 28602
Winston-Salem, North Carolina, United States, 27103
Charleston, South Carolina, United States, 29414
Ladson, South Carolina, United States, 29456
West Columbia, South Carolina, United States, 29169
Germantown, Tennessee, United States, 38138
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
Salt Lake City, Utah, United States, 84107
Fairfax, Virginia, United States, 22031
Lynchburg, Virginia, United States, 24502
Silverdale, Washington, United States, 98383

Best of luck with your investments!

Outlook Therapeutics® Announces Closing of Private Placement of up to $159 Million

GlobeNewswire - 5:10 PM ET 3/18/2024 Investment News

ISELIN, N.J., March 18, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. ( OTLK ) , a biopharmaceutical company working to achieve the first approval for an ophthalmic formulation of bevacizumab for the treatment of retinal diseases in the US and the EU, today announced that it has closed its previously announced private placement, for upfront gross proceeds of approximately $60 million from the issuance and sale of shares of the Company’s common stock and accompanying warrants, before deducting placement agent fees and offering expenses. Outlook Therapeutics has the potential to receive additional gross proceeds of up to $99 million upon the full cash exercise of the warrants issued in the private placement, before deducting placement agent fees and offering expenses.

The private placement was led by Great Point Partners, LLC, with participation from existing investor GMS Ventures as well as new investors Altium Capital, Armistice Capital, Caligan Partners LP, Schonfeld Strategic Advisors, Sphera Healthcare, Velan Capital, Woodline Partners LP, and an undisclosed life sciences dedicated investor.

BofA Securities and BTIG acted as co-placement agents in connection with the financing.

On the EU4/UK commercial activities



Best of luck with your investments!

Thank you
Fyi Tractor Supply (TSCO) which I bought shares in 2009 hit an all time high today

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!

Is this the start of a turnaround

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!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-effective-date-1-20-reverse

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!

When is the share holder meeting?

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


Best of luck with your investments!

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.

https://www.reddit.com/r/OTLK_Investors/s/sK77WVvkHg

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?