Outlook Therapeutics Inc (OTLK) News

Pula In his defense, he did say Mercedes 580 S!

OTLK broke a key resistant level at $2.42 could see a run here.

Seems to be a problem w humanity when were comparing allowing people to see properly to luxury vehicles.

Healthcare systems everywhere have a cost problem. The reality we don't all get to drive Mercedes S-580s.

I fail to understand what the csuite has been doing 5 days a week on salaries in the hundreds of thousands and the eu uk partnership hasnt been fully explored. Everything shouldve been fully explored after crl. But instead you had a ceo that thought the fda wanted animal studies and instead of doing a proper catt study they do 8 week endpoint horseshit so none of this comes as a surprise. This company needs to close. It needs to close and bevacizumab needs to stop being used becausw every opthalmologist on the western world knows faricimab or eylea is what they would always inject in their parents eyes. This has been a big fing game and these thieves have profitted from it. Trenary getting any severance is criminal. He has no soul to even accept a penny

And that is exactly why the FDA will approve. There is too much pressure on them not to. Doctors and payors already use it roughly 60% of the time for new patients. It’s proven effective and safe. The market needs an approved version.

Europe seems to have value, particularly for a company with an established Euro salesforce. That's stating the obvious, I know. I believe there are a few partners that seems like good fits but, as everyone was focused on USA, the partnership opportunity hasn't been fully explored. Even now, the focus is on capital I would assume.

Good points Thermo. What are your thoughts on Europe approval, the revenue it will generate and/or price tag if OTLK sells it off?

I'm time traveling... "this month" meant January 2025. But you all know the data schedule. Sorry for the sloppy writing.

This month, we’ll see the 12 week data for Norse 8. It may look better than the pre-specified 8 week endpoint, or not…

If it does look better, the company will likely file the BLA and there’s a chance it gets approved. But it is impossible to have high conviction of a US approval, regardless of the data.

Which means the first problem is the capital necessary to get to a BLA decision. I see raising the necessary capital as very challenging. Institutions don’t like coin flips.

The company may either fail to raise the capital, leading to its closure, or secure funding under highly dilutive terms. Remember there is about $30M of debt outstanding, and terms will need to be amended.

The FDA has a problem too. If they decline to approve the LYTENAVA BLA, what happens to the 50% of the market that uses off-label Avastin now? If the FDA doesn’t believe LYTENAVA is safe and effective, how can they allow a similar (though inferior in several ways) product to remain in on the market? But, taking it off the market will cause significant disruption.

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

Resubmittal to the FDA

This is quite uncertain, given the current results of N.8. The Company says:

Previously, the Company reported that in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA).

However, the preliminary data from the trial demonstrated an improvement in vision and the presence of biologic activity, as well as a continued favorable safety profile for ONS-5010. Analysis of the data is ongoing as the month 3 data from NORSE EIGHT is being collected, which is expected to be available in January 2025. Upon receipt of the full month 3 efficacy and safety results for NORSE EIGHT, Outlook Therapeutics plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2024

Best of luck with your investments!

Upcoming anticipated milestones:



* Final efficacy data from NORSE EIGHT expected in January 2025;

* Resubmission of the ONS-5010 BLA targeted for Q1 CY2025;

* Initial commercial launches in Europe planned to commence in first half of CY2025; and

* Potential for US FDA approval of ONS-5010 in second half of CY2025.

See: https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2024

Best of luck with your investments!

You know what would be a great Christmas present, seeing insiders buying. That would speak volumes. 

OTLK, under $2

I’m definitely a sick individual

A friend

LOL - Foolish EX says after pumping it non-stop. EX - The Paid manipulator trying his best to make a living....

Karmic law, if not human law, in effect.........

Anybody who says that it is impossible for FDA not to approve after a failed trial is nuts.

I will grant some chance of approval. No way to estimate w/o a better feel for both the trial data and the FDA view of what exactly was needed given they already had a positive P3.

And there is certainly significant value in the EU/UK market.

But to pump that FDA approval is a certainty just makes the board look foolish.

Every online forum has become an echo chamber for britbox clammporing otlk nonsense. He reposts the same nonsense on yahoo reddit here and twits. This is either a very sick individual, or someone in the company or employed by the company.

OG who are you quoting?

This sums it up perfectly.
“I am really convinced that N8 in addition to N1, N2, N3 + the three academic studies on ophatalmic bevacizumab provided to the FDA + confirmation of Safety + resolution of manufacturing issues + EU/UK approval + difficulties of supplies by the 2 remaining off label compounders + lobbying from doctors + patient safety and needs make it absolutely impossible for the FDA not to approve Lytenava”

So I’ve had a couple theories. In Norse 2 the patients were treatment naive, and so they would naturally show much better vision improvement. Is it possible FDA wanted Norse 8 to test with non treatment naive patients to see the difference in the drugs efficacy between the types of patients so Dr’s would have a better understanding of who to use what drug for ? Meaning, Dr’s and payors would all agree they can start new patients on ONS, but as they progress or have already started treatment, use something else for better results?
Another is that the trial was actually a stability test for the FDA to know how fast the drug loses potency, for expiration dates, as someone stated they heard Russ mention he was using older product they had for the trial.
Another is that once all data is processed it’ll show much better results, perhaps even meeting goals or close enough. Another is that it’s irrelevant, as a non inferiority trial only needs to show it’s not significantly worse than another drug, which it has and will show. We don’t know what the FDA’s margin is for that here, but if the other issues that caused the CRL have been resolved I believe it will be approved. The FDA knows it’s being used off label roughly 60% of the time for new patients already. So it works well enough, and the price is right, for Dr’s to start with. The FDA wants to replace it with a safer version that’s an approved. I believe the packaging and safety of the product is what’s the cornerstone issue for them here.

They still have a commercially approved product. That should care some weight, no? Yea the European market isn't as big but it's still (with the NICE rec) potential for positive cash flow. Guess everyone is skeptical of super dilution 

Along with 23% of the rest of the employees.

https://ir.outlooktherapeutics.com/node/11891/pdf

Russ Trenary is out!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-executive-leadership-transition/



ISELIN, N.J., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom earlier this year for LYTENAVA™ (bevacizumab gamma), the first ophthalmic formulation of bevacizumab authorized for the treatment of wet age-related macular degeneration (wet AMD) in adults, today announced that Russell Trenary has stepped down as the Company’s President and Chief Executive Officer (CEO), effective immediately. Lawrence Kenyon, Executive Vice President, Chief Financial Officer and member of the board of directors, has been appointed Interim CEO.

“On behalf of our management team and board, I would like to thank Russ for his dedication and many contributions to the Company and wish him the best in his future endeavors,” commented Randy Thurman, the Company’s Executive Chairman. “We are pleased to have Larry lead Outlook Therapeutics during this transition period. We remain committed to our plans to resubmit the BLA for ONS-5010 in the first quarter of calendar 2025 and to begin sales of LYTENAVA™ in Europe in the first half of calendar 2025.”

Mr. Kenyon has served as the Company’s Chief Financial Officer and Secretary since September 2015. He has been a member of Outlook Therapeutics’ board of directors since August 2018 and also served as the Company’s President and CEO from August 2018 to July 2021.

The Company has engaged an executive search firm to work with the board of directors to identify a permanent CEO.

I had completely missed that news. No wonder the PPS is not recovering. Two bad news in a row.

Ouch.

Best of luck with your investments!

That is excellent news. So how much revenue would the company generate from European sales? 

NICE was right on time :) ! They kept to their schedule

Best of luck with your investments!

And OTLK's PR

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-nice-recommendation-lytenavatm
“We are very pleased to receive the NICE recommendation of LYTENAVA™ (bevacizumab gamma) for patients with wet AMD. As the first positive reimbursement decision worldwide, this builds on our momentum and bolsters our commercialization strategy moving forward,” commented Jedd Comiskey, Senior Vice President, Head of Europe, of Outlook Therapeutics. “We remain committed to providing the UK health system with a cost effective treatment option for treating wet AMD. Looking ahead, our team continues preparations for commercial launch in the UK anticipated in 2025 and continues to work through the pricing and reimbursement processes for EU countries, with launches in the EU anticipated to follow.”

Best of luck with your investments!

NICE and Price of Lytenava vs. other treatments:

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and faricimab ).

* bevacizumab gamma == Lytenava
* aflibercept == Eyela
* faricimab == Vabysmo
* faricimab == Lucentis

Lytenava is likely to be better priced overall.

Best of luck with your investments.

Great find someconcerns Here is the NICE page

https://www.nice.org.uk/guidance/TA1022/chapter/1-Recommendations

Use the least expensive option of the available treatments (including bevacizumab gamma, aflibercept, faricimab and ranibizumab). Take account of administration costs, dosages, price per dose and commercial arrangements. If the least expensive option is unsuitable, people with the condition and their healthcare professional should discuss the advantages and disadvantages of other treatments.


Only continue bevacizumab gamma treatment if an adequate response is maintained. Criteria for stopping should include persistent deterioration in visual acuity and anatomical changes in the retina.

And yes, bevacizumab gamma is Lytenava / ONS-5010

Evidence-based recommendations on bevacizumab gamma (Lytenava) for treating wet age-related macular degeneration in adults.

Best of luck with your investments!

BRIEF-Outlook Therapeutics® Announces NICE Recommendation of LYTENAVA™ (bevacizumab gamma) for the Treatment of Wet AMD

Reuters - 5 minutes ago Investment News

Email Facebook. Twitter. LinkedIn. Print

Dec 4 (Reuters) - Outlook Therapeutics Inc ( OTLK ):

* OUTLOOK THERAPEUTICS® ANNOUNCES NICE RECOMMENDATION OF LYTENAVA™ (BEVACIZUMAB GAMMA) FOR THE TREATMENT OF WET AMD

* OUTLOOK THERAPEUTICS INC ( OTLK ) - FIRST POSITIVE REIMBURSEMENT DECISION WORLDWIDE FOR LYTENAVA™; FIRST LAUNCH ANTICIPATED IN H1 2025

* OUTLOOK THERAPEUTICS INC ( OTLK ) - ENTERS STRATEGIC COLLABORATION WITH CENCORA Source text: Further company coverage:

Thermo, can you explain the $9-$53 target after faille trail?? Ask your body EX for clarification if you have too..

SMH....

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And the $30-$50 range is for what? Please Explain....

I've seen numbers in the $30-50 range 

Has anyone modeled out what the company would be worth per share if dilution was not needed, and Europe sales were at the lower end of the range of projections.

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

The so-called Analyst put a target of $30 on SP prior to the trial complete Failure & he...

then maintains a target of $30 after the complete failure???

How could that be??? SMH

Unfortunately guys, the story is almost over, the active ingredient is the same, dosage is twice as large, effectivness is less, why a doctor should prescribe less efficient drug? I hold position, will survive failure, it doesn't significantly matter if I sell now or wait for FDA possible rejecton due lack of effectivness compared to offlabel.  Still waiting for OTLK disclosure of their financial strategy. 
Best of luck for you 

The entry point was around 1-1.10 on Wednesday. 

If you sell now you deserve to be poor right? Youve averaged down so many times you must own half the company by now

Great place to jump in or average down !

OTLK, new 52 week low

I only focus on what to do next.
Only keep an eye on the past to ensure mistakes aren’t repeated, then your approach is a good one, IMO. :)

The FDA and CMS know?Bevacizumab works. They've allowed off-label utilization of it, and reimbursed for off-label use, for years.
Compounded Avastin is essentially dead. The FDA went after Pine Pharmacy, which accounted for ~50% of the compounded Avastin. I wouldn't be surprised to see other compounding pharmacies exit the market so they don't experience a similar fate as Pine. CMS simply doesn't have the budget to replace every unit of compounded Avastin with Eylea, Lucentis, etc.

The trials goal was never to outperform the expensive specialty products in this space. It was to provide a safer formulation of Bevacizumab, so that patients can still receive an effective initial treatment before progressing to drugs that cost multiples of what we expect Lytenava to cost.

1. The FDA will evaluate both trials as a whole:
* NORSE TWO: Showed strong long-term efficacy (41% vs. 23% improvement in BCVA vs. Lucentis).
* NORSE EIGHT: Failed the non-inferiority endpoint at 8 weeks, raising short-term efficacy concerns.
Key Considerations:
1. Evidence: Long-term data (NORSE TWO) may outweigh short-term gaps.
2. Safety: Consistent safety profile supports approval.
3. Market Need: Cost-effectiveness could justify approval despite biosimilar competition.

The FDA has approved drugs under similar circumstances when there is an unmet need: Drugs addressing limited treatment options or offering cost-effective alternatives (e.g.,
LYTENAVA™ as an on-label alternative to Avastin).
1. Totality of Evidence: Approvals are based on combined trial results, where strong data from one study (e.g., NORSE TWO offsets weaker results from another (e.g., NORSE EIGHT).
2. Safety Profile: Consistent and acceptable safety records are key for consideration.

January will show full 3 month trial data that will be submitted to the FDA. I’m betting the data is better, and will be enough for approval. Either way, EU/UK sales will begin Q12025 making them cash flow positive. I told you a year ago to expect more fuckery. When you’re dealing with billions of dollars it gets shrewd. It wouldn’t surprise me one bit that they released the preliminary data before all was collected knowing it would shake most of the long holders out. Now she is primed for a buyout.
Still holding. We will know more in January.

Two NWBO paid bashers, LC2020 & EX are here trying to save you???
Do the opposite as they have no skin in the game...and are paid to post whatever they posting..

Hi Thermo,

Investing in biotech is risky, and I think those who invest there are OK with risk. I am. On paper, today was not great. I hear arguments and read about companies, I invest based on the public information at hand. There are no guarantees with trials. I've been bitten a few times, and got some nice rewards other times.

Thanks for your input, I for one appreciate it.

Based on the previous Norse trials, I gave N8 a high likelihood of success. That's all it is though, a likelihood. I invested based on the UK/Europe approval, and also on the likelihood N8 would be reach its endpoint. Now the results are out. Also, this story is not over yet.

Anyways, I hope you keep on sharing your thoughts, on this ticker symbol or others.

Kind regards

Best of luck with your investments!

Is there a chance full data will override the non-inferiority outcome? Why FDA should approve something which is significantly less effective but a bit safer than existing product? Financials is a risk I get it: no more money with such preliminary outcome, but what are positive scenarios?

How about starting by using your influence to get a reliable outsider on NWBO's board or an independent CFO, at the very least.