Outlook Therapeutics Inc (OTLK) News

I knew you would agree thermo!!!!

yes, definitely enough said.

OTLK:
From $840 to $5....
Enough Said.....

Though the black redaction marker cut most of the juicy details (including all discounted prices), there are some clues to pricing.

In the OTLK evidence submission on page 105 they have some analysis based on their guesses on others. From that one can see Lytenava has been discounted down to (likely slightly) undercut their estimates on the others. The others have a estimated discounted price of 300-500 GBP. That would make Lytevana getting $250-300 net revenue a decent guess.

The treatment recommendations assert the doc should prescribe the cheapest when possible, though they are allowed a lot of flexibility. This will favor Lytevana as the list is lowest.

AS far as uptake, there is no significant use of use off off-label bavi in the UK as patients have to pay on their own for that choice. So should be fairly decent.

EDIT: I believe it takes 3 months for the draft guidance to become final and start the revenue flow.

Excellent News.

https://www.p3pharmacy.co.uk/clinical-news/1266161-nice-recommends-new-treatment-for-amd

Uk is the largest market after usa

No. This is wrong. The company has to communcate the results at 8 weeks as soon as practicable. Does not have wait 3 months.

Pumper and their EX wannna thing trying....OTLK..
OTLK from the high SP of $840 to $5....
Enough Said.....

3(!)-month non-inferiority study with 8-week efficacy endpoint. I expect results after 3 months at earliest. So end of November/beginning of December.

Yes. It could be possible. The question is when the last enrolled patient got its first injection

Do you know of there is any delay between enrollment and treatment? Also, could be a few days to a week to get most all of the patients in for their final exams.

Certainly people can wait a week or so if need be

So we could see top line pr as early as tomorrow?

Usually result are announced few days after the last patient measurement. If the last injected patient was sep 4, result are ready by today

Now I have no idea how this works, but someone told me that the data is collected by each doctor into a program, which automatically gathers all the data in real time, as it’s all automated

Beware of pumpers, even if its your EX-something.....

Norse 8: 8 weeks past Sept. 5th is Oct. 30th

The very last patient was enrolled on or before Sept 4th:
* https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-completion-enrollment-norse

The study compares results at 8 weeks:

Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8 [Time Frame: Baseline, 8 weeks]
* https://clinicaltrials.gov/study/NCT06190093?tab=table#outcome-measures

From the corporate presentation:



So the company will shortly be / is starting to gather data on both arms of the trial.

This jives with the estimated primary completion date:
* 2024-10 (Final data collection date for primary outcome measure)
No changes there.

And hopefully, the estimated study completion date will hold:
* 2024-11


I do expect an end-of-year or earlier PR on Norse 8.

Best of luck with your investments!

What is with you people recently? Why don't you actually read through my post history and demonstrate how I'm a paid shill?

One of us is clueless, that's for sure.

We should see top line data by the first week of November

I have the same view. Unlikely to speed approval but does enforce the thesis behind the business model, namely that off label beva is not a good approach to treating so many patients. A low priced / fully approved product is needed.

The Pine Pharma news may indicate that the LYTENAVA launch will ramp faster than current expectations. Most analyst models seem conservative in the sales ramp. Some of this was based on the assumption that compounding phama cos would leave the market slowly.

So serious question. With a shortage looming, does this put pressure on the FDA to fast track approval to help meet the need?
From a "what's it worth to us", would have been a lot better for this news to happen next year. OTLK plans to submit in Q1. There is no chance of FDA acting prior to summer, and by then any shortage will be cleared up.

I am skeptical the FDA would speed things up for what is basically a commercial issue (alternatives exist). But a higher market price would be nice.

On a deeper point, this should add to the asserted advantage OTLK has (vs off label bavi players) in an FDA approved manufacturing process. That is probably the real take-away.

So serious question. With a shortage looming, does this put pressure on the FDA to fast track approval to help meet the need?

The discontinuation notice from Pine:

Subject: Discontinuation of Repackaged Bevacizumab

Dear Valued Customer,

We are writing to inform you of an important change in our product offerings. Effective
immediately, we are discontinuing manufacturing the below pharmaceutical products in
prefilled syringes.

ITEM DESCRIPTION
343 BEVACIZUMAB 1.25 MG/0.05 ML INJ - BD TB
963 BEVACIZUMAB 1.25MG/0.05ML INJ - SCLS MN

Prefilled syringes are designed with lubricants to ensure smooth plunger movement, which
is essential for proper function. However, any visible lubricant detected during quality
inspections necessitates the rejection of those units. Unfortunately, this has resulted in
unsustainable batch yields, which has contributed to our decision to discontinue this
product line.

We understand that the discontinuation of these syringes will cause a disruption in service,
and we want to express that this decision was not made lightly. We have truly honored the
opportunity to supply this drug for you and your patients over the last ten years and will
continue to distribute these products while our current supplies last.
We greatly appreciate your understanding and patience during this transition. Should you
have any questions or need further information, please do not hesitate to contact us at
844-218-4138 or support@pinepharmaceuticals.com.

Thank you for your understanding and continued partnership

Center of Medicare: Yep, Pine is out, shortage, etc!!!

https://www.asrs.org/content/documents/aao-asrs-to-cms-re-pine-repackaged-avastin-discontinuation_final.pdf

October 16, 2024
Meena Seshamani, MD, PhD
Deputy Administrator and Director
Center for Medicare
Mailstop C4-26-05
7500 Security Boulevard
Baltimore, MD 21244
VIA ELECTRONIC DELIVERY

Dear Deputy Administrator Seshamani,

The American Academy of Ophthalmology (the Academy)i and the American Society of
Retina Specialists (ASRS)ii are reaching out to provide notice and background around an
upcoming shortage of repackaged Avastin (bevacizumab), which could challenge
Medicare beneficiary access to sight-saving care. On October 11, Pine Pharmaceuticals,
which as far as we know is the largest supplier of repackaged Avastin in the US,
announced that they will be discontinuing production of all Avastin products (see
Appendix A for the discontinuation notice).

At this time, the company has informed our organizations that they have no plans to reenter the market and have only 2-3 weeks of supply remaining. Our organizations have
significant concerns regarding patient access to repackaged Avastin and negative
outcomes stemming from the abrupt discontinuation. We ask that CMS notify all
Medicare contractors, including traditional MACs and Medicare advantage plans, of
this critical medication supply disruption and urge a halt to step therapy and prior
authorization requirements for alternative ophthalmic anti-VEGF therapies to avoid
treatment delays.

Repackaged bevacizumab (Avastin) is the most commonly administered intravitreal drug
worldwide, and therefore a disruption to its availability has a major impact on patients.
This disruption is particularly concerning given the market share that Pine
Pharmaceuticals has as a repackaged Avastin supplier. For ophthalmologists, particularly
retina specialists, in need of repackaged Avastin for patient care, finding alternative
suppliers that can provide timely access will be a significant challenge. Other U.S. Food
and Drug Administration (FDA)-registered 503B outsourcing facilities, such as Leiters
Health, require new customers to go through an onboarding process before new orders
can be filled, which disrupts the normal flow of supply. Additionally, states such as
California have few outsourcing facilities with a license allowing them to ship to their
state.

Repackaged bevacizumab (Avastin) is a critically important treatment option for
ophthalmology patients facing sight-threatening diseases, including age-related macular
degeneration, macular edema, neovascular glaucoma and others. Avastin was first
approved by the Food and Drug Administration (FDA) to treat different types of cancer.
Its use in ophthalmology is considered an “off-label” use. This is the fourth major
disruption to supply of repackaged Avastin in the past five years. In 2019, the efforts of
Optum (formerly Avella) to align their testing procedures with 2018 FDA final guidance,
“Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved
Biologics License Application,” resulted in an extensive shortage. In 2021, Optum halted
production of repackaged Avastin due to out-of-specification test results on select
batches of the product. Last year, we experienced yet another disruption to repacked
Avastin production when there was a recall at Pine Pharmaceuticals due to concerns of
the FDA regarding a potential lack of sterility assurance.

Our top priority is to ensure our patients receive the highest quality care, including timely
access to treatments like repackaged Avastin and any clinically appropriate alternative
medications. Unexpected delays in receiving intravitreal anti-VEGF therapy has been
shown to result in vision loss across multiple conditions.iii That is why our organizations
have opposed existing step therapy policies, which interfere with the patient – physician
relationship and in cases of supply instability, can create significant challenges for
ophthalmology practices. Even when drug supply is stable, step therapy requirements
are administratively burdensome on a physician and their staff as they help patients
navigate complicated and often opaque coverage determination processes. Furthermore,
payor exemption and appeals processes can be complicated and lengthy, making them
onerous for strained physician practices and patients awaiting treatment.

Given the discontinuation by a major supplier and persistent access challenges in the
compounded drug marketplace, it would be appropriate to halt step therapy and prior
authorization requirements for repackaged Avastin alternatives. Facilitating access to
alternative therapies is critical for patient care and will be a significant help to our
ophthalmology practices. Additionally, if a patient must switch therapies due to the
current repackaged Avastin shortage, we believe patients should be allowed to continue
whichever clinically appropriate therapy they have been switched to if it is effectively
treating their disease after the shortage has concluded.

We hope that CMS will take whatever steps necessary within its authority to mitigate the
disruption to important sight-saving therapies. Our organizations welcome the
opportunity to work with you. If you have any questions and/or to coordinate a meeting,
please contact the Academy’s Director of Health Policy, Brandy Keys at bkeys@aao.org
or 202.587.5815, or ASRS’s Vice President of Health Policy, Allison Madson at
allison.madson[ @whosYOcaddy?.
Cc:
Cheri Rice, Deputy Director, Parts C and D, Center for Medicare
Sincerely,
Michael X. Repka, MD, MBA
Medical Director, Governmental Affairs
American Academy of Ophthalmology
Ankoor R. Shah, MD, FASRS
ASRS Practice Management
Committee Chair



i The American Academy of Ophthalmology is the largest association of eye physicians and
surgeons in the United States. A nationwide community of over 20,000 medical doctors, we
protect sight and empower lives by setting
the standards for ophthalmic education, supporting research, and advocating for our patients
and the public

ii ASRS is the largest retina organization in the world, representing over 3,000 board certified
ophthalmologists who have completed fellowship training in the medical and surgical
treatment of retinal diseases. The mission of the ASRS is to provide a collegial open forum for
education, to advance the understanding and treatment of vitreoretinal disease.

iii Song W, Singh RP, Rachitskaya AV. The Effect of Delay in Care among Patients Requiring
Intravitreal Injections. Ophthalmol Retina. 2021 Oct;5(10):975-980. doi:
10.1016/j.oret.2020.12.020. Epub 2021 Jan 1. PMID: 33395587

Appendix A: Discontinuation Notice
4
Subject: Discontinuation of Repackaged Bevacizumab
Dear Valued Customer,
We are writing to inform you of an important change in our product offerings. Effective
immediately, we are discontinuing manufacturing the below pharmaceutical products in
prefilled syringes.
ITEM DESCRIPTION
343 BEVACIZUMAB 1.25 MG/0.05 ML INJ - BD TB
963 BEVACIZUMAB 1.25MG/0.05ML INJ - SCLS MN
Prefilled syringes are designed with lubricants to ensure smooth plunger movement, which
is essential for proper function. However, any visible lubricant detected during quality
inspections necessitates the rejection of those units. Unfortunately, this has resulted in
unsustainable batch yields, which has contributed to our decision to discontinue this
product line.
We understand that the discontinuation of these syringes will cause a disruption in service,
and we want to express that this decision was not made lightly. We have truly honored the
opportunity to supply this drug for you and your patients over the last ten years and will
continue to distribute these products while our current supplies last.
We greatly appreciate your understanding and patience during this transition. Should you
have any questions or need further information, please do not hesitate to contact us at
844-218-4138 or support@pinepharmaceuticals.com.
Thank you for your understanding and continued partnership.
5

Russ Trenary Presentation du Jour

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-participates-virtual-investor-ceo-connect

The usual presentation, nothing really new. Russ reaffirmed some of the same points, such as top line data in Q4 (I think it might end up being January 2025, but that's just me), Norse 8, etc.

The point that I keep finding lacking is how the launch in Germany/UK is going, either from a pure planning/hiring/etc. angle or a partnership and if so, the type of deal reached. That point keeps being put to the side, when the approval in Europe and the UK is months behind us.

Otherwise, same ol' same ol', hence bullish.

Best of luck with your investments!

I’m not saying this is a buy, buy, buy….wink, wink wink

Outlook Therapeutics (OTLK) Buy, $50 PT

Capitulation from the Largest 503B Supplier of Off-Label Intravitreal Bevacizumab Bodes Well for Potential LYTENAVA Launch Next Year; Reiterate BUY

What You Should Know:

We spoke with two representatives from Pine Pharmaceuticals (Private) today, who confirmed that Pine discontinued all repackaged intravitreal bevacizumab products earlier in October. Based on our discussion with OTLK mgmt, it is believed that Pine previously accounted for 40% to 45% of all off-label intravitreal bevacizumab volume as the largest 503B supplier in the US. We view this as significant capitulation that reads through positively to the commercial potential of LYTENAVA (fka ONS-5010). We may see some indication from the FDA re: the agency's stance on compounding pharmacy regulation enforcement prior to LYTENAVA's potential launch next year, with additional clarity on tirzepatide's status (the lawsuit to follow is Outsourcing Facilities Association et al. v. FDA, docket #4:24-cv-00953-P). However, with major compounding pharmacies already bowing out of the intravitreal bevacizumab business, we think OTLK likely does not even need the FDA to clarify their stance on enforcement in order for LYTENAVA to be commercially successful.

...
Compounded bevacizumab is currently utilized by ~70% of retinal specialists in the US as 1L Tx for wet age-related macular degeneration (wAMD), yet remains subject to concerns surrounding quality and supply. We expect these concerns would be resolved with a pharmaceutical-grade, FDA-approved alternative.
...
===================
BTIG

To be clear, I'm not saying this is a buy, buy, buy moment. Financing overhang still dominates. But, once we get through that, the investment thesis looks compelling.

I am not sure how to tell the difference between a Dragonfly Doji and the Triple Lindy.

Regardless, for better or worse, within the next year this company moves into the world of operational companies where it will be evaluated on financial performance.

Show me a good set of books a year from now and I could care less if Rodney faceplants himself or springs to the top.

EDIT: I do know revenue can take a year to kick in, so would still be partially forward looking in one year.

What a beautiful Dragonfly Doji. Bullish.

Its a gem right? Ur friend said so. Lying sack if s. Just repeating what that f00l sj said for years. U belong in jail.

Management clearly stated they are seeking non-dilutive financing

All time low? And this with EU and UK approval. Management is inept. Massive dilution coming.

Hi Thermo, a question on partnership for you

October Company Presentation, https://ir.outlooktherapeutics.com/static-files/b002dd4e-a186-43c4-8721-02de111a2f98

Pretty much the same as the previous one. I tend to look at the partnership for commercialization in the UK and the EU.

1. Slide 12:
Working with Cencora (formerly AmerisourceBergen) and their European Partners to support commercialization in the EU4 & UK
Note: Given Slide 10, one can infer that EU4 = Germany, France, Spain, and Italy.

2. Slide 13:

Establishes Commercial Depth in Advance of Planned LYTENAVA (bevacizumab gamma) Commercial Launch

Besse Medical is One of the Largest Specialty Pharmaceutical Distributors to Retina Specialists

Thermo, if you have some information on this:
Are we to understand the partnership is finalized and it is Cencora and Besse Medical?
Are we to understand OTLK will not launch in Germany in the UK without a partner? (That was mentioned in one of Russ Trenary's recent presentations).

The launch preparation should be in full swing at this time, from recruiting or identifying resources to training to productions for the targeted markets.

Thank you!

Best of luck with your investments!

How did you obtain the information on the new investors in thenlast 30 days? I thought this information was due 45 days after quarter end. Thank you

6 new institutional positions reporting last 30 days, and another 5 increased positions. Also, the CEO just bought 30 grand worth of stock on the open market last week.
Not to mention, there’s been a lot of very large 75,000-100,000 block shares being traded after hours and premarket to stay off the radar

... meant to say a couple of months ago

I agree with you, ex. I proposed a plan a couple of years ago, but the company was not concerned. Obviously, a mistake in hindsight.

No one has brought that up. The major holders -- and the company -- don't seem too worked up about waiting another couple of months.

No pain, no gain, I suppose.

So as of right now the company has top line data on over 75% of the enrolled patients. Why wouldn’t this be sufficient for the warrant holders to either exercise early or to secure funding in the manner as you suggested?

A year from now, if and when the price is over $100, you will feel much differently. If you know what you own, current price is irrelevant, unless you use it to take advantage of lowering your cost average

I would rather they just get the financing or EU deal over with. Stop the slow drip. Retail (at least those like me) are not buying the fade in price because of the financing overhang.

If/When a deal is done I expect the price to start a recovery. I will likely add on the open following such a deal.

Get the damn thing done [talking to OTLK, not you Thermo].

Thermo,

I know you don't frequent the NWBO board anymore due to its descent into chaos, but I was wondering if I could get your thoughts on how you're feeling with everything going on at the moment. Namely, MHRA approval, NICE reimbursement, Flaskworks, combo deals/partnerships, additional submissions to other regulatory agencies.

Cryptic yet fair. Preciate the responses

I've been surprised that management seems way less concerned that I am. That can be read a couple of ways.

Would you prescribe a 70/30% chance of the happy path vs a lesser desireable option?

My guess is the front runner financing option is a synthetic royalty based on European revenues.

I would expect it will be milestone based with the first funds released upon good Ph3 data this November / December. Yes, I know they already have EU approval, but company strength is bolstered by US approval too, and that's probably important to overall viability.

Royalty funding would be sufficient to allow the stock price to reflect data and, as long as the price is $10+, a sufficient number of warrant holders will exercise and allow the cash runway to extend past an FDA decision.

If the above plays out, then no new warrants issued. Obviously, other possibilities involve new dilution, including the issuance of warrants. The phrase -- the situation is fluid -- is appropriate here, in my view.

I still feel financing risk is the primary risk (vs clinical trial risk or even commercialization risk) though there is a reasonable shot at things playing out along this "happy path".

Over 1 million shares traded today including after hours

Does anyone wish to speculate (or know) on how much financing they’ll pursue? $100MM or is it closer to 30-40MM?

@$5 (sweetheart deal) that’d be 20mm shares, maybe a warrant of 1:1 thrown in as sweetner?

The most volume today in over 5 1/2 months, since April 2. And after hours volume is blowing up!, Something is going on.

They may have work to do, but not as much work to do as they did with the original submission, which took 180 days. That’s more the point I was making. So you’re right they may not need the entire time, but it is the government so they probably will.