Outlook Therapeutics Inc (OTLK) News

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.

So strange they would need 180 days to review the one new trial data and CMC issues considering everything else was checked off
The 180 day is the law for major resubmissions regardless of how easy they should be. Even if you take a look at say it is obvious, they have a ton of work to actually do.

This does not mean the FDA will take that long, they can be early. But I would not bet on it.

Unfortunately, not a word about the pink elephant in the room. The upcoming financing. I have enquired via Zoom but have not yet received a reply. I think they are in negotiations, as Thermo has indicated. I hope the dilution will be small. The PPS indicates a financing around $6.

So strange they would need 180 days to review the one new trial data and CMC issues considering everything else was checked off

Today's Conf. Top Line data Q4/Resubmittal Q1 2025

* https://us02web.zoom.us/webinar/register/WN_HkXmgGkFQNaAx0JfHjtrmw#/registration

This was a two-part presentation, an overview with slides from Russ Trenary, then a Q&A session. The questions segment is the more interesting one. It starts around minute 24.

The mantra du jour was "maximizing shareholder value".

1. OTLK Overview

The slide deck is pretty much the one we've seen a few times now. The emphasis this time was on:

* FDA Track, Norse 8: Top line data in Q4; Resubmittal in Q1 2025
* 10 years market exclusivity in Europe
* 12 in the US.
* highlight the off-label Avastin repackaging process and why it's suboptimal
* Engaging with potential commercial partners in Europe

2. Main points from the Q&A session

*Roll out: it sounded like OTLK is going to roll out Germany and the UK earlier, and most likely by themselves, and potentially relying on a partner for other European countries. Russ would not say if any conversations were happening or with whom, but you could get a sense that the Company is engaged and looking at what a deal could look like, including profit-sharing arrangements, joint commercial/marketing activities, and pricing discussions.

* No IP: Russ said that for any biologic, the market exclusivity is based on the first Company to get approval for a molecule for an indication. Russ does not pretend to have a portfolio of patents, he does not need that.

* CRL CMC findings: the Company has established a working relationship with the FDA. During the type C and D meetings, OTLK went over each of the CMC findings and how they are/will address them. The FDA expressed agreement with OTLK on how to resolve the CMC findings. Russ seems confident about the resubmittal. He insisted on the "Complete" word in the CRL: the CRL is supposed to provide *all* the findings that need to be addressed. N8 is one aspect, the CMC is the other. OTLK does not expect to have to address anything else. Russ went over the SPA again.

* 180 day clock: A major amendment to a submittal (OTLK submitted and received the CRL) means a 180 clock upon resubmittal. Russ repeated top-line data in Q4 2024, and resubmittal in Q1 2025.

Russ has done that type of presentation many times. He seemed a bit on automatic to start with and got more enthusiastic with the Q&A session.

Nothing really new for me, except maybe the 180 day clock. Still vague on partnerships for my taste at this stage, but I get it.

Best of luck with your investments!

Active, not recruiting

https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1 finally reflects that the enrollment is officially complete.

Other changes:
Primary completion date: 2024-10
Study completion date: 2024-11

The change happened today, even if the update is date 9/11.

Best of luck with your investments!

Not yet. Work gets in the way :)
Cheers!

Get a chance to listen?

3rd investor conference in September

Russ Trenary wants to the word to get out. The "Closing Bell Series" presentation will be his third. I'll be looking for new tidbits, but I think it's more to get the word out about approval, enrollment, plans, that we already are aware of. I'll be curious in particular about partnerships.

Best of luck with your investments!

If the original terms were "above market" then repricing the warrant would violate NASDAQ rules. However, since the company received shareholder approval for a below market deal, they may be able to make it a little more below market without S/H approval.

But I'm not 100% sure of my opinion. One needs to check with counsel.

What a great buying opportunity. I bought on Friday and plan to buy tomorrow. OTLK virtually derisked IMO.

I.do not think warrant can be repriced without sharholder vote

I also thought it would be highly irregular to sell the ATM at these levels. I just didn’t know what else it could be, so I appreciate the other possibilities !

Hi Thermo,

Would you elaborate on a scenario around European partners? There has been a change in tone and in slides around the European launch. Earlier in the year, Russ Trenary was highlighting the number of sales people in each country, the launch in Germany and the U.K. without much talk of partnerships.

This changed over the last couple of months. Even in today's recorded segment (Chardan, https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-participates-2nd-annual-chardan-virtual ), again, talk about partnership in Europe, not in the U.S.

What could that look like and why would the PPS take a hit?

Many thanks! As usual, I look forward to your thoughts,

Best of luck with your investments!

I'm of the opinion that one of the investors in the March capital raise got nervous and rushed out the door.

Consider this:
- an investor holds 100 shares of common + a warrant exercisable for 150 shares.
- stock is trading $7.50
- the company offers to reduce the warrant strike to $6.50 for 1 week and the investor will receive 1 replacement warrant for each warrant exercised (the company will generally try to negotiate 1/2 warrant per warrant exercised, but it's negotiation, so it depends on leverage).

One trading strategy: sell 100 shares of common, exercise 100 warrant shares. The common held is unchanged (still 100 shrs), the warrant shares are unchanged, but one also has $100 extra cash. The major negative is the acquisition date was reset, so long term capital gains is pushed out into the future.

If one fund is worried the company will make the above offer, then a rush to the door ensues (sell before the other guy does), which is what this looked like to me.

I'm not saying the company made the above offer. They didn't make it to me, and they would. But investors forecast and this is a possible scenario. Other possible scenarios are an EU partner, or a royalty financing tied to EU sales, etc ...

I don't think it is sales off the ATM, since the company would be crazy to hit the market so hard.

Ah ok. Thanks for the explanation. Learn something new everyday. 

OTLK has an outstanding at-the-market [ATM] agreement with BTIG that allows it to issue up to $100.0 million in stock to access capital. They’ve done so before, I believe in 2022, and I was only guessing that perhaps the reason for the increased volume and declining share price was the ATM.

Sorry newbie here. Explain ATM if you could? All I know is it's approaching RS price of $6.46. 

ATM being sold is my opinion

What's with the price action the last two days?

Looks like they may have sold some ATM yesterday.

September Corporate Presentation:

1. Enrollment complete confirmation



Slide 5: Indeed, enrollment is complete as of the first week of September.

Slide 20 puts a checkmark next to enrollment complete.

That's more like it!

2. No more launch map

In August, the launch map focused on Germany and the U.K.. The September presentation only talks about potential partners. I wonder if the 'potential partner' would have the ability to expand the launch regions substantially faster.

Best of luck with your investments!

It just dropped

I am pretty sure this was recorded before the Sept. 4th announcement. We’ll get the revised September company presentation soon.

Thinking a bit more about it, I'm wondering if this was recorded before the Sept. 4th announcement. Russ T. is not at the conference, only one question, from the M.C., nothing else.

Just a thought.

Best of luck with your investments!

Sept 9, 2024 investor's conf

H.C. Wainwright 26th Annual Global Investment Conference - September 9-11, 2024
https://journey.ct.events/view/58e0675c-73a3-47d6-8ff8-03ab41bb5581

1. Enrollment complete?
The usual spill, very much based on the Aug 2024 corporate presentation. However, one thing bothers me. I did not hear from Russ T. that the enrollment was complete. On the contrary, it sounded like it would be complete in Q3. This seems to contradict:
* https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-completion-enrollment-norse

Russ T. may not have updated some of the slides from Aug. :


and



Neither says 'enrollment complete' .

2. European Partnership

Russ T. says that OTLK can be launching in Europe by themselves or with commercial partners and that is still not decided. It's a bit more vague than I would like, which may be by design. It sounds like the cost of launch could be one of the main factors, as opposed to the reach, the market access, and other criteria which could help accelerate OTLK's ramp up. We are only a few months from 2025, again, I would have expected this side to be ironed out.

All in all, the same premise as the typical presentation, with a slight negative on those two points.

I'm still very bullish.

Best of luck with your investments!

OTLK under $10

European Partner Deal Getting Close?

A paragraph in the enrollment completion PR mentioned a European (and potentially other regions outside the US) for commercial purposes:

If approved by the FDA, Outlook Therapeutics plans to commercialize ONS-5010/LYTENAVA™ (bevacizumab-vikg) directly in the U.S. and is also assessing partnering options for LYTENAVA™ (bevacizumab gamma) in Europe and other regions outside of the U.S.

I had seen a reference to a potential partner in the August corporate presentation:
https://ir.outlooktherapeutics.com/static-files/d9b068b8-621b-404f-ac70-d63ae51c0c53 , slide 25

Engaging with Potential Licensing Partners for Commercial Launch in the EU and UK

I would expect language around commercial partners after any deal is done, not before. That leads me to wonder if a deal is far along and details are being negotiated. Should we expect another PR this month, this time around commercial partnership?

Best of luck with your investments!

NORSE EIGHT Topline results expected in Q4 24!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-completion-enrollment-norse

This is excellent news. As usual, they plan, they execute.
Best of luck with your investments!

Thanks OGBritbox Excellent!!! Norse 8 enrollment completion PR here

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-completion-enrollment-norse

ISELIN, N.J., Sept. 04, 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 the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the completion of enrollment for its NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients. NORSE EIGHT is the subject of a Special Protocol Assessment (SPA) agreement with the FDA, and, if successful, is the final anticipated clinical trial required before expected resubmission of the Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010.

NORSE EIGHT is a randomized, controlled, parallel-group, masked, non-inferiority study of 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 is mean change in best corrected visual acuity (BCVA) from baseline to week 8. Outlook Therapeutics remains on track to report NORSE EIGHT topline results in Q4 CY2024. The resubmission of the ONS-5010 BLA is planned for Q1 CY2025.

“We are very pleased to complete this important milestone in our effort to resubmit our BLA for ONS-5010. On behalf of Outlook Therapeutics, I would like to express gratitude to the patients and dedicated teams at the clinical sites, as well as our clinical and regulatory staff, who enrolled this entire patient population in less than 8 months after our SPA agreement from FDA,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. “We remain confident in the potential of ONS-5010, if approved, to meet the needs of retina specialists, patients, and payers. With enrollment now complete, we plan to report topline efficacy results in the fourth calendar quarter of this year.”

As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT) to support the resubmission of the ONS-5010 BLA. In January 2024, Outlook Therapeutics received written agreement on the NORSE EIGHT trial protocol and statistical analysis plan from the FDA under the SPA. The SPA also confirms in writing 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 fully address the clinical deficiency identified in the CRL. In addition, Outlook Therapeutics has completed Type C and Type D meetings with the FDA to address the open chemical, manufacturing and control (CMC) items in the CRL and expects to resolve these comments prior to the expected completion of NORSE EIGHT.

Best of luck with your investments!

Enrollment now completed

OTLK at H.C. Wainwright 26th Investment Conference

Russell Trenary, President and CEO of Outlook Therapeutics will present at the H.C. Wainwright 26th Annual Global Investment Conference being held September 9-11, 2024 in New York, NY.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-present-hc-wainwright-26th-annual-global

Norse 8 enrollment numbers may be updated for that conference, given how close it should be to completion, if not completed. The Corporate presentation may also be updated. And hopefully, the video presentation will be easy to access.

Best of luck with your investments!