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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:
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!
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!
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!
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!
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!
Trifecta realized: 6B
Best of luck to Patients, NWBO, and Longs!
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:
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
OTLK at H.C. Wainwright 26th Investment Conference
This month: Norse 8 enrollment completion expected.
This month, we should have news that the enrollment is complete. From the August 14th CC, https://seekingalpha.com/article/4714514-outlook-therapeutics-inc-otlk-q3-2024-earnings-call-transcript:
OTLK Launch Map
I like geographical maps with pretty colors. This one looks realistic; They've had the European approval in May 2024 and the UK approval in July 2024.
In August 2024, OTLK must have a pretty good view on the launch in those two countries and are executing on the plan. Given their track record, I believe the launch dates in different counties will be close if not exactly as shown here.
Best of luck with your investments!
Revised Timeline for Norse 8
I had been wondering about the enrollment completion and the date on the estimated primary completion date on the clinical trial site. (see previous post).
The August 2024 OTLK presentation has a revised time line:
See: https://ir.outlooktherapeutics.com/events-and-presentations/presentations
which matches better with the current status (Active recruiting) of Norse 8. The topline data is now expected in Q4 2024 and the submittal to the FDA will not be done this year; it is now planned for Q1 2025. That makes more sense. Approval in 2025 is realistic. And in the meantime, European sales will start Q1 2025 with Germany and the UK.
Bullish OTLK. Best of luck with your investments!
Carmel, IN, site added: 61 sites
From today's update on Clinical Trials, this new trial site was added
* Carmel, Indiana, United States, 46290
I would have been happier if this site had been added one month ago. I am now wondering when the study will actually complete. Since the protocol requires a 3 months treatment, the current planned primary completion date of 'Sept 2024' seems off. That date was not changed with the update to Clinical Trials.
Still bullish.
Best of luck with your investments!
Short Seller Misinformation
https://ih.advfn.com/stock-market/NYSE/nuscale-power-SMR/stock-news/94270860/nuscale-power-comments-on-short-seller-report
Hurts the stock, but no penalty for Hunterbrook.
"Hunterbrook is a known short-seller that has a vested interest in sensationalizing information to manipulate the stock market. The Securities and Exchange Commission has not communicated to NuScale that it is the target of a current or prospective investigation, and the Company is unaware of any reason for such an investigation."
un bémol:
The primary completion is estimated to be September 2024. Each patient must have a 3 months treatment. We are at the end of July and the study still says Recruiting. Something does not quite add up.
I guess it's possible that they enrolled 400 patients and are enrolling some 'extra' patients to avoid the "Lost To Follow Up" (LTFU), but it's only a 3 months treatment.
I would expect the 'Recruiting' or the 'Primary Completion Date' to change soon on the clinical trials site. Otherwise, something does not add up. And yes, I'm still bullish (very much so).
My 2 cents.
Best of luck with your investments!
Clinical Trials 'Update': Keeping to the estimated dates.
The latest update, dated 2024-07-23 , is simply ... the date of the update, nothing else has changed.
In particular, the estimated primary completion date and study completion date remain the same as it's been since the trial was first entered in Clinical Trials.
I take that as a sign that enrollment continues as planned and that the Company keeps executing to the plan for an FDA submittal at the end of 2024.
Looking good!
Best of luck with your investments!
Hello HyperPhoenix1,
Your guess as to why the PPS is not rising more rapidly would be as good as any.
Mine is caution after the FDA CRL last year. I believe that Norse 8 will lead to US approval in mid-2025 and that may be what 'the Market' is looking at, together with the first quarter of sales in Germany and the UK. In other words, the Market sense may be that there is time to invest at this point. From my perspective, I see it as an opportunity to add.
Once sales kick in, I do not see the PPS going lower, and as a few of us on this board (including you) are 'guestimating', the PPS could rise quite significantly to warrant a serious investment. I don't need a specific PPS target on a calendar date. I need to know the business model makes sense and the probability for executing on the plan is high.
Best of luck with your investments!
I took a closer look, I really like the structure you put together. I may play with slightly different numbers on my free time. You put together a really nice and clear model.
Thanks so much!
Best of luck with your investments!
Hello HyperPhoenix,
Thank you for clarifying the basis for the hypothesis, that makes sense.
Très cordialement,
H2R
Best of luck with your investments!
Hello HyperPhoenix,
Thank you for putting together this work sheet, very appreciated.
The assumptions are taken from the XL :
OTLK hitting again a planned date, here ahead of time.
This Company has a great track record of executing along announced planned dates and hitting those dates.
During the June 18th presentation, Russ Trenary said they could have a decision from the UK in the next 30 to 60 days. It took even less time.
Best of luck with your investments!
ONS-5010 v. "risk of rare but potentially devastating endophthalmitis" of compounds
Thanks for highlighting this paragraph OGBritBox!
The full sentence from King's College London to be read in light of the legal aspects of approved ONS-5010 v. un-approved Bevacizumab:
" Additionally, a well-controlled pharmaceutical manufacturing operation will allay concerns that compounding pharmacies increase the risk of rare but potentially devastating endophthalmitis."
Who wants to be liable for potential damage to the eye when compound should not be used after approval from a legal standpoint?
Best of luck with your investments!
UK Approval PR
UK MHRA Marketing Authorization of LYTENAVA™
That's one news I was hoping for !
Thanks Thermo,
Consistent information from BTIG, the Company keeps executing on a clear plan, and additional information (for me anyways) around Compound Pharmacies, starting with
Hi Tex18,
Best is to listen to the latest presentation, available from here:
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
For your question, start around minute 17 . In summary:
* Labeling
* Production ramp up / supply
* Pricing / Government discussions
* Access to payers / insurances / country by country
They might be able to start during the holiday period (might), but they prefer not to launch during that time.
Best of luck with your investments!
Aspirational revenue of $2.5B
The following is a simple back of the envelope estimate of aspirational revenue and MC.
Russ Trenary clearly stated the market OTLK is after all current off-label bevacizumab injections in the EU and the US. He provided the following numbers.
* 3.5M injections in the US
* 2.8M injections in the EU
He also gave us a few clues on the pricing over a few presentations
My guess is that it will end up around
* $500 in the US
* $300 in the EU
So the top possible revenue (in a few years, after FDA approval, etc.) would be:
* 300 * 2.8M for the EU = $0.84B
* 500 * 3.5M for the US = $1.75B
=====
* Total Possible Revenue: $2.59B
Norse 8 Current Planning:
* Full enrollment Q3 2024
* Topline Q4 2024
Last month, enrollment was at 30%, so on track.
Russ Trenary during the June 18th investor presentation!
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
UK: in the next month or 2
Could have a decision from the UK on ONS-5010 in the next 30-60 days
Russ Trenary during the June 18th investor presentation!
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
"Ringing the cash register in Europe in 2025" [Russ Trenary during the June 18th investor presentation]
Q1 2025: launch in high pricing countries to set the tone on pricing for other countries, then expand to more EU countries throughout 2025.
OTLK is targeting the entire current Avastin injections, so about 3 million / year in EU and about the same in the US. That's the goal; I had not heard it this clearly thus far.
Payors in the US are looking at the overall cost when starting with off-label and switching to high priced treatments and compare it with ONS-5010 is patients stay on it. That's of interest to payors.
https://ir.outlooktherapeutics.com/news-and-events/event-calendar
And now 60 recruiting sites (out of 60 planned!)
The latest (last?) one is Oakland, California, United States, 94611
The investor's presentation, slide 18, indicates OTLK was planning on 60 recruiting sites:
Wondering if Bill Gates recent interview on CBS Face the Nation, talking about Natrium and TerraPower gave a bit of a boost to SMR. Retail investors can't invest in TerraPower but can in SMR. Gates was pretty articulate and highlighted the renewed bi-partisan interest in Nuclear. Looking at SMR more closely would make sense for those folks looking at energy policies and nuclear in particular.
Best of luck with your investments!
Senti Flipper, could this study be one of them?
https://clinicaltrials.gov/study/NCT04348747
* Phase 2
* Checkpoint Inhibitor ( Pembrolizumab / Keytruda)
* Biological: Anti-HER2/HER3 Dendritic Cell Vaccine
* Principal Investigator:Shipra Gandhi,Roswell Park Cancer Institute
?
Best of luck to Patients, NWBO, and Longs!
June 13, 2924 Seeking Alpha Article
Conclusion:
June 18th webcast