Outlook Therapeutics Inc (OTLK)

[OGBritbox]

Wow, thanks for that! This gives me more confidence than ever. I am doubling down my investment once again as we speak !

[thermo]

Internally we've been at $500M - 750M peak sales.

500M x 4x => 2,000M Enterprise Value / 850M shrs => $2.35 / shr. Given it's a one product company with a finite exclusivity period, we will do a DCF when we have time and refine the revenue multiple. For now, whether it's 3x, 4x, ... it doesn't matter.

Guggenheim analyst -- who put a lot of time into his research -- has:
3.5M off-label Avastin injections per year, which is in line with our proprietary retina market model. Conservatively, we think the company will be able to convert ~1/3 of these patients to branded Lytenava for ~1M injections per year. Assuming a WAC price of $500 per injection and a GTN of 20% (in-line with similar products) we estimate peak sales of $560MM

BTIG:
~70% of retinal specialists use compounded bevacizumab as a 1L regimen for their wAMD patients before proceeding to other Tx options. This is largely owed to its attractive price point compared to other anti-VEGF therapies (~$55-$75 per injection vs. ~$2,000 for Eylea and Lucentis vs. ~$1,200 for biosimilar Lucentis) and well-established non-inferior efficacy vs. Lucentis. There are estimated to be over 740k wAMD patients in the US currently pursuing Tx, so the utilization of compounded bevacizumab is substantial despite the disadvantages of the treatment option (discussed further below).

[Mfgaumond]

Hi Thermo,

Thank you for this post and all your insight. I love your feedback and learning from you. Any more information you can give us into peak revenues and where you think the price of this stock could fall via commercialization or a buyout at this point in time compared to before?

[thermo]

I meant peak revenues, not peak returns.

- To forecast stock returns, we forecast peak revenues, multiply by not too high a multiple (since this is a one -- not first in line -- product company), and then divide by 750M - 850M shares. This value is a lot lower than it used to be (due to the share count) but still a lot higher than it is now.

[thermo]

I paid $0.35 (or lower if the stock drops...but it doesn't look that it will) for common plus warrants (with a strike 10% above the purchase price). The warrants are callable, so the company can raise a significant amount of additional capital from the warrants.

I was referring to Kurt J Hilzinger.

[OGBritbox]

So, how much did you pay per share in the private placement? And when you said "Another well-known board member bought significant stock in the open market above $1.00.", were you referring to Helzinger, or Hope?

[thermo]

What I've written in the past fairly captures my views. I don't try to promote my stocks. I try to be honest. I don't care if others buy, sell, or short my companies.

- Company management had a serious lapse of judgment in mis-designing their trials historically. They claim they were given informal support (not an SPA) from the FDA in 2018 but the 2023 FDA determined they did not provide adequate support for approval. They lost many people a lot of money including their biggest shareholder, who has a board presence. Another well-known board member bought significant stock in the open market above $1.00. So, clearly the people best positioned to judge, misjudged. It happens.

- I discussed this trial design concern with them historically and I accepted their explanation about feedback they received in 2018. That was a serious lapse of judgement on my part. Most retail investors would be surprised to know how often professional investors make mistakes. I've made lots of mistakes yet have become quite well off. We don't have perfect foresight, but we do know how to manage risk.

- The company now has an SPA, so the odds of approval are high. There's never been much debate regarding the efficacy and safety of the drug.

- Shortly, the debate will shift to what market share the company will achieve upon commercial launch. Longer lasting treatments are better, but insurance companies still utilize step-edit programs to hold down claim costs. These longer lasting treatments could push down pricing of biosimilars, which could pressure OTLK. Can I precisely predict all these effects? No. But I know what to look for and I know that OTLK doesn't need too much share of the total market to achieve meaningful revenue.

- After the recent raise, there are a lot of shares outstanding. About 750M. If you look up the share count from various sources, you'll see a much lower number but those are lagging. We go through the existing placement agreement and the note amendment and model out what the future share count will likely be.

- To forecast stock returns, we forecast peak returns, multiply by not too high a multiple (since this is a one -- not first in line -- product company), and then divide by 750M - 850M shares. This value is a lot lower than it used to be (due to the share count) but still a lot higher than it is now.

- So, even though I 've lost a good amount of money, I'm probably going to make a good amount of money before the fat lady sings. Unless, of course, she falls on me first.

[thermo]

I did lower my cost. I'm one of the participants in the private placement.

[glenn1919]

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

[H2R]

This company tells us what they plan, the expected dates, and they keep executing. The communication is clear and to the point. It's in their DNA, they have been practicing this under Russ T.

I like this type of leadership and how shareholders are informed.

Best of luck with your investments!

[H2R]

Russ Trenary on the progress since the CRL:

We are proud of the recent progress our team has made. In January 2024, we received confirmation that the FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA they approved. We also reached agreement 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 address fully the clinical deficiency identified in the CRL. Importantly, the first subject was enrolled in NORSE EIGHT in January 2024,” commented Russell Trenary, President and Chief Executive Officer. “In addition, through a Type A meeting and additional interactions, we have identified the approaches needed to resolve the CMC comments in the CRL. We are working to address the open items and expect to resolve these comments prior to the expected completion of NORSE EIGHT. Finally, we have entered into purchase agreements for a financing of up to $172 million, subject to shareholder approval, to support our regulatory efforts and launch preparations.

Best of luck with your investments!

[H2R]

Updated Anticipated Milestones

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-first-quarter-0

Upcoming Anticipated Milestones

* Closing of private placement financing in March 2024, subject to receipt of stockholder approval and other closing conditions;

* MAA decision date in the EU for ONS-5010 targeted for first half of 2024;

* Completion of NORSE EIGHT in the United States anticipated in 2024; and

* Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.

Best of luck with your investments!

[Pula]

Well then these investors are idiots to give more money to trenary. Moron sat for 2 years doing nothing except giving the same powerpoint lecture around the country on hawaii and ski trips. Had years to do a 2nd adequate trial. Couldnt even ensure "best in class" manufactering went smoothly. Wth does dagnon and evanson do all day long? Cencora? Give me a break. Without an apporoved product who cares. Ema rejection on deck. The fool shouldve pulled ema application until fda concerns were addressed. How do you explain post reverse split+dilution with ema rejection to follow? You going to short this down to 1 after the split? I will. Anyone with a brain should. This c suite is incompetent. How he got ppl to give him more money to drive this into the ground is beyond me. Didnt you hear/read/see the new york academic opthalomologist that is going to lobby the fda to still allow compounding even if lytenava gets approved? Opthalomolgists want to use faricimab and high dose eylea anyway. He still hasnt said when and how hes paying for dme brvo indications. This is a giant train wreck. Thermo....just put your money in the paper shredder instead and recycle.

[Mfgaumond]

I’m actually curious on your thoughts about everything going on? I know you’ve been very vocal in the past and provide good feedback. I’m newer to investing and everyone keeps saying this news is extremely disappointing with the reverse split/private placements etc. Any feedback on this for me to learn better in the market and how it affects every day investors?

How are you feeling with the path to success and potential outcome now? I would assume with some big investors coming in that they know it will surely be successful…

[OGBritbox]

You said that after the CRL you lost a substantial amount of money, did you sell your position? I’m curious, as someone that believes there is a clear path to success, why you wouldn’t use the opportunity to lower your cost average instead of selling.

[thermo]

I wouldn't say that. I just know there was a lot of demand and the participants in the transaction are mostly investors, not traders.

[H2R]

Second Recuiting Site: Utah / Salt Lake City

On Feb. 5th, the clinical trial site was updated to indicate a second trial site in "Salt Lake City, Utah, United States, 84107"

Before that, one site was indicated in "Dallas, Texas, United States, 75231"

That's 2 sites that came up online pretty quickly given the January 23 SPA announcement and the first subject only one week ago! OTLK does not lose time.

For comparison,
* Norse 7 had 3 sites
* Norse 3 had 20 sites
* Norse 2 had 39 sites.

"The NORSE TWO Phase 3 pivotal trial enrolled a total of 228 wet AMD patients at 39 clinical trial sites in the United States. "
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license

So I expect a lot more sites to come online for this study, but I don't know how many to expect. OTLK does forge ahead and I would not be surprised if that number keeps on moving up for the next couple of months. They keep executing!

Best of luck with your investments!

[OGBritbox]

Would you agree they structured the private placement the way they did to incentivize all the hedge funds to push up the price.

[H2R]

First Subject in NORSE EIGHT

After the SPA, after the clinical trial publishing on clinicaltrials.org, after the change of status to recruiting, this step indicates the continued progress of the Company towards their goal.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-doses-first-subject-norse-eight

NORSE EIGHT clinical trial is being conducted under Special Protocol Assessment (SPA) from FDA to support expected resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024, if successful

ISELIN, N.J., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that the first subject has been dosed in the NORSE EIGHT clinical trial evaluating ONS-5010 in neovascular age-related macular degeneration (wet AMD) patients.

The NORSE EIGHT study is a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 treatment naive, 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 will be mean change in Best Corrected Visual Acuity (BCVA) from baseline to Week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

“We are pleased with the continued progress of our ONS-5010 development pathway forward. The start of patient enrollment in NORSE EIGHT represents an important step toward potential FDA approval and launch of ONS-5010. Our team remains focused on the successful execution of the study,” commented Russell Trenary, President and Chief Executive Officer.

Earlier this month, Outlook Therapeutics announced that it received written agreement from the FDA under an SPA for NORSE EIGHT. The FDA has reviewed and agreed upon the NORSE EIGHT trial protocol pursuant to the SPA. If the NORSE EIGHT trial is successful, it would satisfy the FDA’s requirement for a second adequate and well-controlled clinical trial to address fully the clinical deficiency identified in the Complete Response Letter (CRL). In addition, through a Type A meeting and additional interactions, Outlook Therapeutics has identified the approaches needed to resolve the Chemistry, Manufacturing and Controls (CMC) comments in the CRL. Outlook Therapeutics is working to address the open 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!

[H2R]

Now recruiting, Study Completion Expected Oct.



https://classic.clinicaltrials.gov/ct2/history/NCT06190093?B=2&A=1&C=merged#StudyPageTop

Best of luck with your investments!

[glenn1919]

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

[exwannabe]

The SPA is good news (did expect it, but sometimes can drag out),

Norse 8 is a non-inferiority study,. What that means is that they do not have to prove to be better than the ranibizumab, just as good as it. That is very reasonable from a common sense point, but has a tricky stat issue,

There is no such concept as "as good as" in clinical trial stats. Either one is better or not. But we all need the real world concept, so how to fix this?

The trial stat guys came up with a concept of a NI margin. Basically OTLK will be spotted a letter or 2 (do not know the details) and with that must prove to be better. This sounds a bit contorted, but there is no easy way to solve the conundrum

Now back to the FDA.. Obviously if the sponsor just says they want their drug to be spotted some advantage, the FDA may push back. And that is why getting the SPA for a NI trial really matters. The FDA has agreed that whatever NI margin is, is OK by them.

As far as executing the trial, That should be a given. There is ton of data here, we are not talking unknowns.

[Pula]

If they rs this, it will get shorted down to oblivion again like every other pre revenue microcap bio (including those that did get fda approval). Shorted to 1 or less post rs eapecially if they get ema rejection after rs (which they will bc they havent acknowledged solving cmc and i see no reason ema would approve without norse 8 resulrs) This plan is idiotic. I have no idea who is advising these funds to invest. I have no idea why syntone and the jordanians are dumping more in and why they still trust trenary after all the f ups. The fool says things like the bla was "a loveletter to the fda" and goes on twitter to say there will be "a new sheriff in town on august 29th". They have to pay streeter 3 mil per quarter startintlg next quarter which will burn thru this new capital quickly on top of normal cash burn. I can easily seeing this diluted to hundreds of millions of shares again post rs just to keep up w the burn.

I guess they had no other option. There is no "buyer". Whoever is going to start w this nonsense again dont even bother.

I think back to when trenary pulled the bla and still hasnt told us why. At that point it dropped to 67 cents and sling shotted back to 1.20 within a few days. Whoever did that...if they believe in otlk so much....why arent they doing it again now before theres this absurd rs, dilution, extremely toxic debt.

[H2R]

Clinical Trials Site for Norse 8:

https://clinicaltrials.gov/study/NCT06190093?term=norse%20eight&checkSpell=false&rank=1

Not recruiting yet. A good site to check from to to time and see the progress.

Best of luck with your investments!

[muee88]

Thank you, H2R!

[H2R]

NORSE EIGHT :

will be a randomized, controlled, parallel-group, masked, non-inferiority study of approximately 400 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 will be mean change in BCVA from baseline to week 8. Outlook Therapeutics expects NORSE EIGHT topline results and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Best of luck with your investments

[H2R]

The FDA SPA agreement is in!

I keep being impressed with management clarity on planning, deadlines, and execution!

Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces Private Placement of Up to $172 Million to Advance ONS-501

* Obtained clarity from U.S. Food and Drug Administration (FDA) on next steps to advance ONS-5010

* NORSE EIGHT expected to commence in the first quarter of CY2024, enabling potential resubmission of the ONS-5010 Biologics License Application (BLA) by the end of CY2024

* Private placements to top tier institutional investors and insiders include up to $65 million in common stock and up to an additional $107 million upon cash exercise of warrants, subject to closing conditions

*Aggregate financing, subject to achievement of milestones, is expected to be sufficient to take ONS-5010 through potential FDA approval and fund commercial launch

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-receives-fda-agreement-under-special

Best of luck with your investments.

[thermo]

There will be a shareholder vote.

1. approve the shares to be issued in the transaction (since more than 20% are being issue).
2. give the board the ability to enact a reverse to stay on NASDAQ.

The price of the issued shares is the lower of (a) $0.35 and (b) the average price leading up to the shareholder vote. So, if investors focus on the reverse, maybe we can see weakness and "b" above will apply. But this deal brought in a lot of new institutions, and I think most of them don't have a full position. So, this may be one of those rare circumstances where a reverse doesn't hurt the stock.

[evanstony]

The demand for the deal was very strong, demand more than 2x greater than supply. Many institutional investors got zero. Others were cut back 50% - 75% (including me).

Thank you for the update...That indicates to me some very strong inside support... bought a bunch more after the price dropped to the floor.. what are your thoughts about EU approval(s)?? And the less than $1 problem coming up in April??

[thermo]

We now have a clear path to FDA approval.

SPA => short trial => data about Oct 24 => filing Dec 24 / Jan 25 => approval summer/fall 25.

The demand for the deal was very strong, demand more than 2x greater than supply. Many institutional investors got zero. Others were cut back 50% - 75% (including me).

[carp77]

At the rate this stock is dropping you should be able to buy 4 shares for a $1 in February

[H2R]

2024 OTLK Anticipated Milestones

FDA response on NORSE EIGHT Special Protocol Assessment (SPA) in early February 2024;

Commencement of NORSE EIGHT expected in first calendar quarter of 2024;

MAA decision date in the EU for ONS-5010 expected targeted for first half of 2024;

Completion of NORSE EIGHT in the U.S. anticipated in 2024; and

Resubmission of the ONS-5010 BLA expected by the end of calendar year 2024.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-fiscal-year-2023

Best of luck with your investments!

[OGBritbox]

I’m betting we are over $1 by February, with SPA granted, FDA approval is almost guaranteed. EU approval will come soon after, (and most likely will with consideration to the FDA response to the BLA (“proven safe and effective meeting primary endpoint's”, and given SPA on a very short 3 month study for approval) will launch this way past $2. I’ve doubled my position since the CRL, putting my money where my mouth is.

[H2R]

Norse 8: 3-month study, primary endpoint at 2 months. n=400

Now let's see when the FDA approves the SPA. Then it's off to the races for Norse 8.

Best of luck with your investments!

[H2R]

US BLA expected by the end of 2024!

Best of luck with your investments!

[H2R]

Planning to start NORSE EIGHT in Q1 2024

Best of luck with your investments!

[H2R]

SPA Protocol Submitted!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-submits-special-protocol-assessment-spa

ISELIN, N.J., Dec. 19, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that, following receipt of written confirmation of the NORSE EIGHT proposed clinical trial protocol with the U.S. Food and Drug Administration (FDA), Outlook Therapeutics has submitted a Special Protocol Assessment (SPA) request for the required additional adequate and well-controlled study of ONS-5010.

As previously announced, following the Type A meeting with the FDA held in October 2023, the FDA informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary efficacy endpoint at 2 months. Subsequently, as discussed with and recommended by the FDA, Outlook Therapeutics submitted a clinical trial protocol and requested a Type A meeting with the FDA for feedback. The FDA has since provided written feedback on the protocol, which Outlook Therapeutics has incorporated. The revised protocol is the subject of the SPA request, in which Outlook Therapeutics is seeking further confirmation from the FDA that NORSE EIGHT, if successful, addresses the FDA’s requirement for a second adequate and well-controlled clinical trial to support the resubmission of the ONS-5010 BLA for wet AMD. The FDA is expected to provide a response to the SPA in early February 2024.

NORSE EIGHT will be a randomized, controlled, parallel-group, masked study of neovascular age-related macular degeneration 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. Approximately 400 patients are expected to be enrolled in the study.

Outlook Therapeutics expects to resubmit the ONS-5010 BLA by the end of calendar year 2024 to include the results of NORSE EIGHT and the additional CMC work to address the issues identified by FDA in the Complete Response Letter issued in August 2023 to support approval.

“We have been working closely with FDA to meet the remaining requirements provided by the Agency to support approval of ONS-5010. Based on our ongoing discussions with FDA, we believe we have agreement on a clinical trial protocol. With the SPA now submitted, we are preparing to start NORSE EIGHT in the first quarter of 2024,” commented Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics. “We remain dedicated in our pursuit to achieve U.S. FDA approval for the first ophthalmic formulation of bevacizumab and look forward to providing further updates.”

Best of luck with your investments!

[OGBritbox]

I think we could see in that they
"fund" 2024 by issuing stock at $1-$2, that will pull up the price, (like they did in Nov 2021 and Dec 2022)
Or Streeterville could convert at $2/share. That will also bring up the price, then the buyer would be the one buying it up. The stock price has to go up before a buyout is announce. Several ways they could do that. Issuing stock is just one.

[Mfgaumond]

Hey Thermo! How’s everything been? Anything going on behind the scenes you might be able to share with us? Wondering if they’ve reached out to you in regards to more funding. Hope all is well!

[H2R]

Looking at M&A more closely?

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-strategic-organizational

Effective immediately, Joel Prieve, formerly the Senior Vice President of Commercial Operations, has been appointed to the role of Senior Vice President of Licensing and M&A. In this role, he will be responsible for developing and executing the Company's strategy in the areas of licensing and partnerships, as well as evaluating and executing potential merger and acquisition opportunities.

Are there parties interested in acquiring OTLK??

Best of luck with your investments!

[glenn1919]

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

[H2R]

Resubmission on track for EoY 2024!

Resubmission of the ONS-5010 BLA on track for the end of calendar year 2024, pending final agreement on a clinical trial protocol with the FDA and successful completion of the required additional clinical trial

Planned clinical trial expected to be a 3-month non-inferiority study with 60 day efficacy endpoint

ISELIN, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023 regarding the Complete Response Letter (CRL) dated August 29, 2023 for the Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD.

As previously reported, the FDA requires an additional adequate and well-controlled study to support the ONS-5010 BLA. The FDA has informed Outlook Therapeutics that it can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months. As recommended by the FDA at the Type A meeting, Outlook Therapeutics has been working with the Division of Ophthalmology to design an appropriate study to satisfy the FDA’s requirements. The FDA and Outlook Therapeutics have also identified the approaches needed to resolve the CMC comments in the CRL.

“We are encouraged by the productive discussions we have had with the FDA regarding next steps for our ONS-5010 approval pathway. We continue to believe in the potential of ONS-5010 to address the need here in the United States, as well as globally, for an approved ophthalmic bevacizumab that meets FDA standards for the treatment of wet AMD,” commented Russell Trenary, President and CEO of Outlook Therapeutics.

Based on the October Type A meeting and ongoing informal discussions with the FDA, Outlook Therapeutics has submitted a protocol for review at an upcoming Type A meeting with the FDA in December 2023. Upon confirmation of the protocol details with the FDA, Outlook Therapeutics intends to submit a Special Protocol Assessment (SPA) to memorialize the agreement with the FDA on the trial design and confirm that, if successful, this additional study, in combination with the successful completion of the ongoing work related to the CMC requests in the CRL, would support approval of a resubmitted ONS-5010 BLA. Outlook Therapeutics continues to believe that the proposed clinical trial design as included in the Type A meeting request would allow for completion of the study in 2024 and resubmission of the ONS-5010 BLA by the end of calendar year 2024.

Given the circumstances, this is great news!

Best of luck with your investments!

[OGBritbox]

Today is the deadline to file form 13s, so far none have, which means no insiders or institutions have sold a single share since the CRL,

[OGBritbox]

Thank you !

[H2R]

Guggenheim Nov.7, 2023 Notes

https://guggenheim.metameetings.net/events/ini23/sessions/48835-outlook-therapeutics-inc-otlk/webcast?gpu_only=true&kiosk=true

The sound is better than during the live broadcast. My notes below

Q: Overview of OTLK
Russ: goes over the basics of ONS-5010
- Off-label Avastin, $100/injection; 'untoward things can happen during the packaging process'
- OTLK's goal is to have an FDA approval for ONS-5010 with strong standards
- 2 years of pricing research with both doctors and payors, "large swim lane"

- Norse II build upon past trial; successful Norse II on the endpoints; Safety and Efficacy
- Norse III open label

- PDUFA on Aug 29th: CRL
- FDA indicated some CMC: came up with new items which could have been asked way earlier via IR
- FDA wanted to see additional confirmatory evidence, additional clinical evidence
- OTLK set up a Type A meeting which happened a couple weeks ago
- OTLK made their case with all the pre trial and trial meetings with the FDA, OTLK thought they were on track
- Getting the CRL was a surprise, given the guidance, the meeting minutes, etc.
- FDA wants a second study. ("Everyone who got approved before had a second study" which I find bizarre)
- OTLK asked repeatedly what exactly the FDA wanted to cover
- OTLK waiting for the minutes of the meeting
- OTLK feels the verbal agreement from the FDA is well understood and can lead to an end of 2024 results to the FDA
- Instead of a Norse II duration, it's more like a one year duration
- Waiting for details so the new trial will match the FDA direction

Q: How many patients for the new trial
Russ: FDA does not require a number of patients but a p-value (the usual 0.05 value)
So new trial powered for p-value
A manageable number of patients to enroll in a couple of quarters

Q: Norse II FDA feedback?
Russ: Great feedback on the primary and secondary endpoints and p-values. "You met all your endpoints"
Showed superiority.
well controlled trial on the dosing

Q: "Norse IV" (?) SPA? (Note: One of the points I really wanted to hear about)
Russ: OTLK will do its utmost to get the FDA 'bound' to the new demands
Will talk to their attorneys on the benefits of an SPA
Do not want to go through a never ending cycle/delay
OTLK wants a written up FDA memorialization of the requirements

Q: Other information, on Avastin, other
Russ: "doctors were universally eager to help, be a part of the next study"
already have the biggest names in the US to participate in the next study
1. they liked the results of Norse II and during the next trial, their patients will get great care
2. they want this product

Q: Do you have your product ready to go (.. for the next trial)
Russ: (happy chuckle) "We do" OTLK had built some initial inventory; can be used in the next trial
AmerisourceBergen: "We love this product" "We are standing shoulder to shoulder" with OTLK
Brings in their network, payors, contracting, distribution, etc.
Enduring relationship

Q: 100-200 patients : funding needs
Russ: $100K/patients in a trial, so if 200, 300, 400 patients, that's 20, 30, 40 million.
Then about 2 million burn rate without trial, well controlled burn rate
So for an 18 months period, a combination of the number of patients + burn rate.

Q: pricing with regards to biosimilars, coming in a couple of years.
Russ: Ironically, pricing is going higher. Pricing study stands.
Still aiming for the same 'corridor'.
OTLK will be well positioned going forward pricing wise.
Payors, doctors; pricing research on point for OTLK

Q: Update before the end of the year?
Russ: hoping for that timeframe for an update and for certainty on what the FDA wants.

[thermo]

Not my base case expectation but it's possible.

[OGBritbox]

There is a lot of evidence to support the theory that AmerisourceBergen aka Cencora has been going through the process of acquiring them as a bolt on acquisition. If this is the case, they could very well announce after EU approval and assume the costs so as not to change the share structure. Thoughts ?

[thermo]

Launching a product takes some additional investment, so I don't think that will save them. The company will raise funds either through the sale of common stock or through the sale of a royalty, in my view.

1. Common stock. I think this is most likely. They will likely need to add some warrants to the mix.

2. Royalty. These take a portion of revenue until the investor receives some multiple of the initial investment. The more risk, the higher the multiple. I would guess 3x - 4x in this case.

[Mfgaumond]

I really appreciate the time and the effort you put into your posts/responses. Thank you for your feedback. A lot of people are optimistic about the European approval, but I heard most of the time if a drug isn’t approved in the US they will make the same decision over there. Curious your thoughts on that? Also, in regards to dilution I’m hoping they can somehow figure out an alternate option even though I feel it is inevitable (I know it also hurts them because most of their incentives are stock based).

[OGBritbox]

You didn’t mention European Union approval, which is expected around February. I would have to assume with approval in Europe, they then have a positive cash flow that could sustain them without diluting, and obviously that would also raise investor confidence that FDA approval would follow.