Outlook Therapeutics Inc (OTLK)

[pfelgueiras]

Outlook Therapeutics to Present at H.C. Wainwright 23rd Annual Global Investment Conference
ISELIN, N.J., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company?working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab?for use in retinal?indications, today announced that C. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, will participate in a fireside chat during the virtual H.C. Wainwright 23rd Annual Global Investment Conference being held September 13 – 15, 2021.

In addition to the fireside chat, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information about the conference, please visit the conference website.

A video webcast of the fireside chat will be available for viewing on-demand beginning Monday, September 13, 2021 at 7:00 AM ET for those registered for the event and accessible on the Events page in the Investors section of the Outlook Therapeutics website (outlooktherapeutics.com) for 90 days.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-present-hc-wainwright-23rd-annual-global

[pfelgueiras]

OTLK - Corporate Presentation - September 2021 with very good news
https://ir.outlooktherapeutics.com/static-files/9844808b-f00c-49f6-8606-8d1ea9bbf2f2

[pfelgueiras]

August 31, 2021 ; OTLK is still have a continues Uptrend since 9 Trading days
On Tuesday August 31, 2021 OTLK have another day with good volume.
Today above 2M, volume was 2.172.300 shares.
OTLK continue with a BUY pressure by Institutional who are buy more shares and also NEW Institutional start buying OTLK Shares.
OTLK with higher highs and higher lows in this upward trend.
OTLK are in a continues Uptrend since 9 trading days (from August 19, 2021 +30,2%).
Buy and STRONG HOLD, for Bid Profits
I believe September will be a great month for OTLK, ...with a great Uptrend.

[pfelgueiras]

We are at the end of the month. Let's squeeze the shorts at $OTLK!

[johnreiner]

Good stuff Thermo!

[thermo]

Cost containment is a big healthcare theme. ONS-5010 / LYTENAVA™ is part of the solution, in my view. Yes, it will cost more than off label bevacizumab but the majority of anti-vegf costs come from branded products, not off-label. So, overall, the introduction of LYTENAVA is cost containment positive.

I also think the OTLK is developing a pricing / reimbursement strategy that will pay docs more than what they receive with off-label bevacizumab.

As part of its pricing strategy, OTLK hired a consulting firm to survey insurance providers and determine price sensitivity. The results were very positive and indicate insurance providers will be very supportive with their reimbursement policies.

Last point, once a pre-filled syringe is available, the convenience benefit will make LYTENAVA compelling to the docs.

[H2R]

August Investor Presentation


https://ir.outlooktherapeutics.com/static-files/046a3f66-c668-4bc3-a7c1-916236655b42

Good info. I like this slide in particular:



Best of luck with your investments!

[spartex]

From Paul on yahoo "otlk" stock board:

$19.7M cash at the end of June. Burning through cash at rate of $3.3M per month. Approx $4.5M needed for BLA (avg from FDA site). They added $4.5M with the shelf share issued today. They still need more cash and soon.

[H2R]

Thanks thermo!

Kind regards

[H2R]

Hi thermo,

On another ticker, how does my post fit in with you own view?

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=165482823

Thanks for any insight you may want/be able to share.

Kind regards

[spartex]

Something in the 10-Q that the OTLK market doesn't like today?

Fact that they still need to raise some $$$ before end of year?

Thanks

[pfelgueiras]

OTLK - FORM 10-Q Sec Filling For the quarterly period ended June 30, 2021

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021

https://ir.outlooktherapeutics.com/static-files/ab338a3d-dd0e-43a6-bcdb-2613aa09432a

[pfelgueiras]

OTLK - Outlook Therapeutics Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Corporate Update.
RESULTS:
3 Months ended June 30: 2021
Consensus EPS Forecast $(0.08) ; Real (0.07)
("BETTER" Results Than Consensus Forecast)

CORPORATE UPDATE:
Reported positive, statistically significant top-line efficacy and safety data from pivotal Phase 3 NORSE TWO trial of ONS-5010 / LYTENAVA ™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD)
On track to submit new U.S. BLA for ONS-5010 in the first quarter of calendar 2022 and pre-commercial launch planning underway.

Commented Mr. C. Russell Trenary III, President and Chief Executive Officer of Outlook Therapeutics.
“... we possess positive, statistically significant results to support our plans to submit a BLA for ONS-5010 in the first calendar quarter of 2022.
.... is a tremendous amount of opportunity ahead for OTLK
...and the potential of ONS-5010, have continued to reinforce my confidence in our position as an up-and-coming leader in the retina space. We are dedicated to building momentum, shareholder value.
…. We are dedicated to building momentum, shareholder value, and ultimately potentially bringing the first FDA-approved ophthalmic formulation of bevacizumab to the retina community,”

[spartex]

Ok, thanks for your info/thoughts!

[johnreiner]

They approved and registered more shares at the annual meeting a few months back… The pre market data news followed by conference call set up the stock for a nice run! I believe they sold into that run with around 120 million in volume! Technically they don’t have to report it to the quarterly, but I would suspect that a PR is coming soon!

[spartex]

Does OTLK have an open "shelf" that they can sell into the market or to funds?

[johnreiner]

I’m still going with my theory that they sold 30 to 40 million shares on day of PR for phase 3 data! Stay tuned…….

[spartex]

that link says "it doesn't exist anymore". Been recalled? lol

[H2R]

Sounds like they'll need to raise funds before EoY:

At June 30, 2021, Outlook Therapeutics had cash and cash equivalents of $19.7 million. Outlook Therapeutics’ cash and cash equivalents on hand are sufficient to fund planned operations through December 2021.

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

This may actually be a good buying opportunity. I've seen lots of raises initially push the PPS down, only to move back up within a few days.

Given the state of the company (post TLD, de-risked), they should be able to raise funds on fairly good terms.

Best of luck with your investments.

[H2R]

Q3 PR: Pre-commercialization Planning Underway

Pre-commercialization Planning Underway

In anticipation of potential FDA marketing approval in 2022 for ONS-5010, Outlook Therapeutics has begun commercial launch planning activities, including manufacturing with drug substance manufacturer FUJIFILM Diosynth Biotechnologies and best-in-class drug product manufacturer Aji Biopharma Services, along with distribution, sales force planning, physician and payor advisory board outreach, key opinion leader support and payor community engagement. To bring ONS-5010 to market in a way that benefits all stakeholders – clinicians, patients and payors – Outlook Therapeutics has already commenced collaborative discussions with payors and the retina community. Outlook Therapeutics expects ONS-5010, if approved, to be a safe and cost-effective choice for patients, payors and clinicians worldwide for retinal indications.

Outlook Therapeutics is also developing registration documents on a parallel path for approvals in Europe and expects to submit them shortly after completing the submission to the FDA in the United States. Outlook Therapeutics continues to explore potential strategic commercialization partners, such as the existing Syntone Biopharma joint venture in China.

In addition to the clinical development program evaluating ONS-5010 for wet AMD, Outlook Therapeutics has received agreements from the FDA on three Special Protocol Assessments (SPAs) for three additional registration clinical trials. These SPAs cover the protocols for a planned registration clinical trial evaluating ONS-5010 to treat branch retinal vein occlusion (BRVO, NORSE FOUR), and two planned registration clinical trials evaluating the drug candidate for the treatment of diabetic macular edema (DME, NORSE FIVE and NORSE SIX).

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

[johnreiner]

New OTLK Tweet! https://twitter.com/outlooktx/status/1425449489171636233?s=21

[pfelgueiras]

Outlook Therapeutics to Participate at the H.C. Wainwright Ophthalmology Virtual Conference
Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, to participate in The Greatest Unmet Needs Facing Ophthalmology Today panel on Tuesday, August 17th at 9:00 AM ET

As part of the event, Mr. Trenary will participate in the panel, hosted by Matthew Caufield, Equity Research Analyst at H.C. Wainwright, The Greatest Unmet Needs Facing Ophthalmology Today. To register for the event.

https://ir.outlooktherapeutics.com/node/9581/pdf

[pfelgueiras]

Is Outlook Therapeutics (OTLK) Stock About To Start To Soar?
By Amsden Lindsay August 10, 2021, 10:01 AM (on InvestReader)

Outlook Therapeutics (NASDAQ: OTLK) stock has been running between $2 and $3 for most of this year. Last Tuesday, the company released a very important update, which pushed its stock to hit the $3 level again. So, is this stock about to start to soar?

Outlook Therapeutics is a biotech company that develops and commercializes various products for the healthcare market. ONS-5010 is the important one in its products, which is in Phase 3 clinical trial to treat retina diseases. The company reported positive efficacy and safety data from its Phase 3 NORSE TWO trial of ONS-5010. In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary and key secondary efficacy endpoints, and ONS-5010 was safe and well tolerated.

The company said that if ONS-5010 is successful, it will plan to submit for regulatory approval of ONS-5010 in multiple markets. Currently, there is currently no bevacizumab approved for ophthalmic indications in the United States. Globally, the nine major markets account for an estimated $13.1 billion market for anti-VEGF drugs to treat retina diseases. Anyway, that is the long-term potential of positive news surrounding this drug or trial. Therefore, OTLK stock is worth adding to your watchlist.

[pfelgueiras]

OTLK - Corporate Presentation - August 10, 2021
Very good news on Today OTLK Corporate Presentation

https://ir.outlooktherapeutics.com/static-files/046a3f66-c668-4bc3-a7c1-916236655b42

[H2R]

Trying to return the favor, I've been invested in CYRX for a few years now (Got my shares at around $10 on average). I believe it is a growth story.

In case you might want to check it out. (I did write a couple of posts on IHub).

I do not have your background, so it may not be as good a tip as yours for OTLK, then at $1 :)

Best of luck with your investments!

[thermo]

My attempt at humor :)

[H2R]

Funny thermo,

If I bought more, I don't think it would really even register on the graph. My investment level is orders of magnitude below yours :))

Thanks again for sharing your thoughts, I for one really appreciate it!

[CapHillGuy]

$OTLK is delighted to report that NORSE TWO met its primary endpoint with highly statistically significant and clinically relevant data. We look forward to bringing ONS-5010 ophthalmic bevacizumab to the @US_FDA as a BLA for #wetAMD. Read more: https://t.co/YGCuCA6OcO $OTLK pic.twitter.com/bmyzaTVyIW

— Outlook Therapeutics (@OutlookTx) August 9, 2021

[CapHillGuy]

https://www.tipranks.com/news/article/outlook-therapeutic-stock-set-to-see-big-gains-says-analyst/

[johnreiner]

New OTLK Tweet!

https://twitter.com/outlooktx/status/1424755876657782796?s=21

[thermo]

Analyst increases price target:

https://www.tipranks.com/news/article/outlook-therapeutic-stock-set-to-see-big-gains-says-analyst/

What I find interesting is that Tsao (HCW analyst) gets to a $6 target with only an 80% probability of FDA approval. I was at 80% before the latest data release. So, a crude estimate of a target price with approval would be $6/0.8 => $7.5.

I see even more upside once the market understands (a) pre filled syringe packaging will make this a big product (b) the market is so big that it's easy to get to $1B in revs even with Eyelea coming off patent, (c) only a moderate sized sales force is needed to market, (d) they will probably never get to build a sales force because companies that already have ophthalmic sales forces will find this too compelling.

But, I may want to buy more, so PLEASE DON'T BUY OTLK.

[thermo]

thx John

[johnreiner]

New OTLK Tweet!

Thank you to all the patients and physicians who participated in our Phase 3 NORSE TWO trial of ONS-5010 ophthalmic bevacizumab for treatment of #wetAMD. Outlook Therapeutics is excited to report positive safety and efficacy data in the trial. https://t.co/PSQTkM1RgX pic.twitter.com/8Hq1TBV4MI

— Outlook Therapeutics (@OutlookTx) August 6, 2021

[thermo]

Good work, Sherlock

[gregsimac]

AAR Award and Arjay miller scholar, nuff said. You have helped me so thanks for all your honest thoughtful posts, keep them coming.

[goforthebet]

would be nice to stay around 2.50 as a new bottom before it goes higher :)

[H2R]

After the pullback yesterday, the market is digesting the news.

Really liking this stock. Got in at $1 thanks to Thermo, and keeps liking it!

[goforthebet]

interesting BIO and impressed about your spending. I find that amazing and would hope more people would be the same.

btw. I am happy about my buys at 2.11-2.19 today :)

[johnreiner]

Quite impressive , I’ll be following you for sure! I own a transport company and mostly used educated guessing on investments with a bunch of DD. Thanks for the response and information on OTLK…. Best of luck! JR

[whosleftholdindabag]

Thermal, I picked up 250k shares, thank you. GLTA

[thermo]

My background is a BS in engineering, then a Stanford MBA, then worked for 3 hedge funds, one was life science focused.

Then founded my own set of funds, which included the following strategies: fundamental long-short, quantitative long-short, and venture capital. I also structure a lot of investments into private and public companies. The anchor tenant for my fund is often mentioned when people are talking about top global hedge funds. HBO (or some network) made a TV series that, supposedly, was partially based on his fund. I couldn't watch much of it though...too much Hollywood b-s.

As my kids got older, I realized I was spending too much time thinking about things that don't matter, so I gave back most investor money (about $3.5B at its peak). I still have my funds but the money is mostly mine, together a few friends that asked to stay. When I have a good idea, I call my hedge fund friends.

Some of what's written on these boards bewilders me but I occasionally publish in hopes that it may help others a bit.

[sukus]

Just bought a little today. Thanks.

[johnreiner]

Thank you for your very logical opinion on finance and dilution , much appreciated! If you don’t mind me asking , what is your background ? Tia JR

[johnreiner]

I believe warrants are 7 to 1 , stay away! Common stock is the play here!

[goforthebet]

thank you thermo for the very informative post.

[thermo]

Here’s how I think about dilution:

First, it’s inevitable. Growth companies need cash, and they issue securities to get it. If they sell securities below fair value, that’s the proper definition of dilution and it’s an unfortunate reality of investing in growth.

Always adjust for the cash needed to execute a business plan. It’s really a liability, so add the current enterprise value to the required cash and think of that as the ‘real’ enterprise value.

Compare your future expected enterprise value to the current ‘real’ enterprise value and decide if the upside is worth the risk. In the cash of OTLK, I think the answer is obvious since clinical trial risk is basically gone.

There are different ways OTLK can raise money.

(a) A discounted placement. This is the worst choice, because the stock would get hit the morning of the announcement and it would feel bad. I invest in private placements a lot and many times the stock will fall about 10% - 20% down to the deal price. In the long run, it won’t matter much, but who wants to ruin an otherwise good day.

(b) Use their equity line. They have one in place. They can issue sell orders under their existing equity and if they sell about 5% - 10% of the market volume, investors will hardly notice. The stock will face a slight headwind, but no one will have a bad day.

(c) Issue debt and then pay the debt off using their equity line. There are some investors that will buy debt in companies like OTLK. It will cost the company about 15% - 20% annualized. It’s expensive debt but if the company thinks their stock should be $4, then they can issue debt now and tap their equity line when the stock is around $4. The debt doesn’t represent a big risk since they won’t default with the equity line in place. This is the best option, though a little complicated. I made this suggestion to management.

[Flooppy]

Why are the warrants so cheap? And declined so much in the last six months?

[goforthebet]

huge ask... Is there any dilution going on or just scare tactics..

[whosleftholdindabag]

Thank you for the very detailed response! GLTA

[johnreiner]

I’m sharing this! Great stuff….Best of luck!