Outlook Therapeutics Inc (OTLK)

[goforthebet]

https://journalretinavitreous.biomedcentral.com/articles/10.1186/s40942-021-00343-3

[goforthebet]

Analysts Are Bullish on These Healthcare Stocks: Durect (DRRX), Outlook Therapeutics (OTLK)

https://www.tipranks.com/news/blurbs/analysts-are-bullish-on-these-healthcare-stocks-durect-drrx-outlook-therapeutics-otlk?utm_source=stck.pro&utm_medium=referral

[goforthebet]

COO and CCO both awarded 800,000 options at $1.44 with 10 year expiration. If you have shares at today's price, and you can hold as long as they can, they don't make money unless you do.

https://newsfilter.io/a/eb45e430dcb398e035620a727ffbaf1f

[goforthebet]

https://www.chartmill.com/news/OTLK/globenews-2021-12-22-outlook-therapeutics-reports-financial-results-for-fiscal-year-2021-and-provides-corporate-update?utm_source=stocktwits&utm_medium=pressRelease&utm_content=OTLK&utm_campaign=social_tracking

[goforthebet]

Outlook Therapeutics to Present Pivotal Data from NORSE TWO Trial at the 9th International Congress on OCT and OCT Angiography in Rome (ICOOR)/ FLORetina Symposia

Francesco Bandello, MD, FEBO, will present Phase 3 pivotal safety and efficacy data from the NORSE TWO registration trial
December 15, 2021 08:05 ET | Source: Outlook Therapeutics, Inc.
...
ISELIN, N.J., Dec. 15, 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 Francesco Bandello, MD, FEBO, Professor and Chairman of the Department of Ophthalmology, University Vita-Salute, Ospedale San Raffaele, Milan, will present pivotal safety and efficacy data from Outlook Therapeutics’ Phase 3 NORSE TWO registration trial for ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for use in wet age-related macular degeneration (wet AMD). The presentation will take place at the 9th International Congress on OCT and OCT Angiography in Rome (ICOOR)/ FLORetina Symposia, on Saturday, December 18, 2021.

“The results observed for ONS-5010 in the NORSE TWO trial are potentially of great significance for retinal specialists and their patients suffering from wet AMD,” said Dr. Bandello. “I look forward to having an additional approved treatment option for patients that is on-label and specifically formulated and packaged to meet the stringent demands for ophthalmic use.”

Details for Dr. Bandello’s presentation are as follows:

Clinical and Efficacy Outcomes of the NORSE TWO Pivotal Study for ONS-5010, an Ophthalmic Formulation of Bevacizumab
Presenter: Francesco Bandello, MD, FEBO
Session: ICOOR 2021 Hall, Visions of Future by Industry and Engineers, Part 2
Date and time: Saturday, December 18, 2021, 5:48 AM – 5:54 AM Eastern Time (11:48 AM– 11:54 AM Central European Time)

For more information and to register for this event, please visit ICOOR 2021.

https://www.globenewswire.com/news-release/2021/12/15/2352619/0/en/Outlook-Therapeutics-to-Present-Pivotal-Data-from-NORSE-TWO-Trial-at-the-9th-International-Congress-on-OCT-and-OCT-Angiography-in-Rome-ICOOR-FLORetina-Symposia.html

[goforthebet]

I added more yesterday... I believe OTLK is a good buyout candidate, eventually next year already. Any thoughts?

[jimmy667]

Of course. Late in year can always find bargans in pre revenue companies. Naturally if one does not have convction in the prospects of the company then no price is a good price.
I have a strong convicion in the prospects of Outlook. So do other market participants. The offer due to demand was increased 500%and was an all bought deal. Likely they could have increased it more.

[pfelgueiras]

OTLK - Outlook Therapeutics to Present at the 14th Asia-Pacific Vitreo-Retina Society (APVRS) Congress

Suber Huang, MD, MBA, FASRS will present data from the Phase 3 pivotal NORSE TWO registration trial

ISELIN, N.J., Dec. 09, 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 Suber Huang, MD, MBA, FASRS, Founder and CEO of the Retina Center of Ohio, will present safety and efficacy data from Outlook Therapeutics’ Phase 3 pivotal

NORSE TWO trial evaluating ONS-5010 / LYTENAVA™ (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab, for use in wet AMD.
The presentation will take place virtually at the 14th Asia-Pacific Vitreo-Retina Society (APVRS) Congress on December 10, 2021 at 11:20 – 11:30 PM ET (December 11, 2021 at 12:20 – 12:30 PM HKT).

“It is exciting to see the success of the NORSE TWO trial,” said Dr. Huang. “The clinical results from NORSE TWO were highly significant and move Outlook Therapeutics one step closer towards providing patients and retina specialists with the first on-label ophthalmic bevacizumab. If approved, ONS-5010 will avoid the potentially serious adverse events associated with off-label repackaged IV bevacizumab from compounding pharmacies.”

Details for the special plenary session presentation are as follows:

Safety and Efficacy Results of ONS-5010 – An Ophthalmic Bevacizumab from a Phase 3 Study of Monthly Intravitreal ONS-5010 in Subjects with Wet AMD (NORSE TWO)
Presenter: Suber S. Huang, MD, MBA, FASRS
Session: Plenary Session, 0087
Date and time: Friday, December 10, 2021, 11:20 – 11:30 PM ET (Saturday, December 11, 2021, 12:20 – 12:30 PM HKT)

For more information about OTLK see at r/OTLK_Investors

[pfelgueiras]

OTLK - Corporate Presentation DECEMBER 2021 with Good News

https://ir.outlooktherapeutics.com/static-files/70539207-f829-4485-a2ba-6242ea3dbb28

[goforthebet]

nice to see that. I bought yesterday as well :)

[pfelgueiras]

On December 06, 2021 OTLK report more 3 Insiders Buy of Common Stock

TRENARY C RUSSELL III (CEO and President) BOUGHT more 25000 units OTLK shares at $1,39 after this transaction he owns a total of 35,000 shares.

EVANSON JEFF (Chief Commercial Officer) BOUGHT more 35200 units OTLK shares at $1.34 after this transaction he owns a total of 1,177,130 shares.

DAGNON TERRY (Chief Operating Officer) BOUGHT more 25201 units OTLK shares at $1,38 after this transaction he owns a total of 1,163,058 shares.

Sources:

https://ir.outlooktherapeutics.com/static-files/3cb4fe50-ba50-4592-bd9c-0af8e56b8430

https://ir.outlooktherapeutics.com/static-files/97bc9453-7243-4848-b9b5-e604ab0fe8bd

https://ir.outlooktherapeutics.com/static-files/3a4a9e4a-9f3b-4ea0-903c-72924e2b2413

[Golden Bear 86]

Huge thanks for your analysis Thermo. Always a big help.

[johnreiner]

Nice breakdown on the sales market for Outlook! If the middle of the road projections come to fruition the upside from here is astronomical!

[goforthebet]

Yes, I saw that Insider are buying. That is always a good sign. thanks for the info and happy weekend

[DavidW2]

Insiders are loading at this level. I believe it is good price to add or load. A lot of people loaded at $2+. So this price is on sale...

[goforthebet]

true, I do :)

[thermo]

only if you like money

[goforthebet]

I guess 1.33 is a great buy?

[thermo]

Back of the envelope estimate

[DavidW2]

Hmmm..

Your prediction from August 31 was horrible wrong...

[DavidW2]

Don't you think it is funny to talk about buyout now while price is at $1.29? I afraid it will drop to below $1 soon....

It might go back up sometime next year but...

[pfelgueiras]

OTLK Price Target now is $7 to $8
Buyout will be always above price Target.
Never less then $15.
Later Buyout Higer the Price.

[DavidW2]

What is market potential of ONS-5010? if it receive FDA approval?

[DavidW2]

That is impossible price. That is $5.5 B dollar market cap.

$7-$10 might be good price.

[pfelgueiras]

I belive in a Buyout 2022/2023 and can be above $25

[DavidW2]

thermo, your opinion now?

Company has enough cash now to file BLA. Maybe buyout in year 2022?

[VMLG17]

No wonder this morning's pre-market dropped to $1.22. Of course, I took out a giant position in OTLK about two weeks ago at $2.11. I didn't do enough due diligence, I suppose. Fortunately, I'm used to being patient and not panicking as I have an even larger stake in NWBO. It seems a buyout is less likely now, but better in the long-run for shareholders. TIA for any comments...

[pfelgueiras]

$OTLK BUYOUT PROCESS STARTED?:
“BioLexis Pte. Ltd. Owner (GMS Ventures) go to purchase $20 million of OTLK shares to increase their position in OTLK
GMS/BioLexis.

They are doing the same Buyout Strategy that PFIZER did in the TRIL Buyout:

BioLexis owner GMS Ventures, go to increase their investment in OTLK. they will go to Buy more 20 million shares "NOW" and then during the BLA approval process they can launch the Buyout at the time that suits them best.

BioLexis Pte. Limited (BioLexis), the Company’s strategic business partner and largest investor in OTLK.

GMS will make this HUGE investment buying 20 Million Shares because they "KNOW" very well that investment it will be VERY PROFITABLE!

Now OTLK has enough money to finish BLA approval with the Public Offer of $50 Million.

This is one of my vision for OTLK

( See more information about OTLK at r/OTLK_Investors )

[jimmy667]

OTLK increased the offering size by 500% due to demand. I would say the offer was well received indeed. Now OTLK has a fairly comfortable cash runway. Cash problems averted.

[johnreiner]

https://flashalert.me/?symbol=OTLK&source=PR&referer=https://stocktwits.com/&url=https://www.globenewswire.com/news-release/2021/11/24/2340252/0/en/Outlook-Therapeutics-Increases-Previously-Announced-Bought-Deal-Offering-of-Common-Stock-to-50-Million.html&s3=OTLK/2021-11-23/22-32-00_000000/glob/02a0108a8996bf30c0aef30ece65cf36/Outlook-Therapeutics-Increases-Previously-Announced-Bought-Deal-Offering-of-Common-Stock-to-50-Million.html

[pfelgueiras]

OTLK an Excellent Opinion about the Loan.

OTLK >> A very important clue regarding what is happening.

We knew the company was running out of cash.

We also know that they have a large amount of shelf shares still available.

So why would they take out a non-dilutive loan that carries an interest rate instead of selling the shelf?

The only logical reason would be to preserve current share structure.

I cannot believe for one second that they would do this simply to keep current shareholders happy.

If I were to guess it is because there is a negotiated deal for a buyout based on current share structure.

Speculation, but can anyone think of another reason why they would take that loan instead of selling their shelf?

See more info about OTLK at r/OTLK_Investors

(I saw this opinion on the net)

[johnreiner]

Thanks for your input!

[1sdestiny]

I’ll be looking for signs when you start buying again. I’m a thermo minion.

[thermo]

Just a general reply: My strong opinion is that management feels they have a very valuable company. But the stock price is reflecting lack of cash and the biotech sector is under lots of pressure right now, so any equity financing hard.

Strategic negotiations drag on so long, so a company like OTLK always has to have a financing plan just based in funds like mine putting money in.

I know this debt financing group. Yes, the debt is expensive (~ 15% - 20% expected return all in) but that should still be cheaper than issuing equity down here (if one is bullish).

So, I think the debt was fine to issue but we'll see more financing near term, in my view.

[johnreiner]

Thermo , Regarding otlk reading the $10m note it appears they can not issue any stock without the consent of the lender so I am leaning towards it is not being otlk selling stock. In fact the loan terms are very high in cost for otlk which shows they do not want to dilute the stock. Would have been much cheaper to just issue 5m shares of stock but they obviously prefer not to dilute already until after fda filing! Appreciate your opinion… JR

[jimmy667]

Trusting that the loan was a stop gap measure, but wondering why the financing whether by loan or stock sale was undertaken so late. Something, whether a timeline or financing prospects might have slipped. Maybe it is too much to expect for a pre-revenue biotech to take a low risk approach to regulatory approval and a low risk approach to financing as well.

[thermo]

The recent loan takes the pressure off but the company may still opt to place stock. That's what the stock action looks like and they still need more funds to get through YE 2022. Rough biotech tape in which to do a placement.

[jimmy667]

That said I doubled UP on my modest position. This might be the best opportunity to accumulate before the next positive catalyst as I can not foresee further developments which would be perceived as negative. I actually think the loan while not on the best terms and increased the cost of the prior loan as positive because OTLK now has the capital to complete the BLA.

[jimmy667]

Filing of the BLA is expensive. But now they have the cash. I would have preferred that they sell stock instead. They will need to get the BLA right the first time because if not accepted OTLK will be in serious financial difficulty.

[johnreiner]

https://last10k.com/sec-filings/otlk/0001104659-21-140046.htm?utm_source=stocktwits&utm_medium=forum&utm_campaign=8K&utm_term=otlk

[H2R]

Q1 2022 BLA planned: Consistent Timelines

The company keeps to its timeline announced earlier in October.

Based on the strong data from this clinical program, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022.

If the BLA is approved, it is expected to result in 12 years of marketing exclusivity in the US for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

The NORSE TWO pivotal data met both primary and secondary endpoints with statistically significant and clinically relevant results:

* 41.7% (p = 0.0052) ONS-5010 subjects gained ≥ 15 letters of vision
* 56.5% (p = 0.0016) ONS-5010 subjects gained ≥ 10 letters of vision
* 68.5% (p = 0.0116) ONS-5010 subjects gained ≥ 5 letters of vision
* ONS-5010 subjects gained 11.2 letters (p = 0.0043) in BCVA

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-presents-norse-two-phase-3-pivotal-safety

Best of luck with your investments!

[pfelgueiras]

$OTLK PRICE TARGETS and RECOMMENDATIONS on November 04, 2021
PRICE TARGETS/ RECOMMENDATIONS ; Nº of ANALYSTS ESTIMATES

PRICE TARGETS: High $8,40 / Average $7,14 / Low $6,06 :
("CHARTMILL": STRONG BUY-3 Analysts Rating)

PRICE TARGETS: High $8,00 / Average $7,00 / Low $6,00 :
("BARCHART": STRONG BUY-2 Analysts Rating)
("WSJ": BUY-3 Analysts Rating)
("NASDAQ": STRONG BUY-2 Analysts Rating)
("TIP RANKS": MODERATE BUT-2 Aalysts Rating)
("CNN BUSINESS": BUY-3 Aalysts Rating)
("MARKETWATCH": BUY-3 Analysts Rating)
("WALLSTREETZEN": STRONG BUY-2 Analysts Rating)
("WEBULL": BUY-3 Analysts Rating)
("MARKETSCREEN": BUY-3 Analysts Rating)
("BARRONS": BUY-3 Analysts Rating)
("STOCKTARGETADVISOR": BUY-3 Analysts Rating)

See more information about OTLK on r/OTLK_Investors

[johnreiner]

Sweet! OTLK gonna be a huge winner!

[someconcerns]

Good man!

[thermo]

Helping OTLK with capital needs...buying stock via the ATM offering. 915,000 @ 2.07

[H2R]

OTLK Consistent Timelines

The PR's show the planning and then the adjustments to the planning. Compared to other biotechs in clinical trial stages, I find them refreshingly consistent.


From March 31st:

Topline efficacy and safety data from pivotal Phase 3 NORSE TWO study on target to report in calendar Q3 2021, followed by BLA submission by end of 2021

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-safety-profile-norse-three


From August 3rd:

Full data from NORSE TWO will be presented at an ophthalmology conference in the fall of 2021 and submitted for publication in a peer-reviewed journal.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-positive-efficacy-and-safety-data



From September 28th:

Outlook Therapeutics Reports New Positive 12-Month Safety Data from Pivotal Phase 3 NORSE TWO Trial

Full data to be presented at American Academy of Ophthalmology’s Retina Subspecialty Meeting, RET13 - Section X: Late Breaking Developments, Part II on November 13th at 9:17 AM ET

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-new-positive-12-month-safety-data



So I would tend to trust the planning expressed in the latest corporate presentation, dated October 2021:

Compelling pivotal data supports
U.S. FDA BLA submission,
targeted for calendar Q1 2022

https://ir.outlooktherapeutics.com/static-files/70f2afe2-b97b-4e79-8067-64d05f977e77 , page 4


Best of luck with your investments!

[H2R]

Full year data reinforce strong safety profile consistent with previous trials of ONS-5010 and with prior published data on ophthalmic bevacizumab

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-reports-new-positive-12-month-safety-data

ISELIN, N.J., Sept. 28, 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 new 12-month safety data from the pivotal Phase 3 NORSE TWO trial that further confirm the strong safety profile in this study of ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for treatment of neovascular age-related macular degeneration (wet AMD). In August 2021, Outlook Therapeutics announced the topline readout of pivotal data from its NORSE TWO trial, which included 11 months of safety data. The topline data previously reported from NORSE TWO demonstrated clinically relevant and highly statistically significant results as well as a robust safety profile indicating that in the trial ONS-5010 was well tolerated and showed no unanticipated safety signals.

“The full 12-month safety data results move us one step closer to providing patients with an FDA-approved, cGMP-produced drug product that meets ophthalmic FDA standards and avoids the potential risks of repackaged IV bevacizumab,” said C. Russell Trenary III, President and CEO of Outlook Therapeutics. “Our goal is to offer patients, in the United States and globally, a safe and effective, approved ophthalmic bevacizumab. ONS-5010 is specifically formulated to meet requirements to treat retinal diseases like wet AMD. We continue to work towards submitting a Biologics License Application for ONS-5010 to the U.S. Food and Drug Administration for ONS-5010 in the first calendar quarter of 2022.”

Best of luck with your investments!

[H2R]

Sept 13th, positive signals

Outlook Therapeutics’ wet AMD ONS-5010 clinical program for the planned BLA submission consists of three clinical trials, NORSE ONE, NORSE TWO, and NORSE THREE, all of which have now been completed. Most recently, Outlook Therapeutics reported positive topline data from its NORSE TWO pivotal Phase 3 clinical trial. In NORSE TWO, ONS-5010 achieved statistically significant and clinically relevant primary (p = 0.0052) and key secondary (p = 0.0043) efficacy endpoints with 41% of subjects gaining at least 15 letters of BVCA. ONS-5010 was also found to be safe and well tolerated in the NORSE TWO trial.

With the registration clinical trials now completed, Outlook Therapeutics plans to submit a new BLA under the Public Health Service Act (PHSA) 351(a) regulatory pathway in the first quarter of calendar 2022. If the BLA is approved, it is expected to result in 12 years of marketing exclusivity for ONS-5010 as the first and only ophthalmic formulation of bevacizumab approved by the FDA to treat wet AMD.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-presents-positive-norse-three-safety-data

Looking good!

[pfelgueiras]

ONS-5010 (bevacizumab-vikg), for treatment of wet AMD, 12 years market exclusivity under new BLA.

FDA has taken hundreds of unapproved prescription drugs off the market since 2006 and has executed multiple class actions announced through Federal Register Notices.

FDA does not remove an unapproved drug used to treat serious medical conditions until a sufficient and reliable supply of FDA approved drug is available.

FDA Actions to Remove Unapproved Drugs from the Market by Company

https://www.fda.gov/drugs/enforcement-activities-fda/fda-actions-remove-unapproved-drugs-market-company

[pfelgueiras]

On OTLK September 2021 Corporate Presentation (Page 15), Seems once it’s FDA approved it will be illegal for pharmacists to compound it off label.