Outlook Therapeutics Inc (OTLK)

[pfelgueiras]

OTLK - Trenary C Russell III + Dagnon Terry they Bought OTLK Shares on June 21, 2022
TRENARY C RUSSELL III Bought 19,925 shares at $1.06 on June 21, 2022.
DAGNON TERRY Bought 10,000 shares at $1.05 on June 21, 2022.

(See more information about OTLK at r/OTLK_Investors)
SOURCE:
https://ir.outlooktherapeutics.com/static-files/64f27997-0f1c-4ce0-b050-9e7707370f17

https://ir.outlooktherapeutics.com/static-files/22b8fc54-60ef-49c4-a619-e8a2f6ef12eb

[thermo]

Approved earlier this year:

On February 7, 2022, FDA had approved Vabysmo (faricimab-svoa), an injectable therapy for those with wet age-relate macular degeneration (wAMD) and diabetic macular edema. This approval is especially interesting considering that it is the first drug of its kind to be approved for both wAMD and diabetic macular edema.

As I noted, this will be a premium priced product, no different than Eylea.

[herbied47]

Hey Evan. Sorry I couldn’t private message a reply back to you. I haven’t used ihub much lately, but as to NISN, hedge fund Sabby has been the reason for the dip, but it has produced the buying opportunity moving forward. Recent announced 8 million share buyback.

[conix]

Outlook Therapeutics is focused on developing and commercializing a commercially attractive monoclonal antibody for various ophthalmic indications


Outlook Therapeutics confirms BLA re-submission date for its ONS-5010 wet AMD treatment
Outlook Therapeutics submits BLA to FDA for its investigational therapy to treat wet AMD


About the company

Outlook Therapeutics Inc is a late clinical-stage biopharmaceutical company focused on developing and commercializing ONS-5010, a complex, technically challenging and commercially attractive monoclonal antibody, or mAb, for various ophthalmic indications. Its goal is to launch ONS-5010 as the first, and only, approved bevacizumab in the United States, Europe, Japan and other markets for the treatment of wet age-related macular degeneration (wet AMD), diabetic macular edema (DME) and branch retinal vein occlusion (BRVO).


Outlook Therapeutics (NASDAQ:OTLK) Inc has provided an update on its Biologics License Application (BLA) submission for ONS-5010/LYTENAVA (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

The pre-commercial biopharmaceutical company said it has confirmed the additional information necessary to re-submit the BLA for ONS-5010 by September 2022 following receipt of additional correspondence from the US Food and Drug Administration (FDA).

“The additional correspondence from the FDA confirms our commitment to our shareholders to re-submit a completed BLA to FDA by September of this year,” Outlook Therapeutics CEO Russell Trenary said in a statement.

“As stated previously, we believe the results from our clinical trials demonstrated safety and efficacy and we are on track to re-submit this BLA and, if approved, to deliver the first FDA-approved ophthalmic formulation of bevacizumab to the retina community,” Trenary added.


Outlook Therapeutics (NASDAQ:OTLK) Inc said it has voluntarily withdrawn the biologics license application (BLA) for its ophthalmic formulation of bevacizumab (ONS-5010 or Lytenava) after the US Food and Drug Administration (FDA) requested additional information.

The company added that it is actively working to respond to the FDA’s request and plans to resubmit a revised BLA by September. A BLA is a request to introduce, or deliver for introduction, a biological product into interstate commerce.


Outlook Therapeutics (NASDAQ:OTLK) Inc ended its fiscal second quarter with $58.4 million in cash – enough to launch its lead drug ONS-5010 without raising significant additional capital, it said.

ONS-5010, which will be sold under the brand name Lytenava, is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration (AMD) and other retinal diseases.


Outlook Therapeutics (NASDAQ:OTLK) Inc CEO Russ Trenary tells Proactive it has submitted its Biologics License Application to the FDA for ONS-5010, an investigational therapy for the treatment of wet age-related macular degeneration (wet AMD).

If approved, the treatment will be branded as LYTENAVA (bevacizumab-vikg) and could replace the current practice of using unapproved repackaged IV bevacizumab sourced from compounding pharmacies, products that have known risks of contamination and inconsistent potency and availability.

[conix]

Outlook to re-submit application for eye disorder drug in Sept. after FDA correspondence


Jun. 14, 2022 8:45 AM ET
Outlook Therapeutics, Inc. (OTLK)

By: Anuron Mitra, SA News Editor

AMD Abbreviation or acronym of age-related macular degeneration - eye problem in older persons. Word AMD is on foreground near eye model with stethoscope and visual acuity test on blurry background

Outlook Therapeutics (NASDAQ:OTLK) on Tuesday reiterated that it expects to re-submit its biologics license application (BLA) in Sept. for its ONS-5010 formulation for the treatment of wet age-related macular degeneration, a retinal disease.

The company reiterated the expectations for Sept. following the receipt of additional correspondence from the U.S. FDA.

OTLK stock had slumped on May 31 after the company voluntarily withdrew the BLA after the FDA's request for additional information.

[DavidW2]

Insiders have loaded a lot between $1.2-$1.5. Stock should return to $1.5 level soon.

[H2R]

Hi Swampboots,

Check out their corporate presentation:

https://ir.outlooktherapeutics.com/static-files/10b909de-a80a-45af-a98d-470ce9f068ef

Especially slide 9 and 10. They also have good videos.

Best of luck with your investments!

[swampboots]

Is their remedy better than Avastin?

[evanstony]

does this have a fast track status of any kind?... orphan or other???

[H2R]

September resubmission confirmed

The Company issued a PR reiterating the September resubmission timeframe:

Outlook Therapeutics reiterates expected re-submission of BLA by September 2022 following receipt of additional correspondence from U.S. Food and Drug Administration (FDA)

ISELIN, N.J., June 14, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, is providing an update on its Biologics License Application (BLA) submission for ONS-5010 / LYTENAVA™ (bevacizumab-vikg) for the treatment of wet age-related macular degeneration (wet AMD).

As previously announced, Outlook Therapeutics submitted its BLA for ONS-5010 to the FDA in March 2022 and subsequently voluntarily withdrew its submission in May 2022 to provide additional information requested by the FDA. Following receipt of further correspondence from the FDA, Outlook Therapeutics has confirmed the additional information necessary to re-submit the BLA for ONS-5010.

C. Russell Trenary, President and Chief Executive Officer of Outlook Therapeutics, commented, “The additional correspondence from the FDA confirms our commitment to our shareholders to re-submit a completed BLA to FDA by September of this year. As stated previously, we believe the results from our clinical trials demonstrated safety and efficacy and we are on-track to re-submit this BLA and, if approved, to deliver the first FDA-approved ophthalmic formulation of bevacizumab to the retina community.”

The good news with OTLK is that they take their timelines seriously, so I do expect the re-submission to happen according to their PR.

Best of luck with your investments!

[swampboots]

Resubmitted today

[pfelgueiras]

OTLK - Corporate Presentation JUNE 2022
New on Slide 05
• Compelling pivotal data support U.S. FDA BLA submission targeted Sept. 2022
• Launch anticipated Q4 2023, if approved.

New on Slide 27
• Sufficient capital to support pre-launch activities for ONS-5010 and a pathway to potentially support launch if approved.

New on Slide 28
• U.S. FDA BLA submission targeted September 2022 with anticipated approval to follow 8-12 months later.
• Sufficient capital for pre-launch activities and potentially through launch.
(in May they said **"**Sufficient capital through the anticipated approval of the ONS-5010 BLA")

OTLK Did not give any explanation why they withdraw the BLA!
They only said they are "Compelling pivotal data support U.S. FDA BLA submission target Sept. 2022"

( See more information about OTLK at r/OTLK_Investors )

SOURCE:
https://ir.outlooktherapeutics.com/static-files/10b909de-a80a-45af-a98d-470ce9f068ef

[VMLG17]

I’m still here. I got a little lucky on this one, which doesn’t happen often, as I sold at a small loss after the PR about the BLA submission didn’t move the SP much. I had plans to get back in closer to FDA approval, and if a BO were to be announced prior, I was prepared to miss out on it. Now I just see this as a delayed entry point date. I can identify with those who are holding as I’ve been in NWBO for a very long time.

[pfelgueiras]

OTLK - HOLDING STRONG
I hope OTLK investors learn from these wise words from Great Investors who made huge fortunes on the stock market We need to Remember there words:

WARREN BUFFETT Quotes:
1) “The stock market is a device for transferring money from the impatient to the patient.”
2) “Time is the friend of the wonderful business, the enemy of the mediocre.”
3) "Short-term price fluctuations do not affect the long-term value."
4) "If you can control your emotions, you can control your money".

CHARLIE MUNG Quote:
"THE BIG MONEY IS NOT IN THE BUYING AND THE SELLING, BUT IN THE WAITING."

More information about OTLK at r/OTLK_Investors

[DavidW2]

How about pfe & thermo?

[H2R]

Nope, just digesting the info.

1) The Company did not provide a 'clean' submission to the FDA. I'm not super happy with that.
2) The Company has kept their timeline in the past, quite well actually. So their assessment of a September 2022 is a little reassuring.

I was expecting the FDA to provide a PDUFA date. Instead, it's back to the submission step. So not great, but the value is still there. The risk now is that the submission will be marred before even making it to PDUFA. I don't think that will be the case.

As for me, I did not sell any shares. I'm more in 'hold' mode at this point.

Best of luck with your investments!

[DavidW2]

Strange, where are all the people here? Everyone has sold all the shares and gone?

[DavidW2]

Where is thermo?

[DavidW2]

Glad I was right, stupid people sold at 68 cents? Take another three months company will resubmit. I guess this stock will return to $1.2-$1.3

[DavidW2]

Is OTLK a twin of NWBO? Trading almost the same now. LOL

[DavidW2]

Add some more at 69 cents.

[DavidW2]

Thermo, what do you think?

So surprise! Guess need to wait until Sept. after company resubmit BLA.

[maverick_1]

Fortunately I sold and took a small loss!:

8:27a ET 5/31/2022 - Dow Jones
Outlook Therapeutics Withdraws Wet AMD Treatment Application
Mentioned: OTLK

By Will Feuer

Outlook Therapeutics Inc. said it has voluntarily withdrawn its biologics license application for its experimental wet age-related macular degeneration treatment while it responds to the U.S. Food and Drug Administration's request for additional information.

The company said it plans to re-submit a revised application for its experimental treatment, called ONS-5010, or bevacizumab-vikg, by September.

"We are continuing to have productive discussions with the FDA and are committed to providing the additional information necessary to support the application," Chief Executive Russell Trenary said. "We look forward to a successful resubmission and ultimately the potential approval of ONS-5010 for the treatment of wet AMD."

Shares of Outlook Therapeutics tumbled almost 38% to $1.05 in premarket trading.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab under development to be administered as an intravitreal injection for the treatment of wet age-related macular degeneration and other retinal diseases, Outlook Therapeutics said.

Some 1.8 million Americans aged 40 years and older are affected by age-related macular degeneration, according to the U.S. Centers for Disease Control and Prevention. Age-related macular degeneration is the leading cause of permanent impairment of reading and fine or close-up vision among people aged 65 years and older, the agency says.

DIFFERENT STROKES for DIFFERENT FOLKS

[pfelgueiras]

As of today, OTLK BLA Acceptance by FDA can take place on any day.
If you want buy more OTLK Shares is better to do now, so you won't regret it later!

[pfelgueiras]

PDUFA date expected to be announced in June 2022
Source:
https://ir.outlooktherapeutics.com/static-files/3cdc129d-40e0-4c68-a436-f94352c65d12

[thermo]

My estimate will depend on whether they get a priority review. So, need to see that first.

[hope4patients]

What are your thoughts on “launch” timeline?

[thermo]

They're in a good position now but, if they pay off the debt, they are a little short of fully funded through launch. One has to make some assumptions re launch expenses.

[DavidW2]

Company has about $70M cash. Debt is about $22 M. Why not company just pay off debt in July? After that, company still have $48 M cash on hand. That should be enough until FDA approval in year 2023.

[goforthebet]

thank you very much for your thoughts. they are so much appreciated. wish you a nice weekend!

[thermo]

My primary thoughts currently are (a) PDUFA date, and whether OTLK will get priority review, (b) the Streeterville Debt that begins amortizing in July 2022.

Starting in July 2022, the Streeterville Debt is repayable in stock at a discount to the then current market. So, it's a form of toxic debt (e.g., the total shares issuable for repayment is variable) and, if excessive, can depress stock prices. The company can repay it until June. I'm considering ways to solve this problem but haven't come to any conclusions, nor made any proposals, yet.

[goforthebet]

any thoughts on the numbers?? thanks

Outlook Therapeutics GAAP EPS of -$0.09 misses by $0.03

May 13, 2022 8:06 AM ETOutlook Therapeutics, Inc. (OTLK)By: Deepa Sarvaiya, SA News Editor

Outlook Therapeutics press release (NASDAQ:OTLK): Q2 GAAP EPS of -$0.09 misses by $0.03.

At March 31, 2022, Outlook Therapeutics had cash and cash equivalents of $58.4 million, compared to $70.2 million at December 31, 2021.

[H2R]

Thank you, Thermo.

Priority review would be a plus :)

I may be getting monies on a company liquidity event here at my work. depending on the timing of the event and PPS at the time, I'm thinking of investing more in OTLK. Your thoughts are greatly appreciated!

Best of luck with your investments.

[thermo]

My understanding is we should see something around the end of this month +/-. There's a decent change we get a Priority Review, which will signal FDA's view of the importance of Lytenava.

I'm thinking about investing more money. My preferred approach is a direct negotiated investment (I'm not in talks now and, if I was, I couldn't mention it). We're in a bear market, so attractive terms are a requirement, but we'll see what happens.

[H2R]

Hi Thermo,

Would you have any insight as to the acceptance of the BLA by the FDA (not the approval, but that acceptance of the filing / they are OK to work with it to set up a PDUFA)? The filing was announced on March 31, 2022.
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-submits-biologics-license-application-us

I understand if you can't divulge certain information.

Best of luck with your investments!

[pfelgueiras]

OTLK - Corporate Presentation MAY 2022
Good News all as planned
U.S. FDA BLA submitted March 2022 with anticipated approval to follow 9-12 months later.
Sufficient capital through the anticipated approval of the ONS-5010 BLA.

SOURCE:
https://ir.outlooktherapeutics.com/static-files/7590f061-6751-4f3e-89a3-c2101f211735

[pfelgueiras]

OTLK - Corporate Presentation MAY 2022
Good News all as planned
U.S. FDA BLA submitted March 2022 with anticipated approval to follow 9-12 months later.
Sufficient capital through the anticipated approval of the ONS-5010 BLA.

SOURCE:
https://ir.outlooktherapeutics.com/static-files/7590f061-6751-4f3e-89a3-c2101f211735

[pfelgueiras]

OTLK - Corporate Presentation MAY 2022
Good News all as planned
U.S. FDA BLA submitted March 2022 with anticipated approval to follow 9-12 months later.
Sufficient capital through the anticipated approval of the ONS-5010 BLA.

SOURCE:
https://ir.outlooktherapeutics.com/static-files/7590f061-6751-4f3e-89a3-c2101f211735

[conix]

MACD Market

[pfelgueiras]

OTLK - They Started to Build the Sales Team

Executive Director, Provider Market Access
Job ID 2022-1788 Job Locations US-Remoted

Executive Director, Payer Market Access
Job ID 2022-1787 Job Locations US-Remote

Senior Vice President, Sales
Job ID 2022-1784 Job Locations US-Remote

(See more information about OTLK at r/OTLK_Investors)

Outlook Therapeutics is a late clinical-stage biopharmaceutical company working to develop and launch ONS-5010 / LYTENAVA™ (bevacizumab-vikg) as the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010 is approved, Outlook Therapeutics expects to commercialize it as the first and only FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal diseases in the United States, United Kingdom, Europe, Japan, Greater China and other markets. Outlook Therapeutics expects to submit ONS-5010 with the U.S. FDA as a new BLA under the PHSA 351(a) regulatory pathway during the first calendar quarter of 2022.

SOURCE:
https://careers-outlooktherapeutics.icims.com/jobs/search?ss=1

[H2R]

Thanks pfelgueiras!

As guesses go, this one some merit!

1) https://seekingalpha.com/article/4480794-outlook-therapeutics-fda-approval-possible-buyout?mailingid=26453681&messageid=must_reads&serial=26453681.108183&utm_campaign=Must%2BRead%2BJanuary%2B22%2C%2B2022&utm_content=seeking_alpha&utm_medium=email&utm_source=seeking_alpha&utm_term=must_reads
Posted by VMLG17 on this board.

2) I have seen in the last 10 years of looking at biotech BO's after BLA and before PDUFA

3) That PR you provided states "The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder. "

A BO is at least conceivable. I wonder if the current PPS is ripe for it and what the Buyer would be willing to go on top of the current pps.

Best of luck with your investments.

[pfelgueiras]

BioLexis is doing Tax Planning to minimize tax payments selling OTLK shares in a Buyout.

With the agreement among BioLexis, GMS Ventures & Investments (GMS V&I), and certain GMS affiliates on April 21, 2022.

GMS V&I (Venture and Investments) has taken direct ownership of all the shares of Outlook Therapeutics, ...
....that were indirectly owned by GMS Holdings through BioLexis and certain GMS affiliates.

GMS Venture & Investments is a company incorporated under the laws of Cayman Island.

I think they expect to receive a lot of money from the sale of OTLK shares in a Buyout, and are already doing tax planning to minimize tax payments.

Caymen Island is Tax haven for the ultra wealthy and where big business deals happen. They are definitely prepping for something to happen within this year. Count on it !

(See more information about OTLK at r/OTLK_Investors)

[conix]

Macular Degeneration is a growing health cost for medical systems across the globe. Injecting pharmaceuticals into the eye is not the best way to achieve a high level of patient compliance.

Medicare and Medicaid really needs to find an efficacious treatment to slow the progression of Age-Related Macular Degeneration (AMD) that is cost effective--and easy to deliver.

Eyedrop formulations of Metformin, the broadly used diabetes drug, apparently holds some promise --according to the National Eye Institute which just entered into a clinical trial agreement with a small biotech company (CUBT).

But there is a major push in this field for the NIH to fund clinical trials in this huge market. It cost infinitely more to pay for caregivers of blind pagients vs. slowing the progression to blindness.

[pfelgueiras]

OTLK - BioLexis Reorganization Results in GMS Holdings as Largest Shareholder in Outlook Therapeutics ("BUYOUT ON THE WAY?")

April 22, 2022

SINGAPORE and ISELIN, N.J., April 22, 2022 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a pre-commercial biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, and BioLexis Pte Ltd. (“BioLexis”), a strategic shareholder in Outlook Therapeutics, today announced that BioLexis is being reorganized.

The BioLexis reorganization, which does not entail any changes in the indirect ownership of Outlook Therapeutics, provides GMS Holdings with increased flexibility to support the future growth of Outlook Therapeutics as its largest shareholder.

Pursuant to an agreement among BioLexis, GMS Ventures & Investments (“GMS V&I”), and certain of GMS V&I’s affiliates (GMS V&I and its affiliates, “GMS Holdings”), on April 21, 2022, GMS V&I has taken direct ownership of all of the shares of Outlook Therapeutics that were indirectly owned by GMS Holdings through BioLexis.

As the next step in the reorganization, GMS Holdings will cease to be a shareholder in BioLexis and BioLexis will be renamed “Tenshi Healthcare Pte Limited” (or such other name as may be approved by the regulatory authorities in Singapore).

GMS Holdings does not have an economic interest in, or voting rights with respect to, the shares of Outlook Therapeutics that are held by BioLexis. BioLexis directly holds the shares beneficially owned by the minority shareholder in BioLexis, Tenshi Life Sciences Private Limited and Tenshi Life Sciences Pte Limited.

Since the initial investment by BioLexis in 2017, Outlook Therapeutics has undergone a significant transformation and has successfully completed three clinical trials which recently culminated in a BLA submission to the U.S. FDA on March 30, 2022. As the largest investor, GMS Holdings actively supported Outlook Therapeutics by leading and participating in multiple capital raises to support the Outlook Therapeutics growth strategy.

“The submission of a Biologics License Application (BLA) for ONS-5010 / LYTENAVA ™ (bevacizumab-vikg) with FDA is a significant milestone to achieve and places Outlook Therapeutics on a path to potential marketing approval for a very promising therapy,” said Faisal Sukhtian, Executive Director of GMS Holdings and a member of the Board of Directors of BioLexis. “With this milestone accomplished, the shareholders of BioLexis have fully realized their intended objectives for the joint venture.

This reorganization will see the existing partners translate their joint ownership positions in Outlook Therapeutics into direct stakes.”

“We appreciate the longstanding support we have received from BioLexis and look forward to executing on our priorities to create value for all shareholders,” added Russell Trenary, President and CEO of Outlook Therapeutics.

In connection with the reorganization, Outlook Therapeutics and GMS Holdings entered into an Amended and Restated Investor Rights Agreement, which replaces the previous Investor Rights Agreement among Outlook Therapeutics, BioLexis and GMS V&I.

BioLexis no longer has any rights under the Amended and Restated Investor Rights Agreement.

SOURCE: https://ir.outlooktherapeutics.com/node/10356/pdf

[H2R]

OTLK @ Eyecelerator / ASCRS 2022

The Outlook Therapeutics team will be at Eyecelerator @ ASCRS 2022 today in DC. See you there! For more information on $OTLK's ONS-5010 ophthalmic bevacizumab, visit https://outlooktherapeutics.com #WashingtonDC #wetAMD #Eyecelerator
@Eyecelerator
#ASCRS2022

The Outlook Therapeutics team will be at Eyecelerator @ ASCRS 2022 today in DC. See you there! For more information on $OTLK's ONS-5010 ophthalmic bevacizumab, visit https://t.co/UDq2ox30fb #WashingtonDC #wetAMD #Eyecelerator @Eyecelerator #ASCRS2022 pic.twitter.com/q0x1V8Zvwo

— Outlook Therapeutics (@OutlookTx) April 21, 2022

Best of luck with your investments!

[pfelgueiras]

Many thanks H2R,
I also wish you good profits on your investments, I hope you include OTLK.
I invite you to join r/OTLK_Investors, it was created by me, and I am the moderator.
You can see there a lot of information and opinions about OTLK.
I wish you a Happy Easter.
All the best for you.
Pedro Felgueiras

[H2R]

Thanks pfelgueiras, Great video, it sums up in a nutshell the company's outlook (yeah, I know) for approval.

Best of luck with your investments!

[pfelgueiras]

OTLK - Interview about confidence in the FDA approval process for BLA
“Usually to pass FDA you want to have a 95% confidence level that you drug is working…we have in OTLK 99.5% confidence level.”
See the interview with C. Russell Trenary III (OTLK-President & Chief Executive Officer) on Proactive in the link below

(See more information about OTLK at r/OTLK_Investors)

[H2R]

Wong board. Sorry about that post on this board. Moderators, please remove Post 468, on the other company.

[H2R]

SA Article

https://seekingalpha.com/article/4499176-cryoport-risky-investment-upside-potential

A few charts comparing PPS with net income, revenue, debt, total assets...

Best of luck with your investments!