Outlook Therapeutics Inc (OTLK)

[Pula]

They must dilute to pay kenyons bonuses. His incompetence is necessary to maintain critically necessary minimum incompetence to continue to paper shred everyones money for another decade to come. Its too bad there isnt an incompetence olympics. Kenyon trenary and evanson would all podium

[Grey_Ghost]

Wow. Has a European distribution deal been finalized? Nice action today.

[glenn1919]

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

[dstock07734]

Hello, sir,
I was wondering if you noticed the latest discovery of tumor-agnostic trial on rare pediatric cancers conducted by Masaryk University, Brno, Czechia which absolutely has connection with $NWBO's DC technology. I assume you knew it.

In case, you didn't. I listed some of the relevant info.

Here is the registry of the trial.
COMBINED ANTITUMOR THERAPY WITH EX VIVO MANIPULATED DENDRITIC CELLS PRODUCING INTERLEUKIN-12 IN CHILDREN,
ADOLESCENTS AND YOUNG ADULTS WITH PROGRESSIVE, RECURRENT OR PRIMARILY METASTATIC HIGH-RISK TUMORS
https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-003388-39/CZ
https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-516613-21-00

Here are the peer-review publications about the trial.
Personalized dendritic cell vaccine in multimodal individualized combination therapy improves survival in high-risk pediatric cancer patients
https://onlinelibrary.wiley.com/doi/10.1002/ijc.35062

Dendritic Cell-Based Immunotherapy in Advanced Sarcoma and Neuroblastoma Pediatric Patients: Anti-cancer Treatment Preceding Monocyte Harvest Impairs the Immunostimulatory and Antigen-Presenting Behavior of DCs and Manufacturing Process Outcome
https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.01034/full#supplementary-material

Assessment of Immune Response Following Dendritic Cell-Based Immunotherapy in Pediatric Patients With Relapsing Sarcoma
https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2019.01169/full

The results strike me as absolutely stunning. Note that poly-iclc was not included. Any only a few cases had Opdivo involved. All those patients had very serious medical conditions.

We analyzed data from all consecutive patients who received personalized DC vaccine between 2016 and 2022. Inclusion criteria were children and young adults, aged 0–20 years at diagnosis with relapsed/refractory and/or metastasizing high-risk solid tumors diagnosed in 2005–2021

We observed repeated recurrences or progressions, however, with favorable overall survival. Three- and five-year overall survival was 80.8% and 60.2%, and 60.4% and 30.2%, respectively, when calculated from the first progression. This is a notable outcome for such a high-risk cohort in comparison to historical data,21-26 where 3-year survival ranged from 15% to 30% and 5-year survival was generally <15% from recurrence.

One thing I want to point out is that this trial is consisting with another trial which used the combination of DC vaccine with CYT107 to treat three pediatric sarcomas and the trial results were phenomenal.

Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
https://clinicaltrials.gov/study/NCT00923351

Adjuvant Immunotherapy to Improve Outcome in High-Risk Pediatric Sarcomas
https://aacrjournals.org/clincancerres/article/22/13/3182/79179/Adjuvant-Immunotherapy-to-Improve-Outcome-in-High

[Monksdream]

OTLK,under $2

[onebadz68]

Any news would be greatly appreciated. EU sales etc

[Monksdream]

OTLK under $2

[pfelgueiras]

See more information about OTLK on Reddit atr/OTLK_Investors

[Monksdream]

OTLK under $2

[H2R]

Nice Day at OTLK

Not a great volume, but it moved up %9.43. Let's see what next week holds in store. It could be just a flash in the pan.

Best of luck with your investments!

[H2R]

PDUFA : August 27, 2025.

Thanks Mionaer1!!!

I completely missed the PR. That's some great news!

I'll check how to move some funds again this weekend.

Best of luck with your investments

[Mionaer1]

BLA accepted.BLA accepted.BLA accepted.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-acceptance-biologics-license-0
PDUFA August 27, 2025

[Mionaer1]

Back in. Fully diluted shares? 50M IMO. Am I right? Thanks.

[Mfgaumond]

Hahah. How you been Thermo? Any input on the current situation?

[thermo]

Lovely beach here.

[onebadz68]

Perhaps thermo is having an extended stay at The White Lotus. 

[PieperIndy]

So this board is dead lol? Got it.

[PieperIndy]

Crickets chirp chirp. Friday news?

[PieperIndy]

How you feeling about the latest moves @thermo

[OGBritbox]

After the vote I’m predicting we will get some game changing news nobody saw coming. Hold onto your butts…..and shares

[glenn1919]

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

[H2R]

Thanks OGBritbox!

For those who want the link, here it is:

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-re-submits-biologics-license-application-0

The ONS-5010 BLA resubmission is based on the efficacy and safety demonstrated in NORSE EIGHT, as well as additional chemistry, manufacturing and controls (CMC) information requested by the FDA. As previously announced, following Type A meetings with the FDA in Q4 CY2023 to address the ONS-5010 Complete Response Letter (CRL), the FDA informed Outlook Therapeutics that, in order to meet the FDA’s requirement for a second adequate and well-controlled clinical trial of ONS-5010, it could conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 12 week study of treatment naïve patients with a primary efficacy endpoint at 8 weeks (NORSE EIGHT). Outlook Therapeutics believes that the complete data set for NORSE EIGHT and the additional CMC information in the BLA resubmission, combined with the data from the other NORSE clinical trials, provides the required evidence to support approval of the ONS-5010 BLA in the United States.

A decision from the FDA is expected within six months.

Best of luck with your investments!

[OGBritbox]

BLA has been resubmitted

[OGBritbox]

Today I bought 10,000 more shares, bringing my total to just under 20,000 shares at an average of $4.
Very excited to see how the rest of the year plays out.
Extremely bullish

[KIPK]

EX - Shame man. KARMA!!!

[H2R]

Upcoming Milestones

* Resubmission of the ONS-5010 BLA targeted for Q1 CY2025;
* Initial commercial launches in Germany and the UK planned to commence in Q2 CY2025; and
* Potential for US FDA approval of ONS-5010 in Q3 CY2025

ONS-5010 / LYTENAVA™ (bevacizumab-vikg) Biologics License Application (BLA) resubmission on track to meet target of Q1 CY2025
LYTENAVA™ (bevacizumab gamma) on track for first commercial launches in Germany and the United Kingdom (UK) planned for Q2 CY2025

ISELIN, N.J., Feb. 14, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced financial results for the first quarter of fiscal year 2025 and provided a corporate update.

“With all of the recent progress made at Outlook Therapeutics and the upcoming milestones over the next few months, we expect to be a very different company by the end of 2025,” commented Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “In 2025, we plan to start realizing our goal of providing patients, physicians and payers with an approved ophthalmic formulation of bevacizumab. This year, we anticipate beginning to generate the first revenue for Outlook Therapeutics with the launch of LYTENAVA™ in Germany and the UK and our BLA is on track for resubmission this quarter.”

* https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-reports-financial-results-first-quarter-1

Best of luck with your investments!

[OGBritbox]

To take advantage of the low price by getting a lot more shares for my money and lowering my cost average significantly.

[onebadz68]

Why?

[OGBritbox]

Bought a lot more the last 2 weeks

[onebadz68]

I'm not sure either. Lol
Guess I'm just disappointed in myself for putting money on the wrong horse. 

I knew they'd be dilution but wow what a kick in the pocket book. From 60M to 260M shares not to mention more warrants. I know they said they have no plans to issue those additional shares but I've heard that before. 

I believe no decent investors are interested at this point unfortunately. 

One more mention, lol, $600K a year to run a company with 18 employees seems a bit excessive. 

[exwannabe]

Not sure what you expected here, this was already written once the trial fail crashed the price. That is one reason why some wanted to see the company resolve the liquidity issue months ago.

They can still turn this ship around., But it will be cold dark winter first. Hopefully, I am using "winter" in the literal sense.

[onebadz68]

Can't believe no comments on the preliminary proxy statement. 

[H2R]

Dr. Jennifer Kissner's Excellent Presentation

This is the kind of presentation I enjoy. Very clear, well articulated. Overview of the data at 4 w, 8 w, 12 w, mean change in central retinal thickness data. Then the timeline for resubmittal and start of the clock...

I'm starting to feel pretty good about the likelihood of a possible FDA approval by September.

Best of luck with you investments!

[OGBritbox]

Looks good for summer !

[H2R]

Thanks OGBritbox,

Funny, I took pretty much the exact same notes (except for the price in Euro :)) ) Glad you shared them on the board.

I'm posting them here, they recoup yours:

OTLK Conf with Larry Kenyon (I just listened to it live. I'll check if there is a recording)

1. H1 2025 to launch in Europe
2. NICE pricing: lowest OTLK pricing for approved products
3. Price ~ 560 Euro in the UK
4. FDA resubmittal in Q1 (the usual)
5. FDA decision expected before Sept 25. CMC, other CRL issues addressed.

The rest is pretty much the same as usual.

Cheers!

Best of luck with your investments!

[OGBritbox]

Webinar highlights:
UK Price £472
Germany a few months after UK
IN USA: BLA submited in March 2025 and FDA have 180 days to take a decision.
They expect approval by FDA in September 2025

No wonder why they needed to sell some warrants. We should be seeing some money roll in from the EU by summer. Fingers crossed, as it’ll be great for SP

[H2R]

Lawrence A. Kenyon, CFO and Interim CEO of Outlook Therapeutics, will present at LIVE! with Webull Corporate Connect at the Healthcare Investment Webinar on Wednesday, January 29, 2025, at 2:00 PM ET.

#SaveTheDate! Lawrence A. Kenyon, CFO and Interim CEO of Outlook Therapeutics, will present at LIVE! with Webull Corporate Connect at the Healthcare Investment Webinar on Wednesday, January 29, 2025, at 2:00 PM ET.

Register here: https://t.co/R3OQAH46U8 $OTLK @WebullGlobal pic.twitter.com/dQe0jbPhfB

— Outlook Therapeutics (@OutlookTx) January 27, 2025

Looking forward to hearing the interim CEO. Hopefully with news on two fronts:
* the FDA resubmittal status
* the European Launch status.

Best of luck with your investments!

[H2R]

FDA Resubmittal within 2 months

Thanks someconcerns for posting the Jan 23rd PR. Very interesting.

Under Russ Trenary, the Company executed on the plans within their PR deadlines. That has been quite consistent over the year. I would expect this behavior to continue under Lawrence Kenyon.

So when the January 23rd, 2025 PR states:

Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) application for ONS-5010 in the first quarter of calendar 2025.

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-presentation-efficacy-and-safety

which is in line with the January 16th, 2025 PR

“We believe that the statistically significant 12-week results for ONS-5010 in NORSE EIGHT, combined with the complete NORSE EIGHT data set, confirms our successful NORSE TWO pivotal study and will support the resubmission of our BLA in the United States for the treatment of wet AMD,” added Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “Our team continues the necessary work for the planned resubmission of our BLA in the first quarter of calendar 2025.

and they have been planning for resubmittal since the beginning of Norse 8, I tend to believe they will deliver on their timeline.

Before the end of March, the Company should have resubmitted.

Best of luck with your investments!

[someconcerns]

Outlook Therapeutics® Announces Presentation of Efficacy and Safety Results from NORSE EIGHT Clinical Trial Evaluating ONS-5010 for the Treatment of Wet AMD

GlobeNewswire - 9:05 AM ET 1/23/2025 Investment News

Email Facebook. Twitter. LinkedIn. Print

Data presented at Hawaiian Eye and Retina 2025 Meeting
Results confirmed that intravitreal ONS-5010 provided early and sustained anatomic improvements, with steady gains in BCVA and reliable, consistent safety
ONS-5010 demonstrated to be non-inferior to Lucentis at 4 and 12 weeks
Company on track for anticipated BLA resubmission in calendar Q1 2025

ISELIN, N.J., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. ( OTLK ) , a biopharmaceutical company that achieved regulatory approval in the European Union (EU) and the United Kingdom (UK) for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced the presentation of data from NORSE EIGHT at the Hawaiian Eye and Retina 2025 Meeting being held January 18-24, 2025 in Kauai, HI.

As part of the meeting, Baruch D. Kuppermann, MD, PhD, of Gavin Herbert Eye Institute, University of California, Irvine, CA presented the abstract titled, “ONS-5010 (bevacizumab-vikg) versus Ranibizumab for Neovascular Age-related Macular Degeneration: Results from the NORSE-EIGHT Noninferiority Randomized Trial,” highlighting the Company’s recently announced 12-week safety and efficacy results for the NORSE EIGHT clinical trial evaluating ONS-5010 in wet AMD patients.

Image: none

The NORSE EIGHT clinical trial was a randomized, controlled, parallel-group, masked, non-inferiority study of 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 received injections at day 0 (randomization), week 4, and week 8 visits, and returned for a final study visit at week 12. The primary endpoint was mean change in BCVA from baseline to week 8.

“The NORSE EIGHT results provide additional evidence to the retina community that ONS-5010 meets the expectations for an ophthalmic formulation of bevacizumab, without the challenges that can arise from using repackaged, off-label formulations available today. The reductions in central retinal thickness observed in the trial confirmed that ONS-5010 reduced fluid in the retina on par with ranibizumab, and I’ve been encouraged with the consistency of this treatment across all NORSE clinical studies,” said Dr. Kuppermann.

Key Highlights

Mean BCVA at baseline was 58.8 ETDRS letters for the ONS-5010 group and 59.9 letters for the ranibizumab group.
ONS-5010 demonstrated mean BCVA improvements of +3.3, +4.2 and +5.5 letters at Months 1, 2, and 3 respectively.
The difference in mean BCVA between ONS-5010 and ranibizumab was -1.009 letters (95% confidence interval, -2.865, 0.848), meeting the noninferiority margin at Month 3 (p=0.0043) (applying the statistical parameters from the week 8 primary endpoint with the lower bound of the non-inferiority margin at -3.5 with a 95% confidence interval).
As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment with the U.S. Food and Drug Administration (FDA).
Anatomical response was similar between treatments, with a reduction in central retinal thickness of -123.9 microns for ONS-5010 treated eyes and -127.3 microns for the ranibizumab group.
ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab, with no cases of retinal vasculitis reported in either study arm. The most commonly reported adverse event (AE) was conjunctival hemorrhage, which occurred in 5 (2.5%) participants in each group.
Safety results demonstrated across the full duration of NORSE EIGHT are consistent with previously reported safety results from the NORSE ONE, NORSE TWO, and NORSE THREE clinical trials.

“Based on the data seen to date, we continue to be encouraged by the potential of ONS-5010 for the treatment of wet AMD. We believe that the complete data set from all of our NORSE clinical trials supports the resubmission of our BLA in the United States for the treatment of wet AMD, which we remain on track to complete this quarter,” added Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics ( OTLK ).

Based on the completed analysis of the 12-week results, Outlook Therapeutics ( OTLK ) plans to resubmit the Biologics License Application (BLA) application for ONS-5010 in the first quarter of calendar 2025.

For more information about the NORSE EIGHT study, visit clinicaltrials.gov and reference identifier NCT06190093.

In the EU and the UK, ONS-5010/LYTENAVA™ (bevacizumab gamma) has already been granted Marketing Authorization. Outlook Therapeutics ( OTLK ) intends to continue efforts to begin launching in Europe in the first half of calendar 2025.

About ONS-5010 / LYTENAVA™ (bevacizumab-vikg, bevacizumab gamma)

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab for the treatment of wet AMD. LYTENAVA™ (bevacizumab gamma) is the subject of a centralized Marketing Authorization granted by the European Commission in the European Union (EU) and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational.

Bevacizumab-vikg (bevacizumab gamma in the EU and UK) is a recombinant humanized monoclonal antibody (mAb) that selectively binds with high affinity to all isoforms of human vascular endothelial growth factor (VEGF) and neutralizes VEGF’s biologic activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells. Following intravitreal injection, the binding of bevacizumab to VEGF prevents the interaction of VEGF with its receptors on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation in the retina.

About Outlook Therapeutics, Inc. ( OTLK )

Outlook Therapeutics ( OTLK ) is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma), for the treatment of retina diseases, including wet AMD. LYTENAVA™ (bevacizumab gamma) is the first ophthalmic formulation of bevacizumab to receive European Commission and MHRA Marketing Authorization for the treatment of wet AMD. Outlook Therapeutics ( OTLK ) is working to initiate its commercial launch of LYTENAVA™ (bevacizumab gamma) in the EU and the UK as a treatment for wet AMD, expected in the first half of calendar 2025. In the United States, ONS-5010/LYTENAVA™ is investigational, is being evaluated in an ongoing non-inferiority study for the treatment of wet AMD, and if successful, the data may be sufficient for Outlook to resubmit a BLA to the FDA in the United States. If approved in the United States, ONS-5010/LYTENAVA™, would be the first approved ophthalmic formulation of bevacizumab for use in retinal indications, including wet AMD.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “expect,” “may,” “plan,” “potential,” “will,” or “would” the negative of terms like these or other comparable terminology, and other words or terms of similar meaning. These include, among others, Outlook Therapeutics’ plans for commercial launch of LYTENAVA™ in the UK and EU and timing thereof, as well as the potential to launch with a partner, expectations concerning the therapeutic potential of LYTENAVA™ as a treatment of wet AMD, Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, plans to resubmit the BLA for ONS-5010 and the timing thereof, Outlook Therapeutics’ commercialization strategy, expectations concerning decisions of regulatory bodies and the timing thereof, ONS-5010/LYTENAVA™’s potential as the first FDA-approved ophthalmic formulation of bevacizumab for use in treating retinal indications, including wet AMD, in the United States and other statements that are not historical fact. Although Outlook Therapeutics believes that it has a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting Outlook Therapeutics and are subject to risks, uncertainties and factors relating to its operations and business environment, all of which are difficult to predict and many of which are beyond its control. These risk factors include those risks associated with developing and commercializing pharmaceutical product candidates, risks of conducting clinical trials and risks in obtaining necessary regulatory approvals, the content and timing of decisions by regulatory bodies, the sufficiency of Outlook Therapeutics’ resources, as well as those risks detailed in Outlook Therapeutics’ filings with the Securities and Exchange Commission (SEC), including the Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the SEC on December 27, 2024, and future quarterly reports Outlook Therapeutics files with the SEC, which include uncertainty of market conditions and future impacts related to macroeconomic factors, including as a result of the ongoing overseas conflicts, high interest rates, inflation and potential future bank failures on the global business environment. These risks may cause actual results to differ materially from those expressed or implied by forward-looking statements in this press release. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Outlook Therapeutics does not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

Investor Inquiries:
Jenene Thomas
Chief Executive Officer
JTC Team, LLC
T: 908.824.0775
[e-mail]
Image: https://www.globenewswire.com/newsroom/ti?nf=OTMzNjQ4NiM2NzA2NzM0IzIwMjg4MjI=
Image: https://ml.globenewswire.com/media/NmJjMzk3ZTAtZmRiMC00NmZkLWIzOTgtZDI1YjI3OGZmYzk2LTEwNDAzOTM=/tiny/Outlook-Therapeutics-Inc-.png

Image: Primary Logo
Baruch D. Kuppermann, MD, PhD
Image: https://ml.globenewswire.com/media/1b88ce5b-691b-4ff4-8669-1d00607a0867/medium/baruch-d-kuppermann-md-phd.jpg

Baruch D. Kuppermann, MD, PhD
Source: Outlook Therapeutics, Inc. ( OTLK )

[H2R]

This is getting interesting!

https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeuticsr-announces-complete-twelve-week-efficacy

ONS-5010 demonstrated to be non-inferior to Lucentis at 12 weeks

BLA resubmission on track for calendar Q1 2025

Entered into agreements for warrant inducement transaction expected to result in up to $20.4 million in gross proceeds

ISELIN, N.J., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Outlook Therapeutics, or the Company) (Nasdaq: OTLK), a biopharmaceutical company that achieved regulatory approval in the European Union and the United Kingdom for the first authorized use of an ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD), today announced it has completed the analysis of the complete 12-week safety and efficacy results for NORSE EIGHT, the second of two adequate and well controlled clinical trials evaluating ONS-5010 in wet AMD patients. ONS-5010 demonstrated noninferiority to ranibizumab at week 12 in the NORSE EIGHT trial. Based on the completed analysis of the 12-week results, Outlook Therapeutics plans to resubmit the Biologics License Application (BLA) for ONS-5010 in the first quarter of calendar 2025.

Julia A. Haller, MD, Ophthalmologist-in-Chief at Wills Eye Hospital and an Outlook Therapeutics Board member, commented, “The 3-month data from NORSE EIGHT provides additional evidence to confirm what retina specialists expected. The clinical trial continues to demonstrate that ONS-5010 injections result in immediate and sustained anatomic efficacy, with steady gains in visual acuity and reliable, consistent safety.”

The difference in the mean between ONS-5010 and ranibizumab was -1.009 best corrected visual acuity (BCVA) letters with a 95% confidence interval of (-2.865, 0.848) in the NORSE EIGHT trial. Applying the statistical parameters from the week 8 primary endpoint with the lower bound of the non-inferiority margin at -3.5 with a 95% confidence interval, the noninferiority margin was met at week 12 (p=0.0043), indicating that the two study arms are not different at this timepoint. In the intent-to-treat (ITT) population, NORSE EIGHT demonstrated a mean 5.5 letter improvement in BCVA in the ONS-5010 arm and 6.5 letter improvement in BCVA in the ranibizumab arm.

Mean change in BCVA at week 12 Non-Inferiority
ONS-5010 1.25 mg +5.5 letters 95%CI: (-2.865, 0.848)
P-value: 0.0043

Ranibizumab 0.5mg +6.5 letters

Additionally, the change in central retinal thickness, a measure of anatomical response, was similar in both study arms at all three study timepoints.

Mean change in central retinal thickness
Week 4 Week 8 Week 12
ONS-5010 1.25 mg -106.6 microns -117.7 microns -123.9 microns
Ranibizumab 0.5mg -108.4 microns -120.9 microns -127.3microns

As previously announced, in the NORSE EIGHT trial, ONS-5010 did not meet the pre-specified non-inferiority endpoint at week 8 set forth in the special protocol assessment (SPA) with the U.S. Food and Drug Administration (FDA). However, BCVA data across all study timepoints demonstrated an improvement in vision, increasing over time, and the presence of biologic activity. Overall, in NORSE EIGHT, ONS-5010 demonstrated mean visual acuity improvements of +3.3 letters at week 4, +4.2 letters at week 8, and +5.5 letters at week 12.

Additionally, in NORSE EIGHT, ONS-5010 was generally well-tolerated with overall ocular adverse event rates comparable to ranibizumab. The safety results demonstrated across the full duration of NORSE EIGHT are consistent with previously reported safety results from the NORSE ONE, NORSE TWO, and NORSE THREE clinical trials, with no cases of retinal vasculitis reported in either study arm.

“We believe that the statistically significant 12-week results for ONS-5010 in NORSE EIGHT, combined with the complete NORSE EIGHT data set, confirms our successful NORSE TWO pivotal study and will support the resubmission of our BLA in the United States for the treatment of wet AMD,” added Lawrence Kenyon, Chief Financial Officer and Interim Chief Executive Officer of Outlook Therapeutics. “Our team continues the necessary work for the planned resubmission of our BLA in the first quarter of calendar 2025. We remain confident in the potential of ONS-5010/LYTENAVA™ to provide an important therapy for the treatment of wet AMD in place of off-label repackaged bevacizumab that has not received regulatory approval for use in retinal diseases here in the United States.”

In the European Union and the United Kingdom, ONS-5010/LYTENAVA™ (bevacizumab gamma) has already been granted Marketing Authorization. Outlook Therapeutics intends to begin launching in Europe in the first half of calendar 2025.

Best of luck with your investments!

[thermo]

Certainly agree that showing non-inferiority at 12 wks was good. It doesn't erase the 8-wk primary end point miss but, if the FDA wants to approve, it gives them cover. It's far from a certainty but the market would be better off with this drug approved.

Also, many participants in the announced transaction will likely sell the common and hold the warrants. I estimate about 4 million shares for sale from the deal, so there will be some pressure on the stock for a while.

[OGBritbox]

Great news!! I knew the 8 week preliminary was a fake news share grab. Looks like I have to average down some more due to additional dilution, but my bet is FDA is good to go

[alphapuppy]

Lil Kippy. I'm still wagging my tail, buddy!

[KIPK]

The only Dump is Life's Dump on you lil dog..

"Navid dump. I meant Navid dump"

[H2R]

OTLK SVP, Head of Europe, Jedd Comiskey talk on

https://vimeo.com/1040850052/9b4970a560

Taking over the investment talk from Russ Trenary. The message is pretty much the same as it's been for a while now.

Best of luck with your investments!

[alphapuppy]

Pula In his defense, he did say Mercedes 580 S!

[Law of Averages]

OTLK broke a key resistant level at $2.42 could see a run here.

[Pula]

Seems to be a problem w humanity when were comparing allowing people to see properly to luxury vehicles.

[thermo]

Healthcare systems everywhere have a cost problem. The reality we don't all get to drive Mercedes S-580s.

[Pula]

I fail to understand what the csuite has been doing 5 days a week on salaries in the hundreds of thousands and the eu uk partnership hasnt been fully explored. Everything shouldve been fully explored after crl. But instead you had a ceo that thought the fda wanted animal studies and instead of doing a proper catt study they do 8 week endpoint horseshit so none of this comes as a surprise. This company needs to close. It needs to close and bevacizumab needs to stop being used becausw every opthalmologist on the western world knows faricimab or eylea is what they would always inject in their parents eyes. This has been a big fing game and these thieves have profitted from it. Trenary getting any severance is criminal. He has no soul to even accept a penny