Outlook Therapeutics Reports Financial Results for Third Quarter Fiscal Year 2025 and Provides Corporate Update

Rhea-AI Summary

Outlook Therapeutics (NASDAQ: OTLK) reported its Q3 FY2025 financial results and achieved significant milestones. The company recorded its first commercial sales of LYTENAVA™ (bevacizumab gamma) in Europe, marking its transition to a commercial-stage company. For Q3, OTLK reported revenue of $1.5 million and a net loss of $20.2 million ($0.55 per share).

The company has a crucial PDUFA date of August 27, 2025, for ONS-5010/LYTENAVA™ FDA approval in the United States. LYTENAVA™ is now commercially available in Germany and UK for wet AMD treatment, with first patients already dosed. The company ended the quarter with cash and equivalents of $8.9 million.

Positive

• None.

Negative

• Significant net loss of $20.2 million in Q3
• Limited cash position of $8.9 million
• Still awaiting crucial FDA approval in the U.S. market

Insights

Biotech Financial Analyst

Outlook's first European LYTENAVA sales mark commercial transition, but significant cash burn continues as crucial FDA decision approaches.

Outlook Therapeutics has reached a pivotal milestone with first commercial sales of LYTENAVA (bevacizumab gamma) in Europe, specifically in Germany and the UK. This marks the company's transformation from a clinical-stage to a commercial entity. Revenue generation has begun with $1.5 million reported for Q3, representing initial product transfers to distributors.

Despite this progress, the company reported a substantial net loss of $20.2 million ($0.55 per share), though improved from the $0.89 per share loss in the year-ago period. On an adjusted basis, excluding warrant and promissory note valuation impacts, the loss was $15.8 million ($0.44 per share).

The cash position is concerning at just $8.9 million as of June 30, likely insufficient for extended operations without additional financing, especially considering the quarterly burn rate. The company's financial runway appears limited unless commercial traction accelerates dramatically.

The approaching FDA PDUFA date on August 27 represents a crucial inflection point. Following earlier rejection and subsequent resubmission based on the NORSE EIGHT trial data, this regulatory decision will determine whether Outlook can access the lucrative US market, where approximately 2.7 million off-label bevacizumab injections occur annually.

The strategic collaboration with Cencora for global distribution demonstrates preparation for commercialization, but near-term revenue expectations should be tempered as market penetration will take time. While European approval is significant, the US market represents a comparable opportunity that remains contingent on imminent FDA review.

Ophthalmology Specialist

LYTENAVA's EU approval provides first regulated bevacizumab for wet AMD, addressing safety concerns with off-label alternatives while awaiting FDA decision.

The commercialization of LYTENAVA (bevacizumab gamma) in Europe represents a significant advancement in retinal care. This product addresses a critical gap in the market as the first and only authorized ophthalmic formulation of bevacizumab specifically developed for wet AMD. The clinical significance cannot be overstated - approximately 2.8 million bevacizumab injections are administered annually in Europe, but these have historically been off-label, repackaged versions not specifically formulated or approved for ocular use.

From a safety perspective, LYTENAVA offers potential risk mitigation compared to off-label repackaged bevacizumab, which can present sterility concerns, inconsistent concentration, and potential silicone oil droplet contamination from syringes not designed for ophthalmic use. These factors have created reluctance among some retina specialists to use off-label bevacizumab despite its cost advantages.

The regulatory pathway in the US hinges on the NORSE EIGHT study, a non-inferiority trial comparing ONS-5010 to ranibizumab with an 8-week primary endpoint. The FDA specifically requested this design following earlier rejection, suggesting the agency has provided a clear pathway to potential approval.

For clinicians and patients, LYTENAVA potentially offers a best-of-both-worlds scenario: the well-established efficacy profile of bevacizumab with regulatory oversight ensuring consistent manufacturing, sterility, and proper formulation for intravitreal injection. The fact that patients have already been treated in both Germany and the UK indicates acceptance among early-adopting retina specialists, though broader uptake patterns will develop over coming quarters.

• First commercial sales of LYTENAVA™ (bevacizumab gamma) achieved in Europe
• ONS-5010/LYTENAVA™ (bevacizumab-vikg) Prescription Drug User Fee Act (PDUFA) goal date of August 27, 2025, in the United States
  
  

ISELIN, N.J., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today reported financial results for the third quarter of fiscal year 2025 and provided a corporate update.

Financial Highlights for the Fiscal Third Quarter Ended June 30, 2025

For the fiscal third quarter ended June 30, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $20.2 million, or $0.55 per basic and diluted share, and $1.5 million of revenue. Revenue consisted of the initial sales into Germany and the UK for LYTENAVA™ where title to the product has transferred to the distributor. This compares with net loss attributable to common stockholders of $0.89 per basic and diluted share for the same period last year, and no revenue.

For the fiscal third quarter ended June 30, 2025, Outlook Therapeutics also reported an adjusted net loss attributable to common stockholders of $15.8 million, or $0.44 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $19.2 million, or $0.83 per basic and diluted share, for fiscal third quarter 2024.

Adjusted net loss attributable to common stockholders for the fiscal third quarter ended June 30, 2025 excludes $2.3 million of loss from change in fair value of promissory notes and $2.0 million of loss from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal third quarter ended June 30, 2024 excludes $3.4 million of warrant related expenses, $59.5 million of gain from change in fair value of warrant liability and $7.6 million of gain from change in fair value of convertible promissory notes.

As of June 30, 2025, Outlook Therapeutics had cash and cash equivalents of $8.9 million.

Upcoming Near-Term Milestone

• U.S. Food and Drug Administration (FDA) PDUFA goal date for ONS-5010 is August 27, 2025.
  
  

“With the first commercial sales of LYTENAVA™ (bevacizumab gamma) in Europe for the treatment of wet AMD, the transformation of Outlook Therapeutics into a commercial company has begun,” commented Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “We are proud to report that the first patients have already been dosed in both Germany and the UK, and we are pushing ahead with our efforts to enhance the addition of this important therapy to the standard treatment regimen as quickly as possible in these key markets. We continue to execute on our commercial pathway forward and have preparations underway in advance of potential U.S. FDA approval later this month.”

LYTENAVA™ (bevacizumab gamma) European Commercial Update

LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD). LYTENAVA™ (bevacizumab gamma) is the first and only authorized ophthalmic formulation of bevacizumab for use in treating wet AMD in adults in the European Union and UK.

Off-label repackaged bevacizumab is one of the most frequently used first-line anti-VEGF treatments in Europe (approximately 2.8 million injections annually) and the United States (approximately 2.7 million injections annually) for the treatment of retinal diseases. ONS-5010/LYTENAVA™ has potential to mitigate certain risks associated with the current off-label use of repackaged bevacizumab.

As previously announced, Outlook Therapeutics has entered into a strategic collaboration with Cencora to support the commercial launch of LYTENAVA™ globally following regulatory approvals. The collaboration and integrated approach is designed to support market access and efficient distribution of LYTENAVA™ to benefit all stakeholders, including retina specialists, providers and patients in the European Union and UK and, if approved, in the United States.

ONS-5010/LYTENAVA™ (bevacizumab-vikg) Clinical and Regulatory Update

In April 2025, Outlook Therapeutics announced that the FDA acknowledged receipt of the resubmission of the Biologics License Application (BLA) for ONS-5010 (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet AMD. The FDA has determined that the BLA is a Class 2 review, which results in a six-month review period from the date of resubmission. The FDA set a PDUFA goal date of August 27, 2025. ONS-5010, if approved, will be branded as LYTENAVA™ (bevacizumab-vikg) in the United States for the treatment of wet AMD and is expected to receive 12 years of regulatory exclusivity.

The ONS-5010 BLA resubmission was 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.

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 EU and Marketing Authorization granted by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of wet AMD.

In the United States, ONS-5010/LYTENAVA ™ (bevacizumab-vikg) is investigational. In certain European Union Member States ONS-5010/LYTENAVA™ must receive pricing and reimbursement approval before it can be sold.

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.

Outlook Therapeutics is a biopharmaceutical company focused on the development and commercialization of ONS-5010/LYTENAVA™ (bevacizumab-vikg; bevacizumab gamma) to enhance the standard of care for bevacizumab for the treatment of retina diseases. 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 commenced commercial launch of LYTENAVA™ (bevacizumab gamma) in Germany and the UK as a treatment for wet AMD.

In the United States, ONS-5010/LYTENAVA™ (bevacizumab-vikg) is investigational, and a BLA has been resubmitted to the FDA. 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.

Non-GAAP Financial Measures

Outlook Therapeutics prepares its consolidated financial statements in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP) and pursuant to accounting requirements of the Securities and Exchange Commission (SEC). In an effort to provide investors with additional information regarding the results and to provide a meaningful period-over-period comparison of Outlook Therapeutics’ financial performance, Outlook Therapeutics sometimes uses non-U.S. GAAP financial measures (NGFM) as defined by the SEC. In this press release, Outlook Therapeutics uses “adjusted net loss attributable to common stockholders,” which is defined as net loss attributable to common stockholders excluding warrant inducement expenses and changes in fair value of warrants and convertible promissory notes, as well as “adjusted net loss attributable to common stockholders per share of common stock – basic and diluted,” which is defined as net loss attributable to common stockholders per share of common stock – basic and diluted, excluding warrant inducement expenses and changes in fair value of warrants and convertible promissory notes. Management uses these NGFMs because they adjust for certain non-cash items that impact financial results but not cash flows and that management believes are not related to its core business. Management uses these NGFMs to evaluate Outlook Therapeutics’ financial performance against internal budgets and targets. Management believes that these NGFMs are useful for evaluating Outlook Therapeutics’ core operating results and facilitating comparison across reporting periods. Outlook Therapeutics believes these NGFMs should be considered in addition to, and not in lieu of, GAAP financial measures. Outlook Therapeutics’ NGFMs may be different from the same NGFMs used by other companies. Reconciliations to the closest U.S. GAAP financial measures are provided in the tables below.

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,” “on track,” “plan,” “potential,” “target,” “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, plans for commercial launch of LYTENAVA™ in additional markets and the timing thereof, expectations concerning Outlook Therapeutics’ ability to remediate or otherwise resolve deficiencies identified in the CRL issued by the FDA, including with respect to an additional clinical trial and CMC issues, expectations concerning decisions of regulatory bodies and the timing thereof, including market exclusivity, the potential to receive approval from the FDA and the timing thereof, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD and to mitigate certain risks associated with the current off-label use of repackaged bevacizumab, the market opportunity for LYTENAVA™ in Europe and the United States, expectations concerning the relationship with Cencora and the benefits and potential expansion thereof, 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, including the risk that the data from the NORSE EIGHT trial does not support the approval by the FDA of the ONS-5010 BLA, 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 (the 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, as supplemented by the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2025 and future 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, tariffs and trade tensions, fluctuations in interest rates and 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
OTLK@jtcir.com

Outlook Therapeutics, Inc.
Consolidated Statements of Operations
(Amounts in thousands, except per share data)
		Three months ended June 30,								Nine months ended June 30,
			2025				2024				2025				2024
Revenues, net		$	1,505			$	—			$	1,505			$	—
Cost of revenues			440				—				440				—
Gross profit			1,065				—				1,065				—
Operating expenses:
Research and development		$	7,135			$	11,202			$	21,202			$	29,240
Selling, general and administrative			9,679				8,361				29,610				19,586
Loss from operations			(15,749	)			(19,563	)			(49,747	)			(48,826	)
Loss on equity method investment			30				57				100				85
Interest expense (income), net			49				(404	)			19				2,491
Loss (gain) from change in fair value of promissory notes			2,324				(7,563	)			5,739				1,949
Warrant related expenses			—				3,392				—				37,490
Warrant inducement expenses			—				—				33,857				—
Loss (gain) from change in fair value of warrant liability			2,000				(59,454	)			(40,333	)			(9,786	)
(Loss) income before income taxes			(20,152	)			44,409				(49,129	)			(81,055	)
Income tax expense			—				—				3				3
Net (loss) income		$	(20,152	)		$	44,409			$	(49,132	)		$	(81,058	)
Per share information:
Net (loss) income per share of common stock, basic		$	(0.55	)		$	1.91			$	(1.60	)		$	(4.82	)
Net loss per share of common stock, diluted		$	(0.55	)		$	(0.89	)		$	(1.60	)		$	(4.82	)
Weighted average shares outstanding, basic			36,957				23,227				30,664				16,823
Weighted average shares outstanding, diluted			36,957				25,476				30,664				16,823

Condensed Consolidated Balance Sheet Data
(Amounts in thousands)
		June 30, 2025				September 30, 2024
Cash and cash equivalents		$	8,901			$	14,928
Total assets		$	22,392			$	28,823
Current liabilities		$	31,489			$	42,554
Total stockholders' deficit		$	(37,190	)		$	(73,077	)

Reconciliation Between Reported Net Loss (GAAP) and Adjusted Net Loss (Non-GAAP), in each case
Attributable to Common Stockholders
(Amounts in thousands, except per share data)
		Three months ended June 30,								Nine months ended June 30,
		2025				2024				2025				2024
Net (loss) income attributable to common stockholders, as reported (GAAP)		$	(20,152	)		$	44,409			$	(49,132	)		$	(81,058	)
Adjustments for reconciled items:
Loss (gain) from change in fair value of promissory notes			2,324				(7,563	)			5,739				1,949
Warrant related expenses			—				3,392				—				37,490
Warrant inducement expenses			—				—				33,857				—
Loss (gain) from change in fair value of warrant liability			2,000				(59,454	)			(40,333	)			(9,786	)
Adjusted net loss attributable to common stockholders (non-GAAP)		$	(15,828	)		$	(19,216	)		$	(49,869	)		$	(51,405	)
Net (loss) income attributable to common stockholders per share of
common stock - basic as reported (GAAP)		$	(0.55	)		$	1.91			$	(1.60	)		$	(4.82	)
Adjustments for reconciled items:
Loss (gain) from change in fair value of promissory notes			0.06				(0.33	)			0.19				0.12
Warrant related expenses			—				0.15				—				2.23
Warrant inducement expenses			—				—				1.10				—
Loss (gain) from change in fair value of warrant liability			0.05				(2.56	)			(1.32	)			(0.58	)
Adjusted net loss attributable to common stockholders
per share of common stock - basic (non-GAAP)		$	(0.44	)		$	(0.83	)		$	(1.63	)		$	(3.05	)
Net loss attributable to common stockholders per share of
common stock - diluted as reported (GAAP)		$	(0.55	)		$	(0.89	)		$	(1.60	)		$	(4.82	)
Adjustments for reconciled items:
Loss (gain) from change in fair value of promissory notes			0.06				(0.03	)			0.19				0.12
Warrant related expenses			—				0.15				—				2.23
Warrant inducement expenses			—				—				1.10				—
Loss (gain) from change in fair value of warrant liability			0.05				(0.06	)			(1.32	)			(0.58	)
Adjusted net loss attributable to common stockholders
per share of common stock - diluted (non-GAAP)		$	(0.44	)		$	(0.83	)		$	(1.63	)		$	(3.05	)
Weighted average shares outstanding, basic			36,956,582				23,227,069				30,663,988				16,822,774
Weighted average shares - diluted			36,956,582				25,476,438				30,663,988				16,822,774

FAQ

What were Outlook Therapeutics (OTLK) Q3 2025 financial results?

OTLK reported revenue of $1.5 million and a net loss of $20.2 million ($0.55 per share). The company had cash and equivalents of $8.9 million as of June 30, 2025.

When is the PDUFA date for Outlook Therapeutics' ONS-5010/LYTENAVA™?

The FDA has set a PDUFA goal date of August 27, 2025 for ONS-5010/LYTENAVA™ in the United States.

Where is LYTENAVA™ currently commercially available?

LYTENAVA™ (bevacizumab gamma) is now commercially available in Germany and the UK for the treatment of wet age-related macular degeneration (wet AMD).

What is the market potential for LYTENAVA™?

The market potential is significant, with approximately 2.8 million injections annually in Europe and 2.7 million injections annually in the United States for off-label bevacizumab in retinal diseases.

How does LYTENAVA™ differentiate from current treatments?

LYTENAVA™ is the first and only authorized ophthalmic formulation of bevacizumab for wet AMD in the EU and UK, designed to mitigate risks associated with current off-label use of repackaged bevacizumab.