Outlook Therapeutics Reports First Quarter Fiscal Year 2026 Financial Results and Provides Corporate Update

Rhea-AI Summary

Outlook Therapeutics (Nasdaq: OTLK) reported Q1 FY2026 results and a regulatory update on Feb 17, 2026. The company recorded a $23.1M net loss ($0.38/share) and an adjusted net loss of $13.5M ($0.22/share). Unit sales of LYTENAVA more than doubled quarter-over-quarter and Austria launched in January 2026. A Type A meeting request was submitted to the FDA following a Dec 30, 2025 CRL for ONS-5010.

Positive

• Unit sales of LYTENAVA in Europe more than doubled quarter-over-quarter
• Commercial launch of LYTENAVA in Austria in January 2026, with further EU launches planned
• Adjusted net loss improved to $13.5M from $21.6M year-ago adjusted loss

Negative

• Reported $23.1M net loss versus $17.4M net income prior-year period
• Received a CRL from FDA for ONS-5010 requiring additional confirmatory evidence
• Cash and equivalents of $8.7M as of Dec 31, 2025, excluding $2.4M ATM proceeds

Market Reaction

-8.10% $0.45

15m delay 5 alerts

-8.10% Since News

$0.45 Last Price

$0.45 $0.49 Day Range

-$3M Valuation Impact

$33M Market Cap

0.2x Rel. Volume

Following this news, OTLK has declined 8.10%, reflecting a notable negative market reaction. Our momentum scanner has triggered 5 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $0.45. This price movement has removed approximately $3M from the company's valuation.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Silver for real-time data.

Key Figures

Net loss: $23.1 million EPS: $0.38 per share Prior net income: $17.4 million +5 more

8 metrics

Net loss $23.1 million Q1 FY2026 net loss attributable to common stockholders

EPS $0.38 per share Q1 FY2026 basic and diluted loss per share

Prior net income $17.4 million Q1 FY2025 net income attributable to common stockholders

Prior EPS $0.72 per share Q1 FY2025 basic and diluted earnings per share

Adjusted net loss $13.5 million Q1 FY2026 adjusted net loss attributable to common stockholders

Prior adjusted net loss $21.6 million Q1 FY2025 adjusted net loss attributable to common stockholders

Cash and equivalents $8.7 million Cash and cash equivalents as of December 31, 2025

ATM proceeds $2.4 million Net proceeds from at-the-market program after December 31, 2025

Market Reality Check

Price: $0.4900 Vol: Volume 3,117,402 is 1.62x...

high vol

$0.4900 Last Close

Volume Volume 3,117,402 is 1.62x the 20-day average of 1,925,238, indicating elevated interest ahead of/around the earnings update. high

Technical Shares at $0.49 are trading below the 200-day MA of $1.50 and remain 85.55% under the 52-week high, despite being above the 52-week low.

Peers on Argus

OTLK is up 11.11%, while peers show mixed moves: PSTV (+3.15%), VRCA (+1.43%), R...

OTLK is up 11.11%, while peers show mixed moves: PSTV (+3.15%), VRCA (+1.43%), RADX (+0.62%) versus CALC (-7.86%) and FBIOP (-1.24%). This pattern points to a stock-specific reaction to OTLK’s earnings and regulatory update rather than a broad biotechnology sector rotation.

Previous Earnings Reports

5 past events · Latest: Dec 19 (Negative)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 19	Annual results	Negative	-2.9%	Reported FY2025 net loss and modest initial European LYTENAVA revenue.
Aug 14	Quarterly results	Positive	+14.1%	First commercial LYTENAVA sales in Europe and PDUFA date visibility.
May 15	Quarterly results	Negative	+4.5%	Large quarterly net loss despite preparation for EU launches and FDA review.
Feb 14	Quarterly results	Positive	+1.6%	Return to net income and plans to resubmit ONS-5010 BLA and launch in EU.
Dec 27	Annual results	Positive	+18.2%	Reported FY2024 with EU/UK approval of LYTENAVA and planned first launch.

Pattern Detected

Earnings-related news for OTLK has often resulted in positive price moves, even when reporting sizeable net losses, with only one divergence where shares rose despite more negative financial commentary.

Recent Company History

Across recent earnings events, Outlook Therapeutics has balanced sizeable net losses with key strategic milestones. Prior updates highlighted EU/UK approvals for LYTENAVA™, progression of the ONS-5010 program, and the transition to commercial sales in Europe, with cash balances typically under $15M. Price reactions around these earnings have usually aligned with the qualitative tone of the news, and today’s update continues the theme of European commercial expansion alongside U.S. regulatory uncertainty.

Historical Comparison

+7.1% avg move · In the past, OTLK’s earnings or results updates moved the stock by an average of 7.11%. Today’s 11.1...

earnings

+7.1%

Average Historical Move earnings

In the past, OTLK’s earnings or results updates moved the stock by an average of 7.11%. Today’s 11.11% move is somewhat stronger than typical, but still within the range of prior earnings-driven reactions.

Earnings updates trace a progression from EU/UK approvals for LYTENAVA™ through initial German/UK launches and growing European sales, while U.S. ONS-5010 regulatory milestones and setbacks increasingly shape the narrative alongside recurring net losses.

Market Pulse Summary

The stock is down -8.1% following this news. A negative reaction despite the mixed update would fit ...

Analysis

The stock is down -8.1% following this news. A negative reaction despite the mixed update would fit a pattern where investors focus on headline GAAP net loss of $23.1 million and modest cash of $8.7 million rather than adjusted metrics. Ongoing U.S. regulatory uncertainty following the CRL for ONS-5010, even with a pending Type A meeting request, could weigh on sentiment despite growing European LYTENAVA™ unit sales and incremental ATM proceeds of $2.4 million.

Key Terms

type A meeting, u.s. food and drug administration, complete response letter (crl), biologics license application (bla), +4 more

8 terms

type A meeting regulatory

"Type A meeting request submitted to the U.S. Food and Drug Administration"

A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.

u.s. food and drug administration regulatory

"Type A meeting request submitted to the U.S. Food and Drug Administration"

The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.

complete response letter (crl) regulatory

"to discuss the Complete Response Letter (CRL) dated December 30, 2025"

A complete response letter (CRL) is an official communication from a drug or medical device regulator saying an approval application cannot be approved in its current form and listing specific problems that must be fixed. For investors, a CRL is like a referee pausing a game and listing rule violations — it signals extra time, cost and uncertainty before a product can reach market, and it often prompts a reassessment of a company’s near-term prospects.

biologics license application (bla) regulatory

"regarding the Company’s Biologics License Application (BLA) for ONS-5010"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

at-the-market offering program financial

"does not include $2.4 million of net proceeds from sales under its at-the-market offering program"

An at-the-market offering program lets a company sell newly issued shares directly into the open market at current trading prices through a broker, rather than issuing a large block of stock all at once. It matters to investors because it provides the company a flexible way to raise cash over time, which can dilute existing shares gradually and affect earnings per share and stock price depending on how much and when shares are sold—think of it as a faucet the company can open or close to add supply to the market.

warrant liability financial

"excludes $6.7 million of loss from change in fair value of promissory notes and $2.8 million of loss from change in fair value of warrant liability"

Warrant liability is the financial obligation a company records when it grants warrants—special options giving the holder the right to buy company shares at a set price in the future. It matters to investors because changes in this liability can affect a company's reported earnings and overall financial health, similar to how a pending contract can influence a company's future value.

promissory notes financial

"excludes $6.7 million of loss from change in fair value of promissory notes"

A promissory note is a written IOU in which a borrower promises to repay a specific amount to a lender, usually with stated interest and by a set date. Investors care because these notes are a formal debt claim—like holding a scheduled payment stream—so they affect a company’s borrowing costs, cash flow and credit risk; notes can be bought, sold or used as collateral, which influences liquidity and recoveries if things go wrong.

wet age-related macular degeneration medical

"for the treatment of wet age-related macular degeneration (wet AMD)"

A severe eye condition in which abnormal, fragile blood vessels grow beneath the macula — the small central part of the retina responsible for sharp, detailed vision — and leak fluid or blood, causing rapid loss of central sight. Investors care because the condition drives demand for high-cost therapies, medical devices and ongoing care; successful treatments can create sizable markets, affect healthcare spending and influence regulatory and reimbursement decisions, much like fixing a leaking camera lens restores image quality and value.

AI-generated analysis. Not financial advice.

• Continued expansion of LYTENAVA™ (bevacizumab gamma) in Europe underway, including commercial launch in Austria in January 2026
• Additional European launches expected in 2026
• Type A meeting request submitted to the U.S. Food and Drug Administration for ONS-5010
  

ISELIN, N.J., Feb. 17, 2026 (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 announced financial results for the first quarter fiscal year 2026 and provided a corporate update.

“LYTENAVA™ (bevacizumab gamma) is demonstrating increasing adoption in Europe following our initial launches, with growing demand and quarter-over-quarter unit sales growth,” said Bob Jahr, Chief Executive Officer of Outlook Therapeutics. “Building on this momentum, we are actively working towards launching into additional EU markets in the near term, following our January launch into Austria, as part of a broader regional expansion strategy.”

In addition to the planned launches of LYTENAVA in Ireland and the Netherlands in 2026, followed by France, Italy and Spain in 2027, Outlook Therapeutics also continues with its efforts to potentially partner with established companies in other countries in Europe, Latin America and Asia.

Financial Highlights for the Fiscal First Quarter Ended December 31, 2025

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported net loss attributable to common stockholders of $23.1 million, or $ 0.38 per basic and diluted share. This compares with net income attributable to common stockholders of $17.4 million, or $0.72 per basic and diluted share for the same period last year.

For the fiscal first quarter ended December 31, 2025, Outlook Therapeutics reported an adjusted net loss attributable to common stockholders of $13.5 million, or $0.22 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders of $21.6 million, or $0.89 per basic and diluted share for the first fiscal quarter of 2025.

Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2025 excludes $6.7 million of loss from change in fair value of promissory notes and $2.8 million of loss from change in fair value of warrant liability. Adjusted net loss attributable to common stockholders for the fiscal quarter ended December 31, 2024 excludes $40.3 million of gain from change in fair value of warrant liability and $1.3 million of loss from change in fair value of promissory notes.

Revenue in the fiscal quarter ended December 31, 2025 was negatively impacted by an increase in the returns reserve for estimated product returns from the UK distributor resulting from short dated product used for the initial shipments into the distribution channel in June 2025 to support the launch of LYTENAVA in Europe. No further adjustments for these batches are anticipated for the remainder of fiscal year 2026. Overall, unit sales of LYTENAVA in Europe more than doubled in the quarter ended December 31, 2025, as compared to the previous three months.

As of December 31, 2025, Outlook Therapeutics had cash and cash equivalents of $8.7 million, which does not include $2.4 million of net proceeds from sales under its at-the-market offering program after December 31, 2025.

ONS-5010 U.S. Regulatory Update

Outlook Therapeutics has requested a Type A meeting with the U.S. Food and Drug Administration to discuss the Complete Response Letter (CRL) dated December 30, 2025, regarding the Company’s Biologics License Application (BLA) for ONS-5010, an investigational ophthalmic bevacizumab formulation for the treatment of wet age-related macular degeneration (wet AMD). The Company submitted the Type A meeting request to work with the FDA on a path forward to resolving the FDA’s request for additional confirmatory evidence. The timing of the Type A meeting is subject to FDA scheduling, and further updates will be provided as appropriate.

“Outlook Therapeutics remains fully committed to advancing ONS-5010 in the United States,” Mr. Jahr continued. “Our ongoing discussions with the FDA beginning in September 2025 have confirmed alignment on CMC, safety, and the positive results from NORSE TWO, and we look forward to constructive discussions with the FDA as we seek guidance on confirmatory evidence that will withstand current dynamics.”

The CRL identified a single deficiency based on a purported lack of substantial evidence of effectiveness, and recommended submission of additional confirmatory evidence. Outlook Therapeutics believes this determination is inconsistent with the totality of evidence submitted in the BLA, including data from an adequate and well-controlled study and confirmatory evidence of effectiveness. Prior to submitting the Type A meeting request, Outlook Therapeutics conducted informal meetings with the FDA to discuss the CRL.

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

ONS-5010/LYTENAVA™ is an ophthalmic formulation of bevacizumab produced in the United States 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. 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 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 statements that are, or may be deemed to be “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,” “are,” “believe,” “can,” “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, either directly or with a partner, and the timing thereof, expectations concerning Outlook Therapeutics’ plans to conduct a Type A meeting with the FDA and the ability to remediate or otherwise resolve deficiency identified in the CRL, expectations concerning decisions of regulatory bodies and the timing thereof, the potential to receive approval from the FDA, the potential of ONS-5010/LYTENAVA™ as a treatment for wet AMD, the market opportunity for LYTENAVA™ in Europe and 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, including the risk that Outlook Therapeutics is not able to provide sufficient evidence to 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, 2025, filed with the SEC on December 19, 2025, as supplemented by 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

Consolidated Statements of Operations
(Amounts in thousands, except per share data)
		Three Months Ended December 31,
			2025				2024
Revenues, net		$	(1,208	)		$	-
Cost of revenues			30				-
Gross profit			(1,238	)			-
Operating expenses:
Research and development			3,634				9,660
Selling, general and administrative			8,612				11,947
Loss from operations			(13,484	)			(21,607	)
Loss on equity method investment			38				33
Interest income			-				(49	)
Loss from change in fair value of promissory notes			6,744				1,304
Loss (gain) from change in fair value of warrant liability			2,792				(40,273	)
Net (loss) income		$	(23,058	)			17,378
Per share information:
Net (loss) income per share of common stock, basic and diluted		$	(0.38	)		$	0.72
Weighted average shares outstanding, diluted			60,205				24,234

Condensed Consolidated Balance Sheet Data
(Amounts in thousands)
		December 31, 2025				September 30, 2025
Cash and cash equivalents		$	8,677			$	8,083
Total assets		$	18,239			$	18,584
Current liabilities		$	49,056			$	45,815
Total stockholders' deficit		$	(38,549	)		$	(32,188	)

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 December 31,
			2025				2024
Net loss attributable to common stockholders, as reported (GAAP)		$	(23,058	)		$	17,378
Adjustments for reconciled items:
Loss from change in fair value of promissory notes			6,744				1,304
Loss (gain) from change in fair value of warrant liability			2,792				(40,273	)
Adjusted net loss attributable to common stockholders (non-GAAP)		$	(13,522	)		$	(21,591	)
Net loss attributable to common stockholders per share of
common stock - basic as reported (GAAP)		$	(0.38	)		$	0.72
Adjustments for reconciled items:
Loss from change in fair value of promissory notes			0.11				0.05
Loss (gain) from change in fair value of warrant liability			0.05				(1.66	)
Adjusted net loss attributable to common stockholders
per share of common stock - basic (non-GAAP)		$	(0.22	)		$	(0.89	)

FAQ

What did Outlook Therapeutics report for Q1 FY2026 results (OTLK)?

Outlook reported a $23.1M net loss for Q1 FY2026, or $0.38 per share. According to the company, adjusted net loss was $13.5M, reflecting exclusions for fair value changes in notes and warrant liabilities.

How did LYTENAVA sales perform in Europe in Q1 FY2026 for OTLK?

LYTENAVA unit sales in Europe more than doubled quarter-over-quarter. According to the company, Austria launched in January 2026 and additional EU launches are planned in 2026–2027.

What is Outlook Therapeutics' cash position as of December 31, 2025 (OTLK)?

Outlook had $8.7M cash and equivalents at Dec 31, 2025, excluding $2.4M ATM proceeds received after period end. According to the company, liquidity remains a near-term focus.

Why did Outlook Therapeutics submit a Type A meeting request to the FDA for ONS-5010 (OTLK)?

They requested a Type A meeting to address a CRL dated Dec 30, 2025 that called for additional confirmatory evidence. According to the company, prior discussions showed alignment on CMC, safety, and NORSE TWO results.

Did Outlook Therapeutics disclose revenue impacts in Q1 FY2026 (OTLK)?

Yes. Revenue was negatively impacted by an increased returns reserve for short-dated product from the UK distributor. According to the company, no further adjustments for those batches are anticipated in FY2026.

What is Outlook Therapeutics' European commercial expansion plan for LYTENAVA (OTLK)?

The company plans launches in Ireland and the Netherlands in 2026, then France, Italy and Spain in 2027. According to the company, it is also pursuing partnership opportunities in Europe, Latin America and Asia.