Milestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update
No clinical safety or efficacy concerns raised by FDA
MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ended March 31, 2025. The Company also announced the submission of a meeting request to the U.S. Food and Drug Administration (FDA) as the next step in the resolution of CRL issues.
'Our immediate priority is to engage with the U.S. FDA in order to address the CMC-related issues raised in the CRL received for CARDAMYST as a treatment for PSVT,' said Joe Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. 'We are confident we can work with the FDA to fully respond to the CRL and remain committed to the potential of CARDAMYST. If approved, it will be the first and only self-administered therapy for the rapid termination of episodes of PSVT.'
First Quarter and Recent Program Updates
Etripamil for Patients with PSVT
CRL for CARDAMYST™ for PSVT received from FDA. In March 2025, Milestone received a CRL regarding its NDA for CARDAMYST, its lead investigational product for the management of paroxysmal supraventricular tachycardia (PSVT). In the letter, the Agency highlighted two key Chemistry, Manufacturing and Controls (CMC) issues to be addressed: 1) additional information on nitrosamine impurities was requested, based on new draft guidance that was issued during the review of the NDA , and 2) a new inspection of a facility listed in the NDA is required, to ensure it is in compliance with current Good Manufacturing Practices (GMP). The facility, which previously performed a portion of the testing required to release etripamil final product, changed ownership during the review of the NDA. Milestone is prepared to discuss the issues raised in the CRL during the Type A meeting with the FDA.
Patent Issued by the U.S. Patent and Trademark Office (USPTO) on a new Method of Use patent for etripamil nasal spray. The new patent (U.S. Patent No. 12,257,224) covers the repeat dose regimen that was used in the RAPID Phase 3 study that evaluated etripamil in PSVT and is included in the proposed package insert for CARDAMYST. The issued patent potentially extends the intellectual property protection for CARDAMYST in the United States until July 2042, which would be an additional six years of protection for the company's intellectual property portfolio.
CARDAMYST highlighted in independent Survey of Managed Care professionals. Results from an independent survey conducted by Managed Healthcare Executive and The American Journal of Managed Care were published on May 6, 2025. CARDAMYST was selected by 40% of respondents (which included payers, providers and academics) when asked which new drug is expected to make the biggest difference in patient health. A copy of the article can be accessed here.
Commercial Launch Plan investor event held in February. The event, held on February 25, 2025 in New York City, provided an in-depth overview of the Company's commercial strategy for CARDAMYST nasal spray, if approved. A replay of the event, as well as a copy of the slides, can be found on the corporate website here.
Poster on etripamil presented at American College of Cardiology Annual Meeting (ACC.25). The poster titled, 'Consistency and Predictiveness of Conversion Among Multiple Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) treated with Etripamil: Outcomes from the NODE-303 trial,' was presented at the meeting on March 30, 2025 by James Ip, M.D., Professor, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian Hospital. A copy of the poster can be accessed here.
Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR)
Phase 3 protocol in AFib-RVR finalized Milestone has finalized the Phase 3 study protocol following FDA's review and obtained concurrence with the Agency to proceed. The Company is pausing initiation of enrollment of the study due to prioritizing resources to resolve the CRL received on the NDA for etripamil in PSVT.
First Quarter 2025 Financial Results
As of March 31, 2025, Milestone had cash, cash equivalents, and short-term investments of $56.0 million, compared to $69.7 million as of December 31, 2024.
There was no revenue for the first quarter ended March 31, 2025 or for the first quarter of 2024.
Research and development expense for the first quarter of 2025 was $5.0 million, compared with $3.6 million for the prior year period. The increase was primarily due to higher consulting costs in drug manufacturing and regulatory costs.
General and administrative expense for the first quarter of 2025 was $5.2 million, compared with $4.0 million for the prior year period. This increase was driven primarily by an increase in outside service costs, partially offset by a decrease in personnel costs.
Commercial expense for the first quarter of 2025 was $10.4 million, compared with $2.9 million for the prior year period. This increase is a result of additional personnel costs, professional costs and other operational expenses related to preparation for the launch of CARDAMYST. As a result of the CRL, Milestone has temporarily paused the ramping of operational expenditures related to launch, but will maintain the capability to launch quickly, pending approval of CARDAMYST by the FDA.
For the first quarter of 2025, net loss was $20.8 million, compared to $10.4 million for the prior year period.
For further details on the Company's financials, refer to the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC.
About EtripamilEtripamil is Milestone's lead investigational product. It is a novel calcium channel blocker nasal spray under clinical development for frequent and often highly symptomatic episodes of PSVT and AFib-RVR. It is designed as a self-administered rapid response therapy for patients thereby bypassing the need for immediate medical oversight. If approved, etripamil is intended to provide health care providers with a new treatment option to enable on-demand care and patient self-management. This portable, self-administered treatment may provide patients with active management and a greater sense of control over their condition. CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, is well studied with a robust clinical trial program that includes a completed Phase 3 clinical-stage program for the treatment of PSVT and Phase 2 trial for the treatment of patients with AFib-RVR.
About Milestone PharmaceuticalsMilestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company's focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat symptomatic episodic attacks associated with PSVT and AFib-RVR.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 'believe,' 'continue,' 'could,' 'demonstrate,' 'designed,' 'develop,' 'estimate,' 'expect,' 'may,' 'pending,' 'plan,' 'potential,' 'progress,' 'will', 'intend' and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Milestone's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding: the outcomes of future interactions with the FDA, including the potential Type A meeting; Milestone's ability to address the issues raised in the CRL on a timely basis, if at all; the outcome of the potential NDA resubmission; CARDAMYST's potential as a novel treatment option to help patients with PSVT; potential protections afforded by U.S. patents; CARDAMYST's ability to make the biggest difference in patient health, as compared to other available treatment options; the timing of patient enrollment in the Phase 3 study of etripamil for AFib-RVR; and other statements not related to historical facts. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, whether our future interactions with the FDA will have satisfactory outcomes; whether and when, if at all, our NDA for etripamil will be approved by the FDA; uncertainties related to the timing of initiation, enrollment, completion, evaluation and results of our clinical trials; risks and uncertainty related to the complexity inherent in cleaning, verifying and analyzing trial data; and whether the clinical trials will validate the safety and efficacy of etripamil for PSVT or other indications, among others, general economic, political, and market conditions, including deteriorating market conditions due to investor concerns regarding inflation, international tariffs, Russian hostilities in Ukraine and ongoing disputes in Israel and Gaza and overall fluctuations in the financial markets in the United States and abroad, risks related to pandemics and public health emergencies, and risks related the sufficiency of Milestone's capital resources and its ability to raise additional capital in the current economic climate. These and other risks are set forth in Milestone's filings with the U.S. Securities and Exchange Commission (SEC), including in its annual report on Form 10-K for the year ended December 31, 2025 and its quarterly report on Form 10-Q for the quarter ended March 31, 2025, in each case under the caption 'Risk Factors,' as such discussions may be updated from time to time by subsequent filings Milestone may make with the SEC. Except as required by law, Milestone assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Contact: Kim Fox, Vice President, Communications, kfox@milestonepharma.com
Investor Relations Kevin Gardner, kgardner@lifesciadvisors.com
Milestone Pharmaceuticals Inc.Condensed Consolidated Balance Sheets (Unaudited)
March 31, 2025
December 31, 2024
Assets
Current assets
Cash and cash equivalents
$
45,085
$
25,314
Short-term investments
10,873
44,381
Research and development tax credits receivable
994
901
Prepaid expenses
2,356
1,840
Other receivables
1,167
1,490
Total current assets
60,475
73,926
Operating lease right-of-use assets
1,234
1,376
Property and equipment
176
197
Total assets
$
61,885
$
75,499
Liabilities, and Shareholders' (Deficit) Equity
Current liabilities
Accounts payable and accrued liabilities
$
12,421
$
7,555
Operating lease liabilities
542
571
Total current liabilities
12,963
8,126
Operating lease liabilities, net of current portion
758
874
Senior secured convertible notes
54,287
53,352
Total liabilities
68,008
62,352
Shareholders' (Deficit) Equity
Common shares, no par value, unlimited shares authorized, 53,464,273 shares issued and outstanding as of March 31, 2025, 53,353,984 shares issued and outstanding as of December 31, 2024
288,188
288,048
Pre-funded warrants - 12,910,590 issued and outstanding as of March 31, 2025 and 12,910,590 as of December 31, 2024
53,076
53,076
Additional paid-in capital
40,919
39,568
Accumulated deficit
(388,306
)
(367,545
)
Total shareholders' (deficit) equity
(6,123
)
13,147
Total liabilities and shareholders' equity
$
61,885
$
75,499
Milestone Pharmaceuticals Inc.Condensed Consolidated Statements of Loss (Unaudited)
Three months ended March 31,
2025
2024
Revenue
$
—
$
—
Operating expenses
Research and development, net of tax credits
4,978
3,639
General and administrative
5,167
3,953
Commercial
10,378
2,884
Loss from operations
(20,523
)
(10,476
)
Interest income
697
994
Interest expense
(935
)
(872
)
Net loss and comprehensive loss
$
(20,761
)
$
(10,354
)
Weighted average number of shares and pre-funded warrants outstanding, basic and diluted
66,285,406
50,155,111
Net loss per share, basic and diluted
$
(0.31
)
$
(0.21
)

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
24 minutes ago
- Yahoo
Cisco (NASDAQ:CSCO) Posts Q2 Sales In Line With Estimates, Quarterly Revenue Guidance Slightly Exceeds Expectations
Networking technology giant Cisco (NASDAQ:CSCO) met Wall Street's revenue expectations in Q2 CY2025, with sales up 7.6% year on year to $14.67 billion. The company expects next quarter's revenue to be around $14.75 billion, coming in 0.8% above analysts' estimates. Its non-GAAP profit of $0.99 per share was 1.3% above analysts' consensus estimates. Is now the time to buy Cisco? Find out in our full research report. Cisco (CSCO) Q2 CY2025 Highlights: Revenue: $14.67 billion vs analyst estimates of $14.64 billion (7.6% year-on-year growth, in line) Adjusted EPS: $0.99 vs analyst estimates of $0.98 (1.3% beat) Adjusted EBITDA: $5.03 billion vs analyst estimates of $5.51 billion (34.2% margin, 8.9% miss) Revenue Guidance for Q3 CY2025 is $14.75 billion at the midpoint, above analyst estimates of $14.63 billion Adjusted EPS guidance for the upcoming financial year 2026 is $4.03 at the midpoint, in line with analyst estimates Operating Margin: 23.5%, up from 19.2% in the same quarter last year Free Cash Flow Margin: 27.4%, up from 25.9% in the same quarter last year Market Capitalization: $282.7 billion "We delivered a strong close to fiscal 2025, driven by our accelerated innovation and solid execution," said Chuck Robbins, chair and CEO of Cisco. Company Overview Founded in 1984 by a husband and wife team who wanted computers at Stanford to talk to computers at UC Berkeley, Cisco (NASDAQ:CSCO) designs and sells networking equipment, security solutions, and collaboration tools that help businesses connect their systems and secure their digital operations. Revenue Growth A company's long-term sales performance can indicate its overall quality. Any business can put up a good quarter or two, but the best consistently grow over the long haul. With $56.65 billion in revenue over the past 12 months, Cisco is a behemoth in the business services sector and benefits from economies of scale, giving it an edge in distribution. This also enables it to gain more leverage on its fixed costs than smaller competitors and the flexibility to offer lower prices. However, its scale is a double-edged sword because finding new avenues for growth becomes difficult when you already have a substantial market presence. To expand meaningfully, Cisco likely needs to tweak its prices, innovate with new offerings, or enter new markets. As you can see below, Cisco's 2.8% annualized revenue growth over the last five years was sluggish. This shows it failed to generate demand in any major way and is a rough starting point for our analysis. We at StockStory place the most emphasis on long-term growth, but within business services, a half-decade historical view may miss recent innovations or disruptive industry trends. Cisco's recent performance shows its demand has slowed as its revenue was flat over the last two years. This quarter, Cisco grew its revenue by 7.6% year on year, and its $14.67 billion of revenue was in line with Wall Street's estimates. Company management is currently guiding for a 6.6% year-on-year increase in sales next quarter. Looking further ahead, sell-side analysts expect revenue to grow 5.1% over the next 12 months, an improvement versus the last two years. This projection is above the sector average and implies its newer products and services will fuel better top-line performance. Here at StockStory, we certainly understand the potential of thematic investing. Diverse winners from Microsoft (MSFT) to Alphabet (GOOG), Coca-Cola (KO) to Monster Beverage (MNST) could all have been identified as promising growth stories with a megatrend driving the growth. So, in that spirit, we've identified a relatively under-the-radar profitable growth stock benefiting from the rise of AI, available to you FREE via this link. Operating Margin Operating margin is a key measure of profitability. Think of it as net income - the bottom line - excluding the impact of taxes and interest on debt, which are less connected to business fundamentals. Cisco has been a well-oiled machine over the last five years. It demonstrated elite profitability for a business services business, boasting an average operating margin of 24.6%. Looking at the trend in its profitability, Cisco's operating margin decreased by 4.4 percentage points over the last five years. This raises questions about the company's expense base because its revenue growth should have given it leverage on its fixed costs, resulting in better economies of scale and profitability. This quarter, Cisco generated an operating margin profit margin of 23.5%, up 4.3 percentage points year on year. This increase was a welcome development and shows it was more efficient. Earnings Per Share Revenue trends explain a company's historical growth, but the long-term change in earnings per share (EPS) points to the profitability of that growth – for example, a company could inflate its sales through excessive spending on advertising and promotions. Cisco's weak 3.5% annual EPS growth over the last five years aligns with its revenue performance. This tells us it maintained its per-share profitability as it expanded. Like with revenue, we analyze EPS over a shorter period to see if we are missing a change in the business. For Cisco, its two-year annual EPS declines of 1% show it's continued to underperform. These results were bad no matter how you slice the data. In Q2, Cisco reported adjusted EPS of $0.99, up from $0.87 in the same quarter last year. This print beat analysts' estimates by 1.3%. Over the next 12 months, Wall Street expects Cisco's full-year EPS of $3.80 to grow 5.4%. Key Takeaways from Cisco's Q2 Results It was good to see Cisco provide revenue guidance for next quarter that slightly beat analysts' expectations. We were also happy its EPS guidance for next quarter narrowly outperformed Wall Street's estimates. Overall, this print had some key positives. Investors were likely hoping for more, and shares traded down 2.2% to $68.74 immediately following the results. Is Cisco an attractive investment opportunity right now? If you're making that decision, you should consider the bigger picture of valuation, business qualities, as well as the latest earnings. We cover that in our actionable full research report which you can read here, it's free. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
24 minutes ago
- Yahoo
Alvotech Reports Results for the First Six Months of 2025 and Provides a Business Update
Strong performance driven by over 200% growth in product revenues year-on-year Best quarter in Alvotech's history in terms of operating cash flows Continued expansion of commercial partnerships for pipeline assets Alvotech listed on Nasdaq Stockholm Market Conference call and live webcast on Thursday August 14, 2025, 8:00 am ET (12:00pm GMT) REYKJAVIK, Iceland, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the 'Company'), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today reported financial results for the first six months of 2025 and provided a summary of recent pipeline and corporate highlights. Management will conduct a business update conference call and live webcast on August 14, 2025, at 8:00 am ET (12:00 pm GMT). 'The strong results from the first half of the year, with over 200% increase in product revenues year-on-year and the best quarter in our history in terms of operating cash flows, confirm our business momentum and the opportunities that lie ahead. New and expanded partnership agreements reflect the value of our increased development activity. The recent acquisition of Xbrane's R&D facilities in Sweden allows us to further ramp up development of new biosimilars and continue building the industry's most valuable pipeline. With our acquisition of Ivers-Lee Group in Switzerland in July, we continue integration of our end-to-end biosimilars platform,' said Robert Wessman, Chairman and CEO of Alvotech. Activity in Q2 2025 Commercial Agreements Alvotech entered into two agreements to expand the commercial partnership with Advanz Pharma, covering four biosimilar candidates, AVT48, referencing Ilaris® (canakinumab), AVT65, referencing Kesimpta® (ofatumumab), AVT10, referencing Cimzia® (certolizumab pegol), plus an undisclosed biosimilar candidate. Alvotech also announced that it had entered into a collaboration and license agreement with Dr. Reddy's Laboratories Ltd. to co-develop, manufacture and commercialize AVT32, a biosimilar candidate to Keytruda® (pembrolizumab). The collaboration is intended to speed up the development process and extend the global reach of this biosimilar candidate. The parties will be jointly responsible for development and manufacturing, sharing costs and responsibilities. Each party will also have the right to commercialize the product globally, subject to certain exceptions. Acquisitions and Funding Alvotech completed its transaction with Xbrane Biopharma AB ('Xbrane') with the acquisition of its R&D organization in Stockholm, Sweden and rights to a biosimilar candidate to Cimzia® (certolizumab pegol), now known as AVT10. After the end of the second quarter, in July, Alvotech acquired Ivers-Lee Group ('Ivers-Lee'), a family-owned business with headquarters in Burgdorf, Switzerland specializing in providing high-quality assembly and packaging services for the pharmaceutical sector. Ivers-Lee operations will be integrated into Alvotech's Technical Operations division. Among Ivers-Lee's capacities that will be integrated with Alvotech's operations are assembly and packaging of autoinjectors, pre-filled syringes and safety devices and packaging of vials. Alvotech completed two offerings of Swedish Depository Receipts ('SDRs'), with a public offering directed solely into Sweden, generating gross proceeds of approximately SEK 39 million and a private placement directed to Swedish and international institutional investors, generating gross proceeds of SEK 750 million. Over 3,000 new shareholders participated in the public offering and 40 institutional investors participated in the private placement. On May 19, 2025, Alvotech was listed on Nasdaq Stockholm. This is Alvotech's third listing, complementing previous listings on Nasdaq in the US and Iceland. Alvotech entered into an amendment to its existing term loan credit agreement, which provides, among other things, for the reduction of the interest rate, lowering interest expenses by $8.2 million in the first 12 months. Based on the amended agreement the loan consists of a single tranche with an interest rate of SOFR plus 6.0%. Changes to Management On July 9, 2025, Linda Jónsdóttir was appointed Chief Financial Officer, replacing Joel Morales who continues to serve in an advisory function. Linda is a highly experienced international executive with a strong background in finance and corporate leadership, including holding senior roles for 15 years at Marel, such as Director of Treasury and Investor Relations, Chief Financial Officer and Chief Operating Officer. Linda has also served on various boards, in banking, private equity funds and at the Icelandic Chamber of Commerce. Summary of the financial results for the first six months of 2025 Cash position and sources of liquidity: As of June 30, 2025, the Company had cash and cash equivalents of $151.5 million. This strong cash position was positively impacted by robust operational performance, including significant product revenue growth and milestone collections, as well as the successful completion of a Swedish private placement that raised gross proceeds of approximately SEK 789 million. In addition, the Company had borrowings of $1,118.2 million, including $46.0 million of current portion of borrowings. Product Revenue: Product revenue was $204.7 million for the six months ended June 30, 2025, compared to $65.9 million for the six months ended June 30, 2024, reflecting the sales expansion of AVT02 in the U.S., Canada, and European countries, as well as the increased sales of AVT04 in European countries, and the launch of AVT04 in the U.S. License and Other Revenue: License and other revenue was $101.3 million for the six months ended June 30, 2025, compared to $169.7 million for the six months ended June 30, 2024. The year-over-year decrease primarily reflects the timing of milestone achievements, with the prior-year period including significant research and development and performance-based milestones totaling $133.2 million. In the current period, license and other revenue was supported by the completion of key development phases, including $36.8 million related to completion of early development phase for multiple pipeline program, and $21.3 million for the completion of a clinical endpoint study for the AVT23 program. Additionally, $12.8 million was recognized from the achievement of sales targets for AVT04 in Europe and its launch in the U.S. Cost of product revenue: Cost of product revenue was $139.3 million for the six months ended June 30, 2025, compared to $65.2 million for the six months ended June 30, 2024. The increase reflects higher sales volumes driven by the continued expansion of AVT02 in the U.S. and the launch and expansion of AVT04 across multiple markets, including the U.S. and European countries. This increase was partially offset by lower production-related charges, reflecting improved operational efficiency. Research and development (R&D) expenses: R&D expenses were $92.9 million for the six months ended June 30, 2025, compared to $97.5 million for the six months ended June 30, 2024. The modest year-over-year decrease reflects the natural progression of Alvotech's pipeline, with several programs transitioning out of the clinical phase (i.e. AVT03, AVT05, and AVT06) or reaching commercialization (i.e., AVT04). These reductions were partially offset by increased investment in advancing clinical programs, notably AVT16 and AVT29, which contributed to a $33.1 million rise in direct program expenses. General and administrative (G&A) expenses: G&A expenses were $45.3 million for the six months ended June30, 2025, compared to $29.6 million for the six months ended June 30, 2024. The increase in G&A expenses was primarily driven by an increase of $13.6 million in third-party services costs, which included legal fees related to ongoing intellectual property proceedings and advisory costs associated with the Company's Swedish listing and the acquisition of Xbrane's operations. Operating profit: Operating profit was $28.6 million for the six months ended June 30, 2025, compared to $43.4 million for the same period in the prior year. The year-over-year decrease reflects the timing of milestone-related revenue recognized in the prior period, partially offset by increased product sales across key markets. The Company continued to invest strategically in commercialization efforts, regulatory advancement, and pipeline development, positioning Alvotech for long-term growth and operational scale. Finance income: Finance income was $149.2 million for the six months ended June 30, 2025, compared to $80.8 million for the six months ended June 30, 2024. Finance income for the six months ended June 30, 2025 was primarily attributable to the change in fair value of derivative liabilities, which was positively impacted by the decrease in the Company's share price during the period. Finance costs: Finance costs were $72.2 million for the six months ended June 30, 2025, compared to $277.4 million for the six months ended June 30, 2024. The current period's finance costs primarily reflect interest charges on outstanding debt of $1,118.2 million. The prior-year period included $130.4 million in non-cash charges related to the fair value of derivative liabilities, which were negatively impacted by an increase in Alvotech's share price, and $79.1 million in interest charges on debt of $1,055.9 million. Additionally, the early redemption of existing debt in connection with the July 2024 refinancing resulted in a $63.1 million loss on remeasurement due to the acceleration of previously deferred debt issuance costs and discounts in the six months ended June 30, 2024. The year-over-year reduction in finance costs reflects the Company's proactive capital structure management and the transition to a more efficient financing arrangement. Exchange rate differences: Exchange rate differences resulted in a loss of $19.7 million for the six months ended June 30, 2025, compared to a gain of $7.7 million for the six months ended June 30, 2024. The change was primarily driven by fluctuations in foreign currency exchange rates, notably between the Icelandic krona and the U.S. dollar. Gain on modification and extinguishment of financial liabilities: On June 26, 2025, Alvotech announced an amendment to its existing term loan facility, reflecting continued efforts to optimize its capital structure. Under the revised agreement, the Company's lenders agreed to reduce the interest rate to SOFR plus 6.0% and consolidate the facility's two tranches into a single tranche, with an increase of $169.0 to the single tranche. As a result of the amendment, Alvotech recorded a net gain of $16.7 million on the modification and extinguishment of financial liabilities during the six months ended June 30, 2025, primarily driven by the reduction of the interest rate to SOFR plus 6.0% per annum. Income tax benefit / (expense): Income tax benefit was $39.0 million for the six months ended June 30, 2025, compared to an income tax expense of $5.1 million for the six months ended June 30, 2024. The favorable variance was primarily driven by a $47.4 million tax benefit resulting from the strengthening of the Icelandic krona against the U.S. dollar, which increased the U.S. dollar value of Icelandic tax loss carryforwards, which the Company expects to utilize against future taxable profits. This benefit was partially offset by a $3.7 million tax expense related to profitability generated in Iceland during the period. Profit / (loss) for the Period: Reported net profit was $141.7 million, or $0.50 per share and $0.49 per share on a basic and diluted basis, respectively, for the six months ended June 30, 2025, compared to a reported net loss of $153.5 million, or ($0.61) per share on a basic and diluted basis, for the six months ended June 30, 2024. The significant increase reflects strong growth in product revenue, favorable movements in the fair value of derivative liabilities, and lower finance costs following the Company's capital structure optimization. Business update conference call Alvotech will conduct a business update conference call and live webcast on Thursday, August 14, at 8:00 am ET (12:00 noon GMT). Registration for the conference call and access to the live webcast is found on where you will also be able to find a replay of the webcast, following the call for 90 days. About AVT02 (adalimumab) AVT02 is a monoclonal antibody and has been approved as a biosimilar to Humira® (adalimumab) in over 50 countries globally, including the U.S., Europe, Canada, Australia, Egypt, Saudi Arabia and South Africa. It is currently marketed in the U.S. as SIMLANDI and under private label (adalimumab-ryvk), in Europe as HUKYNDRA, in Canada as SIMLANDI and in Australia as ADALICIP. Dossiers are also under review in multiple countries globally. About AVT03AVT03 is a human monoclonal antibody and a biosimilar candidate to Prolia® and Xgeva® (denosumab). Denosumab targets and binds with high affinity and specificity to the RANK ligand membrane protein, preventing the RANK ligand/RANK interaction from occurring, resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer-induced bone destruction [1]. AVT03 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT04 (ustekinumab) AVT04 is a monoclonal antibody and a biosimilar to Stelara® (ustekinumab). AVT04 has been launched in Canada as JAMTEKI, in the EEA as UZPRUVO, in Japan as USTEKINUMAB BS (F) and in the U.S. as SELARSDI (ustekinumab-aekn). Dossiers are also under review in multiple countries globally. About AVT05 AVT05 is a biosimilar candidate for Simponi® and Simponi Aria® (golimumab). Golimumab is a monoclonal antibody that inhibits tumor necrosis factor alpha (TNF alpha). Elevated TNF alpha levels have been implicated in the pathophysiology of several chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis [2]. AVT05 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT06/AVT29AVT06/AVT29 is a recombinant fusion protein and a biosimilar candidate to Eylea® (aflibercept) in different dosing strength which binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [3]. AVT06/AVT29 are investigational products and have not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT10AVT10 is a proposed biosimilar to Cimzia® (certolizumab pegol). Certolizumab pegol is a monoclonal antibody fragment that inhibits tumor necrosis factor alpha (TNF alpha) and is indicated for a variety of inflammatory diseases [4]. AVT10 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT16 AVT16 is a human monoclonal antibody and a biosimilar candidate to Entyvio® (vedolizumab). Vedolizumab targets and binds specifically to the alpha-4-beta-7 protein, which is preferentially expressed on T helper lymphocytes (white blood cells) which migrate into the gastrointestinal tract and cause inflammation characteristic of Ulcerative Colitis and Chron's disease [5]. AVT16 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT23AVT23 is a proposed biosimilar to Xolair® (omalizumab). Omalizumab is a humanized monoclonal antibody that targets free immunoglobulin E (IgE). Xolair, which contains omalizumab, is indicated for severe persistent allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) [6]. AVT23 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT32AVT32 is a biosimilar candidate for Keytruda® (pembrolizumab). Pembrolizumab is a humanized monoclonal antibody that binds to the programmed death receptor-1 (PD-1 receptor) and is indicated for the treatment of several types of cancers [7]. AVT32 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT48AVT48 is a biosimilar candidate for Ilaris® (canakinumab). Canakinumab is a recombinant monoclonal antibody that binds to human immunoglobulin (IL) 1-beta, and is indicated for the treatment of several systemic autoinflammatory diseases [8]. AVT48 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. About AVT65AVT65 is a biosimilar candidate for Kesimpta® (ofatumumab). Ofatumumab is a CD20-directed cytolytic antibody and is indicated for the treatment of relapsing forms of multiple sclerosis (MS). AVT65 is an investigational compound and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed. Sources [1] Prolia product information[2] Simponi product information[3] Eylea product information[4] Cimzia product information[4] Entyvio product information[5] Xolair product information[7] Keytruda product information[8] Ilaris product information[9] Kesimpta product information Use of trademarks Stelara®, Simponi® and Simponi Aria® are registered trademarks of Johnson & Johnson. Humira® is a registered trademark of AbbVie Biotechnology Ltd. Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc and Bayer AG. Prolia® and Xgeva® are registered trademarks of Amgen Inc. JAMTEKI™ is a trademark of JAMP Pharma Group. UZPRUVO® and HUKYNDRA® are registered trademarks of STADA and Alvotech. ADALICIP is a registered trademark of Cipla Australia. Xolair®, Ilaris® and Kesimpta® are registered trademarks of Novartis AG. Keytruda® is a registered trademark of Merck Sharp & Dohme Corp. Cimzia® is a registered trademark of UCB Pharma S.A. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high quality, cost-effective products, and services, enabled by a fully integrated approach and broad in-house capabilities. Alvotech has launched two biosimilars. The current development pipeline includes nine disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. Alvotech's commercial partners include Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (US), STADA Arzneimittel AG (EU), Fuji Pharma Co., Ltd (Japan), Advanz Pharma (EEA, UK, Switzerland, Canada, Australia and New Zealand), Dr. Reddy's (EEA, UK and US), Biogaran (FR), Cipla/Cipla Gulf/Cipla Med Pro (Australia, New Zealand, South Africa/Africa), JAMP Pharma Corporation (Canada), Yangtze River Pharmaceutical (Group) Co., Ltd. (China), DKSH (Taiwan, Hong Kong, Cambodia, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan), YAS Holding LLC (Middle East and North Africa), Abdi Ibrahim (Turkey), Kamada Ltd. (Israel), Mega Labs, Stein, Libbs, Tuteur and Saval (Latin America) and Lotus Pharmaceuticals Co., Ltd. (Thailand, Vietnam, Philippines, and South Korea). Each commercial partnership covers a unique set of product(s) and territories. Except as specifically set forth therein, Alvotech disclaims responsibility for the content of periodic filings, disclosures and other reports made available by its partners. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. Please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube. Alvotech Forward Looking Statements Certain statements in this communication may be considered 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements generally relate to future events or the future financial operating performance of Alvotech and may include, for example, Alvotech's expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, results, level of activities, performance, goals or achievements or other future events, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, and market launches. In some cases, you can identify forward-looking statements by terminology such as 'may', 'should', 'expect', 'intend', 'will', 'estimate', 'anticipate', 'believe', 'predict', 'potential', 'aim' or 'continue', or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech's control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (1) the ability to maintain positive EBITDA and positive cash flows from operations; (2) the ability to maintain stock exchange listing standards; (3) changes in applicable laws or regulations; (4) the possibility that Alvotech may be adversely affected by other economic, business, and/or competitive factors; (5) Alvotech's estimates of expenses and profitability; (6) Alvotech's ability to develop, manufacture and commercialize the products and product candidates in its pipeline; (7) actions of regulatory authorities, which may affect the initiation, timing and progress of clinical studies or regulatory approvals or marketing authorizations; (8) the ability of Alvotech or its partners to respond to inspection findings and resolve deficiencies to the satisfaction of the regulators; (9) the ability of Alvotech or its partners to enroll and retain patients in clinical studies; (10) the ability of Alvotech or its partners to gain approval from regulators for planned clinical studies, study plans or sites; (11) the ability of Alvotech's partners to conduct, supervise and monitor existing and potential future clinical studies, which may impact development timelines and plans; (12) Alvotech's ability to obtain and maintain regulatory approval or authorizations of its products, including the timing or likelihood of expansion into additional markets or geographies; (13) the success of Alvotech's current and future collaborations, joint ventures, partnerships or licensing arrangements; (14) Alvotech's ability, and that of its commercial partners, to execute their commercialization strategy for approved products; (15) Alvotech's ability to manufacture sufficient commercial supply of its approved products; (16) the outcome of ongoing and future litigation regarding Alvotech's products and product candidates; (17) the impact of worsening macroeconomic conditions, including rising inflation and interest rates and general market conditions, conflicts in Ukraine, the Middle East and other global geopolitical tension, on the Company's business, financial position, strategy and anticipated milestones; and (18) other risks and uncertainties set forth in the sections entitled 'Risk Factors' and 'Cautionary Note Regarding Forward-Looking Statements' in documents that Alvotech may from time to time file or furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements made herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed. The recipient agrees that it shall not seek to sue or otherwise hold Alvotech or any of its directors, officers, employees, affiliates, agents, advisors, or representatives liable in any respect for the provision of this communication, the information contained in this communication, or the omission of any information from this communication. ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS Benedikt Stefansson, Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income or Loss for the six months ended 30 June 2025 and 2024 USD in thousands, except for per share amounts Six months ended 30June 2025 Six months ended 30June 2024 Product revenue 204,733 65,912 License and other revenue 101,271 169,678 Other income 143 57 Cost of product revenue (139,272 ) (65,167 ) Research and development expenses (92,889 ) (97,479 ) General and administrative expenses (45,347 ) (29,554 ) Operating profit 28,639 43,447 Loss on sale of interest in joint venture — (2,970 ) Finance income 149,247 80,823 Finance costs (72,190 ) (277,414 ) Exchange rate differences (19,683 ) 7,742 Gain on modification and extinguishment of financial liabilities 16,718 — Non-operating profit / (loss) 74,092 (191,819 ) Profit / (loss) before taxes 102,731 (148,372 ) Income tax benefit / (expense) 38,987 (5,132 ) Profit / (loss) for the period 141,718 (153,504 ) Other comprehensive profit / (loss) Item that will be reclassified to profit or loss in subsequent periods: Exchange rate differences on translation of foreign operations 3,434 121 Total comprehensive profit / (loss) 145,152 (153,383 ) Profit / (loss) per share Basic profit / (loss) for the period per share 0.50 (0.61 ) Diluted profit / (loss) for the period per share 0.49 (0.61 ) Unaudited Condensed Consolidated Interim Statements of Financial Position as of 30 June 2025 and 31 December 2024 USD in thousands Non-current assets 30 June2025 31 December2024 Property, plant and equipment 306,596 284,546 Right-of-use assets 134,481 125,198 Goodwill 12,790 11,330 Other intangible assets 54,688 20,621 Contract assets 32,070 22,710 Other long-term assets 4,338 3,615 Deferred tax assets 338,330 298,360 Total non-current assets 883,293 766,380 Current assets Inventories 155,490 127,889 Trade receivables 108,103 160,217 Contract assets 46,664 67,304 Other current assets 47,579 48,064 Receivables from related parties 173 118 Cash and cash equivalents 151,452 51,428 Total current assets 509,461 455,020 Total assets 1,392,754 1,221,400 Unaudited Condensed Consolidated Interim Statements of Financial Position as of 30 June 2025 and 31 December 2024 USD in thousands Equity 30 June 2025 31 December 2024 Share capital 2,924 2,826 Share premium 2,102,896 2,007,058 Other reserves 15,627 17,272 Translation reserve 1,216 (2,218 ) Accumulated deficit (2,295,991 ) (2,437,709 ) Total equity (173,328 ) (412,771 ) Non-current liabilities Borrowings 1,072,138 1,035,882 Derivative financial liabilities 63,004 210,224 Lease liabilities 136,263 112,137 Contract liabilities 12,914 80,721 Deferred tax liability 2,014 1,811 Total non-current liabilities 1,286,333 1,440,775 Current liabilities Trade and other payables 84,282 67,126 Lease liabilities 13,591 9,515 Current maturities of borrowings 46,026 32,702 Liabilities to related parties 1,641 8,465 Contract liabilities 60,333 15,980 Taxes payable 741 204 Other current liabilities 73,135 59,404 Total current liabilities 279,749 193,396 Total liabilities 1,566,082 1,634,171 Total equity and liabilities 1,392,754 1,221,400 Unaudited Condensed Consolidated Interim Statements of Cash Flows for the six months ended 30 June 2025 and 2024 USD in thousands Cash flows from operating activities Six months ended 30June 2025 Six months ended 30June 2024 Profit (loss) for the period 141,718 (153,504 ) Adjustments for non-cash items: Depreciation and amortization 17,156 14,748 Change in inventory reserves 5,238 (6,936 ) Change in allowance for receivables 703 — Share-based payments 3,418 5,294 Loss on sale of interest in joint venture — 2,970 Gain on modification and extinguishment of financial liabilities (16,718 ) — Finance income (149,247 ) (80,823 ) Finance costs 72,190 277,414 Exchange rate difference 19,683 (7,742 ) Income tax benefit (38,987 ) 5,132 Operating cash flow before movement in working capital 55,154 56,553 Increase in inventories (32,839 ) (15,205 ) Decrease / (increase) in trade receivables 51,411 (52,229 ) (Increase) / decrease in receivables with related parties (55 ) 92 Decrease / (increase) in contract assets 13,624 (27,179 ) (Increase) / decrease in other assets (990 ) 369 Increase / (decrease) in trade and other payables 17,757 (21,758 ) Decrease in contract liabilities (31,743 ) (35,881 ) (Decrease) / increase in liabilities with related parties (3,917 ) 16,677 Increase / (decrease) in other liabilities 8,127 (6,056 ) Cash from (used in) operations 76,529 (84,617 ) Interest received 50 26 Interest paid (8,039 ) (41,037 ) Income tax paid (249 ) (372 ) Net cash from (used in) operating activities 68,291 (126,000 ) Cash flows from investing activities Acquisition of property, plant and equipment (36,805 ) (10,271 ) Acquisition of intangible assets (15,168 ) (1,430 ) Restricted cash in connection with amended bond agreement — 1,132 Proceeds from the sale in joint venture 2,975 — Net cash used in investing activities (48,998 ) (10,569 ) Cash flows from financing activities Six months ended 30June 2025 Six months ended 30June 2024 Repayments of borrowings (7,757 ) (75,059 ) Repayments of principal portion of lease liabilities (4,924 ) (4,815 ) Proceeds from new borrowings 11,267 67,500 Gross proceeds from equity offering 82,481 150,451 Fees from equity offering (3,759 ) (5,812 ) Proceeds from warrants — 4,841 Stock options exercised — 76 Net cash generated from financing activities 77,308 137,182 Increase in cash and cash equivalents 96,601 613 Cash and cash equivalents at the beginning of the year 51,428 11,157 Effect of movements in exchange rates on cash held 3,423 (826 ) Cash and cash equivalents at the end of the period 151,452 10,944 Sign in to access your portfolio
Yahoo
24 minutes ago
- Yahoo
Opus Genetics Announces Financial Results for Second Quarter 2025 and Provides Corporate Update
- Positive 12-month Phase 1/2 clinical data in adult cohort and early pediatric clinical data support potential for meaningful vision restoration with OPGx-LCA5 -- FDA grants Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5 - - Positive topline results reported from VEGA-3 and LYNX-2 Phase 3 trials with Phentolamine Ophthalmic Solution 0.75% - - OPGx-BEST1 on track to enter Phase 1/2 trial in H2 2025 for the treatment of bestrophin-1 related inherited retinal disease - - Non-dilutive funding from patient advocacy groups secured to advance multiple early-stage gene therapy programs - RESEARCH TRIANGLE PARK, N.C., Aug. 13, 2025 (GLOBE NEWSWIRE) -- Opus Genetics, Inc. (Nasdaq: IRD) (the 'Company' or 'Opus Genetics'), a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders, today announced financial results for the second quarter ended June 30, 2025, and provided a corporate update. 'We've made significant progress across our pipeline, with multiple clinical and regulatory milestones achieved this quarter,' said George Magrath, M.D., Chief Executive Officer, Opus Genetics. 'Receiving RMAT designation for our OPGx-LCA5 program underscores the strength of our clinical data and the urgent need for effective gene therapies to treat inherited retinal diseases. We are encouraged by the sustained functional vision improvements observed in adult patients in our clinical trial to date and the early signs of efficacy in the pediatric cohort. In parallel, our advancement of OPGx-BEST1 toward the clinic and the nomination of two additional development candidates in partnership with the Retinal Degeneration Fund and the Global RDH12 Alliance highlight the breadth of our IRD pipeline.' 'Beyond gene therapy, the positive readouts from our two Phase 3 Phentolamine trials represent a major step toward our goal of bringing a new treatment option to millions of patients living with vision challenges. With several upcoming key milestones, including new clinical data, a supplemental New Drug Application (sNDA) submission, and the launch of a pivotal study, we remain focused on execution to deliver transformative treatments to patients with significant unmet needs,' Dr. Magrath concluded. Pipeline Updates OPGx-LCA5 – Gene Therapy for Leber Congenital Amaurosis (LCA) The U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation for OPGx-LCA5, for the treatment of Leber Congenital Amaurosis (LCA) due to genetic variations in the LCA5 gene, signifying the program's potential to address a serious condition and providing a pathway for accelerated development and review. Twelve-month clinical data from adult participants in the Phase 1/2 trial demonstrated sustained improvements in visual function, including visual acuity gains and improved mobility testing scores. This data was presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in May. Initial pediatric data at one-month post-treatment showed vision improvement with no drug-related adverse events; three-month pediatric data is expected to be reported in Q3 2025. OPGx-BEST1 – Gene Therapy for BEST1-Related IRD Preclinical data presented at the American Ophthalmological Society (AOS) in May demonstrated restoration of the retinal pigment epithelium-photoreceptor interface in a canine model of BEST1 using AAV-mediated gene delivery. Investigational New Drug (IND) submission and Phase 1/2 trial initiation remain on track for the second half of 2025. OPGx-RDH12 and OPGx-MERTK – Advancing with Non-Dilutive Support Partnership with the Global RDH12 Alliance provides up to $1.6 million in non-dilutive funding to accelerate development of OPGx-RDH12 for Leber congenital amaurosis (RDH12-LCA). Non-dilutive funding up to $2 million received from the Retinal Degeneration Fund to advance OPGx-MERTK, targeting retinitis pigmentosa caused by MERTK mutations. Preclinical OPGx-MERTK data presented at the American Society of Gene & Cell Therapy (ASGCT) in May showed preservation of retinal function in animal models. Phentolamine Ophthalmic Solution 0.75% – Advancing Toward sNDA Submissions VEGA-3 Phase 3 trial met its primary and multiple secondary endpoints in presbyopia, with 27.2% of treated patients achieving a ≥15-letter gain in near visual acuity (vs. 11.5% on placebo, p<0.0001) and favorable participant reported outcomes and safety profile. LYNX-2 Phase 3 trial met its primary and multiple secondary endpoints in keratorefractive patients with night vision disturbances. Patients showed statistically significant gains in mesopic low contrast vision and improvements in night-driving related symptoms. sNDA submission for presbyopia indication planned for the second half of 2025. LYNX-3 Phase 3 trial expected to initiate enrollment in the second half of 2025 targeting reduced low light vision and nighttime visual disturbances. Additional Medical Meeting Presentations Virtual reality-guided functional testing to support meaningful clinical endpoints in IRD trials was presented at the Retinal Imaging Biomarkers Summit. Upcoming Expected Data Readouts and Program Advancements Report three-month pediatric data from OPGx-LCA5 Phase 1/2 trial in Q3 2025. Initiate enrollment in Phase 1/2 trial for OPGx-BEST1 in H2 2025. Submit Phentolamine sNDA for presbyopia in H2 2025. Initiate enrollment in Phentolamine LYNX-3 Phase 3 trial in H2 2025. Financial Results for the Second Quarter Ended June 30, 2025 Cash Position: As of June 30, 2025, Opus Genetics had cash and cash equivalents of $32.4 million. Based on current operating plans, the Company expects its existing cash resources will fund operations into the second half of 2026. Revenue: License and collaboration revenue totaled $2.9 million for the second quarter of 2025, compared to $1.1 million in the same period in 2024. Revenue in both periods was driven by the Company's collaboration with Viatris, Inc., primarily from reimbursement of R&D services. General and Administrative (G&A) Expenses: G&A expenses were $5.8 million for the second quarter of 2025, compared to $3.4 million for the same period in 2024. The increase was mainly due to higher costs associated with legal and patent-related expenses, payroll, and business development activities. G&A expenses included $0.6 million and $0.5 million in stock-based compensation in the second quarters of 2025 and 2024, respectively. Research and Development (R&D) Expenses: R&D expenses were $6.0 million for the second quarter of 2025, compared to $6.1 million in the prior-year period. The slight decrease was primarily due to lower manufacturing and consulting costs, partially offset by increased clinical trial, toxicology, and payroll-related expenses. R&D expenses related to Phentolamine Ophthalmic Solution 0.75% were fully reimbursed under the Viatris License Agreement. Stock-based compensation within R&D expenses was $0.3 million in both periods. Net Loss: Net loss for the second quarter of 2025 was $7.4 million, or $(0.12) per basic and diluted share, compared to a net loss of $7.8 million, or $(0.30) per basic and diluted share, for the second quarter of 2024. SEC Filing: Additional details on the Company's financial results will be available in its Quarterly Report on Form 10-Q for the period ended June 30, 2025, to be filed with the U.S. Securities and Exchange Commission (SEC). About Opus Genetics Opus Genetics is a clinical-stage biopharmaceutical company developing gene therapies for the treatment of inherited retinal diseases (IRDs) and small molecule therapies for other ophthalmic disorders. The Company's pipeline features AAV-based gene therapies targeting inherited retinal diseases including Leber congenital amaurosis (LCA), bestrophinopathy, and retinitis pigmentosa. Its lead gene therapy candidates are OPGx-LCA5, which is in an ongoing Phase 1/2 trial for LCA5-related mutations, and OPGx-BEST1, a gene therapy targeting BEST1-related retinal degeneration. Opus is also advancing Phentolamine Ophthalmic Solution 0.75%, a partnered therapy currently approved in one indication and being studied in two Phase 3 programs for presbyopia and reduced low light vision and nighttime visual disturbances. The Company is based in Research Triangle Park, NC. For more information, visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements related to cash runway, the clinical development, clinical results, preclinical data, and future plans for Phentolamine Ophthalmic Solution 0.75%, OPGx-LCA5, OPGx-BEST1, RDH12, and earlier stage programs, and expectations regarding us, our business prospects, and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading 'Risk Factors' included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our other filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. In some cases, you can identify forward-looking statements by the following words: 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'aim,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'will,' 'would' or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise. Contacts: InvestorsJenny KobinRemy BernardaIR Advisory Solutionsir@ MediaKimberly HaKKH Opus Genetics, Consolidated Balance Sheets(in thousands, except share amounts and par value) As of June 30, December 31, 2025 2024 Assets (Unaudited) Current assets: Cash and cash equivalents $ 32,429 $ 30,321 Accounts receivable 3,399 3,563 Contract assets and unbilled receivables 1,178 2,209 Prepaids and other current assets 1,433 515 Short-term investments — 2 Total current assets 38,439 36,610 Property and equipment, net 226 252 Total assets $ 38,665 $ 36,862 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 1,465 $ 3,148 Accrued expenses and other liabilities 6,927 8,147 Warrant liabilities 11,800 — Total current liabilities 20,192 11,295 Long-term funding agreement, related party 1,000 — Total liabilities 21,192 11,295 Commitments and contingencies Series A preferred stock, par value $0.0001; 14,146 shares were designated as of June 30, 2025 and December 31, 2024; zero and 14,145.374 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. — 18,843 Stockholders' equity: Preferred stock, par value $0.0001; 9,985,854 shares authorized as of June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024. — — Common stock, par value $0.0001; 125,000,000 shares authorized as of June 30, 2025 and December 31, 2024; 59,908,055 and 31,574,657 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively. 6 3 Additional paid-in capital 172,079 145,719 Accumulated deficit (154,612 ) (138,998 ) Total stockholders' equity 17,473 6,724 Total liabilities, series A preferred stock and stockholders' equity $ 38,665 $ 36,862 Opus Genetics, Consolidated Statements of Comprehensive Loss(in thousands, except share and per share amounts)(Unaudited) For the Three Months EndedJune 30, For the Six Months EndedJune 30, 2025 2024 2025 2024 License and collaborations revenue $ 2,882 $ 1,112 $ 7,252 $ 2,823 Operating expenses: General and administrative 5,766 3,354 12,112 8,024 Research and development 6,022 6,086 13,975 10,835 Total operating expenses 11,788 9,440 26,087 18,859 Loss from operations (8,906 ) (8,328 ) (18,835 ) (16,036 ) Fair value change in warrant and other derivative liabilities 917 — 3,722 — Financing costs 35 — (1,337 ) — Other income, net 534 563 836 1,165 Loss before income taxes (7,420 ) (7,765 ) (15,614 ) (14,871 ) Benefit (provision) for income taxes — — — — Net loss (7,420 ) (7,765 ) (15,614 ) (14,871 ) Other comprehensive loss, net of tax — — Comprehensive loss $ (7,420 ) $ (7,765 ) $ (15,614 ) $ (14,871 ) Net loss per share: Basic and diluted $ (0.12 ) $ (0.30 ) $ (0.32 ) $ (0.59 ) Number of shares used in per share calculations: Basic and diluted 63,376,392 25,827,265 48,712,124 25,175,596 Source: Opus Genetics, in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data