Griffon Corporation Declares Quarterly Dividend

Griffon Corporation Declares Quarterly Dividend

NEW YORK–(BUSINESS WIRE)–
The Board of Directors of Griffon Corporation (NYSE: GFF) (the “Company” or “Griffon”) yesterday declared a regular quarterly cash dividend of $0.22 per share. The dividend is payable on June 17, 2026 to shareholders of record as of the close of business on May 29, 2026.

About Griffon Corporation

Griffon Corporation is a leading provider of residential and commercial building products. The Company is the largest North American manufacturer and marketer of garage doors under the Clopay, IDEAL and Holmes brands, and rolling steel door and grille products under the Clopay, Cornell, and Cookson brands. The Company is also a leading provider of residential, industrial, and commercial ceiling fans sold under the Hunter, Casablanca, and Jan Fan brands.

The AMES North America, Australia, and United Kingdom businesses are classified as discontinued operations.

For more information on Griffon, please see the Company’s website at www.griffon.com.

Company Contact:

Brian G. Harris

EVP & Chief Financial Officer

Griffon Corporation

(212) 957-5000

[email protected]

Investor Relations Contact:

Tom Cook

Managing Director

ICR Inc.

(203) 682-8250

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Residential Building & Real Estate Commercial Building & Real Estate Construction & Property

MEDIA:

Canopy Growth and Spectrum Therapeutics Expand Medical Portfolio with New 30 and 90-Pack Softgels and Enhanced Dosing Options

Canopy Growth and Spectrum Therapeutics Expand Medical Portfolio with New 30 and 90-Pack Softgels and Enhanced Dosing Options

Informed innovation delivers same trusted quality with improved value, flexible dosing, and better alignment with patient needs

SMITHS FALLS, Ontario–(BUSINESS WIRE)–
Canopy Growth Corporation (“Canopy Growth” or the “Company”) (TSX: WEED) (Nasdaq: CGC) and Spectrum Therapeutics today announced an expansion of its Minor Cannabinoid softgel lineup, introducing new 30 and 90-pack formats and additional dosing options across its Optimized Spectrum portfolio.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507336358/en/

Clarity, Unwind, and Daily Relief 90-pack softgel formats are available now to patients through Spectrum Therapeutics

Clarity, Unwind, and Daily Relief 90-pack softgel formats are available now to patients through Spectrum Therapeutics

The expansion builds on the strong performance of existing 30-pack formats and reflects Canopy Growth’s ongoing commitment to improving patient access through targeted, need-state products.

“Our focus has always been on building a portfolio that genuinely reflects what patients and clinics are telling us,” said Andrew Bevan, Senior Vice-President, Medical. “The success of our 30-pack told us patients were looking for more value, more convenience, and greater access to the minor cannabinoid formulations they rely on. This expansion goes beyond pack size – it’s about driving value through innovation, delivering greater flexibility in how patients dose, improving affordability, and responding directly to feedback on efficacy and treatment optimization.”

Together, these innovations support improved patient adherence and stronger clinical alignment.

Expanded Softgel Portfolio

Daytime Formulations

Spectrum Therapeutics Clarity | CBD:CBG 1:1 Softgels | 90-pack

Combining CBD and CBG, this formulation is designed to align with daytime activities and an active lifestyle.

Spectrum Therapeutics Daily Relief | CBD:CBC:CBG 2:1:1 | 90-pack

Now available in a 90-pack format, this product expands access to a core daily-use formulation.

Spectrum Therapeutics Daily Relief | CBD:CBC:CBG 5:2:2 | 30-pack

Developed in response to clinic feedback, this higher-dose format enables more efficient cannabinoid delivery for patients requiring elevated dosing, while maintaining formulation consistency.

Nighttime Formulations

Spectrum Therapeutics Unwind | CBD:CBN 2:1 Softgels | 90-pack

A nighttime formulation designed to support relaxation and end-of-day use.

Spectrum Nighttime Relief | CBN:CBD:THC 1:1:2 Softgels | 90-pack

Expanding the nighttime portfolio, this new formulation is designed to support rest and recovery, offering patients a consistent, longer-duration option.

Availability

Clarity, Unwind, and Daily Relief 90-pack softgel formats are available now to patients through Spectrum Therapeutics. 30-pack of Daily Relief higher-dose format and 90-pack of Nighttime Relief will be available at the end of May.

About Canopy Growth

Canopy Growth is a world-leading cannabis company dedicated to unleashing the power of cannabis to improve lives. Its portfolio of owned and licensed brands including Tweed, 7ACRES, DOJA, Deep Space, Deelish, Claybourne, MTL Cannabis, Low Key by MTL and R’belle, as well as category defining Storz & Bickel, delivers innovative products to consumers across Canada and beyond.

Canopy Growth is Canada’s leading provider of medical cannabis services through Canada House Clinics and serves patients online via Abba Medix. The Company also holds unconsolidated, non-controlling interest in Canopy USA, which provides exposure to the U.S. THC market.

Committed to quality, responsible use, and community, Canopy Growth is shaping a future where cannabis is embraced for its potential to enhance well-being.

For more information visit www.canopygrowth.com

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company or its subsidiaries to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this news release. Examples of such statements and uncertainties include statements with respect to the occurrence, timing and expectations relating to the launch of the Company’s Expand Medical Portfolio of 30 pack and 90 pack formats and expanded dosing portfolio.

Risks, uncertainties and other factors involved with forward-looking information or statements could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information, including risks relating to the dilutive impact of the transactions and future resales of Common Shares in the public market, which may negatively affect the stock price of Common Shares; negative operating cash flow; uncertainty of additional financing; use of proceeds; volatility in the price of the Common Shares; risks relating to the overall macroeconomic environment, which may impact customer spending, costs and margins, including tariffs (and related retaliatory measures), the levels of inflation, and interest rates; expectations regarding future investment, growth and expansion of operations; regulatory and licensing risks; changes in general economic, business and political conditions, including changes in the financial and stock markets; legal and regulatory risks inherent in the cannabis industry, including the global regulatory landscape and enforcement related to cannabis; additional dilution; political risks and risks relating to regulatory change, including with respect to reimbursement rates in the medical cannabis market; risks relating to anti-money laundering laws; compliance with extensive government regulation and the interpretation of various laws regulations and policies; public opinion and perception of the cannabis industry; and such other risks contained in the public filings of the Company filed with Canadian securities regulators and available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the SEC through EDGAR at www.sec.gov/edgar, including under the heading “Risk Factors” in the Company’s annual report on Form 10-K for the fiscal year ended March 31, 2025 and its subsequently filed quarterly reports on Form 10-Q.

In respect of the forward-looking statements and information, the Company has provided such statements and information in reliance on certain assumptions that they believe are reasonable at this time. Although the Company believes that the assumptions and factors used in preparing the forward-looking information or forward-looking statements in this news release are reasonable, undue reliance should not be placed on such information or statements and no assurance can be given that such events will occur in the disclosed time frames or at all. Should one or more of the foregoing risks or uncertainties materialize, or should assumptions underlying the forward-looking information or statements prove incorrect, actual results may vary materially from those described herein as intended, planned, anticipated, believed, estimated or expected. Although the Company has attempted to identify important risks, uncertainties and factors which could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. The forward-looking information and forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake any obligation to publicly update such forward-looking information or forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities laws.

Media Contact: [email protected]

Investor Contact:[email protected]

KEYWORDS: North America Canada

INDUSTRY KEYWORDS: Alternative Medicine Cannabis Retail Health Specialty Natural Resources

MEDIA:

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Clarity, Unwind, and Daily Relief 90-pack softgel formats are available now to patients through Spectrum Therapeutics
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Soluna Announces Monthly Business Update

Soluna Announces Monthly Business Update

ALBANY, N.Y.–(BUSINESS WIRE)–
Soluna Holdings, Inc. (“Soluna” or the “Company”) (NASDAQ: SLNH), a developer of green data centers for intensive computing applications, including Bitcoin mining and AI, announced its April 2026 project site-level operations, developments, and updates.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260507466082/en/

Soluna's Project Dorothy Campus

Soluna’s Project Dorothy Campus

The Company has provided the following Corporate and Site Updates.

Key Company Metrics:

The monthly metrics are now available here.

Corporate Highlights:

  • Soluna closed its $53M acquisition of the Briscoe Wind Farm, achieving full vertical integration and direct ownership of a renewable generation asset for the first time. Read more
  • Soluna acquired full ownership of Project Dorothy 1A, accelerating the site’s development toward an AI-ready campus and deepening our vertical integration strategy. Read more
  • Soluna and Sazmining launched a 3 MW Bitcoin mining operation at Project Dorothy 1B, adding a new hosting partner to our growing Dorothy campus. Read more
  • Soluna announced its fourth expansion with Blockware, surpassing 17 MW of total hosting capacity and reinforcing the depth of our long-term partner relationships. Read more
  • Soluna regained compliance with Nasdaq listing requirements. Read more
  • CEO John Belizaire participated in the Water Tower Research Insights Conference, speaking to our infrastructure model and the AI energy opportunity. Read more
  • CEO John Belizaire joined Disruptor Investor for an X Spaces conversation on Soluna’s positioning at the intersection of renewable energy and AI infrastructure. Listen here
  • Soluna was featured in Power Mining Analysis’ Deep Dive series, highlighting our behind-the-meter model and pipeline advantage. Watch here
  • Luxor published a case study on Soluna, spotlighting our operational approach and execution track record. Learn more

Key Project Updates:

Project Dorothy 1A (25 MW, Bitcoin Hosting) / Project Dorothy 1B (25 MW, Bitcoin Prop-Mining):

  • Transformer repair work impacted the availability of two MDCs at D1A. We expect the MDCs to return to service in early May, at which point D1A will return to full capacity.

  • Prop mining at D1B has been further consolidated following the execution of the hosting agreement with Saz Mining, with two MDCs of S21XP units deployed. D1B now has 6 MDCs planned for hosting and 16 MDCs for prop mining.

  • Deployments for hosting customers to reach full capacity are ongoing, and prop mining will remain operational in the designated hosting MDCs until hosted miners are received.

Project Dorothy 2 (48 MW, Bitcoin Hosting):

  • Operations remained strong for the month, with all customers at full capacity.

Project Sophie (25 MW, Bitcoin Hosting):

  • Operations remained strong for the month, with all customers at full capacity.

Project Kati 1 (83 MW Under Construction, Bitcoin Hosting):

  • Operations for K1A Galaxy (48 MW) have remained steady for the month.

  • Construction of K1B (35 MW, Soluna MDCs / Cormint Containers): Cormint containers have been installed, and mechanical completion for the phase has been achieved. Power commissioning has commenced, and the phase is on track to complete the substation ahead of schedule. Construction of the remaining phases of Soluna MDCs remains on schedule.

Project Kati 2 (300+ MW, Under Development, AI/HPC Hosting):

  • The data center design process is now underway, with leading architectural and engineering firms selected from a competitive RFP process. Both are award-winning firms with deep experience in AI data center projects. Soluna expects to provide additional information on these engagements once contracts are finalized.

  • Hyperscaler and neocloud interest, due diligence, and discussions remain active. Additional parties have joined the process.

  • Geotechnical work was completed on the land parcel for the expansion.

  • The tax abatement process has begun.

  • Drafting of construction RFP underway.

  • Negotiations are underway on the initial gas engine purchase.

Project Dorothy 3 (300+ MW, Under Development, AI/HPC Hosting):

  • Initial 50 MW expansion interconnection load study underway with Goldenspread Electric Cooperative and ONCOR

  • ~400 acres of land to support expansion under LOI; purchase agreement expected to close in the coming weeks

  • Fiber studies underway with leading fiber providers

  • Community relations task force established to proactively engage Briscoe County residents ahead of data center construction

Project Grace (2 MW Under Development, AI/HPC Hosting):

  • Soluna has partnered with the Siemens PTI team to lead technical modeling efforts. Siemens is conducting high-fidelity simulations to validate system performance under dynamic AI load conditions, including rapid demand fluctuations. This work focuses on ensuring the design supports voltage ride-through and mitigates SSO-related risks.

  • The design process is underway with a focus on ensuring technical readiness for AI/HPC deployment.

Pipeline Highlights:

  • Finalizing Power Purchase Agreements (PPAs) and Retail Electric Provider (REP) agreements for Project Annie.

  • Projects Annie and Fei continue to advance outside of the ERCOT Large Flexible Load Batch study process, leveraging the sub-75 MW interconnection pathway to accelerate development timelines.

  • Continuing to advance partnership opportunities and evaluate potential assets with multiple IPPs across the U.S. ISOs.

Customer Success:

View Soluna’s recent AMA here.

Soluna’s updated glossary of terms is available here.

Safe Harbor Statement

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business and our expectations with respect to the development, construction, commissioning, and operation of our project pipeline, including Project Kati 1, Project Kati 2, Project Grace, the expansion of hosting arrangements at Project Dorothy 1B, [the expected return to service of equipment at Project Dorothy 1A], and other statements that are predictive in nature. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident,” and similar statements. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 30, 2026. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except to the extent required by law.

About Soluna Holdings, Inc. (Nasdaq: SLNH)

Soluna is on a mission to make renewable energy a global superpower, using computing as a catalyst. The company designs, develops, and operates digital infrastructure that transforms surplus renewable energy into global computing resources. Soluna’s pioneering data centers are strategically co-located with wind, solar, or hydroelectric power plants to support high-performance computing applications, including Bitcoin Mining, Generative AI, and other compute-intensive applications. Soluna’s proprietary software MaestroOS(™) helps energize a greener grid while delivering cost-effective and sustainable computing solutions and superior returns. To learn more, visit solunacomputing.com and follow us on:

LinkedIn: https://www.linkedin.com/company/solunaholdings/

X (formerly Twitter): x.com/solunaholdings

YouTube: youtube.com/c/solunacomputing

Newsletter: bit.ly/solunasubscribe

Resource Center: solunacomputing.com/resources

Soluna regularly posts important information on its website and encourages investors and potential investors to consult the Soluna investor relations and investor resources sections of its website regularly.

Public Relations

West of Fairfax for Soluna

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Software Professional Services Blockchain Data Management Sustainability Alternative Energy Energy Technology Artificial Intelligence Environment Green Technology Cryptocurrency

MEDIA:

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Soluna’s Project Dorothy Campus

ImmunityBio Reports Record Q1 2026 Results: Net Product Revenue Increased Nearly 2.7x Year-Over-Year to $44 Million in Q1 2026 Expanding on the 2025 Full Year 700% Year-Over-Year Revenue Growth; Cash and Marketable Securities Total $381 Million

ImmunityBio Reports Record Q1 2026 Results: Net Product Revenue Increased Nearly 2.7x Year-Over-Year to $44 Million in Q1 2026 Expanding on the 2025 Full Year 700% Year-Over-Year Revenue Growth; Cash and Marketable Securities Total $381 Million

  • Q1 2026 Revenue Growth with Continued Strong Sales Momentum: $44.2 million, representing an ~168% year-over-year increase compared with Q1 2025 and up 15% from Q4 2025
  • ANKTIVA® Unit Growth: 168% increase in unit sales volume in Q1 2026 compared to Q1 2025
  • ANKTIVA Regulatory Update: ANKTIVA is now approved or authorized across five regulatory jurisdictions, representing approximately 34 countries, including first approval in Asia by the Pharmaceutical Administration Bureau (ISAF) of the Macau Special Administrative Region of the People’s Republic of China. Commercial availability achieved within two months of announcing MENA partnership with Biopharma and Cigalah Healthcare.
  • Cash Position: $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026, up from $242.8 million as of December 31, 2025.
  • Pivotal BCG-Naïve CIS trial (QUILT-2.005): Fully enrolled, with the Independent Data Monitoring Committee (IDMC) confirming no additional enrollment is required. A supplemental BLA (sBLA) submission is on track for 2026
  • BCG-Unresponsive NMIBC with Papillary-Only Disease Category 2A NCCN® Recommendation: NCCN Clinical Practice Guidelines in Oncology have been updated to include ANKTIVA plus BCG for patients with BCG-unresponsive NMIBC with papillary-only disease in addition to CIS, with or without papillary tumors. Both recommendations are Category 2A, representing uniform consensus.

CULVER CITY, Calif.–(BUSINESS WIRE)–
ImmunityBio, Inc. (NASDAQ: IBRX), a biotechnology company, announced financial and operational highlights for the fiscal quarter ended March 31, 2026. The Company reported net product revenue of approximately $44.2 million during the three months ended March 31, 2026, with net product revenue growth in every quarter since ANKTIVA’s commercial launch, including a 168% increase over Q1 2025. This builds on full-year 2025 net product revenue of $113.0 million, a 700% increase over full-year 2024. Q1 2026 net product revenue also represents a 15% sequential increase over the $38.3 million earned during Q4 2025, and the revenue growth expansion of 700% full year growth year-over-year in 2025 continues.

The Company ended the quarter with $380.9 million in cash, cash equivalents and marketable securities as of March 31, 2026.

“We continue to see strong demand for ANKTIVA from both new prescribers and physicians expanding use across multiple eligible patients, including in the maintenance setting,” said Richard Adcock, President and CEO of ImmunityBio. “We have also made meaningful progress expanding market access beyond the U.S., with ANKTIVA now commercially available in Saudi Arabia and additional markets anticipated this year. We are entering Q2 with a strong cash position, growing revenues, and a more experienced commercial organization positioned to support continued growth.”

“We’re encouraged by the steady progress of our clinical programs and regulatory submissions across NMIBC and non-small cell lung cancer (NSCLC),” said Patrick Soon-Shiong, M.D., Founder, Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. “The full enrollment of our pivotal BCG-naïve NMIBC trial, with independent confirmation that no additional patients are required, supports our planned sBLA submission in 2026. In parallel, recent NCCN guideline updates now include ANKTIVA plus BCG for patients with BCG-unresponsive papillary-only disease, reinforcing the growing clinical evidence supporting our approach across a broader spectrum of bladder cancer patients. We are also advancing our NSCLC program in a randomized trial in patients who have progressed following prior checkpoint inhibitor therapy, an area of significant unmet need, alongside continued development of our cell therapy platforms, including CD19-targeted therapies in non-Hodgkin lymphoma and Waldenström’s macroglobulinemia, and PD-L1 t-haNK in glioblastoma.”

Quarterly Financial Highlights

Cash and Marketable Securities Position

As of March 31, 2026, the Company had consolidated cash, cash equivalents, and marketable securities of $380.9 million.

First-Quarter 2026 Financial Summary

Product Revenue, Net

Product revenue, net increased $27.7 million during the three months ended March 31, 2026, as compared to the three months ended March 31, 2025, due to increased net trade sales of ANKTIVA as a result of ongoing commercial activities.

Research and Development Expense

Research and development (R&D) expense increased $19.8 million to $68.0 million during the three months ended March 31, 2026, as compared to $48.2 million during the three months ended March 31, 2025, mainly due to increased clinical trials costs, headcount-related costs, consulting fees, and external manufacturing costs.

Selling, General and Administrative Expense

Selling, general and administrative (SG&A) expense increased $13.1 million to $45.8 million during the three months ended March 31, 2026, as compared to $32.7 million during the three months ended March 31, 2025, mainly due to increased professional services expenses, headcount-related costs, commercial-related expenses, other expense, and equipment expense.

Other Expense, Net

Other expense, net increased $497.5 million to $563.0 million during the three months ended March 31, 2026, as compared to $65.5 million during the three months ended March 31, 2025, primarily due to non-cash changes in the fair value of liabilities mainly driven by the significant increase in our common stock price. These fair value changes impacted our warrant and derivative liabilities, and a related-party convertible note. We also recorded a one-time write off of a convertible note receivable. These changes were partially offset by an increase in interest and investment income and a decrease in interest expense due to lower interest rates.

Net Loss Attributable to ImmunityBio Common Stockholders (Net Loss)

Net loss attributable to ImmunityBio common stockholders was $632.8 million during the three months ended March 31, 2026, as compared to $129.6 million during the three months ended March 31, 2025. The increase in net loss was mainly driven by changes in fair value of warrant and derivative liabilities, and a related-party convertible note due to an increase in our common stock price during the quarter, and the write off of a convertible note receivable, and higher R&D and SG&A expenses described above, which were partially offset by higher product revenue.

Adjusted Net Loss Attributable to ImmunityBio Common Stockholders (Adjusted Net Loss)

Adjusted net loss attributable to ImmunityBio common stockholders increased $3.6 million to $86.2 million during the three months ended March 31, 2026, as compared to $82.7 million during the three months ended March 31, 2025. Adjusted net loss is a non-GAAP financial measure that excludes the impact of certain items, as shown in the non-GAAP reconciliation table below.

 

ImmunityBio, Inc.

Condensed Consolidated Statements of Operations

 

 

Three Months Ended

March 31,

(Unaudited; in thousands, except per share amounts)

 

2026

 

 

 

2025

 

 

 

 

 

Revenue

 

 

 

Product revenue, net

$

44,167

 

 

$

16,509

 

Other revenues

 

39

 

 

 

8

 

Total revenue

 

44,206

 

 

 

16,517

 

Operating costs and expenses

 

 

 

Cost of sales

 

238

 

 

 

58

 

Research and development

 

64,770

 

 

 

45,976

 

Research and development – related parties

 

3,219

 

 

 

2,258

 

Selling, general and administrative

 

44,461

 

 

 

31,977

 

Selling, general and administrative – related parties

 

1,309

 

 

 

677

 

Total operating costs and expenses

 

113,997

 

 

 

80,946

 

Loss from operations

 

(69,791

)

 

 

(64,429

)

Other income (expense), net:

 

 

 

Interest and investment income, net

 

2,314

 

 

 

887

 

Change in fair value of warrant and derivative

liabilities, and related-party convertible note

 

(530,930

)

 

 

(37,452

)

Interest expense – related party

 

(14,559

)

 

 

(15,313

)

Interest expense related to revenue interest liability

 

(13,871

)

 

 

(13,534

)

Interest expense

 

(34

)

 

 

(18

)

Other expense, net

 

(5,917

)

 

 

(41

)

Total other expense, net

 

(562,997

)

 

 

(65,471

)

Loss before income taxes and noncontrolling interests

 

(632,788

)

 

 

(129,900

)

Income tax (expense) benefit

 

(9

)

 

 

234

 

Net loss

 

(632,797

)

 

 

(129,666

)

Net loss attributable to noncontrolling interests, net of tax

 

(15

)

 

 

(20

)

Net loss attributable to ImmunityBio common stockholders

$

(632,782

)

 

$

(129,646

)

Net loss per ImmunityBio common share – basic and diluted

$

(0.62

)

 

$

(0.15

)

Weighted-average number of common shares used in computing

net loss per share – basic and diluted

 

1,026,874

 

 

 

853,162

 

 

ImmunityBio, Inc.

Selected Balance Sheet Data

 

(Unaudited; in thousands)

March 31,

2026

 

December 31,

2025

 

 

 

 

Cash and cash equivalents, and marketable securities

$

380,879

 

 

$

242,818

 

Total assets

 

646,637

 

 

 

501,898

 

Related-party convertible note payable, at fair value

 

678,386

 

 

 

477,093

 

Revenue interest liability

 

404,299

 

 

 

324,615

 

Total liabilities

 

1,515,763

 

 

 

1,001,472

 

Total ImmunityBio stockholders’ deficit

 

(870,006

)

 

 

(500,469

)

Total liabilities and stockholders’ deficit

 

646,637

 

 

 

501,898

 

 

ImmunityBio, Inc.

Summary Reconciliations of Cash Flows

 

 

Three Months Ended

March 31,

(Unaudited; in thousands)

 

2026

 

 

 

2025

 

 

 

 

 

Cash (used in) provided by:

 

 

 

Net cash used in operating activities

$

(75,359

)

 

$

(85,905

)

Net cash (used in) provided by investing activities

 

(31,650

)

 

 

4,129

 

Net cash provided by (used in) financing activities

 

223,926

 

 

 

(982

)

Effect of exchange rate changes on cash and cash equivalents, and restricted cash

 

122

 

 

 

(10

)

Net change in cash and cash equivalents, and restricted cash

 

117,039

 

 

 

(82,768

)

Cash and cash equivalents, and restricted cash, beginning of period

 

89,431

 

 

 

143,912

 

Cash and cash equivalents, and restricted cash, end of period

$

206,470

 

 

$

61,144

 

 

ImmunityBio, Inc.

Reconciliation of Net Loss Attributable to Common Stockholders (GAAP) to Adjusted Net Loss Attributable to Common Stockholders (Non-GAAP)

Adjusted net loss attributable to common stockholders is a non-GAAP financial measure which excludes certain items that are included in net loss attributable to common stockholders, the most directly comparable GAAP financial measure. Items excluded are those which the Company believes affect the comparability of operating results and are typically excluded from published estimates by the investment community, including items whose timing and/or amount cannot be reasonably estimated or are non-recurring.

Adjusted net loss attributable to common stockholders is presented because management believes it provides useful additional information to investors for analysis of the Company’s fundamental business on a recurring basis. In addition, management believes that adjusted net loss attributable to common stockholders is widely used by professional research analysts and others in the valuation, comparison, and investment recommendations of companies such as ImmunityBio.

Adjusted net loss attributable to common stockholders should not be considered in isolation or as a substitute for net loss attributable to common stockholders or any other measure of a company’s financial performance or profitability presented in accordance with GAAP. A reconciliation of the differences between net loss attributable to common stockholders and adjusted net loss attributable to common stockholders is presented below. Because adjusted net loss attributable to common stockholders excludes some, but not all, items that affect net loss attributable to common stockholders and may vary among companies, our calculation of adjusted net loss attributable to common stockholders may not be comparable to similarly titled measures of other companies.

 

Three Months Ended

March 31,

(Unaudited: in thousands)

 

2026

 

 

 

2025

 

 

 

 

 

Net loss attributable to ImmunityBio common stockholders (GAAP)

$

(632,782

)

 

$

(129,646

)

Change in fair value of warrant and derivative liabilities, and related-party convertible note

 

530,930

 

 

 

37,452

 

Stock-based compensation

 

8,169

 

 

 

9,537

 

Write-off of convertible note receivable

 

7,442

 

 

 

 

Adjusted net loss attributable to ImmunityBio common stockholders (non-GAAP)

$

(86,241

)

 

$

(82,657

)

 

About ImmunityBio

ImmunityBio, Inc. is a biotechnology company focused on innovating, developing, and commercializing next-generation immunotherapies designed to activate the patient’s immune system and deliver durable protection against cancer and infectious diseases. Our approach harnesses both the adaptive and innate immune systems with the goal of restoring immune function and generating lasting immunological memory in patients. At the core of our strategy is the Cancer BioShield platform, which is designed to stimulate critical lymphocytes, including natural killer (NK) cells, cytotoxic T cells, and memory T cells via our proprietary IL-15 superagonist, ANKTIVA® (nogapendekin alfa inbakicept). Our Cancer BioShield platform is anchored by this antibody-cytokine fusion protein and is complemented by a portfolio that includes adenovirus-vectored vaccines, allogeneic (off-the-shelf) and autologous NK-cell therapies, and additional immunomodulators intended to promote immunogenic cell death and support durable immune responses while potentially reducing reliance on high-dose chemo-radiation therapy.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements in this press release include, without limitation, statements regarding future operating results and prospects, global commercialization activities and expansion efforts and anticipated timelines, sales momentum and growth, market data, market access initiatives and potential platform expansion, expectations regarding FDA engagement, submissions, responses and timelines, among others.

Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding participation and enrollment and potential results from clinical trials, (ii) whether clinical trials will result in registrational pathways, (iii) whether clinical trial data will be accepted by regulatory agencies, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (vi) potential delays in product availability and regulatory approvals, (vii) ImmunityBio’s ability to retain and hire key personnel, (viii) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (ix) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (x) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xi) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xii) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies.

More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 23, 2026 and in subsequent filings made by ImmunityBio with the SEC, which are available on the SEC’s website at www.sec.gov. ImmunityBio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. ImmunityBio does not undertake any duty to update any forward-looking statement or other information in this press release, except to the extent required by law.

IMMUNITYBIO MEDIA CONTACTS:

Investor Relations:

Hemanth Ramaprakash, PhD, MBA

+1 858-746-9289

[email protected]

Media:

Sarah Singleton

+1 415-290-8045

[email protected]

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Health General Health Pharmaceutical Oncology Health Technology Medical Devices Research Infectious Diseases Science Clinical Trials

MEDIA:

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Harmony Biosciences Reports Q1 Financial Results and Confirms 2026 Net Revenue Guidance of Over $1 Billion; Reinforces 2026 Strategic Priorities

Harmony Biosciences Reports Q1 Financial Results and Confirms 2026 Net Revenue Guidance of Over $1 Billion; Reinforces 2026 Strategic Priorities

WAKIX® Net Revenue Grew 17% to $215.4 Million for First Quarter 2026; On Track for Full Year 2026 Net Revenues over $1 Billion

Continue to Vigorously Protect WAKIX IP into 2030; Filed Suit Against AET Pharma/Sandoz Regarding Infringement of Amorphous Pitolisant Patent

Lifecycle Management Advancing with Pitolisant GR on Track for NDA Filing 2Q26, Pitolisant HD Phase 3 Data in 2027, and Recently Acquired Novel Amorphous Form of Pitolisant to Pursue Broader CNS Indications

Potential Best-in-Class Orexin-2 Agonist with BP-205; Phase 1 Clinical PK Data On Track for Mid-2026

Renewed Focus on Business Development Opportunities with Emphasis on Revenue Potential in the 2028 to 2032 Timeframe

Expansion of the Leadership Team with the Addition of New COO and CFO to Support Scale and Next Phase of Growth

Conference Call and Webcast Today at 8:30 a.m. ET

PLYMOUTH MEETING, Pa.–(BUSINESS WIRE)–
Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q1 2026 revenue of $215.4 million, delivering 17% year‑over‑year growth for WAKIX®. Performance during the quarter reflected continued strong demand, offset by market access headwinds observed every Q1, which were more pronounced this year. This follows the strongest three consecutive quarters in franchise history, and the Company reinforced 2026 full year revenue guidance. The Company also outlined progress across four strategic priorities that it believes underpin long‑term shareholder value.

“Harmony is well positioned for long-term growth, and we are focused on four key pillars to drive value creation. First, protect the pitolisant franchise to ensure durability into the 2030s, supported by multi-layered intellectual property. Second, continued growth of the pitolisant franchise in an evolving market by advancing new formulations and differentiated approaches to solidify our leadership in the sleep/wake market. Third, drive value from our pipeline, led by BP-205, which has the potential to be a highly differentiated and best-in-class orexin-2 agonist across multiple indications. And fourth, a renewed emphasis on business development with a goal to transact on opportunities with revenue potential in the 2028–2032 timeframe,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “Executing on these four pillars positions us well to deliver innovative treatments for patients and generate long-term value for shareholders.”

Key Pillars of Value Creation:

Protect the Pitolisant Franchise

  • ANDA Settlements: 3 additional ANDA settlements were reached in Q1, bringing the total settlements to 6 of the 7 ANDA filers
  • Acquired New IP: Acquired exclusive license to an issued patent out to 2042 for a novel amorphous form of pitolisant, providing Harmony with new development opportunities in broader CNS patient populations
  • Strong IP Protection/Exclusivity: Harmony’s pitolisant IP estate is multi-layered (formulations, methods of use, next-gen applications) and supports WAKIX exclusivity into 2030 (inclusive of 6-months of pediatric exclusivity), with potential protection of the franchise into the 2040s via additional patents/applications
  • Filed Lawsuit: Harmony Biosciences and Novitium filed a patent infringement lawsuit in April against AET Pharma US and Sandoz, alleging infringement of patents covering an amorphous form of pitolisant hydrochloride

Continued Pitolisant Franchise Growth in an Evolving Market

First Quarter 2026 Net Product Revenue for WAKIX

  • Net product revenue for the quarter ended March 31, 2026, was $215.4 million, compared to $184.7 million for the same period in 2025

    • Average number of patients in Q1 was 8,500; exited the quarter with 8,600 average patients

On track to achieve >$1 Billion in narcolepsy net sales in 2026

  • Net revenue projected between $1.0 billion to $1.04 billion for the full year ending December 31, 2026

  • Received FDA approval of pediatric cataplexy indication on February 13th

    • Commercial team initiated full promotional efforts immediately upon approval

  • Pitolisant in Prader-Willi syndrome (PWS)

    • Phase 3 topline data readout expected in 2H 2026

    • Supports Pediatric Exclusivity for WAKIX: Fulfills a key regulatory requirement for six months of additional regulatory exclusivity, extending exclusivity to March 2030

Pitolisant GR (gastro-resistant): On track to extend pitolisant franchise into the 2040s

  • NDA submission on track for Q2 2026; anticipated PDUFA date in Q1 2027

    • Approximately 80-90% of patients with narcolepsy experience GI symptoms as part of their disease

    • Pitolisant GR is designed with enteric coating meant to reduce the potential for GI side effects in patients prone to GI symptoms

    • Enables patients to initiate treatment at a therapeutic dose without titration, an important clinical differentiation

  • Utility patents filed to extend franchise into the 2040s

Pitolisant HD (high dose): Opportunity to expand pitolisant franchise with differentiated labeling

  • Phase 3 registrational clinical trials ongoing in narcolepsy (ONSTRIDE 1) and idiopathic hypersomnia (IH) (ONSTRIDE 2)

    • Topline data expected in 2027; anticipated PDUFA date in 2028

    • Enhanced formulation with optimized PK profile, enteric coating and higher dose to drive greater efficacy

    • Differentiated labeling: fatigue in narcolepsy and sleep inertia in IH

  • Utility patents filed to expand franchise into the 2040s

Exploring novel amorphous form of pitolisant to pursue broader CNS indications

  • This opportunity is based on the exclusive license to Novitium’s issued amorphous pitolisant patent with protection until 2042

  • Current efforts focused on formulation optimization and new modes of delivery in preparation for Phase 1 PK study

Drive Value from our Robust Pipeline

Orexin-2 receptor agonist BP-205 (BP1.15205)

  • BP-205 is Harmony’s lead OX2R agonist, built upon a novel chemical scaffold, with the potential for best-in-class therapy:

    • The most potent OX2R agonist currently in clinical development

    • The high potency enables the potential for significantly lower dosing than current OX2R assets under development

      • Potential for once-daily dosing across NT1, NT2 and IH (supported by favorable preclinical PK profile)

    • High selectivity for OX2R over OX1R and across 150 other receptors of interest

      • Potential for favorable safety/tolerability profile (supported by preclinical safety pharmacology and toxicology data)

  • Phase 1 SAD/MAD clinical study ongoing in Europe; on track for clinical PK, safety, and tolerability data from SAD phase in mid-2026

  • U.S. IND submission planned for mid-2026

  • Plan to initiate Phase 1b study in sleep-deprived healthy volunteers in 2H 2026

  • Exploring use outside of sleep/wake, including cognition, ADHD, mood, and fatigue

EPX-100 (clemizole hydrochloride)

  • One of the most advanced development programs in the 5HT2 (serotonin) agonist class

  • Actively enrolling in two Global Phase 3 registrational trials in rare epilepsies:

    • Lennox‑Gastaut syndrome (LGS) – the LIGHTHOUSE Study
    • Dravet syndrome (DS) – the ARGUS Study
      • Encore safety and effectiveness data from the open-label extension study in DS that showed clinically meaningful reduction in seizures and a favorable safety and tolerability profile was presented at AAN meeting in April 2026

      • Both trials are currently enrolling in North America, Europe, China and India

  • Topline data anticipated in 1H 2027 and potential PDUFA date in 2028

Renewed Emphasis on Business Development

  • Focused on opportunities with revenue potential in 2028–2032

  • Prioritizing assets in Phase 3, in‑registration, or on‑market

  • Therapeutic areas of interest include Sleep/Wake, Epilepsy, Rare/Orphan CNS, and CNS adjacencies beyond rare disease

  • Supported by a strong balance sheet and clear conviction to execute on strategic business development opportunities

  • Strong liquidity position of $870.5 million in cash, cash equivalents, and investments as of March 31, 2026

Personnel Updates

  • Appointed Peter Anastasiou as Chief Operating Officer (effective April 2, 2026) and Glenn Reicin as Chief Financial Officer (effective April 14, 2026), supporting continued focus on strategic growth

First Quarter 2026 Financial Results

Harmony Biosciences reported net product revenue of $215.4 million for the quarter ended March 31, 2026, compared to $184.7 million for the same period in 2025, representing 17% year-over-year growth. This performance reflects both continued demand for WAKIX within the large narcolepsy market opportunity (approximately 80,000 diagnosed patients in the U.S.) and the product’s broad clinical utility. The continued success has been driven by strong execution across the organization from sales effectiveness to marketing and promotion and supported by broad payer coverage and how the company supports patients over time.

Cost of product sold was $44.5 million in the first quarter of 2026, or 20.7% as a percentage of net product revenue, as compared to $32.0 million, or 17.3%, for the same quarter in 2025, representing a 39% increase. The increase in cost of product sold as a percentage of net product revenue was driven by new royalties related to the Novitium license agreement.

Net income for the quarter was $32.5 million, or $0.55 per diluted share, compared to $45.6 million, or $0.78 per diluted share, in Q1 2025. The decline in earnings was entirely driven by the licensing agreements entered into during Q1 2026.

Harmony’s operating expenses include the following:

  • Research and Development expenses were $69.4 million in the first quarter of 2026, as compared to $34.5 million for the same quarter in 2025, representing a 101% increase; the increase was primarily driven by $32.0 million in expenses related to up-front payments for license agreements that were entered into during Q1 2026, providing new development opportunities, which had an after-tax impact to earnings of $0.45 per share

  • Sales and Marketing expenses were $31.7 million in the first quarter of 2026, as compared to $30.7 million for the same quarter in 2025, representing a 3% increase

  • General and Administrative expenses were $32.5 million in the first quarter of 2026, as compared to $31.2 million for the same quarter in 2025, representing a 4% increase

  • Total Operating Expenses were $133.6 million in the first quarter of 2026, as compared to $96.5 million for the same quarter in 2025, representing a 38% increase

As of March 31, 2026, Harmony had cash, cash equivalents and investments of $870.5 million, compared to $882.5 million as of December 31, 2025. The reduction was primarily due to up-front payments for license agreements and payment of ANDA settlements during Q1 2026.

2026 Net Product Revenue Guidance

Reiterated 2026 WAKIX Net Revenue Guidance of $1.0 Billion – $1.04 Billion

Conference Call Today at 8:30 a.m. ET

Harmony is hosting its first quarter 2026 financial results conference call and webcast today, beginning at 8:30 a.m. Eastern time. The live and replay webcast of the call will be available on the investor relations page of our website https://ir.harmonybiosciences.com/.

To participate in the live call by phone, dial: (888) 596-4144 (domestic) or (646) 968-2525 (international, alternate); reference passcode 6626692.

About Harmony Biosciences

Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2026 net product revenue, expectations for the growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; plans to submit an NDA for Pitolisant GR; plans to submit an IND for BP-205; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved, including EPX-100, Pitolisant GT and BP-205; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony’s common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe; and macroeconomic effects and changes in market conditions, including the impact of tariffs, inflation and the risk of recession. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 24, 2026 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

 

HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED

STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

(In thousands, except share and per share data)

 

 

 

 

 

 

 

 

 

 

Three Months Ended March 31,

 

 

2026

 

2025

Net product revenue

 

$

215,387

 

 

$

184,733

 

Cost of product sold

 

 

44,512

 

 

 

31,994

 

Gross profit

 

 

170,875

 

 

 

152,739

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

69,383

 

 

 

34,540

 

Sales and marketing

 

 

31,694

 

 

 

30,711

 

General and administrative

 

 

32,507

 

 

 

31,243

 

Total operating expenses

 

 

133,584

 

 

 

96,494

 

Operating income

 

 

37,291

 

 

 

56,245

 

Other (expense) income, net

 

 

(127

)

 

 

(276

)

Interest expense

 

 

(3,234

)

 

 

(3,836

)

Interest income

 

 

5,757

 

 

 

5,044

 

Income before income taxes

 

 

39,687

 

 

 

57,177

 

Income tax expense

 

 

(7,199

)

 

 

(11,617

)

Net income

 

$

32,488

 

 

$

45,560

 

Unrealized (loss) income on investments

 

 

(759

)

 

 

179

 

Comprehensive income

 

$

31,729

 

 

$

45,739

 

EARNINGS PER SHARE:

 

 

 

 

 

 

Basic

 

$

0.56

 

 

$

0.79

 

Diluted

 

$

0.55

 

 

$

0.78

 

Weighted average number of shares of common stock – basic

 

 

57,819,060

 

 

 

57,309,938

 

Weighted average number of shares of common stock – diluted

 

 

58,776,297

 

 

 

58,524,566

 

 

HARMONY BIOSCIENCES HOLDINGS, INC. AND SUBSIDIARIES

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 
 

 

 

March 31,

 

December 31,

 

 

2026

 

2025

ASSETS

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

 

Cash and cash equivalents

 

$

589,398

 

 

$

752,502

Investments, short-term

 

 

51,520

 

 

 

22,838

Trade receivables, net

 

 

108,222

 

 

 

96,787

Inventory, net

 

 

5,281

 

 

 

5,357

Prepaid expenses

 

 

16,801

 

 

 

16,014

Other current assets

 

 

7,595

 

 

 

13,516

Total current assets

 

 

778,817

 

 

 

907,014

NONCURRENT ASSETS:

 

 

 

 

 

 

Investments, long-term

 

 

229,555

 

 

 

107,127

Intangible assets, net

 

 

83,457

 

 

 

89,418

Deferred tax asset

 

 

153,562

 

 

 

149,699

Other noncurrent assets

 

 

26,433

 

 

 

18,373

Total noncurrent assets

 

 

493,007

 

 

 

364,617

TOTAL ASSETS

 

$

1,271,824

 

 

$

1,271,631

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

 

Trade payables

 

$

28,600

 

 

$

17,693

Accrued compensation

 

 

6,726

 

 

 

18,443

Accrued expenses

 

 

150,107

 

 

 

191,039

Current portion of long-term debt

 

 

20,000

 

 

 

20,000

Other current liabilities

 

 

11,907

 

 

 

4,957

Total current liabilities

 

 

217,340

 

 

 

252,132

NONCURRENT LIABILITIES:

 

 

 

 

 

 

Long-term debt, net

 

 

138,814

 

 

 

143,663

Other noncurrent liabilities

 

 

5,321

 

 

 

5,618

Total noncurrent liabilities

 

 

144,135

 

 

 

149,281

TOTAL LIABILITIES

 

 

361,475

 

 

 

401,413

COMMITMENTS AND CONTINGENCIES (Note 13)

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

 

Common stock—$0.00001 par value; 500,000,000 shares authorized at March 31, 2026, and December 31, 2025, respectively; 57,867,389 and 57,726,170 shares issued and outstanding at March 31, 2026, and December 31, 2025, respectively

 

 

1

 

 

 

1

Additional paid in capital

 

 

717,370

 

 

 

708,968

Accumulated other comprehensive (loss) income

 

 

(413

)

 

 

346

Retained earnings

 

 

193,391

 

 

 

160,903

TOTAL STOCKHOLDERS’ EQUITY

 

 

910,349

 

 

 

870,218

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,271,824

 

 

$

1,271,631

 

Harmony Biosciences Investor Contact:

Brennan Doyle

484-566-3685

[email protected]

Harmony Biosciences Media Contact:

Cate McCanless

202-641-6086

[email protected]

KEYWORDS: Pennsylvania United States North America

INDUSTRY KEYWORDS: Biotechnology Health Pharmaceutical Clinical Trials Oncology

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Black Diamond Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

  • Oral presentation of silevertinib Phase 2 data in frontline EGFRm NSCLC patients, including preliminary DOR and PFS data, to take place at the 2026 ASCO Annual Meeting
  • First patient dosed in the Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII+ GBM
  • Cash, cash equivalents, and investments of $118.3 million as of March 31, 2026, expected to be sufficient to fund operations into 2H of 2028

CAMBRIDGE, Mass., May 07, 2026 (GLOBE NEWSWIRE) — Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, today reported financial results for the first quarter ended March 31, 2026, and provided a corporate update.

“We remain focused on advancing silevertinib into pivotal development and are looking forward to the 2026 ASCO Annual Meeting later this month where an oral presentation of Phase 2 data will highlight silevertinib’s potential to benefit frontline EGFRm NSCLC patients,” said Mark Velleca, M.D., Ph.D., President and Chief Executive Officer of Black Diamond Therapeutics. “Our randomized Phase 2 trial in newly diagnosed EGFRvIII+ GBM also initiated this month with the dosing of our first patient.”

Recent Developments & Upcoming Milestones:

  • In April 2026, Black Diamond announced the following presentations at the upcoming 2026 American Society of Clinical Oncology (ASCO) Annual Meeting from May 29 – June 2, 2026, in Chicago:
    • May 30, 2026, 1:15 PM-2:45 PM CDT: Oral presentation on updated clinical data from the Phase 2 trial in patients with non-classical EGFRm NSCLC in the frontline setting, including preliminary duration of response (DOR) and progression-free survival (PFS) data (Abstract: 8519).
    • May 31, 2026, 9:00 AM-12:00 PM CDT: Poster presentation on the Phase 2 data of silevertinib in recurrent EGFRm NSCLC patients (Abstract: 8620).
    • June 1, 2026, 1:30 PM-4:30 PM CDT: Trial-in-progress poster on the randomized Phase 2 trial of silevertinib in patients with newly diagnosed EGFRvIII-positive GBM (Abstract: TPS2098).
  • In May 2026, the first patient was dosed with silevertinib in combination with temozolomide (TMZ) in the safety lead-in portion of the randomized Phase 2 trial in patients with newly diagnosed EGFRvIII+ GBM (NCT07326566).

Financial Highlights

  • Cash Position: Black Diamond ended the first quarter of 2026 with approximately $118.3 million in cash, cash equivalents, and investments compared to $128.7 million as of December 31, 2025. Net cash used in operations was $10.2 million for the first quarter of 2026 compared to net cash provided by operations of $53.4 million for the first quarter of 2025.
  • Research and Development Expenses: Research and development (R&D) expenses were $7.0 million for the first quarter of 2026, compared to $10.5 million for the same period in 2025. The decrease in R&D expenses was primarily due to the progression of our Phase 2 clinical trial for silevertinib in NSCLC and outlicensing of BDTX-4933 to increase focus on the development of silevertinib.
  • General and Administrative Expenses: General and administrative (G&A) expenses were $4.3 million for the first quarter of 2026, compared to $5.0 million for the same period in 2025. The decrease in G&A expenses was primarily due to the realization of continued operational efficiencies.
  • Net Loss: Net loss for the first quarter of 2026 was $9.0 million, as compared to net income of $56.5 million for the same period in 2025.

Financial Guidance

  • Black Diamond ended the first quarter of 2026 with approximately $118.3 million in cash, cash equivalents and investments which the Company believes is sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second half of 2028.

About Black Diamond Therapeutics

Black Diamond Therapeutics is a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer. The Company’s MasterKey therapies are designed to address a broad spectrum of genetically defined tumors, overcome resistance, minimize wild-type mediated toxicities, and be brain penetrant to treat central nervous system disease. The Company is advancing silevertinib, a brain-penetrant fourth-generation EGFR MasterKey inhibitor targeting EGFR-mutant NSCLC and GBM. For more information, please visit www.blackdiamondtherapeutics.com.

From time to time, we may use our website or our LinkedIn profile at www.linkedin.com/company/black-diamond-therapeutics to distribute material information. Our financial and other material information is routinely posted to and accessible on the Investors section of our website, available at www.blackdiamondtherapeutics.com. Investors are encouraged to review the Investors section of our website because we may post material information on that site that is not otherwise disseminated by us. Information that is contained in and can be accessed through our website or our LinkedIn page is not incorporated into, and does not form a part of, this press release.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the continued development and advancement of silevertinib, including the ongoing Phase 2 clinical trials and the timing of clinical updates for silevertinib in patients with EGFRm NSCLC and in patients with newly diagnosed EGFRvIII+ GBM, the potential of silevertinib to address the unmet medical need for newly diagnosed GBM patients and for newly diagnosed NSCLC patients with non-classical EGFR mutations and benefit patients with NSCLC across multiple lines of therapy, the potential future development plans for silevertinib in NSCLC and GBM, and the Company’s expected cash runway. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include those risks and uncertainties set forth in its Annual Report on Form 10-K for the year ended December 31, 2025, filed with the United States Securities and Exchange Commission and in its subsequent filings filed with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Black Diamond Therapeutics, Inc.

Condensed Consolidated Balance Sheet Data (Unaudited)

(in thousands)

  March 31,
2026
  December 31,
2025
  (in thousands)
Cash, cash equivalents, and investments $ 118,258     $ 128,652  
Total assets $ 132,922     $ 143,010  
Accumulated deficit $ (473,776 )   $ (464,740 )
Total stockholders’ equity $ 104,300     $ 112,211  



Black Diamond Therapeutics, Inc.

Consolidated Statements of Operations (Unaudited)

(in thousands, except per share data)

  Three Months Ended
March 31,
    2026       2025
License revenue $     $ 70,000
Operating expenses:      
Research and development $ 7,003     $ 10,506
General and administrative   4,256       4,964
Total operating expenses   11,259       15,470
Income (loss) from operations   (11,259 )     54,530
Other income (expense):      
Interest income   1,023       595
Other income (expense)   1,200       1,417
Total other income (expense), net   2,223       2,012
Net income (loss) $ (9,036 )   $ 56,542
       
Net income (loss) per share – basic $ (0.16 )   $ 1.00
Net income (loss) per share – diluted $ (0.16 )   $ 0.98
       
Weighted average common shares outstanding – basic   57,233,413       56,663,798
Weighted average common shares outstanding – diluted   57,233,413       57,673,099



Contact

For Investors:
[email protected]

For Media:
[email protected]



Evaxion announces business update and first quarter 2026 financial results

COPENHAGEN, Denmark, May 7, 2026 – Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces first quarter 2026 financial results.

Business highlights (since last quarterly update)

Evaxion has had a good start to the year executing on our plans and achieving our first milestone for 2026 as expected. Highlights include:

  • New data demonstrating an 86% vaccine target recognition by AI-Immunology™ in personalized cancer vaccine EVX-01 is a further scientific validation of the platform’s precision in driving immune response. This marked our first milestone for the year
  • Another new set of data confirming the platform’s unique scalability in glioblastoma
  • Successful completion of the one-year extension of our phase 2 trial with EVX-01 paving the way for presentation of three-year clinical data in the second half of 2026
  • Presentation of potentially superior design concepts for new polio vaccines stemming from our collaboration with The Gates Foundation
  • Organizational optimization for strategy execution with the promotion of Birgitte Rønø to the dual role of Chief Scientific and Chief Operating Officer and the election of Jens Bitsch-Nørhave to the Board of Directors
  • Cash runway unchanged with cash at hand to fund operations into the second half of 2027

“We maintain strong operational momentum as we continue our work to consolidate our position as a leader in AI-based target discovery, drug design and development. The validation of AI-Immunology™ continues to be reinforced with a host of new promising data presented, which forms a solid foundation for our ongoing business development efforts. We are pleased to have further strengthened our organization to focus on these with the promotion of Birgitte Rønø and inclusion of Jens Bitsch-Nørhave as a formal member of our Board of Directors,” says Helen Tayton-Martin, CEO of Evaxion.

Conference call and webcast

Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions.

To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event.

To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event.

Research & Development (R&D) update

Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases.

EVX-01 is our most advanced asset. Developed with AI-Immunology™, it is a personalized cancer vaccine designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results and presented new immunogenicity data from the trial at the American Association for Cancer Research (AACR) Annual Meeting last month.

The data demonstrates that AI-Immunology™ identifies and selects the most therapeutically relevant vaccine targets as 86% of the targets included in EVX-01 trigger a tumor-specific immune response. This is a success rate much higher than what has been reported for other methods.

The record-high vaccine target precision underscores the therapeutic potential of EVX-01 and is also a further validation of AI-Immunology™ as an effective tool for developing potentially transformational treatments in melanoma as well as potentially other cancer indications with high mutational burden. This is of course important for the technology itself, but also very supportive of our ongoing work to enter additional strategic partnerships and business development deals.

At AACR, we also presented new data confirming the scalability of AI-Immunology™ allowing for its application in several diseases. This includes the deadly brain cancer glioblastoma, for which the platform uniquely can identify a novel source of targets to include in therapeutic vaccines, potentially enhancing their efficacy.

The data was generated in collaboration with Duke University School of Medicine and has created significant interest in the field of glioblastoma, an area of high unmet medical need.

We have completed the one-year extension of the phase 2 trial with EVX-01 with the last patient having last physician visit in April. In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect also as stand-alone treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of the induced immune response. We expect to present this data in the second half of 2026.

We also maintain a high activity level within our infectious disease programs as showcased by our presentation of new polio vaccine design concepts stemming from our collaboration with The Gates Foundation. These could potentially be superior to currently used vaccines and provide a basis for designing a specific new polio vaccine.

Current polio vaccines are based on inactivated or attenuated versions of the virus. Whilst these vaccines are effective, they each have shortcomings in certain settings. Thus, it has been a long-standing – but so far unreachable – goal to create a novel polio vaccine that combines the strongest aspects of the existing vaccines.

To achieve this, we have deployed AI-Immunology™ to develop novel vaccine design concepts for a next-generation polio vaccine, which may enhance the chances of completing and sustaining polio eradication once and for all.

Business development update

We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships.

To this end, we were pleased to promote Birgitte Rønø to joint role of Chief Scientific and Chief Operating Officer reflecting optimal internal organization to support partnering activities and internal strategy execution.

Further, we are excited to have welcomed Jens Bitsch-Nørhave to our Board of Directors. With more than 25 years of leadership experience in the biotech and pharmaceutical industry, specializing in corporate strategy, global expansion, and dealmaking, Jens will be a strong contributor to our business development activities.

First quarter 2026 financial results

The financial results for the first quarter 2026 showed a net loss of $3.6 million, compared to $1.6 million first quarter 2025. This is explained by financial income from remeasurement of derivative liability in the first quarter last year, whereas the operating expenses and results were slightly reduced in first quarter 2026.

Research and development (R&D) expenses were $2.3 million for the first quarter 2026, which is a slight increase compared to same period last year, as we progress our pipeline according to plan.

General and administrative (G&A) expenses were $1.5 million for the quarter, compared to $1.7 million in first quarter 2025. The decrease is primarily driven by lower capital market costs.

Financial income of $0.3 million first three months of 2026 compared to $2.4 million same period last year, is due to financial income recorded in 2025 from remeasurement of derivative liability from the January 2025 public offering.

Cash and cash equivalents as of March 31, 2026, were $18.4 million, compared to $23.2 million as of December 31, 2025, and confirms our current cash runway until second half of 2027.

Total equity amounts to $13.2 million as of March 31, 2026, reflecting the net result of the first quarter 2026 when compared to $17.0 million as of December 31, 2025.

Evaxion A/S
Consolidated statement of financial position data
(USD in thousands)

  Mar 31,
2026
Dec 31,

2025
Cash and cash equivalents 18,440 23,234
Total assets 23,642 28,408
Total liabilities 10,435 11,369
Share capital 16,040 15,791
Other reserves 130,891 127,492
Accumulated deficit (133,724) (126,244)
Total equity 13,207 17,039
Total liabilities and equity 23,642 28,408

Evaxion A/S
Consolidated statement of comprehensive loss data
(USD in thousands, except per share data)

  Three Months Ended

Mar 31,
  2026 2025
Revenue 0 0
Research and development (2,298) (2,156)
General and administrative (1,521) (1,712)
Operating gain / loss (3,819) (3,868)
Finance income 305 2,493
Finance expenses (332) (397)
Net gain/ loss before tax (3,845) (1,772)
Income tax benefit 216 192
Net gain / loss for the period (3,629) (1,580)
Net loss attributable to shareholders of Evaxion A/S (3,629) (1,580)
Loss per share – basic and diluted (0.01) (0.01)
Number of shares used for calculation (basic and diluted) 417,010,756 276,311,927



Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
[email protected]

About Evaxion

Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases.        

With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development

We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options.

For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website

Forward-looking statement 
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law. 



Turning Point Brands Announces First Quarter 2026 Results

Turning Point Brands Announces First Quarter 2026 Results

  • Q1 2026 Modern Oral Net Sales increased 133% to $52.0 million, accounting for 42% of total company net sales, up from 21% in Q1 2025.
  • Raising FY 2026 Modern Oral Sales guidance; Introducing FY 2026 EBITDA guidance.

LOUISVILLE, Ky.–(BUSINESS WIRE)–Turning Point Brands, Inc. (“TPB” or “the Company”) (NYSE: TPB), a manufacturer, marketer and distributor of branded consumer products, including alternative smoking accessories and consumables with active ingredients, today announced financial results for the first quarter ended March 31, 2026.

Q1 2026 Financial Highlights

(All results reflect comparisons to prior-year period)

  • Total Consolidated Net Sales increased 16.8% to $124.3 million

    • Stoker’s segment Net Sales increased 48.1%

    • Zig-Zag segment Net Sales decreased 22.4%

  • Gross Profit increased 14.6% to $68.3 million

  • Net Income decreased 19.0% to $11.7 million

  • Adjusted EBITDA decreased 6.5% to $25.9 million (see Schedule A for a reconciliation to net income)

  • Diluted EPS of $0.60 and Adjusted Diluted EPS of $0.76 compared to $0.79 and $0.91 respectively, in the same period one year ago (see Schedule B for a reconciliation to Diluted EPS)

“We delivered a strong first quarter, driven by continued momentum in Modern Oral and disciplined execution across the portfolio,” said Graham Purdy, President and CEO. “We believe we are in the early stages of a generational shift in nicotine consumption, with significant opportunity ahead as the category continues to evolve. We are investing behind our brands, commercial capabilities, and consumer reach to position us to capture meaningful share in white pouch, including through initiatives such as our recently announced TKO partnership featuring UFC. At the same time, our legacy brands continue to generate strong cash flow, providing the foundation to fund our strategic priorities. We remain confident in our ability to scale our modern oral business and drive long-term value for shareholders.”

Stokers Products Segment (70% of total net sales in the quarter)

For the first quarter, Stoker’s segment net sales increased 48.1% from the prior year to $87.6 million, driven by triple-digit growth in Modern Oral net sales.

For the first quarter, Stoker’s segment gross profit increased 39.1% from the prior year to $47.3 million. Gross profit as a percentage of net sales decreased to 54.0% for the three months ended March 31, 2026, from 57.5% of net sales for the three months ended March 31, 2025, primarily driven by margin contribution from modern oral products.

Zig-Zag Products Segment (30% of total net sales in the quarter)

For the first quarter, Zig-Zag segment net sales decreased 22.4% from the prior year to $36.7 million. The decrease in net sales was driven primarily by lower U.S. papers and wraps shipments.

For the first quarter, Zig-Zag segment gross profit decreased 18.1% from the prior year to $20.9 million. Gross profit as a percentage of net sales increased to 57.1% for the three months ended March 31, 2026, from 54.1% for the three months ended March 31, 2025, driven primarily by product mix.

Performance Measures in the First Quarter

Investment in the first quarter focused on sales and marketing efforts to support distribution and brand building. In the first quarter consolidated selling, general and administrative (“SG&A”) expenses increased 53.2% from the prior year to $55.8 million, inclusive of Modern Oral-related sales and marketing investments and increased outbound freight costs.

As of March 31, 2026, ending cash was $192.4 million and net debt was $101.4 million. The Company ended the quarter with total liquidity of $265.0 million, comprised of $192.4 million in cash and $72.6 million of asset backed revolving credit facility capacity.

2026 Outlook

  • Full year Modern Oral Gross Sales of $280-$300 million (from $220- $240 million)

  • Full year Modern Oral Net Sales of $210-$225 million (from $180- $190 million)

  • Full Year Adjusted EBITDA of $70-$90 million, inclusive of investment in Modern Oral sales, marketing, and trade promotions

Earnings Conference Call

As previously disclosed, a conference call with the investment community to review TPB’s financial results has been scheduled for 8:30 a.m. Eastern on Thursday, May 7, 2026. Investment community participants should dial in 10 minutes ahead of time using the toll-free number (800) 715-9871 (international participants should call (646) 307-1963) and follow the audio prompts after typing in the event ID: 4128483. A live listen-only webcast of the call will be available on the Events and Presentations section of the investor relations portion of the Company website (www.turningpointbrands.com). A replay of the webcast will be available on the site two hours following the call.

Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles in the United States (GAAP), this press release includes certain non-GAAP financial measures including EBITDA, Adjusted EBITDA, Adjusted Net Income, Adjusted Diluted EPS, Free Cash Flow, and Adjusted Operating Income (Loss). A reconciliation of these non-GAAP financial measures accompanies this release. Also note that a reconciliation of forward-looking non-GAAP measures, including EBITDA, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation.

About Turning Point Brands, Inc.

Turning Point Brands, Inc. (NYSE: TPB) is a manufacturer, marketer and distributor of branded consumer products including alternative smoking accessories and consumables with active ingredients through its iconic brand portfolio, including Zig-Zag®, Stoker’s®, FRE®, and ALP®. TPB’s products are available in more than 220,000 retail outlets in North America and on sites such as www.zigzag.com, www.frepouch.com, and www.alppouch.com. For the latest news and information about TPB and its brands, please visit www.turningpointbrands.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, including our outlook for 2026 with respect to Modern Oral Gross and Net Sales and Adjusted EBIDTA. Forward-looking statements may generally be identified by the use of words such as “anticipate,” “believe,” “expect,” “intend,” “plan” and “will” or, in each case, their negative, or other variations or comparable terminology. These forward-looking statements include all matters that are not historical facts. By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. As a result, these statements are not guarantees of future performance and actual events may differ materially from those expressed in or suggested by the forward-looking statements. Any forward-looking statement made by TPB in this press release, its reports filed with the Securities and Exchange Commission (the “SEC”) and other public statements made from time-to-time speak only as of the date made. New risks and uncertainties come up from time to time, and it is impossible for TPB to predict or identify all such events or how they may affect it. TPB has no obligation, and does not intend, to update any forward-looking statements after the date hereof, except as required by federal securities laws. Factors that could cause these differences include, but are not limited to, those included in the Company’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed by the Company with the SEC. These statements constitute the Company’s cautionary statements under the Private Securities Litigation Reform Act of 1995.

This press release contains TPB’s preliminary determinations and current expectations, and such information is inherently uncertain. The preliminary estimates provided herein have been prepared by, and are the responsibility of, management and are subject to completion of TPB’s customary quarter-end closing and review procedures and third-party review. As a result, TPB’s reported information in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 may differ from this information, and any such differences may be material. In addition, the information furnished above does not include all of the information regarding TPB’s financial condition and results of operations for the quarter ending March 31, 2026 that may be important to readers. As a result, readers are cautioned not to place undue reliance on the information furnished in this press release and should view this information in the context of TPB’s full first quarter 2026 results when such results are disclosed by TPB in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026.

Financial Statements Follow on Subsequent Pages

Turning Point Brands, Inc.
Consolidated Statements of Income
(dollars in thousands except share data)
(unaudited)

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Net sales

 

$

124,278

 

 

$

106,436

 

Cost of sales

 

 

55,983

 

 

 

46,826

 

Gross profit

 

 

68,295

 

 

 

59,610

 

Selling, general, and administrative expenses

 

 

55,811

 

 

 

36,421

 

Operating income

 

 

12,484

 

 

 

23,189

 

Other expense, net

 

 

63

 

 

 

 

Interest expense, net

 

 

4,423

 

 

 

4,414

 

Investment gain

 

 

(151

)

 

 

(141

)

Income from equity method investment

 

 

(2,983

)

 

 

(150

)

Loss on extinguishment of debt

 

 

 

 

 

1,235

 

Income from continuing operations before income taxes

 

 

11,132

 

 

 

17,831

 

Income tax (benefit) expense

 

 

(2,810

)

 

 

2,040

 

Consolidated net income

 

 

13,942

 

 

 

15,791

 

Net income attributable to non-controlling interest

 

 

2,275

 

 

 

1,396

 

Net income attributable to Turning Point Brands, Inc.

 

$

11,667

 

 

$

14,395

 

 

 

 

 

 

 

 

 

 

Basic income per common share:

 

 

 

 

 

 

 

 

Net income attributable to Turning Point Brands, Inc.

 

$

0.61

 

 

$

0.81

 

Diluted income per common share:

 

 

 

 

 

 

 

 

Net income attributable to Turning Point Brands, Inc.

 

$

0.60

 

 

$

0.79

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

Basic

 

 

19,214,389

 

 

 

17,795,243

 

Diluted

 

 

19,474,877

 

 

 

18,249,306

 

Turning Point Brands, Inc.

Consolidated Balance Sheets

(dollars in thousands except share data)

(unaudited)

 

 

March 31,

 

 

December 31,

 

ASSETS

 

2026

 

 

2025

 

Current assets:

 

 

 

 

 

 

 

 

Cash

 

$

192,439

 

 

$

222,760

 

Accounts receivable, net of allowances of $228 in 2026 and $206 in 2025

 

 

27,473

 

 

 

25,726

 

Inventories, net

 

 

129,580

 

 

 

107,989

 

Other current assets

 

 

68,712

 

 

 

60,675

 

Total current assets

 

 

418,204

 

 

 

417,150

 

Property, plant, and equipment, net

 

 

40,584

 

 

 

36,247

 

Right of use assets

 

 

15,409

 

 

 

14,480

 

Deferred financing costs, net

 

 

1,019

 

 

 

1,180

 

Goodwill

 

 

135,974

 

 

 

136,097

 

Other intangible assets, net

 

 

63,731

 

 

 

64,042

 

Master Settlement Agreement (MSA) escrow deposits

 

 

29,786

 

 

 

29,887

 

Other assets

 

 

67,390

 

 

 

64,667

 

Total assets

 

$

772,097

 

 

$

763,750

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

35,889

 

 

$

20,420

 

Accrued liabilities

 

 

35,394

 

 

 

54,587

 

Total current liabilities

 

 

71,283

 

 

 

75,007

 

Deferred income tax liability

 

 

8,363

 

 

 

8,289

 

Notes payable and long-term debt

 

 

293,885

 

 

 

293,625

 

Other long-term liabilities

 

 

2,034

 

 

 

4,138

 

Lease liabilities

 

 

11,043

 

 

 

10,708

 

Total liabilities

 

 

386,608

 

 

 

391,767

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $0.01 par value; authorized shares 40,000,000; issued and outstanding shares -0-

 

 

 

 

 

 

Common stock, voting, $0.01 par value; authorized shares, 190,000,000; 20,824,677 issued shares and 19,367,534 outstanding shares at March 31, 2026, and 20,589,527 issued shares and 19,132,384 outstanding shares at December 31, 2025

 

 

218

 

 

 

216

 

Common stock, nonvoting, $0.01 par value; authorized shares, 10,000,000; issued and outstanding shares -0-

 

 

 

 

 

 

Additional paid-in capital

 

 

205,542

 

 

 

203,627

 

Cost of repurchased common stock (1,457,143 shares at March 31, 2026 and 1,457,143 shares at December 31, 2025)

 

 

(47,637

)

 

 

(47,637

)

Accumulated other comprehensive loss

 

 

(2,090

)

 

 

(1,563

)

Accumulated earnings

 

 

209,730

 

 

 

199,661

 

Non-controlling interest

 

 

19,726

 

 

 

17,679

 

Total stockholders’ equity

 

 

385,489

 

 

 

371,983

 

Total liabilities and stockholders’ equity

 

$

772,097

 

 

$

763,750

 

Turning Point Brands, Inc.
Consolidated Statements of Cash Flows
(dollars in thousands)
(unaudited)

 

 

Three Months Ended March 31,

 

 

 

2026

 

 

2025

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

Consolidated net income

 

$

13,942

 

 

$

15,791

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

 

 

 

Loss on extinguishment of debt

 

 

 

 

 

1,235

 

Loss on sale of property, plant, and equipment

 

 

 

 

 

40

 

Income from equity method investment

 

 

(2,983

)

 

 

(150

)

Gain on investments

 

 

(15

)

 

 

 

Depreciation and other amortization expense

 

 

1,753

 

 

 

1,309

 

Amortization of other intangible assets

 

 

306

 

 

 

307

 

Amortization of deferred financing costs

 

 

421

 

 

 

448

 

Deferred income tax expense

 

 

96

 

 

 

1,716

 

Stock compensation expense

 

 

2,938

 

 

 

1,664

 

Noncash lease income

 

 

(807

)

 

 

(380

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

(1,941

)

 

 

(5,539

)

Inventories

 

 

(21,700

)

 

 

(8,310

)

Other current assets

 

 

(8,062

)

 

 

(5,399

)

Other assets

 

 

(108

)

 

 

(1,268

)

Accounts payable

 

 

15,637

 

 

 

15,433

 

Accrued liabilities and other

 

 

(21,736

)

 

 

512

 

Net cash (used in) provided by operating activities

 

$

(22,259

)

 

$

17,409

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

Capital expenditures

 

$

(5,139

)

 

$

(2,185

)

Payment for equity investments

 

 

 

 

 

(2,783

)

Purchases of investments

 

 

(2,283

)

 

 

(714

)

Proceeds from sale of investments

 

 

2,351

 

 

 

500

 

MSA escrow deposits, net

 

 

5

 

 

 

(48

)

Net cash used in investing activities

 

$

(5,066

)

 

$

(5,230

)

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

Redemption of 2026 Notes

 

$

 

 

$

(250,000

)

Proceeds from 2032 Notes

 

 

 

 

 

300,000

 

Payment of dividends

 

 

(1,671

)

 

 

(1,385

)

Payments of financing costs

 

 

 

 

 

(6,582

)

Exercise of options

 

 

323

 

 

 

973

 

Redemption of options

 

 

 

 

 

(33

)

Redemption of restricted stock units

 

 

(330

)

 

 

(1,828

)

Redemption of performance based restricted stock units

 

 

(1,014

)

 

 

(2,625

)

Net cash (used in) provided by financing activities

 

$

(2,692

)

 

$

38,520

 

 

 

 

 

 

 

 

 

 

Net (decrease) increase in cash

 

$

(30,017

)

 

$

50,699

 

Effect of foreign currency translation on cash

 

$

(304

)

 

$

(48

)

 

 

 

 

 

 

 

 

 

Cash, beginning of period:

 

 

 

 

 

 

 

 

Unrestricted

 

$

222,760

 

 

$

48,941

 

Restricted

 

 

1,914

 

 

 

1,961

 

Total cash at beginning of period

 

$

224,674

 

 

$

50,902

 

 

 

 

 

 

 

 

 

 

Cash, end of period:

 

 

 

 

 

 

 

 

Unrestricted

 

$

192,439

 

 

$

99,640

 

Restricted

 

 

1,914

 

 

 

1,913

 

Total cash at end of period

 

$

194,353

 

 

$

101,553

 

Non-GAAP Financial Measures

To supplement our financial information presented in accordance with generally accepted accounting principles in the United States, or U.S. GAAP, we use non-U.S. GAAP financial measures, including EBITDA, Adjusted EBITDA, Adjusted Net Income, Adjusted Diluted EPS, and Adjusted Operating Income (Loss). We believe Adjusted EBITDA provides useful information to management and investors regarding certain financial and business trends relating to our financial condition and results of operations. Adjusted EBITDA, Adjusted Net Income, Adjusted Diluted EPS, and Adjusted Operating Income (Loss) are used by management to compare our performance to that of prior periods for trend analyses and planning purposes and are presented to our board of directors. We believe that EBITDA, Adjusted EBITDA, Adjusted Net Income, Adjusted Diluted EPS, Free Cash Flow, and Adjusted Operating Income (Loss) are appropriate measures of operating performance because they eliminate the impact of expenses that do not relate to business performance.

We define “EBITDA” as net income before interest expense, gain (loss) on extinguishment of debt, income tax expense, depreciation, amortization. We define “Adjusted EBITDA” as net income before interest expense, gain (loss) on extinguishment of debt, income tax expense, depreciation, amortization, other non-cash items and other items that we do not consider ordinary course in our evaluation of ongoing operating performance. We define “Adjusted Net Income” as net income excluding items that we do not consider ordinary course in our evaluation of ongoing operating performance. We define “Adjusted Diluted EPS” as diluted earnings per share excluding items that we do not consider ordinary course in our evaluation of ongoing operating performance. We define “Adjusted Operating Income (Loss)” as operating income (loss) excluding other non-cash items and other items that we do not consider ordinary course in our evaluation of ongoing operating performance.

Non-U.S. GAAP measures should not be considered a substitute for, or superior to, financial measures calculated in accordance with U.S. GAAP. EBITDA, Adjusted Net Income, Adjusted EBITDA, Adjusted Diluted EPS, and Adjusted Operating Income (Loss) exclude significant expenses that are required by U.S. GAAP to be recorded in our financial statements and is subject to inherent limitations. In addition, other companies in our industry may calculate this non-U.S. GAAP measure differently than we do or may not calculate it at all, limiting its usefulness as a comparative measure.

In accordance with SEC rules, we have provided, in the supplemental information attached, a reconciliation of the non-GAAP measures to the next directly comparable GAAP measures. Note that a reconciliation of forward-looking non-GAAP measures, including EBITDA, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation.

Schedule A

 

Turning Point Brands, Inc.
Reconciliation of GAAP Net Income to Adjusted EBITDA
(dollars in thousands)
(unaudited)

 

 

 

Three Months Ended

 

 

 

March 31,

 

 

 

2026

 

 

2025

 

Net income attributable to Turning Point Brands, Inc.

 

$

11,667

 

 

$

14,395

 

Add:

 

 

 

 

 

 

 

 

Interest expense, net

 

 

4,569

 

 

 

4,401

 

Loss on extinguishment of debt

 

 

 

 

 

1,235

 

Income tax (benefit) expense

 

 

(2,492

)

 

 

2,040

 

Depreciation expense

 

 

794

 

 

 

828

 

Amortization expense

 

 

1,285

 

 

 

822

 

EBITDA

 

$

15,823

 

 

$

23,721

 

Components of Adjusted EBITDA

 

 

 

 

 

 

 

 

Corporate restructuring (a)

 

 

97

 

 

 

 

ERP/CRM (b)

 

 

 

 

 

211

 

Stock based compensation (c)

 

 

2,938

 

 

 

1,664

 

Transactional expenses and strategic initiatives (d)

 

 

145

 

 

 

176

 

Non-recurring legal (e)

 

 

153

 

 

 

 

FDA PMTA (f)

 

 

290

 

 

 

1,591

 

Mark-to-market gain on Canadian inter-company note (g)

 

 

(116

)

 

 

315

 

Tariff adjustment (h)

 

 

5,903

 

 

 

 

Manufacturing start-up costs (i)

 

 

594

 

 

 

 

Honorarium (j)

 

 

63

 

 

 

 

Adjusted EBITDA

 

$

25,890

 

 

$

27,678

 

 

(a)

Represents costs associated with corporate restructuring, including severance and early retirement.

(b)

Represents cost associated with scoping and mobilization of new ERP and CRM systems and cost of duplicative ERP licenses.

(c)

Represents non-cash stock options, restricted stock, PSRUs, etc.

(d)

Represents the fees incurred for transaction expenses.

(e)

Represents legal expenses incurred in connection with litigation related to an insurance claim.

(f)

Represents costs associated with applications related to FDA premarket tobacco production application (“PMTA”).The PMTA regime requires the Company to submit an application to the FDA to receive marketing authorization to continue to sell certain of its product lines with continued sales permitted during the pendency of the applications. The application is a one-time resource-intensive process for each covered product line; however, due to the nature of the implementation process for those product lines already in the market, applications can take multiple years to complete rather than the typical one-time submission. The Company currently has only two product lines currently subject to the PMTA process, having utilized other regulatory pathway options available for our other product lines. The Company does not expect to submit additional PMTA applications for any new product lines after the submission for the pending two are complete.

(g)

Represents a mark-to-market loss attributable to foreign exchange fluctuation.

(h)

Represents adjustment to current period costs of goods sold to exclude tariffs subject to refund.

(i)

Represents non-recurring expenses incurred during the start-up of manufacturing lines.

(j)

Represents an honorarium gift included in other expense, net.

Schedule B

 

Turning Point Brands
Reconciliation of GAAP Net Income to Adjusted Net Income and Diluted EPS to Adjusted Diluted EPS
(dollars in thousands except share data)
(unaudited)

 

 

Three Months Ended

 

 

Three Months Ended

 

 

 

March 31, 2026

 

 

March 31, 2025

 

 

 

Income from continuing

operations

before income

taxes

 

 

Income tax

expense (m)

 

 

Net loss

attributable to

non-

controlling

interest

 

 

Adjusted Net

Income

 

 

Adjusted

Diluted EPS

 

 

Income from continuing

operations

before income

taxes

 

 

Income tax

expense (m)

 

 

Net loss

attributable to

non-

controlling

interest

 

 

Net Income

 

 

Diluted EPS

 

GAAP Net Income and Diluted EPS

 

$

11,132

 

 

$

(2,810

)

 

$

2,275

 

 

$

11,667

 

 

$

0.60

 

 

$

17,831

 

 

$

2,040

 

 

$

1,396

 

 

$

14,395

 

 

$

0.79

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss on extinguishment of debt (a)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,235

 

 

 

141

 

 

 

 

 

 

1,094

 

 

 

0.06

 

Corporate restructuring (b)

 

 

97

 

 

 

(24

)

 

 

 

 

 

121

 

 

 

0.01

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ERP/CRM (c)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

211

 

 

 

24

 

 

 

 

 

 

187

 

 

 

0.01

 

Stock based compensation (d)

 

 

2,938

 

 

 

(742

)

 

 

 

 

 

3,680

 

 

 

0.19

 

 

 

1,664

 

 

 

190

 

 

 

 

 

 

1,474

 

 

 

0.08

 

Transactional expenses and strategic initiatives(e)

 

 

145

 

 

 

(37

)

 

 

 

 

 

182

 

 

 

0.01

 

 

 

176

 

 

 

20

 

 

 

 

 

 

156

 

 

 

0.01

 

Non-recurring legal (f)

 

 

153

 

 

 

(39

)

 

 

 

 

 

192

 

 

 

0.01

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FDA PMTA (g)

 

 

290

 

 

 

(73

)

 

 

 

 

 

363

 

 

 

0.02

 

 

 

1,591

 

 

 

182

 

 

 

 

 

 

1,409

 

 

 

0.08

 

Mark-to-market loss on Canadian inter-company note (h)

 

 

(116

)

 

 

29

 

 

 

 

 

 

(145

)

 

 

(0.01

)

 

 

315

 

 

 

36

 

 

 

 

 

 

279

 

 

 

0.02

 

Tariff adjustment (i)

 

 

5,903

 

 

 

(1,490

)

 

 

 

 

 

7,393

 

 

 

0.38

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Manufacturing start-up costs (j)

 

 

594

 

 

 

(150

)

 

 

 

 

 

744

 

 

 

0.04

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Honorarium (k)

 

 

63

 

 

 

(16

)

 

 

 

 

 

79

 

 

 

0.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Tax benefit (l)

 

 

 

 

 

9,475

 

 

 

 

 

 

(9,475

)

 

 

(0.49

)

 

 

 

 

 

2,329

 

 

 

 

 

 

(2,329

)

 

 

(0.13

)

Adjusted Net Income and Adjusted Diluted EPS

 

$

21,199

 

 

$

4,124

 

 

$

2,275

 

 

$

14,800

 

 

$

0.76

 

 

$

23,023

 

 

$

4,963

 

 

$

1,396

 

 

$

16,664

 

 

$

0.91

 

 

(a)

Represents loss on extinguishment of debt as a result of the redemptions of the 2026 Notes.

(b)

Represents costs associated with corporate restructuring, including severance and early retirement.

(c)

Represents cost associated with scoping and mobilization of new ERP and CRM systems and cost of duplicative ERP licenses.

(d)

Represents non-cash stock options, restricted stock, PSRUs, etc.

(e)

Represents the fees incurred for transaction expenses.

(f)

Represents legal expenses incurred in connection with litigation related to an insurance claim.

(g)

Represents costs associated with applications related to FDA premarket tobacco production application (“PMTA”).The PMTA regime requires the Company to submit an application to the FDA to receive marketing authorization to continue to sell certain of its product lines with continued sales permitted during the pendency of the applications. The application is a one-time resource-intensive process for each covered product line; however, due to the nature of the implementation process for those product lines already in the market, applications can take multiple years to complete rather than the typical one-time submission. The Company currently has only two product lines currently subject to the PMTA process, having utilized other regulatory pathway options available for our other product lines. The Company does not expect to submit additional PMTA applications for any new product lines after the submission for the pending two are complete.

(h)

Represents a mark-to-market loss attributable to foreign exchange fluctuation.

(i)

Represents adjustment to current period costs of goods sold to exclude tariffs subject to refund.

(j)

Represents non-recurring expenses incurred during the start-up of manufacturing lines.

(k)

Represents an honorarium gift included in other expense, net.

(l)

Represents adjustment from quarterly tax rate to quarterly projected tax rate of 24% in 2026 and 21% in 2025.

(m)

Income tax expense calculated using the effective tax rate for the quarter of -25.2% in 2026 and 11.4% in 2025.

 

Investor Contacts

Turning Point Brands, Inc.

[email protected]

KEYWORDS: Kentucky United States North America

INDUSTRY KEYWORDS: Tobacco Retail Other Retail

MEDIA:

Logo
Logo

EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue

, May 07, 2026 (GLOBE NEWSWIRE) —

EDAP Reports Strong Financial Results with Record First Quarter HIFU Revenue

Seventh Consecutive Quarter of Year-Over-Year HIFU Revenue Growth

  • 78% Growth in First Quarter HIFU Revenue Year-Over-Year
  • 53% Growth in First Quarter U.S. HIFU Procedures Year-Over-Year
  • 83% Growth in First Quarter Focal One Shipments Year-Over-Year Demonstrating Strong Momentum
  • Landmark HIFI-2 Study Results Further Strengthen Focal One Robotic HIFU Market Position

AUSTIN, Texas, May 7, 2026 – EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today reported financial results for the first quarter of 2026.

“We delivered our strongest HIFU quarter to date, with revenue of $11.6 million, representing 78% year over year growth. U.S. Focal One procedure volumes reached a record high for the company with 53% year over year growth. We are executing well against our 2026 priorities and our results reflect a growing HIFU business. This includes expanded capital sales in key markets along with notable increased utilization across our global installed base,” said Ryan Rhodes, Chief Executive Officer. “Internationally, we secured capital sales in the United Kingdom, France, and Hungary where, for the first time, hospitals are investing in Focal One Robotic HIFU to treat both prostate cancer and deep infiltrating endometriosis.”

As previously announced, the landmark HIFI-2 study, published in European Urology Oncology, represents the largest prospective study to date evaluating salvage HIFU treatment following recurrence after failed radiation therapy. The positive study results show promise for use of Focal One HIFU as a breakthrough treatment for this important population of men who have previously been left with limited options that result in long-lasting, debilitating side effects. The publication of the HIFI-2 study further reinforces Focal One’s unique position as a non-invasive, organ-sparing, and function-preserving treatment option for a patient population that has historically faced limited therapeutic alternatives beyond palliative care.

First Quarter 2026 Results         

High-Intensity Focused Ultrasound (HIFU) Business

Total revenue in the HIFU business for the first quarter of 2026 was $11.6 million, compared to $6.5 million for the same period in 2025, representing an increase of 78% year over year. The Company sold eleven Focal One systems during the quarter, versus six system sales in the same period in 2025, representing a year-over-year growth of 83%. Worldwide disposables revenue grew 54% year over year, driven primarily by 53% growth in Focal One procedures in the U.S.

Non-Core Businesses (ESWL and Distribution)

Total revenue from the Company’s non-core businesses for the first quarter of 2026 was $6.2 million, compared to $7.8 million for the same period in 2025. The year over year decline reflects the Company’s strategic decision to focus on the high-growth, high margin opportunity in focal therapy through its Focal One Robotic HIFU platform.

Company

Total worldwide revenue for the first quarter of 2026 was $17.8 million, compared to $14.3 million for the same period in 2025. Gross profit margin on net sales was 45.7%, up from 42.0% for the same period in 2025. The margin improvement was primarily due to a favorable product-mix shift and better absorption of fixed costs, largely attributable to the growth of HIFU revenue.

Operating expenses for the first quarter of 2026 were $15.5 million, compared to $12.3 million for the same period in 2025.

Operating loss for the first quarter of 2026 was $7.4 million, compared to $6.3 million for the same period in 2025.

Net loss for the first quarter of 2026 was $9.1 million, or ($0.24) per share, compared to $7.4 million, or ($0.20) per share, for the same period in 2025.

2026 Financial Guidance

The Company is reiterating its previously issued revenue guidance. The Company’s core HIFU business revenue is expected to be in the range of $50.0 million to $54.0 million, representing 34% to 45% year-over-year growth. Revenue for the Company’s combined non-core ESWL and Distribution business is expected to be in the range of $22.0 million to $26.0 million.

Upcoming Meetings and Events

  • American Urological Association (AUA) Annual Meeting: May 15-18 in Washington D.C.
  • Investor Day: Monday, June 1, 2026 from 8:00-10:00am ET at Nasdaq MarketSite in New York City
  • Jefferies Global Healthcare Conference: Marriott Marquis, June 4th in New York City. EDAP management will present at 2:00pm ET and will participate in one-on-one meetings with investors

Conference Call Information

A conference call and webcast to discuss the first quarter 2026 financial results will be hosted by Ryan Rhodes, Chief Executive Officer, Ken Mobeck, Chief Financial Officer, and François Dietsch, Chief Accounting Officer. Please refer to the information below for conference call dial-in information and webcast registration.         

Date:                        Wednesday, May 7, 2026, at 8:30 a.m. Eastern Time
Domestic:                 1-800-343-4136
International:                 1-203-518-9843
Passcode (Conf ID): EDAP

Webcast:                 https://viavid.webcasts.com/starthere.jsp?ei=1759064&tp_key=77ec2128dc

About EDAP TMS SA

A recognized leader in robotic energy-based therapies, EDAP TMS develops, manufactures, promotes, and distributes worldwide minimally invasive medical devices for various conditions using ultrasound technology. By combining the latest technologies in imaging, robotics, and precise non-invasive energy delivery, EDAP introduced the Focal One® in Europe and the United States as a leading prostate focal therapy platform controlled by urologists, with the potential to expand to multiple indications beyond prostate cancer. For more information on the Company, please visit https://focalone.com.

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements within the meaning of applicable federal securities laws, including Section 27A of the U.S. Securities Act of 1933 (the “Securities Act”) or Section 21E of the U.S. Securities Exchange Act of 1934, which may be identified by words such as “believe,” “can,” “contemplate,” “could,” “plan,” “intend,” “is designed to,” “may,” “might,” “potential,” “objective,” “target,” “project,” “predict,” “forecast,” “ambition,” “guideline,” “should,” “will,” “estimate,” “expect” and “anticipate,” or the negative of these and similar expressions, which reflect our views about future events and financial performance. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy and distribution divisions, as well as risks associated with the current worldwide inflationary environment, the uncertain worldwide economic, political and financial environment, geopolitical instability, climate change and pandemics, or other public health crises, and their related impact on our business operations, including their impacts across our businesses or demand for our devices and services.

Other factors that may cause such a difference may also include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and in particular, in the sections “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 10-K.

Forward-looking statements speak only as of the date they are made. Other than required by law, we do not undertake any obligation to update them in light of new information or future developments. These forward-looking statements are based upon information, assumptions and estimates available to us as of the date of this press release, and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete.

Investor Contact
Louisa Smith
Gilmartin Group
[email protected]

EDAP TMS S.A.
UNAUDITED CONDENSED STATEMENTS OF OPERATIONS BY DIVISION
three months ended March 31, 2026
(Amounts in thousands of U.S. Dollars)

                                       
Three months ended      HIFU                ESWL                Distribution                Reconciling      Total After            
March 31, 2026   Division       Division       Division       Items   Consolidation      
Sales of medical equipment   $8,256        $277        $3,846          $12,379       
Net sales of RPP and leases   2,492        224        91          2,808       
Sales of spare parts, supplies and services   845        1,031        749          2,626       
TOTAL REVENUES   $11,593        $1,533        $4,686          $17,812       
GROSS PROFIT (% of Net Sales)   $5,962   51.4 %   $586   38.2 %   $1,597   34.1 %     $8,146   45.7 %
Research & development expenses   (2,467)        (46)        (84)          (2,597)       
Selling, general & administrative expenses   (9,439)        (218)        (1,282)        (1,976)   (12,915)       
OPERATING PROFIT (LOSS)   ($5,944)        $322        $231        ($1,976)   ($7,366)       

EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of U.S. Dollars, except per share data)

         
    Three Months Ended:
       March 31,       March 31, 
    2026   2025
    $US   $US
Sales of medical equipment   $12,379   $9,432
Net sales of RPP and leases   2,808   2,273
Sales of spare parts, supplies and services   2,626   2,563
TOTAL NET SALES   17,812   14,267
Other revenues    
TOTAL REVENUES   17,812   14,267
Cost of sales   (9,666)   (8,274)
GROSS PROFIT   8,146   5,993
Research & development expenses   (2,597)   (2,583)
Selling, general & administrative expenses   (12,915)   (9,719)
Total operating expenses   (15,512)   (12,302)
OPERATING LOSS   (7,366)   (6,309)
Interest (expense) income, net   (1,714)   15
Currency exchange gains (loss), net   142   (1,006)
LOSS BEFORE INCOME TAXES   (8,938)   (7,300)
Income tax (expense) credit, net   (145)   (144)
NET LOSS   ($9,083)   ($7,444)
Earnings per share – Basic & diluted   ($0.24)   ($0.20)
Average number of shares used in computation of basic & diluted EPS   37,481,986   37,392,086

EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(Amounts in thousands of U.S. Dollars)

         
       March 31,       December 31, 
    2026   2025
    $US   $US
Cash, cash equivalents and short-term investments   $15,012   $20,452
Accounts receivable, net   20,328   22,583
Inventory   13,332   12,830
Other current assets   1,691   1,299
TOTAL CURRENT ASSETS   $50,364   $57,164
Property, plant and equipment, net   13,007   13,505
Goodwill   2,773   2,834
Other non-current assets   5,915   5,495
TOTAL ASSETS   $72,059   $78,997
Accounts payable & other accrued liabilities   21,846   20,692
Deferred revenues, current portion   7,819   7,098
Short term borrowing   5,248   5,986
Other current liabilities   2,595   3,365
TOTAL CURRENT LIABILITIES   $37,508   $37,141
Operating and finance lease liabilities, non-current   2,345   2,429
Long-term debt, non-current   17,604   15,903
Deferred revenues, non-current   1,063   966
Other long-term liabilities   3,439   3,145
TOTAL LIABILITIES   $61,959   $59,584
TOTAL SHAREHOLDERS’ EQUITY   $10,101   $19,413
TOTAL LIABILITIES & SHAREHOLDERS’ EQUITY   $72,059   $78,997

EDAP TMS S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Amounts in thousands of U.S. Dollars)

         
       Three Months Ended      Three Months Ended
    March 31,    March 31, 
    2026   2025
    $US   $US
NET INCOME (LOSS)   ($9,083)   ($7,444)
Adjustments to reconcile net income (loss) to net cash generated by (used in) operating activities(1)   3,368   1,235
OPERATING CASH FLOW   (5,715)   (6,209)
Increase/Decrease in operating assets and liabilities   2,743   867
NET CASH GENERATED BY (USED IN) OPERATING ACTIVITIES   (2,972)   (5,342)
Additions to capitalized assets produced by the company and other capital expenditures   (754)   (1,304)
NET CASH GENERATED BY (USED IN) INVESTING ACTIVITIES   (754)   (1,304)
NET CASH GENERATED BY (USED IN) FINANCING ACTIVITIES   (1,372)   (1,254)
NET EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS   (341)   1,591
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   ($5,440)   ($6,309)

(1) including share based compensation expenses for $302 thousand for the three months ended March 31, 2026 and $339 thousand for the three months ended March 31, 2025.


Stardust Power Announces Q1 2026 Earnings Release Date, Conference Call

GREENWICH, Conn., May 07, 2026 (GLOBE NEWSWIRE) — Stardust Power Inc. (NASDAQ: SDST) (“Stardust Power” or the “Company”), an American developer of battery-grade lithium carbonate, today announced that it will release its Q1 2026 financial results after market close on Thursday May 14, 2026.

Roshan Pujari, Founder and Chief Executive Officer and Uday Devasper, Chief Financial Officer will host a conference call at 5:30pm ET on Thursday May 14, 2026, to discuss the Company’s results.

Participants may access the call by clicking the participant call link to ask questions:

https://register-conf.media-server.com/register/BIb28e4f24893b4687979885d0f892c76a Upon registering at the link, you will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details.

You can also access the call via live audio webcast using the website link to listen in:

https://edge.media-server.com/mmc/p/4xg8b9a5

Participants should log in at least 15 minutes early to receive instructions.

About Stardust Power Inc.

Stardust Power is a developer of battery-grade lithium carbonate designed to bolster America’s energy security through resilient supply chains. The Company plans to build a strategically located lithium refinery in Muskogee, Oklahoma, with the capacity to produce up to 50,000 metric tons of battery-grade lithium carbonate annually. Committed to sustainability at every stage, Stardust Power trades on Nasdaq under the ticker “SDST.”

For more information, visit www.stardust-power.com 

Stardust Power Contacts

For Investors:

Johanna Gonzalez
[email protected]

For Media:

Michael Thompson
[email protected]