enGene Announces Updated Interim Results From LEGEND Pivotal Cohort

enGene Announces Updated Interim Results From LEGEND Pivotal Cohort

54% complete response (CR) rate at any time; 43% six‑month CR rate

Low rate of progression to muscle-invasive or higher disease (3.2%)

Low percentage of patients experienced treatment-related adverse events (TRAEs) (55%), nearly all of which were mild

Low percentage of patients experienced TRAEs leading to treatment interruption (2.4%) or discontinuation (2.4%)

Kaplan-Meier estimate of 12-month CR rate is 25%

enGene to host webcast to discuss results today, May 7, 2026, at 8:00 a.m. ET

BOSTON & MONTREAL–(BUSINESS WIRE)–
enGene Therapeutics Inc. (Nasdaq: ENGN or “enGene” or the “Company”), a clinical-stage, non-viral genetic medicines company, today reported additional interim results from the pivotal cohort of its ongoing, Phase 2 LEGEND trial of detalimogene voraplasmid (also known as detalimogene) in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) patients with carcinoma in situ (CIS) with or without concomitant papillary disease, which enrolled 125 patients. These data, as of April 21, 2026, demonstrated that patients treated with detalimogene achieved a 54% complete response (CR) at any time and a 43% CR rate at six months. The progression rate to muscle-invasive or advanced disease was low, at 3.2%. Detalimogene was generally well tolerated with 55% of patients having experienced a treatment-related adverse event, mostly mild (Grade 1 and 2).

“These updated data continue to reinforce the favorable safety and tolerability profile of detalimogene and its clinical activity in a heavily pretreated, high-risk NMIBC patient population with limited therapeutic options. Importantly, the low rate of progression to muscle-invasive disease leaves patients eligible for other bladder-sparing therapies,” said Ron Cooper, President and Chief Executive Officer, enGene. “While durability outcomes to date are not what we hoped, these data are preliminary. We are focused on evaluating the totality of the data as it evolves and plan to continue to engage with the FDA and the medical community.”

LEGEND Pivotal Cohort Data Update

The interim analysis is based on the 125 patients enrolled in Cohort 1. Patients who discontinued without any disease evaluation or who discontinued after a CR were considered not evaluable for subsequent landmark CR analysis.

Efficacy overview:

  • 54% (95% CI: 45%, 63%) CR at any time (67/124)

    • 91% of responses occurred at first disease assessment

  • 43% (95% CI: 34%, 52%) CR rate at 6 months (52/121) with 14% (6/43) of patients having successfully converted from non-CR to CR post re-induction

  • Two re-induced patients have not yet had a 6-month assessment

  • Of the 52 responders at 6 months:

    • 37/44 patients who had a 9-month assessment were in CR; an additional 8 patients are pending evaluation

    • 13/22 patients who had a 12-month assessment were in CR; an additional 11 patients are pending evaluation

  • A maximum of 21 patients, including the 2 currently undergoing re-induction, still have the potential to achieve a CR at 12 months

  • The Kaplan-Meier (KM) estimate of the 12-month duration of response (DoR) is 25% (95% CI: 11%, 41%)

  • The KM estimate for median DoR is 37.3 weeks (range: 31.6-43.9 weeks)

  • Low rate of progression to muscle invasive or more advanced disease (3.2%)

Safety overview:

  • 55% of patients experienced a treatment-related adverse event (TRAE)

    • Among patients with any TRAE, 91% experienced Grade 1-2 TRAEs

  • Grade ≥3 TRAEs were reported in 6 patients (4.8%)

  • Low percentage of patients experienced TRAEs leading to treatment interruption (2.4%) and treatment discontinuation (2.4%)

Among the 32 patients who had their first disease assessment after the last data analysis (October 24, 2025, reported November 11, 2025), CR rates were lower than previously reported results. The CR rate at any time was 39% and at 6 months was 32% for these patients. A preliminary subgroup analysis has not revealed any material differences in demographics or key disease characteristics. A more comprehensive analysis of these patients, including potential contributing factors, is ongoing.

As a beneficiary of FDA’s RMAT designation and a participant in the FDA’s CDRP program, enGene has completed the required FDA manufacturing validation batches and submitted a Statistical Analysis Plan (SAP) to the agency. The Company plans further engagement with the FDA as it approaches a potential Biologics License Application (BLA) filing and plans to provide an update in the second half of 2026.

The Company plans to share these data with the broader medical community at a Plenary Presentation at the upcoming American Urological Association meeting on May 15, 2026.

Safety Information

The overall tolerability profile associated with detalimogene is favorable. Of the 125 patients assessed for safety in Cohort 1, 69 patients (55%) experienced at least one TRAE, which were mainly Grade 1/2 in severity. The most common TRAEs were fatigue (22%), dysuria (14%), micturition urgency (12%), pollakiuria (12%), and bladder spasm (11%). Six patients experienced Grade ≥3 TRAEs, including one Grade 4 TRAE, which has resolved. There were no Grade 5 TRAEs reported. TRAEs leading to dose discontinuations (2.4%) and dose interruptions (2.4%) were rare.

Conference Call

enGene will host a conference call and live webcast at 8:00 a.m. ET today, May 7, 2026. Individuals interested in listening to the conference call may do so by clicking the following link, which is also available at the “Investors” section of the Company’s website at www.engene.com/investors. Following the live webcast, an archived version of the call will also be available on the Company’s website for 90 days.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Non-muscle invasive bladder cancer (NMIBC) is a disease that poses a significant burden on both patients and clinics and has a massive economic impact on the healthcare system. NMIBC occurs when cancer cells grow in the tissues that line the interior of the bladder, but the cancer has not yet penetrated the muscle of the bladder wall. NMIBC can present as papillary outgrowths from the bladder wall, which are typically resected, or as carcinoma in situ (CIS), which consists of flat, multifocal lesions that cannot be resected. The two forms can also co-occur. About 75%-80% of new bladder cancer diagnoses are NMIBC. Patients suffering from high-risk NMIBC who are unresponsive to the standard of care, Bacillus Calmette-Guérin (BCG), face high rates of disease recurrence (50%-70%) and are potentially subject to full removal of the bladder (cystectomy) as a curative but life-altering next step.

About Detalimogene Voraplasmid

Detalimogene is a novel, investigational, non-viral gene therapy for patients with high-risk, non-muscle invasive bladder cancer (NMIBC), including Bacillus Calmette-Guérin (BCG)-unresponsive disease. It is designed to be instilled in the bladder and elicit a powerful yet localized anti-tumor immune response.

Detalimogene was developed using the Company’s Dually Derivatized Oligochitosan® (DDX) platform, a technology designed to transform how gene therapies are accessed by patients and utilized by clinicians. Medicines developed with the DDX platform can potentially overcome the limitations of viral-based gene therapies, reduce complexities related to safe handling and cold storage, and streamline both manufacturing processes and administration paradigms.

Detalimogene has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) based on its potential to address the high unmet medical need for patients with BCG-unresponsive carcinoma in situ (CIS) NMIBC with or without resected papillary tumors who are unable to undergo cystectomy. These designations are intended to expedite the development and review of drugs to serious or life-threatening conditions and fill an unmet medical need. Detalimogene has also been selected for the FDA’s Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program, designed to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy.

About the LEGEND Trial

Detalimogene is being evaluated in the ongoing, open-label, multi-cohort, Phase 2 LEGEND trial to establish its safety and efficacy in high-risk NMIBC. LEGEND’s pivotal cohort (Cohort 1) consists of 125 patients with high-risk, BCG-unresponsive NMIBC with CIS (with or without papillary disease) and is designed to serve as the basis of the Company’s planned Biologics License Application (BLA) filing. In addition to this pivotal cohort, LEGEND includes three additional cohorts, including NMIBC patients with CIS who are naïve to treatment with BCG (Cohort 2a); NMIBC patients with CIS who have been exposed to BCG but have not received adequate BCG treatment (Cohort 2b); and BCG-unresponsive high-risk NMIBC patients with papillary-only disease (Cohort 3).

About enGene

enGene is a clinical-stage biotechnology company mainstreaming non-viral genetic medicine through the delivery of therapeutics to mucosal tissues and other organs, with the goal of creating new ways to address diseases with high clinical needs. enGene’s lead program is detalimogene voraplasmid (also known as detalimogene) for patients with non-muscle invasive bladder cancer (NMIBC), a disease with a high clinical burden. Detalimogene is being evaluated in the ongoing multi-cohort LEGEND Phase 2 trial, which includes a pivotal cohort studying detalimogene in high-risk, Bacillus Calmette-Guérin (BCG)-unresponsive patients with carcinoma in situ (CIS) with or without concomitant papillary disease. Detalimogene was developed using enGene’s proprietary Dually Derivatized Oligochitosan (DDX) platform, which enables penetration of mucosal tissues and delivery of a wide range of sizes and types of cargo, including DNA and various forms of RNA.

To learn more, please visitenGene.com and follow us on LinkedIn, X and BlueSky.

Forward-Looking Statements

Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). enGene’s forward-looking statements include, but are not limited to, statements relating to the Company’s future plans, expectations, intentions, strategies and objectives. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate”, “appear”, “approximate”, “believe”, “continue”, “could”, “estimate”, “expect”, “foresee”, “goal”, “intend”, “may”, “might”, “plan”, “possible”, “potential”, “predict”, “project”, “seek”, “should”, “would”, and similar expressions (or the negative version of such words or expressions) may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements may include, for example, statements about: detalimogene’s potential efficacy, durability, safety, tolerability and ease of use profile, the development of detalimogene, the potential benefits of detalimogene, plans regarding regulatory interactions and a potential BLA submission for detalimogene, plans regarding updates on the LEGEND study, including clinical data and engagement with the FDA, and the potential benefits of medicines developed with the DDX platform. Such statements are subject to numerous important factors, risks and uncertainties, many of which are beyond enGene’s control, that may cause actual events or results to differ materially from enGene’s current expectations. For example, there can be no guarantee that detalimogene will successfully complete necessary clinical development phases, including achieving positive results in the pivotal cohort of the LEGEND study, or that those results or any feedback from regulatory authorities will ultimately lead to BLA submission for, and the approval of, detalimogene.

Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks, uncertainties and assumptions relating to a number of other factors, which could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the inability of preliminary clinical data to predict the final results of the trial, changes in the results from enGene’s clinical trials, including due to new data collected from the ongoing LEGEND study or future studies, subsequent analysis of existing data, and audit and verification procedures; the content and timing of decisions made by the FDA and other regulatory authorities; the Company’s ability to recruit and retain qualified scientific and management personnel, establish clinical trial sites and enroll patients in its clinical trials, execute on the Company’s clinical development plans; and its ability to secure regulatory approval on anticipated timelines, and other risks and uncertainties detailed in filings with Canadian securities regulators on SEDAR+ and with the U.S. Securities and Exchange Commission (“SEC”) on EDGAR, including those described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended October 31, 2025 (copies of which may be obtained at www.sedarplus.ca or www.sec.gov).

You should not place undue reliance on any forward-looking statements, which speak only as of the date on which they are made. enGene anticipates that subsequent events and developments will cause enGene’s assessments to change. While enGene may elect to update these forward-looking statements at some point in the future, enGene specifically disclaims any obligation to do so, unless required by applicable law. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved.

Media contact:

JC Molina

[email protected]

Investor contact:

Lauren Stival Hopfer

[email protected]

KEYWORDS: Massachusetts United States North America Canada

INDUSTRY KEYWORDS: Biotechnology General Health Pharmaceutical Health

MEDIA:

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BETA Technologies to Participate in Upcoming Investor Conferences

BETA Technologies to Participate in Upcoming Investor Conferences

SOUTH BURLINGTON, Vt.–(BUSINESS WIRE)–
BETA Technologies, Inc. (NYSE: BETA) (“BETA” or “the Company”), an electric aerospace company, today announced its participation at the following upcoming investor conferences:

  • On Wednesday, May 13, 2026, Herman Cueto, Chief Financial Officer and Devon Rothman, Head of Investor Relations and FP&A, will participate in a fireside chat at Bank of America’s 33rd Annual Industrials, Transportation & Airlines Key Leaders Conference in New York, NY.

  • On Thursday, May 14, 2026, Herman Cueto will participate in a fireside chat at Morgan Stanley’s Innovation & Impact Summit in New York, NY.

  • On Thursday, May 21, 2026, Devon Rothman will participate in a panel at Wolfe Research’s 19th Annual Global Transportation & Industrials Conference in New York, NY.

If you would like to request a meeting, please reach out to BETA’s Investor Relations team or your respective conference representative for more details.

About BETA Technologies, Inc.

BETA (NYSE: BETA) is an aerospace company designing, manufacturing and selling high-performance electric aircraft, advanced electric propulsion systems, components and charging systems to top operators worldwide. BETA has built and flown its family of ALIA aircraft, consisting of both conventional fixed-wing electric aircraft (the “ALIA CTOL”) and electric vertical takeoff and landing aircraft (the “ALIA VTOL”), more than 130,000 nautical miles, including multiple trips across the United States. BETA is deploying a network of charging infrastructure to enable the growing industry with more than 100 sites across the United States and internationally. BETA’s intentional approach to developing the enabling technologies necessary to electrify aviation unlocks lucrative aftermarket revenue opportunity over the life of each aircraft. These highly scalable enabling technologies allow BETA to serve a customer base across cargo and logistics, defense, passenger and medical end markets and unlock cost-effective and safe missions. BETA was named the #1 company on TIME’s list of the World’s Top GreenTech Companies of 2025. Visit www.beta.team for more information about BETA and its products.

Media:

[email protected]

Investors:

Devon Rothman, Head of Investor Relations and FP&A

[email protected]

KEYWORDS: New York Vermont United States North America

INDUSTRY KEYWORDS: Engineering Aerospace Manufacturing

MEDIA:

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Rapport Therapeutics Reports First Quarter 2026 Financials and Provides Business Update

Phase 2a follow-up period data for RAP-219 in focal onset seizures (FOS) demonstrated sustained seizure reduction, including a 90% median reduction in clinical seizures over baseline in weeks 9-12 

RAP-219 Phase 2 trial in bipolar mania topline results now expected in the fourth quarter of 2026, ahead of previous 1H 2027 guidance

RAP-219 Phase 3 program in FOS remains on track for initiation in the second quarter of 2026

Pipeline programs, including RAP-219 long-acting injectable formulation, RAP-219 in primary generalized tonic-clonic seizures, and α6β4 nAChR in chronic pain and migraine, continue to advance

Strategic collaboration and license agreement entered into with Tenacia Biotechnology to develop and commercialize RAP-219 in Greater China across indications

Ended the first quarter of 2026 with $476.8 million in cash, cash equivalents and short-term investments, excluding restricted cash, expected to fund operations into the second half of 2029

BOSTON and SAN DIEGO, May 07, 2026 (GLOBE NEWSWIRE) — Rapport Therapeutics, Inc. (Nasdaq: RAPP) (“Rapport” or the “Company”), a clinical-stage biotechnology company dedicated to the discovery and development of small molecule precision medicines for patients with neurological or psychiatric disorders, today reported financial results for the quarter ending March 31, 2026, and provided a business update.

“We entered 2026 with strong momentum across the RAP-219 development program, highlighted by compelling new follow-up Phase 2a data recently presented at AAN that further reinforces RAP-219’s treatment effect in focal onset seizures and builds confidence as we enter our Phase 3 trials,” said Abraham N. Ceesay, chief executive officer of Rapport. “With multiple important development milestones ahead, including continued advancement of our epilepsy franchise, progress in bipolar mania, and development of our long-acting injectable formulation, we believe we are well positioned to continue building value across our pipeline.”

CORPORATE HIGHLIGHTS

RAP-219 in Epilepsy

  • Positive Phase 2a Follow-up Period Data Reinforces RAP-219’s Sustained Activity in Focal Onset Seizures. In April 2026, Rapport presented new 8-week follow-up period data from its Phase 2a trial of RAP-219 in patients with drug-resistant FOS at the American Academy of Neurology (AAN) Annual Meeting.

    • Therapeutic levels of RAP-219 were sustained, resulting in continued biomarker and clinical responses in the 8-week follow-up period (weeks 9-16).
    • RAP-219 continued to demonstrate clinically meaningful improvements in long episodes (LEs) and clinical seizures during the follow-up period, with an 80% median reduction in LEs and 90% median reduction in clinical seizures compared to baseline in weeks 9-12 and a 68% median reduction in LEs and 59% median reduction in clinical seizures compared to baseline in weeks 13-16.
    • Based on pharmacokinetic (PK) data collected across the Company’s Phase 1 and Phase 2 trials and further supported by population PK modeling, RAP-219 is now estimated to have a 22-day half-life, compared to the prior reported estimate of 14 days.
  • Phase 3 Program in FOS. Following feedback from an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in December 2025, the Company accelerated the initiation of its Phase 3 program in FOS, which is on track to begin in the second quarter of 2026.
  • Open-label Trial Initiated. The Company is enrolling patients from its Phase 2a FOS trial into an open-label, long-term safety trial. Data from the trial is expected to be released in the second half of 2026.
  • Expansion into Primary Generalized Tonic-Clonic Seizures (PGTCS). Building on the robust clinical data generated in FOS, Rapport plans to initiate a Phase 3 trial of RAP-219 in PGTCS in the first half of 2027, expanding its epilepsy franchise into the most common type of generalized seizure.

Additional Pipeline Updates

  • Bipolar Mania Phase 2 Trial Topline Results Expected Ahead of Plan. Enrollment in the Phase 2 trial is progressing well and topline results are now expected in the fourth quarter of 2026, ahead of the previous guidance of first half of 2027. Additionally, the Company modified the trial’s statistical analysis plan and increased target enrollment, enabling the trial to potentially be considered as confirmatory evidence of effectiveness. Following completion of the Phase 2 trial, and subject to the results, the Company plans to engage with the FDA in an End-of-Phase 2 meeting to align on the design of a potential Phase 3 program to support a New Drug Application for the treatment of bipolar mania.
  • Long
    -Acting Injectable Formulation Development Continues. Development of RAP-219’s long-acting injectable formulation continues to advance, with IND-enabling activities underway and initial Phase 1 pharmacokinetic data expected in 2027.
  • α6β4 Program Advancing Toward Clinic. Rapport continues IND-enabling activities for its α6β4 nAChR agonist development candidate, which is being developed as a potential novel non-opioid treatment for chronic pain and migraine.

Business Updates

  • Strategic Collaboration with Tenacia Biotechnology. In March 2026, Rapport entered into a strategic collaboration and license agreement with Tenacia Biotechnology (Hong Kong) Co., Ltd. (the Tenacia License Agreement) for the development and commercialization of RAP-219 in Greater China across indications, including FOS and bipolar mania.

FIRST QUARTER 2026 FINANCIAL RESULTS

  • Net Loss: Net Loss for the first quarter of 2026 was $19.9 million, as compared to $24.1 million for the prior year period.
  • Collaboration Revenue: Collaboration revenues were $20.0 million for the first quarter of 2026, as compared to zero for the prior year period due to the execution of the Tenacia License Agreement in the first quarter of 2026.
  • Research and Development (R&D) Expenses: R&D expense was $32.7 million for the first quarter of 2026, as compared to $19.6 million for the prior year period. The increase in R&D expense was primarily driven by operational costs related to clinical development and costs to support the progression of the Company’s overall pipeline.
  • General and Administrative (G&A) Expenses: G&A expense was $11.5 million for the first quarter of 2026, as compared to $7.5 million for the prior year period. The increase in G&A expense was primarily driven by costs associated with the growth of the business.
  • Cash Position: The Company ended the first quarter of 2026 with $476.8 million in cash, cash equivalents and short-term investments, excluding restricted cash, compared to $490.5 million as of December 31, 2025.
  • Cash Runway: The Company expects that cash, cash equivalents, and short-term investments as of March 31, 2026, will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2029.



About RAP-219

RAP-219 is an investigational and potential first-in-class, clinical-stage TARPγ8-specific AMPA receptor (AMPAR) negative allosteric modulator (NAM). Whereas AMPARs are distributed widely in the central nervous system, the receptor associated protein (RAP) TARPγ8 is expressed only in discrete brain regions, including the hippocampus and neocortex, where focal seizures often originate. By contrast, TARPγ8 has minimal expression in the hindbrain, where drug effects are often associated with intolerable adverse events. With this precision approach, the Company believes RAP-219 has the potential to provide a differentiated profile as compared to traditional neuroscience medications. Due to the role of AMPA biology in various neurological disorders and the selective targeting of TARPγ8, the Company believes RAP-219 has pipeline-in-a-product potential and is evaluating the compound as a potential treatment for patients with focal onset seizures, primary generalized tonic-clonic seizures and bipolar mania. A long-acting injectable formulation of RAP-219 is also in development and could be the first of its kind in epilepsy.

About Rapport Therapeutics

Rapport Therapeutics is a clinical-stage biotechnology company dedicated to discovering and developing small molecule precision medicines for patients with neurological and psychiatric disorders. The Company’s founders made pioneering discoveries related to the function of receptor associated proteins (RAPs) in the brain, which form the basis of Rapport’s RAP technology platform. The platform enables a differentiated approach to generate precision small molecule product candidates with the potential to overcome many limitations of conventional neurology drug discovery. Rapport’s precision neuroscience pipeline includes the Company’s lead investigational drug, RAP-219, which is designed to achieve neuroanatomical specificity through selective targeting of a RAP expressed only in discrete regions of the brain. The pipeline is anchored by the Company’s epilepsy portfolio, including FOS and primary generalized tonic-clonic seizures, as well as bipolar mania. The Company is also advancing additional discovery and preclinical programs leveraging its platform, including in chronic pain and migraine and in hearing and vestibular disorders.

Availability of Other Information About Rapport Therapeutics

Rapport Therapeutics uses and intends to continue to use its Investor Relations website and LinkedIn (Rapport Therapeutics) as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website and LinkedIn, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts. The contents of the Company’s website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: the clinical development of RAP-219 for the treatment of FOS, PGTCS and bipolar mania, including the initiation, timing, progress, results and future data releases of our ongoing and planned clinical trials; the expected timing and initiation of the Company’s Phase 3 trials in FOS; the expected timing and preliminary results of the open-label trial in FOS; the anticipated timing and topline results from the Company’s Phase 2 trial in bipolar mania; the anticipated timing of the Phase 3 trial in PGTCS; the anticipated timing of a Phase 1 trial for the long-acting injectable formulation of RAP-219; the potential of Rapport’s RAP technology platform;  expectations for the efficacy, tolerability, and commercial potential of RAP-219; and expectations for Rapport’s uses of capital, expenses and financial results, including its cash runway into the second half of 2029.

Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect Rapport’s business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; Rapport’s ability to execute on its strategy including obtaining the requisite regulatory approvals on the expected timeline, if at all; uncertainties relating to preclinical and clinical development activities; the Company’s dependence on third parties to conduct clinical trials, manufacture its product candidates and develop and commercialize its product candidates, if approved; Rapport’s ability to attract, integrate and retain key personnel; risks related to the Company’s financial condition and need for substantial additional funds in order to complete development activities and commercialize a product candidate, if approved; risks related to regulatory developments and approval processes of the U.S. Food and Drug Administration and comparable foreign regulatory authorities; risks related to establishing and maintaining Rapport’s intellectual property protections; and risks related to the competitive landscape for Rapport’s product candidates; as well as other risks described in “Risk Factors,” in the Company’s Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Rapport’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Rapport’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Rapport expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

Investor Contact

Leigh Salvo
New Street IR
[email protected]

Condensed Consolidated Balance Sheet Data
(In thousands)
(unaudited)



 
    March 31,

2026
    December 31,

2025
 
Assets            
Current assets            
Cash and cash equivalents   $ 78,056     $ 52,645  
Accounts receivable     58        
Short-term investments     398,726       437,894  
Restricted cash     105       105  
Prepaid expenses and other current assets     7,750       7,917  
Total current assets     484,695       498,561  
Property and equipment, net     2,518       2,976  
Operating lease right of use asset, net     9,327       9,909  
Other assets     1,057       985  
Total assets   $ 497,597     $ 512,431  
Liabilities and Stockholders’ Equity            
Current liabilities            
Accounts payable   $ 6,561     $ 4,190  
Accrued expenses and other current liabilities     8,721       12,104  
Operating lease liability     2,615       2,755  
Total current liabilities     17,897       19,049  
Operating lease liability, net of current portion     8,188       8,729  
Total liabilities     26,085       27,778  
Common Stock     48       48  
Additional paid-in capital     727,054       719,287  
Accumulated other comprehensive income     (505 )     546  
Accumulated deficit     (255,085 )     (235,228 )
Total stockholders’ equity     471,512       484,653  
Total liabilities and stockholders’ equity   $ 497,597     $ 512,431  

Condensed Consolidated Statement of Operations
(In thousands, except share and per share data)
(unaudited)
 
    For the three months ended March 31,    
    2026     2025    
Collaboration Revenue   $ 20,000     $    
Operating expenses              
Research and development     32,716       19,572    
General and administrative     11,499       7,536    
Total operating expenses     44,215       27,108    
Loss from operations     (24,215 )     (27,108 )  
Other income:              
Interest income     4,358       3,045    
Total other income     4,358       3,045    
Net loss   $ (19,857 )   $ (24,063 )  
Net loss per share attributable to common stockholders, basic
and diluted
  $ (0.42 )   $ (0.68 )  
Weighted-average common shares outstanding, basic and diluted     47,236,618       35,266,577    

Condensed Consolidated Statements of Cash Flows

(In thousands)
(unaudited)
 
    For the three months ended

March 31,
 
    2026     2025  
       
Net cash used in operating activities   $ (13,061 )   $ (20,237 )
Net cash provided by investing activities     37,941       21,031  
Net cash provided by financing activities     531       5  
Net increase in cash, cash equivalents and restricted cash   $ 25,411     $ 799  



Scholar Rock Reports First Quarter 2026 Financial Results and Recent Business Highlights

Scholar Rock Reports First Quarter 2026 Financial Results and Recent Business Highlights

  • FDA accepted apitegromab Biologics License Application (BLA) for treatment of children and adults with spinal muscular atrophy (SMA) with September 30, 2026 Prescription Drug User Fee Act (PDUFA) action date
  • Accepted apitegromab BLA includes two fill-finish facilities, Catalent Indiana LLC (part of Novo Nordisk), and a second U.S.-based facility
  • FDA has completed reinspection of Catalent Indiana; classification of facility expected within 90 days following reinspection, in accordance with FDA guidelines
  • Second fill-finish facility on track to have commercial apitegromab supply in early Q3 2026
  • Scholar Rock is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026
  • Cash, cash equivalents, and marketable securities of $480 million as of March 31, 2026; includes an additional $100 million in debt and $98 million in net cash proceeds from the Company’s at-the-market (ATM) program
  • Management to host a conference call today at 8:00 a.m. ET

CAMBRIDGE, Mass.–(BUSINESS WIRE)–
Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology to advance musculoskeletal health, today reported financial results for the first quarter ended March 31, 2026, and provided an update on recent company developments.

“With the FDA’s acceptance of our apitegromab BLA, we have achieved another critical milestone as we work with urgency to deliver on our mission to bring the world’s first muscle-targeted treatment to the SMA community,” said David L. Hallal, Chairman and Chief Executive Officer of Scholar Rock. “We are grateful for the FDA’s continued high level of engagement, and we are pleased that important progress continues to be made at both of our fill-finish facilities. Our U.S. commercial team stands ready to launch apitegromab on or at any time prior to the September 30th PDUFA date.”

Mr. Hallal continued, “Our balance sheet is strong, our clinical-stage pipeline continues to advance, and we are poised, now more than ever, to usher in the next phase of innovation for patients with SMA.”

Business Highlights and Upcoming Milestones

Apitegromab

Apitegromab is an investigational fully human monoclonal antibody designed to inhibit myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle. It is the first and only muscle-targeted therapeutic candidate in SMA to demonstrate a statistically significant and clinically meaningful benefit in a pivotal Phase 3 clinical trial (SAPPHIRE).

SMA Program

  • Apitegromab BLA accepted by FDA with September 30, 2026 PDUFA action date. The accepted BLA includes two fill-finish facilities, Catalent Indiana and a second U.S.-based fill-finish facility.
  • FDA completed reinspection of Catalent Indiana. Following the FDA’s acceptance of the apitegromab BLA, the Agency completed reinspection of Catalent Indiana. In accordance with FDA guidelines, classification of the facility is anticipated within 90 days following reinspection.
  • Significant progress continues at second fill-finish facility. Apitegromab commercial supply from this facility is expected to be available early in the third quarter of 2026.
  • Preparations ongoing for U.S. commercial launch. The Commercial team continues to expand its reach and engagement with key stakeholders, including a significant presence at the Muscular Dystrophy Association (MDA) Clinical & Scientific Conference, which was held March 8 – 11, 2026 in Orlando, FL and at the upcoming 2026 Annual SMA Conference, which is being held June 25 – 28, 2026 in Orlando, FL. The U.S. commercial team is prepared to launch apitegromab immediately upon FDA approval.
  • European Medicines Agency (EMA)regulatory review ongoing. A Committee for Medicinal Products for Human Use (CHMP) opinion for the apitegromab Marketing Authorisation Application (MAA) is anticipated near mid-2026. The Scholar Rock team in Europe continues to engage with key stakeholders on SMA disease awareness and education initiatives, including at the 5th International Scientific Congress on SMA, which was held March 11 – 14, 2026 in Budapest, Hungary. The Company is planning for an apitegromab launch in Europe in the second half of 2026, beginning with Germany.
  • Enrollment progressing in Phase 2 OPAL clinical trial. Patients continue to be enrolled and dosed in the Phase 2 OPAL study (NCT07047144). The trial is evaluating apitegromab in infants and toddlers with SMA under two years of age who have received an approved SMN1-targeted gene therapy or who are receiving ongoing treatment with an approved SMN2-targeted therapy.
  • Subcutaneous apitegromab development continues to progress. Scholar Rock is advancing a subcutaneous formulation of apitegromab intended to provide optionality for patients as a small volume, self- or caregiver-administered anti-myostatin antibody suitable for an autoinjector. A Phase 1 study in healthy volunteers has been completed. Further development activities are ongoing, including anticipated FDA and EMA regulatory engagements following apitegromab approvals.

FSHD Program

  • Phase 2 FORGE trial on track for initiation in mid-2026. Scholar Rock is developing apitegromab for the treatment of people with facioscapulohumeral muscular dystrophy (FSHD). FSHD is a rare, progressive neuromuscular disease characterized by muscle atrophy and functional decline, affecting approximately 30,000 individuals across the U.S. and Europe. Initiation of a Phase 2 randomized, double-blind, placebo-controlled trial, called FORGE, is expected in mid-2026.

SRK-439

SRK-439 is a novel, investigational, subcutaneously administered myostatin inhibitor that binds to pro- and latent myostatin with high affinity and selectivity (i.e., no GDF11 or Activin A binding). Based on preclinical data, SRK-439 has the potential to potently inhibit myostatin and increase muscle mass.

  • Phase 1 healthy volunteer study ongoing. A Phase 1 study evaluating SRK-439 in healthy volunteers is underway, with topline data expected in the second half of 2026.

First Quarter 2026 Financial Results

Scholar Rock reported a net loss of $105.5 million, including stock-based compensation of $18.2 million, for the quarter ended March 31, 2026, compared to a net loss of $74.7 million, including stock-based compensation of $13.4 million, for the quarter ended March 31, 2025. Net loss per common share was $0.83 for the quarter ended March 31, 2026, compared to $0.67 per common share for the quarter ended March 31, 2025.

  • The Company did not record any revenue for the quarters ended March 31, 2026 and 2025.

  • Research and development expense was $51.8 million, including $6.5 million in stock-based compensation, for the quarter ended March 31, 2026, compared to $48.7 million, including $4.0 million in stock-based compensation, for the quarter ended March 31, 2025.

  • General and administrative expense was $50.2 million, including $11.7 million in stock-based compensation, for the quarter ended March 31, 2026, compared to $28.4 million, including $9.4 million in stock-based compensation, for the quarter ended March 31, 2025.

  • As of March 31, 2026, Scholar Rock had cash, cash equivalents, and marketable securities of $479.9 million. This reflects a drawdown of $100.0 million from the Company’s debt facility and net cash proceeds of $98.0 million from the Company’s at-the-market (ATM) program.

Conference Call Information

Scholar Rock will host a conference call and webcast today, Thursday, May 7, at 8:00 a.m. ET to review its first quarter 2026 financial results and discuss recent business updates. To access the live audio webcast, please go to “Events and Presentations” in the Investors section of the Scholar Rock website at http://investors.scholarrock.com.

To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call.

A replay of the webcast will be available on the Company’s website for approximately 90 days.

About Scholar Rock

Scholar Rock is a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.

Scholar Rock® is a registered trademark of Scholar Rock, Inc.

Availability of Other Information About Scholar Rock

Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly known as Twitter) and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, progress and timing of its clinical trials and development programs for apitegromab, including its subcutaneous formulation, SRK-439 and its preclinical programs, and indication selection and development timing, including the timing of any regulatory submissions, decisions and anticipated approvals, the therapeutic potential, clinical benefits and safety of any product candidates, its ability to address the observations identified in the complete response letter, expectations regarding actions by the FDA after its reinspection of the Catalent Indiana facility; the expected timing and outcome of FDA review of the accepted BLA for apitegromab, including the September 30, 2026 PDUFA action date; expectations regarding the availability and timing of commercial supply of apitegromab from Catalent Indiana and a second U.S.-based fill-finish facility, including expected supply from the second fill-finish facility; expectations regarding commercial launch timing, and the achievement of important milestones, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “could,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements 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. These risks and uncertainties include, without limitation, whether preclinical and clinical data, including the results from the Phase 3 SAPPHIRE trial and any results from ongoing or future clinical trials, including the Phase 2 OPAL clinical trial, the Phase 2 FORGE trial and the Phase 1 clinical trial of SRK-439, will be sufficient to support regulatory approval or further development; that preclinical and clinical data, including the results from the Phase 2 or Phase 3 clinical trial of apitegromab, data from any ongoing or future trials of apitegromab or data for SRK-439, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidates; whether the FDA will accept the remediations to the Catalent Indiana fill finish facility in response to the FDA Observations, whether the updated BLA will be sufficient to support regulatory approval, Scholar Rock’s ability to manage expenses or provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline; information provided or decisions made by regulatory authorities; competition from third parties that are developing products for similar uses; Scholar Rock’s ability to obtain, maintain and protect its intellectual property; and Scholar Rock’s dependence on third parties for development and manufacture of product candidates including, without limitation, to supply any clinical trials as well as those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

 
Scholar Rock Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
 
 
Three Months Ended March 31,

 

2026

 

 

2025

 

 
Operating expenses
Research and development

$

51,814

 

$

48,678

 

General and administrative

 

50,202

 

 

28,412

 

Total operating expenses

 

102,016

 

 

77,090

 

Loss from operations

 

(102,016

)

 

(77,090

)

Other income (expense), net

 

(3,494

)

 

2,367

 

Net loss

$

(105,510

)

$

(74,723

)

 
Net loss per share, basic and diluted

$

(0.83

)

$

(0.67

)

 
Weighted average common shares outstanding, basic and diluted

 

127,277,144

 

 

111,838,272

 

 

Scholar Rock Holding Corporation

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands)

 
March 31, 2026 December 31, 2025
Assets
Cash, cash equivalents and marketable securities

$

479,944

$

367,563

Other current assets

 

35,340

 

17,584

Total current assets

 

515,284

 

385,147

Other assets

 

19,970

 

19,125

Total assets

$

535,254

$

404,272

 
Liabilities and Stockholders’ Equity
Current liabilities

$

59,643

$

55,419

Long-term liabilities

 

199,598

 

103,365

Total liabilities

 

259,241

 

158,784

Total stockholders’ equity

 

276,013

 

245,488

Total liabilities and stockholders’ equity

$

535,254

$

404,272

 

Investor Contact

Laura Ekas, Ph.D.

[email protected]

917-439-0374

Media Contact

Molly MacLeod, Ph.D.

[email protected]

802-579-5995

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Medical Supplies FDA Health Genetics Clinical Trials Biotechnology

MEDIA:

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Xeris Biopharma Reports First Quarter 2026 Financial Results

Xeris Biopharma Reports First Quarter 2026 Financial Results

Total product revenue increased 43% year-over-year to over $82 million

Recorlev net revenue increased 95% year-over-year to $50 million

Tightens full-year 2026 total revenue guidance to $380 million to $390 million

Hosts conference call and webcast today at 8:30 a.m. ET

CHICAGO–(BUSINESS WIRE)–
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the first quarter ended March 31, 2026.

“We are thrilled with our outstanding start to 2026, delivering first quarter net product revenue growth of 43%, reflecting the successful execution of our strategy,” said John Shannon, CEO. “Recorlev was the standout performer, with net revenue nearly doubling year-over-year, driven by growth across our patient base and increased awareness across the prescriber base. Also in the quarter, we successfully completed the expansion of our commercial team, and we expect the impact of these targeted investments to become more evident in the second half of 2026 and beyond.”

Shannon continued, “Looking ahead, we remain confident in our ability to deliver on our full-year financial targets. Recorlev’s strong Q1 and continued momentum gives us the confidence to raise the bottom end of our full year 2026 total revenue guidance. Our updated guidance of $380 million to $390 million represents more than 30% growth at the midpoint. Beyond our commercial execution, 2026 represents a pivotal year for our pipeline, with the anticipated Phase 3 initiation of XP-8121 later in the year marking a significant value creation inflection point. Our strong financial foundation enables us to advance these strategic priorities while creating sustainable long-term value for shareholders.”

First Quarter 2026 Highlights

 

Three months ended

March 31,

 

Change

 

2026

 

2025

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

Recorlev

$

49,768

 

$

25,530

 

$

24,238

 

95

 

Gvoke

 

20,800

 

 

20,845

 

 

(45

)

 

Keveyis

 

11,886

 

 

11,427

 

 

459

 

4

 

Product revenue, net

 

82,454

 

 

57,802

 

 

24,652

 

43

 

Royalty, contract and other revenue

 

673

 

 

2,317

 

 

(1,644

)

(71

)

Total revenue

$

83,127

 

$

60,119

 

$

23,008

 

38

 

  • Recorlev® net revenue was $49.8 million – an increase of approximately 95% compared to the first quarter of 2025. This growth was primarily due to increased patient demand.
  • Gvoke® net revenue was $20.8 million – flat compared to the first quarter of 2025.
  • Keveyis® net revenue was $11.9 million – an increase of approximately 4% compared to the first quarter of 2025.

Gross margin improved to 87%, up from 85% in the same period last year. The improvement was primarily driven by favorable product mix dynamics.

Research and development (R&D) expenses increased $1.0 million or 13% in the first quarter of 2026 compared to the same period last year. The increase in R&D expenses primarily reflect higher personnel-related expenses to support XP-8121.

Selling, general and administrative (SG&A) expenses increased $9.1 million or 21% in the first quarter of 2026 compared to the same period last year. This increase mainly reflects higher personnel related expense to support the commercial enterprise, including the Recorlev expansion.

Net income for the first quarter was $2.2 million, compared to a net loss of $9.2 million in the same period last year.

Adjusted EBITDA1for the first quarter was $15.1 million, an improvement of $10.7 million compared to the same period last year.

Total Shares Outstanding were 172,642,055 at April 30, 2026.

Upcoming Events

  • Craig-Hallum Institutional Investor Conference: Senior management will participate in 1×1 meetings on May 28, 2026 in Minneapolis, MN. Please contact the sponsor to arrange meetings with management.
  • Jefferies Global Healthcare Conference: Senior management will participate in 1×1 meetings and a fireside chat on June 3, 2026 in New York, NY. The fireside chat will be webcast live, with access available via the “Events” section of the Xeris Investor Relations website. Please contact the sponsor to arrange meetings with management.

Conference Call and Webcast Details

Xeris will host a conference call and webcast at 8:30 a.m. Eastern Time today to discuss the Company’s financial and operational results. Interested parties may pre-register for the conference call by following this link: https://events.q4inc.com/attendee/925563770. Attendees can also join via the “Events” section of the Xeris Investor Relations website.

The webcast, replay and other information related to the event can be accessed on the investor website https://xerispharma.com/investor-relations.

1 Adjusted EBITDA is a non-GAAP financial measure. See “Note Regarding Use of Non-GAAP Financial Measures” and the corresponding financial tables at the end of this press release for definitions and reconciliations of non-GAAP measures.

Note Regarding Use of Non-GAAP Financial Measures

This press release includes financial results prepared in accordance with generally accepted accounting principles in the United States (GAAP) and also certain historical and forward-looking non-GAAP financial measures, namely Adjusted EBITDA. This non-GAAP financial measure is not meant to be considered in isolation and should be read in conjunction with the Company’s consolidated financial statements prepared in accordance with GAAP, and was not prepared under any comprehensive set of accounting rules or principles. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP, and the calculation of the non-GAAP financial measure included herein may differ from similarly titled measures used by other companies. The Company believes that the presentation of Adjusted EBITDA, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of the Company’s ongoing and projected operating performance, exclusive of factors that do not directly affect what the Company considers to be its core operating performance, as well as unusual events. The Company believes this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and evaluate its performance. In addition, management believes that Adjusted EBITDA is important in evaluating the administrative costs of operating the Company’s business.

Adjusted EBITDA is GAAP net income (loss) before income tax (benefit) expense, plus interest and other income, less depreciation and amortization, interest expenses, share based compensation and debt refinancing fees.

About Xeris

Xeris (Nasdaq: XERS) is a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products: Recorlev®, for the treatment of endogenous Cushing’s syndrome; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia; and Keveyis®, a proven therapy for primary periodic paralysis. Xeris also has a pipeline of development programs led by XP-8121, a Phase 3-ready, once-weekly subcutaneous injection for hypothyroidism, as well as multiple early-stage programs leveraging Xeris’ technology platforms, XeriSol® and XeriJect®, for its partners.

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans, opportunities, and prospects for Xeris Biopharma Holdings, Inc., including statements regarding financial guidance for full-year 2026, including the potential for revenue growth, the Company’s ability to continue to generate net income, Recorlev’s growth potential, expectations on the impact of the commercial team expansion in the second half of 2026 and beyond, the ability to continue to deliver on all full-year financial targets, the effectiveness of the Company’s strategic execution, the Company’s ability to continue on its current growth trajectory and continue to drive patient demand, advancing its strategic initiatives, its ability to create sustainable long-term value for shareholders, the ability to continue to demonstrate sustained momentum across the portfolio and the market and therapeutic potential of its products and product candidates, including its expectations regarding the timely execution of XP-8121’s ongoing development leading into the start of its Phase 3 clinical trial and the expected timing of the XP-8121 Phase 3 clinical trial later in 2026, the potential utility of its formulation platforms, the advancement of its pipeline, and other statements containing the words “achieve,” “anticipate,” “continue,” “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results (including revenue and sales in the near- and long-term), performance or achievements, industry results, market opportunity and developments to differ materially from those expressed in or implied by such forward-looking statements (including its 2026 guidance), include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, its and collaborators’ ability to protect its intellectual property and proprietary technology, the accuracy and completeness of its assumptions and its ability to accurately estimate future financial results and market opportunities, and general macroeconomic and geopolitical conditions, including the possibility of an economic downturn, political unrest, trade disputes, changes in U.S. governmental priorities and resources, announced or implemented tariffs or export controls and market volatility. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Annual Report on Form 10-K and subsequent filings with the U.S. Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. The risks described herein and in Xeris’ U.S. Securities and Exchange Commission filings are not the only risks the Company faces. Additional risks and uncertainties not currently known to it or that it currently deems immaterial may also impact its business operations or financial results. Forward-looking statements in this communication are based on information available to management, as of the date of this communication and, while the Company believes its assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, the Company does not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

 

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

 

 

Three Months Ended March 31,

 

2026

 

2025

 

(unaudited)

 

(unaudited)

Product revenue, net

$

82,454

 

 

$

57,802

 

Royalty, contract and other revenue

 

673

 

 

 

2,317

 

Total revenue

 

83,127

 

 

 

60,119

 

Costs and expenses:

 

 

 

Cost of goods sold

 

10,574

 

 

 

8,728

 

Research and development

 

8,783

 

 

 

7,753

 

Selling, general and administrative

 

53,144

 

 

 

44,018

 

Amortization of intangible assets

 

2,710

 

 

 

2,710

 

Total costs and expenses

 

75,211

 

 

 

63,209

 

Income (loss) from operations

 

7,916

 

 

 

(3,090

)

Other expenses

 

(5,682

)

 

 

(6,130

)

Net income (loss) before benefit from income taxes

 

2,234

 

 

 

(9,220

)

Income tax benefit

 

 

 

 

 

Net income (loss)

$

2,234

 

 

$

(9,220

)

 

 

 

 

Net income (loss) per common share – basic

$

0.01

 

 

$

(0.06

)

Net income (loss) per common share – diluted

$

0.01

 

 

$

(0.06

)

 

 

 

 

Weighted average common shares outstanding

 

 

 

Basic

 

170,523,208

 

 

 

152,445,935

 

Diluted

 

177,631,154

 

 

 

152,445,935

 

 

XERIS BIOPHARMA HOLDINGS, INC.

Non-GAAP Financial Measures – EBITDA and Adjusted EBITDA

(in thousands, unaudited)

 

 

Three Months Ended March 31,

 

2026

 

2025

GAAP Net income (loss)

$

2,234

 

 

$

(9,220

)

Adjustments

 

 

 

Interest and other income

 

(1,202

)

 

 

(1,175

)

Interest expense

 

6,884

 

 

 

7,305

 

Income tax benefit

 

 

 

 

 

Depreciation and amortization

 

3,047

 

 

 

3,025

 

EBITDA

$

10,963

 

 

$

(65

)

Adjustments

 

 

 

Share-based compensation (a)

 

4,140

 

 

 

4,443

 

Adjusted EBITDA

$

15,103

 

 

$

4,378

 

 

(a) Includes non-cash, stock-based compensation, net of forfeitures.

 

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

March 31, 2026

 

December 31, 2025

Assets

(unaudited)

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

111,750

 

$

111,042

Trade accounts receivable, net

 

56,295

 

 

51,050

Inventory, net

 

74,234

 

 

68,673

Prepaid expenses and other current assets

 

9,403

 

 

9,548

Total current assets

 

251,682

 

 

240,313

Property and equipment, net

 

5,033

 

 

4,945

Operating lease right-of-use assets

 

21,949

 

 

22,112

Goodwill

 

22,859

 

 

22,859

Intangible assets, net

 

85,368

 

 

88,078

Other assets

 

5,122

 

 

5,220

Total assets

$

392,013

 

$

383,527

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

11,467

 

$

3,076

Current operating lease liabilities

 

6,271

 

 

6,232

Other accrued liabilities

 

32,287

 

 

33,155

Accrued trade discounts and rebates

 

45,492

 

 

43,253

Accrued returns reserve

 

18,723

 

 

18,969

Other current liabilities

 

4,353

 

 

4,889

Total current liabilities

 

118,593

 

 

109,574

Long-term debt, net of unamortized debt issuance costs

 

221,224

 

 

220,335

Non-current operating lease liabilities

 

31,058

 

 

31,531

Other liabilities

 

8,127

 

 

8,398

Total liabilities

 

379,002

 

 

369,838

Total stockholders’ equity

 

13,011

 

 

13,689

Total liabilities and stockholders’ equity

$

392,013

 

$

383,527

 

Investor Contact

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

[email protected]

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Health General Health Clinical Trials Research Science Pharmaceutical Biotechnology

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Gogo Announces First Quarter Results


Total Revenue of $226.3 million;



Equipment Revenue up 22% Year-Over-Year to $38.6 million on Record ATG Unit Sales


Net Income of $13.1 million, Adjusted EBITDA



1



of $53.3 million, up 41% Sequentially


Gogo Galileo and 5G Expected to Ramp in 2026

BROOMFIELD, Colo., May 07, 2026 (GLOBE NEWSWIRE) — Gogo Inc. (NASDAQ: GOGO) (“Gogo” or the “Company”), a leading global provider of broadband connectivity services for the business and military/government aviation markets, today announced its financial results for the quarter ended March 31, 2026.

“We are pleased with our results in the quarter as Gogo continues its transformation from a domestic provider of air-to-ground (“ATG”) connectivity into a global provider of high-speed broadband to the underpenetrated business and military/government aviation markets,” said Chris Moore, CEO of Gogo. “Gogo Galileo is scaling globally, our sovereign 5G network is live and gaining traction amongst our business and military/government aviation customers, and our geostationary earth orbit (“GEO”) business continues to be resilient.”

Zac Cotner, CFO of Gogo, commented, “Our first quarter reflects the strong demand for our next-generation products as demonstrated by our record ATG and robust Gogo Galileo shipments. Further, our $21.1 million debt principal repayment in April underscores our commitment to de-lever the balance sheet, which remains our top capital allocation priority.”


Q1 2026 Financial Highlights

  • Total revenue of $226.3 million decreased 2% compared to Q1 2025 and 2% compared to Q4 2025.

             Equipment Revenue

    • Equipment revenue of $38.6 million increased 22% compared to Q1 2025 and was flat compared to Q4 2025.
    • ATG equipment units sold in Q1 2026 totaled 511, an all-time record, and was up 8% compared to Q4 2025.
    • Q1 equipment units shipped for Gogo Galileo, Gogo’s new cutting-edge Low Earth Orbit (“LEO”) satellite broadband service, totaled 92, down 42% compared to Q4 2025. Cumulative Gogo Galileo equipment shipments reached 410 units.

      Service Revenue

    • Service revenue of $187.7 million decreased 5% compared to Q1 2025 and decreased 2% compared to Q4 2025.
      • Business aviation service revenue of $154.4 million decreased 9% compared to Q1 2025 and 4% compared to Q4 2025.
      • Military / Government service revenue of $33.4 million increased 14% compared to Q1 2025 and 7% compared to Q4 2025.
  • Aircraft online (“AOL”) as of March 31, 2026:
    • Total ATG AOL2 of 6,116 decreased 11% versus Q1 2025 and 4% versus Q4 2025.
      • ATG AVANCE AOL of 4,851 increased 3% compared to March 31, 2025 and decreased 2% compared to December 31, 2025.
      • ATG C-1 AOL of 557 increased 69% from 330 as of December 31, 2025. Gogo’s C-1 solution is a simple box swap designed to allow connectivity for Classic ATG customers on Gogo’s new LTE network which is expected to come online in 2026.
    • Broadband GEO AOL of 1,306 increased 2% compared to March 31, 2025 and decreased 1% compared to December 31, 2025.
    • Gogo Galileo AOL of 111 increased 50% from 74 as of December 31, 2025.
  • Net income for the quarter was $13.1 million, which includes a $4.9 million pre-tax reduction to the earn-out accrual related to the Satcom Direct acquisition. Net income was $12.0 million in Q1 2025 and ($10.0) million in Q4 2025.
  • Adjusted EBITDA1 of $53.3 million decreased 14% compared to Q1 2025 and increased 41% compared to Q4 2025. Adjusted EBITDA includes $6.1 million of expense incurred in the quarter for ongoing litigation matters.
  • Net cash (used in) provided by operating activities was $(7.2) million in Q1 2026, down from $32.5 million in Q1 2025 and down from $8.5 million in Q4 2025.
  • Free Cash Flow1 of $(19.2) million in Q1 2026 was down from $30.0 million in Q1 2025 and down from $(4.9) million in Q4 2025. Free Cash Flow in the quarter was impacted by annual bonus payouts of $14 million and a reduction in accounts payable and accruals related to inventory purchases.
  • Cash and cash equivalents was $103.5 million as of March 31, 2026 compared to $125.2 million as of December 31, 2025 and $70.3 million as of March 31, 2025.




Recent Developments

  • The Company received approval for an extension under the FCC Reimbursement Program related to its LTE network deployment through November 8, 2026.
  • NetJets Europe is expected to fully roll out Gogo Galileo in the first half of 2026, comprising over half of our current Gogo Galileo AOL. Gogo has also started fleet installations with NetJets North America.
  • Gogo has been awarded approximately $7.5 million in contracts from the National Oceanic and Atmospheric Administration (“NOAA”) that will be delivered over the next five years.
  • The Company has now completed 35 Gogo Galileo commercial supplemental type certificates (“STCs”), covering a total addressable market of approximately 7,000 aircraft. Fourteen additional STCs are expected in the second and third quarters of 2026.
  • Gogo made a $40.0 million earn-out payment in April 2026 related to the Satcom Direct acquisition, due to the strong 2025 performance of the GEO business.
  • Gogo made a $21.1 million principal payment in April 2026 on the HPS term loan facility which is in alignment with our strategy to de-lever the balance sheet.


Reaffirms 2026 Financial Guidance

Gogo reiterates its 2026 financial guidance provided in February.

  • Total revenue in the range of $905 million to $945 million, split ~80% service revenue and ~20% equipment revenue.
  • Adjusted EBITDA1 in the range of $198 million to $218 million, which includes $3 million in strategic investments and $8 million of ongoing litigation expense.
  • Free Cash Flow1 in the range of $90 million to $110 million (based on a range of net cash provided by operating activities of $108 million to $128 million). This Free Cash Flow guidance includes $30 million slated for strategic investments in 2026, net of any FCC reimbursement.
  • Net capital expenditures of $20 million. This assumes $45 million in reimbursement from the FCC Reimbursement Program.


1 See “Non-GAAP Financial Measures” below.



2 See “Key Business Metrics” below.


Conference Call

The Company will host its first quarter conference call on May 7, 2026 at 8:30 a.m. ET. A live webcast of the conference call, as well as a replay, will be available online on the Investor Relations section of the Company’s investor website at https://ir.gogoair.com.

Q1 Earnings Call Webcast Link: https://edge.media-server.com/mmc/p/u2r8pusu

Participants can use the below link to retrieve your unique conference ID to use to access the conference call.
https://register-conf.media-server.com/register/BIc4f987ec8e6641bcacc75d30405fcd9f


Non-GAAP Financial Measures

We report certain non-GAAP financial measurements, including Adjusted EBITDA and Free Cash Flow in the discussion above. Management uses Adjusted EBITDA and Free Cash Flow for business planning purposes, including managing our business against internally projected results of operations and measuring our performance and liquidity. These supplemental performance measures also provide another basis for comparing period-to-period results by excluding potential differences caused by non-operational and unusual or non-recurring items. These supplemental performance measurements may vary from and may not be comparable to similarly titled measures used by other companies. Adjusted EBITDA and Free Cash Flow are not recognized measurements under accounting principles generally accepted in the United States, or GAAP. When analyzing our performance with Adjusted EBITDA or liquidity with Free Cash Flow, as applicable, investors should (i) evaluate each adjustment in our reconciliation to the corresponding GAAP measure, and the explanatory footnotes regarding those adjustments, (ii) use Adjusted EBITDA in addition to, and not as an alternative to, net income (loss) attributable to common stock as a measure of operating results, and (iii) use Free Cash Flow in addition to, and not as an alternative to, consolidated net cash provided by (used in) operating activities when evaluating our liquidity. No reconciliation of the forecasted amounts of Adjusted EBITDA for fiscal 2026 is included in this release because we are unable to quantify certain amounts that would be required to be included in the corresponding GAAP measure without unreasonable efforts, due to high variability and complexity with respect to estimating certain forward-looking amounts, and we are therefore unable to estimate the probable significance of such amounts. We believe such reconciliation would imply a degree of precision that would be confusing or misleading to investors.


Key Business Metrics

Our management regularly reviews financial and business metrics, including the key business metrics in this press release under “Supplemental Information – Key Business Metrics,” to evaluate the performance of our business and our success in executing our business plan, make decisions regarding resource allocation and corporate strategies, and evaluate forward-looking projections. Certain of these business metrics may be added, removed or updated from time to time as our business evolves.


Cautionary Note Regarding Forward-Looking Statements


Certain disclosures in this press release and related comments by our management include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding our business outlook, industry, business strategy, plans, goals and expectations concerning our market position, international expansion, future technologies, future operations, margins, profitability, future efficiencies, capital expenditures, liquidity and capital resources and other financial and operating information. When used in this discussion, the words “anticipate,” “assume,” “believe,” “budget,” “continue,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “future” and the negative of these or similar terms and phrases are intended to identify forward-looking statements in this press release. Forward-looking statements are based on our current expectations regarding future events, results or outcomes. These expectations may or may not be realized. Although we believe the expectations reflected in the forward-looking statements are reasonable, we can give you no assurance these expectations will prove to have been correct. Some of these expectations may be based upon assumptions, data or judgments that prove to be incorrect. Actual events, results and outcomes may differ materially from our expectations due to a variety of known and unknown risks, uncertainties and other factors. Although it is not possible to identify all of these risks and factors, they include, among others, the following: our ability to continue to generate revenue from the provision of our connectivity and other service offerings; our development and fixed-price contracts; our reliance on our key OEMs and dealers for equipment sales; our dependence on single-source, third party satellite network providers; the impact of competition; our ability to maintain high-quality customer support; our reliance on third parties for equipment components and services; our participation in U.S. government contracts; our participation in non-U.S. government contracts; the finite useful life of satellites; the impact of global supply chain and logistics issues, tariffs and inflationary trends; the continued expansion of our business outside of the United States and its impact of such expansion on our corporate culture; foreign currency risk; our ability to recruit, train and retain highly skilled employees, and the loss of any key personnel; the impact of pandemics or other outbreaks of contagious diseases, and the measures implemented to combat them; the impact of adverse economic conditions and geopolitical instability; our ability to fully utilize portions of our deferred tax assets; the impact of climate change and other sustainability-related matters; our ability to evaluate or pursue strategic opportunities; our recently-deployed Gogo 5G and Gogo Galileo services may not compete well in  the market or face problems relating to implementation;  our ability to innovate next-generation technologies and provide products and services useful to our customers and passengers without delay in developing or deploying such technologies, products and services; our ability to maintain our rights to use our licensed 4Mhz of ATG spectrum in the United States and obtain rights to additional spectrum if needed; the impact of service interruptions or delays, cybersecurity incidents, technology failures, equipment damage or system disruptions or failures; the impact of assertions by third parties of infringement, misappropriation or other violations; our ability to protect our intellectual property rights; risks associated with the use of artificial intelligence in our products and services; the impact of our use of open-source software; the impact of equipment failure or material defects or errors in our software; our ability to comply with applicable foreign ownership limitations; the impact of government regulation of communication networks, and the internet; our possession and use of personal information; risks associated with participation in the FCC Reimbursement Program; our ability to comply with anti-bribery, anti-corruption and anti-money laundering laws; the extent of expenses, liabilities or business disruptions resulting from litigation; the impact of the distribution of income among various jurisdictions in which we operate as well as changes in tax law or regulation on our U.S. and non-U.S. tax liabilities; the impact of changes in laws and regulations on U.S. government contractors; the impact of our substantial indebtedness; our ability to obtain additional financing to refinance or repay our existing indebtedness; the impact of restrictions and limitations in the agreements and instruments governing our debt; the impact of increases in interest rates; the impact of a substantial portion of our indebtedness being secured by substantially all of our assets; the impact of a substantial change in rating assigned by a rating agency; the volatility of our stock price; our ability to fully utilize our tax losses; the dilutive impact of potential future stock issuances; the impact of our stockholder concentration; our ability to fulfill the obligations of being  a public company; the impact of an identified material weakness in our internal controls; the impact of certain provisions of our charter, bylaws, and Delaware law; and other factors listed under the caption “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2025 as filed with the Securities and Exchange Commission (“SEC”) on February 27, 2026 and in our subsequent quarterly reports on Form 10-Q as filed with the SEC.

Any one of these factors or a combination of these factors could materially affect our financial condition or future results of operations and could influence whether any forward-looking statements contained in this report ultimately prove to be accurate. Our forward-looking statements are not guarantees of future performance, and you should not place undue reliance on them. All forward-looking statements speak only as of the date made and we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.


About Gogo

Gogo is the only multi-orbit, multi-band in-flight connectivity provider offering connectivity technology purpose-built for business and military/government mobility aviation. Its industry-leading product portfolio offers best-in-class solutions for all aircraft types, from small to large and heavy jets and beyond.

The Gogo offering uniquely incorporates Air-to-Ground technology and access to multiple satellite constellations to deliver consistent, global tip-to-tail connectivity through a sophisticated suite of software, hardware, and advanced infrastructure supported by a 24/7/365 in person customer support team.

Gogo consistently strives to set new standards for reliability, security and innovation and is shaping the future of inflight aviation to make it easier for every customer to stay connected.

 
Gogo Inc. and Subsidiaries
Unaudited Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
 
    For the Three Months

Ended March 31,
 
    2026     2025  
Revenue:            
Service revenue   $ 187,732     $ 198,612  
Equipment revenue     38,587       31,695  
Total revenue     226,319       230,307  
Operating expenses:            
Cost of service revenue (exclusive of amounts shown below)     98,314       94,047  
Cost of equipment revenue (exclusive of amounts shown below)     34,988       29,326  
Engineering, design and development     6,492       13,875  
Sales and marketing     13,491       14,210  
General and administrative     26,208       29,519  
Depreciation and amortization     15,139       14,143  
Total operating expenses     194,632       195,120  
Operating income     31,687       35,187  
Other expense (income):            
Interest income     (1,154 )     (590 )
Interest expense     16,846       16,558  
Change in fair value of Earnout Liability     (4,943 )      
Other expense (income), net     (95 )     234  
Total other expense     10,654       16,202  
Income before income taxes     21,033       18,985  
Income tax provision     7,948       6,943  
Net income   $ 13,085     $ 12,042  
             
Net income attributable to common stock per share:            
Basic   $ 0.10     $ 0.09  
Diluted   $ 0.10     $ 0.09  
Weighted average number of shares:            
Basic     135,656       132,472  
Diluted     136,849       135,314  

 
Gogo Inc. and Subsidiaries

Unaudited Condensed Consolidated Balance Sheets

(in thousands)
 
    March 31,     December 31,  
    2026     2025  
Assets            
Current assets:            
Cash and cash equivalents   $ 103,544     $ 125,206  
Accounts receivable, net of allowances of $8,462 and $6,783, respectively     115,141       112,558  
Inventories     101,794       98,853  
Assets held for sale     26,268       26,253  
Prepaid expenses and other current assets     83,723       69,039  
Total current assets     430,470       431,909  
Non-current assets:            
Property and equipment, net     116,529       117,274  
Intangible assets, net     233,382       248,818  
Goodwill     193,187       193,187  
Operating lease right-of-use assets     55,585       57,990  
Other non-current assets, net of allowances of $603 and $538, respectively     49,805       44,928  
Deferred income taxes     202,236       209,666  
Total non-current assets     850,724       871,863  
Total assets   $ 1,281,194     $ 1,303,772  
Liabilities and stockholders’ equity            
Current liabilities:            
Accounts payable   $ 81,688     $ 92,514  
Accrued liabilities     117,709       139,020  
Deferred revenue     36,360       35,194  
Current portion of long-term debt     23,589       2,500  
Total current liabilities     259,346       269,228  
Non-current liabilities:            
Long-term debt     813,043       833,579  
Non-current operating lease liabilities     52,871       55,772  
Other non-current liabilities     37,914       44,064  
Total non-current liabilities     903,828       933,415  
Total liabilities     1,163,174       1,202,643  
Stockholders’ equity            
Common stock     14       13  
Additional paid-in capital     1,291,858       1,288,294  
Accumulated other comprehensive income     285       44  
Accumulated deficit     (1,174,137 )     (1,187,222 )
Total stockholders’ equity     118,020       101,129  
Total liabilities and stockholders’ equity   $ 1,281,194     $ 1,303,772  

 
Gogo Inc. and Subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands)
 
    For the Three Months

Ended March 31,
 
    2026     2025  
Operating activities:            
Net income   $ 13,085     $ 12,042  
Adjustments to reconcile net income to cash provided by operating activities:            
Depreciation and amortization     15,139       14,143  
Loss on asset disposals, abandonments and write-downs     208       13  
Provision for expected credit losses     1,855       945  
Deferred income taxes     7,273       6,136  
Stock-based compensation expense     4,833       5,491  
Amortization of deferred financing costs and interest rate caps     1,356       1,577  
Accretion of debt discount     462       416  
Change in fair value of Earnout Liability     (4,943 )      
Change in fair value of convertible note investment     (230 )     253  
Changes in operating assets and liabilities:            
Accounts receivable     (4,341 )     (4,785 )
Inventories     (2,939 )     4,148  
Prepaid expenses and other current assets     (11,590 )     (3,527 )
Contract assets     (4,665 )     (1,947 )
Accounts payable     (2,051 )     126  
Accrued liabilities     (20,941 )     2,716  
Deferred revenue     973       (2,438 )
Accrued interest     (5 )     (2,046 )
Other non-current assets and liabilities     (715 )     (791 )
   Net cash (used in) provided by operating activities     (7,236 )     32,472  
Investing activities:            
Purchases of property and equipment     (25,721 )     (2,751 )
Acquisition of intangible assets—capitalized software     (2,292 )     (3,418 )
Proceeds from FCC Reimbursement Program for property, equipment and intangibles     14,886       564  
Proceeds from interest rate caps     1,180       3,170  
   Net cash used in investing activities     (11,947 )     (2,435 )
Financing activities:            
Payments on term loan     (625 )     (625 )
Payments on financing leases     (15 )     (2 )
Stock-based compensation activity     (1,971 )     (947 )
   Net cash used in financing activities     (2,611 )     (1,574 )
Effect of exchange rate changes on cash     129       55  
(Decrease) increase in cash, cash equivalents and restricted cash     (21,665 )     28,518  
Cash, cash equivalents and restricted cash at beginning of period     125,690       42,304  
Cash, cash equivalents and restricted cash at end of period   $ 104,025     $ 70,822  
Cash, cash equivalents and restricted cash at end of period   $ 104,025     $ 70,822  
Less: current restricted cash     87       70  
Less: non-current restricted cash     394       470  
Cash and cash equivalents at end of period   $ 103,544     $ 70,282  
Supplemental cash flow information:            
Cash paid for interest   $ 17,472     $ 20,926  
Cash paid for taxes     160       162  
Non-cash investing activities:            
Purchases of property, equipment and intangibles in liabilities   $ 6,933     $ 6,112  

 
Gogo Inc. and Subsidiaries
Supplemental Information – Disaggregated Revenue
(in thousands, unaudited)
 
    For the Three Months Ended March 31,  
    2026     2025  
Service revenue by type            
Satellite broadband   $ 80,102     $ 77,679  
ATG broadband     64,802       75,970  
Narrowband and other     42,828       44,963  
Total service revenue by type   $ 187,732     $ 198,612  
Service revenue by market            
Business aviation   $ 154,355     $ 169,281  
Military / Government     33,377       29,331  
Total service revenue by market   $ 187,732     $ 198,612  
             
Equipment revenue            
Satellite broadband   $ 12,413     $ 6,375  
ATG broadband     19,654       18,672  
Narrowband and other     6,520       6,648  
Total equipment revenue   $ 38,587     $ 31,695  

 
Gogo Inc. and Subsidiaries

Supplemental Information – Key Business Metrics
 
    For the Three Months
Ended March 31,
 
    2026     2025  
Aircraft online (at period end)            
ATG AVANCE     4,851       4,716  
Gogo Biz     1,265       2,186  
Total ATG     6,116       6,902  
GEO aircraft online     1,306       1,280  
Gogo Galileo aircraft online     111        
Average monthly connectivity service revenue per ATG aircraft online   $ 3,351     $ 3,451  
ATG units sold     511       317  
                 
  • AVANCE aircraft online. We define AVANCE aircraft online as the total number of aircraft equipped with our AVANCE L5 or L3 system for which we provide ATG services to business aviation customers in the last month of the period presented. This number excludes military/government AVANCE aircraft online.
  • Gogo Biz aircraft online. We define Gogo Biz aircraft online as the total number of aircraft not equipped with our AVANCE L5 or L3 system for which we provide ATG services to business aviation customers in the last month of the period presented. This number excludes commercial aircraft operated by Intelsat’s airline customers as well as military/government aircraft receiving ATG service.
  • GEO aircraft online. We define GEO aircraft online as the total number of aircraft for which we provide GEO broadband services to business aviation customers as of the last day of each period presented. This number excludes aircraft receiving services through GEO satellite networks that are end-of-life and military/government GEO aircraft online.
  • Gogo Galileo aircraft online. We define Gogo Galileo aircraft online as the total number of aircraft for which we provide Gogo Galileo LEO broadband services in the last month of the period presented. This number excludes military/government Gogo Galileo aircraft online. This metric was not presented prior to the fiscal year ended December 31, 2025, as Gogo Galileo was only first deployed in 2025.
  • Average monthly connectivity service revenue per ATG aircraft online (“ARPU”). We define ARPU as the aggregate ATG connectivity service revenue for the period divided by the number of months in the period, divided by the number of ATG aircraft online during the period (expressed as an average of the month end figures for each month in such period). Revenue share earned from Intelsat is excluded from this calculation.
  • ATG units sold. We define units sold as the number of ATG units for which we recognized revenue during the period.

For more information, see “Key Business Metrics” above.

Gogo Inc. and Subsidiaries

Supplemental Information – Revenue and Cost of Revenue

(in thousands, unaudited)
 
    For the Three Months

Ended March 31,
    % Change  
    2026     2025     2026 over 2025  
Service revenue   $ 187,732     $ 198,612       (5.5 )%
Equipment revenue     38,587       31,695       21.7 %
Total revenue   $ 226,319     $ 230,307       (1.7 )%
                   
    For the Three Months

Ended March 31,
    % Change  
    2026     2025     2026 over 2025  
Cost of service revenue(1)   $ 98,314     $ 94,047       4.5 %
Cost of equipment revenue(1)   $ 34,988     $ 29,326       19.3 %


(1)   Excludes depreciation and amortization expense.

Gogo Inc. and Subsidiaries

Reconciliation of GAAP to Non-GAAP Measures

(in thousands, unaudited)
 
    For the Three Months

Ended March 31,
    For the Three Months Ended December 31,  
    2026     2025     2025  
Adjusted EBITDA:                  
Net income (loss) attributable to common stock (GAAP)   $ 13,085     $ 12,042     $ (9,996 )
Interest expense     16,846       16,558       17,567  
Interest income     (1,154 )     (590 )     (1,425 )
Income tax provision     7,948       6,943       1,405  
Depreciation and amortization     15,139       14,143       15,805  
EBITDA     51,864       49,096       23,356  
Stock-based compensation expense     4,833       5,491       5,552  
Change in fair value of Earnout Liability     (4,943 )           (7,100 )
Acquisition and integration-related costs(1)     1,815       6,467       1,493  
Amortization of acquisition-related inventory step-up costs           748       497  
Litigation settlement accrual costs                 10,010  
Change in fair value of convertible note investment     (230 )     253       4,010  
Adjusted EBITDA   $ 53,339     $ 62,055     $ 37,818  
                   
Free Cash Flow:                  
Net cash provided by operating activities (GAAP)(2)   $ (7,236 )   $ 32,472     $ 8,503  
Consolidated capital expenditures(2)     (28,013 )     (6,169 )     (40,429 )
Proceeds from FCC Reimbursement Program for property, equipment and intangibles(2)     14,886       564       25,499  
Proceeds from interest rate caps(2)     1,180       3,170       1,482  
Free cash flow   $ (19,183 )   $ 30,037     $ (4,945 )


(1)   For the three months ended March 31, 2026, the figure consists of severance and other compensation-related costs of $1.2 million and integration support costs of $0.6 million. For the three months ended March 31, 2025, the figure consists of due diligence and advisory fees of $3.9 million and severance and other compensation-related costs of $2.6 million. For the three months ended December 31, 2025, the figure consists of integration-related advisory fees of $0.3 million and severance and other compensation-related costs of $1.2 million.



(2)   See Unaudited Condensed Consolidated Statements of Cash Flows.

Gogo Inc. and Subsidiaries

Reconciliation of Estimated Full-Year GAAP Net Cash

Provided by Operating Activities to Non-GAAP Measures

(in millions, unaudited)


 
  FY 2026 Range  
  Low     High  
Free Cash Flow:          
Net cash provided by operating activities (GAAP) $ 108     $ 128  
Consolidated capital expenditures   (65 )     (65 )
Proceeds from FCC Reimbursement Program for property, equipment and intangibles   45       45  
Proceeds from interest rate caps   2       2  
Free cash flow $ 90     $ 110  



Definition of Non-GAAP Measures

EBITDA represents net income attributable to common stock before interest expense, interest income, income taxes and depreciation and amortization expense.

Adjusted EBITDA represents EBITDA adjusted for (i) stock-based compensation expense, (ii) acquisition and integration-related costs, including amortization of acquisition-related inventory step-up costs and changes in fair value of the Earnout Liability, (iii) litigation settlement accrual costs, and (iv) change in fair value of convertible note investment. Our management believes that the use of Adjusted EBITDA eliminates items that management believes have less bearing on our operating performance, thereby highlighting trends in our core business which may not otherwise be apparent. It also provides an assessment of controllable expenses, which are indicators management uses to determine whether current spending decisions need to be adjusted in order to meet financial goals and achieve optimal financial performance.

We believe that the exclusion of stock-based compensation expense from Adjusted EBITDA provides a clearer view of the operating performance of our business and is appropriate given that grants made at a certain price and point in time do not necessarily reflect how our business is performing at any particular time. While we believe that investors should have information about any dilutive effect of outstanding options and the cost of that compensation, we also believe that stockholders should have the ability to consider our performance using a non-GAAP financial measure that excludes these costs and that management uses to evaluate our business.

Acquisition and integration-related costs include direct transaction costs, such as due diligence and advisory fees and certain compensation and integration-related expenses as well as the amortization of acquisition-related inventory step-up costs. We believe it is useful for an understanding of our operating performance to exclude acquisition and integration-related costs from Adjusted EBITDA because they are infrequent, are outside of the ordinary course of our operations and do not reflect our operating performance.

We believe it is useful for an understanding of our operating performance to exclude the changes in fair value of the Earnout Liability related to the acquisition of Satcom Direct from Adjusted EBITDA because this activity is outside of the ordinary course of our operations and does not reflect our operating performance.

We believe it is useful for an understanding of our operating performance to exclude litigation settlement accrual costs from Adjusted EBITDA because this activity is outside of the ordinary course of our operations and does not reflect our operating performance.

We believe it is useful for an understanding of our operating performance to exclude the change in fair value of convertible note investment from Adjusted EBITDA because this activity is not related to our operating performance.

We also present Adjusted EBITDA as a supplemental performance measure because we believe that this measure provides investors, securities analysts and other users of our consolidated financial statements with important supplemental information with which to evaluate our performance and to enable them to assess our performance on the same basis as management.

Free Cash Flow represents net cash provided by operating activities, plus the proceeds received from the FCC Reimbursement Program and the interest rate caps, less purchases of property and equipment and the acquisition of intangible assets. We believe that Free Cash Flow provides meaningful information regarding our liquidity. Management believes that Free Cash Flow is useful for investors because it provides them with an important perspective on the cash available for strategic measures, after making necessary capital investments in property and equipment to support the Company’s ongoing business operations and provides them with the same measures that management uses as the basis of making capital allocation decisions.

Investor Relations Contact: Media Relations Contact:
Collected Strategies Stacey Giglio
+1 212-379-2072 +1 321-361-6101

[email protected]

[email protected]



Rare Earths Americas Announces Closing of $63.3 Million Upsized Initial Public Offering

Rare Earths Americas Announces Closing of $63.3 Million Upsized Initial Public Offering

MANCHESTER, Ga.–(BUSINESS WIRE)–Rare Earths Americas, Inc. (“REA” or the “Company”), a critical minerals company advancing a portfolio of prospective heavy rare earths focused projects in the United States and in Brazil, announced today the closing of its upsized initial public offering of 3,333,331 shares of its common stock. The gross proceeds from the offering were approximately $63.3 million, before deducting underwriting discounts and commissions and estimated offering expenses. The shares commenced trading on the NYSE American LLC on May 6, 2026, under the ticker symbol “REA”.

REA intends to use the net proceeds from the offering (i) to fund land acquisition and option payments, drilling, metallurgical test work, permitting and SK-1300 technical report summary preparation at the Shiloh Project; (ii) to fund exploration, evaluation, land consolidation, metallurgy, engineering and permitting studies at the Alpha and Constellation Projects; and to the extent available (iii) to evaluate non-material exploration projects, including Homer and Liberty Peak, as well as for working capital and other general corporate purposes.

Cantor acted as the lead book-running manager for the proposed offering. Stifel acted as book-running manager for the proposed offering. Canaccord Genuity and B. Riley Securities acted as co-managers for the proposed offering.

A registration statement relating to the offering of securities was declared effective by the U.S. Securities and Exchange Commission on May 5, 2026. The offering was made only by means of a final prospectus. Copies of the final prospectus relating to the offering may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate Department, 1201 Wills Street, Suite 600, Baltimore, Maryland 21231, by telephone at (855) 300-7136, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Rare Earths Americas

Rare Earths Americas, Inc. (REA) is an exploration stage company advancing a portfolio of critical minerals projects focused on high-grade heavy rare earth mineral assets in the United States and Brazil. REA’s portfolio includes three material projects, that could position REA as a critical node in non-Chinese rare earth supply chains, aligning with Western industrial objectives and national security priorities. Rare earths elements are essential for advanced U.S. industries including robotics, electric vehicles, energy, defense, and consumer electronics.

Forward-Looking Statements & Technical Notes

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this press release, including statements regarding the initial public offering of the Company, the realization of any potential advantages, benefits and the impact of, and opportunities created by, the offering and the ability of the Company to utilize the proceeds of the offering in the manner intended, are forward-looking statements. These statements 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. Generally, forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” or the negative connotation thereof. The forward-looking statements are based on certain assumptions which could change materially in the future. You should not place undue reliance on these forward-looking statements.

The Company does not undertake to update any forward-looking statement or forward-looking information, except in accordance with applicable securities laws.

REA is an exploration-stage company with no proven or probable mineral reserves and no revenues. Results may differ due to geological, technical, market and other factors.

[email protected]

KEYWORDS: Georgia United States North America

INDUSTRY KEYWORDS: EV/Electric Vehicles Machine Tools, Metalworking & Metallurgy Robotics Mining/Minerals Consumer Electronics Batteries Technology Automotive Natural Resources Semiconductor Engineering Automotive Manufacturing Manufacturing

MEDIA:

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MBX Biosciences Announces Appointment of Mark Soued as Chief Commercial Officer and Inducement Grant Award

CARMEL, Ind. and BURLINGTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) — MBX Biosciences, Inc. (Nasdaq: MBX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies for the treatment of endocrine and metabolic disorders, today announced the appointment of Mark R. Soued, MBA, as Chief Commercial Officer (CCO). Mr. Soued brings more than two decades of commercial leadership across global biopharmaceutical organizations, with deep expertise in product launches, market access, and building high-performing commercial teams.

“Mark is an exceptional commercial leader with a demonstrated ability to build and scale commercial organizations and bring products to market,” said Kent Hawryluk, President and Chief Executive Officer of MBX Biosciences. “His track record of delivering landmark product launches and generating significant revenue growth at organizations like Alnylam and Pfizer makes him uniquely positioned to lead MBX’s commercialization efforts as we continue to advance our pipeline of clinically validated, proprietary Precision Endocrine Peptides™.”

“I am excited to join MBX Biosciences at such a pivotal moment in the company’s development,” said Mr. Soued. “The team has built a differentiated pipeline and world-class team with the potential to meaningfully address unmet needs in endocrine and metabolic diseases. I look forward to helping shape and execute a commercial strategy that brings these therapies to the patients who need them most.”

Mark Soued is a seasoned commercial biopharma executive with extensive experience building and growing global commercial organizations overseeing multiple product launches, sales and marketing, market access, and lifecycle management. Most recently, Mr. Soued served as Senior Vice President, Head of US at Alnylam Pharmaceuticals, where he led the Company’s US amyloidosis business, including the category-defining launch of AMVUTTRA® in ATTR cardiomyopathy. Prior to that, he served as Senior Vice President, Head of Global Commercial at Alnylam, where he built a global commercial organization spanning six functions and four inline products. Earlier in his career, Mr. Soued held a series of senior commercial leader roles at Pfizer, including Regional President for North America’s Hospital Business Unit, Vice President and Global Rare Cardiology Franchise Head, and multiple international leadership positions across Asia Pacific and Northwestern Europe. He led the successful US launch of VYNDAQEL®/VYNDAMAX® and negotiated a multi-billion US government contract for PAXLOVID®, among other milestones. Mr. Soued holds an MBA from Northwestern University’s Kellogg School of Management and a B.S. in Finance from the University of Colorado. He is fluent in English and French.

Inducement Grant

In connection with the appointment of Mr. Soued as Chief Commercial Officer, on May 1, 2026, MBX granted Mr. Soued an inducement equity award, which was approved by the Company’s board of directors in accordance with Nasdaq Listing Rule 5635(c)(4). The inducement award consisted of non-qualified stock options to purchase an aggregate of 160,000 shares of the company’s common stock with an exercise price of $29.78 per share, which is equal to the closing price of the company’s common stock as reported by Nasdaq on May 1, 2026. The option has a 10-year term and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of April 29, 2026, and the remainder vesting in 36 equal monthly installments for the three years thereafter, subject to Mr. Soued’s continued service. The award is subject to the terms and conditions of the company’s 2026 Inducement Plan and the terms and conditions of the stock option agreement covering the grant.

About
MBX Biosciences

MBX Biosciences is a biopharmaceutical company focused on the discovery, development and commercialization of novel precision peptide therapies based on its proprietary PEP™ platform, for the treatment of endocrine and metabolic disorders. The Company is advancing a pipeline of novel candidates for endocrine and metabolic disorders with clinically validated targets, established endpoints for regulatory approval, significant unmet medical needs and large potential market opportunities. The Company’s pipeline includes canvuparatide (MBX 2109) for the treatment of chronic hypoparathyroidism (HP) preparing for Phase 3 development; an obesity portfolio that includes MBX 4291 in Phase 1 development, as well as multiple discovery and pre-clinical obesity candidates; and imapextide (MBX 1416) for the treatment of post-bariatric hypoglycemia (PBH) in Phase 2 development. The Company is based in Carmel, Indiana. To learn more, please visit the Company website at www.mbxbio.com and follow it on LinkedIn.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, each as amended. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, express or implied statements regarding: MBX Biosciences’ expectations regarding Mr. Soued’s ability to help advance commercialization, MBX Biosciences’ expectations regarding the further advancement of its pipeline of programs in endocrine and metabolic disorders; and MBX Biosciences’ plans for delivery of differentiated endocrine and metabolic compounds to underserved patients.

Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect MBX Biosciences’ business, operating results, financial condition and stock value. Factors that could cause actual results to differ materially from those currently anticipated include: risks relating to the Company’s research and development activities; uncertainties relating to preclinical and clinical development activities; uncertainties relating to preclinical and clinical development activities; the risk that preliminary results may not be indicative of later results; MBX Biosciences’ ability to attract, integrate and retain key personnel; as well as other risks described in “Risk Factors,” in MBX Biosciences’ Annual Report on Form 10-K for the year ended December 31, 2024 filed with the Securities and Exchange Commission (SEC), as well as subsequent filings with the SEC. MBX Biosciences expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law, and claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

MBX uses and intends to continue to use its Investor Relations website as a means of disclosing material nonpublic information and for complying with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the Company’s Investor Relations website, in addition to following the Company’s press releases, SEC filings, public conference calls, presentations, and webcasts.

Media Contact:

George Shea
We. Communications
[email protected]

Investor Contact:

Jim DeNike
MBX Biosciences
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b8b07cf9-9fda-4eb3-8581-f664b7c317b1



The Middleby Corporation Reports First Quarter Results

The Middleby Corporation Reports First Quarter Results

  • Q1 2026 results exceeded high end of guidance range for revenue, Adj. EBITDA and Adj. EPS
  • Organic sales growth of +8% in Commercial Foodservice and +25% in Food Processing
  • Raises FY 2026 guidance; revenue growth of +4-6% in Commercial Foodservice and +4-7% in Food Processing
  • Solid order growth of +39% and book-to-bill ratio of 1.09x for Food Processing over the trailing twelve months
  • Food Processing Spin on track for July 6, 2026
  • Repurchased 2.4 million shares (4.9% of equity) in Q1 2026 and 3.5 million shares (7.1% of equity) YTD 2026

FIRST QUARTER CONTINUING OPERATIONS HIGHLIGHTS

  • Net Sales of $840 million increased 15% over prior year; 12% on organic basis
  • Operating income of $133 million as compared to $130 million in prior year, includes $9.9 million for strategic transaction costs associated with the business portfolio transformation
  • Adjusted EBITDA of $181 million as compared to $161 million in prior year
  • Diluted GAAP EPS of $1.81 as compared to $1.56 in prior year
  • Adjusted EPS of $2.16 as compared to $1.87 in prior year
  • Q1 ending net leverage at 2.3x

ELGIN, Ill.–(BUSINESS WIRE)–
The Middleby Corporation (NASDAQ: MIDD), a leading worldwide manufacturer of equipment for the commercial foodservice and food processing industries, today reported net earnings for the first quarter of 2026.

Tim FitzGerald, CEO of The Middleby Corporation said, “We delivered an extremely strong first quarter with outperformance at both segments relative to our expectations. Our Commercial Foodservice segment generated 8.1% organic growth, driven by continued double-digit growth with our dealer partners and better than expected performance with chains which returned to positive growth in the quarter. We’re particularly excited about the momentum in ice and beverage categories, where our strategic investments in recent years are allowing us to capitalize on emerging trends across the industry. Our Food Processing segment generated exceptional results with 25% organic growth, while backlog continued to grow, now standing at $416 million. In addition to our strong segment-level results, our aggressive capital allocation strategy continues, with over $520 million deployed in share repurchases so far in 2026, reducing our share count by approximately 7%, building on the 9% reduction achieved in 2025.”

FitzGerald concluded, “I am excited for what the next few months holds for Middleby. That starts today with sharing the excellent results we achieved across both segments and raising our guidance for the year. It continues next Tuesday during our Investor Day in New York as we lay out the vision for the exciting future ahead for both segments. Our portfolio transformation culminates with the planned July 6 separation into two pure-play standalone public companies, with a new and exciting chapter for both companies. Following this transaction, Middleby will operate as a focused Commercial Foodservice innovation leader with industry-leading 26% segment-level EBITDA margins, while Food Processing becomes an independent growth platform with segment-level margins over 20% and significant organic and acquisition expansion opportunities. We look forward to showcasing our long-term vision at our Investor Day next Tuesday as both companies unlock their full potential as independent leaders in their respective markets.”

2026 First Quarter Financial Results

All results presented are on a continuing operations basis.

  • Net sales increased 15.0% in the first quarter over the comparative prior year period. Excluding the impacts of acquisitions and foreign exchange rates, sales increased 11.9% in the first quarter over the comparative prior year period.

  • A reconciliation of organic net sales (a non-GAAP measure) by segment is as follows:

($ in millions)

Commercial

Foodservice

 

Food

Processing

 

Total

Company

Net Sales

$

615.5

 

 

$

224.4

 

 

$

839.9

 

 

 

 

 

 

 

Reported Net Sales Growth

 

9.4

%

 

 

33.7

%

 

 

15.0

%

Acquisitions

 

%

 

 

4.5

%

 

 

1.0

%

Foreign Exchange Rates

 

1.3

%

 

 

4.2

%

 

 

2.0

%

Organic Net Sales Growth (1) (2)

 

8.1

%

 

 

25.0

%

 

 

11.9

%

 

 

 

 

 

 

(1) Organic net sales growth defined as total sales growth excluding impact of acquisitions and foreign exchange rates

(2) Totals may be impacted by rounding

  • Adjusted EBITDA (a non-GAAP measure) was $180.6 million in the first quarter compared to $161.5 million in the prior year.

  • A reconciliation of organic adjusted EBITDA (a non-GAAP measure) by segment is as follows:

($ in millions)

Commercial

Foodservice

 

Food

Processing

 

Total

Company (1)

Adjusted EBITDA

$

158.4

 

 

$

41.4

 

 

$

180.6

 

 

 

 

 

 

 

Adjusted EBITDA %

 

25.7

%

 

 

18.5

%

 

 

21.5

%

Acquisitions

 

%

 

 

(0.8

)%

 

 

(0.2

)%

Foreign Exchange Rates

 

(0.1

)%

 

 

(0.1

)%

 

 

(0.1

)%

Organic Adjusted EBITDA % (2) (3)

 

25.8

%

 

 

19.5

%

 

 

21.8

%

 

 

 

 

 

 

(1) Includes corporate and other general company expenses, which impact Segment Adjusted EBITDA, and amounted to $19.2 million.

(2) Organic Adjusted EBITDA defined as Adjusted EBITDA excluding impact of acquisitions and foreign exchange rates.

(3) Totals may be impacted by rounding

  • Operating cash flows during the first quarter amounted to $87.8 million compared to $137.3 million in the prior year. Operating cash flows also reflect $9.9 million for strategic transaction costs associated with the business portfolio transformation.

  • The total leverage ratio per our credit agreements was 2.3x. The trailing twelve-month bank agreement pro-forma EBITDA was $781.2 million.

  • Net debt, defined as debt less cash, at the end of the 2026 fiscal first quarter amounted to $1.7 billion as compared to $2.0 billion at the end of fiscal 2025. Our borrowing availability at the end of the first quarter was approximately $2.5 billion.

2026 Outlook

Management also provided the following expectations for the second quarter and full year 2026:

 

2nd Qtr, 2026

 

Full Year 2026

 

Commercial

Foodservice

 

Food

Processing

 

Total

Company

 

Commercial

Foodservice

 

Food

Processing

 

Total

Company

Net sales

$600-$620 M

 

$215-230 M

 

$815-850 M

 

$2.44-2.49 B

 

$915-945 M

 

$3.36-3.44 B

Growth

5%

 

3%

 

4%

 

5%

 

9%

 

6%

Organic Growth

3-7%

 

-5% to +2%

 

 

 

4-6%

 

4-7%

 

 

Adjusted EBITDA

$154-164 M

 

$45-49 M

 

$180-192 M

 

$645-668 M

 

$186-208 M

 

$758-790 M

Adjusted Earnings Per Share (1)

 

 

 

 

$2.27-2.39

 

 

 

 

 

$9.54-9.70

 

 

 

 

 

 

 

 

 

 

 

 

(1) FY 2026 Adjusted EPS expectation is the sum of the four quarters of Adjusted EPS, please reference earnings slides for further detail on guidance

Conference Call

The company has scheduled a conference call to discuss the first quarter results at 10 a.m. Eastern/9 a.m. Central Time on May 7th. The conference call is accessible through the Investor Relations section of the company website at www.middleby.com. If website access is not available, attendees can join the conference by dialing (844) 676-5090, or (412) 634-6754 for international access. The conference call will be available for replay from the company’s website.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release or otherwise attributable to the company regarding the company’s business which are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding our expectations with respect to our future performance and the outcome of our strategic review. The company cautions investors that such statements are estimates of future performance and are highly dependent upon a variety of important factors that could cause actual results to differ materially from such statements. Such factors include variability in financing costs; quarterly variations in operating results; dependence on key customers; international exposure; foreign exchange and political risks affecting international sales; changing market conditions; the impact of competitive products and pricing; the timely development and market acceptance of the company’s products; the availability and cost of raw materials; and other risks detailed herein and from time-to-time in the company’s SEC filings. Any forward-looking statement speaks only as of the date hereof, and the company does not undertake any obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law.

The Middleby Corporation is a global leader in the foodservice industry. The company develops and manufactures a broad line of solutions used in commercial foodservice and food processing. Middleby showcases its advanced solutions in the Middleby Innovation Kitchens for commercial foodservice and industrial baking and protein Innovation Centers for food processing solutions.

 

THE MIDDLEBY CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS

(Amounts in 000’s, Except Per Share Information)

(Unaudited)

 

 

Three Months Ended

 

1st Qtr, 2026

 

1st Qtr, 2025

Net sales

$

839,908

 

 

$

730,623

 

Cost of sales

 

516,718

 

 

 

438,045

 

Gross profit

 

323,190

 

 

 

292,578

 

 

 

 

 

Selling, general and administrative expenses

 

188,297

 

 

 

161,809

 

Restructuring expenses

 

1,539

 

 

 

1,248

 

Income from operations

 

133,354

 

 

 

129,521

 

 

 

 

 

Interest expense and deferred financing amortization, net

 

25,480

 

 

 

18,821

 

Net periodic pension benefit

 

(2,429

)

 

 

(1,516

)

Other (income)/expense, net

 

(2,621

)

 

 

960

 

Earnings from continuing operations before income taxes

 

112,924

 

 

 

111,256

 

 

 

 

 

Provision for income taxes

 

27,640

 

 

 

26,193

 

Net earnings from continuing operations

 

85,284

 

 

 

85,063

 

 

 

 

 

(Loss)/earnings from discontinued operations, net of tax

 

(135,357

)

 

 

7,289

 

Net (loss)/earnings

$

(50,073

)

 

$

92,352

 

 

 

 

 

Net (loss)/earnings per share:

 

 

 

Basic from continuing operations

$

1.81

 

 

$

1.59

 

Basic from discontinued operations

 

(2.87

)

 

 

0.14

 

Basic (loss)/earnings per share

$

(1.06

)

 

$

1.72

 

 

 

 

 

Diluted from continuing operations

$

1.81

 

 

$

1.56

 

Diluted from discontinued operations

 

(2.87

)

 

 

0.13

 

Diluted (loss)/earnings per share

$

(1.06

)

 

$

1.69

 

 

 

 

 

Weighted average number of shares

 

 

 

Basic

 

47,232

 

 

 

53,594

 

Diluted

 

47,243

 

 

 

54,621

 

 

THE MIDDLEBY CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(Amounts in 000’s)

(Unaudited)

 

 

Apr 4, 2026

 

Jan 3, 2026

ASSETS

 

 

 

 

 

 

 

Cash and cash equivalents

$

177,065

 

$

222,239

Accounts receivable, net

 

608,028

 

 

573,039

Inventories, net

 

728,388

 

 

692,589

Prepaid expenses and other

 

97,786

 

 

111,176

Prepaid taxes

 

25,707

 

 

41,159

Current assets held for sale – discontinued operations

 

10,865

 

 

1,102,441

Total current assets

 

1,647,839

 

 

2,742,643

Property, plant and equipment, net

 

424,961

 

 

431,622

Goodwill

 

1,794,037

 

 

1,799,649

Other intangibles, net

 

1,044,998

 

 

1,061,192

Long-term deferred tax assets

 

7,390

 

 

8,209

Pension benefits assets

 

107,799

 

 

106,444

Equity method investment

 

155,293

 

 

Note receivable

 

84,186

 

 

Other assets

 

155,484

 

 

165,407

Total assets

$

5,421,987

 

$

6,315,166

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current maturities of long-term debt

$

44,154

 

$

44,420

Accounts payable

 

215,386

 

 

206,666

Accrued expenses

 

571,051

 

 

574,810

Current liabilities held for sale – discontinued operations

 

8,199

 

 

242,335

Total current liabilities

 

838,790

 

 

1,068,231

Long-term debt

 

1,829,866

 

 

2,128,582

Long-term deferred tax liability

 

195,323

 

 

156,723

Accrued pension benefits

 

7,467

 

 

7,629

Other non-current liabilities

 

175,610

 

 

177,772

Stockholders’ equity

 

2,374,931

 

 

2,776,229

Total liabilities and stockholders’ equity

$

5,421,987

 

$

6,315,166

 

THE MIDDLEBY CORPORATION

NON-GAAP SEGMENT INFORMATION

(Amounts in 000’s, Except Percentages)

(Unaudited)

 

 

Commercial

Foodservice

 

Food

Processing

 

Total

Company (1)

Three Months Ended April 4, 2026

 

 

 

 

 

Net sales

$

615,536

 

 

$

224,372

 

 

$

839,908

 

Segment income from continuing operations

$

139,666

 

 

$

34,365

 

 

$

133,354

 

Income from continuing operations % of net sales

 

22.7

%

 

 

15.3

%

 

 

15.9

%

 

 

 

 

 

 

Depreciation

 

7,244

 

 

 

3,705

 

 

 

11,500

 

Amortization

 

10,623

 

 

 

2,721

 

 

 

13,344

 

Restructuring expenses

 

689

 

 

 

(57

)

 

 

1,539

 

Acquisition related adjustments

 

178

 

 

 

689

 

 

 

867

 

Strategic transaction costs

 

 

 

 

 

 

 

9,945

 

Stock compensation

 

 

 

 

 

 

 

10,074

 

Segment adjusted EBITDA from continuing operations (2)

$

158,400

 

 

$

41,423

 

 

$

180,623

 

Adjusted EBITDA from continuing operations % of net sales

 

25.7

%

 

 

18.5

%

 

 

21.5

%

 

 

 

 

 

 

Three Months Ended March 29, 2025

 

 

 

 

 

Net sales

$

562,717

 

 

$

167,906

 

 

$

730,623

 

Segment income from continuing operations

$

132,097

 

 

$

23,510

 

 

$

129,521

 

Income from continuing operations % of net sales

 

23.5

%

 

 

14.0

%

 

 

17.7

%

 

 

 

 

 

 

Depreciation

 

6,630

 

 

 

2,891

 

 

 

10,346

 

Amortization

 

11,294

 

 

 

2,914

 

 

 

14,208

 

Restructuring expenses

 

1,137

 

 

 

111

 

 

 

1,248

 

Acquisition related adjustments

 

272

 

 

 

638

 

 

 

401

 

Strategic transaction costs

 

 

 

 

 

 

 

3,473

 

Stock compensation

 

 

 

 

 

 

 

2,288

 

Segment adjusted EBITDA from continuing operations

$

151,430

 

 

$

30,064

 

 

$

161,485

 

Adjusted EBITDA from continuing operations % of net sales

 

26.9

%

 

 

17.9

%

 

 

22.1

%

 

 

 

 

 

 

(1) Includes corporate and other general company expenses, which impact Segment Adjusted EBITDA, and amounted to $19.2 million and $20.0 million for the three months ended April 4, 2026 and March 29, 2025, respectively.

(2)Foreign exchange rates favorably impacted Segment Adjusted EBITDA by approximately $2.4 million for the three months ended April 4, 2026.

 

THE MIDDLEBY CORPORATION

NON-GAAP INFORMATION

(Amounts in 000’s, Except Percentages)

(Unaudited)

 

 

Three Months Ended

 

1st Qtr, 2026

 

1st Qtr, 2025

 

$

 

Diluted per share

 

$

 

Diluted per share

Net earnings from continuing operations

$

85,284

 

 

$

1.81

 

 

$

85,063

 

 

$

1.56

 

Amortization (1)

 

13,969

 

 

 

0.30

 

 

 

16,005

 

 

 

0.29

 

Restructuring expenses

 

1,539

 

 

 

0.03

 

 

 

1,248

 

 

 

0.02

 

Acquisition related adjustments

 

867

 

 

 

0.02

 

 

 

401

 

 

 

0.01

 

Net periodic pension benefit

 

(2,429

)

 

 

(0.05

)

 

 

(1,516

)

 

 

(0.03

)

Strategic transaction costs

 

9,945

 

 

 

0.21

 

 

 

3,473

 

 

 

0.06

 

Minority investment adjustments

 

(1,806

)

 

 

(0.04

)

 

 

 

 

 

 

Income tax effect of pre-tax adjustments

 

(5,411

)

 

 

(0.12

)

 

 

(4,608

)

 

 

(0.08

)

Adjustment for shares excluded due to anti-dilution effect on GAAP net earnings (2)

 

 

 

 

 

 

 

 

 

 

0.04

 

Adjusted net earnings from continuing operations

$

101,958

 

 

$

2.16

 

 

$

100,066

 

 

$

1.87

 

 

 

 

 

 

 

 

 

Diluted weighted average number of shares

 

47,243

 

 

 

 

 

54,621

 

 

 

Adjustment for shares excluded due to anti-dilution effect on GAAP net earnings (2)

 

 

 

 

 

 

(1,028

)

 

 

Adjusted diluted weighted average number of shares

 

47,243

 

 

 

 

 

53,593

 

 

 

 

 

 

 

 

 

 

 

(1) Includes amortization of deferred financing costs and convertible notes issuance costs.

(2) Adjusted diluted weighted average number of shares was calculated based on excluding the dilutive effect of shares to be issued upon conversion of the notes to satisfy the amount in excess of the principal since the company’s capped call offsets the dilutive impact of the shares underlying the convertible notes. The calculation of adjusted diluted earnings per share excludes the principal portion of the convertible notes as this will always be settled in cash. Given the settlement of the convertible notes in the third quarter of 2025 the weighted average number of shares will no longer require an adjustment in 2026.

 

Three Months Ended

 

1st Qtr, 2026

 

1st Qtr, 2025

Net Cash Flows Provided By (Used In):

 

 

 

Operating activities (1)

$

87,812

 

 

$

137,284

 

Investing activities (2)

 

556,527

 

 

 

(27,568

)

Financing activities

 

(684,665

)

 

 

(57,091

)

 

 

 

 

Free Cash Flow

 

 

 

Cash flow from operating activities (1)

$

87,812

 

 

$

137,284

 

Less: Capital expenditures (3)

 

(7,939

)

 

 

(26,463

)

Free cash flow

$

79,873

 

 

$

110,821

 

 

 

 

 

(1) Includes strategic transaction costs associated with the business portfolio review of $9.9 million for the three months ended April 4, 2026.

(2) Includes proceeds from sale of 51% interest in Residential Kitchen Equipment Group, net of cash transferred, of $564.6 million for the three months ended April 4, 2026.

(3) Includes purchase of previously leased food processing manufacturing facility for the three months ended March 29, 2025.

USE OF NON-GAAP FINANCIAL MEASURES

The company supplements its consolidated financial statements presented on a GAAP basis with this non-GAAP financial information to provide investors with greater insight, increase transparency and allow for a more comprehensive understanding of the information used by management in its financial and operational decision-making. The non-GAAP financial measures disclosed by the company should not be considered a substitute for, or superior to, financial measures prepared in accordance with GAAP, and the financial results prepared in accordance with GAAP and reconciliations from these results should be carefully evaluated. In addition, the non-GAAP financial measures included in this press release do not have standard meanings and may vary from similarly titled non-GAAP financial measures used by other companies.

The company believes that organic net sales growth, adjusted EBITDA, organic adjusted EBITDA, segment adjusted EBITDA, net debt, net leverage, adjusted net earnings and adjusted diluted per share measures are useful as supplements to its GAAP results of operations to evaluate certain aspects of its operations and financial performance, and its management team primarily focuses on non-GAAP items in evaluating performance for business planning purposes. The company also believes that these measures assist it with comparing its performance between various reporting periods on a consistent basis, as these measures remove from operating results the impact of items that, in its opinion, do not reflect its core operating performance including, for example, intangibles amortization expense, impairment charges, restructuring expenses, and other charges which management considers to be outside core operating results.

The company believes that free cash flow is an important measure of operating performance because it provides management and investors with a measure of cash generated from operations that is available for mandatory payment obligations and investment opportunities, such as funding acquisitions, repaying debt and repurchasing our common stock.

The company believes that its presentation of these non-GAAP financial measures is useful because it provides investors and securities analysts with the same information that Middleby uses internally for purposes of assessing its core operating performance.

Investor relations inquiries:

Rebecca Ellin

SVP of Investor Strategy and Corporate Development

[email protected]

Media inquiries:

Darcy Bretz

VP of Corporate Communications

[email protected]

Kate Schneiderman

Managing Director, ICR

[email protected]

KEYWORDS: Illinois United States North America

INDUSTRY KEYWORDS: Food Tech Retail Restaurant/Bar Technology Manufacturing Food/Beverage Machinery

MEDIA:

Delcath Systems Announces Presentation of New Data on Percutaneous Hepatic Perfusion with Melphalan in Liver-Dominant Metastatic Breast Cancer at ESMO Breast Cancer 2026

Delcath Systems Announces Presentation of New Data on Percutaneous Hepatic Perfusion with Melphalan in Liver-Dominant Metastatic Breast Cancer at ESMO Breast Cancer 2026

QUEENSBURY, N.Y.–(BUSINESS WIRE)–
Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that new data from a retrospective analysis by independent investigators on percutaneous hepatic perfusion with melphalan (M-PHP) using the CHEMOSAT® Hepatic Delivery System was presented today at the ESMO Breast Cancer Congress 2026.

Presentation details

  • Congress: ESMO Breast Cancer Congress 2026
  • Date: May 7, 2026
  • Session: 13:15 (local congress time)
  • Format: E-poster
  • Title: Safety and Feasibility of Percutaneous Hepatic Perfusion with Melphalan in Patients with Liver-Dominant Metastatic Breast Cancer
  • Presenter: Cornelia Lieselotte Angelika Dewald, MD (Hannover Medical School)
  • Abstract number: 574eP

Background

Liver-dominant metastatic breast cancer remains a significant clinical challenge, as progression in the liver can be a major driver of morbidity and may limit the effectiveness of systemic therapies. M-PHP is a liver-directed procedure designed to deliver high-dose melphalan to the liver while reducing systemic exposure through extracorporeal hemofiltration.

About the analysis

Independent investigators at three European centers retrospectively identified 15 patients with liver-dominant metastatic breast cancer treated with M-PHP (CHEMOSAT) at three European centers. The analysis evaluated feasibility, safety, and tumor response per RECIST v1.1.

Key findings (retrospective cohort; N=15)

  • Patient population: Fifteen patients were treated between September 2015 and May 2024 after a median of 4 prior systemic therapy lines (range 1–6).
  • Treatment delivery: Patients received a median of 1 M-PHP cycle (range 1–7), typically followed by ICU admission of 1–2 days.
  • Safety: 67% of patients required blood transfusions (primarily packed red blood cells). Intra-/peri-procedural adverse events occurred in 60% of patients (primarily hematologic or hemodynamic). Grade 3–4 post-procedure adverse events occurred in 80% of patients, predominantly bone marrow suppression with neutropenic-related infections; events typically onset early (median 1 day) and resolved in a median of 7 days.
  • Liver response: Hepatic partial response was observed in 9 of 15 treated patients (60%); 3 patients were not evaluable for response.
  • Overall survival: Median overall survival from first M-PHP was 6.0 months (95% CI, 2.9–NR; range 0.1–76.5); 33% (5/15) of patients were alive at last follow-up. Median follow-up was 55.6 months (95% CI, 53.7–NR).

“These data from independent European investigators represent real-world evidence supporting the use of HEPZATO KIT and CHEMOSAT in liver-dominant metastatic breast cancer and underscore the need for further evaluation in this heavily pretreated population,” said Gerard Michel, Chief Executive Officer of Delcath Systems.

HEPZATO KIT is currently being evaluated in a randomized Phase 2 trial in metastatic breast cancer patients with liver dominant disease (PHP-MBC-202; ClinicalTrials.gov identifier NCT06875128).

About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company’s proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.

In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath’s proprietary Hepatic Delivery System (HDS). The HDS is used to isolate the hepatic venous blood from the systemic circulation while simultaneously filtrating hepatic venous blood during melphalan infusion and washout. The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure.

HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation. Please see the full Prescribing Information, including BOXED WARNING, for HEPZATO KIT.

In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver.

Investor Relations Contact:

ICR Healthcare

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Oncology Medical Devices Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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