Assertio to Be Acquired by Zydus Worldwide DMCC for $23.50 Per Share in Cash

On May 13, 2026 Assertio Holdings, Inc. (Nasdaq: ASRT) ("Assertio" or the "Company") reported that, following an engagement process outlined under the revised merger agreement (the "Garda Merger Agreement") with Garda Therapeutics, Inc. ("Garda"), the Company’s Board of Directors (the "Board") approved a definitive agreement with Zydus Worldwide DMCC, a subsidiary of Zydus Lifesciences Limited ("Zydus") to acquire all outstanding shares of Assertio common stock for $23.50 per share in cash, representing total consideration of approximately $166.4 million (the "Zydus Offer"). The Board determined that the Zydus Offer constituted a "Superior Proposal" under the Garda Merger Agreement and authorized the Company to terminate the Garda agreement announced on May 4, 2026 and enter into the transaction with Zydus (the "Zydus Transaction").

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The Zydus Offer of $23.50 per share in cash represents a 30.6% premium to the $18.00 per share all-cash transaction with Garda announced on April 8, 2026, a 7.8% premium to the $21.80 per share all-cash transaction with Garda announced on May 4, 2026, and a 75.8% premium to the Company’s unaffected closing stock price on March 20, 2026 – the day before significant share price and trading volume movement.

In making its determination that the Zydus Offer represented a Superior Proposal, the Board considered Zydus’ strong execution profile, including that the Zydus Offer has no financing contingencies, requires no third-party financing, and is fully guaranteed by a creditworthy Zydus entity, providing Assertio with direct recourse in the event of a breach or failure to close.

Heather Mason, Chair of the Assertio Board of Directors, stated: "We are pleased that the comprehensive and disciplined strategic review process undertaken by the Board has yielded this outcome. After carefully evaluating all relevant factors, including price, certainty of value, execution risk and overall transaction terms, the Board determined that the Zydus offer represents the best path available to Assertio shareholders. I want to thank everyone involved for their continued dedication throughout this process."

Transaction Overview

Under the terms of the Zydus Transaction, Zydus will promptly commence a tender offer to acquire all outstanding shares of Assertio common stock for $23.50 per share in cash, without interest, representing total cash consideration of approximately $166.4 million. The Board unanimously recommends that Assertio stockholders tender their shares into the Zydus Transaction.

The Zydus Transaction is expected to close in the second quarter of 2026, subject to customary closing conditions, including the tender of a majority of the Company’s outstanding shares. No regulatory approvals are expected to be required.

Following the successful completion of the tender offer, Zydus will acquire any remaining shares through a second-step merger at the same price of $23.50 per share in cash. Upon completion of the transaction, Assertio’s common stock will no longer be listed on Nasdaq.

Assertio will file a current report on Form 8-K with the U.S. Securities and Exchange Commission (the "SEC") containing a summary of the terms and conditions of the Zydus Transaction. The Company also expects to file a Schedule 14D-9 with the SEC in connection with the tender offer, which will include additional information regarding the transaction and the strategic review process.

Advisors

Moelis & Company LLC is serving as financial advisor, Gibson, Dunn & Crutcher LLP as legal counsel, and Longacre Square Partners as strategy and communications advisor to Assertio.

(Press release, Assertio Holdings, MAY 13, 2026, View Source [SID1234665653])

BriaCell Adds Penn Medicine’s Abramson Cancer Center as Clinical Site in Pivotal Phase 3 Breast Cancer Study

On May 13, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care reported the addition of Penn Medicine’s Abramson Cancer Center, an internationally recognized cancer center, as a clinical trial site in BriaCell’s ongoing pivotal Phase 3 clinical study (Bria-ABC).

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BriaCell has received increased interest from leading cancer centers and continued enrollment momentum following the independent inclusion of its Phase 3 clinical trial in Nature Medicine’sarticle, " Eleven clinical trials that will shape medicine in 2026". The Phase 3 Bria-ABC study is evaluating BriaCell’s lead clinical candidate, Bria-IMT, in combination with an immune checkpoint inhibitor versus physician’s choice of treatment in advanced breast cancer.

"We are pleased to partner with Penn Medicine’s Abramson Cancer Center, a world-renowned cancer institute, as a clinical site in BriaCell’s Phase 3 study," stated Dr. William V. Williams, BriaCell’s President & CEO. "We look forward to working with the cancer experts at Penn to offer the Bria-IMT regimen to patients with metastatic breast cancer with the goal of making a meaningful difference for patients who have not responded to prior therapies."

"The addition of Penn Medicine’s Abramson Cancer Center supports our goal of expanding access to BriaCell’s novel immunotherapy regimen to patients with metastatic breast cancer across the greater Philadelphia region," said Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer.

Other recently activated sites include:

Indiana University Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, IN
University of Virginia (UVA) Comprehensive Cancer Center, Charlottesville, VA
Baptist Health South Florida, Coral Gables, FL
SCRI Oncology Partners, Nashville, TN
An interim analysis of the pivotal Phase 3 study will be conducted after 144 patient events, defined as deaths, have occurred. Overall survival (OS) is the primary endpoint. The study compares the Bria-IMT regimen in combination with an immune checkpoint inhibitor versus physician’s choice of treatment in patients with advanced metastatic breast cancer. The Bria-IMT combination regimen has received FDA Fast Track designation, reflecting its potential to address a serious unmet medical need.

For additional information on BriaCell’s pivotal Phase 3 study, please visit ClinicalTrials.gov NCT06072612.

(Press release, BriaCell Therapeutics, MAY 13, 2026, View Source [SID1234666090])

Precigen Reports First Quarter 2026 Financial Results and Business Updates

On May 13, 2026 Precigen, Inc. (Nasdaq: PGEN), a commercial-stage biopharmaceutical company specializing in the advancement of innovative precision medicines to improve the lives of patients, reported first quarter 2026 financial results and business updates.

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"We are thrilled with the strength of the PAPZIMEOS launch and the pace of revenue growth as we drive broad commercial success across the US and work toward expanded market opportunities in additional geographies and the pediatric patient population," said Helen Sabzevari, PhD, President and CEO of Precigen. "Looking ahead, we are excited to advance the next chapter of our AdenoVerse platform through the continued development of PRGN-2009 in HPV-associated cancers, and look forward to sharing more details on our broader pipeline progress later this year. We are also proud to once again collaborate with the Recurrent Respiratory Papillomatosis Foundation in recognizing RRP Awareness Day for the third consecutive year on June 11, reflecting our deep and long-standing commitment to the RRP community. This year’s event carries particular significance as adult patients now have access to an approved treatment, PAPZIMEOS, for the first time in the more than 100-year history of this disease."

"We are encouraged by the strong progress we are seeing as PAPZIMEOS continues to gain traction, with approximately 400 patients currently enrolled in the PAPZIMEOS patient hub, of which a noteworthy 25% are from the community setting," said Phil Tennant, Chief Commercial Officer of Precigen. "We are focused on converting hub enrollment into treated patients, and we look forward to building on this progress in the second quarter and beyond as more sites become activated, the impact of the permanent J-code takes hold, and our targeted site support helps deliver a seamless journey to treatment."

KEY PROGRAM HIGHLIGHTS

PAPZIMEOS: First-line Standard of Care for the Treatment of Adults with RRP

PAPZIMEOS (zopapogene imadenovec-drba) is a non-replicating adenoviral vector-based immunotherapy designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with RRP. In August 2025, the US Food and Drug Administration (FDA) granted full approval of PAPZIMEOS with a broad label for the treatment of adults with RRP. PAPZIMEOS is the first and only FDA-approved therapy for the treatment of adults with RRP and the first treatment that addresses the root cause of RRP.

· National prescribing growth: PAPZIMEOS is being prescribed nationwide across both major medical centers and community practices, with patients spanning a range of disease severities actively receiving treatment. Building on strong community practice demand, the Company’s target footprint has been expanded beyond the initial list, with increased engagement across community practices reflecting the broad interest seen since the full deployment of the PAPZIMEOS field team in September 2025.

· Patient hub enrollment: Enrollment in Precigen’s patient hub reached approximately 400 registered patients, reflecting robust and growing demand from both patients and physicians. Notably, 25% of hub-enrolled patients are from the community setting, underscoring the broad reach of PAPZIMEOS beyond academic and major centers and reinforcing that PAPZIMEOS can be effectively integrated into routine clinical practice beyond major centers. Beyond hub enrollment, the Company’s field teams continue to identify additional patients outside the hub, further underscoring the breadth of unmet need and commercial opportunity in the RRP community.

· Positive payer coverage: PAPZIMEOS has private health plan coverage spanning approximately 215 million US lives, including the significant majority of leading insurers. With additional coverage under Medicare and Medicaid, PAPZIMEOS is accessible to an estimated 297 million US lives, or over 90% of insured lives in the US, reflecting broad and growing payer support for the therapy.

· Permanent J-code accelerating site activations and patient access: Effective April 1, 2026, the Centers for Medicare and Medicaid Services assigned a permanent J-code (J3404) to PAPZIMEOS, and early indicators suggest this is already streamlining site activations. J-codes are standardized reimbursement codes that enable healthcare providers to bill government and commercial insurers for physician-administered therapies, and the permanent J-code designation is expected to further simplify claims processing and facilitate broader patient access across both medical centers and community practices.

· PAPZIMEOS recommended as standard of care first-line treatment: In January 2026, an expert position paper sponsored and published by the Recurrent Respiratory Papillomatosis Foundation and authored by 16 leading physicians in the field of RRP recommended PAPZIMEOS as the new standard of care first-line treatment for adults with RRP in the US.

· Upcoming ASCO (Free ASCO Whitepaper) clinical presentation: The Company will present updated durability of response data at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place in Chicago from May 29 to June 2, 2026, with a presentation titled "Zopapogene imadenovec-drba, a novel non-replicating adenoviral vector-based immunotherapy: Effects on complete and durable responses in recurrent respiratory papillomatosis pivotal trial."

· Strong presence at key medical and scientific meetings: At AAO-HNSF 2025, SITC (Free SITC Whitepaper) 2025, EUROGIN 2026, and COSM 2026, the Company presented long-term durable complete responses with PAPZIMEOS, and at ISPOR Europe 2025, the Company published data demonstrating the substantial healthcare resource utilization and patient-reported quality-of-life burden of RRP, underscoring the disease’s significant clinical, economic, and human impact.

· Redosing study enrolling patients: The Company’s open-label study to evaluate safety, vector shedding, and retreatment efficacy of zopapogene imadenovec-drba in adults with RRP is currently enrolling (clinical trial identifier: NCT06538480).

· MAA under review by the EMA: Following submission in November 2025, the Marketing Authorization Application for PAPZIMEOS for the treatment of adults with RRP was validated by the European Medicines Agency and is under review. PAPZIMEOS was granted orphan drug designation by the European Commission.

· RRP Awareness Day 2026: For the third consecutive year, Precigen will collaborate with the Recurrent Respiratory Papillomatosis Foundation to co-host RRP Awareness Day on June 11. The annual initiative is dedicated to educating the public and medical community about RRP by amplifying the voices of patients, caregivers, advocates, and the healthcare community supporting them.

PRGN-2009 AdenoVerse Immunotherapy in HPV-associated Cancers

PRGN-2009 is an investigational AdenoVerse immunotherapy designed to activate the immune system to recognize and target HPV-associated cancers.

· PRGN-2009 Phase 2 clinical trials under a cooperative research and development agreement (CRADA) with the National Cancer Institute (NCI) in newly diagnosed HPV-associated oropharyngeal cancer are ongoing.
· A multicenter Phase 2 clinical trial of PRGN-2009 in combination with pembrolizumab in recurrent/metastatic cervical cancer is ongoing.
· The Company plans to highlight progress across its AdenoVerse portfolio, including an update on PRGN-2009, by end of year.

FINANCIAL HIGHLIGHTS

"We are pleased with the launch performance of PAPZIMEOS, recognizing $21.6 million of net revenue in the first full quarter of its launch. In the second quarter of 2026, we are seeing continued strength in revenue growth from PAPZIMEOS," said Harry Thomasian Jr., Chief Financial Officer of Precigen. "As of March 31, 2026, the Company’s cash, cash equivalents, and investments totaled $56.7 million, which based on payment terms, did not include any collection of PAPZIMEOS related accounts receivable since launch of approximately $25.7 million. Based on our current revenue outlook and present financial forecast, we continue to believe that our current cash position and anticipated cash to be received from PAPZIMEOS sales will fund operations through cash flow break-even by the end of 2026. Our forecasted expenditures include additional investments to progress both clinical and pre-clinical assets."

First Quarter 2026 Financial Results Compared to Prior Year Period

Total revenues increased by $21.9 million compared to the three months ended March 31, 2025. The significant increase in total revenues for the three months ended March 31, 2026 was due to the ramp up of commercial sales of PAPZIMEOS following its FDA approval in August 2025. Revenues related to the sale of PAPZIMEOS for the three months ended March 31, 2026 were $21.6 million. No PAPZIMEOS sales were recorded for the three months ended March 31, 2025, as the product had not yet been approved.

R&D expenses decreased by $4.8 million compared to the three months ended March 31, 2025, primarily due to the change in the accounting treatment of manufacturing costs as a result of the FDA approval of PAPZIMEOS.

Selling, general, and administrative (SG&A) expenses increased by $8.7 million compared to the three months ended March 31, 2025. This increase was primarily driven by commercial activities related to PAPZIMEOS following its FDA approval in August 2025.

Total other expense, net, decreased by $29.6 million compared to the three months ended March 31, 2025. This change was primarily attributable to the absence of a $32.5 million charge related to the increase in the fair value of warrant liabilities that was recorded in the prior-year period. The remaining change (an increase in other expense) primarily relates to an increase of $2.9 million in interest expenses related to long term debt that originated in the third quarter of 2025.

Net loss was $7.9 million, or $0.02 per basic and diluted share, for three months ended March 31, 2026, compared to a net loss of $54.2 million, or $0.18 per basic and diluted share, for the three months ended March 31, 2025.

(Press release, Precigen, MAY 13, 2026, View Source [SID1234665638])

Takeda Announces FY2025 Full Year Results and FY2026 Outlook, Highlighted by Excellent Pipeline Progress and Solid FY2025 Results

On May 13, 2026 Takeda (TOKYO:4502/NYSE:TAK) reported financial results for the fiscal year 2025 (period ended March 31, 2026). The Company delivered solid results in line with its latest FY2025 Management Guidance, reflecting strong OPEX savings, mitigating revenue headwinds while continuing to invest in future growth.

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Key Highlights for FY2025

Revenue decreased by 1.7% YoY at actual exchange rates (AER), resulting from the loss of exclusivity for VYVANSE which was partially mitigated by Growth and Launch Products. On a Core basis, Revenue decreased by 2.6% at Constant Exchange Rate (CER).
Core Operating Profit increased by 0.8% YoY at AER and declined by 0.9% at CER, protected by OPEX savings, while still investing for growth.
Reported Operating Profit increased by 19.3% YoY at AER, also reflecting a step-down in amortization expenses for VYVANSE and lower restructuring expenses.
Core EPS increased by 5.2% YoY at AER and by 3.1% at CER, while reported EPS increased by 78.1% YoY.
Adjusted Free Cash Flow amounted to JPY 684.5 billion, in line with forecast, and the Company ended fiscal year with strong cash balance.
Delivered key milestones for oveporexton, rusfertide, and zasocitinib, with positive Phase 3 readouts; completed regulatory submissions for oveporexton and rusfertide, and launch preparations underway.
Takeda Chief Executive Officer (CEO)-elect, Julie Kim, commented:
"FY2025 was a pivotal year, validating the strength of our execution against demanding development and regulatory milestones, the resilience of our commercial portfolio and our strong position with three major launches planned in the next 12 months and the most robust late-stage pipeline in our history. Our growth roadmap is built around two strategic horizons: transforming for growth through near-term launches and strengthening competitiveness and accelerating growth by transitioning to a new cohort of blockbuster brands, together positioning us for long-term profitable growth and patient impact."

Takeda Chief Financial Officer, Milano Furuta, commented:
"In FY2025, despite topline headwinds, we delivered solid profit and cash flow through disciplined cost control, while directing growth investment toward new product launches and the pipeline. In FY2026, we will continue to focus on transforming operations and protecting profitability while delivering successful launches and advancing our pipeline. Strong cash flow generation and deleveraging will support long-term investment for growth acceleration and ensure competitive returns for our shareholders."

Full-year FY2026 Forecast and Guidance
Based on the current business outlook and planned investment profile, Takeda issued the following FY2026 forecast and management guidance.

(Billion yen, except percentages and per share amounts)

Item

FY2026
FORECAST

FY2026

MANAGEMENT GUIDANCE

Core Change at CER

(Non-IFRS)

Revenue

4,640.0

Core Revenue (Non-IFRS)

4,640.0

Low- single digit % decline

Operating Profit

420.0

Core Operating Profit (Non-IFRS)

1,160.0

5% ~ 8% decline

Net Profit

166.0

EPS (Yen)

104

Core EPS (Yen (Non-IFRS)

472

Mid-teens % decline

Adjusted Free Cash Flow (Non-IFRS)

650.0-750.0

Annual Dividend per Share (Yen)

204

Pipeline Achievements Set the Stage for Future Growth
Our three leading late-stage assets are positioned for regulatory approvals in the U.S. and other geographies in FY2026-2027. We expect this will be a pivotal period for launches and investment with clear near-term wins and proof points over the next 12–24 months.

oveporexton:

Oveporexton is potentially a first-of-its-kind orexin agonist designed to address the underlying orexin deficiency that causes narcolepsy type 1.
Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for oveporexton in the second half of 2026 and has also completed regulatory filings in Japan and China.
rusfertide:

Rusfertide is a potential first‑in‑class hepcidin mimetic that has demonstrated rapid, stable, and durable hematocrit control in patients with polycythemia vera, or PV, and has the potential to shift the standard of care in this blood cancer.
Granted Priority Review by the U.S. FDA, Takeda is preparing for a U.S. commercial launch for rusfertide in the second half of 2026.
zasocitinib:

Zasocitinib is poised to be a leading oral treatment option for psoriasis patients with the potential to significantly expand the oral segment in a growing psoriasis market.
Takeda is making decisive investments to support a planned regulatory filing in 2026 and a commercial launch in the first half of 2027.
FINANCIAL HIGHLIGHTS for FY2025 Ended March 31, 2026

(Billion yen, except percentages and per share amounts)

Item

FY2025

(Billion JPY)

FY2024

(Billion JPY)

YoY Growth

(AER)

Revenue

4,505.7

4,581.6

-1.7%

Operating Profit

408.8

342.6

+19.3%

Margin

9.1%

7.5%

+1.6pp

Net Profit

191.8

107.9

+77.7%

EPS (Yen)

122

68

+78.1%

Operating Cash Flow

1,041.4

1057.2

-1.5%

Adjusted Free Cash
Flow (Non-IFRS)

684.5

769.0

-11.0%

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

Item

FY2025

(Billion JPY)

FY2024

(Billion JPY)

YoY Growth

(AER)

YoY Growth

(CER)

Revenue

4,505.7

4,579.8

-1.6%

-2.6%

Operating Profit

1,172.5

1,162.6

+0.8%

-0.9%

Margin

26.0%

25.4%

+0.6pp

Net Profit

814.1

775.6

+5.0%

+2.9%

EPS (Yen)

517

491

+5.2%

+3.1%

Capital Allocation and Shareholder Returns
Takeda maintains a disciplined capital allocation framework that prioritizes investments in new launches and R&D innovation to drive growth and enables the company to deliver returns to shareholders under its progressive dividend policy. In FY2025, the proposed annual dividend was JPY 200 per share, and year-end adjusted net debt/adjusted EBITDA was 2.6x.

Additional Information About Takeda’s FY2025 Results
Takeda will host a conference call for investors and analysts on Wednesday, May 13, 2026, at 7:00 PM JST / 6:00 AM EDT to discuss its full-year 2025 financial results.

A live webcast of the conference call, along with presentation materials, will be available on the investor relations section of Takeda’s website at www.takeda.com/investors. The presentation will contain further details on Takeda’s FY2025 results, commercial progress, pipeline updates, and other financial information, including key assumptions for the FY2026 forecast and definitions of non-IFRS measures.

(Press release, Takeda, MAY 13, 2026, View Source [SID1234665654])

Abeona Therapeutics® Reports First Quarter 2026 Results and Provides Pipeline Update

On May 13, 2026 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results for the first quarter of 2026, highlighting commercial momentum for ZEVASKYN.

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Steady increase in ZEVASKYN adoption with three patients completing treatment in the first quarter of 2026, one treatment to date in the second quarter, one biopsy currently in manufacturing process, and six additional patients expected to be biopsied in the second quarter, three of whom have biopsies scheduled.
Qualified treatment center (QTC) network expands to six sites with the activation of New York-Presbyterian / Columbia University Irving Medical Center in New York, NY and Children’s Hospital of Philadelphia (CHOP).
Patient access to ZEVASKYN continues to grow with published coverage policies now in place for 95% of commercially insured U.S. lives.
Data presentation at SID2026 on sustained wound healing and long-term safety after one-time pz-cel application: 12-year case report and 5-year Phase 3 data
"We are excited that an increasing number of patients at our QTCs are getting scheduled for ZEVASKYN slots this quarter," said Vish Seshadri, PhD, President and CEO of Abeona Therapeutics. "We’re encouraged by the recent acceleration of onboarding efforts of QTCs to activate, so they can begin to treat patients with ZEVASKYN."

Pipeline Update

Building on its proven end-to-end competency in engineered cell therapy, Abeona will focus its development efforts on ABO-701, a recently licensed radically novel engineered T-cell therapy targeting Prostate-Specific Membrane Antigen (PSMA). PSMA is a validated target for advanced prostate cancer, which is a leading cause of cancer mortality, with more than 30,000 deaths annually in the U.S. despite multiple approved therapies and recent advances in the field.

ABO-701 is an autologous engineered T-cell therapy that carries a Synthetic Immune Receptor (SIR-T) designed to overcome the limitations of CAR and TCR approaches. The SIR-T platform underlying ABO-701 was developed by Preet M. Chaudhary, M.D., Ph.D., Professor of Medicine and Chief of Jane Ann Nohl Division of Hematology and Center for the Study of Blood Diseases at University of Southern California (USC) Keck School of Medicine and Director of USC Blood and Marrow Transplant and Cell Therapy Program. The patents covering the SIR-T platform are owned by Angeles Therapeutics, Inc. In pre-clinical studies, ABO-701 has demonstrated durable tumor control in mouse models and modest levels of cytokine release – a profile that has been elusive to other engineered cell therapies in the solid tumors.

Abeona expects to file an Investigational New Drug (IND) application and commence first-in-human studies with ABO-701 in the second half of 2027 while engaging a contract development and manufacturing organization for supply readiness in the meantime. This development plan and timing allow the Company to maintain its focus on commercializing ZEVASKYN.

As part of the Company’s portfolio optimization, Abeona has deprioritized its in-house ophthalmology programs.

First Quarter 2026 Financial Results

Abeona reported net product revenue of $8.7 million in the first quarter ending March 31, 2026. This represents a quarter-over-quarter increase in net product revenue of $6.3 million compared to $2.4 million in the fourth quarter of 2025.

Cost of sales for the first quarter of 2026 was $2.7 million, primarily driven by scaling of commercial ZEVASKYN. This represents a quarter-over-quarter increase in cost of sales of $1.7 million compared to $1.0 million in the fourth quarter of 2025, reflecting three patient treatments in the first quarter of 2026 versus one patient treatment in the prior quarter.

Total research and development (R&D) expenses were $9.6 million for the first quarter of 2026 compared to $9.9 million in the first quarter of 2025. The first quarter of 2026 includes a single up-front payment of $7.0 million for in-licensing of the PSMA-SIR-T asset, now ABO-701. Excluding this transaction, R&D spending decreased by $7.4 million. The reduction in expenses was primarily due to costs capitalized into inventory and engineering runs and other production costs that are no longer considered research and development due to FDA approval of ZEVASKYN in April of 2025.

Selling, general and administrative (SG&A) expenses for the first quarter of 2026 were $19.5 million, a $9.7 million increase over the first quarter of 2025. This increase primarily reflects Abeona’s commercial transition following the April 2025 FDA approval of ZEVASKYN, including $5.4 million in personnel and stock-based compensation, $1.9 million of certain engineering and training expenses previously classified as R&D that were transitioned to SG&A post-approval, and the remainder due to other commercial costs related to ZEVASKYN.

Net loss was $(17.1) million for the quarter ending March 31, 2026, or $(0.30) per basic and diluted common share. Net loss for the first quarter of 2025 was $(12.0) million, or $(0.24) per basic and diluted common share.

Cash, cash equivalents and short-term investments totaled $168.3 million as of March 31, 2026, compared to $191.4 million as of December 31, 2025.

Conference Call Details

The Company will host a conference call and webcast on Wednesday, May 13, 2026, at 8:30 a.m. ET to discuss its financial results and corporate progress. To access the call, dial 888-506-0062 (U.S. toll-free or, 973-528-0011 (international) and Entry Code: 305519 five minutes prior to the start of the call. A live, listen-only webcast with slides can be accessed on the Investors & Media section of Abeona’s website at View Source An archived webcast replay will be available for 30 days following the call.

(Press release, Abeona Therapeutics, MAY 13, 2026, View Source [SID1234665620])