On May 12, 2026 Prelude Therapeutics Incorporated (Nasdaq: PRLD), a clinical-stage precision oncology company, reported its financial results for the first quarter ended March 31, 2026 and provided an update on its R&D pipeline and other corporate developments.

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"Through this first quarter of 2026, our company has continued to demonstrate focused execution of the strategic priorities we set forth late last year." stated Kris Vaddi, Ph.D., Chief Executive Officer of Prelude. "Since the beginning of this year, we’ve advanced PRT12396 into first-in-human studies, presented promising preclinical data from our highly selective KAT6A degrader development candidate, continued to progress towards a development candidate from our mCALR program and importantly, extended our cash runway into the second quarter of 2028."

Program Updates and Upcoming Milestones

Mutant selective JAK2V617F JH2 inhibitor program

JAK2V617F is the primary driver mutation responsible for disease progression in the majority of patients living with myeloproliferative neoplasms (MPNs). The mutation impacts approximately 95% of patients with polycythemia vera (PV), 60% of patients with essential thrombocythemia (ET) and 55% of patients with myelofibrosis (MF). Identifying JAK2 JH2 inhibitors that selectively target V617F+ cells has long been the goal for advancing the treatment of MPNs.

Prelude has designed and identified novel allosteric inhibitors that bind into the JAK2 JH2 "deep pocket" where the V617F mutation resides. These candidates demonstrate mutant specific inhibition in multiple preclinical models of MPNs. Prelude believes this approach may have the potential to reduce mutant allele burden, slow or even reverse disease progression, and transform treatment outcomes for MPN patients.

PRT12396, Prelude’s lead, mutant-selective JAK2V617F inhibitor received IND clearance from the U.S. Food and Drug Administration, as previously announced in February 2026 and recently initiated and commenced enrollment into a Phase 1 study of PRT12396 in patients with PV and MF.

The JAK2V617F inhibitor program is subject to an exclusive option agreement with Incyte announced in November 2025.

Highly selective KAT6A oral degrader program

KAT6 is an emerging and recently validated target in the treatment of ER+ breast cancer. Prelude discovered and is developing first-in-class, highly potent, highly selective and orally bioavailable KAT6A selective degraders. The Company has selected a development candidate, PRT13722 and remains on track to file an IND application in mid-2026, and pending clearance, phase 1 study initiation expected in the 2nd half of 2026. Prelude believes that selectively degrading KAT6A has the potential for improved efficacy, tolerability and combinability with other agents relative to non-selective inhibitors of KAT6A/B.

The Company presented preclinical data supporting this hypothesis at the AACR (Free AACR Whitepaper) Annual Meeting 2026. The presentation can be found at Publications – Prelude Therapeutics.

Degrader payloads for next generation DACs

Prelude is leveraging our expertise in targeted protein degradation to discover and develop novel degrader payloads for use with next generation DACs. We have developed highly potent SMARCA2/4 and CDK9 degrader payloads optimized for efficacy, tolerability and developability when coupled to a wide range of different antibodies. Building on our existing DAC partnership with AbCellera, the Company’s payloads and corresponding payload-linkers are available for licensing to additional partners to expand the reach of this new technology.

We have recently published preclinical data demonstrating that next generation DACs using Prelude degrader payloads have potential for significantly better in vivo efficacy and tolerability compared to traditional cytotoxic ADCs when tested head-to-head in xenograft models. These data can be found at: Publications – Prelude Therapeutics

Mutated calreticulin (mCALR) DAC discovery program

Mutant CALR is a neoantigen presented on the cell surface of malignant myeloid cells but not normal cells and is found in approximately 25-35% of patients with MF and essential thrombocythemia (ET). Recently, a mCALR-targeted monoclonal antibody demonstrated robust clinical activity in high-risk ET patients. Prelude is exploring mCALR-targeted DACs using the Company’s proprietary degrader payloads as a differentiated approach for patients with CALR mutations. This early discovery program is wholly owned and controlled by Prelude.

The Company presented the preclinical data from the program at the European Hematology Association (EHA) (Free EHA Whitepaper) 2025 Congress in June and the American Society of Hematology (ASH) (Free ASH Whitepaper) 67th Annual Meeting in December 2025. The presentations can be found at Publications – Prelude Therapeutics.

Corporate Updates

In April 2026, the Company announced the appointment of Charles Morris, M.D. as Chief Medical Officer.

Upcoming Investor Conferences

The Company will participate in the 2026 Jefferies Global Healthcare Conference taking place in New York City. On Wednesday, June 3, 2026 at 12:15 PM ET, Kris Vaddi, Ph.D., Chief Executive Officer, Peggy Scherle, Ph.D., Chief Scientific Officer and Bryant Lim, Chief Financial Officer will participate in a fireside chat.

The Company will also participate in the Goldman Sachs 47th Annual Global Healthcare Conference taking place in Miami, FL. On Wednesday, June 10, 2026 at 11:20 AM ET, Kris Vaddi, Ph.D., Chief Executive Officer, Peggy Scherle, Ph.D., Chief Scientific Officer and Bryant Lim, Chief Financial Officer will participate in a fireside chat.

First Quarter 2026 Financial Results 

Cash, Cash Equivalents, Restricted cash and Marketable securities:

Cash, cash equivalents, restricted cash and marketable securities as of March 31, 2026 were $84.8 million. Subsequent to March 31, 2026, the Company completed an underwritten offering with gross proceeds of approximately $90 million. Based on preliminary estimates, the Company anticipates that its existing cash, cash equivalents, restricted cash and marketable securities will fund Prelude’s operations into the second quarter of 2028.

Research and Development (R&D) Expenses:

For the three months ended March 31, 2026, R&D expense decreased to $13.6 from $28.8 million for the prior year period. Included in the R&D expense for the three months ended March 31, 2026 was $1.1 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $2.3 million for the three months ended March 31, 2025. Along with the decrease in stock-based compensation expense, the decrease was primarily related to lower expense incurred for our SMARCA2 clinical trials which we paused in 2025. Research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial-related activities.

General and Administrative (G&A) Expenses:

For the three months ended March 31, 2026, G&A expenses decreased to $5.2 million from $5.8 million for the prior year period. Included in general and administrative expenses for the threemonths ended March 31, 2026, was $0.9 million of non-cash expense related to stock-based compensation expense, including employee stock options, compared to $1.6 million for the three months ended March 31, 2025. The decrease in general and administrative expenses was primarily due to a decrease in stock-based compensation along with a decrease in employee-related expenses.

Net Loss:

For the three months ended March 31, 2026, net loss was $10.4 million, or $0.13 per share compared to $32.1 million, or $0.42 per share, for the prior year period. Included in the net loss for the three months ended March 31, 2026, was $2.0 million of non-cash expenses related to the impact of expensing share-based payments, including employee stock options due in part to fewer employees, as compared to $3.8 million for the same period in 2025.

(Press release, Prelude Therapeutics, MAY 12, 2026, View Source [SID1234665555])

On May 12, 2026 Insilico Medicine ("Insilico", 03696.HK), a biotechnology company powered by generative artificial intelligence, reported that the company has entered a strategic collaboration agreement with Suzhou Ribo Life Science Co., Ltd. ("Ribo", 06938.HK), a globally leading clinical-stage company in oligonucleotide therapeutics. Building upon the automation, intelligence and scalability capabilities of Insilico’s LifeStar 2 laboratory, the two parties will further deepen the existing experimental service cooperation, combining the end-to-end R&D capabilities of Insilico’s proprietary Pharma.AI platform with Ribo’s profound expertise in oligonucleotide therapeutics development, aiming for comprehensive efficiency boost in the oligonucleotide drug R&D cycle.

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"We are now in a new era of AI-guided clinical research and development. Insilico Medicine and Ribo are highly aligned in terms of innovation capabilities, as well as missions and visions in our respective fields, and we are very pleased to see our previous successful collaboration grow into this comprehensive strategic cooperation," said Li-Ming Gan, co-CEO & Global R&D President of Ribo. "Through years of technological advancements and existing AI tools, Ribo has entered a track of rapid development with intensive output of drug candidates and efficient advancement of clinical trials. Now empowered by Insilico Medicine’s globally leading AI solution, we anticipate an even more powerful catalyst for our differentiated strategic development stage. We look forward to sparking innovation through close cooperation between both parties, further enhancing the efficiency and certainty of our drug development, and accelerating AI-driven oligonucleotide therapies to benefit all of humanity."

"We are very pleased to sign this strategic cooperation agreement with Ribo today. Insilico and Ribo have maintained close communication and mutual trust. Also, it is worth noting that Ribo is the first partner on high-throughput experimental services of our LifeStar 2 automated laboratory platform, demonstrating the industrial empowerment of our automated laboratory platform," said Feng Ren, PhD, Co-CEO and CSO of Insilico Medicine. "With the continuous innovation of AI algorithms, Insilico Medicine’s Pharma.AI platform has recently introduced multiple major upgrades. Through in-depth discussions, both parties have reached consensus on cooperation opportunities, where we can leverage the Pharma.AI platform to empower multiple scenarios in oligonucleotide drug development. We will work together to enable end-to-end empowerment, further expand the boundaries of AI empowerment, and strive to meet unmet clinical needs."

Ribo (06938.HK) is a global pioneer in the development of oligonucleotide-based therapeutics. It has established a vertically integrated R&D platform with a comprehensive suite of technologies that support the entire lifecycle of oligonucleotide therapeutics, and a diversified pipeline portfolio covering multiple major and chronic disease areas including cardiovascular, metabolic, renal, and liver diseases. Ribo’s proprietary RiboGalSTAR liver-targeting technology platform has advanced seven products to clinical stages, with efficacy and safety well validated in clinical trials. Meanwhile, its RiboPepSTAR technology platform has made significant progress in extra hepatic areas such as kidney, cardiac, metabolism, and adipose tissue. Through partnerships valued over USD 6 billion with multiple MNCs, Ribo has its R&D platform and scientific capabilities highly recognized by the international market.

As a globally leading AI-powered drug discovery technology company, Insilico Medicine has enabled Rentosertib, the drug candidate with AI-driven novel target and AI-empowered innovative structure with Pharma.AI, the proprietary end-to-end AI drug discovery platform, and delivered the first proof of concept (POC) in a Phase IIa clinical trial. Based on continuous advancements of Pharma.AI, Insilico has established over 40 proprietary innovative pipelines and keeps expanding into new modality areas such as peptides, antibody-drug conjugates (ADC), and proteolysis-targeting chimeras (PROTAC).

In the field of oligonucleotide therapeutics development, AI is already playing a considerable role in processes including target screening and identification, and data modeling and simulation. Through evaluation of target clinical effects in large patient databases, AI supports prediction of clinical efficacy and safety, improving the efficiency and certainty of clinical research. The cooperation will combine Insilico’s AI system covering the entire drug development process with Ribo’s three-dimensionally integrated oligonucleotide therapeutics development platform to enhance efficiency at various research stages and accelerate the R&D process of innovative oligonucleotide therapeutics.

(Press release, Insilico Medicine, MAY 12, 2026, View Source [SID1234665571])

On May 12, 2026 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a clinical-stage company focused on developing promising new therapies in oncology and obesity, reported a corporate update and announced financial results for the 2026 first quarter ended March 31, 2026.

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"We’ve continued to build strong momentum with CRB-701 and CRB-913, setting the stage for rapidly approaching inflection points for both the oncology and obesity programs," said Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.

"Having reached broad alignment with the FDA, we’re on track to start a registrational study for CRB-701 in second-line HNSCC this summer. We’ll report updated data at ASCO (Free ASCO Whitepaper) 2026 that will provide clear insight into CRB-701’s differentiated profile in 2L HNSCC and its upcoming registrational study. We’ll also present updated data in 2L cervical cancer, a patient population with few treatment options. Turning to obesity, we have reached last patient/first visit in our CANYON-1 Phase 1b study and are on schedule to report 16-week, 240-patient data for CRB-913 this summer. CRB-913 represents a unique oral obesity drug with a non-GLP-1 and non-incretin mechanism of action and has the potential for weight loss and long-term weight management. We’re excited about CRB-913’s promise to deliver an orthogonal drug class into the obesity treatment landscape."

Key Corporate and Program Updates

CRB-701 is a next-generation, highly stable Nectin-4 targeting antibody drug conjugate (ADC) being developed to treat HNSCC and cervical cancer. The U.S. Food and Drug Administration (FDA) has granted Fast Track designations to CRB-701 for the treatment of both cancer types. CRB-701 is licensed from CSPC Megalith Biopharmaceutical Co. Ltd. China.

Announced broad alignment with the FDA on the registration path for CRB-701 in HNSCC and cervical cancers and continued interactions with the FDA to finalize the protocols and statistical analysis plans for the registrational studies.
Anticipated catalysts for CRB-701 in 2026:
Report monotherapy data from the Phase 1/2 study of CRB-701 in both HNSCC and cervical cancers at the upcoming 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. Link here for press release with more details.
Initiate a registrational study for CRB-701 in second-line HNSCC this summer.
Report CRB-701 + Keytruda combination data in first-line HNSCC patients in early Q1 2027 to support potential further registration-enabling trials.

CRB-913 is a highly peripherally restricted oral CB1 inverse agonist for the treatment of obesity.

Completed enrollment of last patient and completion of the first clinical visit in the Company’s CANYON-1 Phase 1b clinical trial of CRB-913 for the treatment of obesity. The CANYON-1 study follows patients over a 12-week treatment period followed by a 4-week safety follow-up and is on track to be completed in the summer of 2026.
Anticipated catalyst for CRB-913 in 2026:
Report topline CANYON-1 Phase 1b dose-ranging 16-week study (n=240) in summer 2026.

Financial Results for the Quarter Ended March 31, 2026

The Company reported a net loss of approximately $23.0 million, or a net loss per basic and diluted share of $1.23, for the three months ended March 31, 2026, compared to a net loss of approximately $17.0 million, or a net loss per basic and diluted share of $1.39, for the three months ended March 31, 2025.

Operating expenses increased by $4.5 million to approximately $24.3 million for the three months ended March 31, 2026, compared to approximately $19.8 million for the three months ended March 31, 2025. The increase was primarily attributable to an increase in clinical development expenses.

The Company had $138.2 million of cash, cash equivalents, and investments on hand as of March 31, 2026, which is expected to fund operations into 2028 based on current operating plans and planned expenditures.

(Press release, Corbus Pharmaceuticals, MAY 12, 2026, View Source [SID1234665531])

On May 12, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for cancer, reported first quarter 2026 financial results and provided a corporate update.

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"In its first full quarter of commercial availability, KOMZIFTI generated $5.8 million in net revenue, with early launch dynamics indicating growing physician adoption and utilization patterns based on product profile. We believe these early signals support KOMZIFTI’s potential to become the leading therapy in relapsed/refractory NPM1-mutant AML," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "Supported by a robust clinical development program designed to establish it as a broadly combinable backbone across the AML treatment continuum, and with multiple data readouts expected this year across frontline and combination settings, we are well positioned for the next phase of growth."

Recent Developments

KOMZIFTI Launch Performance (First Quarter 2026)

KOMZIFTI delivered a strong first full quarter of commercial performance, with early indicators supporting adoption and continued momentum:

$5.8 million in net product revenue in the first full quarter of commercial sales

85 new patient starts and 157 total prescriptions, reflective of both uptake and repeat use

> 93% payer coverage achieved, with favorable positioning across plans covering more than 12 million lives
Early market dynamics, including repeat prescribing, expanding use across treatment settings, initial combination use and instances of switching from other menin inhibitors, indicate growing physician adoption based on product profile.

Advancing Ziftomenib Across the Acute Myeloid Leukemia (AML) Treatment Continuum

Kura continues to execute on its strategy to establish ziftomenib as a broadly combinable backbone therapy across AML:

KOMET-017 (Phase 3 Frontline Program): Ongoing site activation and patient enrollment for both studies across global sites with strong early progress

KOMET-008 (FLT3 Relapsed/Refractory [R/R] Population): Ongoing enrollment evaluating ziftomenib combined with gilteritinib in patients with R/R AML harboring FLT3-ITD/NPM1 co-mutations

KOMET-007 (FLT3 Frontline Population): Ongoing enrollment evaluating ziftomenib combined with quizartinib plus cytarabine and daunorubicin (7+3) induction chemotherapy in patients with newly diagnosed AML harboring FLT3-ITD/NPM1 co-mutations

Japanese Registrational Trial: First patient dosed in Phase 2 trial (jRCT2031250550) for treatment of R/R NPM1-m AML, representing a significant step toward bringing a potential new treatment option to patients in Japan
Multiple clinical data readouts expected in 2026 across combination regimens and treatment settings, supporting ziftomenib’s potential use broadly across the AML landscape.

Solid Tumor Pipeline Progress

Kura continues to advance darlifarnib as a novel approach to overcoming resistance in targeted therapy:

Proof-of-mechanism data for darlifarnib in combination with cabozantinib: At the 2026 International Kidney Cancer Symposium: Europe (IKCS) conference, Kura presented proof-of-mechanism data for darlifarnib in combination with cabozantinib in patients with clear cell renal cell carcinoma previously treated with cabozantinib

The data support darlifarnib’s potential to overcome resistance and resensitize tumors to VEGF TKI therapy, with
44% objective response rate (ORR)
94% disease control rate (DCR)
Tumor shrinkage in 75% of patients
FIT-001 Phase 1b dose expansion: Enrollment is ongoing
2026 Commercial Priorities and Anticipated Development Milestones

Kura expects multiple value-driving catalysts in 2026 across commercial development and clinical development:

KOMZIFTI Commercial Execution

Drive clear differentiation within the menin inhibitor class
Deliver sustained quarter-over-quarter growth in revenue and adoption
Establish leading class share in R/R NPM1-m AML
Ziftomenib – Frontline AML

Present updated results for ziftomenib / 7+3 combination in frontline NPM1-m/KMT2A-r AML (KOMET-007) in an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in June 2026
Ziftomenib – Relapsed/Refractory AML

Publish data for ziftomenib plus venetoclax + azacitidine in R/R NPM1-m AML (1H 2026)
Present preliminary KOMET-008 data for ziftomenib and gilteritinib combination in R/R NPM1-m/FLT3-m AML (2H 2026)
Ziftomenib and Menin Inhibition – Expansion Beyond AML

Continue enrollment of KOMET-015 evaluating ziftomenib + imatinib in gastrointestinal stromal tumors (GIST)
Progress preclinical development of next-generation menin inhibitor for use in other solid tumors
Darlifarnib

Present preliminary clinical data for darlifarnib plus adagrasib in KRASG12C-mutated solid tumors at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in May 2026
Present updated Phase 1a data with the first report of long-term follow-up for darlifarnib plus cabozantinib in advanced RCC (2H 2026)
KO-7246 (Next-Generation Menin Inhibitor)

Advance KO-7246 into IND-enabling studies for diabetes and cardiometabolic disease
Present additional preclinical data for menin inhibitors in diabetes
First Quarter 2026 Financial Results

Net product revenue: $5.8 million, compared to none for Q1 2025
Collaboration revenue: $12.5 million, compared to $14.1 million for Q1 2025
R&D expenses: $65.3 million, compared to $56.0 million for Q1 2025, primarily driven by advancement of ziftomenib combination trials, including KOMET-017
SG&A expenses: $31.6 million, compared to $22.8 million for Q1 2025, reflecting commercialization-related investments
Net loss: $73.3 million, compared to $57.4 million for Q1 2025. Net loss includes $8.4 million in non-cash, share-based compensation expense compared to $7.8 million for the same period in 2025.
As of March 31, 2026, Kura had $580.8 million in cash, cash equivalents and short-term investments, compared to $667.2 million as of December 31, 2025.

The Company believes its cash, cash equivalents and short-term investments as of March 31, 2026, when combined with $180 million in anticipated payments under the collaboration agreement with Kyowa Kirin, will be sufficient to fund the ziftomenib AML program through the topline results from the first pivotal Phase 3 KOMET-017 frontline trial, anticipated in 2028.

Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, May 12, 2026, to discuss financial results and to provide a corporate update. A live webcast and archived replay of the event will be available here or from the Investors section of the Company’s website at www.kuraoncology.com.

(Press release, Kura Oncology, MAY 12, 2026, View Source [SID1234665544])

On May 12, 2026 The Board of Directors of Recordati S.p.A. approved the Group’s Interim Report as of 31st March 2026, representing additional voluntary financial reporting. The report was prepared using the assessment, measurement and recognition criteria prescribed by international accounting standards (IFRS). The financial statements as of 31st March 2026 will be available by 15th May 2026 at the company’s offices and on the company’s website (www.recordati.it) and can also be viewed on the authorised storage system 1Info (www.1Info.it).

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Rob Koremans, Chief Executive Officer of Recordati, commented: "Recordati has delivered a strong start to the year, driven by excellent momentum in Rare Diseases and resilient in-market growth of the Specialty & Primary Care promoted portfolio. We are pleased to report further progress in advancing our R&D pipeline. We see significant opportunity for pasireotide in PBH following positive Phase 2 results and are progressing sutimlimab into a Phase 3 study in ITP. Isturisa continues to perform very well, with ongoing expansion in the U.S. across both overt and non-overt Cushing’s syndrome populations. Overall, we remain well positioned to deliver on our strategic and financial objectives for 2026 and beyond."

Q1 2026 Financial highlights

Consolidated net revenue for the first quarter of 2026 was € 713.4 million, up 4.9% or 8.7% on a like-for-like(3) basis at CER (+7.9% excluding Türkiye) versus the first quarter of 2025. This was driven, in particular, by the strong momentum from the Rare Diseases business. The adverse FX impact for the first quarter of 2026 was € 29.1 million (-4.3%), mainly driven by the U.S. dollar and Turkish lira devaluation.

Rare Diseases revenue was € 292.4 million for the first quarter of 2026, up 14.8%, or 22.4% at CER as compared to the first quarter of 2025, driven by strong volume growth across the Endocrinology and Hemo-Oncology franchises. The Endocrinology franchise achieved net revenue of € 120.7 million, an increase of 38.1%, reflecting continued growth of Isturisa (€ 86.3 million, +56.8%), driven mostly by strong new patient uptake across geographies, particularly in the U.S., and growth of Signifor (€ 34.4 million, +6.3%). The Hema-Oncology franchise achieved net revenue of € 113.2 million, growing by 18.2%, reflecting the strong momentum of Enjaymo across geographies (€ 43.9 million, +37.6%) and Qarziba (€ 42.9 million, +13.9%), as well as growth of Sylvant (€ 22.8, million +1.8%). The Metabolic franchise achieved net revenue of € 58.5 million, a decrease of 18.3%, reflecting phasing of Carbaglu across geographies and slightly lower demand of Panhematin in the U.S. against a strong performance in the first quarter of 2025.

Specialty & Primary Care revenue was € 404.4 million for the first quarter of 2026, down 1.0% or up 0.2% on a like-for-like basis(3) at CER as compared to the first quarter of 2025(7), reflecting continued in-market growth of the promoted portfolio (+5%(8)) and some expected one-off headwinds. In particular, the Cardiovascular franchise achieved net revenue of € 113.7 million, an increase of 1.5%, and the Gastrointestinal franchise achieved net revenue of € 69.4 million, an increase of 2.1%, with continued good in-market performance of key products in both therapeutic areas. The Urology franchise achieved net revenue of € 104.4 million, a decrease of 4.3%, due to a high prior-year base following a product relaunch in Russia in 2025, and the Cough & Cold franchise achieved net revenue of € 29.6 million, a decrease of 12.8% due to a weaker season in key markets.

EBITDA(1) was € 283.6 million for the first quarter of 2026, up 5.0% compared to the first quarter of 2025, with margin of 39.7% of net revenue. Strong revenue performance and the positive mix effect at gross profit level was partially offset by a higher level of investments to support the U.S. expansion, primarily for Isturisa, the continued development of Enjaymo, ongoing geographic expansion in Rare Diseases as well as the launch of Vazkepa in Specialty & Primary Care.

Adjusted operating income(9) was €231.1 million in the first quarter of 2026, an increase of 5.4% versus the first quarter of 2025. This represents 32.4% of net revenue, compared with 32.2% in the prior year, supported by strong operating performance. Operating income was € 229.6 million in the first quarter of 2026, up 17.3% over the first quarter of 2025, reflecting gross margin-related non-cash charges of € 22.4 million in 2025, arising mostly from the unwind of the fair value step up of the acquired Enjaymo inventory. Non-recurring costs were € 1.5 million versus € 1.1 million in the first quarter of 2025.

Financial expenses were € 28.9 million, down by € 2.1 million compared to the previous year. Net exchange losses over the period were € 1.9 million, slightly higher as compared to losses of € 1.8 million in the first quarter of 2025. The impact of hyperinflation was negative € 2.0 million, the same as in the first quarter of 2025.

Adjusted net income(2) was € 188.1 million, 26.4% of net revenues, up by 7.2% compared to the same period of 2025, benefitting from higher adjusted operating income, lower financial expenses and a lower tax rate resulting from a positive country mix. Net income was € 153.1 million, 21.5% of net revenue, an increase of 22.4% versus the prior year, reflecting positive operating income, lower financial expenses and a lower income tax rate versus the first quarter of 2025.

Free cash flow(4) was € 92.1 million for the first quarter of 2026, a decrease of € 66.7 million versus the first quarter of 2025, reflecting higher EBITDA which was offset by higher working capital absorption and income taxes paid.

Net debt(5) as of March 31, 2026 was € 1,985.2 million, or leverage of just below 2.0x EBITDA, compared to net debt of € 2,037.3 million on December 31, 2025.

Shareholders’ equity was € 2,060.3 million.

Pipeline Development

The Phase 2 trial evaluating pasireotide for the treatment of post-bariatric hypoglycemia met its primary endpoint with a dose-dependent and significant increase in glucose levels during a standardized meal test (p<0.02)(10). This was associated with a lowering of level 2 and 3 hypoglycemia (not significant), particularly in patients with higher baseline hypoglycemia rates (post-hoc analysis). Recordati is scheduled to meet with the FDA to discuss potential next steps.

Immune thrombocytopenia (ITP) is a rare autoimmune disease, characterized by increased platelet destruction and decreased platelet production/release. Main symptoms include an increased risk of bleeding events, fatigue, decreased quality of life, increased risk of thrombosis (increased morbidity and mortality). Refractory ITP represents a significant unmet need, with around 20-30% failing several lines of therapy. On the basis of encouraging FDA feedback as well as early encouraging clinical evidence showing that sutimlimab, by targeting the classical complement pathway, can lead to a rapid and sustained platelet response in patients refractory to multiple lines of treatment, Recordati has decided to advance sutimlimab into a pivotal registrational Phase 3 trial for the treatment of chronic ITP.

The other lifecycle management programs are progressing in line with plans.

Corporate Development

On January 29, 2026, Recordati announced a collaboration and license agreement with Moderna to develop and commercialize worldwide mRNA-3927, an investigational product for the treatment of propionic acidemia (PA). Under the terms of the agreement, Moderna will continue to lead the development of mRNA-3927, in collaboration with Recordati, and if approved, Recordati will lead global commercialization. mRNA-3927 is a post proof-of-concept, investigational product aimed to restore propionyl-CoA carboxylase (PCC) enzyme activity in patients with propionic acidemia. If approved, this could be the first disease-modifying treatment option on the market for this severe disease. mRNA-3927 is currently being evaluated in a potential registrational clinical study. The target patient enrollment has been reached, with a potential data readout expected by the end of 2026.

Business outlook

The Group confirms its financial targets for full year 2026 as follows:

Net revenue between € 2,730 and € 2,800 million with FX headwind of ~-3.5%
EBITDA(1) between € 995 and € 1,030 million; margin of +/- 36.5% with FX headwind of ~-4.0%
Adjusted net income(2) between € 655 and € 685 million; margin of +/- 24.0%
The full year 2027 targets(11) remain unchanged, with strong organic growth complemented by bolt-on business development and M&A.

Additional resolutions

Performance share plan 2023-2025: assessment of the level of achievement of the performance targets for the first cycle (2023 grant)

With reference to the incentive plan of Recordati S.p.A. ("Recordati" or the "Company") named the "2023–2025 Performance Share Plan" (the "Plan"), approved by the Shareholders’ Meeting of the Company held on 21st April 2023, and to the related first award cycle resolved upon by the Board of Directors on 27th June 2023, notice is hereby given that, on today’s date, the Board of Directors of the Company, acting upon the proposal of the Remuneration and Appointments Committee, to the extent within its remit, and in accordance with the provisions of the relevant rules, has assessed the level of achievement of the performance targets relating to the first cycle of the Plan.

On 27th June 2026, being the date on which the vesting period will be completed, the beneficiaries’ entitlement to receive up to a maximum aggregate number of 388,630 ordinary shares of Recordati, granted free of charge pursuant to the Plan, will vest. Such number may be reduced in accordance with the terms and conditions of the Plan, including in the event of termination of the relationship with the Recordati Group prior to such date. Within the above maximum aggregate number, the shares attributable to the Chief Executive Officer of Recordati amount to no. 30,485.

For further information on the Plan (12), reference should be made to the relevant Information Document, which is available on the Company’s website in the "Governance" section, under "Remunerations".

Performance share plan 2026-2028: assignment of rights provided under the first cycle (subject to certain conditions)

With reference to the "2026–2028 Performance Share Plan" (the "Plan") of Recordati approved by its shareholders’ meeting on 29th April 2026, notice is hereby given that today the Board of Directors of the Company, upon proposal of the Company’s Remuneration and Nominations Committee – within the scope of its competence and in accordance with the provisions of the relevant regulations – resolved to grant to the beneficiaries of the Plan a total of no. 528,913 rights (the "Rights") to receive ordinary shares of the Company, which fall within the first allocation cycle of the Plan. The Chief Executive Officer of Recordati has been assigned no. 24,251 Rights.

The grant of the Rights will cease to have any effect in case the potential voluntary tender offer on all ordinary shares of the Company aimed at its delisting – communicated on 25 March 2026(13) by CVC to the Company by means of a conditional non-binding indication of interest – is launched and the delisting is completed by the date of the Annual General Meeting approving the 2026 financial statements.

For further information on the Plan (12), reference should be made to the relevant Information Document, which is available on the Company’s website in the "Governance" section, under "Remunerations".

(1) Net income before income taxes, financial income and expenses, depreciation, amortization and write-downs of property, plant and equipment, intangible assets and goodwill, non-recurring items and non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS.
(2) Net income excluding amortization and write-downs of intangible assets (except software) and goodwill, non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3, monetary net gains/losses from hyperinflation (IAS 29), net of tax effects.
(3) Proforma growth calculated excluding revenue of Vazkepa for Q1 2026 and Cardicor for Q1 2025 and Q1 2026 (Specialty & Primary Care).
(4) Total cash flow excluding financing items, milestones, dividends, purchases of treasury shares net of proceeds from exercise of stock options.
(5) Cash and cash equivalents, less bank debts and loans, which include the measurement at fair value of hedging derivatives.
(6) Italian Legislative Decree 25/2016, which implements Directive 2013/50/EU, no longer stipulates the submission of an interim management report, which was previously required in terms of paragraph 5 of Art. 154-ter of Legislative Decree 58/1998
(7) The 2025 figures have been restated to reflect the reclassification of certain brands from Other Therapeutic areas to Cardiovascular and Gastrointestinal areas in 2026. The amount of reclassification for Q1 2025 is as follows: €2.5 million from Other Therapeutic areas to Cardiovascular and €4.4 million from Other Therapeutic areas to Gastrointestinal.
(8) IQVIA Feb RQ-2026 vs Feb RQ-2025.
(9) Net income before income taxes, financial income and expenses and non-recurring items, non-cash charges arising from the allocation of the purchase price of acquisitions to the gross margin of acquired inventory as foreseen by IFRS 3.
(10) p=0.0106 (50 µg s.c. pasireotide vs placebo); p=0.0010 (100 µg s.c. pasireotide vs. placebo); p< 0.0001 (200 µg s.c. pasireotide vs placebo).
(11) FY 2027 targets: Net Revenue €3,000 – €3,200 million, EBITDA €1,140 – €1,225 million, Adjusted Net Income €770- €820 million, excluding potential impact from tariffs and/or most favored nation pricing policies in the U.S.
(12) Table no. 1 referred to in paragraph 4.24 of Annex 3A, Form 7, to the Issuers’ Regulation no. 11971/1999, will be published in the manner and within the timeframe set out in Article 84-bis, paragraph 5, letter a), of the same Issuers’ Regulation.
(13) Please refer to the press release issued by the Company on this regard on 26th March 2026.

Conference Call

Recordati will host a conference call on May 13th, at 2:00 p.m. CET (1:00 p.m. GMT+1) to present the results for the first quarter of 2026. Please find the pre-registration link here with all the dial-in details and a calendar invitation to follow.

Alternatively, if not pre-registered, the dial-in numbers for the conference call are:

Italy + 39 02 802 09 11, toll free 800 231 525
UK + 44 1 212818004, toll free (44) 0 800 0156371
USA +1 718 7058796, toll free (1) 1 855 2656958
France +33 1 70918704
Germany +49 6917415712

Participants are invited to dial in 10 minutes before the start of the conference call. If operator assistance is required to connect, please dial *0.

The slides that will be referenced during the call will be available at www.recordati.com under Investors/Company Presentations.

(Press release, Recordati, MAY 12, 2026, View Source [SID1234665556])