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])

On May 12, 2026 Halia Therapeutics, Inc., a clinical-stage biopharmaceutical company developing first-in-class therapies targeting the NLRP3 inflammasome and related inflammatory pathways, reported final Phase 2 results for ofirnoflast (HT-6184) in patients with lower-risk myelodysplastic syndrome (LR-MDS). The data will be presented in an oral session at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Hybrid Congress, June 11–14, 2026, in Stockholm, Sweden. The accepted abstract is available today on the EHA (Free EHA Whitepaper) Congress platform.

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The company also announced the appointment of Han Myint, MD, FACP, as Chief Medical Officer. Dr. Myint will lead Halia’s global clinical development, medical affairs, and safety strategy as the company prepares to advance ofirnoflast into pivotal development and progresses its broader pipeline grounded in human genetic resilience and innate immune biology.

Final Phase 2 Results to Be Presented at EHA (Free EHA Whitepaper)2026

The open-label, single-arm Phase 2 trial enrolled 37 adults with IPSS-R very low- to intermediate-risk MDS (score ≤4.5) who had symptomatic anemia or red blood cell (RBC) transfusion dependence and were refractory to, intolerant of, or ineligible for erythropoiesis-stimulating agents (ESAs). Ofirnoflast was administered orally at 2 mg once daily on a 5-days-on/2-days-off schedule for up to 32 weeks. The primary endpoint was hematological improvement (HI) per IWG 2018 criteria. Highlights from the accepted abstract include:

67% overall HI rate among 30 evaluable patients, with multilineage activity: 62% HI-E, 60% HI-P, and 50% HI-N
55% RBC transfusion independence for ≥8 weeks among transfusion-dependent patients (10/18), with 39% sustained for ≥16 weeks
Median duration of transfusion independence of 28.5 weeks
75% HI-E among non-transfusion-dependent patients (9/12)
Median hemoglobin rise of 4.5 g/dL in HI-E and transfusion-independence responders (range 0.1–7.1 g/dL)
No treatment-related serious adverse events; treatment-related adverse events occurred in 27% of patients, with a single Grade ≥3 event (hypertension)
Activity observed across WHO MDS subtypes and mutational backgrounds, including patients with and without SF3B1 or del(5q)
Additional efficacy, safety, biomarker, and quality-of-life data will be presented at the EHA (Free EHA Whitepaper)2026 Congress.

"These final Phase 2 results validate our approach of targeting upstream innate immune biology in lower-risk MDS," said David J. Bearss, Ph.D., President, Chief Executive Officer, and co-founder of Halia Therapeutics. "Ofirnoflast has demonstrated durable transfusion independence, multilineage hematological improvement, and a favorable safety profile in a patient population with significant unmet need."

Han Myint, MD, FACP Appointed Chief Medical Officer

Dr. Myint brings more than three decades of experience spanning academic medicine, biotechnology and global pharmaceutical organizations, with deep expertise in hematologic malignancies, oncology drug development and late-stage clinical strategy.

Dr. Myint is an internationally recognized hematologist-oncologist and biopharmaceutical executive with more than three decades of experience spanning academic medicine, biotechnology and large pharmaceutical organizations. Throughout his career, he has led the development of innovative therapies across solid tumors, hematologic cancers and cellular immunotherapy programs, with experience advancing candidates from early-stage research through regulatory approval and commercialization.

"The addition of Han to our leadership team strengthens our ability to execute the next phase of the ofirnoflast development program with clinical and regulatory execution, as we advance toward pivotal development," continued Bearss. "He is one of the rare leaders who has worked across malignant hematology, global drug development, academic medicine, and late-stage commercialization. His experience in myeloid diseases, pivotal trial strategy, and regulatory engagement is directly aligned with where Halia is headed."

Commenting on his appointment, Dr. Myint said, "I am excited to join Halia at such a pivotal moment. The ofirnoflast Phase 2 data support a differentiated therapeutic approach in lower-risk MDS, where patients continue to need new oral options that can improve hematopoiesis and reduce transfusion burden. Halia’s broader platform, rooted in human genetic resilience and innate immune biology, provides a compelling foundation for developing medicines across serious hematologic and inflammatory diseases. I look forward to advancing ofirnoflast and the pipeline through the next stages of clinical development."

About Han Myint, MD, FACP

Dr. Myint is a hematologist-oncologist and drug-development leader with more than 30 years of experience across academia, biotechnology, and global pharmaceutical organizations. Previously, he was Chief Medical Officer of NextCure, Inc., overseeing first-in-human and proof-of-concept oncology trials, and Chief Medical Officer of NexImmune, Inc., a clinical-stage developer of T cell–based immunotherapies.

Earlier in his industry career, Dr. Myint held senior leadership roles at Celgene Corporation (now part of Bristol Myers Squibb), including Global Myeloid Disease Lead and Co-Chair of the Global Myeloid Franchise Team, where he contributed to the development, approval, and global launch of therapies for myeloid diseases including Thalassemia, MF, MDS and AML.

Before transitioning to industry, Dr. Myint was an academic hematologist-oncologist and stem cell transplant physician. He served as Professor of Medicine and Director of Stem Cell Transplantation and the Hematological Malignancies Program at the University of Colorado, Denver, where he built a FACT-accredited and Center of Excellence-designated stem cell transplant program. He previously held academic leadership roles at Rush University Medical Center. Dr. Myint received his MBBS from the Institute of Medicine in Yangon and completed postgraduate training in internal medicine and hematology in the United Kingdom, followed by advanced hematology/oncology and stem cell transplantation training in the United States. He is a fellow of the Royal College of Pathologists, London, UK, Royal College of Physicians & Surgeons, Glasgow, Royal College of Physicians of Edinburgh, and American College of Physicians.

EHA2026 Presentation Details

Title: Ofirnoflast, a First-in-Class NEK7 Inhibitor, Induces Robust Transfusion Independence and Multilineage Hematological Improvement in Lower-Risk Myelodysplastic Syndrome (LR-MDS): Phase 2 Results
Abstract number: S174
Session: Oral Session s426 — Myelodysplastic Syndromes – Clinical
Presenting author: Varun Bafna, MD
Date and time: Friday, June 12, 2026, 17:15–18:30 CEST
Location: A2-3 Hall, Stockholmsmässan, Stockholm, Sweden, and virtual on the EHA (Free EHA Whitepaper) Congress platform

About Ofirnoflast (HT-6184)

Ofirnoflast is Halia’s first-in-class, oral, allosteric NEK7 inhibitor designed to modulate NLRP3 inflammasome activation upstream of inflammatory signaling. By targeting NEK7 before NLRP3 assembly, ofirnoflast prevents inflammasome formation and disrupts a key pathway implicated in ineffective hematopoiesis. Halia is advancing ofirnoflast as a potential disease-modifying therapy for lower-risk MDS, with broader development opportunities across inflammasome-driven diseases.

(Press release, Halia Therapeutics, MAY 12, 2026, View Source [SID1234665572])

On May 12, 2026 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 and FLT3 inhibitor, reported its business update and financial results for the quarter ended March 31, 2026.

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Operational Highlights

TakeAim Lymphoma

Emavusertib is currently undergoing testing in combination with the Bruton’s tyrosine kinase inhibitor (BTKi) ibrutinib in the TakeAim Lymphoma Phase 1/2 open-label, single arm expansion trial in patients with Relapsed or Refractory (R/R) Primary CNS Lymphoma (PCNSL) (CA-4948-101, NCT03328078). Patient enrollment in this study is currently ongoing. As a result of discussions with FDA and EMA, the ongoing phase 1/2 study is intended to support filings for accelerated approval of emavusertib in PCNSL in the US and Europe. Emavusertib has been granted orphan drug designation by both FDA and EMA in PCNSL.
TakeAim CLL

Emavusertib is also being tested in the recently initiated open label TakeAim CLL Phase 2 clinical trial of emavusertib in combination with the BTKi zanubrutinib in patients with Chronic Lymphocytic Leukemia (CLL) (CA-4948-203, NCT07271667). The goal of combining emavusertib with a BTKi is to enable a dual blockade of NF-kB, a key driver of disease in CLL and NHL, by inhibiting both the TLR and BCR pathways. The current standard of care is the use of BTK inhibitors, which block the BCR pathway and can deliver high response rates, though typically only partial responses. Previous clinical studies have shown that adding emavusertib, which blocks the TLR pathway, to a BTKi regimen can enable patients with NHL to achieve deeper responses, including complete remission or undetectable minimal residual disease (MRD) and the potential for time-limited treatment, outcomes which represent the potential for a paradigm shift in the management of CLL.
Solid Tumors

Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis, presented a poster with initial clinical data in gastric and esophageal cancer at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium in January 2026. In this study, patients are treated with emavusertib in combination with FOLFOX and anti-PD1 +/- trastuzumab as first-line therapy for metastatic or unresectable gastroesophageal cancers. The poster titled A phase I trial of emavusertib (CA-4948) in combination with FOLFOX/ PD-1 inhibitor +/- trastuzumab as first-line treatment for untreated unresectable gastric and esophageal cancer showed results for 16 evaluable patients demonstrating a manageable toxicity profile and encouraging preliminary results.
Dr. Patrick Grierson, Siteman Cancer Center, Washington University in St Louis will have an abstract titled A phase I trial of emavusertib (CA-4948) in combination with gemcitabine and nab-paclitaxel in metastatic or unresectable pancreatic ductal adenocarcinoma (PDAC) available online at View Source on May 21, 2026 at 5:00 PM EDT.
Upcoming Milestones

Curis expects to announce the dosing of the initial 5 patients in the TakeAim CLL combination study with zanubrutinib by mid-2026, with data expected in December 2026.
Also, the Company expects updated emavusertib clinical data from the TakeAim Lymphoma combination study with ibrutinib in patients with R/R PCNSL in the first half of 2027.
Corporate

On January 9, 2026, the Company announced the closing of a private placement (the "January 2026 PIPE Financing") with gross proceeds of up to $80.8 million, including initial gross proceeds of approximately $20.2 million with three series of warrants (A, B, and C) which can be exercised for up to $20.2 million each according to the terms and conditions of the financing agreement. All three series of warrants are exercisable at $0.75 per share, subject to conditions defined in the financing agreement with respect to the Series B warrants, and have the following termination conditions:

Series A warrants terminate on January 8, 2031;
Series B warrants terminate 30 days after the Company announces dosing of the fifth patient in the Phase 2 clinical trial in CLL, subject to conditions defined in the financing agreement; and
Series C warrants terminate on July 8, 2027.
First Quarter 2026 Financial Results

For the quarter ended March 31, 2026, Curis reported a net loss of $24.2 million, or $1.25 per share on both a basic and diluted basis, as compared to a net loss of $10.6 million, or $1.25 per share on both a basic and diluted basis in 2025.

There were no revenues for the quarter ended March 31, 2026 due to the sale of Erivedge royalties to Oberland in the fourth quarter of 2025. Revenues, net were $2.4 million for the quarter ended March 31, 2025, comprising royalty revenues from Genentech and Roche’s net sales of Erivedge.

Research and development expenses were $6.4 million and $8.5 million for the quarters ended March 31, 2026 and 2025, respectively. The decrease was primarily attributable to lower employee related and manufacturing costs.

General and administrative expenses were $5.1 million and $4.0 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was primarily attributable to expenses associated with the January 2026 PIPE Financing, partially offset by lower employee related costs.

Other expense, net was $12.7 million and $0.5 million for the quarters ended March 31, 2026 and 2025, respectively. The increase was attributable to the change in fair value of the warrant liability associated with the January 2026 PIPE Financing, partially offset by no expense related to the sale of future royalties in 2026.

As of March 31, 2026, Curis’s cash and cash equivalents totaled $15.0 million, and the Company had approximately 40.0 million shares of common stock outstanding.

Cash Runway Guidance

Curis believes its cash and cash equivalents as of March 31, 2026 of $15.0 million, together with anticipated gross proceeds of up to an additional $20.2 million from the exercise of the January 2026 PIPE Financing Series B Warrants upon the public announcement of dosing the 5th CLL patient in our TakeAim CLL study expected later this year, should enable the Company’s planned operations into the second half of 2027.

Conference Call Information

Curis management will host a conference call today, May 12, 2026, at 4:30 p.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial (800)-836-8184 from the United States or (646)-357-8785 from other locations, shortly before 4:30 p.m. ET. The conference call can also be accessed here on the Curis website in the Investors section.

(Press release, Curis, MAY 12, 2026, View Source [SID1234665532])

On May 12, 2026 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing "off the shelf" allogeneic cell therapies for serious medical conditions, reported its first quarter 2026 financial and operating results. The Company will host a conference call today at 4:30 p.m. Eastern Time to discuss these results and to provide a business update.

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"This quarter, we continued to build on our developmental and clinical accomplishments. Most notably, we applied our proprietary cell manufacturing technology platform, AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering), to launch COR1, our new, wholly-owned corneal endothelial cell therapy program. COR1 is a preclinical asset which we believe benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our platform. We also achieved our first milestone with our AlloSCOPE 5D manufacturing initiative, aimed at addressing the challenges of large scale production of undifferentiated pluripotent stem cells. If successful at a larger scale, the overall goal is to leverage this initiative, together with a differentiation protocol, to address the insufficient supply of islet cells needed to support a potential treatment of Type 1 Diabetes," stated Brian M. Culley, Lineage CEO.

"In parallel, we advanced our DOSED study, successfully administering OPC1 to a second chronic SCI participant using a novel delivery system. We also established a new Scientific Advisory Board with recognized and established cell therapy executive Joachim Fruebis, PhD, as its founding member. Dr. Fruebis’ extensive experience across ophthalmology, neurology, diabetes, and other key therapeutic areas will help drive the evolution of our cell therapy platform and help to translate our innovations into clinical and commercial success. We look forward to additional updates on further appointments to our SAB throughout the year."

"This will be an exciting year for Lineage. Our current cell therapy pipeline features seven separate cell types, two of which are in the clinic, and each of which is in development for a discrete indication addressing a significant unmet need. We remain focused on advancing our innovative pipeline through disciplined internal spending and support from external partners, in line with our long-term strategy of creating a leading portfolio of cell-based transplant programs, all based on our core technology and our AlloSCOPE manufacturing platform," concluded Mr. Culley.

Select Business Highlights

RG6501 (OpRegen Cell Therapy)
Positive RG6501 (OpRegen cell therapy) Phase 1/2a clinical study 3 year results encore featured at Foundation Fighting Blindness’ Retinal Therapeutics Innovation Summit 2026, suggest evidence of sustained gains in best corrected visual acuity (BCVA) and partial structural restoration of the retina, including re-appearance of an RPE layer and features associated with recovery of photoreceptors.
Positive long-term clinical outcomes reported following a single administration of OpRegen cell therapy.
Clinical data reported at 12-, 24-, and 36-months for Cohort 4 (less advanced disease) of the Phase 1/2a study (12 patients) has continued to demonstrate a consistent and durable treatment effect, with OpRegen-treated eyes exhibiting mean BCVA scores above baseline at each of these timepoints in these patients.
Notably, five patients who received extensive coverage of OpRegen cell therapy across their geographic atrophy (GA) lesion are demonstrating long-term outcomes consistent with meaningful disease stabilization and even improvement through 36 months.
Ongoing execution of Lineage’s contributions to its collaboration with Roche and Genentech. The ongoing Phase 2a GAlette Study is currently enrolling at 17 clinical sites in the U.S. and Israel.
In addition to testing other surgical parameters, Genentech currently plans to evaluate proprietary surgical delivery devices in the Phase 2a GAlette study that have potential advantages over available off-the-shelf devices.
Ongoing efforts to further support development of OpRegen cell therapy under a separate services agreement with Genentech, signed May 2024, including: (i) activities to support the ongoing Phase 1/2a study long term follow-up and the currently enrolling Phase 2a GAlette study; and (ii) additional technical training and materials related to our cell therapy technology platform to support commercial manufacturing strategies.
OPC1 Program (Spinal Cord Injury)
Second chronic SCI participant treated in the Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device (DOSED) study.
Second treated participant was a neurologically complete SCI injury (American Spinal Injury Association Impairment Scale [AIS] grade A), with single neurological levels of injury (NLI) at level T4 to T5, and the novel delivery system successfully administered a one-time injection of OPC1.
Opened second clinical site in the DOSED study, Rancho Research Institute, in conjunction with Rancho Los Amigos National Rehabilitation Center.
COR1 Program (Corneal Endothelial Disease)
Launched COR1, our corneal endothelial cell therapy (CEnC) program, a wholly-owned preclinical asset which we believe benefits from our existing ophthalmology and manufacturing expertise and represents a natural next application of our technology platform.
Applicable indications for COR1 are expected to include Fuchs Endothelial Corneal Dystrophy (FECD) and Bullous Keratopathy.
Utilizing Lineage’s proprietary cell manufacturing and expansion platform, AlloSCOPE, the Company is manufacturing "off the shelf" corneal endothelial cells with identity, morphological, and functional characteristics which meet initial internal criteria and support further development.
Lineage plans to advance this new product candidate into translational models to support potential clinical testing.
ILT1 Manufacturing Initiative
Successfully met our first milestone for our ILT1 manufacturing initiative, demonstrating a highly scalable and fully suspension-based process for generating undifferentiated pluripotent cells using one of our proprietary cell lines.
Initial work accomplished at 0.5 liter scale and supports further development into a larger multi-liter format.
If successful at larger scale, Lineage may seek to demonstrate AlloSCOPE 5D scalability with one or more internal or partner-sourced hypo-immune or non hypo-immune cell lines, suitable to support potential islet cell differentiation and preclinical testing.
This initiative inverts traditional cell therapy product development by focusing on the challenge of large-scale production of a potential cell-based product candidate prior to conducting preclinical and clinical testing.
The goal of ILT1 is to establish a production modality that can support an expansion through differentiation process, entirely in a dynamic culturing system, which if successful, could potentially solve a major hurdle to production and commercialization of an islet cell therapy product candidate for the potential treatment of Type 1 Diabetes.
ReSonance (ANP1) Program (Hearing Loss)
First internally-developed program, an auditory neuron cell transplant to treat hearing loss built on our AlloSCOPE platform.
Research collaboration established in 2025 with William Demant Invest A/S (WDI) to jointly advance preclinical development of ReSonance over a term of three years.
WDI collaboration represents an important demonstration of the speed, efficiency, and value creation of the AlloSCOPE platform.
Up to $12 million of development costs was agreed to be contributed by WDI in 2025, which was intended to cover activities including, cell manufacturing, proof-of-concept studies, translational/functional models, delivery development, outcome measures, regulatory strategy, and market analysis.
Successfully completed 3 engineering manufacturing runs, with preparations underway for internal technology transfer to current Good Manufacturing (cGMP) team.
Established novel model of deafening to support ReSonance functional preclinical testing under the collaboration.
Scientific Advisory Board (SAB)
Established SAB to provide strategic counsel and insights into the development of Lineage’s novel cell transplant pipeline.
Founding member Joachim Fruebis, Ph.D., is an accomplished scientist and leader with an extensive career driving R&D innovation in biotechnology and pharma. His in-depth expertise spans small molecules, biologics, and advanced therapies across multiple therapeutic areas including ophthalmology, neurology, diabetes and obesity, cardiovascular, metabolic, and rare diseases. Dr. Fruebis’ experience includes pioneering cell therapy strategies and integrating cutting-edge technologies and approaches to accelerate drug discovery timelines, including at Novo Nordisk, BlueRock Therapeutics, Bioverativ and Bayer.
Additional SAB members are expected to be added throughout the remainder of the year.
Appointment of Priyantha Herath, M.D., Ph.D., as Senior Vice President & Head of Clinical
Priyantha is a Board-certified specialist neurologist, with extensive experience spanning early translational development, regulatory affairs and clinical development through successful Phase 3 clinical trial execution. He brings a broad clinical perspective to Lineage, having treated more than 20,000 patients with neurodegenerative diseases in varied phenotypes, direct patient care which has contributed to a deep understanding of disease presentation, progression, and meaningful outcomes and we welcome his expertise and leadership in this new role.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities of $53.4 million as of March 31, 2026 is expected to support planned operations into Q2 2028.

First Quarter Operating Results

Revenues: Revenue is generated primarily from collaboration revenues, royalties, and other revenues. Total revenues for the three months ended March 31, 2026 were approximately $1.7 million, a net increase of $0.2 million as compared to $1.5 million for the same period in 2025. The increase was primarily driven by collaboration revenue recognized under our new research collaboration agreement with WDI.

Operating Expenses: Operating expenses are composed of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended March 31, 2026 were $9.3 million, an increase of $1.3 million as compared to $8.0 million for the same period in 2025.

R&D Expenses: R&D expenses for the three months ended March 31, 2026 were $4.2 million, an increase of $1.1 million as compared to $3.1 million for the same period in 2025. The net increase was primarily driven by $0.3 million for our OPC1 program, $0.2 million for our ReSonance program, and approximately $0.7 million for our preclinical and other undisclosed programs.

G&A Expenses: G&A expenses for the three months ended March 31, 2026 were approximately $5.1 million, an increase of $0.2 million as compared to $4.9 million for the same period in 2025. The net increase was primarily driven by personnel costs, partially offset by services provided by third parties.

Loss from Operations: Loss from operations for the three months ended March 31, 2026 was $7.6 million, an increase of $1.1 million as compared to $6.5 million for the same period in 2025.

Other Income/(Expenses): Other income/(expenses) for the three months ended March 31, 2026 reflected other income of $2.8 million, compared to other income of approximately $2.4 million for the same period in 2025. The net increase was primarily driven by exchange rate fluctuations related to Lineage’s international subsidiaries and no warrant-related financing transaction costs incurred as compared to the prior year’s quarter.

Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended March 31, 2026 was $4.8 million, or $0.02 per share (basic) and $0.03 per share (diluted), compared to a net loss of $4.1 million, or $0.02 per share (basic and diluted), for the same period in 2025.

Conference Call and Webcast

Interested parties may access today’s conference call by dialing (800) 715-9871 from the U.S. and Canada and should request the "Lineage Cell Therapeutics Call" (Conference ID: 9229676). A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through May 19, 2026, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 9229676.

About the AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) Platform

The AlloSCOPE (Allogeneic, Scalable, Consistent, Off-the-shelf, Pluripotent Cell Engineering) platform highlights the key attributes of Lineage’s in-house technology and describes a differentiation and production modality from which Lineage can manufacture millions of doses of an allogeneic, cell-based product derived from a single initial pluripotent cell line, conferring consistent, cost-effective, and scalable cell-based production and which can be applied across multiple programs. From our proprietary AlloSCOPE platform, we successfully completed a current Good Manufacturing Practice ("cGMP") production run from a custom, two-tiered cell banking system, featuring a genetically-stable master cell bank (MCB) created from a single, well-characterized pluripotent cell line, which generated a working cell bank (WCB), which then provided the source material for two final cell-based product candidates. AlloSCOPE "5D" describes an application of AlloSCOPE with the goal of higher scale production with reduced manipulation.

(Press release, Lineage Cell Therapeutics, MAY 12, 2026, View Source [SID1234665545])