Market Newsdesk

– $5.8 million in KOMZIFTI™ (ziftomenib) net product revenue in first full quarter of commercialization –

– Robust new patient starts and early launch dynamics, including repeat use, switching and combination adoption, reflect strong early momentum –

– Broad and rapid payer access achieved, with > 93% coverage and favorable positioning across > 12 million lives –

– Multiple 2026 data readouts expected to support ziftomenib as a broadly combinable backbone across AML –

– $580.8 million in cash, cash equivalents and short-term investments, plus $180 million in anticipated collaboration payments, expected to support advancement of ziftomenib AML program through first topline KOMET-017 Phase 3 results –

– Management to host webcast and conference call today at 4:30 p.m. ET –

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

“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) 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 KRAS^G12C-mutated solid tumors at the upcoming American Society of Clinical Oncology (ASCO) 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.

About Kura Oncology

Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website and follow us on X and LinkedIn.

Forward-Looking Statements

This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, Kura’s future performance in 2026; the commercial potential of KOMZIFTI; KOMZIFTI’s potential market leadership in R/R NPM1-m AML; KOMZIFTI’s potential as a broadly combinable backbone across the AML treatment continuum; Kura’s research, preclinical and clinical development activities; plans and projected timelines for ziftomenib, darlifarnib, KO-7246 and other preclinical assets; the expected timing and presentation of results and data from clinical trials; and Kura’s anticipated cash runway. Factors that may cause actual results to differ materially include risks associated with market competition, market acceptance and commercialization of KOMZIFTI; risks associated with the conduct of preclinical studies and clinical trials; risks that Kura’s actual future financial and operating results may differ from its expectations or goals; the risk that Kura’s product candidates may not receive regulatory approval; the potential for KOMZIFTI or Kura’s product candidates to have unexpected adverse side effects; the risk that Kura may not be able to obtain additional financing; the risk that the collaboration with Kyowa Kirin is unsuccessful; and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

FLT3, Fms-like tyrosine kinase 3 gene; KMT2A, lysine methyltransferase 2A gene; NPM1, nucleophosmin 1 gene; -m, mutant; -r, rearranged; ITD, Internal Random Duplication; KRAS, Kirsten Rat Sarcoma Virus oncogene homolog.

KURA ONCOLOGY, INC.
Statements of Operations Data
(unaudited)
(in thousands, except per share data)
						Three Months Ended
						March 31,
						2026							2025
Revenue
Product revenue, net						$	5,766						$	—
Collaboration revenue							12,499							14,108
Total revenue							18,265							14,108
Operating expenses
Cost of product sales							262							—
Research and development							65,263							55,973
Selling, general and administrative							31,555							22,835
Total operating expenses							97,080							78,808
Other income, net							5,490							7,497
Income tax expense							8							226
Net loss						$	(73,333				)		$	(57,429			)
Net loss per share, basic and diluted						$	(0.83				)		$	(0.66			)
Weighted average number of shares used in computing net loss per share, basic and diluted							88,610							87,415

KURA ONCOLOGY, INC.
Balance Sheet Data
(unaudited)
(in thousands)
		March 31,				December 31,
		2026				2025
Cash, cash equivalents and short-term investments		$	580,823			$	667,240
Working capital			522,286				591,689
Total assets			652,551				738,363
Long-term liabilities			443,172				447,254
Accumulated deficit			(1,247,421	)			(1,174,088	)
Stockholders’ equity			107,883				174,135

About KOMZIFTI™ (ziftomenib)

KOMZIFTI (ziftomenib) is an oral menin inhibitor approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible NPM1 mutation who have no satisfactory alternative treatment options.

Ziftomenib is in development for the treatment of frontline and R/R AML harboring NPM1 mutations, KMT2A translocations and FLT3 mutations, with the potential to be combined with approved therapies and benefit a broad spectrum of patients.

IMPORTANT SAFETY INFORMATION FOR KOMZIFTI FROM THE U.S. PRESCRIBING INFORMATION

Boxed WARNING: DIFFERENTIATION SYNDROME

Differentiation syndrome, which can be fatal, has occurred with KOMZIFTI. Signs and symptoms may include fever, joint pain, hypotension, hypoxia, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, pulmonary infiltrates, acute kidney injury, and rashes. If differentiation syndrome is suspected, interrupt KOMZIFTI, and initiate oral or intravenous corticosteroids with hemodynamic and laboratory monitoring until symptom resolution; resume KOMZIFTI upon symptom improvement.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome

KOMZIFTI can cause fatal or life-threatening differentiation syndrome (DS). DS is associated with rapid proliferation and differentiation of myeloid cells. Symptoms of DS, including those seen in patients treated with KOMZIFTI, may include fever, hypoxia, joint pain, hypotension, dyspnea, rapid weight gain or peripheral edema, pleural or pericardial effusions, acute kidney injury, and rashes.

In the clinical trial, DS occurred in 29 (26%) of 112 patients with R/R AML with an NPM1 mutation who were treated with KOMZIFTI at the recommended dosage. DS was Grade 3 in 13% and fatal in two patients. In broader evaluation of all patients with any genetic form of AML treated with KOMZIFTI monotherapy in clinical trials, DS occurred in 25% of patients. Four fatal cases of DS occurred out of 39 patients with KMT2A-rearranged AML treated with KOMZIFTI. KOMZIFTI is not approved for use in patients with KMT2A-rearranged AML.

In the 112 patients with an NPM1 mutation, DS was observed with and without concomitant hyperleukocytosis, in as early as 3 days and up to 46 days after KOMZIFTI initiation. The median time to onset was 15 days. Two patients experienced more than one DS event. Treatment was interrupted and resumed in 15 (13%) patients, while it was permanently discontinued in 2 (2%) patients.

Prior to starting treatment with KOMZIFTI, reduce the WBC counts to less than 25 x 10⁹/L. If DS is suspected, interrupt KOMZIFTI, initiate oral or intravenous corticosteroids (e.g., dexamethasone 10 mg every 12 hours) for a minimum of 3 days with hemodynamic and laboratory monitoring. Resume treatment with KOMZIFTI at the same dose level when signs and symptoms improve and are Grade 2 or lower. Taper corticosteroids over a minimum of 3 days after adequate control or resolution of symptoms. Symptoms of DS may recur with premature discontinuation of corticosteroid treatment.

QTc Interval Prolongation

KOMZIFTI can cause QTc interval prolongation. In the clinical trial, QTc interval prolongation was reported as an adverse reaction in 12% of 112 patients treated with KOMZIFTI at the recommended dosage for R/R AML with an NPM1 mutation. QTc interval prolongation was Grade 3 in 8% of patients. The heart-rate corrected QT interval (using Fridericia’s method) (QTcF) was greater than 500 msec in 9% of patients, and the increase from baseline QTcF was greater than 60 msec in 12% of patients. KOMZIFTI dose reduction was required for 1% of patients due to QTc interval prolongation. QTc prolongation occurred in 14% of the 42 patients less than 65 years of age and in 10% of the 70 patients 65 years of age or older.

Correct electrolyte abnormalities, including hypokalemia and hypomagnesemia, prior to treatment with KOMZIFTI. Perform an ECG prior to initiation of treatment with KOMZIFTI, and do not initiate KOMZIFTI in patients with QTcF > 480 msec. Perform an ECG at least once weekly for the first four weeks on treatment, and at least monthly thereafter. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms (Grade 3). In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval, more frequent ECG monitoring may be necessary. Concomitant use of KOMZIFTI with drugs known to prolong the QTc interval may increase the risk of QTc interval prolongation, result in a greater increase in the QTc interval and adverse reactions associated with QTc interval prolongation, including Torsades de Pointes, other serious arrhythmias, and sudden death.

Embryo-Fetal Toxicity

Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 6 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with KOMZIFTI and for 3 months after the last dose.

ADVERSE REACTIONS

Fatal adverse reactions occurred in 4 (4%) patients who received KOMZIFTI, including 2 with differentiation syndrome, 1 with infection, and 1 with sudden death. Serious adverse reactions were reported in 79% of patients who received KOMZIFTI. Serious adverse reactions occurring in ≥ 5% of patients included infection without an identified pathogen (29%), febrile neutropenia (18%), bacterial infection (16%), differentiation syndrome (16%), and dyspnea (6%).

Dosage interruption of KOMZIFTI due to an adverse reaction occurred in 54% of patients. Adverse reactions that required dose interruption in ≥ 2% of patients included infection without an identified pathogen (15%), differentiation syndrome (13%), febrile neutropenia (5%), pyrexia (4%), electrocardiogram QT prolonged (4%), leukocytosis (4%), bacterial infection (3%), cardiac failure (2%), cholecystitis (2%), diarrhea (2%), pruritus (2%), and thrombosis (2%). Dose reduction of KOMZIFTI due to an adverse reaction occurred in 4% of patients. Permanent discontinuation of KOMZIFTI due to an adverse reaction occurred in 21% of patients. Adverse reactions that required permanent discontinuation of KOMZIFTI in ≥ 2% of patients were infection without an identified pathogen (8%), bacterial infection (4%), cardiac arrest (2%), and differentiation syndrome (2%).

Most common (≥ 20%) adverse reactions, including laboratory abnormalities, were aspartate aminotransferase increased (53%), infection without an identified pathogen (52%), potassium decreased (52%), albumin decreased (51%), alanine aminotransferase increased (50%), sodium decreased (49%), creatinine increased (45%), alkaline phosphatase increased (41%), hemorrhage (38%), diarrhea (36%), nausea (35%), fatigue (34%), edema (30%), bacterial infection (28%), musculoskeletal pain (28%), bilirubin increased (27%), potassium increased (26%), differentiation syndrome (26%), pruritus (23%), febrile neutropenia (22%), and transaminases increased (21%).

DRUG INTERACTIONS

Drug interactions may occur when KOMZIFTI is concomitantly used with:

• Strong or Moderate CYP3A4 Inhibitors: Monitor patients more frequently for KOMZIFTI-associated adverse reactions.
• Strong or Moderate CYP3A4 Inducers: Avoid concomitant use of KOMZIFTI.
• Gastric Acid Reducing Agents: Avoid concomitant use of KOMZIFTI with proton pump inhibitors (PPIs), H2 receptor antagonists (H2RAs), or locally acting antacids. If concomitant use with H2RAs or locally acting antacids cannot be avoided, modify KOMZIFTI administration time.
  • Take KOMZIFTI 2 hours before or 10 hours after administration of an H2 receptor antagonist.
  • Take KOMZIFTI 2 hours before or 2 hours after administration of a locally acting antacid.
• Drugs that Prolong the QTc Interval: Avoid concomitant use of KOMZIFTI. If concomitant use cannot be avoided, obtain ECGs when initiating, during concomitant use, and as clinically indicated. Interrupt KOMZIFTI if the QTc interval is > 500 ms or the change from baseline is > 60 ms.

USE IN SPECIFIC POPULATIONS

Pregnancy: Based on findings in animals and its mechanism of action, KOMZIFTI can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status in females of reproductive potential prior to starting KOMZIFTI.

Lactation: Because of the potential for adverse reactions in the breastfed child, advise women not to breastfeed during treatment with KOMZIFTI and for 2 weeks after the last dose.

Infertility: Based on findings in animals, KOMZIFTI may impair fertility in females and males of reproductive potential.

Please see full Prescribing Information, including Boxed WARNING.

Contacts

Investors and media:
Greg Mann
858-987-4046
[email protected] 

JACKSONVILLE, Fla., May 12, 2026 (GLOBE NEWSWIRE) — CSX Corp. (NASDAQ: CSX) announced that the Company’s Board of Directors approved a $0.14 per share quarterly dividend on the Company’s common stock. The dividend is payable June 15, 2026, to shareholders of record at the close of business May 29, 2026.

About CSX and its Disclosures

CSX, based in Jacksonville, Florida, is a premier transportation company. It provides rail, intermodal and rail-to-truck transload services and solutions to customers across a broad array of markets, including energy, industrial, construction, agricultural, and consumer products. For nearly 200 years, CSX has played a critical role in the nation’s economic expansion and industrial development. Its network connects every major metropolitan area in the eastern United States, where nearly two-thirds of the nation’s population resides. It also links more than 240 short-line railroads and more than 70 ocean, river and lake ports with major population centers and farming towns alike. 

This announcement, as well as additional financial information, is available on the Company’s website at investors.csx.com. CSX also uses social media channels to communicate information about the company. Although social media channels are not intended to be the primary method of disclosure for material information, it is possible that certain information CSX posts on social media could be deemed to be material. Therefore, we encourage investors, the media, and others interested in the company to review the information we post on Facebook and on X, formerly known as Twitter. The social media channels used by CSX may be updated from time to time. More information about CSX Corporation and its subsidiaries is available at www.csx.com.

Contact:
Matthew Korn, CFA, Investor Relations and Corporate Communications
904-366-4515

Austin Staton, Corporate Communications
855-955-6397

Positive pre-BLA meeting with FDA alignment reached on KYSA-8 single-arm trial in stiff person syndrome (SPS); rolling BLA submission initiated

Miv-cel pivotal trial primary analysis results in SPS demonstrated robust, durable effect in indication with no approved therapies; launch preparations continue with appointment of Nadia Dac as Chief Commercial Officer

Enrollment advances in Phase 3 trial in generalized myasthenia gravis (gMG), further derisked by Phase 2 longer-term follow-up data demonstrating durable efficacy out to one year

EMERYVILLE, Calif., May 12, 2026 (GLOBE NEWSWIRE) — Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today reported business and portfolio progress, and financial results for the first quarter ended March 31, 2026.

“As the first company to submit a BLA for an autoimmune CAR T therapy, gaining alignment with the FDA on a single-arm trial and a clear path to submission for miv-cel is a significant milestone for not only Kyverna but also the field,” said Warner Biddle, Chief Executive Officer of Kyverna Therapeutics. “This achievement underscores both the hard work and dedication of our entire organization and the promising potential of miv-cel, starting with stiff person syndrome. As we execute our rolling BLA submission and prepare for launch in 2027, we are laying the foundation for a multi-indication neuroimmunology franchise that reinforces our leadership position in autoimmune CAR T. More broadly, we are well positioned to establish a new therapeutic paradigm, delivering durable drug-free, disease-free remission for patients.”

Recent Progress in Neuroimmunology CAR T Franchise

• FDA Alignment on SPS BLA submission: Kyverna held a positive pre-BLA meeting with the FDA, in which the company gained alignment on its regulatory path for miv-cel in SPS, including a rolling BLA submission and all core components of its BLA package:
  • KYSA-8 single-arm pivotal Phase 2 trial is sufficient to support the BLA submission
  • Primary endpoint measurement is the Timed 25-foot Walk (T2FW) test at 16 weeks
  • Clinical safety package
  • Preclinical package
  • Chemistry, Manufacturing, and Controls (CMC) package  

In addition, the Company will include additional analysis of its completed natural history study presented at the 2026 American Academy of Neurology (AAN) annual meeting and planned one-year follow-up data from KYSA-8. The natural history data provide context that further reinforces the magnitude of miv-cel’s clinical impact in SPS as a progressive, debilitating disease with significant unmet medical need.

The Company has initiated its rolling BLA submission, seeking priority review under the program’s Regenerative Medicine Advanced therapy (RMAT) designation, and anticipates completing the submission in Q4 2026.

• KYSA-8 Primary Analysis Data Demonstrate Robust, Durable Treatment Effect in Patients with SPS:
  • In April, Kyverna presented findings from the primary analysis of the pivotal KYSA-8 trial of miv-cel in a late-breaking oral presentation at the 2026 AAN annual meeting. The presentation expanded on previously reported positive topline results, demonstrating statistically significant, durable clinical benefit across all primary and secondary endpoints at 16 weeks, with reversal of disability scores following a single dose of miv-cel. In addition, 100% of patients remained free of immunotherapies for SPS as of Week 16 and through last follow-up. Miv-cel was also well tolerated.
  • The Company will share one-year follow-up data in the second half of 2026, which is expected to further demonstrate miv-cel’s durable treatment effect. Notably, the first two SPS patients treated with a single dose of miv-cel through the IH pathway in Germany¹ have achieved durable efficacy of over 15 and 26 months, respectively, without the need for chronic immunotherapies.
  • Kyverna also presented outcomes from a large, multicenter, retrospective natural history study examining the impact of SPS on walking speed at AAN, which further contextualizes the transformative clinical data for miv-cel and supports the use of Timed 25-Foot Walk (T25FW) as a valid longitudinal measure of mobility in SPS. The study included 153 patients treated with off-label immunotherapies or symptomatic medications and with T25FW assessments available. The majority of patients showed minimal (<20%) or no improvement in T25FW and required increasing reliance on walking aids over time. Changes in T25FW correlated with changes in disability assessed by Modified Rankin Scale (mRS) over time. These findings further highlight the limited impact of current treatment approaches.

• Enrollment Ongoing in Phase 3 Portion of KYSA-6 Registrational Trial for gMG:
  • In April 2026, Kyverna presented longer-term follow-up data from the Phase 2 portion of the KYSA-6 clinical trial of miv-cel in an oral presentation at AAN, supporting miv-cel’s potential to deliver durable drug-free, disease-free remission with a well-tolerated safety profile. The updated data demonstrated deep and durable clinical responses across all key outcome measures, with sustained benefit observed through one year following a single dose of miv-cel. Notably, 100% of patients achieved clinically meaningful, rapid and robust reductions in Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scores from baseline (the co-primary endpoints of the Phase 3 portion of the trial), regardless of prior biologic exposure, and at deeper levels observed compared to the interim analysis reported in October 2025. In addition, biomarker and mechanistic data further supported miv-cel’s differentiated clinical profile.
  • Kyverna expects to share longer-term Phase 2 follow-up data in gMG in the second half of 2026 and continues to enroll patients in its FDA-aligned Phase 3 gMG clinical trial across 15 activated sites globally.

• Positive Miv-cel Data in Progressive Multiple Sclerosis (PMS):
  
  • Updated follow-up data of up to twelve months from Stanford University’s Phase 1 investigator-initiated trial (IIT) of miv-cel in PMS were presented at the Stanford Blood and Marrow Transplantation and Cellular Therapy Symposium in May 2026. A total of six patients have been treated receiving either 33M (n=3) or 100M (n=3) CAR T cells, using an alternative bendamustine lymphodepleting (LD) regimen, with four patients having reached 12 months of follow-up. Data showed robust CAR T expansion in blood and cerebrospinal fluid (CSF), and reconstitution of naïve B-cells supportive of immune reset. Of the 5 patients with post-treatment assessments, all achieved improvement or stability in their disability scores at last follow up, as measured by the expanded disability status scale scores (EDSS). Additional biomarker data, including CSF oligoclonal bands and kappa free light chain, continue to support favorable immunological impact. Among patients with available data in fatigue scores, 100% (4/4) showed improvements in scores from baseline. All patients remained off other immunomodulatory therapies and miv-cel was well-tolerated with no high-grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
  • Kyverna expects to provide a development update, including reporting additional data from the Phase 1 IIT study, in the second half of 2026.

Additional Pipeline Opportunities

• • Kyverna continues to explore miv-cel with​ no LD or an alternative LD regimen and the potential for outpatient administration supported by miv-cel’s consistent and well-tolerated safety profile.

Recent Business Highlights

• Appointment of Nadia Dac as Chief Commercial Officer to further strengthen Company’s commercial expertise: Ms. Dac, a seasoned commercial leader in neurology and rare diseases, brings more than 30 years of U.S. and global commercial leadership in the biopharmaceutical industry, executing successful new product launches and building high-performing commercial organizations, including those making the transition to commercial-stage for the first time.
• Kyverna has advanced its SPS launch-readiness activities, including commercial site activation activities, payer engagement, and healthcare professional (HCP) education. The Company’s current manufacturing capacity is expected to fully support commercial launch of miv-cel.

Financial Results for the First Quarter Ended March 31, 2026

• Kyverna reported $236.4 million in cash, cash equivalents, and marketable securities as of March 31, 2026. The Company continues to expect to have a cash runway into 2028.
• Research and Development (R&D) expenses were $30.1 million for the first quarter ended March 31, 2026.
• General and Administrative (G&A) expenses were $11.3 million for the first quarter ended March 31, 2026.
• For the quarter ended March 31, 2026, the Company reported a net loss of $39.7 million, or a net loss per common share of $0.66.

About miv-cel (mivocabtagene autoleucel, KYV-101)

Miv-cel is a fully human, autologous, CD19-targeting CAR T-cell therapy with CD28 co-stimulation, designed for potency and tolerability, which is under investigation for B-cell-driven autoimmune diseases. With a single administration, miv-cel has potential to achieve deep B-cell depletion and immune system reset to deliver durable drug-free, disease-free remission in autoimmune diseases. 

About Kyverna Therapeutics

Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience. For more information, please visit https://kyvernatx.com.

Forward-looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words, without limitation, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these or similar identifying words. Forward-looking statements in this press release include, without limitation, those related to: Kyverna’s regulatory path for SPS, including the rolling BLA submission for SPS, the anticipated information to be included therein and the expected timing for completing such submission, as well as potential for priority review under an RMAT designation; the Phase 3 trial for gMG and status of enrollment in such trial; Kyverna’s foundation for a multi-indication neuroimmunology franchise and its potential leadership position in autoimmune CAR-T; Kyverna’s potential readiness for commercial launch of miv-cel in SPS, including the sufficiency of its manufacturing capacity and cash runway; Kyverna’s potential first-in-class neuroimmunology CAR T franchise; the potential for outpatient administration of miv-cel in SPS; miv-cel’s potential to deliver durable drug-free, disease-free remission in gMG or other autoimmune diseases; miv-cel’s well-tolerated safety profile; the potential that the one-year follow-up data for SPS will further demonstrate miv-cel’s durability of treatment effect; and Kyverna’s expected upcoming pipeline milestones and anticipated timing for sharing data, including for SPS, gMG, PMS and additional pipeline opportunities. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties related to market conditions, the possibility that results from prior clinical trials, named-patient access activities and preclinical studies may not necessarily be predictive of future results; the possibility that the FDA or other regulatory agencies may require additional trials or studies to support its intended BLA submission; intellectual property rights; and other factors discussed in the “Risk Factors” section of Kyverna’s previously filed Annual Report on Form 10-K for the year ended December 31, 2025 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 to be filed with the U.S. Securities and Exchange Commission on or about the date hereof. Any forward-looking statements contained in this press release are based on the current expectations of Kyverna’s management team and speak only as of the date hereof, and Kyverna specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

For more information, please contact:


Investors: [email protected]
Media: [email protected]

¹ Similar to expanded access or compassionate use in the United States, IH or “Individueller Heilversuch,” also known as “named-patient basis access,” is a regulatory mechanism in Germany that allows for the supply of a treatment that has not received marketing authorization for an individual patient in response to a request by the treating physician on behalf of the named patient. This option can be pursued for the expected benefit of a patient who has exhausted all available treatment options, under the discretion of the treating physician with the patient’s consent. The use of KYV-101 in the IH setting is not a substitute for, nor intended to replace, Kyverna’s clinical trials. The goal is not to assess the effectiveness of a potential therapy, but rather to provide an individual patient with a possible efficacious approach when all other treatment options have failed, as determined by the patient’s physician.

Kyverna Therapeutics, Inc. Statements of Operations and Comprehensive Loss (in thousands, except share and per share data) (Unaudited)
		Three Months Ended March 31,
		2026				2025
Operating expenses
Research and development		$	30,073			$	37,433
General and administrative			11,294				9,975
Total operating expenses			41,367				47,408
Loss from operations			(41,367	)			(47,408	)
Interest income			2,327				2,825
Interest expense			(667	)			(25	)
Other expense, net			(21	)			(27	)
Total other income, net			1,639				2,773
Net loss			(39,728	)			(44,635	)
Other comprehensive income (loss)
Unrealized loss on available-for-sale marketable securities, net			(193	)			(106	)
Total other comprehensive loss			(193	)			(106	)
Net loss and other comprehensive loss		$	(39,921	)		$	(44,741	)
Net loss per share attributable to common stockholders, basic and diluted		$	(0.66	)		$	(1.03	)
Weighted-average shares of common stock outstanding, basic and diluted			60,434,200				43,215,577

Kyverna Therapeutics, Inc. Condensed Balance Sheets (in thousands) (Unaudited)
		March 31,				December 31,
		2026				2025
Assets
Current assets
Cash and cash equivalents and available-for-sale marketable securities		$	236,446			$	279,253
Prepaid expenses and other current assets			5,280				3,700
Total current assets			241,726				282,953
Restricted cash			551				551
Property and equipment, net			1,343				1,546
Operating lease right-of-use assets			8,192				3,568
Finance lease right-of-use assets			198				305
Other non-current assets			5,014				4,903
Total assets		$	257,024			$	293,826
Liabilities, redeemable convertible preferred stock and stockholders’ equity
Current liabilities		$	29,674			$	36,487
Non-current liabilities			31,770				25,063
Stockholders’ equity			195,580				232,276
Total liabilities, redeemable convertible preferred stock and stockholders’ equity		$	257,024			$	293,826

HOLMDEL, N.J., May 12, 2026 (GLOBE NEWSWIRE) — BIO-key^® International, Inc. (Nasdaq: BKYI), a global leader in Identity and Access Management (IAM) and biometric authentication technologies, today announced that it has received written notification from The Nasdaq Stock Market LLC that the trading of its common stock will be suspended on Nasdaq effective with markets’ close today, Tuesday, May 12, 2026. BIO-key has received approval from OTC Markets Group for its common stock to be quoted on the OTC Market under the same symbol commencing May 13, 2026. BIO-key’s shares are being suspended because its closing bid price, which has been above $1 the past eight consecutive trading days, did not meet Nasdaq’s extension requirement that its closing bid price be above $1 for a minimum of ten or more consecutive trading days by May 4^th and because the Company has not yet to filed its Annual Report on Form 10K for the year ended December 31, 2025.

Under Nasdaq rules, BIO-key intends to request a hearing before a Nasdaq Hearings Panel to demonstrate compliance and the resumption of trading on the Nasdaq Capital Market, however there can be no assurance the Hearings Panel will grant relief from Nasdaq suspension.

BIO-key Chairman and CEO Michael DePasquale commented, “Through shareholder support and our concerted efforts to regain compliance with Nasdaq’s continued listing standards via a reverse split, we have restored our share price to a level well in excess of Nasdaq’s $1 minimum closing bid price requirement. Unfortunately, due to the timing of the reverse split, we were unable to maintain this share price level for the previous 10 trading days and our listing currently has been suspended. We are undertaking corrective measures to regain compliance, including retaining expert listing consultants to assist us in this process. With their guidance, we are taking steps that we believe provide us the best opportunity to have trading resume on Nasdaq expeditiously. There is precedent and very real potential to achieve this goal but no guarantee of success.

“Despite this action, our business has never been in a stronger position, with a growing base of recurring revenue, significant interest in our biometric technology’s ability to solve pervasive cybersecurity vulnerabilities, a solid financial position, and a streamlined cost structure. All of these factors support our expectation of achieving profitability in the first half of 2026 as we previewed last month, with expectations for:

• 2026 first half (1H’26) revenues to rise 50% to $5M vs. $3.3M in 1H’25 and $6.0M in 2025;
• 1H’26 profitability vs. a $1.9M net loss in 1H’25
• Our 1H’26 cash position to remain in line with our cash position at year-end 2025.

“To provide liquidity for our common stock during the Nasdaq suspension, we have secured OTC Markets Group approval for our shares to be quoted on the OTC Markets following our Nasdaq suspension. We remain confident in our business trajectory and our prospects to resolve our Nasdaq listing suspension in the near term.”

Situation Background:

BIO-key’s common stock was not in compliance with Nasdaq’s $1 minimum closing bid price requirement and faced a deadline of May 4^th to regain compliance. On April 20^th, BIO-key stockholders approved a reverse split to regain compliance with Nasdaq’s $1 minimum closing bid price requirement. BIO-key implemented a 1-for-10 reverse split, which became effective with commencement of trading on April 30^th. As a result of the reverse split, BIO-key’s share price and minimum closing bid has been above Nasdaq’s $1 minimum closing bid requirement.

However, the implementation and effectiveness of the reverse split was delayed to comply with Nasdaq’s updated 10-day notification requirement, and BIO-key’s minimum closing bid price had not exceeded the $1 threshold for ten consecutive days as of May 4^th deadline. In addition, the Company has not yet filed its Annual Report on Form 10-K for the year ended December 31, 2025 as required by Nasdaq’s continued listing requirements. As a result Nasdaq has informed BIO-key that its Nasdaq trading will be suspended as of the close of business on May 12^th.

Regulatory Background

In early 2025 Nasdaq amended its Listing Rules to extend the advance notice by which a listed company effecting a reverse stock split must submit a Company Event Notification Form to at least 10 calendar days prior to the proposed market effective date of a reverse stock split, from the prior requirement of 5 business days (Listing Rules 5250(e)(7) and IM-5250-3). Additionally, Nasdaq adopted a rule suspending trading after 360 days of Continued Listing Rule non-compliance, and eliminated a related policy to allow shares to continue to trade on Nasdaq during the appeals process. In its place, Nasdaq Listing Rules require immediate suspension for failure to meet the bid price compliance within 360 days, while maintaining the ability for a Company to appeal the delist notice to a Nasdaq appointed Hearings Panel.

About BIO-key International, Inc. (

www.BIO-key.com

)

BIO-key is revolutionizing authentication and cybersecurity with biometric-centric, multi-factor identity and access management (IAM) software securing access for over forty million users. BIO-key allows customers to choose the right authentication factors for diverse use cases, including phoneless, tokenless, and passwordless biometric options. Its cloud-hosted or on-premise PortalGuard IAM solution provides cost-effective, easy-to-deploy, convenient, and secure access to computers, information, applications, and high-value transactions.

BIO-key Safe Harbor Statement
All statements contained in this press release other than statements of historical facts are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 (the “Act”). The words “estimate,” “project,” “intends,” “expects,” “anticipates,” “believes” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements are made based on management’s beliefs, as well as assumptions made by, and information currently available to, management pursuant to the “safe-harbor” provisions of the Act. These statements are not guarantees of future performance or events and are subject to risks and uncertainties that may cause actual results to differ materially from those included within or implied by such forward-looking statements. These risks and uncertainties include, without limitation, our history of losses and limited revenue; our ability to raise additional capital to satisfy working capital needs; our ability to continue as a going concern; our ability to protect our intellectual property; changes in business conditions; changes in our sales strategy and product development plans; changes in the marketplace; continued services of our executive management team; security breaches; competition in the biometric technology and identity access management industries; market acceptance of biometric products generally and our products under development; our ability to convert sales opportunities to customer contracts; our ability to expand into Asia, Africa and other foreign markets; fluctuations in foreign currency exchange rates; the duration and extent of continued hostilities in Ukraine and its impact on our European customers; the impact of tariffs and other trade barriers which may make it more costly for us to import inventory from China and Hong Kong and certain product components from South Korea; delays in the development of products, the commercial, reputational and regulatory risks to our business that may arise as a consequence of non-compliance with Securities and Exchange Commission (“SEC”) and Nasdaq periodic reporting requirements; our temporary loss of the use of a Registration Statement on Form S-3 to register securities in the future; any disruption to our business that may occur on a longer-term basis should we be unable to continue to maintain effective internal controls over financial reporting, and statements of assumption underlying any of the foregoing as well as other factors set forth under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and other filings with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date made. Except as required by law, we undertake no obligation to disclose any revision to these forward-looking statements whether as a result of new information, future events, or otherwise.

Engage with BIO-key:
Facebook – Corporate:	https://www.facebook.com/BIOkeyInternational/
LinkedIn – Corporate:	https://www.linkedin.com/company/bio-key-international
X – Corporate:	@BIOkeyIntl
X – Investors:	@BIO_keyIR
StockTwits:	BIO_keyIR

Investor Contacts:

William Jones, David Collins
Catalyst IR
[email protected] or 212-924-9800

Positive topline data from Phase 2 HORIZON trial of MZE829 in patients with broad AMKD provide proof-of-concept and support advancement into pivotal trial; additional HORIZON data expected in late 2026 or early 2027

Phase 2 proof-of-concept clinical trials evaluating MZE782 in PKU and CKD on track to initiate in 2026

Strong balance sheet with $528 million in cash, cash equivalents and marketable securities; inclusive of net proceeds from the $150 million registered offering and $20 million MZE001 milestone payment in April 2026; cash runway expected to extend into 2029

SOUTH SAN FRANCISCO, Calif., May 12, 2026 (GLOBE NEWSWIRE) — Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today reported financial results for the first quarter ended March 31, 2026, highlighting recent progress and business updates.

“We continue to execute across our clinical pipeline in 2026, and with positive topline data reported from our Phase 2 HORIZON trial of MZE829 in broad AMKD in the first quarter, we are more confident than ever in our potential to harness the power of genetics to transform the lives of patients,” said Jason Coloma, Ph.D., chief executive officer of Maze. “Looking ahead to the rest of the year, we remain on track to initiate a Phase 2 trial of MZE782 in PKU around the middle of this year with topline data expected in 2027, and an additional Phase 2 study is expected to initiate in CKD in the second half of this year. We also look forward to reporting additional results from the HORIZON study in late 2026 or early 2027, and to advancing MZE829 into a pivotal trial in moderate AMKD patients without diabetes, including those with FSGS. With a strong balance sheet and expected cash runway into 2029, we continue to focus on clinical execution and pivotal study preparation.”

Program Progress and Anticipated Milestones

MZE829 for APOL1-Mediated Kidney Disease (AMKD)

MZE829 is an oral, small molecule, dual-mechanism APOL1 inhibitor that Maze is advancing as a potential treatment for patients with AMKD, a subset of chronic kidney disease (CKD) estimated to affect over one million people in the United States alone.

• In March 2026, Maze announced positive topline data from the Phase 2 HORIZON trial evaluating MZE829 in patients with broad AMKD, representing the first-ever clinical proof-of-concept data in this genetically-defined, broad AMKD population. The results demonstrated that treatment with MZE829 led to a clinically meaningful mean reduction in proteinuria, as measured by urinary albumin-to-creatinine ratio (uACR), of 35.6% at week 12 in broad AMKD patients, with 50% of patients achieving a greater than 30% reduction in uACR. In patients with severe focal segmental glomerulosclerosis (FSGS), treatment with MZE829 led to a mean reduction in uACR of 61.8%. In patients with AMKD without diabetes, treatment with MZE829 resulted in a clinically meaningful mean reduction in uACR of 48.6%. In patients with AMKD with diabetes, five patients were evaluable per protocol for efficacy, with two patients achieving at least a 30% reduction in uACR. No serious adverse events or severe treatment-related adverse events were observed.
• Based on the topline results from HORIZON, Maze plans to initiate a pivotal trial in patients with moderate AMKD without diabetes, including those with FSGS, in the first half of 2027, subject to regulatory feedback.

MZE782 for Phenylketonuria (PKU) and CKD

MZE782 is an oral, small molecule targeting the solute transporter, SLC6A19, with potential to be a best-in-class therapy for patients with PKU, an inherited metabolic disorder, and a first-in-class treatment for the estimated five million U.S. patients with CKD who inadequately respond to currently available CKD therapies.

• Maze plans to initiate two Phase 2 proof-of-concept trials of MZE782 evaluating plasma phenylalanine (Phe) reduction in PKU and proteinuria reduction in CKD by mid-2026 and in the second half of 2026, respectively. Topline data from the PKU Phase 2 trial is expected in 2027.

Recent Corporate Highlights

• In April 2026, Maze completed a registered offering of its common stock and pre-funded warrants for gross proceeds of approximately $150 million, before deducting underwriting discounts and commissions and other offering expenses payable by Maze.

First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $362.9 million as of March 31, 2026, compared to $360.0 million as of December 31, 2025. Maze expects that its cash, cash equivalents and marketable securities as of March 31, 2026, together with the proceeds from the registered offering completed in April 2026 and a $20 million milestone payment received from Shionogi & Co., Ltd. in April 2026, will fund operations into 2029 based on its current business plan.

License Revenue: License revenue was $20.0 million for the quarter ended March 31, 2026. No license revenue was recognized for the quarter ended March 31, 2025. License revenue recognized in the first quarter of 2026 reflects the achievement of a milestone pursuant to the exclusive license agreement with Shionogi & Co., Ltd. for the rights to MZE001, an investigational oral glycogen synthase 1 (GYS1) inhibitor that aims to address Pompe disease by limiting disease-causing glycogen buildup.

Research & Development (R&D) Expenses: R&D expenses were $34.1 million and $27.6 million for the quarter ended March 31, 2026 and 2025, respectively. The increase primarily reflects higher clinical trial expenses for the Phase 2 trial of MZE829 in AMKD and start-up activities for the planned Phase 2 trial of MZE782 in PKU and higher personnel-related costs, including non-cash stock-based compensation expense.

General & Administrative (G&A) Expenses: G&A expenses were $12.4 million and $7.8 million for the quarter ended March 31, 2026 and 2025, respectively. The increase primarily reflects higher personnel-related expenses, including non-cash stock-based compensation expense, and costs for professional services.

Net Loss: Net loss was $24.2 million, or $0.45 per share, and $32.8 million, or $1.15 per share, for the quarter ended March 31, 2026 and 2025, respectively.

About Maze Therapeutics

Maze Therapeutics is a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel small molecule precision medicines for patients with kidney and metabolic diseases. Guided by its Compass™ platform, Maze pursues genetically validated targets by integrating variant discovery and functionalization to discover and advance small molecule programs with first- or best-in-class potential. Maze’s pipeline is led by MZE829, a dual-mechanism APOL1 inhibitor in Phase 2 development for APOL1-mediated kidney disease (AMKD), and MZE782, a SLC6A19 inhibitor advancing to Phase 2 with the potential to treat both phenylketonuria (PKU) and chronic kidney disease (CKD). Maze is headquartered in South San Francisco. For more information, please visit mazetx.com, or follow Maze on LinkedIn and X.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the current beliefs and expectations of management. All statements other than statements of historical fact are statements that could be deemed forward-looking statements, including, without limitation, statements concerning the company’s future plans and prospects, any expectations regarding the safety or efficacy of MZE829, MZE782 and other candidates under development, the ability of MZE829 to treat AMKD or other indications, the ability of MZE782 to treat PKU, CKD or other indications, the planned timing of the company’s clinical trials, data results and further development of MZE829, MZE782 and other therapeutic candidates, the company’s expected cash runway, and the ability to drive financial results and stockholder value. In addition, when or if used in this press release, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “will,” “predict” and similar expressions and their variants, as they relate to the company may identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Although the company believes the expectations reflected in such forward-looking statements are reasonable, the company can give no assurance that such expectations will prove to be correct. Readers are cautioned that actual results, levels of activity, safety, performance or events and circumstances could differ materially from those expressed or implied in the company’s forward-looking statements due to a variety of factors, including risks and uncertainties related to the company’s ability to advance MZE829, MZE782 and its other therapeutic candidates, obtain regulatory approval of and ultimately commercialize the company’s therapeutic candidates, the timing and results of preclinical studies and clinical trials, the company’s ability to fund development activities and achieve development goals, its ability to protect its intellectual property, general business and economic conditions, and risks related to the impact on its business of macroeconomic conditions, including inflation, volatile interest rates, tariffs, instability in the global banking sector, and public health crises. Further information on potential risk factors that could affect the company’s business and its financial results are detailed under the heading “Risk Factors” included in the documents the company files from time to time with the U.S. Securities and Exchange Commission, including the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date of this press release and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

IR/Corporate Contact:

Amy Bachrodt, Maze Therapeutics
[email protected]

Media Contact:

Amanda Lazaro, 1AB Media
[email protected]

Maze Therapeutics, Inc. Select Condensed Financial Information (in thousands, except share and per share amounts) (unaudited)
Condensed Statements of Operations
	Three Months Ended
	March 31,
	2026				2025
License revenue	$	20,000			$	—
Operating expenses:
Research and development		34,148				27,580
General and administrative		12,405				7,821
Total operating expenses		46,553				35,401
Loss from operations		(26,553	)			(35,401	)
Other income (expense):
Interest and other income, net		3,211				2,615
Interest expense		(866	)			—
Total other income, net		2,345				2,615
Net loss	$	(24,208	)		$	(32,786	)
Net loss per share, basic and diluted	$	(0.45	)		$	(1.15	)
Weighted-average shares of common stock outstanding used to compute net loss per share, basic and diluted		53,897,216				28,628,430

Condensed Balance Sheet Data
	March 31,				December 31,
	2026				2025
Cash, cash equivalents and marketable securities	$	362,938			$	360,031
Total assets	$	419,710			$	397,127
Total liabilities	$	78,009			$	42,161
Total stockholders’ equity	$	341,701			$	354,966

ORLANDO, Fla., May 12, 2026 (GLOBE NEWSWIRE) — IZEA Worldwide, Inc. (NASDAQ: IZEA), a leading influencer marketing company that makes Creator Economy solutions for marketers, reported its financial and operational results for the first quarter ended March 31, 2026.

Q1 2026
Financial Summary Compared to
Q1 2025

• Revenue was $6.6 million, off $1.4 million (18%) compared to $8.0 million, driven by the shedding of small, unprofitable, non-recurring small and mid-size business (SMB) accounts
• Managed Services bookings declined 17% to $6.3 million, primarily reflecting contract timing within several large enterprise accounts, which we expect to contribute to growth in 2026
• Total costs and expenses decreased 10% to $7.7 million, compared to $8.6 million, reflecting a normalized cost base positioned to scale with revenue growth
• Net loss totaled $0.8 million, or $(0.04) per share, compared to a net loss of $0.1 million, or $(0.01) per share
• Adjusted EBITDA* for the quarter was $(0.5) million, compared to $(0.1) million
• Cash and equivalents as of March 31, 2026 totaled $46.5 million, declining $4.4 million during the quarter, primarily reflecting working capital timing

Q1 2026
Highlights

• IZEA won new business from Hulu, ASUS, Garanimals, and Emmi Roth
• IZEA launched ZED, its proprietary creator economy marketing operations platform infused with AI, designed to connect brands and creators through a unified operating system, enabling teams to plan smarter campaigns, collaborate seamlessly, automate workflows, and measure impact in real time
• IZEA executed many high-impact creator campaigns including a global fandom activation for Warner Bros.’ Wuthering Heights, gaming activations for Acer, vehicle showcases for Jeep, and launch support for Netflix Games
• IZEA strengthened its talent base with a dozen strategic growth hires, including Lindsey Gamble as Vice President of Creator Strategy and Innovation, bringing a powerful combination of deep influencer marketing expertise and enterprise-scale marketing leadership

* Adjusted EBITDA and revenue from on-going operations are non-GAAP financial measures. Refer to the definition and reconciliation of these measures under “Use of Key Metrics and Non-GAAP Financial Measures.”

Management Commentary

“Q1 marked a pivotal milestone for IZEA as we completed our transition to an enterprise-focused business model,” said Patrick Venetucci, CEO. “Over the past year, we made the disciplined decision to exit lower-margin SMB work, which reset our economic foundation and drove a nearly $19 million swing in profitability in 2025. Today, we have a higher-quality, more predictable revenue base anchored by large enterprise clients, with growing relationships and increasing revenue per account. Over the past twelve months, we have seen double-digit growth across our enterprise portfolio, supported by new client wins and continued momentum in our creative and technology capabilities, including the launch of ZED, our proprietary AI-powered platform. We believe this transformation positions IZEA for accelerated growth and long-term value creation.”

Q1 2026
Financial Results

Total revenue for the first quarter of 2026 was $6.6 million, compared to $8.0 million in the prior year period, a decrease of $1.4 million, or 18%. The decline primarily reflects the Company’s deliberate shift toward growing its core enterprise customer base and reducing reliance on non-core, lower-margin customers, supporting a focus on improving the quality, sustainability, and long-term profitability of revenue. The decrease was also, to a lesser extent, impacted by contract timing differences across several enterprise accounts during the quarter, which are expected to contribute to growth in 2026.

Cost of revenue for the first quarter of 2026 was $3.6 million, a decrease of $0.8 million, or 18%, compared to the prior-year period. The decrease was primarily driven by lower overall delivery volume, consistent with the decline in revenue, and a more favorable mix of higher-margin enterprise engagements.

Costs and expenses, excluding the cost of revenue, totaled $4.1 million for the first quarter of 2026, a decrease of $0.1 million, or 3%, compared to the first quarter of 2025. Sales and marketing expense totaled $0.9 million, down 17% from $1.1 million in the prior-year period, primarily due to lower payroll and related expenses, partially offset by program costs to support growth initiatives. General and administrative expenses were $3.0 million, an increase of $0.1 million, or 3%, year over year, primarily driven by higher payroll and related expenses, net of continued cost management initiatives.

Net loss in the first quarter of 2026 was $0.8 million, or $(0.04) per share, as compared to a net loss of $0.1 million, or $(0.01) per share in the first quarter of 2025, based on 17.3 million and 17.0 million average shares outstanding, respectively.

Adjusted EBITDA (as defined below, a non-GAAP measure management used as a proxy for operating cash flow) totaled $(0.5) million in the first quarter of 2026, compared with $(0.1) million in the comparative period.

As of March 31, 2026, our cash and cash equivalents totaled $46.5 million. The company has no outstanding long-term debt.

We previously announced our commitment to repurchase up to $10.0 million of our stock in the open market, subject to certain restrictions. Through March 31, 2026, we have purchased a total of 523,268 shares, investing $1.3 million under the repurchase program. No share purchases were made in the current quarter.

Conference Call

IZEA will hold a conference call to discuss its first quarter 2026 results on Tuesday, May 12, 2026, at 5:00 p.m. ET. IZEA’s CEO Patrick Venetucci and CFO Peter Biere will host the call, followed by a question and answer period.

Date: Tuesday, May 12, 2026
Time: 5:00 p.m. ET
Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1760886&tp_key=951f9d5729
Toll-free dial-in number: 1-877-407-4018
International dial-in number: 1-201-689-8471

Please call the conference telephone number five (5) minutes before the start time. An operator will register your name and organization. A call replay will be made available approximately 3 hours after the conference ends until Tuesday, May 19, 2026, at 11:59 p.m. ET.

Toll-free replay number: 1-844-512-2921
International replay number: 1-412-317-6671
Replay ID: 13760257

About IZEA Worldwide, Inc.

IZEA Worldwide, Inc. (“IZEA”) is a full-service creator economy agency powered by our proprietary ZED technology, with a mission to make Creator Economy solutions for marketers. We do this by lighting up the Creator Economy with IZEAs—our strategies, campaigns, and solutions that build brands and drive demand. Since launching the industry’s first-ever influencer marketing platform in 2006, IZEA has facilitated nearly 4 million collaborations between brands and creators.

Use of Key Metrics and Non-GAAP Financial Measures

Managed Services Bookings is a key metric representing total sales orders received during a period, net of cancellations and refunds. Contracts vary by customer and scope, ranging from custom content projects to integrated marketing campaigns, and generally extend from several months up to a year. Managed Services Bookings provide a useful measure of overall demand but are not necessarily predictive of quarterly revenue, as the timing of revenue recognition varies with contract size, complexity, and customer arrangements. Certain customers enter into annual spend commitments that establish a defined budget for services to be performed throughout the year, while others engage the Company for specific campaigns or deliverables. These differing contract structures may influence the timing and distribution of bookings and related revenue. The Company uses this metric to evaluate customer and market trends, to plan operational staffing, and to inform product development initiatives.

“Adjusted EBITDA” is a non-GAAP financial measure under the Securities and Exchange Commission rules. EBITDA is commonly defined as “earnings before interest income and expense, taxes, depreciation, and amortization.” IZEA defines “Adjusted EBITDA” as earnings or loss before interest expense, interest income, taxes, depreciation and amortization, non-cash stock-based compensation, gain or loss on asset disposals or impairment, and certain other unusual or non-cash income and expense items such as gains or losses on settlement of liabilities and exchanges, and changes in the fair value of derivatives, if applicable. We believe that Adjusted EBITDA provides useful information to investors as it primarily excludes non-cash and non-operating transactions, and it provides consistency to facilitate period-to-period comparisons.

Not all companies calculate bookings and Adjusted EBITDA in the same manner. These metrics and financial measures, as presented by IZEA, may not be comparable to those presented by other companies. Moreover, these metrics and financial measures have limitations as analytical tools. You should not consider them in isolation or as a substitute for an analysis of our results of operations or, with respect to non-GAAP financial measures, as reported under GAAP. A reconciliation of Adjusted EBITDA and revenue and costs from on-going operations to the most directly comparable GAAP measures is presented in the financial tables included in this press release.

Safe Harbor Statement

All statements in this release that are not based on historical fact are “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies, and expectations, can generally be identified by the use of forward-looking terms such as “may,” “will,” “would,” “could,” “should,” “expect,” “anticipate,” “hope,” “estimate,” “optimistic,” “believe,” “intend,” “ought to,” “likely,” “projects,” “plans,” “pursue,” “strategy” or “future,” or the negative of these words or other words or expressions of similar meaning. Examples of forward-looking statements include, among others, statements we make regarding expectations concerning product development and platform launches, future financial performance and operating results, including regarding recognition of bookings as revenues, the share repurchase authorization and any use of such authorization, growth, or maintenance of customer relationships, and expectations concerning IZEA’s business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements as a result of various factors, including, among others, the following: competitive conditions in the content and social sponsorship segment in which IZEA operates; failure to popularize one or more of the marketplace platforms of IZEA; our ability to maintain disclosure controls and procedures and internal control over financial reporting; our ability to satisfy the requirements for continued listing of our common stock on the Nasdaq Capital Market; changing economic conditions that are less favorable than expected; and other risks and uncertainties described in IZEA’s periodic reports filed with the Securities and Exchange Commission. The forward-looking statements made in this release speak only as of the date of this release, and IZEA assumes no obligation to update any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.

Press Contact

John Francis
IZEA Worldwide, Inc.
Phone: 407-674-6911
Email: [email protected]

IZEA Worldwide, Inc.

Unaudited Consolidated Balance Sheets

	March 31, 2026				December 31, 2025
Assets
Current assets:
Cash and cash equivalents	$	46,502,356			$	50,886,850
Accounts receivable, net		5,853,585				3,398,479
Prepaid expenses		622,896				830,509
Other current assets		125,321				9,002
Total current assets		53,104,158				55,124,840
Property and equipment, net of accumulated depreciation		6,209				17,131
Software development costs, net of accumulated amortization		2,426,122				2,335,745
Total assets	$	55,536,489			$	57,477,716
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		758,442				779,434
Accrued expenses		1,413,805				3,050,995
Contract liabilities		4,892,795				4,729,767
Total current liabilities		7,065,042				8,560,196
Total liabilities		7,065,042				8,560,196
Commitments and Contingencies		—				—
Stockholders’ equity:
Preferred stock; $.0001 par value; 10,000,000 shares authorized; no shares issued and outstanding		—				—
Common stock; $0.0001 par value; 50,000,000 shares authorized; shares issued: 18,253,298 and 18,150,878, respectively, shares outstanding: 17,364,175 and 17,261,755, respectively.		1,825				1,815
Treasury stock at cost: 889,123 and 889,123 shares at March 31, 2026 and December 31, 2025, respectively		(2,344,698	)			(2,344,698	)
Additional paid-in capital		155,904,372				155,568,812
Accumulated deficit		(105,032,252	)			(104,254,729	)
Accumulated other comprehensive loss		(57,800	)			(53,680	)
Total stockholders’ equity		48,471,447				48,917,520
Total liabilities and stockholders’ equity	$	55,536,489			$	57,477,716

IZEA Worldwide, Inc. Unaudited Consolidated Statements of Operations
	Three Months Ended March 31,
		2026				2025
Revenue	$	6,573,232			$	7,968,363
Costs and expenses:
Cost of revenue		3,630,001				4,401,574
Sales and marketing		930,574				1,121,782
General and administrative		3,035,506				2,940,507
Depreciation and amortization		149,247				160,352
Total costs and expenses		7,745,328				8,624,215
Loss from operations		(1,172,096	)			(655,852	)
Other income (expense):
Interest expense		(372	)			(1,654	)
Other income (expense), net		394,945				514,706
Total other income (expense), net		394,573				513,052
Net loss		(777,523	)			(142,800	)
Weighted average common shares outstanding – basic and diluted		17,310,313				16,927,166
Basic and diluted loss per common share	$	(0.04	)		$	(0.01	)

IZEA Worldwide, Inc. Unaudited Consolidated Statements of Comprehensive Loss
	Three Months Ended March 31,
		2026				2025
Net loss	$	(777,523	)		$	(142,800	)
Other comprehensive loss
Unrealized gain loss on securities held		—				(13,903	)
Unrealized gain loss on currency translation		(4,120	)			(109,459	)
Total other comprehensive loss		(4,120	)			(123,362	)
Total comprehensive loss	$	(781,643	)		$	(266,162	)

IZEA Worldwide, Inc. Revenue Details Revenue details by type:
	Three Months Ended March 31,
		2026				2025			$ Change			% Change
Managed Services revenue		6,553,171	100	%		7,907,410	99	%		(1,354,239	)	(17)%
SaaS Services revenue		20,061	—	%		60,953	1	%		(40,892	)	(67)%
Total revenue	$	6,573,232	100	%	$	7,968,363	100	%	$	(1,395,131	)	(18)%

IZEA Worldwide, Inc. Reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA
	Three Months Ended March 31,
		2026				2025
Net loss	$	(777,523	)		$	(142,800	)
Non-cash stock-based compensation		402,166				285,132
Non-cash stock issued for payment of services		90,010				90,002
Depreciation and amortization		149,247				160,352
Interest expense		372				1,654
Interest income		(395,012	)			(471,190	)
Adjusted EBITDA	$	(530,740	)		$	(76,850	)
Revenue	$	6,573,232			$	7,968,363
Adjusted EBITDA as a % of revenue	(8.1		)%		(1.0		)%