On May 4, 2026 Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are pleased with IBTROZI’s ongoing launch trends in the first quarter of 2026, as we continue to deepen its adoption across lines of therapy and make significant progress in becoming the standard of care for people living with advanced ROS1-positive NSCLC. The newly updated long-term follow-up data from our pivotal studies presented at AACR (Free AACR Whitepaper) demonstrated an unprecedented durability for IBTROZI of now more than four years in TKI-naïve patients, further supporting healthcare providers and their patients’ confidence in selecting IBTROZI. With our partners, we are well on our way to bringing this important medicine to patients in need around the world," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are also thrilled to have secured exclusive global development and commercialization rights to safusidenib. We look forward to advancing the pivotal Phase 3 SIGMA study for patients with high-risk IDH1-mutant glioma, where targeted treatment options are incredibly limited. Additionally, we are well on track to provide updates on our drug-drug conjugate platform later this year as we further our mission to tackle some of the toughest challenges in cancer treatment."

First Quarter 2026 and Recent Corporate Highlights:

IBTROZI (taletrectinib), ROS1 inhibitor: Advanced ROS1+ NSCLC

In the first quarter of 2026, Nuvation Bio reported $18.5 million in net product revenues for IBTROZI.
In the first quarter of 2026, more than half of the approximately 200 new patients who started treatment with IBTROZI for advanced ROS1+ NSCLC were TKI-naïve, reflecting a sustained high rate of adoption and confidence in IBTROZI among healthcare professionals and patients. Since launch in late June 2025, over 600 patients have started IBTROZI.
In April 2026, Nuvation Bio presented updated pooled results from the TRUST-I and TRUST-II studies of IBTROZI in both TKI-naïve and TKI-pretreated patients at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. Notably, in the pooled TKI-naïve population, IBTROZI demonstrated robust confirmed overall response rates (cORR), median duration of response (mDOR) and median progression-free survival (mPFS) in TKI-naïve patients. Updated results from the TRUST-I study were also simultaneously published in the Journal of Clinical Oncology.
For TKI-naïve patients (n=157): the analysis showed a cORR of 89.8%, a mDOR of 49.7 months, a mPFS of 46.1 months and an intracranial response rate of 76.5% in patients with brain metastases (n=17). Median overall survival (OS) was not yet reached.
For TKI-pretreated patients (n=113): the analysis showed a cORR of 55.8%, a mDOR of 16.6 months, a mPFS of 9.7 months and an intracranial response rate of 65.6% in patients with brain metastases (n=32). Median OS was 29.8 months. Notably, 98% of TKI-pretreated patients (111/113) enrolled following progressive disease on entrectinib or crizotinib rather than intolerance, a higher bar for efficacy. The remaining two patients were enrolled following intolerance to a prior TKI.
A pooled safety analysis demonstrated a favorable and generally manageable safety profile for IBTROZI, consistent with its prescribing information and no new safety signals were identified with longer follow-up.
In April 2026, Nuvation Bio announced that taletrectinib (IBTROZI) has been added to the latest National Comprehensive Cancer Network Clinical Practice Guidelines (NCCN Guidelines) in Oncology for Central Nervous System (CNS) cancers. Specifically, the NCCN Guidelines for CNS Cancers now recommend taletrectinib (IBTROZI) as a systemic therapy option for ROS1+ NSCLC patients with brain metastases.
In March 2026, Nuvation Bio announced with Eisai Co., Ltd. that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for taletrectinib for the treatment of advanced ROS1+ NSCLC. The filing is being considered for full approval and will follow a standard review timeline.
On January 11, 2026, Nuvation Bio entered an exclusive license and collaboration agreement with Eisai Co., Ltd. to develop, register and commercialize taletrectinib for the treatment of ROS1+ NSCLC in Europe and certain other territories outside of the U.S., China and Japan.
Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma

In April 2026, Nuvation Bio announced that it has acquired the Japan rights to safusidenib from Daiichi Sankyo, giving Nuvation Bio full global development and commercialization rights. The agreement also transfers ownership of the global clinical development program to Nuvation Bio, inclusive of clinical trials, past and current data generation, and future publications.
Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting. As of February 2026, 12 of the 27 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years.
In January 2026, Nuvation Bio announced the finalization of the protocol amendment for the ongoing global Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care (G203). At that time, Nuvation Bio also announced that the trial would enroll a non-pivotal single-arm cohort to examine the efficacy and safety of safusidenib in chemotherapy- and radiotherapy-naïve patients with grade 3 IDH1-mutant oligodendroglioma with the primary endpoint of this arm being objective response rate.
Drug-drug conjugate (DDC) platform: Solid tumors

Nuvation Bio continues to explore new preclinical candidates for this novel modality and aims to provide further updates by year-end 2026.
Corporate Update:

In March 2026, Nuvation Bio appointed Stephen Dang, Ph.D., as Chief Legal Officer. Dr. Dang originally joined Nuvation Bio in 2021 and has over 18 years of experience in the biopharmaceutical industry across all stages of the drug product life cycle.
First Quarter 2026 Financial Results
As of March 31, 2026, Nuvation Bio had cash, cash equivalents, and marketable securities of $533.7 million.

Product Revenue, Net
To date, Nuvation Bio’s only source of product revenue remains from the U.S. sales of IBTROZI, which Nuvation Bio began distributing to its U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $18.5 million for the three months ended March 31, 2026.

Collaboration and License Agreements Revenue
For the three months ended March 31, 2026, collaboration and license agreements revenue was $64.7 million, compared to $3.1 million for the three months ended March 31, 2025. The increase is primarily due to a $58.7 million increase in license revenue because of the upfront payment received under the Eisai agreement, a $2.4 million increase in product supply, a $1.5 million increase in royalty revenue, and was offset by a $1.0 million decrease in research and development service revenue.

Taletrectinib was included in China’s National Reimbursement Drug List effective January 1, 2026. Royalty revenue for the quarter from collaboration agreements for China and Japan was $1.7 million.

Research and Development Expenses
For the three months ended March 31, 2026, research and development expenses were $35.0 million, compared to $24.6 million for the three months ended March 31, 2025. The increase was primarily due to a $1.5 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $8.9 million increase in third-party costs related to clinical trials.

Selling, General and Administrative Expenses
For the three months ended March 31, 2026, selling, general, and administrative expenses were $38.3 million, compared to $35.4 million for the three months ended March 31, 2025. The increase was due to a $5.7 million increase in salaries and other benefits driven by the increase in headcount and stock-based compensation, and $0.1 million increase in taxes, offset by a $1.7 million decrease in sales and marketing expenses and $1.2 million decrease in professional fees.

Net income
For the three months ended March 31, 2026, Nuvation Bio reported a net income of $5.4 million, or $0.02 per share on a basic basis and $0.01 per share on a diluted basis. The net loss for the comparable period in 2025 was $53.2 million, or $(0.16) per share on a basic and diluted basis.

Conference Call and Webcast
Nuvation Bio will host a conference call and webcast today, May 4, 2026, at 4:30 pm ET to discuss its financial results for the first quarter of 2026 and provide business updates.

Investors and the general public are invited to listen to the live webcast and may register on the Investor Relations section of the Nuvation Bio website. To access the live conference call, participants can dial +1 833-461-5787 (U.S. toll-free) and enter access code 266802059. An archived recording will be available on Nuvation Bio’s website for 90 days following the event.

About ROS1+ NSCLC
Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing central nervous system (CNS) metastases.

About IBTROZI
IBTROZI is an oral, potent, CNS-active, selective, next-generation ROS1 inhibitor therapy. On June 11, 2025, following Priority Review and Breakthrough Therapy designations for both TKI-naive and TKI-pretreated disease, the U.S. Food and Drug Administration (FDA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC. Learn more about taletrectinib in the U.S. at IBTROZI.com.

About the TRUST Clinical Program
The TRUST clinical program comprises three registrational studies evaluating the safety and efficacy of IBTROZI. TRUST-I (NCT04395677) and TRUST-II (NCT04919811) are Phase 2 single-arm studies evaluating IBTROZI for the treatment of adults with advanced ROS1+ NSCLC in China (N=173) and globally (N=189), respectively. The primary endpoint of both studies is confirmed objective response rate (cORR) as assessed by an independent review committee. TRUST-IV (NCT07154706) is a Phase 3 placebo-controlled study evaluating IBTROZI for the adjuvant treatment of adults with resected early-stage ROS1+ NSCLC. The study will enroll approximately 180 patients in the U.S., Canada, Europe, Japan and China. The primary endpoint is disease-free survival as determined by investigator, and the primary completion date is estimated to be in 2030. Nuvation Bio is also sponsoring TRUST-III (NCT06564324), a confirmatory randomized Phase 3 study evaluating IBTROZI versus crizotinib in 194 patients in China with advanced ROS1+ NSCLC who have not previously received ROS1 TKIs.

Indication
IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC).

IMPORTANT SAFETY INFORMATION FOR IBTROZI (taletrectinib)

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months).

Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients.

Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients.

Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months).

ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients.

QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner.

In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients.

Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.

Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients.

Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months).

Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation.

Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients.

Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman.

ADVERSE REACTIONS
Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%).

The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%).

DRUG INTERACTIONS

Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use.
Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI.
OTHER CONSIDERATIONS

Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity.
Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose.
Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible.
Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established.
Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation.
Please see accompanying full Prescribing Information.

About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.

About Safusidenib
Safusidenib is an investigational, oral, brain-penetrant, selective inhibitor of mutant IDH1. It is being studied in patient populations with significant unmet medical need, including settings where there are limited or no approved targeted treatment options. In Phase 1 and Phase 2 clinical studies, safusidenib demonstrated encouraging clinical activity, including delayed disease progression and durable responses across a range of tumor grades and risk groups, with a favorable risk-benefit profile that supports the currently enrolling Phase 3 SIGMA study.

About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.

(Press release, Nuvation Bio, MAY 4, 2026, View Source [SID1234665060])

On May 4, 2026 Krystal Biotech, Inc. (the "Company") (NASDAQ: KRYS) reported financial results for the first quarter ending March 31, 2026 and provided a business update.

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"Following a successful 2025, we are entering 2026 with strong momentum, including two potential registrational study readouts and continued global expansion for VYJUVEK," said Krish S. Krishnan, Chairman and Chief Executive Officer of Krystal Biotech. "With three pipeline products receiving platform designation, each development milestone strengthens the regulatory dataset, which could accelerate future programs and potentially reduce development risk. This compounding advantage underscores the value of the platform model we have been building since day one."

VYJUVEK (beremagene geperpavec-svdt, or B-VEC)
for the Treatment of Dystrophic Epidermolysis Bullosa (DEB)

The Company recorded $116.4 million in VYJUVEK net product revenue for the first quarter of 2026, an increase of 32% compared to the prior year first quarter. Gross margin for the first quarter of 2026 was 95%.

In the United States, the Company has secured over 695 reimbursement approvals for VYJUVEK and continues to broaden the prescriber base across the country, with over 60 new prescribers in the first quarter of 2026 and over 570 unique prescribers since launch. The Company has also launched patient support initiatives that leverage the recent VYJUVEK label update and increased administration flexibility to help DEB patients and their families conveniently integrate VYJUVEK into lifelong wound healing routines as their standard of care.

Overseas, the Company estimates that over 140 patients in Germany, France and Japan have been prescribed VYJUVEK. Pricing discussions with German and French reimbursement authorities are ongoing. The Company expects negotiations to continue until at least 2H 2026 in Germany and 2027 in France. The Company is also advancing pricing discussions with reimbursement authorities in Italy to enable a potential launch in 2H 2026 and recently initiated pricing discussions with Spanish reimbursement authorities. Based on initial interactions with Spanish authorities, the Company now expects to launch in Spain in 2H 2026. The timing of launch in other European jurisdictions will depend on the cadence and outcomes of regulatory interactions and pricing negotiations.

Ophthalmology

Two registrational readouts anticipated in 2026

KB803 for the treatment and prevention of corneal abrasions in DEB patients

The Company’s registrational, intra-patient, double-blind, decentralized, placebo-controlled study (IOLITE) with crossover design evaluating KB803 for the treatment and prevention of corneal abrasions in DEB patients is now fully enrolled. A total of 16 patients have been enrolled in the study. The primary efficacy endpoint of IOLITE will be the change in the average number of days per month with corneal abrasion symptoms while receiving KB803 versus placebo. The Company estimates that, as enrolled, IOLITE has at least 90% power to detect an effect size of at least 25% reduction in symptom days, allowing for a dropout rate up to 20%. Powering assumptions are based on the average symptomatic days per month and standard deviation data from subjects enrolled in the natural history study who would be eligible for IOLITE. The Company expects to report top-line results in 4Q 2026. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT07016750.

KB801 for the treatment of neurotrophic keratitis (NK)

The Company continues to enroll in EMERALD-1, the Company’s registrational, 1:1 randomized, double-masked, multicenter, placebo-controlled study evaluating KB801 for the treatment of NK. The Company expects to complete full enrollment of 60 patients in EMERALD-1 and announce data before year end. Details about the study can be found at www.clinicaltrials.gov under NCT identifier: NCT06999733.

Respiratory

KB407 for the treatment of cystic fibrosis (CF)

In April, the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 viral vector used in KB407, providing the program with the same potential development and manufacturing efficiencies previously granted to KB801. Potential benefits of the designation include shortening of preclinical and chemistry, manufacturing, and controls (CMC) review cycles during development for follow-on products, creating a compounding regulatory advantage.

Based on interactions with the FDA, the Company is initiating an open label, single-arm study to evaluate safety of repeat dose KB407 for 24 weeks in five patients with CF who are ineligible for, do not tolerate, or do not benefit from modulator therapy. Dosing is expected to start later this month. Details of the study can be found at www.clinicaltrials.gov under NCT identifier: NCT05504837. The Company expects to complete enrollment in 2Q 2026 and report results before year end.

Concurrently, the Company is working closely with the FDA and the Cystic Fibrosis Foundation (CFF) on an innovative registrational study design and statistical analysis plan that explores using prospectively collected natural history data from the CFF to supplement placebo control data for evaluation of KB407 treatment effect. The Company will share the design and associated statistical analysis of the registrational study following alignment with the FDA, which is anticipated in 2H 2026, and expects to initiate the registrational study in 2027.

Previously, in January, the Company announced the successful delivery and expression of wild-type cystic fibrosis transmembrane conductance regulator protein in the lungs of patients with CF treated with KB407.

KB408 for the treatment of alpha-1 antitrypsin deficiency (AATD) lung disease

The Company continues to enroll in repeat dose Cohort 2B of SERPENTINE-1, the Company’s open label dose escalation study evaluating KB408 in adult patients with AATD with a Pi*ZZ or a Pi*ZNull genotype and expects to report interim data for this cohort in 2026. Cohort 2B is designed to evaluate the safety and tolerability of repeat KB408 dosing at the same dose level that was previously shown to safely deliver SERPINA1 to the lungs of AATD patients after a single dose. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT06049082.

Dermatology

KB111 for the treatment of Hailey-Hailey disease (HHD)

In April, the FDA also granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 viral vector used in KB111, providing the program with the same regulatory efficiencies available for KB801 and KB407. The Company is developing an HHD-specific severity scale necessary for the clinical evaluation of KB111 and expects to complete scale development and validation in 1H 2026. Later this month, the Company also expects to initiate HALITE-1, an open-label study evaluating the safety of repeat dose KB111, administered once weekly for 12 weeks, in approximately seven patients with HHD. The Company expects to report HALITE-1 study results in 2H 2026. The Company also plans to submit the results from HALITE-1 along with the registrational study design for discussions with the FDA in 2H 2026 to enable a potential registrational study start in 2027.

Oncology

Inhaled KB707 for the treatment of non-small cell lung cancer (NSCLC)

The Company is enrolling patients with advanced NSCLC in a dose expansion cohort of KYANITE-1 evaluating inhaled KB707 in combination with chemotherapy. KYANITE-1 is a Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating inhaled KB707, either as monotherapy or in combination, in patients with locally advanced or metastatic solid tumors of the lung. The Company expects to report interim efficacy data and potential registrational study plans later this year. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT06228326.

Intratumoral KB707 for the treatment of injectable solid tumors

The Company continues to follow patients previously enrolled in OPAL-1, the Company’s Phase 1/2 open label, multi-center, dose escalation and expansion study evaluating intratumoral KB707 in patients with locally advanced or metastatic solid tumor malignancies. The Company will update development plans for intratumoral KB707 as additional safety and efficacy data are collected from the study. Details of the study can be found at www.clinicaltrials.gov under NCT identifier NCT05970497.

Aesthetics

KB304 for the treatment of wrinkles of the décolleté

Jeune Aesthetics, Inc., a wholly owned subsidiary of the Company, expects to initiate a Phase 2 study of its lead program KB304 in 2027.

Financial Results for the Three Months Ended March 31, 2026:

Product revenue, net totaled $116.4 million and $88.2 million for the three months ended March 31, 2026 and March 31, 2025, respectively.
Cost of goods sold totaled $6.3 million and $5.0 million for the three months ended March 31, 2026 and March 31, 2025, respectively.
Research and development expenses for the three months ended March 31, 2026 were $15.3 million, inclusive of $2.2 million of stock-based compensation, compared to $14.3 million, inclusive of stock-based compensation of $2.5 million for the three months ended March 31, 2025.
Selling, general, and administrative expenses for the three months ended March 31, 2026 were $41.0 million, inclusive of stock-based compensation of $11.4 million, compared to $32.6 million, inclusive of stock-based compensation of $11.0 million, for the three months ended March 31, 2025.
Net income for the three months ended March 31, 2026 was $55.9 million, or $1.91 per common share (basic) and $1.83 per common share (diluted). Net income for the three months ended March 31, 2025 was $35.7 million, or $1.24 per common share (basic) and $1.20 per common share (diluted).
For additional information on the Company’s financial results for the three months ended March 31, 2026, please refer to the Form 10-Q filed with the SEC.
Financial Guidance

($ in millions) FY 2026 Guidance
Non-GAAP Research and Development ("R&D") and Selling, General and Administrative ("SG&A") expense(1) $175.0 – $195.0
(1) Refer to Non-GAAP Financial Measures section below for additional information. Non-GAAP combined R&D and SG&A expense guidance does not include stock-based compensation as we are currently unable to confidently estimate Full Year 2026 stock-based compensation expense. As such, we have not provided a reconciliation from forecasted non-GAAP to forecasted GAAP combined R&D and SG&A Expense in the above. This could materially affect the calculation of forward-looking GAAP combined R&D and SG&A Expense as it is inherently uncertain.

Conference Call

The Company will host an investor webcast on May 4, 2026, at 8:30 am ET.

Investors and the general public can access the live webcast at:
View Source

For those unable to listen to the live conference call, a replay will be available for 30 days on the Investors section of the Company’s website at www.krystalbio.com.

About VYJUVEK

VYJUVEK is a non-invasive, topical, redosable genetic medicine designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. VYJUVEK is approved in the United States, Europe, and Japan.

U.S. INDICATION

VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.

IMPORTANT SAFETY INFORMATION

Adverse Reactions

The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or View Source

Contraindications

None.

Warnings and Precautions

VYJUVEK gel may be applied by a healthcare provider, a caregiver, or the patient.

After treatment, patients and caregivers should be careful not to touch treated wounds and dressings until the next dressing change.

Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.

Patients should avoid touching or scratching wound sites or wound dressings.

In the event of an accidental exposure flush with clean water for at least 15 minutes.

For more information, see full U.S. Prescribing Information.

(Press release, Krystal Biotech, MAY 4, 2026, View Source [SID1234665059])

On May 4, 2026 MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported that it entered into an expanded royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr). MacroGenics and Sagard entered into the initial ZYNYZ royalty purchase agreement in June 2025.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte Corporation pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones.

Under the terms of the amended royalty purchase agreement, MacroGenics receives a $60 million upfront payment from Sagard and is eligible to receive an additional 2026 sales-based milestone of up to $20 million for the sale of its royalty rights on global net sales of ZYNYZ. All royalty rights will revert back to MacroGenics once Sagard has received total payments of either 1.7x its investment by September 30, 2032, or 2.0x its investment at any time thereafter.

Additional information regarding the expanded royalty purchase agreement is provided in a Current Report on Form 8-K filed by MacroGenics with the U.S. Securities and Exchange Commission.

About ZYNYZ

Zynyz (retifanlimab) is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), indicated in combination with carboplatin and paclitaxel (platinum-based chemotherapy) for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC) in the U.S, Europe and Japan and as a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression or intolerance to platinum-based chemotherapy in the U.S.

Zynyz is also indicated as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in the U.S., EU, Canada and Switzerland.

Zynyz is marketed by Incyte in the U.S.

Zynyz is a registered trademark of Incyte.

(Press release, MacroGenics, MAY 4, 2026, View Source [SID1234665057])

On May 4, 2026 Twist Bioscience Corporation (NASDAQ: TWST), a mid-cap growth and value biotech company, reported financial results and business highlights for the second quarter ended March 31, 2026.

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"We had a strong performance in the first half of fiscal 2026, ending the second quarter with our thirteenth consecutive quarter of growth. Revenue exceeded guidance, coming in at $110.7 million, growth of over 19% compared to the second quarter of 2025," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "As we look ahead, we remain focused on delivering consistent, measurable growth designed to scale over time. We expect to chart toward profitability while simultaneously building on the strong momentum we are seeing across the portfolio. We continue to anticipate achieving adjusted EBITDA breakeven in the fourth quarter of fiscal 2026 while holding gross margin above 52% for the fiscal year."

See "Non-GAAP Information" below for a discussion of the measure adjusted EBITDA.

FISCAL 2026 SECOND QUARTER FINANCIAL RESULTS

•Revenue: Total revenues for the second quarter of fiscal 2026 grew 19% to $110.7 million compared to $92.8 million for the same period of fiscal 2025.
◦DNA Synthesis and Protein Solutions (DSPS) revenue grew 28% to $53.3 million for the second quarter of fiscal 2026 compared to $41.6 million for the same period of fiscal 2025, and grew 4% sequentially, compared to $51.1 million for the first quarter of fiscal 2026.
◦NGS Applications (NGS) revenue grew 12% to $57.4 million for the second quarter of fiscal 2026 compared to $51.1 million for the same period of fiscal 2025, and grew 9% sequentially, compared to $52.6 million for the first quarter of fiscal 2026.
•Cost of Revenues: Cost of revenues for the second quarter of fiscal 2026 increased to $53.6 million compared to $46.8 million for the same period of fiscal 2025.
•Gross Margin: Gross margin for the second quarter of fiscal 2026 increased to 51.6% compared to 49.6% for the same period of fiscal 2025.

•Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2026 decreased to $19.7 million compared to $23.9 million for the same period of fiscal 2025.
•Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of fiscal 2026 were $76.1 million compared to $63.7 million for the same period of fiscal 2025.
•Litigation Settlement: We reached a settlement in principle regarding the securities class action for approximately $17.1 million. $7.2 million was booked for litigation settlement costs, net of recoveries in the second quarter of fiscal 2026.
•Net Loss: Net loss for the second quarter of fiscal 2026 increased to $44.0 million, or $0.71 per share, compared to $39.3 million, or $0.66 per share, for the same period of fiscal 2025.
•Adjusted EBITDA: Adjusted EBITDA for the second quarter of fiscal 2026 was $(13.3) million compared to $(14.8) million for the same period of fiscal 2025. See the table included in this release for a reconciliation between adjusted EBITDA, which excludes litigation settlement costs, and net loss attributable to common stockholders, the most directly comparable GAAP financial measure.
•Cash Position: As of March 31, 2026, the company had approximately $172 million in cash, cash equivalents and short-term investments.

Recent Highlights:

•Shipped products to approximately 2,583 customers in the second quarter of fiscal 2026, versus approximately 2,431 in the same period of fiscal 2025.
•Physically shipped approximately 300,000 genes in the second quarter of fiscal 2026, compared with approximately 227,000 in the same period of fiscal 2025.
•Entered into bispecific licensing agreement to become the co-exclusive provider, together with Invenra, of Invenra’s B-Body bispecific antibody platform, extending Twist’s antibody discovery services.
•Amazon Web Services announced Twist as a wet lab partner for Amazon Bio Discovery, its AI-powered drug discovery application.
•Launched the Twist TrueAmp Library Preparation Kit and Twist PCR-Free WGS Library Preparation Kit, each designed to address a wide range of sample input, including low input and challenging sample types, to enable clinical research.

Fiscal 2026 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2026. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below.

For the full fiscal year 2026, Twist expects:

•Total revenue in the range of $442 million to $447 million, growth of 17% to 19%, compared to prior guidance of $435 to $440 million.
•Gross margin to be above 52% for fiscal 2026

For the third quarter, Twist expects:

•Total revenue of approximately $114 million to $115 million, growth of approximately 19% year over year at the midpoint. As previously discussed, we expect NGS to be the driver of sequential growth in H2 and return to 20% growth by 4Q.

For the fourth quarter, Twist expects:

•To achieve adjusted EBITDA breakeven for the fourth quarter of fiscal 2026

(Press release, Twist Bioscience, MAY 4, 2026, View Source [SID1234665054])

On May 4, 2026 Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of novel nPulse technology using proprietary Nanosecond Pulsed Field Ablation (nanosecond PFA or nsPFA) energy, reported business updates and financial results for the first quarter ended March 31, 2026.

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Recent Business Highlights

Endocardial Catheter AF Ablation

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Announced strategic prioritization of the nPulse Cardiac Catheter System following landmark clinical data, presented at AF Symposium, demonstrating exceptional procedure efficiency and durable outcomes.
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Presented late-breaking data at Heart Rhythm 2026. The expanded data set included increased evaluable patient counts from the first-in-human European feasibility study showing sustained 100% procedural success by Holter monitor at 6 months (95/95 evaluable patients), 96% procedural success by Holter monitor at 12 months (51/53), and 90% Kaplan-Meier estimate of freedom from atrial arrythmias (AF/AFL/AT) at 12 months.

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Commenced enrollment in NANOPULSE-AF, the U.S. IDE pivotal clinical trial, with first patients treated in early April 2026. Enrollment is now anticipated to be completed in early-Q4 2026.

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Added key leadership with Dr. David Kenigsberg transitioning to full-time Chief Medical Officer and Liane Teplitsky joining as Chief Operating Officer to support pivotal trial execution and commercial preparation.

Surgical AF Ablation
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Continued to progress the NANOCLAMP-AF, U.S. IDE pivotal trial for concomitant surgical AF ablation, with enrollment expected to be completed by the end of the first half of 2027.

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Treated over 60 patients to date across three sites in the first-in-human European feasibility study. Electroanatomical mapping results from the three months follow up on 34 patients were presented at the European Heart Rhythm Association 2026 showing 94% durable and consistent pulmonary vein isolations, 100% posterior box isolation, and 41 second average total ablation time, consistent with the positive clinical data reported in October 2025.

Soft Tissue Ablation

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Generated $0.4 million in revenue from nPulse Vybrance capital and disposables.

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Presented data at NASIT demonstrating 74% benign thyroid nodule volume reduction rate with no regrowth at 15-22 months follow-up.

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Completed enrollment of first 50 patients in PRECISE-Benign Thyroid Nodule study, and expanded potential enrollment to 100 patients.

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Enrolled first patients in first-in-human feasibility study for papillary thyroid microcarcinoma in collaboration with MD Anderson Cancer Center, with enrollment expected to complete by year-end 2026.

"This was a defining quarter for Pulse Biosciences. We sharpened our strategic focus on electrophysiology based on landmark clinical outcomes that reinforced the durability and efficiency of AF treatment with the nPulse catheter and commenced enrollment in our U.S. IDE pivotal trial of our nPulse Cardiac Catheter System," said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. "Based on high investigator enthusiasm and early pivotal study progress, we are pleased to update our anticipated enrollment completion timing to early-Q4, 2026. The momentum we are building positions us to advance critical clinical and regulatory milestones that will bring the transformative potential of nanosecond PFA technology to patients and physicians globally."

Ms. Liane Teplitsky joined Pulse Biosciences as Chief Operating Officer and brings a wealth of experience in electrophysiology at this consequential moment of our strategic focus. Her impact on the nPulse Cardiac Catheter program will enable accelerated clinical development, and her impact is already evident through relationships with leading physicians as well as internal and external business leaders.

First Quarter 2026 Financial Results

Total revenue for the three months ended March 31, 2026 was $0.4 million, including both capital and disposable sales.

Total GAAP costs and expenses, representing cost of product revenue, research and development, and selling, general and administrative expenses, for the three months ended March 31, 2026, were $19.6 million, an increase of $1.6 million compared to $18.0 million in the prior year period. The increase was primarily driven by increased investment in clinical programs, partially offset by lower stock-based compensation expense. Non-GAAP costs and expenses for the three months ended March 31, 2026, were $17.4 million, an increase of $4.7 million compared to $12.7 million in the prior year period.

GAAP net loss for the three months ended March 31, 2026 was ($18.6) million compared to ($16.8) million for the three months ended March 31, 2025. Non-GAAP net loss for the three months ended March 31, 2026 was ($16.4) million compared to ($11.4) million for the three months ended March 31, 2025.

Cash and cash equivalents totaled $68.3 million as of March 31, 2026, compared to $119.3 million as of March 31, 2025 and $80.7 million as of December 31, 2025. Cash used in operating activities in the first quarter of 2026 totaled $14.6 million, compared to $13.5 million used in the same period in the prior year, and $14.8 million used in the fourth quarter of 2025. The Company has an ATM program in effect with approximately $60 million of availability. In addition, the Company has an effective $200 million shelf registration statement.

Reconciliations of GAAP to Non-GAAP cost and expenses and net loss have been provided in the tables following the financial statements in this press release. An explanation of these measures is also included below under the heading "Non-GAAP Financial Measures."

Grant of Inducement Options

In May 2026, the Company granted options to four new employees of the Company to purchase a collective total of up to 15,000 shares of Company common stock. These awards were granted as an inducement material to their becoming employees of the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were approved by the Company’s Compensation Committee. The inducement awards were granted on May 2, 2026, pre-market. The options have a ten-year term and an exercise price of $20.83 per share, the closing price per share of the Company’s common stock as reported by Nasdaq on May 1, 2026, the last closing price prior to grant, and all will be subject to time-based vesting over four years, with 1/4 of each award vesting annually, subject to the employee’s continued employment with Pulse Biosciences. The options are subject to the terms and conditions of the 2017 Inducement Equity Incentive Plan, as amended to date, and the award agreements entered into with each recipient.

Webcast and Conference Call Information

Pulse Biosciences’ management will host a conference call Thursday, May 7, 2026, beginning at 1:30pm PT. Investors interested in listening to the conference call may do so by dialing 1-800-715-9871 from the U.S. or 1-646-307-1963 internationally and providing Conference ID 2636693. A live and recorded webcast of the event will be available at View Source

(Press release, Pulse Biosciences, MAY 4, 2026, View Source [SID1234665053])