AI Earnings Predictions for Nuvation Bio Inc. (NUVB)

EX-99.1

2 d261840dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Second Quarter 2026 Financial Results and Provides Business Update

Achieved $31.7 million in second quarter 2026 total revenue, including $23.2 million in net product revenue for IBTROZI® (taletrectinib)

IBTROZI is the most prescribed ROS1 TKI in in both first-line and overall new patient starts in 2026 based on IQVIA claims from first five months of the year

~85% of the approximately 160 new patients were TKI-naïve, representing QoQ growth of ~30% in this setting

Announced positive updated long-term Phase 2 data for safusidenib and significant expansion of clinical program to address broad spectrum of IDH1-mutant glioma

Robust balance sheet with cash, cash equivalents, and marketable securities of $661.0 million as of June 30, 2026; additional $36.5 million in net proceeds secured in July 2026 from exercise of the convertible senior notes overallotment option

Company to host a conference call today at 8:00 am ET

NEW YORK—August 6, 2026— Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the second quarter ended June 30, 2026, and provided a business update.

“IBTROZI is now the most prescribed ROS1 TKI in both first-line and overall new patient starts in 2026, based on IQVIA claims data from the first five months of the year, reflecting the medical community’s growing conviction that IBTROZI’s durability profile belongs at the front of the treatment sequence. Consistent with this, approximately 85% of new prescriptions this quarter were for TKI-naïve patients who have the potential to be on therapy for many years. The continued shift toward TKI-naïve use highlights the increasing recognition of our long-term follow-up data in TRUST-I, which show a confirmed 90% response rate and a median duration of response of 50 months,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “This efficacy profile, combined with a generally tolerable safety profile and as the only brain-penetrant ROS1 inhibitor today without a CNS warning and precaution in its label, reinforces our belief that IBTROZI is becoming the standard of care for patients with advanced ROS1-positive NSCLC.”

Dr. Hung continued, “We are equally excited about the progress of safusidenib, with our updated Phase 2 data showing further deepening and durable responses in IDH1-mutant gliomas. We now plan to evaluate the potential of this investigational medicine across the broad spectrum of patients in hopes of fulfilling our ultimate goal of providing an effective therapy for nearly every patient with this disease. During the second quarter, we also strengthened our balance sheet through our convertible notes offering, providing us with the financial flexibility to continue to invest in growing our portfolio.”

Second Quarter 2026 and Recent Highlights:

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

•

In the second quarter of 2026, Nuvation Bio reported $23.2 million in net product revenues for IBTROZI, and a 25% quarter-over-quarter growth that reflects the continued adoption and durability of treatment.

•

Importantly, about 85% of the approximately 160 new patient starts were TKI-naïve, which is about a 30% quarter-over-quarter growth in this treatment setting.

•

In June 2026, Nuvation Bio announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) validated the Marketing Authorisation Application (MAA) submitted by partner Eisai Co., Ltd. for taletrectinib for the treatment of advanced ROS1-positive non-small cell lung cancer (ROS1+ NSCLC).

•

In May 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for IBTROZI with updated efficacy data in TKI-naïve and TKI-pretreated advanced ROS1+ NSCLC, with a target action date of January 4, 2027. The submission includes an additional 10 months of data from the pivotal TRUST-I and TRUST-II studies as of an August 2025 data cutoff, demonstrating a median duration of response (mDOR) of 49.7 months and median progression-free survival (mPFS) of 49.6 months in TKI-naïve patients in TRUST-I and mDOR of 19.4 months in TKI-pretreated patients in TRUST-II. In the TRUST-II study, the mDOR had not yet been reached in TKI-naïve patients at the time of the data cutoff and is subject to change as the data mature. Importantly, the safety profile remained consistent with prior reports, and no new signals were identified.

•

In May 2026, Nuvation Bio announced new patient-reported outcomes data from the pivotal TRUST-II study of IBTROZI in patients with advanced ROS1+ NSCLC, presented at the 2026 ASCO Annual Meeting. Findings showed that 88% of patients reported improved or stable global health quality-of-life scores at first assessment, cognitive function scores improv

EX-99.1

2 d132166dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports First Quarter 2026 Financial Results and Provides Business Update

Achieved $18.5 million in first quarter of 2026 net product revenues for IBTROZI® (taletrectinib); majority

of the approximately 200 patients started on IBTROZI in the first quarter of 2026 were TKI-naïve,

highlighting continued momentum in the first-line setting

Presented newly updated clinical data demonstrating IBTROZI’s impressive durability of response and

progression-free survival in TKI-naïve and

TKI-pretreated patients with advanced ROS1-positive

(ROS1+)

non-small cell lung cancer (NSCLC) at AACR 2026

Announced acquisition of Japan rights to safusidenib from Daiichi Sankyo, enabling global development and

commercialization of promising investigational medicine

Strong balance sheet with cash, cash equivalents, and marketable securities of $533.7 million as of

March 31, 2026

Company to host a conference call today at 4:30 pm ET

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

“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 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) 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 Marc

EX-99.1

2 d15383dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Successfully started 216 patients on IBTROZI® (taletrectinib) in the fourth quarter of 2025, for a total of 432 new patient starts since launch in the second half of June 2025

Entered into exclusive licensing and collaboration agreement with Eisai on January 11, 2026, for taletrectinib in Europe and additional countries outside U.S., China and Japan

Published positive Phase 2 study results for safusidenib demonstrating durable responses for the treatment of grade 2 IDH1-mutant glioma

Strong balance sheet with cash, cash equivalents, and marketable securities of $529.2 million as of December 31, 2025

Company to host a conference call today at 4:30 pm ET

NEW YORK—March 2, 2026— Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

“We ended our transformational 2025 with a strong fourth quarter that underscored IBTROZI’s rapid adoption, and we believe our medicine is becoming the new standard of care for people living with advanced ROS1+ NSCLC across treatment lines. In 2026, we look forward to further building upon our successful U.S. launch, and partnering closely with Eisai to bring IBTROZI to more patients around the globe,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We are also excited and eager to progress our promising pipeline, with safusidenib now being studied in the pivotal Phase 3 SIGMA trial across those living with high-risk and high-grade IDH1-mutant glioma where significant needs exist for these patients. Lastly, we continue to evaluate additional internal preclinical candidates and external business development opportunities in hopes of furthering our mission to tackle some of the toughest challenges in cancer treatment.”

Fourth Quarter 2025 and Recent Corporate Highlights:

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

•

In the fourth quarter of 2025, 216 new patients started treatment on IBTROZI for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), reflecting the high rate of adoption and confidence in IBTROZI among healthcare professionals and patients.

•

With 432 new patients started since launch in the second half of June 2025, the treatment adoption rate is approximately six times greater than that of prior recent ROS1 tyrosine kinase inhibitor (TKI) launches based on IQVIA data.

•

On January 11, 2026, the Company 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, the Middle East, North Africa, Russia, Turkey, Canada, Australia, New Zealand, Singapore, the Philippines, Indonesia, Thailand, Malaysia, Vietnam, and India.

•

In the fourth quarter of 2025, the Company received a $25 million milestone payment from Nippon Kayaku as a result of establishing the reimbursement price in Japan.

•

In October 2025, the Company presented clinical data from the pivotal TRUST-II study evaluating IBTROZI in patients previously treated with entrectinib, a brain-penetrant ROS1 therapy at the European Society of Medical Oncology (ESMO) Congress 2025.

•

IBTROZI demonstrated a confirmed overall response rate of 80% in 10 patients whose tumors progressed following treatment with entrectinib.

Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma

•

In December 2025, the Company announced the publication of positive results from a Phase 2 study of safusidenib in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant gliomas. The findings were first published online on November 8, 2025, in Neuro-Oncology.

•

Safusidenib demonstrated durable responses, with an ORR of 44% and 88% of patients were progression-free at 24 months.

•

The findings supported favorable interactions with the U.S. Food and Drug Administration (FDA) and the now finalized protocol amendment making the SIGMA study (G203) a Phase 3, pivotal trial evaluating safusidenib maintenance treatment in high-risk and high-grade IDH1-mutant gliomas. The study now also includes an additional exploratory cohort in grade 3 oligodendroglioma.

•

In October 2025, the Company enrolled the first patient in the global SIGMA study (G203).

Fourth Quarter and Full Year 2025 Financial Results

As of December 31, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $529.2 million.

Product Revenue, Net

To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began distributing IBTROZI to our U.S. customers in June 2025. Net product revenue from U.S. sales of IBTROZI was approximately $15.7 million and $24.7 million for