NUVB

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Exhibit 99.1

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

Achieved $45.0 million in third quarter 2026 total revenue, including $27.5 million in net product revenue for IBTROZI® (taletrectinib)

IBTROZI continues to be the most prescribed ROS1 TKI and established as the ROS1 market leader in new patient starts and total active patients for both first-line and all lines of therapy combined, based on IQVIA claims data

FDA approved a supplemental New Drug Application (sNDA) for IBTROZI, updating label to reflect median duration of response of 49.7 months in TKI-naïve ROS1+ NSCLC patients in TRUST-I

FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma

Cash, cash equivalents, and marketable securities of $663.4 million as of September 30, 2026

Company to host a conference call today at 4:30 p.m. ET

NEW YORK, November 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 third quarter ended September 30, 2026, and provided a business update.

“Just over one year after launch, IBTROZI was established as the market leader in advanced ROS1+ NSCLC, for both new patient starts and active patients across all lines of therapy combined, based on IQVIA claims data,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Our rapid rise to market leadership reflects growing provider confidence in IBTROZI’s durability of more than four years in TKI-naïve patients and a generally favorable safety profile that helps patients stay on therapy. With our recent sNDA approval, the label now reflects IBTROZI’s 49.7-month median duration of response in TRUST-I, giving physicians clear data to guide treatment decisions and supporting its use early in a patient’s care.”

Dr. Hung continued, “The FDA’s recent Fast Track Designation for safusidenib underscores both the significant unmet need in IDH1-mutant glioma and the potential of this investigational medicine to address it. We are moving quickly to advance our comprehensive development program, with two Phase 2 and two pivotal Phase 3 studies spanning multiple IDH1-mutant glioma subpopulations, designed to reach a broad spectrum of patients with this disease.”

Third Quarter 2026 and Recent Highlights:

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

•

In the third quarter of 2026, Nuvation Bio reported $27.5 million in net product revenue for IBTROZI, an 18% quarter-over-quarter growth that reflects the continued adoption and durability of treatment.

•

New patient starts in Q3 remained consistent with the prior quarter at approximately 160 patients, despite an approximately 15% quarter-over-quarter decline in new patient starts across the overall ROS1-positive non-small cell lung cancer (ROS1+ NSCLC) tyrosine kinase inhibitor (TKI) market, based on IQVIA claims data. Of these starts, 65% were TKI-naïve, demonstrating that IBTROZI is becoming standard of care in the first-line treatment setting. The remaining starts, in TKI-pretreated patients, show that physicians also continue to prescribe IBTROZI in later lines.

•

In September 2026, Nuvation Bio announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for IBTROZI, four months ahead of the January 4, 2027, target action date. The updated label reflects a median duration of response (mDOR) of 49.7 months in TKI-naïve patients, based on a median patient follow-up of 51 months from the pivotal TRUST-I study. No changes were made to the safety sections of the label.

•

In September 2026, Nuvation Bio announced new subgroup analyses from the pivotal TRUST-I and TRUST-II studies, presented at the IASLC 2026 World Conference on Lung Cancer (WCLC), showing consistent efficacy across key patient subgroups.

•

In October 2026, Nuvation Bio presented updated TRUST-II efficacy and safety data for IBTROZI in patients previously treated with entrectinib at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.

Safusidenib, mIDH1 inhibitor: IDH1-mutant glioma

•

In August 2026, Nuvation Bio announced that the FDA granted Fast Track Designation to safusidenib for the treatment of IDH1-mutant glioma. The designation was supported by favorable data from the safusidenib clinical program, including updated long-term results from the Phase 2 J201 study, and provides for more frequent interactions with the FDA throughout development.

•

In July 2026, Nuvation Bio announced updated long-term data and new clinical studies for safusidenib:

•

Updated Phase 2 J201 data in patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma showed a centrally assessed ORR of 51.9% at a median follow-up of 38.8 months. Median progression-free survival

(PFS)

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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

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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

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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

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EX-99.1

Exhibit 99.1

Nuvation Bio Reports Preliminary Fourth Quarter and Full Year 2025 Financial Results and Provides 2026 Outlook Ahead of 44th Annual J.P. Morgan Healthcare Conference

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

Preliminary IBTROZI net product revenue of approximately $15.7 million in the fourth quarter and $24.7 million since launch

Preliminary unaudited cash, cash equivalents and marketable securities of approximately $529.2 million as of December 31, 2025

Company to present at 44th Annual J.P. Morgan Healthcare Conference tomorrow, January 13, at 3:45 p.m. PT/6:45 p.m. ET

NEW YORK—January 12, 2026— Nuvation Bio

Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced preliminary fourth quarter and full year 2025 net product revenue for IBTROZI® (taletrectinib) and provided a 2026 outlook ahead of its presentation at the 44th Annual J.P. Morgan Healthcare Conference in San Francisco, CA.

Preliminary Fourth Quarter and Full Year 2025 Financial Results and IBTROZI Commercial Results

•

In the third quarter, the company’s first full quarter of sales, 204 new patients started treatment on IBTROZI for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC)

•

In the fourth quarter, 216 new patients started treatment on IBTROZI for advanced ROS1+ NSCLC, exceeding internal projections and in spite of the holiday-adjacent weeks where new patient starts can be limited in this rare disease

•

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

•

Preliminary fourth quarter and full year 2025 IBTROZI net product revenue was $15.7 million and $24.7 million, respectively

•

Received $25 million milestone payment from Nippon Kayaku as a result of establishment of the reimbursement price in Japan in Q4

•

Preliminary unaudited cash, cash equivalents and marketable securities are expected to be approximately $529.2 million as of December 31, 2025

2026 Priorities and Upcoming Milestones

•

Continue to grow IBTROZI new patient starts in advanced ROS1+ NSCLC, particularly in the first-line setting, while supporting continuity of therapy for current patients to achieve maximum potential benefits

•

Entered exclusive license and collaboration agreement with Eisai Co., Ltd. on January 11, 2026 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

•

Advance the pipeline, including:

•

Continue enrollment of G203 as a phase 3, registration-enabling study evaluating safusidenib in high-grade and high-risk IDH1-mutant gliomas

•

Ongoing evaluation of preclinical candidates from our drug-drug conjugate (DDC) platform

•

Pursue business development opportunities to expand the pipeline and further our mission of tackling some of the toughest challenges in cancer treatment

•

Maintain a robust cash position and strong balance sheet that can support continued investment in future growth

“2025 was a defining year for Nuvation Bio as we evolved into a commercial-stage company with the mid-June FDA approval of IBTROZI in the U.S.,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “In just two full quarters of commercial launch, IBTROZI is now the preferred TKI for people living with advanced ROS1+ NSCLC and their healthcare providers, becoming the new standard of care across treatment lines. This rapid adoption reflects confidence in IBTROZI’s impressive duration of response of over four years and its manageable safety profile.

“We are also incredibly excited about the potential of safusidenib, which delivered promising clinical results in grade 2 IDH1-mutant gliomas and is now in a pivotal trial for high-grade disease as well as low-grade disease with high-risk features, where significant patient needs are unaddressed by the current standard of care. We believe that 2026 will be another important year for our company with a continued focus on bringing IBTROZI to even more patients in the U.S. and around the world, and progressing our promising pipeline with urgency.”

The 2025 net product revenues and cash, cash equivalents and marketable securities included in this release are preliminary and are therefore subject to adjustment. The preliminary net product revenue results are based on management’s initial analysis of operations for the year ended December 31, 2025. The Company expects to issue full financial results for the fourth-quarter

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Exhibit 99.1

Nuvation Bio Reports Third Quarter 2025 Financial Results and Provides Business Update

Successfully started 204 patients on IBTROZITM (taletrectinib) in the third quarter of 2025

Updated data continue to show IBTROZI’s unprecedented durability in TKI-naïve, advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), with median Duration of Response (DOR) increased to 50 months as of August 2025

Enrolled first patient in global, randomized study of safusidenib with registrational intent for maintenance treatment of high-grade IDH1-mutant glioma

Enrolled first patient in TRUST-IV phase 3 study of IBTROZI for the

adjuvant treatment of ROS1+ early-stage NSCLC

Strong balance sheet with cash, cash equivalents, and marketable securities of $549.0 million as of September 30, 2025

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

NEW YORK—November 3, 2025— 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 third quarter ended September 30, 2025, and provided a business update.

“We are thrilled that 204 new patients have received IBTROZI during our first full quarter as a commercial-stage company,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Our early launch progress underscores our team’s expertise in rare disease and ability to execute, as well as the positive sentiment of the community for the value of our medicine. We are also pleased to share that IBTROZI’s robust durability profile continues to mature and now shows a 50-month median duration of response as of the latest August data cut-off.”

Dr. Hung continued, “Our broader pipeline also continues to progress with urgency. After multiple collaborative discussions with the U.S. FDA, we reached alignment on our pivotal study plans for safusidenib and recently dosed our first patient for the maintenance treatment of high-grade IDH1-mutant glioma.”

Third Quarter 2025 and Recent Corporate Highlights:

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

•

In the third quarter, 204 new patients started treatment with IBTROZI.

•

In September 2025, the Company presented new and updated long-term results from the pivotal Phase 2 TRUST-I and TRUST-II studies of IBTROZI at the IASLC 2025 World Conference on Lung Cancer (WCLC), highlighting durability of responses and favorable safety profile across both trials with additional follow-up time.

•

In September 2025, our partner Nippon Kayaku received approval of IBTROZI from Japan’s Ministry of Health, Labour and Welfare for the treatment of patients with advanced ROS1+ NSCLC.

•

The Company will receive a $25 million milestone payment upon the first establishment of the reimbursement price in Japan, which is expected by year end.

•

In September 2025, the Company enrolled the first patient in the TRUST-IV phase 3 study of IBTROZI for the adjuvant treatment of ROS1+ early-stage NSCLC.

•

In October 2025, the Company presented 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 ten patients whose tumors progressed following treatment with entrectinib.

•

Today, the company is announcing that IBTROZI’s median DOR has matured to 50 months as of an August 2025 data cut-off from the pooled TRUST-I and TRUST-II studies.

•

The Company plans to prepare a supplemental New Drug Application (sNDA) to include the updated data in the IBTROZI label and will provide additional data from the August 2025 data cut-off at a medical conference in 2026.

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

•

In October 2025, the Company enrolled the first patient in the G203 study, a global, randomized study of safusidenib for maintenance treatment of high-grade IDH1-mutant glioma.

•

Following an in-progress protocol amendment aligned on with the U.S. Food

and Drug Administration (FDA), the Company plans to enroll 300 patients to support potential approval.

•

Following discussion with the U.S. FDA, the Company has decided not to pursue a head-to-head randomized study of safusidenib against vorasidenib to support approval in non-enhancing grade 2 IDH1-mutant glioma.

•

The Company plans to evaluate safusidenib in high-risk subgroups of

low-grade IDH1-mutant glioma for which vorasidenib is not approved.

NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

•

The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 by year end 2025.

Third Quarter 2025 Financial Results

As of September 30, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $549.0 million.

Product Revenue, Net

To date, our o

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Exhibit 99.1

Nuvation Bio Reports Second Quarter 2025 Financial Results and Provides Business Update

Received U.S. Food and Drug Administration (FDA) approval for IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) on June 11, 2025

Successfully started 70 patients on IBTROZI as of July 31, 2025, approximately seven weeks after U.S. FDA approval

National Comprehensive Cancer Network® added taletrectinib (IBTROZI) as a Preferred Option to Clinical Practice Guidelines in Oncology for advanced ROS1+ NSCLC on June 20, 2025

Strong balance sheet with cash, cash equivalents, and marketable securities of $607.7 million as of June 30, 2025

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

New York, August 7, 2025 – Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, today reported financial results for the second quarter ended June 30, 2025, and provided a business update.

“With FDA approval of IBTROZI, we’re proud of our swift evolution into a commercial-stage company executing across functions to deliver a differentiated therapy to 70 patients in just seven weeks,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Since our launch, we have had the opportunity to make a difference for patients at all different stages of their journey with advanced ROS1-positive NSCLC, including those who are TKI-naïve, those who have progressed on another TKI or early-line treatment, and those who have switched from prior therapy due to tolerability issues or desire for a brain-penetrant, next generation ROS1 TKI. We were also very pleased by the incredibly rapid designation of taletrectinib (IBTROZI) as a preferred option in the NCCN guidelines for advanced ROS1-positive NSCLC across lines of therapy. This recommendation is driven by IBTROZI’s efficacy, safety, and once-daily dosing that further underscore its potential to redefine the standard of care.”

Dr. Hung continued, “Meanwhile, we’re advancing our broader pipeline with urgency, moving safusidenib toward one or more pivotal trials in IDH1-mutant glioma and advancing NUV-1511 through an early study in advanced solid tumors. We look forward to sharing our progress from these programs later this year.”

Second Quarter 2025 and Recent Corporate Highlights:

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

•

In June 2025, the Company received U.S. FDA approval for IBTROZI (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

•

As of July 31, 2025, 70 patients have started treatment with IBTROZI, driven by prescriptions from over 50 different prescribers across community centers, academic centers, and integrated delivery networks.

•

In June 2025, the Company announced that taletrectinib (IBTROZI) has been added as a Preferred Agent in the latest National Comprehensive Cancer Network® Clinical Practice Guidelines (NCCN Guidelines®) in Oncology for NSCLC, updated on June 20. Specifically, the NCCN Guidelines® now include taletrectinib (IBTROZI) as a Preferred Agent for both first-line and subsequent therapy for ROS1+ NSCLC, including specific recommendations for those with brain metastases and resistance mutations.

•

In May 2025, the Company presented new data from a matching-adjusted indirect comparison study evaluating IBTROZI versus entrectinib in ROS1+ NSCLC in a poster session at ISPOR 2025, the Professional Society for Health Economics and Outcomes Research’s annual conference, demonstrating significantly improved outcomes for IBTROZI in TKI-naïve ROS1+ NSCLC.

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

•

The Company published an updated trial design of the randomized Phase 2 study of safusidenib in diffuse IDH1-mutant glioma, which will now evaluate maintenance treatment with safusidenib against placebo in high grade IDH1-mutant glioma.

•

Discussions with the FDA regarding registration-enabling trials of safusidenib are ongoing, and the Company plans

to provide additional updates in the second half of 2025.

NUV-1511, drug-drug conjugate

(DDC): Advanced solid tumors

•

The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 in the second half of 2025.

Corporate Updates

•

In June 2025, the Company received $200 million as part of non-dilutive financing agreements with Sagard Healthcare Partners, including $150 million in royalty interest financing and $50 million under a term loan following U.S. FDA approval of IBTROZI. The Company has access to an additional $50 million under the term loan at its option until June 30, 2026.

Second Quarter 2025 Financial Results

As of June 30, 2025, Nuvation Bio had cash, cash equivalents, and marketable securities of $607.7 million.

Product Revenue, Net

On June 11, 2025, w

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EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports First Quarter 2025 Financial Results and Provides Business Update

New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) under U.S. Food and Drug Administration (FDA) Priority Review; Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025

Published pooled results from pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in Journal of Clinical Oncology demonstrating high response rates, durable responses, and a favorable safety profile

Strong balance sheet with cash, cash equivalents, and marketable securities of $461.7 million as of March 31, 2025

Company to host a conference call today at 4:30 p.m. ET

New York, May 7, 2025 – Nuvation Bio Inc. (NYSE: NUVB), a global oncology company tackling some of the toughest challenges in cancer treatment, today reported financial results for the first quarter ended March 31, 2025, and provided a business update.

“Nuvation Bio continued to execute with focus in the first quarter as we prepare for the potential U.S. approval and launch of taletrectinib for advanced ROS1-positive non-small cell lung cancer,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Data recently published in the Journal of Clinical Oncology and presented at the European Lung Cancer Congress and the American Association for Cancer Research Annual Meeting further reinforce taletrectinib’s potential to deliver a differentiated profile with strong efficacy, high central nervous system activity, and favorable tolerability. We also continue to advance our broader pipeline, including safusidenib and NUV-1511, for which we plan to provide program updates later this year. With a team that has successfully brought numerous oncology therapies to market and a strong balance sheet, we are well-positioned to enter our next chapter as a commercial-stage company.”

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

•

The Priority Review of the Company’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) is progressing on time with all planned inspections now completed. The PDUFA goal date of June 23, 2025 positions Nuvation Bio to commercialize taletrectinib in the U.S., if approved, in mid-2025.

•

In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for adult patients with locally advanced or metastatic ROS1+ NSCLC. As part of an exclusive license agreement, Innovent Biologics is commercializing taletrectinib in Greater China.

•

In February 2025, Nuvation Bio launched an Expanded Access Program (EAP) in the U.S., enabling eligible patients with advanced ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal TRUST-II study.

•

In March 2025, Nippon Kayaku completed submission of a Marketing Authorization Application for taletrectinib for advanced ROS1+ NSCLC to Japan’s Pharmaceuticals and Medical Devices Agency. As part of an exclusive license agreement, Nippon Kayaku will commercialize taletrectinib in Japan.

•

In March 2025, new data from a matching-adjusted indirect comparison study evaluating taletrectinib versus crizotinib in advanced ROS1+ NSCLC were presented at the European Lung Cancer Congress.

•

In April 2025, results from the pivotal Phase 2 TRUST-I and TRUST-II studies were published in Journal of Clinical Oncology.

•

In April 2025, new nonclinical data for taletrectinib in ROS1+ NSCLC were presented at the American Association for Cancer Research Annual Meeting.

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

•

The Company expects to provide an update on the pivotal study design for the safusidenib program in the second half of 2025.

NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

•

The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 in the second half of 2025.

NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

•

As previously announced, the Company is evaluating next steps for the NUV-868 program, including external partnership opportunities or further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.

Corporate Updates:

•

In March 2025, Nuvation Bio secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners. The Company will receive $150 million in royalty interest financing and $50 million in debt upon U.S. FDA approval of taletrectinib by September 30, 2025, with access to an additional $50 million in debt at the Company’s option until June 30, 2026, as long as the Company has achieved first U.S. commercial sale. The royalty interest financing is expected to fully fund the U.S. commercial launch of taletrectinib; the pro forma cash balance is expected to fully fund development of

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EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to the New Drug Application (NDA) for taletrectinib for advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC); Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025

Innovent Biologics’ commercialization of taletrectinib underway in China after recent line agnostic approval for advanced ROS1+ NSCLC; Nippon Kayaku completed submission of a Marketing Authorization Application (MAA) for taletrectinib in Japan for the same indication

Launched an Expanded Access Program (EAP) in the U.S. for taletrectinib for advanced ROS1+ NSCLC in February 2025

Strong balance sheet with cash, cash equivalents, and marketable securities of $502.7 million as of December 31, 2024

Secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners in March 2025

New York, March 6, 2025 – Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.

“Nuvation Bio had a transformative year in 2024, marked by significant milestones. We acquired AnHeart Therapeutics, reported positive pivotal data for taletrectinib, and submitted the NDA for taletrectinib, which was accepted by the U.S. FDA for Priority Review. This sets the stage for a potential U.S. commercial launch following our PDUFA goal date of June 23. We are also proud to now offer an Expanded Access Program in the U.S. for taletrectinib, addressing the urgent needs of patients with advanced ROS1-positive NSCLC,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Beyond taletrectinib, we anticipate further updates in 2025 from our additional pipeline programs, including safusidenib and NUV-1511. With an exceptionally talented team and the closing of our recent non-dilutive financings of up to $250 million, we are well-positioned to continue toward our goal of improving the lives of people with cancer.”

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

•

In December 2024, the U.S FDA accepted and granted Priority Review to the Company’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval). The PDUFA goal date of June 23, 2025, positions Nuvation Bio to commercialize taletrectinib in the U.S., if approved, in mid-2025.

•

In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for adult patients with locally advanced or metastatic ROS1+ NSCLC. As part of an exclusive license agreement, Innovent Biologics is commercializing taletrectinib in Greater China.

•

In February 2025, Nuvation Bio launched an EAP in the U.S., enabling eligible patients with advanced ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal TRUST-II study.

•

In March 2025, Nippon Kayaku completed submission of a MAA for taletrectinib for advanced ROS1+ NSCLC to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). As part of an exclusive license agreement, Nippon Kayaku will commercialize taletrectinib in Japan.

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

•

Safusidenib is a potentially best-in-class, novel, oral, brain penetrant inhibitor of mutant IDH1.

•

Phase 2 study in patients with diffuse IDH1-mutant glioma is ongoing.

NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

•

NUV-1511, the Company’s first clinical-stage DDC, fuses a targeting

agent to a widely used chemotherapy agent.

•

Phase 1/2 dose escalation study in patients with advanced solid tumors is ongoing.

NUV-868, BD2-selective BET inhibitor: Advanced solid tumors

•

As previously announced, the Company is evaluating next steps for the NUV-868 program, including external partnership opportunities or further development in combination with approved products for indications in which BD2-selective BET inhibitors may improve outcomes for patients.

Corporate Update:

•

In March 2025, Nuvation Bio secured up to $250 million in non-dilutive financings from Sagard Healthcare Partners. The Company will receive $150 million in royalty interest financing and $50 million in debt upon U.S. FDA approval of taletrectinib by September 30, 2025, with access to an additional $50 million in debt at the Company’s option after first commercial sale. The royalty interest financing is expected to fully fund the U.S. commercial launch of taletrectinib. The Company’s pro forma cash balance is expected to fully fund development of the Company’s clinical-stage pipeline and create a path to potential profitability without a need for additional fundraising.

Fourth Quarter and Full Year 2024 Financial Results

As of Decemb

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EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Third Quarter 2024 Financial Results and Provides Business Update

Submitted New Drug Application (NDA) for taletrectinib to the U.S. Food and Drug Administration (FDA) in October for the treatment of patients with advanced ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC), positioning Company to commercialize taletrectinib, if approved, as early as mid-2025

Presented positive pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib in patients with advanced ROS1+ NSCLC at the 2024 European Society of Medical Oncology (ESMO) Congress

Appointed industry veteran Philippe Sauvage as the company’s Chief Financial Officer (CFO) in October

Strong balance sheet with cash, cash equivalents, and marketable securities of $549.1 million as of September 30, 2024

New York, November 6, 2024 – Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the third quarter ended September 30, 2024, and provided a business update.

David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio, reflected on the quarter and stated: “In the third quarter, we continued to execute on our goal of bringing taletrectinib to people living with ROS1-positive NSCLC as quickly as possible, which has been our focus since we closed the acquisition of AnHeart Therapeutics earlier this year. In October, we completed the rolling submission of our NDA for line agnostic full approval of taletrectinib in advanced ROS1-positive NSCLC, which was supported by the pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies that we presented at ESMO. We believe that these data – a confirmed objective response rate of 89% and median duration of response approaching four years in the TKI-naïve setting – are the strongest data seen to date in the ROS1 space and increase taletrectinib’s potential to become a best-in-class treatment option. Additionally, we are excited about the momentum of our overall pipeline, including safusidenib, our mutant IDH1 inhibitor for both low- and high-grade diffuse IDH1-mutant glioma, where we plan to make meaningful clinical progress next year, and NUV-1511, our first drug-drug conjugate, which we continue to dose escalate in the clinic.”

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC

•

Completed submission of an NDA for taletrectinib to the U.S. FDA for the treatment of advanced ROS1+ NSCLC (line agnostic) in October, in alignment with feedback from the U.S. FDA as part of a pre-NDA meeting.

•

Company expects the U.S. FDA to accept its NDA submission for full approval as early as year-end 2024, which, if approved, will allow Nuvation Bio to launch taletrectinib in the U.S. as early as mid-2025.

•

Taletrectinib is the only ROS1 tyrosine kinase inhibitor (TKI) currently in development that has received Breakthrough Therapy Designation from the U.S. FDA for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs (line agnostic).

•

Pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies were presented at the 2024 ESMO Congress in September. The pooled analysis supported the Company’s NDA submission for taletrectinib.

•

Key highlights from the pooled analysis include:

•

Confirmed objective responses in 89% of taletrectinib-treated patients with advanced ROS1+ NSCLC who were tyrosine kinase inhibitor (TKI)-naïve and 56% of those who were TKI-pretreated in the study.

•

Taletrectinib demonstrated durable responses and prolonged disease control with long-term follow up; median

duration of response (DOR) and median progression-free survival (PFS) in TKI-naïve patients were 44 months and 46 months, respectively.

•

Taletrectinib’s safety and tolerability profile appeared favorable, including a low treatment discontinuation rate of 7%.

•

Data from the global, pivotal Phase 2 TRUST-II study were presented at the 2024 World Conference on Lung Cancer in September as part of the press program.

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

•

Safusidenib is a potentially best-in-class, novel, oral, brain penetrant inhibitor of mutant IDH1.

•

Phase 2 study of safusidenib in patients with diffuse IDH1-mutant glioma remains ongoing.

NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

•

NUV-1511, the Company’s first clinical-stage DDC, fuses a targeting

agent to a widely used chemotherapy agent.

•

Phase 1/2 dose escalation study of NUV-1511 in patients with various advanced solid tumors remains ongoing.

NUV-868,

BD2-selective BET inhibitor: Advanced solid tumors

•

As previously announced, the Company is evaluating next steps for the NUV-868 program, including further development in combination with approved produ

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EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Second Quarter 2024 Financial Results and Provides Business Update

Efficacy and safety data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, published in the Journal of Clinical Oncology and presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

Company to present pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies at the European Society of Medical Oncology (ESMO) Congress 2024, which will support Nuvation Bio’s planned New Drug Application (NDA) in the United States

Company to present data from the global, pivotal Phase 2 TRUST-II study at the 2024 World Conference on Lung Cancer (WCLC)

Taletrectinib Granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of ROS1-positive non-small cell lung cancer (NSCLC) and other NSCLC indications

Strong balance sheet with cash, cash equivalents, and marketable securities of $577.2 million as of June 30, 2024

New York, August 5, 2024 – Nuvation Bio Inc. (NYSE: NUVB), a late clinical-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology, today reported financial results for the second quarter ended June 30, 2024, and provided a business update.

“In the second quarter, we were pleased to share data at ASCO from TRUST-I, the pivotal study of taletrectinib in China, which although immature due to an early data cutoff, demonstrated taletrectinib’s efficacy, durability, and safety profiles. At WCLC, we will be presenting data from TRUST-II, the global, pivotal Phase 2 study of taletrectinib, while at ESMO we will present more mature and comprehensive taletrectinib data, including pooled efficacy and safety data from both pivotal TRUST-I and TRUST-II studies. The ESMO data set will be used to support our planned NDA filing in the U.S. and, assuming regulatory approval, will position us to commercialize taletrectinib in 2025,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We are also progressing the global Phase 2 study of safusidenib and continuing to dose escalate in a Phase 1/2 study of our first clinical-stage drug-drug conjugate, NUV-1511. As we focus on our late-stage pipeline and prepare to potentially bring taletrectinib to patients in the U.S. in 2025, we have decided not to initiate a Phase 2 study of NUV-868 in the solid tumor indications studied to date. This decision comes after careful review of the data generated in the Phase 1 monotherapy study and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide. We are exploring next steps for NUV-868 in new indications and will share updates as available. We are proud of Nuvation Bio’s transformational momentum in the first half of this year and look forward to building upon it as we tackle some of the greatest unmet needs in oncology.”

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive NSCLC

•

Latest data from the Phase 2 TRUST-I clinical study evaluating taletrectinib in patients in China with advanced ROS1-positive NSCLC was published in the Journal of Clinical Oncology and presented at the 2024 ASCO Annual Meeting.

•

Latest pooled data from the pivotal Phase 2 TRUST-I and TRUST-II studies to be presented at the ESMO Congress 2024 in September, which will support the Company’s planned NDA in the U.S.

•

Latest data from the global, pivotal Phase 2 TRUST-II study to be presented at the WCLC in September.

•

Granted Orphan Drug Designation by the U.S. FDA for the treatment of ROS1-positive NSCLC and other NSCLC indications.

Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma

•

Global phase 2 study of safusidenib for treatment of patients with diffuse IDH1-mutant glioma remains ongoing.

NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors

•

Phase 1/2 dose escalation study of NUV-1511 for the treatment of patients with various advanced solid tumors remains ongoing.

NUV-868,

BD2-selective BET inhibitor: Advanced solid tumors

•

Concluded the Phase 1b dose escalation study of NUV-868 in combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC.

•

Completed an internal analysis of efficacy and safety data collected from the Phase 1 monotherapy and Phase 1b combination studies of NUV-868. Following this analysis, Nuvation Bio decided not to initiate a Phase 2 study of NUV-868 as a monotherapy or in combination with olaparib or enzalutamide in the advanced solid tumor indications that were part of the Phase 1 and Phase 1b study designs. The Company is evaluating next steps for the NUV-868 program, including further development in combination with

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EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports First Quarter 2024 Financial Results and Provides Business Update

Acquisition of AnHeart Therapeutics transformed Nuvation Bio into a late-stage, global oncology company with potential to become a commercial organization by the end of 2025

Updated data from the pivotal Phase 2 TRUST-I clinical study of taletrectinib, a ROS1 inhibitor, to be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

First patient treated in a Phase 1/2 study of NUV-1511, the company’s first drug-drug conjugate (DDC) to enter the clinic, for the treatment of various advanced solid tumors

Strong balance sheet with cash, cash equivalents, and marketable securities of $597.0 million as of March 31, 2024

New York, May 14, 2024 – Nuvation Bio Inc. (NYSE: NUVB), a late-stage, global biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the first quarter ended March 31, 2024, and provided a business update.

“The first quarter of 2024 included multiple significant events for Nuvation Bio. We announced and subsequently completed the acquisition of AnHeart Therapeutics, which transformed Nuvation Bio into a late-stage, global company developing multiple clinical programs for some of the most difficult-to-treat cancers. We also treated the first patient in a Phase 1/2 study of NUV-1511, our first DDC to enter the clinic,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “With our robust cash balance and the recent appointment of Colleen Sjogren as our Chief Commercial Officer, along with some new key hires and the integration of new colleagues from AnHeart, we are thoughtfully scaling our organization to execute on our goal of potentially becoming a commercial organization by the end of 2025, while continuing to advance multiple internal programs in various stages of preclinical and clinical development.”

Recent Pipeline Updates:

Taletrectinib, ROS1 inhibitor: Advanced ROS1-positive non-small cell lung cancer (NSCLC)

•

Taletrectinib is being evaluated for the treatment of patients with advanced ROS1-positive NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I in China, and TRUST-II, a global study.

•

Updated data from the Phase 2 TRUST-I clinical study (NCT04395677) evaluating taletrectinib in patients in China with advanced ROS1-positive NSCLC will be reported in an oral presentation (abstract #8520) at the 2024 ASCO Annual Meeting on Saturday, June 1, 2024, at 4:30-6:30 p.m. CT/5:30-7:30 p.m. ET.

Safusidenib, mIDH1 inhibitor: Grades 2 and 3 IDH1-mutant glioma

•

Safusidenib is being evaluated in a global Phase 2 study for the treatment of patients with grades 2 and 3 IDH1-mutant glioma.

NUV-868, BD2-selective

BET inhibitor: Advanced solid tumors

•

NUV-868 is being evaluated in a Phase 1b dose escalation study in

combination with olaparib for the treatment of patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide for the treatment of patients with mCRPC.

NUV-1511, DDC: Advanced solid tumors

•

NUV-1511, the Company’s first clinical-stage DDC, is being evaluated

in a Phase 1/2 study for the treatment of patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu® and/or Trodelvy® per approved U.S. Food and Drug Administration (FDA) labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, mCRPC, advanced pancreatic cancer, and platinum-resistant ovarian cancer (PROC).

Corporate Updates:

•

Announced entry into a definitive agreement to acquire AnHeart Therapeutics in March 2024 and completed the acquisition in April 2024.

•

Appointed Colleen Sjogren as Chief Commercial Officer. Ms. Sjogren will lead Nuvation Bio’s commercial strategy and operations, including marketing, sales, and market access.

First Quarter 2024 Financial Results

As of March 31, 2024, Nuvation Bio had cash, cash equivalents and marketable securities of $597.0 million.

For the three months ended March 31, 2024, research and development expenses were $12.8 million, compared to $18.8 million for the three months ended March 31, 2023. The decrease was primarily due to a $6.7 million decrease in third-party research services and drug manufacturing costs as a result of completing the Phase 1 monotherapy study of NUV-868, offset by a $0.7 million increase in personnel-related costs driven by stock-based compensation and other benefits.

For the three months ended March 31, 2024, general and administrative expenses were $7.3 million, compared to $7.7 million for the three months ended March 31, 2023. The decrease was due to a $0.5 million decrease in profes

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EX-99.1

Exhibit 99.1

Nuvation Bio Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Determined maximum tolerated dose (MTD) in Phase 1 monotherapy study of NUV-868; Phase 1b

studies of NUV-868 in combination with olaparib or enzalutamide remain ongoing

Received U.S. Food and Drug Administration (FDA) clearance of Investigational New Drug (IND)

application for NUV-1511, the first clinical candidate from our novel drug-drug conjugate (DDC)

platform

Strong balance sheet with cash, cash equivalents and marketable securities of $611.2 million as of December 31, 2023

New York, February 29, 2024 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

“We are pleased to announce completion of a Phase 1 monotherapy study of NUV-868 and determination of a MTD that will help inform our ongoing Phase 1b combination studies. As we announced in January, we received FDA clearance of our IND application for NUV-1511 and look forward to initiating a Phase 1/2 study for the first clinical candidate from our DDC platform in the first half of this year,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Nuvation strongly executed across our pipeline of cancer therapies in 2023 and we plan to build on this progress in 2024 as we remain committed to bringing novel and differentiated therapies to patients with the most difficult-to-treat cancers.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

•

Phase 1 monotherapy study is complete. Nuvation Bio has completed the Phase 1 monotherapy study in advanced solid tumors and determined the MTD in patients.

•

Phase 1b combination studies remain ongoing. Nuvation Bio continues to conduct the Phase 1b studies of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.

NUV-1511, Drug-Drug Conjugate

Platform: Advanced solid tumors

•

IND cleared for first clinical candidate, NUV-1511. Nuvation Bio received IND clearance from the FDA for the treatment of patients with various advanced solid tumors and remains on track to dose the first patient in a Phase 1/2 study of NUV-1511 in the first half of 2024.

Corporate Update:

•

Appointed Dr. Robert Mashal to Board of Directors. Dr. Mashal’s experience as a seasoned pharmaceutical executive and medical oncologist will provide valuable insights.

Fourth Quarter and Full Year 2023 Financial Results

As of December 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $611.2 million.

For the three months ended December 31, 2023, research and development expenses were $15.4 million, compared to $16.9 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.7 million decrease in third-party costs related to research services and manufacturing driven by the termination of the NUV-422 program offset by a $0.2 million increase in personnel-related costs. Research and development expenses for the year ended December 31, 2023 were $71.3 million compared to $87.8 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, general and administrative expenses were $5.5 million, compared to $7.4 million for the three months ended December 31, 2022. The decrease was primarily due to a $1.3 million decrease in personnel-related costs, $0.6 million decrease in insurance, a $0.2 million decrease in professional fees, a $0.1 million decrease in taxes and a $0.1 million decrease in miscellaneous expenses offset by $0.2 million increase in legal fees, and a $0.2 million increase in occupancy. General and administrative expenses for the year ended December 31, 2023 were $28.5 million compared to $31.9 million for the year ended December 31, 2022.

For the three months ended December 31, 2023, Nuvation Bio reported a net loss of $13.8 million, or $(0.06) per share. This compares to a net loss of $20.8 million, or $(0.10) per share, for the comparable period in 2022. Net loss for the year ended December 31, 2023 was $75.8 million compared to $104.2 million for the year ended December 31, 2022.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded i

EX-99.1

2 d563136dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Third Quarter 2023 Financial Results and Provides Business Update

Phase 1 monotherapy study of NUV-868 and Phase 1b study of NUV-868 in combination with olaparib or enzalutamide are ongoing

Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023

Strong balance sheet with cash, cash equivalents, and marketable securities of $619.3 million as of September 30, 2023

New York, November 2, 2023 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the third quarter ended September 30, 2023, and provided a business update.

“We remain focused on strong clinical execution of our NUV-868 program for advanced solid tumors,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We look forward to expanding our clinical pipeline with an IND submission for our first DDC clinical candidate expected before the end of the year, building upon our unwavering commitment to bringing transformative cancer therapies to patients who need them most.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid

tumors

•

Dosing underway in the Phase 1 monotherapy study and both regimens of the Phase 1b combination study. Nuvation Bio continues to treat patients in the Phase 1 monotherapy study of NUV-868 in advanced solid tumors, the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and the Phase 1b study of NUV-868 in combination with enzalutamide in patients with mCRPC.

Drug-Drug Conjugate Platform: Solid tumors

•

Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.

Third Quarter 2023 Financial Results

As of September 30, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $619.3 million. For the three months ended September 30, 2023, research and development expenses were $18.6 million, compared to $21.3 million for the three months ended September 30, 2022. The decrease was primarily due to a $0.7 million decrease in personnel-related costs driven by a headcount reduction as well as a $2.0 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.

For the three months ended September 30, 2023, general and administrative expenses were $7.8 million, compared to $8.1 million for the three months ended September 30, 2022. The decrease was primarily due to a $0.6 million decrease in insurance and a $0.1 million decrease in recruiting and computer expenses offset by a $0.4 million increase in personnel-related costs driven by stock-based compensation and other benefits.

For the three months ended September 30, 2023, Nuvation Bio reported a net loss of $19.6 million, or $(0.09) per share. This compares to a net loss of $27.2 million, or $(0.12) per share, for the comparable period in 2022.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These

forward-looking statements include, but are not limited to, statements regarding the potential therapeutic benefit of Nuvation Bio’s product candidates, the expected continued momentum of Nuvation Bio’s clinical trials and the expected

timing of an IND filing for Nuvation Bio’s first DDC clinical candidate.

EX-99.1

2 d517241dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Second Quarter 2023 Financial Results and Provides Business Update

Enrollment ongoing in the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide

Enrollment ongoing in the Phase 1 monotherapy study of NUV-868

Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023

Announced formation of oncology-focused Scientific Advisory Board

Strong balance sheet with cash, cash equivalents and marketable securities of $630.9 million as of June 30, 2023

New York, August 3, 2023 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the second quarter ended June 30, 2023, and provided a business update.

“We continue to enroll patients in the Phase 1 and Phase 1b studies of NUV-868 where dose escalation is ongoing. We also look forward to expanding our pipeline as we progress our first nominated DDC clinical candidate toward an IND filing, which we expect by the end of 2023,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “Lastly, we announced the formation of our Scientific Advisory Board, composed of leading experts in oncology drug and clinical development. We are excited to work alongside them to bring innovative new therapies to cancer patients.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

•

Dosing underway in both regimens of the Phase 1b combination study. Nuvation Bio continues to enroll the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.

•

Dosing underway in the Phase 1 monotherapy study. Nuvation Bio continues to enroll the Phase 1 monotherapy study in advanced solid tumors.

Drug-Drug Conjugate Platform: Solid tumors

•

Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.

Corporate Updates

•

Announced formation of oncology-focused Scientific Advisory Board. The Scientific Advisory Board will work

alongside the Nuvation Bio management team to advance its pipeline of therapeutic candidates for some of the most difficult-to-treat cancers.

Second Quarter 2023 Financial Results

As of June 30, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $630.9 million. For the three months ended June 30, 2023, research and development expenses were $18.6 million, compared to $28.9 million for the three months ended June 30, 2022. The decrease was primarily due to a $0.7 million decrease in personnel-related costs driven by a headcount reduction as well as a $9.6 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.

For the three months ended June 30, 2023, general and administrative expenses were $7.5 million, compared to $8.9 million for the three months ended June 30, 2022. The decrease was primarily due to a $0.6 million decrease in insurance, a $0.6 million decrease in recruiting and computer expenses, a $0.6 million decrease in legal fees and a $0.2 million decrease in other professional fees offset by a $0.6 million increase in personnel-related costs driven by stock-based compensation and other benefits.

For the three months ended June 30, 2023, Nuvation Bio reported a net loss of $20.6 million, or $(0.09) per share. This compares to a net loss of $34.9 million, or $(0.16) per share, for the comparable period in 2022.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimat

EX-99.1

2 d301084dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports First Quarter 2023 Financial Results and Provides Business Update

Enrollment ongoing in the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide

Enrollment ongoing in the Phase 1 monotherapy study of NUV-868

Expect to submit an IND for first Drug-Drug Conjugate (DDC) clinical candidate by year end 2023

Strong balance sheet with cash, cash equivalents and marketable securities of $646.6 million as of March 31, 2023

New York, May 4, 2023 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the first quarter ended March 31, 2023, and provided a business update.

“We saw strong clinical execution in the first quarter as we continued to enroll patients in the Phase 1 monotherapy and Phase 1b combination studies of NUV-868,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We look forward to submitting an IND for our first DDC clinical candidate by the end of this year, demonstrating our ongoing effort to tackle some of the greatest unmet needs in oncology.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

•

Dosing underway in both regimens of the Phase 1b combination study. The Company continues to enroll the Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer and other solid tumors, and in combination with enzalutamide in patients with mCRPC.

•

Dosing underway in the Phase 1 monotherapy study. The Company continues to enroll the Phase 1 monotherapy study in advanced solid tumors.

Drug-Drug Conjugate Platform: Solid tumors

•

Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.

First Quarter 2023 Financial Results

As of March 31, 2023, Nuvation Bio had cash, cash equivalents and marketable securities of $646.6 million.

For the three months ended March 31, 2023, research and development expenses were $18.8 million, compared to $20.7 million for the three months ended March 31, 2022. The decrease was primarily due

to a $1.3 million decrease in personnel-related costs driven by a headcount reduction as well as a $0.6 million decrease in third-party costs related to research services and manufacturing primarily due to the termination of the NUV-422 program.

For the three months ended March 31, 2023, general and administrative expenses were $7.7 million, compared to $7.5 million for the three months ended March 31, 2022. The increase was primarily due to a $1.1 million increase in personnel-related costs driven by stock-based compensation and other benefits offset by a $0.3 million decrease in insurance, a $0.3 million decrease in legal fees and a $0.3 million decrease in other professional fees.

For the three months ended March 31, 2023, Nuvation Bio reported a net loss of $21.7 million, or $(0.10) per share. This compares to a net loss of $21.3 million, or $(0.10) per share, for the comparable period in 2022.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These

forward-looking statements include, but are not limited to, statements regarding the potential therapeutic benefit of Nuvation Bio’s product candidates, the expected continued momentum of Nuvation Bio’s clinical trials and the expected

timing of an IND filing for Nuvation Bio’s first DDC c

EX-99.1

2 d481540dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Nuvation Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update

Initiated both dosing regimens of the Phase 1b study of NUV-868 in combination with olaparib or enzalutamide

Dosing ongoing for Phase 1 monotherapy study of NUV-868

Nominated undisclosed Drug-Drug Conjugate (DDC) as first clinical candidate; expect to submit an IND by year end 2023

Strong balance sheet with cash, cash equivalents and marketable securities of $661.0 million as of December 31, 2022

New York, March 15, 2023 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.

“In the fourth quarter, we dosed the first patient in both dosing regimens of our Phase 1b study of NUV-868 in combination with olaparib or enzalutamide. This milestone sustains the program’s strong momentum, which we expect to continue in 2023. As we advance the Phase 1 monotherapy and combination studies of NUV-868, we look forward to more deeply understanding how this therapy may be able to improve the lives of patients with advanced solid tumors,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. “We also expect to submit an IND for the first clinical candidate from our DDC platform by the end of the year.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

•

Dosed the first patient in both dosing regimens of the Phase 1b combination study. In December 2022, Nuvation Bio initiated a Phase 1b study of NUV-868 in combination with olaparib in patients with ovarian cancer, pancreatic cancer, metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer, and other solid tumors, and in combination with enzalutamide in patients with mCRPC.

•

Dosing underway in the Phase 1 monotherapy study. The Company continues to enroll the Phase 1 monotherapy study in advanced solid tumors.

Drug-Drug Conjugate Platform: Solid tumors

•

Nominated first clinical candidate. Nuvation Bio expects to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023.

Fourth Quarter and Full Year 2022 Financial Results

As of December 31, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $661.0 million.

For the three months ended December 31, 2022, research and development expenses were $16.9 million, compared to $22.0 million for the three months ended December 31, 2021. The decrease was primarily due to a $3.7 million decrease in third-party costs related to research services and manufacturing, as well as a $1.5 million decrease in personnel-related costs driven by the termination of the NUV-422 program offset by a $0.1 million increase in miscellaneous expenses. Research and development expenses for the year ended December 31, 2022 were $87.8 million compared to $69.0 million for the year ended December 31, 2021.

For the three months ended December 31, 2022, general and administrative expenses were $7.4 million, compared to $7.6 million for the three months ended December 31, 2021. The decrease was primarily due to a $0.4 million decrease in legal fees, a $0.2 million decrease in professional fees, and a $0.2 million decrease in miscellaneous expenses offset by a $0.5 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation and a $0.1 million increase in taxes. General and administrative expenses for the year ended December 31, 2022 were $31.9 million compared to $24.3 million for the year ended December 31, 2021.

For the three months ended December 31, 2022, Nuvation Bio reported a net loss of $20.8 million, or $(0.10) per share. This compares to a net loss of $25.1 million, or $(0.12) per share, for the comparable period in 2021. Net loss for the year ended December 31, 2022 was $104.2 million compared to $86.8 million for the year ended December 31, 2021.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press releas

EX-99.1

2 d410431dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Privileged and confidential

Nuvation Bio Reports Third Quarter 2022 Financial Results and Provides

Business Update

Dosing underway for Phase 1 monotherapy study of NUV-868 in advanced solid tumors

Expect to initiate Phase 1b combination study of NUV-868 by the end of 2022

On track to nominate first clinical candidate from Drug-Drug Conjugate (DDC) platform by the end of 2022

Strong financial position provides cash runway through 2028; cash, cash equivalents and marketable securities of $673.9 million as of September 30, 2022

New York, November 3, 2022 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the third quarter ended September 30, 2022, and provided a business update.

“We are encouraged by the continued clinical progress of NUV-868 and look forward to the initiation of Phase 1b combination cohorts later this year, which we anticipate will provide better understanding of the potential benefit this therapy can offer a wide range of patients with advanced solid tumors,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “We also expect to nominate the first clinical candidate from our DDC platform by the end of 2022, underscoring the growth-driving capabilities of this platform as we work to tackle some of the greatest unmet needs in oncology.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid

tumors

•

Dosing ongoing in the Phase 1 monotherapy study of NUV-868. Nuvation Bio continues to enroll the Phase 1 monotherapy study in advanced solid tumors. The Company expects to initiate the Phase 1b study of NUV-868 in combination with olaparib in ovarian, pancreatic, metastatic castration-resistant prostate and triple negative breast cancers, or in combination with enzalutamide in metastatic castration-resistant prostate cancer, by the end of 2022.

Drug-Drug Conjugate Platform: Solid tumors

•

Nomination of first clinical candidate from the DDC platform is expected by the end of 2022.

Third Quarter 2022 Financial Results

As of September 30, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $673.9 million.

Privileged and confidential

For the three months ended September 30, 2022, research and development expenses were $21.3 million, compared to $17.1 million for the three months ended September 30, 2021. The increase was primarily due to restructuring costs of $1.6 million related to severance and benefit costs and $5.7 million related to contract termination costs offset by $2.8 million decrease in third-party costs related to research services and manufacturing, as well as a $0.3 million decrease in personnel-related costs driven by the termination of the NUV-422 program.

For the three months ended September 30, 2022, general and administrative expenses were $8.0 million, compared to $5.7 million for the three months ended September 30, 2021. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $0.2 million increase in occupancy expenses, a $0.1 million increase in professional fees, and a $0.1 million of restructuring costs related to severance and benefit costs.

For the three months ended September 30, 2022, Nuvation Bio reported a net loss of $27.2 million, or $(0.12) per share. This compares to a net loss of $22.0 million, or $(0.11) per share, for the comparable period in 2021.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These

forward-looking statements i

EX-99.1

2 d312793dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Privileged and confidential

Nuvation Bio Reports Second Quarter 2022 Financial Results and Provides Business Update

Dosing underway for Phase 1 monotherapy study of NUV-868 in advanced solid tumors

Strong financial position provides cash runway through 2028; cash, cash equivalents and marketable securities of $703.8 million as of June 30, 2022

New York, August 4, 2022 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today reported its financial results for the second quarter ended June 30, 2022, and provided a business update.

“We are committed to advancing innovative therapies as quickly and safely as possible for people with cancers that do not currently have adequate treatment options. As previously announced, this commitment has led us to re-prioritize our pipeline and focus on our BET inhibitor, NUV-868, which is progressing in an ongoing Phase 1 study, and our novel small molecule DDC platform,” said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. “With $703.8 million in cash, cash equivalents and marketable securities as of June 30, 2022, and our experienced team — including our new Chief Medical Officer, David Liu, M.D., Ph.D., and our new Chief Regulatory Officer, Kerry Wentworth — we are well positioned to advance our programs for the benefit of patients and our stakeholders.”

Recent Business Updates

NUV-868, BD2-Selective BETi: Advanced solid tumors

•

Dosing underway in the Phase 1 monotherapy study of NUV-868. The recently initiated Phase 1 study in advanced solid tumors, including ovarian, pancreatic, metastatic castration-resistant prostate and triple negative breast cancers, is designed to determine the safety and dose of NUV-868 to be used as a monotherapy and in combination with olaparib or enzalutamide for the Phase 2 and Phase 2b portions of the study.

Corporate Updates

•

Strengthened executive management team. The Company appointed David Liu, M.D., Ph.D., as Chief Medical Officer in July 2022, and Kerry Wentworth as Chief Regulatory Officer in May 2022. Both leaders are also part of the Executive Committee.

Second Quarter 2022 Financial Results

As of June 30, 2022, Nuvation Bio had cash, cash equivalents and marketable securities of $703.8 million.

For the three months ended June 30, 2022, research and development expenses were $28.9 million, compared to $14.0 million for the three months ended June 30, 2021. The increase was primarily due to a $12.3 million increase in third-party costs related to research services and manufacturing to advance our current preclinical programs and Phase 1/2 clinical trial, as well as a $2.5 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation.

Privileged and confidential

For the three months ended June 30, 2022, general and administrative expenses were $8.9 million, compared to $6.4 million for the three months ended June 30, 2021. The increase was primarily due to a $1.9 million increase in personnel-related costs driven by an increase in headcount and stock-based compensation, a $0.4 million increase in other miscellaneous expenses, a $0.1 million increase in legal fees, a $0.1 million increase in taxes, a $0.1 million increase in occupancy expenses, and a $0.1 million increase in insurance, offset by a $0.2 million decrease in professional fees.

For the three months ended June 30, 2022, Nuvation Bio reported a net loss of $34.9 million, or $0.16 per share. This compares to a net loss of $19.3 million, or $0.09 per share, for the comparable period in 2021.

On August 1, 2022, Nuvation Bio announced a restructuring, including a 35% workforce reduction, to reduce operating costs and align its organization with its re-prioritized development programs.

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “es

EX-99.1

2 d379263dex991.htm

EX-99.1

EX-99.1

Exhibit 99.1

Privileged and confidential

Nuvation Bio Announces Discontinuation of NUV-422

Clinical Development Program

Company prioritizes NUV-868, its BD2 selective BET inhibitor currently in a Phase 1 dose escalation

study in advanced solid tumors, and its novel small molecule Drug-Drug Conjugate (DDC) platform

Company restructuring and cost savings associated with NUV-422 program discontinuation to extend cash runway through 2028

New York, August 1, 2022 – Nuvation Bio Inc. (NYSE: NUVB), a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that it will prioritize NUV-868 and development of its novel small molecule DDC platform and discontinue clinical development of NUV-422.

The decision to discontinue clinical development of NUV-422 is the result of an internal risk-benefit analysis

factoring in feedback received from the U.S. Food and Drug Administration (FDA) in a partial clinical hold letter for the Company’s monotherapy Phase 1/2 study (Protocol NUV-422-02) and clinical hold letters for its combination Phase 1b/2 studies (Protocols NUV-422-03 and NUV-422-04). The FDA verbally placed a partial clinical hold on the Phase 1 dose escalation portion of the Company’s NUV-422-02 study in June 2022. At that time, the Company had proactively paused enrollment of new patients following the emergence of a safety signal, uveitis, which is a form of inflammation of the eye. Furthermore, the FDA requested a mitigation plan to address the adverse event of uveitis. Given that the etiology of uveitis associated with NUV-422 is not understood and that its development appears unpredictable, the Company believes that it would be difficult to craft an effective mitigation plan without significant further research.

Nuvation Bio will intensify its focus and concentrate its resources on the clinical development of NUV-868, its BD2-selective BET inhibitor, and identifying a lead clinical candidate from its novel small molecule DDC platform. Enrollment is ongoing in the Phase 1 monotherapy study of NUV-868, and the Company has planned Phase 1b studies of NUV-868 in combination with olaparib or enzalutamide to enhance the potential value of this program across multiple tumor types.

A reduction in work force of 35% and other cost savings associated with the NUV-422 program discontinuation will enable Nuvation Bio to extend its cash runway through 2028. The Company expects to report a balance of approximately $703.8 million in cash, cash equivalents and marketable securities as of June 30, 2022.

“Nuvation Bio was founded on a commitment to advance a broad pipeline of innovative therapies as quickly and safely as possible for people with cancers that do not currently have adequate treatment options. As part of this commitment, we have always operated as a scientifically rigorous, data-driven company. Following an extensive analysis of the Phase 1 dose escalation study of NUV-422 in solid tumors, we made the determination that uveitis cannot be safely managed. We sincerely thank all patients and investigators who were part of the NUV-422 clinical program for their prodigious efforts. We also thank our employees for their commitment to the Nuvation Bio mission. It was a difficult decision to discontinue the program and we are extremely grateful for each of their contributions,” said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio.

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Dr. Hung added: “We believe that our disciplined, data-driven and timely decision to prioritize our other programs over the NUV-422 program based on our most recent clinical data serves to increase our probability of ultimate success in our efforts to bring game-changing drugs to patients who desperately need them. To that end, we are excited to continue enrolling patients in the NUV-868 Phase 1 study and are encouraged by our progress with our novel small molecule DDC platform. With a robust cash balance and a world class drug development team, we are well positioned to progress these priority programs in some of the most difficult-to-treat cancers.”

About Nuvation Bio

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Nuvation Bio’s proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world’s leading prostate cancer medicines. Nuvation Bio has offices in New York and San Francisco. For more information, please visit www.nuvationbio.com.

Forward Looking Statements

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