The earnings call highlights significant progress towards the potential approval and launch of taletrectinib, underpinned by strong clinical data and a solid financial position. However, there are concerns about the increased net loss and potential challenges in achieving rapid market penetration.

Company Guidance

During the Nuvation Bio First Quarter 2025 Financial Results and Business Update Conference Call, the company provided comprehensive guidance on several key metrics related to their anticipated FDA approval and launch of taletrectinib, a next-generation ROS1 inhibitor for non-small-cell lung cancer (NSCLC). The call highlighted taletrectinib's impressive clinical trial metrics, including an 89% confirmed overall response rate (ORR) in treatment-naïve patients, a median progression-free survival (PFS) of 46 months, and a median duration of response (DOR) of 44 months. The company underscored the drug’s strong intracranial activity, with a 77% confirmed intracranial ORR in treatment-naïve patients with brain metastases, and a favorable safety profile with low discontinuation rates. Nuvation Bio is preparing for a U.S. commercial launch with a seasoned team and a market strategy aimed at maximizing early use and long-term persistence. Financially, the company reported R&D expenses of $24.6 million and SG&A expenses of $35.4 million for the first quarter, ending with $461.7 million in cash and cash equivalents, supplemented by a $250 million non-dilutive financing agreement with Sagard Healthcare Partners. Their financial strategy focuses on minimizing additional capital needs to achieve profitability, with the primary KPI post-approval being the number of patients on therapy.

Taletrectinib's Potential FDA Approval

Taletrectinib is expected to receive FDA approval by June 23, 2025, marking a significant milestone for Nuvation Bio as it transitions to a commercial-stage company.

Clinical Trial Success for Taletrectinib

Taletrectinib demonstrated an 89% overall response rate in treatment-naïve patients, with a median progression-free survival of 46 months and a median duration of response of 44 months.

Positive Safety Profile

Taletrectinib has shown a low discontinuation rate of 6.5% and manageable adverse events, making it a well-tolerated treatment option.

Strong Financial Position

Nuvation Bio ended the quarter with $461.7 million in cash and a $250 million non-dilutive financing agreement with Sagard Healthcare Partners.

Strategic Commercial Readiness

Nuvation Bio has a veteran commercial team with a focused strategy to launch taletrectinib effectively and efficiently upon approval.

Nuvation Bio (NUVB) Earnings, Revenues Date & History

The upcoming earnings date is based on a company’s previous reporting, and may be updated when the actual date is announced

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NUVB Earnings History

Report Date	Fiscal Quarter	Forecast / EPS	Last Year's EPS	EPS YoY Change	Slides	Play Transcript
Nov 05, 2025	2025 (Q3)	-0.17 / -	-0.15	―	―	―
Aug 07, 2025	2025 (Q2)	-0.17 / -0.17	-1.89	91.01% (+1.72)	―
May 07, 2025	2025 (Q1)	-0.15 / -0.16	-0.07	-128.57% (-0.09)	―
Mar 06, 2025	2024 (Q4)	-0.13 / -0.15	-0.06	-150.00% (-0.09)	―	―
Nov 06, 2024	2024 (Q3)	-0.13 / -0.15	-0.09	-66.67% (-0.06)	―	―
Aug 05, 2024	2024 (Q2)	-0.06 / -1.89	-0.09	-2000.00% (-1.80)	―	―
May 14, 2024	2024 (Q1)	-0.09 / -0.07	-0.1	30.00% (+0.03)	―	―
Feb 29, 2024	2023 (Q4)	-0.10 / -0.06	-0.1	40.00% (+0.04)	―	―
Nov 02, 2023	2023 (Q3)	-0.10 / -0.09	-0.12	25.00% (+0.03)	―	―
Aug 03, 2023	2023 (Q2)	-0.11 / -0.09	-0.16	43.75% (+0.07)	―	―

The table shows recent earnings report dates and whether the forecast was beat or missed. See the change in forecast and EPS from the previous year.

Beat

Missed

NUVB Earnings-Related Price Changes

Report Date	Price 1 Day Before	Price 1 Day After	Percentage Change
Aug 07, 2025	$2.35	$2.34	-0.43%
May 07, 2025	$2.04	$2.10	+2.94%
Mar 06, 2025	$1.89	$2.02	+6.88%
Nov 06, 2024	$2.54	$2.62	+3.15%

Earnings announcements can affect a stock’s price. This table shows the stock's price the day before and the day after recent earnings reports, including the percentage change.

FAQ

When does Nuvation Bio (NUVB) report earnings?

Nuvation Bio (NUVB) is schdueled to report earning on Nov 05, 2025, After Close (Confirmed).

What is Nuvation Bio (NUVB) earnings time?

Nuvation Bio (NUVB) earnings time is at Nov 05, 2025, After Close (Confirmed).

Where can I see when companies are reporting earnings?

You can see which companies are reporting today on our designated earnings calendar.

What companies are reporting earnings today?

You can see a list of the companies which are reporting today on TipRanks earnings calendar.

What is NUVB EPS forecast?

NUVB EPS forecast for the fiscal quarter 2025 (Q3) is -0.17.

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