On May 6, 2025 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage biotechnology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported financial results for the first quarter 2025, and provided corporate updates (Press release, Sensei Biotherapeutics, MAY 6, 2025, View Source [SID1234652595]).

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"This was a breakthrough quarter for Sensei," said John Celebi, President and CEO. "We observed favorable signs of clinical activity in patients with PD-(L)1-resistant cancers from our dose expansion cohort—patients who face poor odds and few options. Beyond the responses we have observed, what’s striking is the emerging potential for prolonged benefit, with some PD-(L)1-resistant patients approaching a year on study. In a population with historically low response rates and fleeting benefit from PD-(L)1 rechallenge, we observed response rates nearly three times higher than what would typically be expected in this setting. With dose expansion enrollment now complete, we’re laser-focused on finalizing a Phase 2 strategy for solnerstotug, guided by the full dataset we plan to present later this year."

Highlights and Milestones

Solnerstotug (formerly SNS-101) is a conditionally active antibody designed to selectively target the immune checkpoint VISTA (V-domain Ig suppressor of T cell activation) within the tumor microenvironment. VISTA is implicated in numerous cancer indications and its expression correlates with low survival rates.

Sensei is conducting a multi-center Phase 1/2 clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of solnerstotug as both a monotherapy and in combination with Regeneron’s PD-1 inhibitor Libtayo (cemiplimab) in patients with advanced solid tumors.

Recent updates include:

In March, Sensei announced preliminary data from the dose expansion stage of its ongoing Phase 1/2 trial, showing favorable activity in patients with PD-(L)1 resistant "hot" tumors.
Enrollment is now complete with a total of 63 patients:
10 MSS CRC patients in the monotherapy arm
53 patients in the cemiplimab combination arm consisting of 10 MSS CRC patients and 43 PD-(L)1 resistant "hot" tumor patients.
Full dose expansion data from the Phase 1/2 study expected by year-end 2025.
A replay of the March 2025 webcast related to these preliminary results, featuring study investigator Dr. Shiraj Sen, is available on the Sensei website.

Other corporate highlights included:

Canaccord Genuity Horizons in Oncology Virtual Conference: On April 7, 2025, John Celebi, President and CEO of Sensei Biotherapeutics, participated in a panel discussion titled "New Radiotherapy and Targeted Therapy Approaches." The panel focused on emerging innovations in cancer treatment and Sensei’s approach to selectively modulating the tumor microenvironment. A replay of the discussion is available on the conference website.
Oppenheimer’s 35th Annual Healthcare Life Sciences Conference: On February 11, 2025, Mr. Celebi delivered a presentation at Oppenheimer’s 35th Annual Healthcare Life Sciences Conference. The presentation provided insights into the company’s clinical progress and strategic direction. A webcast of the presentation is available in the Investors section of the Sensei website.
First Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $34.3 million as of March 31, 2025, as compared to $41.3 million as of December 31, 2024. Sensei expects its current cash balance to fund operations into the second quarter of 2026.

Research and Development (R&D) Expenses: R&D expenses were $3.7 million for the quarter ended March 31, 2025, compared to $4.9 million for the year ended March 31, 2024. The decrease in R&D expenses was primarily attributable to lower personnel costs, and lower facilities and lab supply costs, partially offset by increased expense associated with clinical trials.

General and Administrative (G&A) Expenses: G&A expenses were $3.5 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 2024. The decrease in G&A expense was due to lower personnel costs partially offset by higher consulting fees.

Net Loss: Net loss was $6.9 million for the quarter ended March 31, 2025, compared to $8.0 million for the quarter ended March 31, 2024.

On May 6, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, reported financial results for the quarter ended March 31, 2025 (Press release, Tempus, MAY 6, 2025, View Source [SID1234652612]).

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Revenue increased 75.4% year-over-year to $255.7 million in the first quarter of 2025
Quarterly gross profit increased 99.8% year-over-year, reaching $155.2 million with continued gross margin improvement in both Genomics and Data and services
Announced multi-year, strategic collaborations with AstraZeneca and Pathos to work together to build the largest multimodal foundation model in oncology, resulting in additional $200.0 million in data licensing and model development fees over the next 3 years
Increasing full year 2025 revenue guidance to $1.25 billion, representing approximately 80% growth year-over-year. Expect positive Adjusted EBITDA of $5 million for full year 2025, increasing approximately $110 million over 2024
"The business is performing well with revenues growing, margins improving, and our costs remaining in check, allowing us to demonstrate significant year-over-year operating leverage," said Eric Lefkofsky, Founder and CEO of Tempus. "Our strategic investments in AI have us uniquely positioned to advance what is possible in diagnostics and drug development, as evidenced by our announcement to build the largest foundation model in oncology with AstraZeneca and Pathos. We believe this is just the beginning as more and more healthcare providers and life science companies embrace AI."

First Quarter Summary Results

Quarterly revenue increased 75.4% year-over-year to $255.7 million in the first quarter of 2025.
Genomics contributed $193.8 million in revenue in the first quarter of 2025, growing 88.9% compared to the first quarter of 2024.
Oncology testing (legacy Tempus clinical) revenue delivered $119.0 million, up 31.0% year-over-year in the first quarter of 2025, with approximately 20% volume growth.
Hereditary testing (legacy Ambry Genetics) contributed $63.5 million in revenue in the first quarter, with approximately 23% unit growth.
Revenue from Data and services totaled $61.9 million in the first quarter of 2025, delivering 43.2% growth versus the first quarter of 2024, led by Insights (data licensing), which grew 58.0% year-over-year.
Generated $155.2 million in quarterly gross profit, reflecting a 99.8% improvement year-over-year.
Reported a net loss of ($68.0 million) in the first quarter of 2025, including $28.2 million in stock compensation expense and related employer payroll taxes and fair value losses of $31.8 million related to our marketable equity securities, compared to a net loss of ($64.7 million) in the first quarter of 2024.
Adjusted EBITDA of ($16.2 million) in the first quarter of 2025 compared to ($43.9 million) in the first quarter of 2024, an improvement of $27.8 million year-over-year.
First Quarter and Recent Operational Highlights

Announced multi-year, strategic collaborations with AstraZeneca and Pathos to work together to build a multimodal foundation model in oncology, which include $200.0 million in additional data licensing and model development fees to Tempus over the next 3 years.
Completed the acquisition of Ambry Genetics on February 3, 2025.
Disclosed a collaboration with Illumina combining its AI technologies with Tempus’ comprehensive multimodal data platform to train genomic algorithms and accelerate clinical adoption of molecular testing.
Reported the acquisition of Deep 6 AI, broadening Tempus’s reach and enhancing applications like Next and TIME.
Launched olivia, an AI-enabled personal health concierge app for patients nationally.
Nationally launched xT CDx with ADLT pricing established at $4,500 per test.
First Quarter Financial Results

Three Months Ended March 31,

2025

2024

Change

(in thousands, except percentages and per share amounts)

(unaudited)

Revenue

$

255,737

$

145,820

75.4

%

Gross profit

$

155,203

$

77,697

99.8

%

Loss from operations

$

(68,689

)

$

(53,274

)

NM(1)

Non-GAAP loss from operations

$

(25,777

)

$

(53,274

)

51.6

%

Net loss

$

(68,037

)

$

(64,743

)

NM(1)

Adjusted EBITDA

$

(16,174

)

$

(43,926

)

63.2

%

Net loss per share attributable to common shareholders, basic and diluted

$

(0.40

)

$

(1.47

)

72.8

%

Non-GAAP net loss per share

$

(0.24

)

$

(1.03

)

76.3

%

____________
(1)

Not meaningful due to the impact of including stock compensation expense and related employer payroll taxes

Financial Outlook and Guidance

Tempus now expects full year 2025 revenue of approximately $1.25 billion for the consolidated Tempus and Ambry Genetics business, which represents approximately 80% annual growth, and Adjusted EBITDA of $5 million for full year 2025, an improvement of approximately $110 million over 2024.

For additional information on the quarter, including a letter from our CEO and CFO, please visit our investors relations site at investors.tempus.com.

Webcast and Conference Call Information

A conference call and webcast will begin today, May 6, 2025 after market close at 4:30 p.m. Eastern Time. Interested parties may access details at:

Conference ID: 4680302
Domestic Dial-in Number: (888) 672-2415
International Dial-in Number: (646) 307-1952
Live webcast: View Source

The webcast may be accessed on the company’s investor relations website at investors.tempus.com. For those unable to listen to the live webcast, a recording will be made available on the company’s website after the event and will be accessible for one year. Visit the investor relations website to find the company’s latest deck, and commentary on the quarter by Eric Lefkofsky, Founder and CEO and Jim Rogers, CFO, which will be discussed on the conference call and webcast.

On May 5, 2025 Actuate Therapeutics, Inc. (NASDAQ: ACTU) ("Actuate" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment of high-impact, difficult-to-treat cancers through the inhibition of glycogen synthase kinase-3 beta (GSK-3β), reported that elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) met the primary endpoints and achieved statistical significance in topline results from its ongoing Phase 2 (Actuate-1801 Part 3B) trial in first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) (Press release, Actuate Therapeutics, MAY 6, 2025, View Source [SID1234652561]).

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The topline results, which demonstrate a substantial improvement in median overall survival benefit in the elraglusib/GnP combination arm compared to the results announced in December 2024, will be presented on May 31, 2025, at the Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper).

"Pancreatic cancer is one of the most aggressive and difficult-to-treat malignancies, where patients urgently need new therapeutic options," said Daniel Schmitt, President & Chief Executive Officer of Actuate. "There have been no major advances in improving survival in first-line treatment of metastatic pancreatic cancer in over a decade. Demonstrating statistically significant increases in both median overall survival and percent of patients reaching one-year survival and beyond, along with a favorable risk-benefit profile in this Phase 2 trial, further demonstrates elraglusib’s potential to shift the treatment paradigm in mPDAC. We are incredibly excited to present the topline data at ASCO (Free ASCO Whitepaper). Based on the significant improvement in survival we have seen to date in the combination arm, we look forward to working with US and EU regulators in the second half of this year to map out the path to advancing elraglusib to NDA and registration and making the drug available to patients as expeditiously as possible."

ASCO Presentation Details:

Abstract Title: Preliminary results from the randomized phase 2 study (1801 part 3B) of elraglusib in combination with gemcitabine/nab-paclitaxel (GnP) versus GnP alone in patients (pts) with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).

Abstract Number: 4006

Session Title: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Presenter: Devalingam Mahalingam, MD, PhD

Oral Presentation Date and Time: Saturday, May 31, 2025, 4:48 PM CDT

About Actuate-1801 Part 3B Study

The Actuate-1801 Part 3B study (NCT03678883) is a randomized, controlled Phase 2 trial of elraglusib with GnP versus GnP alone in first-line mPDAC. The trial enrolled 286 mPDAC patients with no prior systemic treatment for metastatic disease, who were randomized 2:1 to the elraglusib treatment arm (elraglusib + GnP) or the control arm (GnP alone). Elraglusib is administered at a dose of 9.3 mg/kg by IV infusion on Day 1 of each week of a 28-day cycle. The primary endpoint for this study is median overall survival, with OS summarized throughout the study by estimates of 1-year survival. Secondary endpoints are DCR, ORR, PFS, and AE.

About GSK-3β

Inhibition of GSK-3β may inhibit tumor growth and improve survival through several complimentary mechanisms that include enhancement of chemotherapy activity, activation of innate anti-tumor immunity, and regulation of gene expression, leading to alterations in tumor metabolism and Epithelial-to-Mesenchymal Transition (EMT).

On May 6, 2025 Keros Therapeutics, Inc. ("Keros" or the "Company") (Nasdaq: KROS), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics to treat a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta ("TGF-ß") family of proteins, reported financial results for the quarter ended March 31, 2025 (Press release, Keros Therapeutics, MAY 6, 2025, View Source [SID1234652580]).

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"In the first quarter, we reported initial topline results from the Phase 1 clinical trial of KER-065 that met key objectives and yielded valuable insights. These findings position us well as we prepare to engage with regulators with the aim of advancing KER-065 to a Phase 2 clinical trial in the first quarter of 2026," said Jasbir S. Seehra, Ph.D., Chair and Chief Executive Officer. "As our Board of Directors continues its review process to evaluate strategic alternatives to enhance stockholder value for the Company, we remain focused on the execution of our strategy and advancing the development of our pipeline of novel therapeutics. We expect to report data in the second quarter of 2025 from the Phase 2 TROPOS trial evaluating cibotercept (KER-012) in patients with pulmonary arterial hypertension and we plan to evaluate the appropriate development strategy for cibotercept following that data readout."

First Quarter 2025 Financial Results

Keros reported a net income of $148.5 million in the first quarter of 2025 as compared to a net loss of $43.1 million in the first quarter of 2024. The increase of $191.6 million was largely due to revenue recognized related to Keros’ license agreement with Takeda Pharmaceuticals U.S.A., Inc., partially offset by increased research and development efforts as well as additional investments to support the achievement of Keros’ clinical and corporate goals.

Research and development expenses were $48.7 million for the first quarter of 2025 as compared to $38.3 million for the same period in 2024. The increase of $10.5 million was primarily due to additional research and development efforts, manufacturing activities and personnel expenses to support the advancement of Keros’ pipeline.

General and administrative expenses were $10.5 million for the first quarter of 2025 as compared to $10.3 million for the same period in 2024. The increase of $0.2 million was primarily due to an increase in other external expenses to support Keros’ organizational growth.

Keros’ cash and cash equivalents as of March 31, 2025 was $720.5 million compared to $559.9 million as of December 31, 2024. Based on current operating assumptions, Keros expects that its cash and cash equivalents as of March 31, 2025 will enable Keros to fund its operating expenses and capital expenditure requirements into 2029.

On May 6, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the first quarter 2025 and associated Company developments (Press release, Supernus, MAY 6, 2025, View Source [SID1234652596]).

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"Our first quarter results reflect, once again, double-digit revenue growth from our core products, as well as strong growth in adjusted operating earnings," said Jack Khattar, President and CEO of Supernus. "In addition, we are pleased to be bringing ONAPGO to market, another growth driver for our business. ONAPGO represents a novel approach for adults with Parkinson’s disease who are experiencing motor fluctuations."

Commercial Highlights

Total IQVIA prescriptions(2) for Qelbree were 214,908 for the first quarter 2025, an increase of 22% compared to the same period in the prior year. For March 2025, total monthly prescriptions reached an all-time high of 75,277. Qelbree continues to expand its base of prescribers, with approximately 34,416 prescribers in the first quarter of 2025, up from 27,902 prescribers in the same period last year.

In April 2025, the Company launched ONAPGO, the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. Initial physician response is encouraging based on very early activity in the launch.
Product Pipeline Update

SPN-817 – Novel first-in-class highly selective AChE inhibitor for epilepsy

The Phase 2b randomized, double-blind, placebo-controlled study of 3mg and 4mg twice daily doses is ongoing with a targeted enrollment of approximately 258 adult patients with treatment resistant focal seizures.
SPN-820 – Novel first-in-class molecule that increases mTORC1 mediated synaptic function for depression

The Company plans to initiate a follow-on Phase 2b multi-center, randomized, double-blind, placebo-controlled trial in approximately 200 adults with major depressive disorder (MDD). The study will examine the safety and tolerability of SPN-820 2400 mg given intermittently (twice weekly) as an adjunctive treatment to the current baseline antidepressant therapy, as well as assess the rapid onset of improvement in depressive symptoms.
SPN-443 – Novel stimulant for ADHD/CNS

The Company completed a Phase 1 pharmacokinetic study of two oral formulations in healthy adults. Both formulations of SPN-443 showed adequate bioavailability and were well tolerated. The Company expects to disclose a lead indication for the product candidate by the end of 2025.
Financial Highlights

This section includes information on non-GAAP financial measures. See "Non-GAAP Financial Information" section for information on non-GAAP financial measures. In addition, a reconciliation of applicable GAAP to non-GAAP financial information is included at the end of this press release.

Revenues

The following table provides information regarding total revenues (dollars in millions):

Three Months Ended
March 31,
2025 2024 Change %
(unaudited)
Net product sales
Qelbree $ 64.7 $ 45.1 44 %
GOCOVRI 30.7 26.5 16 %
APOKYN 15.0 16.7 (10 )%
Trokendi XR 12.8 16.0 (20 )%
Oxtellar XR 10.2 26.9 (62 )%
Other(3) 8.6 7.2 19 %
Total net product sales 142.0 138.4 3 %
Royalty, licensing and other revenues(4) 7.8 5.2 51 %
Total revenues $ 149.8 $ 143.6 4 %

Total revenues excluding Trokendi XR and Oxtellar XR net sales (non-GAAP)(1) $ 126.8 $ 100.7 26 %

Other Financial Highlights

Operating loss was $(10.3) million for the three months ended March 31, 2025, compared to operating loss of $(3.2) million for the same period in 2024. The change was primarily due to higher contingent consideration loss, mainly related to the achievement of ONAPGO-related milestones, and higher selling and marketing expenses.
Adjusted operating earnings (non-GAAP) were $25.9 million for the three months ended March 31, 2025, compared to $22.3 million for the same period in 2024.
Net loss and diluted loss per share were $(11.8) million and $(0.21) for the three months ended March 31, 2025, compared to net earnings and diluted earnings per share of $0.1 million and $0.00 for the three months ended March 31, 2024.
At March 31, 2025, cash, cash equivalents, and current and long-term marketable securities were approximately $463.6 million compared to $453.6 million as of December 31, 2024. This increase was primarily due to cash generated from operations partially offset by the $25.0 million payment of ONAPGO-related milestone in the first quarter of 2025.
Full Year 2025 Financial Guidance

For the full year 2025, the Company reiterates its full year financial guidance as set forth below (dollars in millions):

Current Guidance
(as of February 25, 2025)
Total revenues (includes approximately $65 million – $75 million of Trokendi XR and Oxtellar XR)(5)(6) $600 – $630
Combined R&D and SG&A expenses $435 – $460
Operating earnings (loss) $(15) – $10
Adjusted operating earnings (non-GAAP)(1) $105 – $130