On November 6, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the third quarter ended September 30, 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"September 25, 2025 was a historic day for Crinetics with the approval of Palsonify for the treatment of people with acromegaly," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "For years, acromegaly patients have endured significant challenges with existing therapies. Since approval, our team has executed seamlessly to get Palsonify to patients and the launch is off to a very good start. Healthcare providers both at pituitary centers and in the community have written prescriptions, and we are seeing uptake in patients switching from prior therapies and in those newly initiating medical therapy. With the approval milestone, we are now a fully integrated pharmaceutical company. Five clinical trials across our deep pipeline are advancing and our financial position remains robust. We are executing with speed and focus on our mission to bring life-changing treatments to the patients who need them most."

Third Quarter 2025 and Recent Highlights:
PALSONIFY was approved by the U.S. Food and Drug Administration (FDA) on September 25, 2025 for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Crinetics’ field force has called on over 95% of the top priority healthcare provider targets. Additionally, approximately 95% of filled prescriptions are from switch patients and 5% are from naïve patients, reflecting the demographics of the acromegaly population. Payer reimbursement has not been a barrier to treatment, with approximately 50% of filled prescriptions reimbursed.
Presented three abstracts from clinical development programs at North American Neuroendocrine Tumor Society Annual Meeting (NANETS 2025), highlighting neuroendocrine tumor research progress. Crinetics shared data showing investigator-assessed progression free survival rate of 74% following one year of treatment with paltusotine and details from the first-in-human study of the nonpeptide drug conjugate (NDC) candidate CRN09682 in patients with somatostatin receptor 2-expressing tumors.
Key Upcoming Milestones:
Crinetics expects the first patients to randomize in the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the fourth quarter of 2025.
Crinetics is making continued progress on the development program for atumelnant across multiple trials. Crinetics expects the first patients to randomize in the CALM-CAH Phase 3 study in adults with congenital adrenal hyperplasia (CAH) and the BALANCE-CAH Phase 2/3 study in pediatrics in the fourth quarter of 2025. Glucocorticoid reduction data from Cohort 4 of the Phase 2 study and 13-week data from the Phase 2 open-label extension study will be shared early in 2026.
Planning, including regulatory interactions, for the next study of atumelnant in ACTH-dependent Cushing’s syndrome (ADCS) is underway. Initiation of the Phase 2/3 study is expected to begin in the first half of 2026.
Crinetics expects the first patient to receive CRN09682 in the dose escalation phase of a Phase 1/2 study in the fourth quarter of 2025. This is the first candidate from the NDC platform and the study will include an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors.
Based on emerging data from Investigational New Drug (IND)-enabling studies, focus of the thyroid stimulating hormone receptor (TSHR) antagonist program has shifted to bringing forward an alternative candidate with a superior profile. There is also follow-up preclinical work needed on the IND-enabling studies for the SST3 program that will postpone its IND submission.
Third Quarter 2025 Financial Results:
Revenues were $0.1 million for the quarter ended September 30, 2025. All revenues were derived from the paltusotine licensing agreement with Sanwa Kagaku Kenkyusho Co., Ltd. There were no revenues for the same period in 2024.
Research and development expenses were $90.5 million for the quarter ended September 30, 2025, compared to $61.9 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $10.9 million and increased clinical and manufacturing activities costs of $10.2 million, driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $52.3 million for the quarter ended September 30, 2025, compared to $25.9 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $10.2 million primarily due to the increase in headcount and an increase in outside services costs of $12.0 million to support our overall growth and the commercial launch of PALSONIFY.
Net loss for the quarter ended September 30, 2025, was $130.1 million, compared to a net loss of $76.8 million for the same period in 2024.
Cash, cash equivalents, and investments totaled $1.1 billion as of September 30, 2025, compared to $1.4 billion as of December 31, 2024. Based on current projections, Crinetics expects that its cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2029. For 2025, Crinetics continues to anticipate cash used in operations to be between $340 and $370 million.
Conference Call and Webcast Details
Management will hold a live conference call and webcast today, Thursday, November 6 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-646-844-6383 (international) and refer to Access Code 166837. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.

Upcoming Investor Events
Crinetics management will be attending the following events in the coming months:

2025 Stifel Healthcare Conference, November 11-13 in New York, NY.
Piper Sandler 37th Annual Healthcare Conference, December 2-4 in New York, NY.
Citi’s 2025 Global Healthcare Conference, December 2-4 in Miami, FL.
8th Annual Evercore Healthcare Conference, December 2-4 in Coral Gables, FL.
Please check the website for updates regarding the timing of the live presentation webcasts, if any, and for replay information.

(Press release, Crinetics Pharmaceuticals, NOV 6, 2025, View Source [SID1234659562])

On November 6, 2025 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the third quarter ended September 30, 2025 and provided an overview of recent business highlights.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In Q3 2025, we gained significant momentum on our strategy to develop innovative oncology therapies that substantially increase patient survival," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "The vast majority of our study sites are enrolling, driving towards multiple data readouts in 2026 across a number of tumor types. We have now expanded our CHS-114 CCR8 Treg depleter clinical program to include colorectal cancer, an area of growing unmet need, impacting even younger patients."

"The importance of CCR8 as a cancer target is highlighted by the 2025 Nobel Prize in Physiology or Medicine, which recognized the pivotal role of Treg cells in peripheral immune tolerance and their pathological role in autoimmunity and cancer," said Theresa LaVallee, PhD, Coherus Chief Scientific and Development Officer. Coherus Oncology was recently honored to present our clinical data on CHS-114 showing the cytolytic antibody’s potency and selectively, with robust tumoral Treg depletion, immune activation and a good safety profile at a SITC (Free SITC Whitepaper) presentation focused on a deep dive into development of antibodies targeting CCR8 Tregs, reflecting our scientific leadership in this rapidly evolving field."

"Our clinical programs target tumor types where there is a clear biological rationale and a significant unmet medical need with available therapies," said Rosh Dias, MD, Chief Medical Officer. "We have previously shown encouraging data for both casdozokitug and CHS-114, and we expect maturing datasets from our ongoing studies throughout 2026."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC), in all patient subsets and across all lines of therapy.
LOQTORZI net revenue for Q3 2025 was $11.2 million, a 12% increase over $10.0 million in Q2 2025 and a 92% increase over LOQTORZI net revenue of $5.8 million in Q3 2024. Growth in Q3 2025 was driven largely by higher patient demand from both increasing new account starts as well as repeat use in existing accounts. Average duration of treatment among existing patients also continues to grow.
Increasing awareness of the revised National Comprehensive Cancer Network (NCCN) guidelines granting LOQTORZI preferred status within the NPC indication continues to drive strong demand growth among head & neck cancer specialists. The Company’s focus remains on deepening adoption within general oncologists in the community setting by driving education on clinical data and updated NCCN guidelines. While half of all NPC patients in the U.S. are managed in this setting, market penetration will continue at a steady and gradual pace due to the rarity of patients seen by these oncologists.

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

LOQTORZI is a next-generation PD-1 marketed in the U.S. in two indications.

Coherus plans to maximize the value of this medicine by combining LOQTORZI with internal pipeline candidates, CHS-114 and casdozokitug, for additional solid tumor indications and entering into capital-efficient external partnerships for label expansions.
In October 2025, the Cancer Research Institute announced the first patient enrolled in the third cohort of the ongoing Immunotherapy Platform Study in Platinum-Resistant High-Grade Serous Ovarian Cancer (IPROC) (NCT04918186). The third cohort of the Phase 2 trial is evaluating LOQTORZI in combination with ENB Therapeutics’ ENB-003 for the treatment of ovarian cancer.

CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding.

Updated biomarker data from the Phase 1b study dose expansion study in 2L+ head and neck squamous cell carcinoma (HNSCC) will be presented on Saturday, November 8, 2025 at the 40th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
Phase 1b CHS-114/toripalimab combination dose optimization studies in 2L HNSCC and 2L gastric cancers are underway, with initial data readouts for HNSCC expected in 1H 2026.
A Phase 1b study evaluating the CHS-114/toripalimab combination, with and without chemotherapy, in 1L and 2L esophageal squamous cell carcinoma (ESCC), respectively, is underway with a first data readout expected in mid-2026.
A Phase 1b/2a study evaluating CHS-114/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.

Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC).

Enrollment is ongoing in the Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in 1L HCC, with the first data readout expected in mid-2026.
On November 2, 2025, new data was presented at the Cytokines 2025 annual meeting demonstrating casdozokitug promotes NK and T cell activity, and antitumor response in patients with advanced solid tumors. These biomarker data continue to support treatment with casdozokitug which leads to inhibition of IL-27 signaling and enhanced cytolytic immune activity (by NK and T cells). The new data reveal these biomarker changes following treatment of HCC patients with casdozokitug and standard of care are associated with clinical response (and thus, support an important contribution of casdozokitug).

THIRD QUARTER 2025 FINANCIAL RESULTS

Net revenue from continuing operations was $11.6 million and $6.1 million during the three months ended September 30, 2025 and 2024, respectively, and $29.4 million and $18.7 million during the nine months ended September 30, 2025 and 2024, respectively. LOQTORZI net product revenue increased $5.3 million and $16.9 million compared to the three and nine months ended September 30, 2024, respectively, driven primarily by volume growth of LOQTORZI, which launched in December 2023. The increase in the nine-month period was partially offset by a decrease in other revenue primarily driven by a $6.1 million upfront fee recognized in the prior year for the out-license of rights to commercialize toripalimab within Canada.

Cost of goods sold (COGS) from continuing operations was $3.7 million and $2.7 million during the three months ended September 30, 2025 and 2024, respectively, and $9.8 million and $6.0 million during the nine months ended September 30, 2025 and 2024, respectively. The increases were primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $27.3 million and $22.1 million for the three months ended September 30, 2025 and 2024, respectively, and $77.9 million and $71.1 million during the nine months ended September 30, 2025 and 2024, respectively. The increases were primarily due to increased costs for development of casdozokitug and CHS-114, partially offset by savings from reduced activities related to other programs, reduced headcount, and lower infrastructure costs.

Selling, general and administrative (SG&A) expenses from continuing operations were $24.9 million and $28.1 million during the three months ended September 30, 2025 and 2024, respectively, and $77.0 million and $95.9 million during the nine months ended September 30, 2025 and 2024, respectively. The decreases were driven primarily by lower headcount and decreased operating costs following Coherus’ recent divestitures, partially offset by a $1.6 million net impairment charge in the third quarter of 2025 for the write-off of an intangible asset and associated contingent value right ("CVR") liability related to GSK4381562, acquired in the Surface Oncology, Inc. acquisition. The decrease in the nine-month period was further due to a net $6.8 million charge in the first quarter of 2024 for the write-off of an intangible asset and associated CVR liability related to NZV930, which was also acquired in the Surface Oncology, Inc. acquisition.

Interest expense from continuing operations was $2.3 million and $2.8 million during the three months ended September 30, 2025 and 2024, respectively, and $6.8 million and $8.8 million during the nine months ended September 30, 2025 and 2024, respectively. The decrease in the nine-month period was primarily due to the prepayment of the remaining $75.0 million of the principal amount due under the 2027 Term Loans on May 8, 2024, partially offset by interest on the $38.7 million senior secured term loan facility and the LOQTORZI portion of the Revenue Participation Right Purchase and Sale Agreement, each commencing May 8, 2024.

Net loss from continuing operations for the third quarter of 2025 was $44.5 million, or $(0.38) per share on a diluted basis, compared to a net loss of $47.6 million, or $(0.41) per share on a diluted basis, for the same period in 2024. Net loss for the nine months ended September 30, 2025 was $136.8 million, or $(1.18) per share on a diluted basis, compared to net loss of $169.3 million, or $(1.48) per share on a diluted basis, for the same period in 2024.

Non-GAAP net loss from continuing operations for the third quarter of 2025 was $38.9 million, or $(0.33) per share on a diluted basis, compared to $40.0 million, or $(0.35) per share for the same period in 2024. Non-GAAP net loss for the nine months ended September 2025 was $118.8 million, or $(1.02) per share on a diluted basis, compared to a net loss of $127.1 million, or $(1.11) per share for the same period in 2024. See "Non-GAAP Financial Measures" below for a discussion on how Coherus calculates non-GAAP net loss from continuing operations and a reconciliation to the most directly comparable GAAP measures.

Cash, cash equivalents and marketable securities totaled $191.7 million as of September 30, 2025, compared to $126.0 million as of December 31, 2024. A majority of the $67.0 million in accrued rebates, fees and reserves reflected on the September 30, 2025 balance sheet were UDENYCA-related obligations that did not transfer in the divestiture and are expected to be settled in a front-weighted fashion over the remainder of the year and into 2026.

Conference Call Information

When: Thursday, November 6, 2025, starting at 5:00 p.m. Eastern Standard Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: View Source

Webcast: View Source

A live and archived webcast will be available on the "Investors" section of the Coherus website at View Source

Please dial in 15 minutes early to ensure a timely connection to the call.

(Press release, Coherus Oncology, NOV 6, 2025, View Source [SID1234659561])

On November 6, 2025 Cerus Corporation (Nasdaq: CERS) reported financial results for the third quarter ended September 30, 2025, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We continue to make great strides in improving the safety and availability of transfused blood components around the globe and the record quarterly product revenue results reflect that progress. Product revenue growth was driven by strong global commercial execution and growing awareness of the benefits conferred by our INTERCEPT Blood System. Furthermore, hospital demand for INTERCEPT fibrinogen complex or IFC in the U.S. continues to increase, bolstered by the many positive case studies from large academic hospitals that have implemented IFC in routine use," said William "Obi" Greenman, Cerus’ president and chief executive officer.

Additional highlights include:

Third-quarter 2025 total revenue comprised of (in millions, except percentages):
Three Months Ended

Nine Months Ended

September 30,

Change

September 30,

Change

2025

2024

$

%

2025

2024

$

%

Product Revenue

$52.7

$46.0

$6.7

15%

$148.4

$129.5

$18.9

15%

Government Contract Revenue

7.5

4.6

2.9

63%

20.8

15.1

5.7

38%

Total Revenue

$60.2

$50.7

$9.6

19%

$169.2

$144.6

$24.6

17%

Numbers may not sum due to rounding. Percentages calculated from unrounded figures.

Hospital demand for IFC continues to increase with third quarter volumes (equivalent to FC15* therapeutic units) up approximately 110% compared to the prior year period. Q3 U.S. IFC sales totaled $3.9 million, up from $2.3 million during the prior year period.
Completed enrollment in the U.S. RedeS trial, the second pivotal U.S. Phase 3 clinical trial designed to evaluate the safety and efficacy of red blood cells prepared with the INTERCEPT Blood System for Red Blood Cells (RBCs) in patient populations requiring RBC transfusion for acute and chronic anemia. Study results are expected in the second half of 2026.
Third quarter GAAP net loss attributable to Cerus narrowed to $0.02 million, near breakeven. Third-quarter non-GAAP adjusted EBITDA totaled $5.0 million.
Cash, cash equivalents, and short-term investments were $78.5 million at September 30, 2025, supported by $1.9 million of operating cash flow generation for the quarter.
Revenue

Product revenue during the third quarter of 2025 was $52.7 million, compared to $46.0 million during the prior year period. This year-over-year increase of 15% was led by growth in IFC and global platelet sales.

Third-quarter 2025 government contract revenue was $7.5 million, compared to $4.6 million during the prior year period. Our government contract revenue was comprised of funding associated with research and development (R&D) activities related to the INTERCEPT RBC program as well as efforts related to the development of next-generation pathogen reduction technology to treat whole-blood and development of lyophilized IFC. The year-over-year increase was primarily driven by increasing enrollment in the Phase 3 RedeS trial for the INTERCEPT RBC system covered under the Company’s 2016 agreement with BARDA and the activities for the advancement of the INTERCEPT RBC system covered under the Company’s 2024 BARDA contract.

Product Gross Profit and Margin

Product gross profit for the third quarter of 2025 was $28.1 million, increasing by 7% over the prior year period. Product gross margin for the third quarter of 2025 was 53.4% compared to 56.9% for the third quarter of 2024. As contemplated in the Company’s previous remarks, import tariffs, inflationary pressure, and higher IFC production costs to meet increasing demand impacted product gross margin compared to the prior year period.

Operating Expenses

Total operating expenses for the third quarter of 2025 were $34.4 million compared to $31.8 million for the same period of the prior year, reflecting a year-over-year increase of 8%.

R&D expenses for the third quarter of 2025 were $15.8 million, compared to $14.0 million in the third quarter of 2024. The primary drivers for the increase in R&D expenses were higher government contract costs incurred to support our government research activities and the resulting government contract revenue, as well as enrollment in the Phase 3 RedeS trial and U.S. development costs on INT200, the new LED-based illumination device.

SG&A expenses totaled $18.6 million for the third quarter of 2025, compared to $17.8 million for the third quarter of 2024. Year-over-year SG&A expenses were relatively consistent due to multiple offsetting factors and reflect the Company’s ongoing focus on driving leverage.

Net Loss Attributable to Cerus Corporation

Net loss attributable to Cerus Corporation for the third quarter of 2025 was $0.02 million, or $0.00 per basic and diluted share, compared to a net loss attributable to Cerus Corporation of $2.9 million, or $0.02 per basic and diluted share, for the same period of the prior year. Net loss attributable to Cerus Corporation for the first nine months of 2025 was $13.4 million compared to net loss attributable to Cerus Corporation of $18.4 million for the first nine months of 2024.

Non-GAAP Adjusted EBITDA

Non-GAAP adjusted EBITDA for the third quarter of 2025 rose to a positive $5.0 million, compared to non-GAAP adjusted EBITDA of positive $4.4 million for the same period of the prior year. Non-GAAP adjusted EBITDA for the first nine months of 2025 was a positive $6.1 million compared to non-GAAP adjusted EBITDA of positive $2.5 million for the first nine months of 2024.

The Company is well positioned to achieve its previously stated goal of positive full-year 2025 non-GAAP adjusted EBITDA. For additional information, please see definitions and the reconciliation of this non-GAAP measure to net loss attributable to Cerus Corporation accompanying this release.

Balance Sheet and Cash Flows

At September 30, 2025, the Company had cash, cash equivalents, and short-term investments of $78.5 million, compared to $80.5 million at December 31, 2024. The Company’s revolving line of credit allows for an additional $15.0 million as of September 30, 2025, which is dependent on eligible assets supporting the borrowing base.

For the third quarter of 2025, cash generated from operations totaled $1.9 million compared to $4.1 million generated during the same period of the prior year.

Raising Full-Year 2025 Product Revenue Guidance

The Company now expects full-year 2025 product revenue to be in the range of $202 million to $204 million, reflecting growth of 12% to 13% from 2024. Included in this range is full-year 2025 IFC revenue guidance between $16 million to $17 million. Previously, the Company’s 2025 product revenue guidance range was $200 million to $203 million, including IFC revenue guidance between $16 million to $18 million.

Quarterly Conference Call

The Company will host a conference call at 4:30 P.M. ET this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source

A replay will be available on Cerus’ website approximately three hours after the call through November 27, 2025.

(Press release, Cerus, NOV 6, 2025, View Source [SID1234659560])

On November 6, 2025 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported its financial results for the third quarter of fiscal year 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Third Quarter Highlights:
Revenue was $104.6 million, compared to $94.8 million in the third quarter of 2024, representing growth of 10%.
Software revenue was $43.8 million, compared to $35.9 million in the third quarter of 2024, representing growth of 22%.
Services revenue was $60.8 million, compared to $58.9 million in the third quarter of 2024, representing growth of 3%.
Net income was $1.5 million, compared to a net loss of $1.4 million in the third quarter of 2024, representing growth of 211%.
Adjusted EBITDA was $35.2 million, compared to $33.1 million in the third quarter of 2024, representing growth of 7%.
"In the third quarter, we continued to make good progress towards our full-year revenue and profitability targets," said William Feehery, Chief Executive Officer. "We recently launched several new software products, including CertaraIQ for QSP modeling, which we believe will expand the use of biosimulation technology in drug development. We remain focused on investing in our R&D and commercial efforts to position Certara for sustainable, long-term growth."

"We saw strong demand in the quarter for biosimulation solutions in software and QSP services, though we have observed some spending hesitancy in other parts of the services business. We are raising our 2025 profitability targets and narrowing our revenue guidance to reflect the most likely range of outcomes as we approach the end of the year," said John Gallagher, Chief Financial Officer.

Third Quarter 2025 Results
Total revenue for the third quarter of 2025 was $104.6 million, representing year-over-year growth of 10% on a reported basis and on a constant currency basis. Total revenue included $5.8 million of Chemaxon revenue. The overall increase in revenue was primarily driven by contribution from M&A and growth in our biosimulation software and services portfolio. Please see note (1) in the section "A Note on Non-GAAP Financial Measures" below for more information on constant currency revenue.

Software revenue for the third quarter of 2025 was $43.8 million, representing year-over-year growth of 22% on a reported basis and 21% on a constant currency basis. Organic software revenue growth was 6%. Software growth was driven by contribution from M&A and biosimulation software.

Services revenue for the third quarter of 2025 was $60.8 million, representing year-over-year growth of 3% on a reported basis and on a constant currency basis. Services growth was driven by biosimulation services.

Total Bookings for the third quarter of 2025 were $96.6 million representing a year-over-year growth of 1%. Total Bookings included $4.5 million of Chemaxon bookings.

Software Bookings for the third quarter of 2025 were $40.8 million, representing a year-over-year growth of 17%. Organic software bookings grew 5% year-over-year. The increase in software bookings was primarily due to strength in Certara’s core biosimulation software and contribution from Chemaxon.

Services Bookings for the third quarter of 2025 were $55.8 million, representing 9% a year-over-year decrease. The decrease in service bookings was mainly influenced by softer trends among our tier-one customers, predominantly in the Regulatory services business.

Total cost of revenues for the third quarter of 2025 was $39.7 million, an increase of $2.5 million from $37.2 million in the third quarter of 2024, primarily due to higher software amortization expense, professional and consulting costs, and license fees.

Total operating expenses for the third quarter of 2025 were $61.9 million, which increased by $6.9 million from $55.0 million in the third quarter of 2024. Higher operating expenses were primarily due to a $5.4 million increase in employee-related costs, a $1.4 million increase in stock based compensation cost, and $0.8 million increase in equipment and software expenses, and a $0.6 million increase in depreciation and amortization expense, partially offset by higher capitalized R&D costs and lower facility and lease related expense.

Adjusted EBITDA for the third quarter of 2025 was $35.2 million compared to $33.1 million for the third quarter of 2024, an increase of $2.2 million. See note (2) in the section A Note on Non-GAAP Financial Measures below for more information on adjusted EBITDA.

Diluted earnings per share for the third quarter of 2025 was $0.01, as compared to a diluted loss per share of $(0.01) in the third quarter of 2024.

Net income for the third quarter of 2025 was $1.5 million, compared to a net loss of $1.4 million in the third quarter of 2024. The $2.9 million increase in income was primarily due to an increase in gross profit, higher tax benefits, and an increase in net other income, partially offset by an increase in operating expenses.

Adjusted net income for the third quarter of 2025 was $22.2 million compared to $20.3 million for the third quarter of 2024, an increase of $2.0 million. Adjusted diluted earnings per share for the third quarter of 2025 was $0.14, flat compared to $0.13 for the third quarter of 2024. See note (3) in the section A Note on Non-GAAP Financial Measures below for more information on adjusted net income and adjusted diluted earnings per share.

THREE MONTHS ENDED SEPTEMBER 30, NINE MONTHS ENDED SEPTEMBER 30,
2025 2024 2025 2024
Key Financials (in millions, except per share data)
Revenue $ 104.6 $ 94.8 $ 315.2 $ 284.8
Software revenue $ 43.8 $ 35.9 $ 136.9 $ 113.4
Service revenue $ 60.8 $ 58.9 $ 178.3 $ 171.4
Total bookings $ 96.6 $ 96.1 $ 326.8 $ 300.8
Software bookings $ 40.8 $ 34.8 $ 128.2 $ 109.8
Service bookings $ 55.8 $ 61.3 $ 198.6 $ 191.0
Net income (loss) $ 1.5 $ (1.4 ) $ 4.3 $ (18.6 )
Diluted earnings per share $ 0.01 $ (0.01 ) $ 0.03 $ (0.12 )
Adjusted EBITDA $ 35.2 $ 33.1 $ 102.0 $ 88.5
Adjusted net income $ 22.2 $ 20.3 $ 56.1 $ 48.2
Adjusted diluted earnings per share $ 0.14 $ 0.13 $ 0.35 $ 0.30
Cash and cash equivalents $ 172.7 $ 233.0

2025 Financial Outlook
Certara is updating its guidance for the full year 2025:

Full year 2025 revenue to be in the range of $415 million to $420 million.
Full year adjusted EBITDA margin to be approximately 32%.
Full year adjusted diluted earnings per share is expected to be in the range of $0.45 – $0.47.
Fully diluted shares are expected to be in the range of 160 million to 162 million.
Please note that the Company has not reconciled adjusted EBITDA (including its related margin) or adjusted diluted earnings per share forward-looking guidance included in this press release to the most directly comparable GAAP measures because this cannot be done without unreasonable effort due to the variability and low visibility with respect to costs related to acquisitions, financings, and employee stock compensation programs, which are potential adjustments to future earnings. We expect the variability of these items to have a potentially unpredictable, and a potentially significant, impact on our future GAAP financial results.

Webcast and Conference Call Details
Certara will host a conference call today, November 6, 2025, at 5:00 p.m. ET to discuss its third quarter 2025 financial results. Investors interested in listening to the conference call are required to register online in advance of the call. A live and archived webcast of the event will be available on the "Investors" section of the Certara website at View Source

(Press release, Certara, NOV 6, 2025, View Source [SID1234659559])

On November 6, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the third quarter ended September 30, 2025, and provided a business update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This quarter was marked by highly encouraging data from our ongoing CRDF-004 trial evaluating onvansertib in combination with standard of care for first-line RAS-mutated mCRC. At the July 8, 2025 data cutoff, the 30mg onvansertib cohort demonstrated a 19% improvement in confirmed ORR, faster time to response, deeper tumor regression, and early signs of separation in the progression-free survival curves when compared to standard of care alone," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "The study is on track for the next clinical update in the first quarter of 2026, where we’ll look for a continuation of onvansertib’s favorable tolerability profile and more mature duration of response and progression-free survival data."

Continued Dr. Erlander, "Onvansertib is uniquely positioned to address a significant medical need and commercial opportunity, with approximately 150,000 new CRC patients diagnosed annually in the U.S. alone. With median progression-free survival of less than 12 months on standard of care and few promising therapies in development for RAS-mutated mCRC, we are optimistic that onvansertib has the potential to redefine first-line care for patients."

Company highlights for the quarter ended September 30, 2025:

•
Announced positive data from the ongoing CRDF-004 Phase 2 randomized trial evaluating two doses of onvansertib in combination with standard of care ("SoC") for the treatment of first-line RAS-mutated metastatic colorectal cancer ("mCRC")
o
As of the July 8, 2025 data cut-off, the Phase 2 CRDF-004 trial demonstrated a 19% improvement in confirmed objective response rate ("ORR") in the 30mg onvansertib arm compared to the control arm in the intent-to-treat population.
o
While the median progression-free survival ("PFS") has not yet been reached, early PFS data show a trend favoring the 30mg onvansertib arm versus control.
o
Dose dependent responses were observed across all endpoints, including ORR, PFS, early tumor shrinkage, and depth of response.
o
Onvansertib continues to be well-tolerated, with no major or unexpected toxicities observed.

•
An update from the ongoing Phase 2 CRDF-004 trial in first-line RAS-mutated mCRC is expected in 1Q 2026.

Third Quarter 2025 Financial Results:

Liquidity, cash burn, and cash runway

As of September 30, 2025, Cardiff Oncology had approximately $60.6 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the third quarter of 2025 was approximately $10.8 million, an increase of $0.3 million from $10.5 million for the same period in 2024.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $12.1 million for the three months ended September 30, 2025, a decrease of $0.7 million from $12.8 million for the same period in 2024. The decrease in operating expenses was primarily due to a reduction in clinical trial expenses and a decrease in preclinical activities.

(Press release, Cardiff Oncology, NOV 6, 2025, View Source [SID1234659558])