On November 6, 2025 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, reported an update on the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nexiguran ziclumeran (nex-z) and announced other business updates and financial results for the third quarter ended September 30, 2025.

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"We were deeply saddened to learn that the patient who experienced Grade 4 liver transaminase elevations and increased total bilirubin following a dose of nex-z in the MAGNITUDE Phase 3 clinical trial, as reported on October 27, 2025, passed away last night," said Intellia President and Chief Executive Officer John Leonard, M.D. "We have been advised by the treating physician that this is a case with complicating comorbidities, and it is being further evaluated. As we await the FDA’s clinical hold letter, we are working with clinical investigators and external experts to better understand the liver-related events that have been observed within MAGNITUDE and to develop our risk mitigation plan."

"We continue to believe in nex-z’s potential to address important unmet needs for patients with ATTR amyloidosis," Dr. Leonard continued. "Regarding our other late-stage investigational product for the treatment of HAE, lonvo-z, we have made considerable progress over the course of 2025. Enrollment was completed in the HAELO Phase 3 clinical trial of lonvo-z in September, less than nine months after we dosed our first patient in the trial, putting us on track to share topline data by mid-2026. We look forward to presenting longer-term data from our Phase 1/2 clinical trial of lonvo-z on Saturday at ACAAI."

Recent Updates About Nexiguran Ziclumeran (nex-z) for Transthyretin (ATTR) Amyloidosis

Nex-z is an investigational in vivo CRISPR-based therapy designed to inactivate the TTR gene in the liver, thereby preventing the production of transthyretin (TTR) protein. Nex-z offers the possibility of halting and reversing disease by driving a deep, consistent and potentially lifelong reduction in TTR protein after a single dose. Intellia leads the development and commercialization of nex-z in collaboration with Regeneron Pharmaceuticals, Inc.

On October 29, 2025, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the Investigational New Drug applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM) and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.

More than 650 patients with ATTR-CM are currently enrolled in MAGNITUDE, and 47 patients with ATTRv-PN are enrolled in MAGNITUDE-2. To date, Grade 4 liver transaminase elevations have been reported in less than one percent of all patients enrolled in MAGNITUDE and no Grade 4 liver transaminase elevations have been reported in MAGNITUDE-2.

Intellia recently mandated that all MAGNITUDE and MAGNITUDE-2 clinical sites increase their monitoring of patient laboratory values in the weeks after dosing. The company continues to consult with clinical investigators and other experts to investigate the transaminase elevations and consider potential additional risk mitigation strategies while awaiting the FDA’s formal clinical hold letter. Given the clinical hold, the company has suspended its milestone guidance for nex-z pending regulatory alignment. Intellia plans to provide an update after it has finalized a plan with regulators on the path forward.

ATTR Amyloidosis with Cardiomyopathy (ATTR-CM):
On November 10, 2025 at the 2025 American Heart Association (AHA) Scientific Sessions, longer-term data will be presented in a late-breaker oral session from the company’s ongoing Phase 1 clinical trial in patients with ATTR-CM. Details about this session are as follows:
Title: Updated Phase 1 Clinical Trial Outcomes of CRISPR Gene Editing with Nexiguran Ziclumeran (Nex-z, NTLA-2001) in Patients with Transthyretin Amyloidosis with Cardiomyopathy
Session: Rewriting the Code for Cardiac Amyloid: Novel Identification, Treatment, and Cure
Date and Time: Monday, November 10, 2025, at 3:17 p.m. ET
Presenter: Julian Gillmore, M.D., Ph.D., Professor of Medicine, National Amyloidosis Centre, UCL Division of Medicine, Royal Free Hospital, U.K.
Hereditary ATTR Amyloidosis with Polyneuropathy (ATTRv-PN):
In September 2025, the company presented positive longer-term follow-up data from its Phase 1 clinical trial in an oral presentation at the 5th International ATTR Amyloidosis Meeting for Patients and Doctors in Baveno, Italy. The results were simultaneously published in the New England Journal of Medicine.

Recent Updates About Lonvoguran Ziclumeran (lonvo-z) for Hereditary Angioedema (HAE)

Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapy designed to inactivate the KLKB1 gene in the liver that offers the possibility of dramatically reducing or eliminating HAE attacks by driving consistent, deep and potentially lifelong reduction in kallikrein levels after a one-time treatment.

Dosing in the global Phase 3 HAELO clinical trial was initiated in January 2025 and enrollment was completed in September 2025. Patients in this trial are receiving a 50 milligram (mg) dose of lonvo-z. Intellia expects to:
Report HAELO topline data by mid-2026;
Submit a Biologics License Application (BLA) to the FDA in the second half of 2026; and
Continue preparing for an anticipated U.S. commercial launch in the first half of 2027.
On November 8, 2025 at the American College of Allergy, Asthma & Immunology Annual Scientific Meeting (ACAAI), longer-term clinical data will be presented in an oral session from all patients who received a 50 mg dose of lonvo-z in Intellia’s ongoing Phase 1/2 clinical trial. Details about this session are as follows:
Title: Two-Year Durability/Safety of One-time Lonvoguran Ziclumeran (Lonvo-z, NTLA-2002) 50 mg in Patients with Hereditary Angioedema
Session: Distinguished Industry & Late-Breaking Oral Abstracts – Session 1
Date and Time: Saturday, November 8, 2025, at 5:13 p.m. ET
Presenter: Danny Cohn, M.D., Ph.D., Internist, Department of Vascular Medicine, Amsterdam University Medical Center

Third Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $669.9 million as of September 30, 2025, compared to $861.7 million as of December 31, 2024. In the third quarter of 2025, the company raised $114.5 million of net equity proceeds from its "At the Market" (ATM) program. The company’s cash, cash equivalents and marketable securities as of September 30, 2025, are now expected to fund operations into mid-2027 and through lonvo-z’s anticipated U.S. commercial launch for HAE.
Collaboration Revenue: Collaboration revenue was $13.8 million for the third quarter of 2025, compared to $9.1 million for the third quarter of 2024. The $4.7 million increase was mainly driven by cost reimbursements related to the company’s collaboration with Regeneron Pharmaceuticals, Inc.
R&D Expenses: Research and development (R&D) expenses were $94.7 million for the third quarter of 2025, compared to $123.4 million for the third quarter of 2024. The $28.7 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services, partially offset by an increase in clinical trial expenses related to lonvo-z. Stock-based compensation expense included in R&D expenses was $12.2 million for the third quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $30.5 million for the third quarter of 2025, compared to $30.5 million for the third quarter of 2024. Stock-based compensation expense included in G&A expenses was $7.4 million for the third quarter of 2025.
Net Loss: Net loss was $101.3 million for the third quarter of 2025, compared to $135.7 million for the third quarter of 2024.

Conference Call Information

The company will host a conference call and webcast today at 6:00 p.m. ET to discuss recent updates and the company’s third quarter 2025 financial results. To join the webcast, please visit the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com. To join by phone, U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726 approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call. A replay of the webcast will be available at intelliatx.com for approximately 90 days.

(Press release, Intellia, NOV 6, 2025, View Source [SID1234659574])

On November 6, 2025 Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on creating and delivering engineered cells as medicines, reported financial results and business highlights for the third quarter 2025.

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Sana announced it will prioritize future development activity for SC451, a HIP-modified stem cell-derived pancreatic islet cell therapy for type 1 diabetes, and for SG293, an in vivo CAR T with CD8-targeted fusogen delivery of a CD19-directed CAR. The company continues to see meaningful progress in its type 1 diabetes program, particularly in advancing SC451 toward an IND. In addition, Sana improved the potency and manufacturability of its next-generation in vivo CAR T product platform, and the company is incorporating these updates into SG293 and expects to file an IND for this program as early as 2027. The company has suspended development of its two allogeneic cell therapy CAR T programs – SC291 in B-cell mediated autoimmune diseases and SC262 in oncology.

"Given our recent progress and the potentially transformative impact with SC451 in type 1 diabetes, as well as with our in vivo CAR T platform across a range of diseases, now is the time to concentrate our efforts in these programs," said Steve Harr, President and CEO of Sana. "Our goal for SC451 in type 1 diabetes is a single treatment leading to normal blood glucose with no need for further insulin treatment or immunosuppression, and the past several quarters of clinical results, manufacturing progress, and regulatory developments have solidified our confidence that this is possible. Additionally, as we progress toward our goals of filing an IND and beginning our Phase 1 clinical trial next year, we believe now is the time to free up resources to invest in scaling this important therapy. Separately, we have increased the potency of in vivo CAR T platform, and based upon preclinical data, believe we have the opportunity to develop best-in-class therapies with a single treatment and no conditioning chemotherapy for a range of B-cell cancers and B-cell mediated autoimmune diseases. Based upon our momentum and given the resources required to fully exploit these opportunities, we have made the difficult decision to suspend our allogeneic CAR T programs, including SC291 and SC262. While these programs increased our confidence in our HIP platform, we believe the impact we can have for patients and shareholders is now greater with increased focus on SC451 and in vivo CAR T cells."

Recent Corporate Highlights

Published positive results from an investigator-sponsored, first-in-human study transplanting UP421, an allogeneic primary islet cell therapy engineered with hypoimmune platform (HIP) technology, into a patient with type 1 diabetes without the use of any immunosuppression.

UP421 is a primary human HIP-modified pancreatic islet cell therapy for patients with type 1 diabetes. The goal of this investigator-sponsored trial (IST) is to understand safety, immune evasion, islet cell survival, and beta cell function, as measured by C-peptide production, of HIP-modified pancreatic islet cells transplanted into type 1 diabetes patients without the use of any immunosuppression. The trial is being conducted under a clinical trial authorization at Uppsala University Hospital with Dr. Per-Ola Carlsson as the principal investigator.
Results of the study through 6 months after cell transplantation demonstrate the survival and function of pancreatic beta cells as measured by the presence of circulating C-peptide, a biomarker indicating that transplanted beta cells are producing insulin. C-peptide levels also increase with a mixed meal tolerance test at these timepoints, consistent with insulin secretion in response to a meal. 12-week PET-MRI scanning demonstrated islet cells at the transplant site. The study identified no safety issues, and the HIP-modified islet cells evaded immune detection.
The New England Journal of Medicine (NEJM) published a journal article titled "Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression" (DOI: 10.1056/NEJMoa2503822). The article discusses 12-week results from this study. NEJM also published an accompanying editorial that further describes both the Sana technology and progress in the field (DOI: 10.1056/NEJMe2507578).
Sana and Uppsala University Hospital expect to report additional data from the IST, including longer-term follow-up.
Advancing our focused pipeline across two platforms:

Hypoimmune Platform – Type 1 diabetes – Sana continues pre-clinical development of SC451, an O-negative, HIP-modified, iPSC-derived pancreatic islet cell therapy, which uses the same HIP technology as UP421. Sana has had multiple interactions with regulators over the past several months, including an FDA INTERACT meeting, the results of which increase confidence in moving forward with our HIP-edited master cell bank for GMP manufacturing and our nonclinical testing plan. Sana expects to file an IND and begin our Phase 1 clinical trial for SC451 as early as 2026.
Fusogen Platform – In vivo CAR T cells – SG293 is the next-generation version of our prior SG299 product candidate and was renamed to reflect an updated construct and manufacturing process. SG293 is a CD8-targeted fusosome that delivers to CD8+ T cells the genetic material to make CD19-directed CAR T cells while avoiding potentially troublesome delivery to tissues such as the liver. SG293 builds on data from SG299, showing cell-specific delivery and deep B-cell depletion – as measured by depletion in circulating and lymph node B cells as well as a phenotypic reset when B cells return – in non-human primates without the use of any lymphodepleting chemotherapy. Sana intends to explore SG293 in both B-cell cancers and B-cell mediated autoimmune diseases. The company expects to file an IND for SG293 as early as 2027.
SC291 (HIP-modified CD19-directed allogeneic CAR T) in autoimmune diseases and SC262 (HIP-modified CD22-directed allogeneic CAR T) in oncology – Sana recently published in the journal Cell Stem Cell an article titled "Hypoimmune CD19 CAR T cells evade allorejection in patients with cancer and autoimmune disease," which provides additional clinical data showing how HIP-modified cells avoid immune attack (doi.org/10.1016/j.stem.2025.07.009). Nevertheless, as the company seeks to further prioritize resources and follow promising data in the SC451 and fusogen programs, Sana has suspended enrollment and further internal investment in the respective Phase 1 trials.
Raised aggregate gross proceeds of $133.2 million from sales of common stock through Sana’s at-the-market offering facility (ATM) and equity financing in the third and fourth quarters of 2025; expected cash runway into late 2026.

Closed public offering in August 2025 of 24.3 million shares of Sana’s common stock, including 3.4 million shares pursuant to the full exercise of the underwriters’ option to purchase additional shares, and pre-funded warrants to purchase 1.5 million shares of Sana’s common stock. The gross proceeds from this offering were $86.3 million before deducting underwriting discounts and commissions and offering expenses.
Raised gross proceeds of $29.5 million in the third quarter of 2025 and an additional $17.4 million in the fourth quarter of 2025 from sales of common stock through Sana’s ATM.
Third Quarter 2025 Financial Results

GAAP Results

Cash Position: Cash, cash equivalents, and marketable securities as of September 30, 2025 were $153.1 million compared to $152.5 million as of December 31, 2024. The increase of $0.6 million was primarily driven by net proceeds from equity financings of $109.7 million and other cash inflows of $2.4 million, partially offset by cash used in operations of $111.2 million.
Research and Development Expenses: For the three and nine months ended September 30, 2025, research and development expenses, inclusive of non-cash expenses, were $30.1 million and $97.1 million, respectively, compared to $53.2 million and $170.5 million for the same periods in 2024. The decreases of $23.1 million and $73.5 million for the three and nine months ended September 30, 2025 compared to the same periods in 2024, respectively, were primarily due to the portfolio prioritization announced in the fourth quarter of 2024, which resulted in lower research, laboratory, and clinical development costs, lower personnel-related costs, including non-cash stock-based compensation, and a decrease in facility and other allocated costs. Research and development expenses include non-cash stock-based compensation of $3.2 million and $12.0 million, respectively, for the three and nine months ended September 30, 2025, and $6.5 million and $19.5 million for the same periods in 2024.
Research and Development Related Success Payments and Contingent Consideration: For the three and nine months ended September 30, 2025, Sana recognized non-cash expenses of $3.1 million and $15.3 million, respectively, compared to a non-cash gain of $5.5 million and a non-cash expense of $4.6 million for the same periods in 2024, in connection with the change in the estimated fair value of the success payment liabilities and contingent consideration in aggregate. The value of these potential liabilities fluctuates significantly with changes in Sana’s market capitalization and stock price.
General and Administrative Expenses: General and administrative expenses for the three and nine months ended September 30, 2025, inclusive of non-cash expenses, were $10.3 million and $32.1 million, respectively, compared to $14.1 million and $46.8 million for the same periods in 2024. The decreases of $3.8 million and $14.7 million for the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024 were primarily due to lower personnel-related costs, including non-cash stock-based compensation, due to a decrease in headcount in connection with the portfolio prioritization announced in the fourth quarter of 2024, and decreased legal and consulting fees. General and administrative expenses include non-cash stock-based compensation of $2.3 million and $7.1 million for the three and nine months ended September 30, 2025, respectively, compared to $4.3 million and $11.8 million for the same periods in 2024.
Impairment of Long-Lived Assets: For the nine months ended September 30, 2025, non-cash impairment of long-lived assets was $44.6 million, compared to zero for the same period in 2024. The non-cash impairment, recorded in the second quarter of 2025, was primarily related to Sana’s manufacturing facility in Bothell, Washington and certain laboratory and office space in Seattle, Washington. Because of the increased availability of manufacturing capacity at third-party contract development and manufacturing organizations (CDMOs) for cell and gene therapy products as well as progress in understanding its near-term manufacturing needs, Sana expects to use CDMOs to meet its manufacturing needs at present and has suspended further build-out of internal manufacturing capabilities.
Net Loss: Net loss for the three and nine months ended September 30, 2025 was $42.2 million, or $0.16 per share, and $185.3 million, or $0.75 per share, respectively, compared to $59.9 million, or $0.25 per share, and $217.7 million, or $0.95 per share, for the same periods in 2024.
Non-GAAP Measures

Non-GAAP Operating Cash Burn: Non-GAAP operating cash burn for the nine months ended September 30, 2025 was $108.0 million compared to $153.1 million for the same period in 2024. Non-GAAP operating cash burn is the decrease in cash, cash equivalents, and marketable securities, excluding cash inflows from financing activities, costs related to the portfolio prioritizations in the fourth quarters of 2024 and 2023, and the purchase of property and equipment.
Non-GAAP Net Loss: Non-GAAP net loss for the three and nine months ended September 30, 2025 was $39.0 million, or $0.15 per share, and $125.4 million, or $0.51 per share, respectively, compared to $64.7 million, or $0.27 per share, and $208.3 million, or $0.91 per share, for the same periods in 2024. Non-GAAP net loss excludes non-cash expenses and gains related to the change in the estimated fair value of contingent consideration and success payment liabilities, and non-cash impairment losses recorded in 2025.

(Press release, Sana Biotechnology, NOV 6, 2025, View Source [SID1234659590])

On November 6, 2025 AbCellera (Nasdaq: ABCL) reported financial results for the third quarter of 2025. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated.

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"AbCellera successfully delivered on two corporate priorities this quarter by starting activities at our new clinical manufacturing facility and substantially completing our platform investments," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "We ended the quarter with approximately $680 million dollars in available liquidity to execute on our strategy and will continue to prioritize advancing our two lead programs through Phase 1 clinical studies and building our pipeline."

Q3 2025 Business Summary

Generated a net loss of $57.1 million, compared to a net loss of $51.1 million in 2024.
Expanded the leadership team with the appointment of Sarah Noonberg, M.D., Ph.D., as Chief Medical Officer.
ABCL635 and ABCL575 continue to progress through Phase 1 clinical trials.
Reached a cumulative total of 103 partner-initiated program starts with downstreams.
Key Business Metrics

Cumulative Metrics

September 30, 2024

September 30, 2025

Change %

Partner-initiated program starts with downstreams

95

103

8

%

Molecules in the clinic

14

18

29

%

AbCellera started discovery on an additional partner-initiated program with downstreams to reach a cumulative total of 103 partner-initiated program starts with downstreams in Q3 2025 (up from 95 on September 30, 2024). AbCellera and its partners have advanced a cumulative total of 18 molecules into the clinic (up from 14 on September 30, 2024).

Discussion of Q3 2025 Financial Results

Revenue – Total revenue was $9.0 million, compared to $6.5 million in Q3 2024.
Research & Development (R&D) Expenses – R&D expenses were $55.0 million, compared to $41.0 million in Q3 2024. A greater proportion of R&D expenses are used on internal programs, including $15.0 million of specific investments in two internal programs in the third quarter.
Sales & Marketing (S&M) Expenses – S&M expenses were $2.9 million, compared to $3.1 million in Q3 2024.
General & Administrative (G&A) Expenses – G&A expenses were $22.1 million, compared to $19.1 million in Q3 2024.
Net Loss – Net loss of $57.1 million, or $(0.19) per share on a basic and diluted basis, compared to net loss of $51.1 million, or $(0.17) per share on a basic and diluted basis, in Q3 2024.
Liquidity – $523 million of total cash, cash equivalents, and marketable securities and approximately $159 million in available non-dilutive government funding, bringing total available liquidity to approximately $680 million to execute on AbCellera’s strategy.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

(Press release, AbCellera, NOV 6, 2025, View Source [SID1234659618])

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.

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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 Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported third quarter 2025 financial results and provides a corporate update.

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Corporate Update

INVINCIBLE-4 Study: Phase 2 randomized open-label, multicenter study to analyze the clinical activity, safety, and tolerability of INT230-6 given before administration of the standard of care ("SOC") treatment in patients with early-stage, operable triple-negative breast cancer and SOC alone. The primary endpoint is the change in the pathological complete response rate for the combination compared to the SOC alone.

In October 2024, in collaboration with the Swiss Cancer Group, formerly the Swiss Cancer Group for Clinical Cancer Research (SAKK), the Company initiated and dosed our first patient in the INVINCIBLE-4 Study. In September 2025, the Company paused new patient enrollment to revise the dosing regimen for patients receiving INT230-6 in cohort A due to some patients in Cohort A experiencing localized skin irritation near the tumor site. The Company plans to file a protocol amendment for this revision in dosing in the first quarter of 2026, and expects to reinitiate enrollment for the 54-patient study in the first quarter of 2026. The Company is targeting to complete enrollment by the end of 2026 and will likely add resources to help sites enroll.

INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second and third line treatment for specific soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Agency (for France, Germany, Italy, Poland, and Spain), and Australia’s Therapeutic Goods Administration. The primary endpoint in the INVINCIBLE-3 Study is overall survival. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company continues to treat patients enrolled in this study, maintain the database, conduct pharmacovigilance and other study related activities in cooperation with its third-party contract research organizations to reduce ongoing costs during this pause. Once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment in the INVINCIBLE-3 Study.

IT-01 Study Manuscript Publication: On October 29, 2025, eBioMedicine, a Lancet Discovery Science journal, published the Company’s phase 1/2 IT-01 clinical study manuscript, "Safety and Efficacy of Intratumourally Administered INT230-6 in Adult Patients with Advanced Solid Tumours: Results from an Open-Label Phase 1/2 Dose Escalation Study," for the treatment of metastatic or refractory cancers. The manuscript included the following data results:
•In heavily pretreated patients with advanced disease having over 20 different types of cancer who had progressed following multiple prior lines of therapy, intratumoral INT230-6 achieved:
◦A disease control rate of 75% (48/64 patients) and median overall survival (mOS) of 11.9 months; these results compare favorably in phase 1/2 studies that historically reported an mOS of 4 to 7 months
◦In a metastatic sarcoma subset population receiving only INT230-6, the median overall survival was 21.3 months
•In an exploratory analysis comparing patients receiving INT230-6 at a total dose (in mL) that treated greater than 40% of the patient’s total tumor burden ("TTB") compared to those treated with less than 40% of their TTB, the:
◦Disease control rate was 83.3% (40/48) compared to 50% (8/16)
◦Median overall survival was 18.7 months (95% CI: 11.5–23.5) compared to 3.1 months (95% CI: 1.6–5.9) with a hazard ratio (HR) of 0.17 (95% CI: 0.081–0.342); P<0.0001
◦Improved survival was consistent across a range of low to high tumor burden and tumor sizes
•Approximately 20% of patients in the >40% group had uninjected tumors shrink, abscopal effects
•Fifteen of 64 patients survived for more than 21 months
•INT230-6 induced a qualitative decrease in proliferating cancer cells in injected tumors and a qualitative increase in activated T-cells infiltrating the tumor microenvironment
•No dose-limiting toxicities were reported among 64 monotherapy patients; seven patients had a grade 3 (10.9%) with no grade 4 or 5 treatment-related adverse events
•Pharmacokinetic results showed that greater than 95% of the active cytotoxic agents remained in the injected tumors

Capital Raises and Cash Runway: the Company has raised $13.6 million in gross proceeds since the beginning of the third quarter of 2025.
•$7.5 million raised in the third quarter of 2025 via the Company’s ATM (net proceeds of $7.2 million).
•$2.1 million raised in October 2025 via the Company’s ATM (net proceeds of $2.0 million).
•$4.0 million raised in October 2025 in a registered direct offering with an institutional investor, before deducting the placement agent’s fees and related offering expenses (net proceeds of $3.7 million).
With the capital raised to date, the Company has extended its cash runway until the end of the first quarter of 2027.

"In the past four months, we were able to substantially improve our balance sheet with multiple fundraising transactions. In particular, the October 2025 registered direct offering was significant, as this brought in a new long-term fundamental, healthcare-savvy investor. The new capital raised in 2025 enables us to execute on our business strategy until the end of the first quarter of 2027 without any additional funds. In addition, our peer-reviewed paper published in the Lancet Discovery Group’s journal, eBioMedicine, provides another level of validation of the potential of our lead drug INT230-6, injected directly into tumors, to treat multiple types of cancer in both the metastatic and local disease settings. We believe this is the first peer-review publication of a local therapy alone to report disease control rate, the potential for an overall survival benefit and a 20% patient abscopal rate in metastatic disease," stated Lewis H. Bender, Intensity Founder, President and CEO. "Lastly, working with our collaboration partners at the Swiss Cancer Institute, we analyzed the data from the patients in the Phase 2 randomized controlled INVINCIBLE-4 study, and have identified a path forward to restarting the study, which is expected to be in the first quarter of 2026. The endpoint will remain pathological complete response, which is accepted by FDA for accelerated approval."

Third Quarter 2025 Financial Results

Research and development expenses were $1.6 million for the three months ended September 30, 2025, compared to $2.2 million for the same period in 2024. Clinical trial expenses decreased $0.4 million primarily due to lower INVINCIBLE-3 Study costs. In March 2025, the Company paused new site activations and patient enrollments in the INVINCIBLE-3 Study, due to funding constraints. Prior to this pause, the trial had enrolled 21 patients. The Company will continue to treat all patients enrolled in this study in cooperation with our third-party contract research organizations during this pause, and once sufficient funding is obtained, the Company plans to restart site activations and patient enrollment.

General and administrative expenses were $1.2 million for the three months ended September 30, 2025, compared to $1.4 million for the same period in 2024. Consulting expense decreased due to less business development activity compared to the prior year period.

Overall, net loss was $2.7 million for the three months ended September 30, 2025, compared to a net loss of $3.5 million for the three months ended September 30, 2024.

As of September 30, 2025, cash and cash equivalents totaled $7.1 million.

About INT230-6
INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

(Press release, Intensity Therapeutics, NOV 6, 2025, View Source [SID1234659575])