On May 11, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies broadly to patients with cancer and autoimmune diseases, reported data this week featuring its off-the-shelf CAR T-cell programs FT819, FT839, and FT836 at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting to be held in Boston, MA, May 11–15, 2026.

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"We are excited to highlight our leadership in delivering off-the-shelf CAR T cells with less-intensive or no conditioning chemotherapy to ensure broad patient accessibility," said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. "With FT819, we are demonstrating that it is feasible to drive CAR T-cell efficacy with less-intensive or no conditioning chemotherapy in SLE and believe that eliminating the need for intensive conditioning chemotherapy has the potential to significantly improve the safety and clinical benefit of cellular therapies. With our next generation CAR T-cell programs, FT836 and FT839, we are illustrating that through precise multiplexed-engineering of iPSCs to generate clonal master banks that serve as the starting point for large scale manufacture of uniform and consistent drug product, it is feasible to tackle complex multicellular diseases, support functional persistence without the need for intensive conditioning chemotherapy, and create synergy with standard-of-care therapies to deliver effective treatments for patients with unmet need."

Presentation Summaries Include:

Title: FT819 Drives B cell Compartment Remodeling of Patients with Systemic Lupus Erythematosus Without Conditioning Chemotherapy; Poster Presentation Date / Time: Tuesday, May 12, 5:00 PM – 6:30 PM ET

FT819 is the Company’s off-the-shelf, CD19-targeted, iPSC-derived CAR T-cell program, which is currently being investigated in a Phase 1 study for patients with moderate-to-severe systemic lupus erythematosus (SLE) including lupus nephritis and extrarenal lupus (NCT06308978). Data presented this week shows that in Regimen B of the Phase 1 study with a data cutoff of April 9, 2026, a single dose of FT819 without conditioning chemotherapy and in the presence of background therapy demonstrated meaningful clinical responses at dose level 1 in patients with active SLE, with 3 of 3 patients achieving systemic lupus erythematosus responder index (SRI-4) and 2 of 3 patients achieving lupus low disease activity state (LLDAS). The positive clinical outcomes were supported mechanistically by the observation that B cells in the periphery as well as in secondary lymphoid tissue (nasopharyngeal swabs) were significantly depleted. Notably, depletion (79% on average) of major B cell clones (as defined by B cell receptor sequencing) were observed, with the depletion lasting up to 12 months following treatment. Collectively, preliminary data demonstrate that treatment with FT819 without conditioning chemotherapy and in the presence of background therapy can drive comprehensive changes in B cell repertoire that are associated with clinical benefit, alongside a favorable safety profile. Patient treatment at the higher dose of 900 million cells (dose level 2) has been initiated.

Title: FT839: A Multi-Antigen Targeting Off-the-Shelf dual-CAR T cell for the Treatment of Pathogenic B and T Cells in Autoimmune Diseases; Oral Presentation Date / Time: Thursday, May 14, 8:30 AM – 8:45 AM ET

FT839 is a next generation, off-the-shelf dual CAR T-cell therapy targeting CD19 and CD38 to deplete multiple pathogenic immune cell populations that drive hematological and complex autoimmune diseases, including rheumatoid arthritis (RA), type I diabetes, and multiple sclerosis. Preclinical data to be presented show broad, selective depletion of pathogenic immune cell subtypes in RA and SLE disease samples, including over 99% of B cells, plasmablasts, and plasma cells and more than 90% of activated CD4+ and CD8+ T cells, while sparing non-activated T cells, which comprise most of the endogenous T-cell population. The presentation will also demonstrate that targeting capabilities of FT839 are further enhanced through synergistic pairing with standard-of-care (SOC) therapeutic monoclonal antibodies (mAb; e.g. rituximab) or clinically approved T-cell engagers (e.g. epcoritamab), to activate either the engineered Fc receptor, hnCD16, or the novel CD3 Fusion receptor, respectively, improving cytolytic activity by ~3.5-6x on CAR antigen negative targets. With Sword and ShieldTM technology, FT839 persistence is enhanced ~60x compared to CAR T cells lacking Sword and ShieldTM engineering in HLA-mismatched allogeneic settings, while the generation and expansion of product-specific immune cell responses are severely blunted (~1/900), thereby reducing the need for intensive conditioning chemotherapy. Importantly, non-product specific T cells were spared. FT839 is produced through a scalable and reproducible process that enables on-demand availability of a homogenous CAR T-cell therapy, overcoming key accessibility and safety limitations of autologous CAR T-cell therapies, selectively depleting disease-driving B lineage and activated T cells for the treatment of patients with complex autoimmune and hematological diseases.

Title: CAR T cells Targeting pan-Tumor Antigens MICA/B can be Uniquely Combined with SOC Treatments without Conditioning Chemotherapy for Broad and Effective Therapeutic Application in Cancer; Poster Presentation Date / Time: Wednesday, May 13, 5:00 PM – 6:30 PM ET

FT836 is a next generation, off-the-shelf CAR T-cell therapy that targets the novel and inducible pan-tumor antigens MICA/B. FT836 is engineered to enable rational combination with SOC therapeutics such as mAbs, chemotherapy, radiotherapy, and immune modulators across both hematological malignancies and solid tumor settings. Integrated engineered elements, including Sword and Shield technology, support broader and more universal application without the requirements for conditioning chemotherapy. Preclinical data to be presented demonstrate potent and durable control of multiple solid and liquid xenograft tumor models of varying origin and antigen expression by FT836 activity as a monotherapy or in combination with mAbs, such as trastuzumab, cetuximab, or daratumumab (up to 100% tumor control), underscoring its broad and universal therapeutic potential in cancer. FT836 also features Sword and Shield technology, enabling improved persistence (~20-30x) and selective containment of product-specific immune cell responses (~5x product specific and ~1x nonspecific), thereby enabling clinical strategies that are not reliant on conditioning chemotherapy. FT836 is shown to be rationally combined with established SOC therapeutics, including chemotherapy or radiotherapy, that complement its unique mechanisms of action and engineering profile to specifically upregulate both MICA/B (~2-3x) and the CXCR2 ligand CXCL8 (3-4X) expression, enhancing both the cytolytic activity (~5x) and specific trafficking (~2-3x) of FT836. In addition, FT836 is compatible with multiple myeloma standard of care therapeutics such as Bortezomib and Lenalidomide which further enhances the cytolytic activity of FT836 (1.25x + lenalidomide). Collectively, these data demonstrate the broad utility of FT836 and its ability to rationally combine with SOC therapeutic agents without the need for conditioning chemotherapy, supporting expanded patient access across both hematological and solid tumor indications. FT836 is currently being evaluated clinically in advanced solid tumor patients in combination with the trastuzumab and cetuximab (NCT07216105) and in relapsed and/or refractory multiple myeloma in combination with daratumumab (NCT07221032).

(Press release, Fate Therapeutics, MAY 11, 2026, View Source [SID1234665434])

On May 11, 2026 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported business updates and announced financial results for the fiscal quarter ended March 31, 2026.

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"We continue to execute well across our RAS-targeting franchise, advancing ERAS-0015 clinical development ahead of schedule," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "The best-in-class potential of ERAS-0015 is striking, highlighted by robust responses in patients with KRAS G12X lung or pancreatic cancer, along with favorable safety and tolerability results primarily consisting of low-grade adverse events in our recently reported data. Notably, we believe ERAS-0015 has the potential to become a backbone of combination therapy based in part on the initial panitumumab combination data we shared last month. We continue to advance monotherapy expansion and combination dose escalation cohorts, with data from both anticipated in the first half of 2027."

Dr. Lim continued, "In parallel, our pan-KRAS inhibitor ERAS-4001 is progressing through Phase 1 dose escalation, with preliminary safety, tolerability, pharmacokinetics, and early efficacy data expected in the second half of 2026. We are encouraged by the differentiated potential of our RAS-targeting franchise to meaningfully transform the treatment landscape for RAS-driven cancers and look forward to sharing further updates in the coming months."

Research and Development (R&D) Highlights

•
Entered into a Clinical Trial Collaboration and Supply Agreement (CTCSA) with Merck: In May 2026, Erasca announced that it had entered into a CTCSA with Merck (known as MSD outside of the United States and Canada) under which ERAS-0015 will be combined with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab). Pursuant to the CTCSA, Merck will supply pembrolizumab at no cost, and Erasca will be the trial sponsor.
•
Robust Preliminary Dose Escalation Monotherapy Data for ERAS-0015: In April 2026, Erasca announced positive preliminary dose escalation data for ERAS-0015 monotherapy including robust response rates in KRAS G12X non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The safety and tolerability results were generally favorable, with mostly low-grade adverse events (AEs), limited dose reductions due to treatment-related adverse events (TRAEs), and no discontinuations due to TRAEs. Pharmacokinetic (PK) data showed dose-dependent exposure with no observed plateau, supporting the selection of 24 mg and 32 mg QD (once daily) as recommended doses for expansion. In addition, encouraging early combination data support the potential of ERAS-0015 in combination with panitumumab. (U.S. monotherapy trial AURORAS-1 data cutoff (DCO) 4Apr2026; China monotherapy trial JYP0015M101 DCO 27Feb2026; U.S. panitumumab combination trial DCO 31Mar2026.)
•
Initiated Monotherapy Expansion and Combination Dose Escalation: In April 2026, Erasca announced that dose escalation of ERAS-0015 in combination with anti-EGFR monoclonal antibody panitumumab was initiated in the first quarter of 2026 and that the monotherapy expansion cohorts for ERAS-0015 were initiated in the second quarter of 2026. Both of these milestones were completed ahead of the original second half of 2026 guidance.
•
Entered into a CTCSA with Tango Therapeutics (Tango): In March 2026, Erasca announced that it had entered into a CTCSA with Tango under which ERAS-0015 will be combined with vopimetostat (Tango’s PRMT5 inhibitor). Pursuant to the CTCSA, Erasca will supply ERAS-0015 at no cost, and Tango will be the trial sponsor.
•
U.S. Composition of Matter Patent Issued for ERAS-4001: In February 2026, Erasca announced that the U.S. Patent and Trademark Office issued patent No. 12,552,813, which protects the composition of matter and related compositions for potentially first-in-class pan-KRAS inhibitor ERAS-4001 until June 2043, absent any patent term adjustments or extensions.

Corporate Highlights

•
Expanded License Agreement Territory for ERAS-0015:In March 2026, Erasca announced the expansion of its existing licensing agreement with Joyo Pharmatech Co., Ltd. (Joyo) to include China, Hong Kong, and Macau, providing Erasca with worldwide rights to its potential best-in-class pan-RAS molecular glue ERAS-0015.
•
Completed Upsized Financing: In January 2026, Erasca completed a successful upsized public offering, raising approximately $258.8 million in gross proceeds. The transaction, supported by high-quality new and existing healthcare-focused investors, significantly strengthened Erasca’s balance sheet.

Key Upcoming Milestones

•
AURORAS-1: Phase 1 trial for ERAS-0015 (pan-RAS molecular glue) in patients with RAS-mutant solid tumors
o
Monotherapy expansion data expected in the first half of 2027
o
Combination dose escalation data planned for the first half of 2027
•
BOREALIS-1: Phase 1 trial for ERAS-4001 (pan-KRAS inhibitor) in patients with KRAS-mutant solid tumors
o
Preliminary safety, tolerability, PK, and initial efficacy Phase 1 monotherapy data expected in the second half of 2026
o
Initiation of monotherapy expansion cohorts and combination dose escalation cohorts planned for 2027

First Quarter 2026 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $408.5 million as of March 31, 2026, compared to $341.8 million as of December 31, 2025. Erasca expects its cash, cash equivalents, and marketable securities to fund operations into the second half of 2028.

Research and Development (R&D) Expenses: R&D expenses were $27.3 million for the quarter ended March 31, 2026, compared to $26.0 million for the quarter ended March 31, 2025. The increase was primarily driven by increases in personnel costs, including stock-based compensation expense, and expenses incurred in connection with clinical trials, preclinical studies, and discovery activities, partially offset by decreases in outsourced services, consulting fees, and facilities-related expenses and depreciation. Erasca also recorded $150.0 million of in-process R&D expense during the quarter ended March 31, 2026 for the exercise of the option to expand its territory to worldwide under Erasca’s ERAS-0015 license agreement.

General and Administrative (G&A) Expenses: G&A expenses were $10.6 million for the quarter ended March 31, 2026, compared to $9.7 million for the quarter ended March 31, 2025. The increase was primarily driven by personnel costs, including stock-based compensation expense.

Net Loss: Net loss was $183.4 million, or $(0.60) per basic and diluted share, for the quarter ended March 31, 2026, compared to $31.0 million, or $(0.11) per basic and diluted share, for the quarter ended March 31, 2025.

(Press release, Erasca, MAY 11, 2026, View Source [SID1234665433])

On May 11, 2026 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported that company management will participate in fireside chats at two upcoming investor conferences:

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H.C. Wainwright 3rd Annual BioConnect Investor Conference on Tuesday, May 19th at 4:30 p.m. ET.
Jefferies Global Healthcare Conference on Wednesday, June 3rd at 3:10 p.m. ET.

Live webcasts of the fireside chats will be available through the investor relations section of the Company’s website at ir.discmedicine.com and an archived replay will be available after each event.

(Press release, Disc Medicine, MAY 11, 2026, View Source [SID1234665432])

On May 11, 2026 Coherus Oncology, Inc. (Nasdaq: CHRS), reported financial results for the first quarter 2026, and provided an overview of recent business highlights.

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"We are executing well on our integrated financial, commercial and development strategy that maximizes LOQTORZI’s potential in NPC and in combination with our pipeline products." said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We also continue to explore opportunities across cancers and non-proprietary novel combinations with tagmokitug, our potentially best-in-class CCR8 Treg depleter, and are encouraged given our previously reported clinical data including anti-tumor activity, safety data, tumor biomarker data and PK data."

"Casdozokitug is the only known clinical stage IL-27 antagonist, and the first line HCC study in combination with LOQTORZI is now fully enrolled. We are tracking to initial data around mid-year." said Rosh Dias, MD, Chief Medical Officer. "The tagmokitug program is also on track, with continued enrollment across all cohorts. We also continue to progress the first-in-class pasritamig combination study in metastatic castration-resistant prostate cancer (mCRPC), which we anticipate initiating in the fall. We are on target for multiple data readouts as planned in 2026."

RECENT BUSINESS HIGHLIGHTS

LOQTORZI (toripalimab-tpzi) Commercial Updates

● LOQTORZI revenue for Q1 2026 was $11.8 million, a 61% increase over $7.3 million in Q1 2025, and a 5% decrease versus the $12.4 million in Q4 2025, driven by the impact of severe weather events in Q1 as well as normal seasonality.
● Encouragingly, Q1 saw the highest volume of new patient starts to date. New patient starts came from increased breadth from new account starts and greater depth from prior ordering accounts. It is important to note that average duration of treatment among existing patients also continued to grow.
● LOQTORZI remains the only FDA-approved and available treatment in the U.S. for recurrent, locally advanced or metastatic nasopharyngeal carcinoma (NPC) representing an estimated overall $250 million addressable market.
● Commercial focus in 2026 is on educating physicians that LOQTORZI is:
o the only approved and available therapy for R/M nasopharyngeal carcinoma;

o the only preferred Category 1 first-line treatment option recommended by the National Comprehensive Cancer Network (NCCN) in combination with cisplatin and gemcitabine; and
o the only preferred subsequent-line treatment recommended by the National Comprehensive Cancer Network (NCCN).
We will continue to appropriately communicate the six-year overall survival (OS) follow-up results from the Phase 3 JUPITER-02 trial evaluating LOQTORZI plus chemotherapy versus chemotherapy alone.

ADVANCEMENT OF INNOVATIVE, NEXT-GENERATION ONCOLOGY PIPELINE

Tagmokitug is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Preclinical and clinical biomarker research published in Molecular Cancer Therapeutics, show that tagmokitug demonstrates no off-target binding and selectively and significantly eliminates CCR8+ T regulatory cells, with a pronounced increase in intratumoral CD8 T cells, enabling the presence of tumor killing T cells.

● The Phase 1b tagmokitug/toripalimab combination dose optimization studies in 2L HNSCC and 2L upper GI adenocarcinoma cancers are underway, with initial data readouts expected in mid-2026.
● A Phase 1b study evaluating the tagmokitug/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 2H 2026.
● A Phase 1b/2a study evaluating tagmokitug/toripalimab combination in 4L+ colorectal cancer is enrolling patients and initial data is expected in 2H 2026.
● A Phase 1b clinical study in patients with metastatic castration-resistant prostate cancer (mCRPC) in combination with pasritamig, a T-cell engaging bispecific antibody, is anticipated to begin in the fall of 2026.
Casdozokitug is a first-in-class IL-27 antagonistic antibody currently being evaluated in a Phase 2 study in patients with first line unresectable hepatocellular carcinoma (uHCC) to assess treatment benefit, safety and response biomarkers. Data presented during ASCO (Free ASCO Whitepaper) GI 2025 demonstrated a 38% overall response rate and a 17% complete response rate with the addition of casdozokitug to the current standard of care.

● Enrollment is complete in the randomized Phase 2 trial of casdozokitug/toripalimab/bevacizumab in 1L uHCC and the first data readout is expected in mid-2026.
EQUITY FINANCING

● During the first quarter of 2026, Coherus sold 32,890,000 shares of its common stock in a public offering, including 4,290,000 shares issued pursuant to the exercise of the underwriters’ over-allotment option in full for proceeds of $53.6 million, net of underwriters’ discounts, commissions and offering expenses.
FIRST QUARTER 2026 FINANCIAL RESULTS

Net revenue from continuing operations was $12.3 million and $7.6 million during the three months ended March 31, 2026 and 2025, respectively. LOQTORZI net product revenue increased $4.5 million compared to the three months ended March 31, 2025, driven primarily by volume growth of LOQTORZI.

Cost of goods sold (COGS) from continuing operations was $3.8 million and $2.7 million during the three months ended March 31, 2026 and 2025, respectively. The increase was primarily due to volume growth of LOQTORZI.

Research and development (R&D) expenses from continuing operations were $21.5 million and $24.4 million for the three months ended March 31, 2026 and 2025, respectively. The decrease was primarily due to savings from reduced headcount and lower infrastructure costs, partially offset by increased development costs for casdozokitug.

Selling, general and administrative (SG&A) expenses from continuing operations were $23.1 million and $26.0 million during the three months ended March 31, 2026 and 2025, respectively. The decrease was driven primarily by lower headcount and decreased operating costs resulting from Coherus completing the exit from the biosimilar business in 2025.

Net (loss) from continuing operations for the first quarter of 2026 was $36.9 million, or $(0.27) per share on a diluted basis, compared to a net loss of $47.4 million, or $(0.41) per share on a diluted basis, for the same period in 2025.

Non-GAAP net loss from continuing operations for the first quarter of 2026 was $33.9 million, or $(0.25) per share on a diluted basis, compared to $40.9 million, or $(0.35) per share for the same period in 2025. 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 $167.0 million as of March 31, 2026, compared to $172.1 million as of December 31, 2025. These balances were inclusive of Transition Service Agreement (TSA)-related collections that will be applied to associated TSA payables and accrued liabilities which totaled $61.6 million and $65.1 million as of March 31, 2026 and December 31, 2025, respectively.

Conference Call Information

When: Monday, May 11, 2026, 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, MAY 11, 2026, View Source [SID1234665431])

On May 11, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported its first quarter 2026 financial results.

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First Quarter Highlights:
Revenue was $106.9 million, compared to $106.0 million in the first quarter of 2025, representing growth of 1%.
Software revenue was $49.7 million, compared to $46.4 million in the first quarter of 2025, representing growth of 7%.
Services revenue was $57.2 million, compared to $59.6 million in the first quarter of 2025, representing a decrease of 4%.
Net loss was $8.8 million, compared to a net income of $4.7 million in the first quarter of 2025, representing a decrease of 285%.
Adjusted EBITDA was $31.7 million, compared to $34.8 million in the first quarter of 2025, representing a decrease of 9%.
"I am pleased with the progress we made in my first quarter at Certara," said Jon Resnick, Chief Executive Officer. "We are taking decisive steps to sharpen our execution and position Certara for long-term growth, including divesting our Medical Writing business, reorganizing around two focused growth areas, and accelerating our enterprise-wide AI program. Together, these actions strengthen our ability to transform drug development and deliver greater value to our customers and shareholders."

"Our first quarter performance reflects improvement in software, which came in above plan across key metrics. Services performance was mixed, reflecting execution and go-to-market challenges that we expect to resolve during the second half of the year," said John Gallagher, Chief Financial Officer. "With the divestiture of our Regulatory and Medical Writing Business, we expect the mix of software and services revenue to be approximately even. Our updated 2026 guidance reflects the impact of the divestiture during the second quarter, and revenue growth expectations of 0% – 4% excluding the Regulatory and Medical Writing Business."

First Quarter 2026 Results
Total revenue for the first quarter of 2026 was $106.9 million, representing year-over-year growth of 1% on a reported basis. Software revenue for the first quarter of 2026 was $49.7 million, representing year-over-year growth of 7% on a reported basis. Services revenue for the first quarter of 2026 was $57.2 million, representing a year-over-year decrease of 4% on a reported basis.

Total Bookings for the first quarter of 2026 were $115.3 million, representing a year-over-year decrease of 2%.

Software Bookings for the first quarter of 2026 were $48.7 million, representing a year-over-year increase of 20%. The increase in software bookings was attributable to strong customer demand across our platform.

Services Bookings for the first quarter of 2026 were $66.6 million, representing a year-over-year decrease of 14%. The decrease in services bookings was primarily driven by the timing of contract recognition and execution.

Total cost of revenues for the first quarter of 2026 was $41.6 million, an increase of $0.1 million from $41.5 million in the first quarter of 2025. Cost levels were consistent with the same quarter in the prior year.

Total operating expenses for the first quarter of 2026 were $69.6 million, which increased by $12.7 million from $56.9 million in the first quarter of 2025. Higher operating expenses were primarily due to a $7.4 million increase in business acquisition contingent consideration expense, a $2.8 million increase in employee-related costs, a $1.0 million increase in equipment and software expenses, a $0.9 million increase in executive recruiting and retention expenses, a $0.8 million increase in lease abandonment expense, primarily due to the absence of a non-recurring gain recognized in the prior year that reduced expenses in that period, and a $0.8 million increase in amortization of intangible assets, partially offset by higher capitalized R&D costs.

Net loss for the first quarter of 2026 was $8.8 million, compared to a net income of $4.7 million in the first quarter of 2025. The $13.5 million decrease in net income was primarily driven by higher operating expenses, increased tax expenses, and increased total other expenses, partially offset by higher revenues.

Diluted loss per share for the first quarter of 2026 was $0.06, as compared to diluted earnings per share of $0.03 in the first quarter of 2025.

Adjusted EBITDA for the first quarter of 2026 was $31.7 million compared to $34.8 million for the first quarter of 2025, a decrease of $3.1 million. See note (1) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on adjusted EBITDA.

Adjusted net income for the first quarter of 2026 was $14.5 million compared to $22.2 million for the first quarter of 2025, a decrease of $7.7 million. Adjusted diluted earnings per share for the first quarter of 2026 was $0.09, compared to $0.14 for the first quarter of 2025. See note (2) in the section titled "A Note on Non-GAAP Financial Measures" below for more information on adjusted net income and adjusted diluted earnings per share.

THREE MONTHS ENDED MARCH 31,
2026 2025
Key Financials (in millions, except per share data)
Revenue $ 106.9 $ 106.0
Software revenue $ 49.7 $ 46.4
Service revenue $ 57.2 $ 59.6
Total bookings $ 115.3 $ 118.2
Software bookings $ 48.7 $ 40.8
Service bookings $ 66.6 $ 77.4
Net income (loss) $ (8.8 ) $ 4.7
Diluted earnings per share $ (0.06 ) $ 0.03
Adjusted EBITDA $ 31.7 $ 34.8
Adjusted net income $ 14.5 $ 22.2
Adjusted diluted earnings per share $ 0.09 $ 0.14
Cash and cash equivalents $ 149.5 $ 189.4
Divestiture of global medical writing and related regulatory services business:
On May 08, 2026, we completed the sale of our global medical writing and related regulatory services business to Veristat, LLC for cash consideration of $85.0 million, with an additional $15.0 million placed in escrow and to be released to the Company upon the satisfaction of certain post-closing covenants, and additional contingent consideration of up to $35.0 million in the form of an earn-out based on the financial performance of such business for a specified period following closing. Net proceeds from the transaction are expected to be used for general corporate purposes, including funding our ongoing operations.

2026 Financial Outlook
Certara is updating its guidance for the full year 2026, to reflect the completed divestiture of the Regulatory and Medical Writing Business:

Full year 2026 revenue is expected to be $395 million – $405 million, including Regulatory and Medical Writing revenue of approximately $18 million.
Growth excluding the Regulatory and Medical Writing Business is expected to be 0% – 4%.
Full year 2026 Adjusted EBITDA margin is expected to be approximately 30% – 32%, including contribution from the Regulatory and Medical Writing business.
Full year adjusted diluted earnings per share is expected to be in the range of $0.35 – $0.41.
Fully diluted shares are expected to be in the range of 157 million – 159 million.
Please note that the Company has not reconciled adjusted EBITDA, adjusted EBITDA 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, May 11, 2026, at 8:30 a.m. ET to discuss its first quarter 2026 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, MAY 11, 2026, View Source [SID1234665430])