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])

On May 11, 2026 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene editing platform to develop life-saving cell and gene therapies, reported financial results for the first quarter 2026, ending March 31, 2026 and provided a business update.

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"The interim pivotal data published by Allogene on cema-cel, a product originally developed by Cellectis as UCART19, are a proud validation of our vision: that allogeneic, off-the-shelf cell therapy candidates could deliver transformative outcomes for cancer patients. We believe this approach has the potential to dramatically expand access to CAR-T beyond what autologous therapies can reach today" said André Choulika, Ph.D., Co-Founder and Chief Executive Officer of Cellectis. "As we look ahead to Q4 2026, with the expected interim pivotal Phase 2 data for lasme-cel in relapsed or refractory B-ALL, and the full Phase 1 dataset for eti-cel in relapsed or refractory NHL, Cellectis is approaching its own defining moment. We are excited about what lies ahead."

Allogeneic CAR-T Pipeline

Lasme-cel in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) – BALLI-01

The Pivotal Phase 2 BALLI-01 trial is ongoing.

Phase 1 data highlights :

100% ORR in the target Phase 2 population
83% overall response rate (ORR) at recommended Phase 2 dose (RP2D)
In target Phase 2 population: all patients became eligible to transplant
Favorable safety profile: low rates of ≥ grade 3 cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) at 2.5% and 5% respectively
14.8 months median overall survival (OS) in patients who achieved minimal residual disease (MRD)-negative complete remission with incomplete hematology recovery (CR/CRi)
The first interim analysis for the pivotal Phase 2 of the BALLI-01 trial is expected in Q4 2026 (n=40). Cellectis anticipates submitting a Biologics License Application (BLA) in 2028.

Eti-cel in relapsed or refractory non-Hodgkin lymphoma (r/r NHL) – NATHALI-01

The Phase 1 NATHALI-01 trial is ongoing.

Preliminary Phase 1 data highlights:

At current dose level: 88% ORR, 63% complete response (CR) rate after 2+ prior lines of therapy
93% of subjects had prior CD19 CAR-T
Cellectis expects to present the full Phase 1 dataset in Q4 2026, including results from the low dose interleukin-2 (IL-2) combination cohorts.

TALE-based epigenetic editing platform to turn genes off without altering DNA

On April 27, 2026, Cellectis announced new research on a TALE-based epigenetic editing approach, that does not cut or permanently modify the DNA sequence, making it a potentially safer alternative for genome editing, at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting, that is taking place on May 11-15, 2026.
Key data highlights:

Cellectis developed TALEM (Transcription Activator-Like Effector-based epigenetic Modulators), engineered fusion proteins that precisely target genomic loci to switch genes on or off through epigenetic editing, without cutting or permanently modifying the DNA sequence. Using a high-throughput screening system capable of rapidly assembling and testing hundreds of TALEM candidates, Cellectis demonstrated >90% stable gene silencing across two distinct targets: a gene highly expressed in liver cells and a gene implicated in T-cell exhaustion, a key challenge in cancer immunotherapy.
The abstract is live on the ASGCT (Free ASGCT Whitepaper) website. The poster will be available on Cellectis’ website on May 13, 2026 at 5 pm ET.

Partnerships

AstraZeneca – Joint Research and Collaboration Agreement

Activities are continuing under the Joint Research and Collaboration Agreement with AstraZeneca, which leverages Cellectis’ gene editing expertise and manufacturing capabilities to develop up to 10 novel cell and gene therapy products for areas of high unmet medical need, including oncology, immunology and rare genetic disorders.
Servier (through its sublicensee Allogene) – Anti-CD19 CAR-T

Cema-cel is a product candidate licensed to Servier under the License, Development and Commercialization Agreement signed by and between les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and Cellectis (the "Servier Agreement") and sublicensed by Servier to Allogene in certain territories.

On April 13, 2026, Cellectis highlighted the interim pivotal data announced by Allogene, from Allogene’s sponsored ALPHA3 trial evaluating cema-cel in first-line consolidation for large B-cell lymphoma (LBCL). Cema-cel is derived from the UCART19 product initially developed by Cellectis.
Key data highlights reported by Allogene:

The futility analysis (n=24) showed that 58.3% of patients in the cema-cel arm achieved MRD negativity versus 16.7% in the observation arm, a 41.6% absolute difference. Allogene reported that based on specific benchmark literature, a difference of 25-30% in the MRD clearance could translate into meaningful clinical benefit at study completion.
The cema-cel treatment was generally well-tolerated, with most patients (10/12) managed on an outpatient basis post-infusion and no cases of CRS, ICANS, graft-versus-host disease (GvHD), treatment-related Serious Adverse Events and no hospitalizations for treatment-related Adverse Events.
Allogene announced that study accrual is anticipated to be complete by the end of 2027 and that it anticipates an interim Event-Free Survival (EFS) analysis in mid-2027 and the primary EFS analysis in mid-2028. If positive, Allogene announced that these results could support a BLA submission.
Under the Servier Agreement, Cellectis is eligible to up to $340 million in development and sales milestones as well as low double-digit royalties on sales of licensed CD19 products, including cema-cel developed in LBCL.

Iovance

In May 2026, Iovance announced that a Phase 1/2 trial, IOV-GM1-201, is enrolling using IOV-4001, a PD-1 inactivated TIL therapy, in previously treated advanced melanoma and non-small cell lung cancer (NSCLC).
Subsequent events

On April 20, 2026, Life Technologies Corporation ("LTC"), a subsidiary of Thermo Fisher, purported to terminate license agreements between LTC and Cellectis in 2014, which grant Cellectis non-exclusive rights under certain patents, the Halle Patent Therapeutic License, the Halle Patent Research License, and the GeneArt and Seamless Cloning Patent Therapeutic License (the « LTC Agreements »). This purported termination follows TFS’s allegations that we failed to comply with our obligations under the LTC Agreements, as previously disclosed. Simultaneously therewith, LTC commenced an arbitration before the American Arbitration Association, naming Cellectis S.A. and Cellectis Bioresearch, Inc. as Respondents. LTC’s arbitration demand alleges that Cellectis has breached the LTC License Agreements by underpaying sublicense royalties and otherwise failing to comply with our obligations under the LTC Agreements. According to us, this termination is invalid and LTC’s claims under this arbitration demand are without merit.
Financial Results

Cash: As of March 31, 2026, Cellectis had $188 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into Q4 2027.

This compares to $211 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2025. The $23 decrease was mainly driven by cash inflows of $13.0 million from revenue and $2.9 million of interest received from our financial and cash-equivalent investments, offset by payments to suppliers of $14.5 million, payroll-related payments (wages, bonuses and social charges) totaling $18.6 million, lease liability payments of $3.4 million, repayment of $1.4 million under the "PGE" loan, and capital expenditures of $0.3 million.

We currently foresee focusing our cash spending at Cellectis in supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of lasme-cel, eti-cel and potential new product candidates, and operating our state-of-the-art manufacturing capabilities in Paris (France) and Raleigh (North Carolina).

Revenues and Other Income: Consolidated revenues and other income were $7.5 million for the three-month period ended March 31, 2026, compared to $12.0 million for the same period in 2025. This $4.5 million decrease between the three-month periods ended March 31, 2025 and 2026 was mainly attributable to a $4.9 million decrease in revenues driven by the evolution of activities performed under the AZ JRCA.

R&D Expenses: Consolidated R&D expenses were $27.2 million for the three-month period ended March 31, 2026, compared to $21.9 million for the same period in 2025, representing an increase of $5.3 million, mainly due to a $3.6 million increase in personnel expenses and a $2.0 million increase in purchases and external expenses.

SG&A Expenses: Consolidated SG&A expenses were $5.6 million for the three-month period ended March 31, 2026, compared to $4.7 million for the same period in 2025. The $0.9 million increase was mainly due to a $0.4 million increase in stock-based compensation expenses and related social charges as well as a $0.4 million increase in purchases and other expenses.

Net financial gain (loss): We had a consolidated net financial gain of $7.4 million for the three-month period ended March 31, 2026, compared to a $3.9 million net financial loss for the three-month period ended March 31, 2025. This $11.4 million increase in net financial result reflects a $5.6 million increase in financial income and a $5.8 million decrease in financial expenses. The rise in financial income was mainly attributable to (i) a $4.5 million increase in non-cash gains on fair value measurements primarily explained by a $6.5 million gain on the fair value measurement of the Tranches A, B and C of EIB warrants in the three months ended March 31, 2026 compared to a $1.8 million gain in the three months ended March 31, 2025, (ii) a $2.0 million increase in foreign exchange gains, partially offset by (iii) a $1.1 million decrease in income from cash, cash equivalents and financial assets. The decrease in financial expenses was mainly due to a (i) $6.5 million decrease in foreign exchange loss, partially offset by (ii) a $0.2 million increase in interests on financial liabilities.

Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $17.8 million (or a $0.18 loss per share) for the three-month period ended March 31, 2026, compared to a $18.1 million net loss (or a $0.18 loss per share) for the three-month period ended March 31, 2025. The $0.4 million decrease in net loss was primarily driven by (i) a $11.4 million improvement in net financial result, from a net financial loss of $3.9 million as of March 31, 2025 to a net financial gain of $7.4 million as of March 31, 2026, partly offset by (ii) a $11.0 million increase in operating loss.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $16.1 million (or a $0.16 loss per share) for the three-month period ended March 31, 2026, compared to a net loss of $17.2 million (or a $0.17 loss per share) for the three-month period ended March 31, 2025.

The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with IAS 34 Interim Financial Reporting, and should be read in conjunction with the Group’s last annual consolidated financial statements as at and for the year ended December 31, 2025.

(Press release, Cellectis, MAY 11, 2026, View Source [SID1234665429])