On August 4, 2025 Mural Oncology plc (Nasdaq: MURA), reported its financial results for the second quarter of 2025 and provided a business update (Press release, Mural Oncology, AUG 4, 2025, View Source [SID1234654729]). On April 15, 2025, Mural announced that it was discontinuing all clinical development of its lead product candidate, nemvaleukin alfa, and was commencing the exploration of strategic alternatives focused on maximizing shareholder value. The Company is continuing to explore strategic alternatives.

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Following its announcement on April 15, 2025, Mural has taken steps to conserve its remaining cash, including the implementation of a reduction in workforce by approximately 90%, the discontinuation of the clinical development of nemvaleukin alfa, and the termination of its other research and development activities, including the research and development of its IL-18 and IL-12 programs. As of June 30, 2025, the company had approximately $77.1 million in cash and cash equivalents. The company estimates that, if it has not consummated a transaction or other strategic alternative by December 31, 2025, its cash and cash equivalents as of such date will total approximately $43 to $48 million. This estimate reflects anticipated costs to be incurred in connection with finalization of the discontinuation of the company’s remaining activities and expected residual operating expenses (e.g. lease expense, salary and benefits for remaining employees, insurance costs). This cash guidance is subject to a number of assumptions and actual cash balances may differ materially, particularly if the Company consummates a transaction or other strategic alternative prior to December 31, 2025. Mural has not included in its cash guidance, additional costs that may be incurred as a result of, or in connection with, any strategic alternative it may pursue, including, but not limited to, an offer for or other acquisition of the company, merger, business combination or other transaction, including a possible wind-down and liquidation of the company (e.g., legal and financial advisor fees and severance costs for remaining employees).

Further updates and developments will be disclosed as appropriate or where necessary under regulatory requirements. There can be no assurance that the company’s exploration of strategic alternatives will result in the company pursuing a transaction or that any acquisition or other transaction involving the company will be completed, nor as to the terms on which any acquisition or other transaction will occur, if at all.

Financial Results for the Quarter Ended June 30, 2025

Cash Position: As of June 30, 2025, cash and cash equivalents were $77.1 million.

R&D Expenses: Research and development expenses were $23.3 million for the second quarter of 2025 compared to $27.5 million for the second quarter of 2024. This decrease was primarily due to decreased employee-related expenses following the reduction-in-force implemented by the company during the second quarter of 2025 and the decreased spend on the ARTISTRY-7 clinical trial of nemvaleukin due to the termination of the development of nemvaleukin. These decreases were partially offset by an increase in spend on early discovery programs upon completion of certain manufacturing activities and on the ARTISTRY-6 trial of nemvaleukin related to the top-line read-out and wind-down of the trial during the second quarter of 2025.

G&A Expenses: General and administrative expenses were $8.1 million for the second quarter of 2025 compared to $6.7 million for the second quarter of 2024. This increase in G&A expenses was primarily due to increased employee-related expenses associated with employee termination and retention benefits and increased legal expenses associated with corporate activities, partially offset by decreased share-based compensation expense resulting from an increase in the awards that were forfeited or were expected to be forfeited following the reduction-in-force.

Restructuring and Impairment Expenses: Mural incurred $17.5 million in restructuring and impairment charges during the second quarter of 2025, consisting of severance and termination benefits related to the reduction-in-force, an impairment charge related to lab equipment sold during the second quarter of 2025 and contract termination and write-offs related to the termination of the company’s research and development programs.

Net Loss: Net loss was $48.0 million for the second quarter of 2025 compared to $31.6 million for the second quarter of 2024. The increase in net loss was primarily driven by the restructuring and impairment charges incurred during the second quarter of 2025.

Cash Guidance: Mural estimates that its cash and cash equivalents will be approximately $43.0 million – $48.0 million as of December 31, 2025, if it has not consummated a transaction or other strategic alternative by such date.

On August 4, 2025 XOMA Royalty Corporation ("XOMA Royalty") (NASDAQ: XOMA) and LAVA Therapeutics N.V. ("LAVA") (NASDAQ: LVTX) reported they have entered a definitive share purchase agreement (the "Purchase Agreement" and the transactions set forth in the Purchase Agreement, the "Transactions") whereby XOMA Royalty will acquire LAVA for (i) USD between $1.16 and $1.24 per share in cash, consisting of (A) USD $1.16 (the "Base Price Per Share") in cash per share (the "LAVA common stock"), plus (B) an additional amount of cash of up to $0.08 per Share (such amount as finally determined in accordance with the Purchase Agreement, the "Additional Price Per Share," and together with the Base Price Per Share, the "Cash Amount"), plus (ii) a non-transferable contingent value right ("CVR") per share representing the right to receive 75% of the net proceeds related to LAVA’s two partnered assets and 75% of any net proceeds from any out license or sale of LAVA’s unpartnered programs (Press release, Lava Therapeutics, AUG 4, 2025, View Source [SID1234654728]).

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"We believe the structure of this transaction has the potential to benefit both LAVA and XOMA Royalty shareholders over time," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "We are adding economics related to LAVA’s partnered programs investigating the utility of gamma delta bispecific antibodies, which hold significant promise for patients."

"The Purchase Agreement with XOMA Royalty announced today is the result of a thorough and wide-ranging strategic review process, conducted with the support of our legal and financial advisors, aimed at maximizing shareholder value while participating in the sustained success of LAVA’s business," said Steve Hurly, Chief Executive Officer of LAVA.

In accordance with its fiduciary duties under Dutch law, LAVA’s Board of Directors (the "Board") has unanimously determined that the Transactions are in the best interests of LAVA and the sustainable success of its business, having carefully considered the interests of LAVA shareholders, employees, and all other relevant stakeholders and has approved the Purchase Agreement. The Board unanimously recommends that shareholders support the Offer, accept the Offer and vote in favor of the resolutions to be proposed to LAVA’s shareholders’ meeting, as noted below.

Transaction Terms

Pursuant and subject to the terms of the Purchase Agreement, XOMA Royalty will commence a tender offer (the "Offer") by August 15, 2025, to acquire all outstanding shares of LAVA common stock. The closing of the Offer is subject to certain conditions, including the tender of LAVA common stock representing at least 80% (or, in certain cases, 75%) of LAVA’s issued and outstanding shares, the condition that certain resolutions are adopted by LAVA’s shareholders meeting; a minimum cash balance at closing, and other customary closing conditions. Following a subsequent offering period, LAVA will undergo a corporate reorganization designed to result in XOMA Royalty acquiring 100% of the shares in LAVA’s successor and all then-remaining LAVA shareholders (other than XOMA Royalty) receiving the same cash and CVR consideration per share as is provided in the tender offer, subject to applicable withholding taxes. LAVA will hold a shareholder’s meeting in connection with the Transactions. The closing of the Transactions is expected in the fourth quarter of 2025.

In connection with the Transactions, the Company plans to discontinue its Phase 1 clinical trial of LAVA-1266 for acute myeloid leukemia and myelodysplastic syndrome and initiate the wind-down of the LAVA-1266 program.

Advisors

XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP and Loyens & Loeff N.V, who acted as U.S. and Dutch legal advisors, respectively. Leerink Partners is acting as exclusive financial advisor to LAVA, Cooley LLP is acting as U.S. legal advisor to LAVA and NautaDutilh N.V. is acting as Dutch legal advisor to LAVA.

On August 4, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), 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 that in July 2025 the Company added $6.6 million in gross proceeds ($6.3 million net) by selling 19,868,658 shares of its common stock via its At-the-Market offering (the "ATM") at an average price of $0.3323 per share (Press release, Intensity Therapeutics, AUG 4, 2025, View Source [SID1234654727]). Following such sales of common stock pursuant to the ATM, the Company has 46,035,081 shares of common stock issued and outstanding as of July 31, 2025.

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"We were able to take advantage of strong liquidity and favorable prices in our stock last month. The proceeds from these ATM sales strengthen our balance sheet considerably and allow us to continue to advance the clinical trials into the second half of 2026," said Lewis H. Bender, President and CEO of Intensity. "We are also pleased to announce that the average price per share for these ATM sales was more than 10% higher than our recently completed June 2025 public offering, and the costs to raise this incremental capital were much lower. We will continue to be selective and strategic in the deployment of the remainder of the ATM."

About At the Market Transactions

"At-the-Market" (ATM) offerings, also known as "ATM" programs, refer to a method where a public company sells its newly issued shares directly into the existing trading market at the prevailing market price, rather than through a traditional underwritten offering. This approach allows companies to raise capital opportunistically and incrementally, as needed, with minimal disruption to the market and typically lower costs.

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.

On August 4, 2025 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the second quarter ended June 30, 2025 (Press release, CRISPR Therapeutics, AUG 4, 2025, View Source [SID1234654716]).

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"We are entering the second half of the year with momentum across both our commercial and clinical programs," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "The activation of 75 authorized treatment centers for CASGEVY has been achieved, marking a meaningful step in expanding patient access, while clinical trials across multiple other programs continue to advance. Looking ahead, we expect several key milestones including the presentation of complete Phase 1 data for CTX310, as well as updates across our oncology and autoimmune portfolios. Our focus remains on delivering transformative therapies for patients with critical unmet needs."

Recent Highlights and Outlook

Hemoglobinopathies and CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY is a non-viral, ex vivo, CRISPR/Cas9 gene-edited cell therapy for eligible patients with sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT), designed to eliminate both vaso-occlusive crises (VOCs) and transfusion requirements. CASGEVY is approved in the U.S., Great Britain, the EU, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain (Bahrain), Qatar, Canada, Switzerland and the United Arab Emirates (UAE) for the treatment of both SCD and TDT. Building on the foundational launch in 2024, significant progress is being made to bring this transformative therapy to patients worldwide.
The target of activating 75 authorized treatment centers (ATCs) globally has been achieved, marking an important milestone in the commercial rollout of CASGEVY. Since launch through June 30, approximately 115 patients have completed their first cell collection, and 29 patients have received infusions of CASGEVY, including 16 infused in the second quarter. The launch of CASGEVY is building strong momentum, positioning the program for significant growth and broader impact.
Through reimbursement agreements, Vertex has secured access for eligible SCD and TDT patients in 10 countries. Recent agreements include Northern Ireland, Scotland and Denmark. Efforts are ongoing with government and reimbursement authorities globally to secure access for eligible patients.
CRISPR Therapeutics continues to advance its next-generation approaches designed to significantly broaden the addressable patient population for SCD and TDT. The Company’s internally developed targeted conditioning program, an anti-CD117 (c-Kit) antibody-drug conjugate (ADC), remains on track in preclinical development. In parallel, the Company is making continued progress in its in vivo editing platform aimed at enabling direct editing of hematopoietic stem cells (HSC) without the need for conditioning. By potentially eliminating the need for conditioning, this approach could unlock access to transformative therapies for a significantly larger patient population.
Immuno-Oncology and Autoimmune Disease Programs

Clinical trials are ongoing for the Company’s next-generation allogeneic CAR T product candidates, CTX112 and CTX131, targeting CD19 and CD70, respectively, across multiple indications. Both candidates incorporate novel potency edits designed to significantly enhance CAR T cell expansion and cytotoxicity, positioning them as potential best-in-class therapies.
CTX112, targeting CD19, is in development for hematologic malignancies and autoimmune diseases. Preliminary clinical data support a differentiated profile with strong clinical benefit combined with the convenience of an "off-the-shelf" therapy.
In relapsed or refractory B-cell malignancies, encouraging results from the ongoing Phase 1/2 clinical trial led to the FDA granting Regenerative Medicine Advanced Therapy (RMAT) designation for CTX112 in relapsed or refractory follicular lymphoma and marginal zone lymphoma.
A Phase 1 trial of CTX112 is ongoing in autoimmune indications, including systemic lupus erythematosus (SLE), systemic sclerosis and inflammatory myositis. Preliminary safety, pharmacokinetic, and pharmacodynamic data from oncology trials support its potential in autoimmune indications.
The Company plans to provide a broad update for CTX112 in oncology and autoimmune disease in the second half of 2025.
CTX131, targeting CD70, is in development for both solid tumors and hematologic malignancies. Clinical trials for CTX131 are ongoing, with an update expected in 2025.
CRISPR Therapeutics’ immuno-oncology and autoimmune disease efforts are supported by a wholly-owned, U.S. manufacturing facility located in Framingham, MA. This investment enables the production of clinical and commercial-stage good manufacturing practice (GMP) materials across the Company’s allogeneic cell therapy programs.
In Vivo Liver Editing Programs

CRISPR Therapeutics is advancing a pipeline of in vivo gene editing candidates targeting major unmet needs in cardiovascular and metabolic diseases using its proprietary lipid nanoparticle (LNP) delivery platform.
CTX310 is in an ongoing Phase 1 clinical trial targeting ANGPTL3 in patients with homozygous familial hypercholesterolemia (HoFH), severe hypertriglyceridemia (SHTG), heterozygous familial hypercholesterolemia (HeFH), or mixed dyslipidemias. ANGPTL3 loss-of-function mutations are linked to reduced in low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and a lower risk of atherosclerotic cardiovascular disease (ASCVD), without adverse effects on overall health. In the U.S., more than 40 million patients have elevated LDL, severely elevated TGs or both. CTX310 is initially focused on a high-risk subset of this group with the greatest unmet medical need and limited effective treatment options.
In June, the Company reported data for CTX310, demonstrating dose-dependent reductions in ANGPTL3, TG, and LDL following a single administration. As dose-range finding continues, data to date demonstrate peak reductions of up to 82% in TG and LDL reductions of up to 86% at DL4 without any clinically significant changes in liver enzymes and a safety and tolerability profile consistent with previous findings.
These initial results represent a significant milestone in the advancement of CRISPR Therapeutics’ proprietary LNP delivery technologies for gene editing in the liver. The Company anticipates presenting the complete Phase 1 data for CTX310 at a medical meeting in the second half of 2025.
CTX320 is in an ongoing Phase 1 clinical trial targeting the LPA gene in patients with elevated lipoprotein(a) [Lp(a)], a genetically determined risk factor associated with an increased incidence of major adverse cardiovascular events (MACE). Elevated Lp(a) levels affect up to 20% of the global population and remain unaddressed by current therapies. The Company plans to provide an update in the first half of 2026.
CRISPR Therapeutics continues to advance two preclinical programs: CTX340, targeting angiotensinogen (AGT) for the treatment of refractory hypertension, and CTX450, targeting 5’ aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias (AHP). Both candidates are currently in IND/CTA-enabling studies.
SRSD107

In May, the Company entered a strategic collaboration with Sirius Therapeutics to jointly develop and commercialize small interfering RNA (siRNA) therapies, beginning with SRSD107, a long-acting Factor XI (FXI) siRNA. Under the partnership, development and commercialization will be shared, with CRISPR Therapeutics leading efforts in the U.S. and Sirius in Greater China. The agreement also grants CRISPR Therapeutics the option to nominate two additional siRNA targets for future development. This collaboration expands CRISPR Therapeutics’ capabilities, enabling the development of a broader range of transformative gene-based medicines beyond its current gene-editing programs in the clinic.
In July, the European Medicines Agency (EMA) authorized the initiation of a Phase 2 clinical trial of SRSD107 for thromboembolic disorders. The study is designed to evaluate the safety and efficacy of SRSD107 in preventing post-operative venous thromboembolism in patients undergoing total knee arthroplasty and aims to confirm its anticoagulant potential.
Regenerative Medicine Programs

CRISPR Therapeutics continues to advance its regenerative medicine efforts in Type 1 diabetes (T1D). In addition to CTX211, the Company is developing next-generation programs focusing on induced pluripotent stem cell (iPSC) derived, allogeneic, gene-edited, beta islet cell precursors. These approaches aim to enable insulin independence in T1D patients without the need for chronic immunosuppression. The Company expects to provide an update in 2025.
Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $1,721.2 million as of June 30, 2025, compared to $1,903.8 million as of December 31, 2024. The decrease in cash was primarily driven by operating expenses, as well as the $25.0 million upfront cash payment made as part of the Sirius Agreement, offset by proceeds from interest income and proceeds from the issuance of common shares and option exercise activity.
R&D Expenses: R&D expenses were $69.9 million for the second quarter of 2025, compared to $80.2 million for the second quarter of 2024. The decrease in R&D expense was primarily driven by a decrease in employee-related expenses, including stock-based compensation expenses.
Acquired In-Process R&D Expenses: Acquired in-process R&D expenses were $96.3 million for the second quarter of 2025 related to costs incurred upon entering the Sirius Agreement during the second quarter of 2025.
G&A Expenses: General and administrative expenses were $18.9 million for the second quarter of 2025, compared to $19.5 million for the second quarter of 2024.
Collaboration Expense: Collaboration expense, net, was $45.2 million for the second quarter of 2025, compared to $52.1 million for the second quarter of 2024. The decrease in collaboration expense, net, was primarily attributable to an increase in CASGEVY revenue, as well as a decrease in operating expenses for the program.
Net Loss: Net loss was $208.5 million for the second quarter of 2025, compared to a net loss of $126.4 million for the second quarter of 2024.
About CASGEVY (exagamglogene autotemcel [exa-cel])
CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate recurrent vaso-occlusive crises (VOCs) for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved for certain indications in multiple jurisdictions for eligible patients.

About the CRISPR Therapeutics – Vertex Collaboration for CASGEVY
CRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CASGEVY represents the first potential treatment to emerge from the joint research program. Under an amended collaboration agreement, Vertex now leads global development, manufacturing, and commercialization of CASGEVY and splits program costs and profits worldwide 60/40 with CRISPR Therapeutics. Vertex is the manufacturer and exclusive license holder of CASGEVY.

About CTX112
CTX112 is being developed for both oncology and autoimmune indications. CTX112 is a next-generation, wholly-owned, allogeneic CAR T product candidate targeting Cluster of Differentiation 19, or CD19, which incorporates edits designed to evade the immune system, enhance CAR T potency, and reduce CAR T exhaustion. CTX112 is being investigated in an ongoing clinical trial designed to assess safety and efficacy of the product candidate in adult patients with relapsed or refractory B-cell malignancies who have received at least two prior lines of therapy. In addition, CTX112 is being investigated in an ongoing clinical trial designed to assess the safety and efficacy of the product candidate in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis.

About CTX131
CTX131 is being developed for both solid tumors and hematologic malignancies, including T cell lymphomas (TCL). CTX131 is a next-generation, wholly-owned, allogeneic CAR T product candidate targeting Cluster of Differentiation 70, or CD70, an antigen expressed on various solid tumors and hematologic malignancies. CTX131 incorporates edits designed to evade the immune system, prevent fratricide, enhance CAR T potency, and reduce CAR T exhaustion. CTX131 is being investigated in ongoing clinical trials designed to assess the safety and efficacy of the product candidate in adult patients with relapsed or refractory solid tumors and hematologic malignancies, including TCL.

About In Vivo Programs
CRISPR Therapeutics has established a proprietary lipid nanoparticle (LNP) platform for the delivery of CRISPR/Cas9 to the liver. The Company’s in vivo portfolio includes its lead investigational programs, CTX310 (directed towards angiopoietin-related protein 3 (ANGPTL3)) and CTX320 (directed towards LPA, the gene encoding apolipoprotein(a) (apo(a)), a major component of lipoprotein(a) [Lp(a)]). Both are validated therapeutic targets for cardiovascular disease. CTX310 and CTX320 are in ongoing clinical trials in patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, mixed dyslipidemias, or severe hypertriglyceridemia, and in patients with elevated lipoprotein(a), respectively. In addition, the Company’s research and preclinical development candidates include CTX340 and CTX450, targeting angiotensinogen (AGT) for refractory hypertension and 5’-aminolevulinate synthase 1 (ALAS1) for acute hepatic porphyria (AHP), respectively.

About SRSD107
SRSD107 is a novel double-stranded small interfering ribonucleic acid (siRNA). Developed initially by Sirius Therapeutics, SRSD107 specifically targets the human coagulation factor XI (FXI) mRNA and inhibits FXI protein expression, thereby blocking the intrinsic coagulation pathway and promoting anticoagulant/anti-thrombotic effects.

On August 4, 2025 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 second quarter 2025 ending June 30, 2025 and business updates (Press release, Cellectis, AUG 4, 2025, View Source [SID1234654715]).

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"I am pleased to announce that Cellectis will host an Investor R&D Day in New York City on October 16, 2025. The Company’s leadership team and key opinion leaders will present the Phase 1 dataset and outline the late-stage development strategy for lasme-cel (UCART22) in r/r B-ALL and will share insights on the Company’s vision and differentiated capabilities," said André Choulika, Ph.D., Chief Executive Officer at Cellectis.

"Our teams have remained focused on advancing research and developing solutions for patients with unmet medical needs. In July 2025, we completed the end-of-Phase 1 multidisciplinary meetings with both the FDA and EMA for lasme-cel in r/r B-ALL. We are excited about a pivotal Phase 2 which we expect to initiate in the second half of this year."

Pipeline Highlights

UCART Clinical Programs

BALLI-01 study evaluating lasme-cel (UCART22) in relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)

In July 2025, Cellectis completed the multidisciplinary end-of-Phase 1 regulatory interactions with both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Preparations are currently underway in anticipation for an amendment to initiate a pivotal Phase 2 of lasme-cel in r/r B-ALL, which is expected in H2 2025.
Cellectis will present the Phase 1 dataset and late-stage development strategy for lasme-cel in r/r B-ALL at an Investor R&D Day that will take place on October 16, 2025 in New York City.
NatHaLi-01 study evaluating eti-cel (UCART20x22) in relapsed or refractory B-cell non-Hodgkin lymphoma (r/r NHL)

Cellectis continues to focus on the enrollment of patients in the NatHaLi-01 study and expects to present a Phase 1 readout for eti-cel in r/r NHL in late 2025.
Partnerships

Servier – Anti-CD19 CAR-T

In May 2025, Allogene Therapeutics, Inc. ("Allogene"), Servier’ sublicensee, announced that, as part of the ALPHA3 clinical trial evaluating cemacabtagene ansegedleucel (cema-cel) in first-line consolidation for large B-cell lymphoma, the milestone for lymphodepletion regimen selection and futility analysis has been shifted by approximately two quarters and is now expected by Allogene in the first half of 2026.
On August 1, 2025, Allogene announced that it has selected standard fludarabine and cyclophosphamide (FC) as the lymphodepletion regimen to be used in its ALPHA3 study. The arm testing FC plus ALLO-647, an anti-CD52 mAb (FCA), is now closed to further enrollment. According to Allogene, this decision, made ahead of the scheduled futility analysis, was prompted by a Grade 5 adverse event in the FC plus ALLO-647 arm that has been attributed to the use of ALLO-647. According to Allogene, this event was deemed unrelated to cema-cel. Allogene further announced that the amended ALPHA3 trial now proceeds as a randomized study with two arms, comparing cema-cel after standard FC lymphodepletion to observation, the current standard of care. Statistical design of the trial and the prespecified study conduct remain the same. The next milestone will be the futility analysis comparing MRD conversion and is expected by Allogene to occur 1H 2026.
Allogene – Anti-CD70 CAR-T

In June 2025, Allogene presented updated data from the Phase 1 TRAVERSE study of ALLO-316 in renal cell carcinoma during an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. The presentation focused on the Phase 1b expansion cohort from the Phase 1 TRAVERSE study in which patients were treated with a standard regimen of cyclophosphamide and fludarabine following by a single dose of 80 million CAR-T cells.
AstraZeneca – Joint Research and Collaboration Agreement

Research and development activities are continuing to advance for the three cell and gene therapy programs under our Joint Research and Collaboration Agreement with AstraZeneca in November 2023 (the "AZ JRCA"): one allogeneic CAR-T for hematological malignancies, one allogeneic CAR-T for solid tumors, and one in vivo gene therapy for a genetic disorder.
Servier arbitration

With respect to the ongoing arbitration proceeding through the Centre de Médiation et d’Arbitrage de Paris, the arbitral decision is expected to be rendered on or before December 15, 2025.
Corporate Updates

Annual Shareholders’ Meeting

On June 26, 2025, Cellectis held a Shareholders General Meeting at the Biopark auditorium in Paris, France. At the meeting, during which approximately 57% of voting rights were exercised, resolutions 1 through 23 and resolutions 25 and 26 were adopted, while resolution 24 was rejected, consistent with the recommendations of the Board of Directors. The detailed results of the vote and the resolutions are available on Cellectis’ website: View Source
The Cellectis Shareholders’ Meeting appointed Mr. André Muller as a director of the Company’s Board of Directors, with immediate effect. In addition, at the close of this meeting, the term of Mr. Axel-Sven Malkomes expired, and the previously announced resignation of Mr. Pierre Bastid became effective. In connection with these changes to the Board of Directors, the Board of Directors appointed André Muller, Donald Bergstrom, and Rainer Boehm as the members of the Company’s Audit Committee.
Financial Results

Cash, cash equivalent and fixed-term deposits: As of June 30, 2025, Cellectis had $230 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current and non-current financial assets. The Company believes its cash, cash equivalents and fixed-term deposits will be sufficient to fund its operations into H2 2027.

This compares to $264 million in consolidated cash, cash equivalents, restricted cash and fixed-term deposits classified as current financial assets as of December 31, 2024, with no fixed-term deposits classified as non-current financial assets as of such date. This $33.2 million change includes $13.4 million of cash-in from our revenue, $5.1 million of interest income from our financial and cash-equivalent investments, offset by cash payments from Cellectis to suppliers of $23.2 million, Cellectis’ wages, bonuses and social expenses paid of $23.6 million, the payments of lease debts of $5.4 million, the repayment of the "PGE" loan of $2.6 million and the payments of capital expenditures for $0.7 million.

We currently foresee focusing our cash spending in supporting the development of our pipeline of product candidates, including the manufacturing and clinical trial expenses of lasme-cel (UCART22), eti-cel (UCART20x22) 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 $30.2 million for the six-month period ended June 30, 2025, compared to $16.0 million for the six-month period ended June 30, 2024. This $14.2 million increase between the six-month period ended June 30, 2024 and 2025 was mainly attributable to a $20.0 million increase in revenue recognized under AstraZeneca Joint Research Collaboration Agreement in the first half 2025 based on the progress of our performance obligation rendered under the three research programs, partly offset by a slight decrease in other income by $0.6 million and by a one-off development milestone revenue of $5.4 million recorded last year as of June 30, 2024 under the Servier License Agreement.

R&D Expenses: Consolidated R&D expenses were $45.0 million for the six-month period ended June 30, 2025, compared to $45.8 million for the six-month period ended June 30, 2024, down by $0.8 million mainly driven by a decrease in purchases & external expenses and other expenses of $1.7 million, offset by an increase of $0.7 million in depreciation & amortization expenses and by a slight increase of $0.2 million in R&D personnel expenses related to non-cash stock based compensation.

SG&A Expenses: Consolidated SG&A expenses were $9.8 million for the six-month period ended June 30, 2025, compared to $9.0 million for the six-month period ended June 30, 2024. The $0.8 million change is mainly due to a non-cash stock-based compensation increase of $0.3 million and an increase of $0.6 million in purchases and external expenses, partially offset for by a decrease in amortization expenses of $0.1 million.

Other operating income and expenses: Other operating income increased slightly by $0.1 million between the six-month periods ended June 30, 2024, and 2025.

Net financial gain (loss): We had a consolidated net financial loss of $18.1 million for the six-month period ended June 30, 2025, compared to an $18.0 million net financial gain for the six-month period ended June 30, 2024. This $36.1 million difference reflects mainly (i) a one-off $14.3 million gain in change in fair value of the derivative instrument component of the Subsequent Investment Agreement dated November 7, 2023 between us and AstraZeneca Holdings (the "SIA"), which was recognized in the six-month period ended June 30, 2024, (ii) a $3.5 million decrease in change in fair value of the warrants issued to the European Investment Bank ("EIB"), as required by our finance contract entered into with EIB in December 2022, (iii) a $22.5 million increase in foreign exchange loss and a $1.0 million decrease in foreign exchange gain over the period due to the USD devaluation and (iv) a $0.3 million increase in interests on financial and lease liabilities, partially offset by (v) a $0.4 million increase in income from our financial investments and cash-equivalents, (vi) a $4.5 million decrease in loss on fair value mainly due to our investment in shares of Cibus, Inc., which was entirely sold in the first quarter of 2025 and (vii) a $0.6 million gain in fair value of foreign exchange derivatives recorded during the period.

Net Income (loss) Attributable to Shareholders of Cellectis: Consolidated net loss attributable to shareholders of Cellectis was $41.9 million (or a $0.42 net loss per share) for the six-month period ended June 30, 2025, compared to a $19.6 million net loss (or a $0.24 net loss per share) for the six-month period ended June 30, 2024. The $22.2 million change in net loss was primarily driven by (i) an increase in revenues and other income of $14.2 million and (ii) a $0.1 million decrease in operating expenses and other operating income, offset by (iii) a $36.1 million change from a net financial gain of $18.0 million as of June 30, 2024 to a net financial loss of $18.1 million as of June 30, 2025 and (iv) a decrease in deferred tax asset income of $0.5 million.

Adjusted Net Income (Loss) Attributable to Shareholders of Cellectis: Consolidated adjusted net loss attributable to shareholders of Cellectis was $39.6 million (or a $0.40 loss per share) for the six-month period ended June 30, 2025, compared to a net loss of $17.9 million (or a $0.22 loss per share) for the six-month period ended June 30, 2024.

The interim condensed consolidated financial statements of Cellectis have been prepared in accordance with International Financial Reporting Standards, as issued by the International Accounting Standards Board ("IFRS").

Please see "Note Regarding Use of Non-IFRS Financial Measures" for reconciliation of GAAP net income (loss) attributable to shareholders of Cellectis to adjusted net income (loss) attributable to shareholders of Cellectis.

CELLECTIS S.A.
INTERIM CONDENSED STATEMENT OF CONSOLIDATED FINANCIAL POSITION (unaudited)
($ in thousands)

As of
December 31, 2024 June 30, 2025
ASSETS
Non-current assets
Intangible assets 1,116 1,153
Property, plant, and equipment 45,895 42,790
Right-of-use assets 29,968 27,383
Non-current financial assets 7,521 35,491
Other non-current assets 11,594 16,127
Deferred tax assets 382 382
Total non-current assets 96,476 123,326
Current assets
Trade receivables 6,714 8,776
Subsidies receivables 14,521 16,382
Other current assets 5,528 7,333
Cash and cash equivalent and Current financial assets 260,306 198,151
Total current assets 287,069 230,641
TOTAL ASSETS 383,544 353,966
LIABILITIES
Shareholders’ equity
Share capital 5,889 5,902
Premiums related to the share capital 494,288 433,549
Currency translation adjustment (39,537 ) (33,885 )
Retained earnings (292,846 ) (266,592 )
Net income (loss) (36,761 ) (41,863 )
Total shareholders’ equity – Group Share 131,033 97,111
Non-controlling interests - -
Total shareholders’ equity 131,033 97,111
Non-current liabilities
Non-current financial liabilities 50,882 55,856
Non-current lease debts 34,245 32,264
Non-current provisions 1,115 1,303
Total non-current liabilities 86,241 89,424
Current liabilities
Current financial liabilities 16,134 18,230
Current lease debts 8,385 7,477
Trade payables 18,664 17,522
Deferred revenues and deferred income 112,161 113,379
Current provisions 828 875
Other current liabilities 10,097 9,949
Total current liabilities 166,269 167,432
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY 383,544 353,966

Cellectis S.A.
INTERIM CONDENSED STATEMENTS OF CONSOLIDATED OPERATIONS (unaudited)
For the six-month period ended June 30, 2025
($ in thousands, except per share amounts)

For the six-month period ended June 30,
2024 2025

Revenues and other income
Revenues 12,589 27,380
Other income 3,412 2,842
Total revenues and other income 16,002 30,222
Operating expenses
Research and development expenses (45,841 ) (45,012 )
Selling, general and administrative expenses (8,986 ) (9,780 )
Other operating income (expenses) 721 804
Total operating expenses (54,107 ) (53,988 )

Operating income (loss) (38,105 ) (23,766 )

Financial gain (loss) 18,023 (18,098 )

Income tax 455 -

Net income (loss) (19,627 ) (41,863 )
Attributable to shareholders of Cellectis (19,627 ) (41,863 )
Basic net income (loss) attributable to shareholders of Cellectis, per share ($/share) (0.24 ) (0.42 )
Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) (0.24 ) (0.42 )

Number of shares used for computing
Basic 80,881,026 100,231,292
Diluted 80,881,026 100,231,292

UNAUDITED STATEMENTS OF CONSOLIDATED OPERATIONS
For the three-month period ended June 30, 2025
($ in thousands, except per share amounts)

For the three-month period ended June 30,
2024 2025

Revenues and other income
Revenues 8 061 16,725
Other income 1,442 1,469
Total revenues and other income 9,504 18,193
Operating expenses
Research and development expenses (23,518 ) (23,080 )
Selling, general and administrative expenses (3,882 ) (5,078 )
Other operating income (expenses) 686 378
Total operating expenses (26,714 ) (27,779 )

Operating income (loss) (17,211 ) (9,586 )

Financial gain (loss) (8,251 ) (14,150 )

Income tax 193 -

Net income (loss) (25,270 ) (23,736 )
Attributable to shareholders of Cellectis (25,270 ) (23,736 )
Attributable to non-controlling interests - -
Basic and diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) (0.28 ) (0.24 )
Diluted net income (loss) attributable to shareholders of Cellectis, per share ($/share) (0.28 ) (0.24 )

Number of shares used for computing
Basic 89,852,142 100,305,204
Diluted 89,852,142 100,305,204