On February 26, 2026 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported financial results for the three and twelve months ended December 31, 2025, and provided an operating forecast and business update. Ligand management will host a conference call and webcast today beginning at 8:30 a.m. Eastern time to discuss this announcement and answer questions.

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"We delivered strong fourth quarter results, exceeding our initial full-year adjusted EPS guidance by approximately 30%. This growth was driven by better-than-expected performance across several products in our royalty portfolio, including the successful out-licensing and partner launch of Zelsuvmi. These results highlight the strength of our team and their ability to invest in high-value assets that address significant unmet clinical needs. As we enter 2026, we have a strong balance sheet and are well positioned to execute on our broad pipeline of investment opportunities that we believe position us to continue driving growth and creating long-term shareholder value," said Todd Davis, CEO of Ligand.

Fourth Quarter 2025 Financial Results

Total revenues and income for the fourth quarter of 2025 were $59.7 million, compared with $42.8 million for the same period in 2024, with the 39% increase driven primarily by royalty revenue. Royalties for the fourth quarter of 2025 were $50.5 million, compared with $34.8 million for the same period in 2024, with the 45% increase primarily attributable to increases in sales of Travere Therapeutics’ Filspari, and Merck’s Capvaxive and Ohtuvayre. Captisol sales were $7.8 million for the fourth quarter of 2025, compared with $7.9 million for the same period in 2024. Contract revenue and income was $1.3 million for the fourth quarter of 2025, compared with $0.1 million for the same period in 2024.
Cost of Captisol was $3.0 million for the fourth quarter of 2025, compared with $2.8 million for the same period in 2024. Amortization of intangibles was $8.1 million for the fourth quarter of 2025, compared with $8.3 million for the same quarter in 2024. Research and development expenses were $3.5 million for the fourth quarter of 2025, compared with $4.4 million for the same period in 2024. General and administrative expenses were $25.0 million for the fourth quarter of 2025, compared with $25.6 million for the same period in 2024. Financial royalty asset impairment was $6.2 million for the fourth quarter of 2025 related to Agenus returned partner programs, compared to $4.1 million for the same period in 2024 related to the discontinuation of Takeda’s soticlestat program. There was no fair value adjustment to partner program derivatives for the fourth quarter of 2025. Fair value adjustment to partner program derivatives was $7.2 million for the fourth quarter of 2024 primarily due to the discontinued development of certain Agenus partnered programs.
GAAP net income was $44.8 million, or $2.12 per diluted share for the fourth quarter of 2025, compared with a net loss of $31.1 million, or $1.64 per share, for the same period in 2024. GAAP net income for the fourth quarter of 2025 included a gain of $22.1 million from our short-term investments. Adjusted net income for the fourth quarter
1 A reconciliation of forward‑looking non‑GAAP core adjusted earnings per diluted share to the most directly comparable GAAP measures was provided in the Company’s Investor Day presentation on December 9, 2025, which is available on the Company’s investor relations website. The Company is reiterating that guidance in this release and has not updated the underlying assumptions reflected in that reconciliation

of 2025 was $42.7 million, or $2.02 per diluted share, compared with $25.2 million, or $1.27 per diluted share, for the same period in 2024. The increase in adjusted net income was driven primarily by the 45% increase in royalty revenue. See the table below for a reconciliation of net income (loss) to adjusted net income.
As of December 31, 2025, Ligand had cash, cash equivalents and short-term investments of $733.5 million.
Full Year 2025 Financial Results
Total revenues and income for the full year 2025 were $268.1 million, compared with $167.1 million for the full year 2024. Royalties for the full year 2025 were $161.0 million, compared with $108.8 million for the full year 2024, with the increase primarily attributable to increases in sales of Travere Therapeutics’ Filspari, Recordati’s Qarziba, and Merck’s Capvaxive and Ohtuvayre. Captisol sales were $40.2 million for full year 2025, compared with $30.9 million for the full year 2024, with the increase due to the timing of customer orders. Contract revenue and income was $66.9 million for the full year 2025, compared with $27.5 million for the full year 2024, with income from the Pelthos Therapeutics spin-out transaction being the main driver of the increase, partially offset by 2024 Ohtuvayre approval and commercial launch milestone payments.
Cost of Captisol was $14.5 million for the full year 2025, compared with $11.1 million for the full year 2024, with the increase due to higher Captisol sales. Amortization of intangibles was $32.7 million for the full year 2025, compared with $33.0 million for the full year 2024. Research and development expenses were $81.2 million for the full year 2025, compared with $21.4 million for the full year 2024, with the increase primarily attributable to a $44.3 million one-time charge in connection with the royalty financing agreement with Castle Creek Biosciences to fund the Phase 3 clinical study of D-Fi (FCX-007) and a $17.8 million one-time charge in connection with the royalty financing agreement with Orchestra BioMed to fund its late-stage partnered cardiology programs, which were accounted for as research and development funding arrangements under ASC 730-20. General and administrative expenses were $92.4 million for the full year 2025, compared with $78.7 million for the full year 2024. This increase was primarily driven by higher stock-based compensation expenses associated with the vesting of performance stock unit awards, investments made in scaling the Company’s business development function and Pelthos transaction costs. Financial royalty asset impairment was $6.2 million for the full year 2025 related to the Agenus returned partnered programs, compared to $30.6 million for the full year 2024, primarily due to the impairment loss related to the discontinuation of Takeda’s soticlestat program. There was no fair value adjustment to partner program derivatives for the full year 2025. Fair value adjustment to partner program derivatives was $15.1 million for the full year 2024 primarily due to the discontinued development of certain Agenus partnered programs.
GAAP net income was $124.5 million, or $6.13 per diluted share, for the full year 2025, compared to a net loss of $4.0 million, or $0.22 per share, for the full year 2024. Core adjusted net income for the full year 2025 was $165.1 million, or $8.13 per diluted share, compared with core adjusted net income of $108.5 million, or $5.74 per diluted share, for the full year 2024. The increase in core adjusted net income in 2025 was driven primarily by increases in royalty revenue and Zelsuvmi out-license income. Core adjusted net income represents a non-GAAP financial measure. See the table below for a reconciliation of net income (loss) to core adjusted net income.
2026 Financial Guidance
Ligand is reaffirming its 2026 financial guidance introduced at the Company’s Investor Day on December 9, 2025. The Company continues to expect adjusted earnings per diluted share1 of approximately $8.00 to $9.00. Ligand also expects 2026 royalty revenue to be in the range of $200 million to $225 million, revenue from sales of Captisol to be in the range of $35 million to $40 million and contract revenue to be in the range of $10 million to $20 million, resulting in total revenue of $245 million to $285 million.
Fourth Quarter 2025 and Recent Business Highlights
Ohtuvayre
•On January 27, 2026, Nuance Pharma announced that the National Medical Products Administration (NMPA) of China has officially accepted for review the New Drug Application (NDA) for Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease.
Filspari

•On November 26, 2025, Renalys Pharma, Inc., now Chugai Pharmaceuticals, announced positive topline results from its Phase 3 clinical study of sparsentan, an orally administered dual endothelin and angiotensin II receptor antagonist, in Japanese patients with IgA nephropathy (IgAN). Based on these results, Chugai plans to submit a NDA in Japan in 2026.
•On January 13, 2026, Travere announced the U.S. Food and Drug Administration (FDA) extended the review timeline of its supplemental New Drug Application (sNDA) for Filspari in focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target action date is April 13, 2026.
•On February 19, 2026, Travere announced total U.S. Filspari net product sales for the fourth quarter of 2025 to be $103 million, representing 108% growth compared to the prior year period. U.S. Filspari new patient start forms reached an all time high of 908 in the fourth quarter of 2025.
Qtorin Rapamycin
•On December 15, 2025, Palvella announced positive topline results from its Phase 2 TOIVA study of Qtorin 3.9% rapamycin anhydrous gel for the treatment of cutaneous venous malformations (cutaneous VMs). The trial achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints, including dynamic change endpoints and static severity endpoints and was well-tolerated, with no drug-related serious adverse events reported.
•On December 16, 2025, Palvella announced that the FDA granted Fast Track Designation to Qtorin rapamycin for the treatment of angiokeratomas. Angiokeratomas are characterized by lymphatic-derived skin lesions that can persistently bleed and significantly impact quality of life. There are currently no FDA-approved therapies in existence for the estimated 50,000 diagnosed U.S. patients. With Fast Track designation, Qtorin rapamycin for angiokeratomas may be eligible for Accelerated Approval and Priority Review in the future, if applicable criteria are met. Palvella plans to initiate a Phase 2 trial evaluating Qtorin rapamycin for clinically significant angiokeratomas in the second half of 2026.
•On January 9, 2026, Palvella provided a corporate update and 2026 outlook providing the following Qtorin rapamycin updates:
◦Palvella is accelerating U.S. launch readiness for Qtorin rapamycin for microcystic LMs which has the potential to become the first FDA-approved therapy and a first-line, standard-of-care treatment for this serious, lifelong disease affecting an estimated more than 30,000 diagnosed patients in the U.S.
◦Following positive Phase 2 results for Qtorin rapamycin for the treatment of cutaneous venous malformations announced in December 2025, requested a Preliminary Breakthrough Therapy Designation Advice meeting with the FDA, anticipated in the first quarter of 2026
•On February 24, 2026, Palvella announced positive topline results from its Phase 3 SELVA study of Qtorin rapamycin for the treatment of microcystic LMs. The Phase 3 trial met its primary endpoint with statistically significant improvement on the Microcystic LM Investigator Global Assessment and achieved statistical significance on its pre-specified key secondary endpoint and all four secondary efficacy endpoints. Qtorin rapamycin was well tolerated, with no drug-related serious adverse events reported and systemic rapamycin levels below 2 ng/mL at all timepoints for all participants. 98% of participants who completed the efficacy evaluation period elected to continue to receive Qtorin rapamycin in the ongoing treatment extension period. An NDA submission is planned for the second half of 2026.
Tzield/Teizeild
•On October 20, 2025, Sanofi announced the FDA accepted for expedited review the sBLA for Tzield to delay the progression of stage 3 type 1 diabetes (T1D) in adults and pediatric patients eight years of age and older recently diagnosed with stage 3 T1D. The FDA nominated Tzield for the Commissioner’s National Priority Voucher (CNPV) pilot program based on its potential to address a large unmet medical need. Sanofi expects a regulatory decision from the FDA in the first half of 2026.

•On January 5, 2026, Sanofi announced the FDA accepted for priority review the sBLA for Tzield to expand the current age indication from eight years and above, to as young as one year old and above to delay the onset of stage 3 T1D in patients diagnosed with stage 2 T1D. The sBLA is supported by the positive interim one-year data from the ongoing PETITE-T1D phase 4 study. The target action date for the FDA decision is April 29, 2026.
•On January 12, 2026, Sanofi announced the European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and older with stage 2 T1D. The approval is based on positive results from the TN-10 phase 2 study demonstrating that Teizeild delayed the onset of stage 3 T1D by a median of two years compared to placebo.
Other Program Updates
•On November 6, 2025, UroGen announced it made the strategic decision to discontinue development of UGN-301 (zalifrelimab) following completion of its Phase 1 dose escalation study and provided notice of termination to Agenus. While the study confirmed proof of concept, UGN-301’s overall clinical profile did not meet UroGen’s internal benchmarks for advancement to Phase 2.
•On November 7, 2025, Pelthos Therapeutics announced it acquired U.S. commercialization rights to Xepi (ozenoxacin) Cream, 1%. Xepi is a non-fluorinated quinolone antimicrobial indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients two months of age and older. Ligand is entitled to a low single-digit royalty on net sales of Xepi.
•On December 3, 2025, Gilead announced that it provided 1,200 vials of its antiviral therapy, remdesivir, to the Ministry of Health of Ethiopia to help combat the country’s first outbreak of Marburg Virus Disease (MVD). Marburg Virus Disease is a rare but severe hemorrhagic fever with high mortality rates, requiring swift intervention to prevent further spread. Gilead is working closely with the Ministry of Health of Ethiopia to provide remdesivir for emergency use. Remdesivir is Captisol enabled and Ligand is entitled to revenue from material sales of Captisol for the use of remdesivir.
•On December 18, 2025, Athira, now Leona Bio, announced that it acquired the development and commercialization rights to lasofoxifene, a promising clinical asset in a potentially registrational Phase 3 trial for the treatment of metastatic breast cancer. The ongoing Phase 3 ELAINE-3 clinical trial is greater than 50% enrolled with data expected in mid-2027. Ligand is entitled to a tiered 6-10% royalty on future net sales of lasofoxifene.
•On January 15, 2026, Agenus announced the closing of its $141 million strategic collaboration with Zydus. The agreement is designed to accelerate global development and potential commercialization of Agenus’ botensilimab and balstilimab (BOT/BAL) immunotherapy combination program. The collaboration provides Agenus with strategic capital and committed, long-term biologics manufacturing capacity in the United States to support BOT/BAL clinical development, authorized early access pathways, and commercial supply preparation. Agenus is initiating a global Phase 3 registrational trial evaluating BOT/BAL in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. The trial will enroll approximately 800 patients across more than 100 sites in Canada, France, Australia, and New Zealand.
Adjusted Financial Measures
Ligand reports adjusted net income from continuing operations, adjusted net income per diluted share and adjusted earnings per diluted share in addition to, and not as a substitute for, financial measures calculated in accordance with GAAP, and does not consider such measures superior to GAAP results. The Company also reports "core" versions of these measures, which exclude any realized gains from the sale of Viking Therapeutics common stock.
Adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to evaluate management performance and determine certain elements of management compensation. GAAP results include items such as share‑based compensation expense, amortization of acquisition‑related and intangible assets, changes in contingent liabilities, mark‑to‑market adjustments on investments in public companies, transaction‑related costs and related tax effects, which are excluded from adjusted results and are detailed in the reconciliations included at the end of this press release.

A reconciliation of forward‑looking non‑GAAP adjusted earnings per diluted share to the most directly comparable GAAP measures was provided in the Company’s Investor Day presentation on December 9, 2025, which is available on the Company’s investor relations website. The Company is reiterating that guidance in this release and has not updated the underlying assumptions reflected in that reconciliation.

Conference Call
Ligand management will host a conference call and webcast today beginning at 8:30 a.m. Eastern time (5:30 a.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 715-9871 (North America toll-free number) using the conference ID 3661098. International participants outside of Canada may use the toll number (646) 307-1963 and use the same conference ID. To participate via live or replay webcast, a link is available at www.ligand.com.

(Press release, Ligand, FEB 26, 2026, View Source [SID1234663082])

On February 26, 2026 Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, reported the signing of a term sheet for a strategic asset acquisition with Celyn Therapeutics, Inc., a privately held biotechnology company backed by OrbiMed and Torrey Pines Investment. Under the proposed terms of the agreement, Kairos Pharma will acquire worldwide rights to two highly differentiated, clinical-stage oncology assets targeting non-small cell lung cancer (NSCLC): CL-273, a pre-IND, reversible, wild-type-sparing pan-EGFR inhibitor, and CL-741, a Phase 1-ready, orally available type IIb c-MET kinase inhibitor.

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John Yu, M.D., Kairos Pharma Chief Executive Officer, commented: "We anticipate this acquisition will significantly expand our oncology pipeline with late-preclinical and Phase 1-ready assets in a multi-billion dollar market with substantial unmet medical needs. With this acquisition, if completed, we will strengthen our armamentarium to reverse oncology drug resistance – by implementing therapeutics that specifically target resistance mutations that arise from targeting the EGFR receptor. Importantly, our established clinical consortia on the West Coast, anchored at Cedars-Sinai Medical Center in Los Angeles, provides us with the clinical infrastructure and expertise to rapidly initiate and execute Phase 1 and Phase 2 studies for both compounds."

Kairos Pharma believes the scientific rationale for combining a pan-EGFR inhibitor with a c-MET inhibitor in non-small cell lung cancer as demonstrated with these two assets is compelling and well-validated clinically. MET amplification represents one of the most important resistance mechanisms in EGFR-mutant NSCLC, and the ability to address both pathways with highly selective, brain-penetrant molecules represents a significant therapeutic advance. The Company anticipates that CL-273’s wild-type-sparing profile and broad coverage of EGFR mutations, combined with CL-741’s potent and selective c-MET inhibition, upon acquisition, will position it to develop best-in-class monotherapies as well as a differentiated combination regimen. Mechanistically, dual inhibition of EGFR and MET pathways can overcome compensatory signaling that drives resistance, deepens tumor responses, and extends progression-free survival in this difficult-to-treat patient population.

Kinase inhibitors for cancer treatment were estimated to be valued at $60.7B in 2025. Of these, EGFR inhibitors represented 32.5% of the market in 2025 (Future Market Insights).

CL-273, developed using a proprietary AI-driven drug discovery platform, targets the EGFR mutated lung cancer treatment, a market valued at $16.2B in 2026 (Future Market Insights). EGFR mutations are present in approximately 10-15% of NSCLC cases in Western populations and up to 50% in Asian populations (CoherentMI), creating a substantial addressable patient population for targeted therapies.

CL-741 addresses the cMet inhibitor market which is experiencing rapid growth, valued at more than $2B and projected to reach over $10B by 2030 with a CAGR in excess of 17% (Biospace). The c-MET metastatic NSCLC market represents a high-value niche with significant unmet medical needs, with c-MET amplification being a critical resistance mechanism for EGFR-targeted therapies. C-MET alterations, including MET exon 14 skipping mutations and MET amplification, is a driver of multiple cancer types inclusive of gastric, liver, and renal cancer.

"Our proprietary AI-driven drug design platform has enabled the discovery of a highly efficacious, wild-type-sparing, pan-mutant EGFR inhibitor. This molecule offers a 4-to-5-fold broader safety margin than current competitive inhibitors," stated Nikolay Savchuk, Ph.D., CEO of Celyn Therapeutics. "By partnering with Kairos Pharma and leveraging their clinical consortia at Cedars-Sinai Medical Center, we are positioned to rapidly advance CL-273 and CL-741. This collaboration combines Kairos’s operational expertise with our innovative pipeline to create an optimal pathway for patients fighting EGFR-mutant and c-MET-driven lung cancers."

Clinical studies have demonstrated that combination treatment with EGFR and MET inhibitors for EGFR-mutant, MET-amplified NSCLC patients is able to achieve progression-free survival of approximately 7 months, representing a significant advance over single-agent therapy (SAVANNAH trial).

CL-273 is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor specifically engineered for EGFR-mutant non-small cell lung cancer (NSCLC). Preclinical data demonstrate that CL-273 maintains broad-spectrum activity against classical EGFR mutations including Exon 19 and 21 deletions and Exon 20 insertions, atypical mutations, and resistance-associated variants that bypass currently approved tyrosine kinase inhibitors (TKIs).

A defining feature of CL-273 is its exceptional selectivity index. By sparing wild-type EGFR, studies to date have shown CL-273 offers a 4–5 fold wider therapeutic window, suggesting significantly improved safety and tolerability over existing therapies. Designed for high brain and lung permeability to address metastatic disease, CL-273 possesses favorable ADME properties and has successfully completed GLP toxicology studies. The program is currently pre-IND, with first-in-human clinical trials projected to commence in 2026.

CL-741 is an orally available, small-molecule, type IIb c-MET kinase inhibitor designed to be highly selective for c-MET with broad coverage of activating and acquired resistance mutations in solid tumors. The compound was discovered as a drug-like lead with potent activity across multiple c-MET resistance mutants and is being developed for c-MET-driven advanced solid tumors, with a primary focus on non-small cell lung cancers harboring MET exon 14 skipping alterations and MET amplification.

The acquisition of both CL-273 and CL-741, if the acquisition is successfully completed, are anticipated to enable Kairos Pharma to pursue a differentiated dual-target strategy addressing both primary EGFR mutations and MET-mediated resistance mechanisms. MET amplification is one of the most common mechanisms of acquired resistance to EGFR TKIs.

Developing CL-273 and CL-741 together provides a rational combination therapy approach for EGFR-mutant NSCLC patients who either harbor baseline MET amplification/overexpression or acquire MET-driven resistance on EGFR-TKI therapy. Combined EGFR and MET inhibition has already demonstrated meaningful clinical response rates and survival benefit with other agents in this setting. Pairing CL-273 with CL-741 could deepen and prolong responses, reduce outgrowth of MET-mediated escape clones, and potentially expand the addressable population of MET-dependent, EGFR-mutant tumors.

(Press release, Kairos Pharma, FEB 26, 2026, View Source [SID1234663081])

On February 26, 2026 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies, reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

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"The past year marked a period of significant execution and progress for Janux as we continued to translate the promise of our tumor-activated platform into meaningful clinical and strategic advances. Recent JANX007 clinical results demonstrate clinical activity and a consistent and predictable safety profile in mCRPC and support continued advancement in taxane-naïve patients as well as other expansion cohorts," said David Campbell, Ph.D., President and CEO of Janux.

"In early 2026, we announced a collaboration with Bristol Myers Squibb that provides near-term capital and further validates the potential of our platform. We also continue to strengthen our team to support the next phase of clinical and pipeline growth. With additional product candidates entering the clinic in 2026, we believe Janux is well positioned to execute on our clinical strategy and continue to build long-term value for patients and shareholders."

BUSINESS HIGHLIGHTS AND RECENT DEVELOPMENTS:

Clinical & Pipeline Progress

•
Janux presented updated interim Phase 1 data for JANX007 (PSMA-TRACTr) in December 2025. As of the October 15, 2025 data cutoff, 109 patients had been treated across Phase 1 cohorts:
•
Durable clinical activity was observed across both once-weekly (QW) and every-two-week (Q2W) cohorts, with median radiographic progression-free survival (rPFS) ranging from 7.9 to 8.9 months. The rPFS in the Q2W cohort compared favorably to the QW expansion group.
•
Data demonstrated high prostate-specific antigen (PSA) response rates including deep PSA declines. Anti-tumor activity was observed, with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients.

•
Ongoing dose optimization of JANX007 monotherapy is focused on taxane-naïve mCRPC.
•
The Phase 1 study also includes expansion cohorts evaluating JANX007 in combination with darolutamide, an androgen receptor pathway inhibitor, to further characterize safety and clinical activity in taxane-naïve mCRPC.
•
Additional expansion cohorts are evaluating JANX007 monotherapy in patients with PARP inhibitor-refractory mCRPC, supporting assessment of activity in a high-unmet-need population.
•
JANX008 (EGFR-TRACTr) continues to enroll in its Phase 1 clinical trial in a defined group of solid tumors, with expansion cohorts underway to further characterize safety and clinical activity.
•
JANX011 (CD19-ARM) is actively enrolling its Phase 1 clinical trial in healthy volunteers.

Strategic Collaboration

•
In January 2026, Janux announced a collaboration and exclusive worldwide license agreement with Bristol Myers Squibb to develop a novel tumor-activated therapeutic targeting a validated solid tumor antigen.
•
Under the terms of the agreement, Janux is eligible to receive $50 million in upfront and near-term milestone payments, with the potential for additional development, regulatory and commercial milestones totaling approximately $800 million, as well as tiered royalties on global product sales, if successful.
•
Janux will lead preclinical development through IND submission, with Bristol Myers Squibb assuming responsibility for subsequent clinical development and global commercialization.

Corporate & Leadership

•
Janux recently announced the appointment of William Go, M.D., Ph.D. as Chief Medical Officer, strengthening the Company’s clinical leadership as additional programs enter the clinic in 2026 and progress toward later-stage development.

Upcoming Milestones

•
The Company expects to provide additional clinical data for JANX007 in 2026 or present these data at a future medical meeting.
•
The Company expects to provide additional clinical update for JANX008 in 2026.
•
The Company expects to announce initial clinical update from the Phase 1 study of JANX011 in healthy volunteers by year-end 2026.

FOURTH QUARTER AND FULL YEAR 2025 FINANCIAL RESULTS:

•
Cash and cash equivalents and short-term investments: As of December 31, 2025, Janux reported cash and cash equivalents and short-term investments of $966.6 million, compared to $1.03 billion on December 31, 2024.
•
Research and development expenses: Research and development expenses were $31.5 million for the quarter and $125.9 million for the year ended December 31, 2025, compared to $20.8 million and $68.4 million for the same quarter and year in 2024.

•
General and administrative expenses: General and administrative expenses were $10.9 million for the quarter and $41.8 million for the year ended December 31, 2025, compared to $8.2 million and $41.0 million for the same quarter and year in 2024.
•
Net loss: Net loss was $31.9 million for the quarter and $113.6 million for the year ended December 31, 2025, compared to $20.2 million and $69.0 million for the same quarter and year in 2024.

(Press release, Janux Therapeutics, FEB 26, 2026, View Source [SID1234663080])

On February 26, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that senior leadership plans to present at the following upcoming conferences:

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TD Cowen 46th Annual Healthcare Conference
Presentation: March 2, 2026 at 9:50 a.m. ET
Boston, MA
Barclays 28th Annual Global Healthcare Conference
Fireside Chat: March 11, 2026 at 9:30 a.m. ET
Miami, FL
The live and archived webcasts will be available at View Source

(Press release, Iovance Biotherapeutics, FEB 26, 2026, View Source [SID1234663079])

On February 26, 2026 Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, reported business updates and financial results for the fourth quarter and year ended December 31, 2025.

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"2025 was a time of accomplishment and resiliency for Intellia as we presented encouraging longer term Phase 1/2 clinical data for both lonvo-z and nex-z, rapidly enrolled patients in our three Phase 3 trials, commenced activities to prepare for a potential lonvo-z launch in HAE and responded to the clinical holds on our nex-z Phase 3 trials late in the year," said Intellia President and Chief Executive Officer John Leonard, M.D. "We expect the year ahead to be a pivotal one, highlighted by our topline Phase 3 data and planned BLA submission for lonvo-z, which has the potential to transform the HAE treatment paradigm by freeing most patients from both their attacks and chronic therapy. Additionally, we are focused on resuming our forward momentum with nex-z by completing patient enrollment in MAGNITUDE-2 and resolving the clinical hold on MAGNITUDE."

Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)

Lonvo-z is a wholly owned, investigational in vivo CRISPR-based therapeutic candidate designed to inactivate the KLKB1 gene in the liver, drive consistent, deep and potentially lifelong reduction in kallikrein levels, and dramatically reduce or eliminate HAE attacks via a one-time treatment.

In the fourth quarter at the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting, Intellia presented positive clinical data from a pooled analysis of all patients who received a 50 milligram (mg) dose of lonvo-z in the company’s ongoing Phase 1/2 clinical trial in patients with HAE. Observations from the analysis included durable reductions in plasma kallikrein in all patients at month 24, a high percentage of patients achieving prolonged attack-free status (for at least seven months and up to 32 months for patients with the longest follow-up) and a well-tolerated safety profile for lonvo-z.
Intellia sponsored a blinded market research study in late 2025 with 104 U.S. HAE patients and 151 U.S. HAE treating physicians. After reviewing a blinded target product profile aligned with lonvo-z’s Phase 1/2 clinical data, 99% of patients said they would be at least somewhat likely – and 64% said they would be extremely or very likely – to take lonvo-z if prescribed. Additionally, 92% of healthcare providers indicated they would prescribe a product with this profile, estimating they would prescribe it to 54% of the approximately 4,000 patients with HAE under their care.
This weekend, the company will present four posters at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place February 27 – March 2 in Philadelphia, Pennsylvania (poster numbers 003, 005, 061 and 716). The presentations include three-year follow-up data from patients receiving a one-time 50 mg dose of lonvo-z and new survey findings assessing the chronic treatment burden and unmet needs among patients living with HAE.
Dosing in the global HAELO Phase 3 clinical trial was initiated in January 2025 and was completed in September 2025, with 80 patients enrolled. Intellia expects to report HAELO topline data by mid-2026 and, if the data are supportive, submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the second half of 2026.
To prepare for a planned launch in the first half of 2027, the company has expanded its field medical team, strengthened engagement with treating physicians and patient advocacy groups, initiated its payer engagements and advanced its launch strategy. In 2026, the company intends to build its field sales and reimbursement teams, finalize its distribution models, identify U.S. treatment centers and advance its pricing and access planning strategy.
Nexiguran Ziclumeran (Nex-z) for Transthyretin (ATTR) Amyloidosis

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

In the fourth quarter at the American Heart Association (AHA) Scientific Sessions, Intellia presented positive follow-up data from the ongoing Phase 1 clinical trial of nex-z in patients with ATTR amyloidosis with cardiomyopathy (ATTR-CM). Observations from these longer-term data included consistent and durable reductions in serum TTR through up to three years of follow up, stability or improvement in multiple markers of cardiomyopathy for most patients and encouraging mortality data.
As previously reported, on October 29, 2025, the FDA placed a clinical hold on the Investigational New Drug (IND) applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials for patients with ATTR-CM and hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), respectively.
On January 27, 2026, the company announced the FDA lifted the clinical hold on the IND for MAGNITUDE-2. The company is in the process of resuming MAGNITUDE-2 enrollment.
Intellia’s engagement with FDA is ongoing regarding the clinical hold on the IND for the MAGNITUDE Phase 3 clinical trial of nex-z for patients with ATTR-CM. The company plans to provide an update once alignment has been achieved on the path forward for this program.
Fourth Quarter and Full-Year 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $605.1 million as of December 31, 2025, compared to $861.7 million as of December 31, 2024. The company’s cash, cash equivalents and marketable securities as of December 31, 2025 are expected to fund operations into the second half of 2027 and through lonvo-z’s anticipated U.S. commercial launch for HAE.

Collaboration Revenue: Collaboration revenue was $23.0 million for the fourth quarter of 2025, compared to $12.9 million for the fourth quarter of 2024. The increase was primarily driven by the recognition of $9.0 million in revenue related to the termination of the license and collaboration agreement with SparingVision SAS and an increase in cost reimbursements related to the company’s collaboration with Regeneron.
R&D Expenses: Research and development (R&D) expenses were $88.7 million for the fourth quarter of 2025, compared to $116.9 million for the fourth quarter of 2024. The $28.2 million decrease was primarily driven by employee-related expenses, stock-based compensation, research materials and contracted services, partially offset by an increase in facility-related expenses as well as clinical trial expenses related to nex-z. Stock-based compensation expense included in R&D expenses was $10.5 million for the fourth quarter of 2025.
G&A Expenses: General and administrative (G&A) expenses were $33.1 million for the fourth quarter of 2025, compared to $32.4 million for the fourth quarter of 2024. Stock-based compensation expense included in G&A expenses was $6.2 million for the fourth quarter of 2025.
Net Loss: Net loss was $95.8 million for the fourth quarter of 2025, compared to $128.9 million for the fourth quarter of 2024.

Conference Call Information
The company will host a conference call and webcast today at 8:00 a.m. ET to discuss recent updates and the company’s fourth quarter and full-year 2025 financial results. To join the webcast, please visit the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com. To join by phone, U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726 approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call. A replay of the webcast will be available for approximately 90 days.

(Press release, Intellia, FEB 26, 2026, View Source [SID1234663078])